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Early Warning Score Qualitative Study
Thousands of hospitals have recently implemented rapid response systems (RRSs), attempting to reduce mortality outside of intensive care units (ICUs).[1, 2] These systems have 2 clinical components, a response (efferent) arm and an identification (afferent) arm.[3] The response arm is usually composed of a medical emergency team (MET) that responds to calls for urgent assistance. The identification arm includes tools to help clinicians recognize patients who require assistance from the MET. In many hospitals, the identification arm includes an early warning score (EWS). In pediatric patients, EWSs assign point values to vital signs that fall outside of age‐based ranges, among other clinical observations. They then generate a total score intended to help clinicians identify patients exhibiting early signs of deterioration.[4, 5, 6, 7, 8, 9, 10, 11]
When experimentally applied to vital sign datasets, the test characteristics of pediatric EWSs in detecting clinical deterioration are highly variable across studies, with major tradeoffs between sensitivity, specificity, and predictive values that differ by outcome, score, and cut‐point (Table 1). This reflects the difficulty of identifying deteriorating patients using only objective measures. However, in real‐world settings, EWSs are used by clinicians in conjunction with their clinical judgment. We hypothesized that EWSs have benefits that extend beyond their ability to predict deterioration, and thus have value not demonstrated by test characteristics alone. In order to further explore this issue, we aimed to qualitatively evaluate mechanisms beyond their statistical ability to predict deterioration by which physicians and nurses use EWSs to support their decision making.
| Score and Citation | Outcome Measure | Score Cut‐point | Sens | Spec | PPV | NPV |
|---|---|---|---|---|---|---|
| ||||||
| Brighton Paediatric Early Warning Score[5] | RRT or code blue call | 4 | 86% | NR | NR | NR |
| Bristol Paediatric Early Warning Tool[6, 11] | Escalation to higher level of care | 1 | ER | ER | 63% | NR |
| Cardiff and Vale Paediatric Early Warning System[7] | Respiratory or cardiac arrest, HDU/ICU admission, or death | 1 | 89% | 64% | 2% | >99% |
| Bedside Paediatric Early Warning System score, original version[8] | Code blue call | 5 | 78% | 95% | 4% | NR |
| Bedside Paediatric Early Warning System score, simplified version[9] | Urgent ICU admission without a code blue call | 8 | 82% | 93% | NR | NR |
| Bedside Paediatric Early Warning System score, simplified version[10] | Urgent ICU admission or code blue call | 7 | 64% | 91% | 9% | NR |
METHODS
Overview
As 1 component of a larger study, we conducted semistructured interviews with nurses and physicians at The Children's Hospital of Philadelphia (CHOP) between May and October 2011. In separate subprojects using the same participants, the larger study also aimed to identify residual barriers to calling for urgent assistance and assess the role of families in the recognition of deterioration and MET activation.
Setting
The Children's Hospital of Philadelphia is an urban, tertiary‐care pediatric hospital with 504 beds. Surgical patients hospitalized outside of ICUs are cared for by surgeons and surgical nurses without pediatrician co‐management. Implementation of a RRS was prompted by serious safety events in which clinical deterioration was either not recognized or was recognized and not escalated. Prior to RRS implementation, a code blue team could be activated for patients in immediate need of resuscitation, or, for less‐urgent needs, a pediatric ICU fellow could be paged by physicians for informal consults.
A multidisciplinary team developed and pilot‐tested the RRS, then implemented it hospital‐wide in February 2010. Representing an aspect of a multipronged approach to improve safety culture, the RRS consisted of (1) an EWS based upon Parshuram's Bedside Paediatric Early Warning System,[8, 9, 10] calculated by hand on a paper form (see online supplementary content) at the same frequency as vital signs (usually every 4 hours), and (2) a 30‐minute response MET available for activation by any clinician for any concern, 24 hours per day, 7 days per week. Escalation guidelines included a prompt to activate the MET for a score that increased to the red zone (9). For concerns that could not wait 30 minutes, any hospital employee could activate the immediate‐response code blue team.
Utilization of the RRS at CHOP is high, with 23 calls to the MET per day and a combined MET/code‐blue team call rate of 27.8 per 1000 admissions.[12] Previously reported pediatric call rates range from 2.8 to 44.0, with a median of 9.6 per 1000 admissions across 6 studies.[13, 14, 15, 16, 17, 18, 19] Since implementation, there has been a statistically significant net reduction in critical deterioration events (unpublished data).
Participants
We recruited nurses and physicians who had recently cared for children age 18 years on general medical or surgical wards with false‐negative or false‐positive EWSs (instances when the score failed to predict deterioration). Recruitment ceased when we reached thematic data saturation (a qualitative research term for the point at which no new themes emerge with additional interviews).[20]
Data Collection
Through a detailed review of the relevant literature and consultation with experts, we developed a semistructured interview guide (see online supplementary content) to elicit nurses' and physicians' viewpoints regarding the mechanisms by which they use EWSs to support their decision making.
Experienced qualitative research scientists (F.K.B. and J.H.H.) trained 2 study interviewers (B.P. and K.M.T.). In order to minimize social‐desirability bias, the interviewers were not clinicians and were not involved in RRS operations. Each interview was recorded, professionally transcribed, and imported into NVivo 8.0 software for analysis (QSR International, Melbourne, Australia).
Data Analysis
We coded the interviews inductively, without using a predetermined set of themes. This approach is known as grounded theory methodology.[21] Two team members coded each interview independently. They then reviewed their coding together and discussed discrepancies until reaching consensus. In weekly meetings while the interviews were ongoing, we compared newly collected data with themes that had previously emerged in order to guide further thematic development and refinement (the constant comparative method).[22] After all of the interviews were completed and consensus had been reached for each individual interview, the study team convened a series of additional meetings to further refine and finalize the themes.
Human Subjects
The CHOP Institutional Review Board approved this study. All participants provided written informed consent.
RESULTS
Participants
We recruited 27 nurses and 30 physicians before reaching thematic data saturation. Because surgical patients are underrepresented relative to medical patients among the population with false‐positive and false‐negative scores in our hospital, this included 3 randomly selected surgical nurses and 7 randomly selected surgical physicians recruited to ensure thematic data saturation for surgical settings. Characteristics of the participants are displayed in Table 2.
| Physicians (n=30) | Nurses (n=27) | |||
|---|---|---|---|---|
| ||||
| N | % | N | % | |
| Race | ||||
| Asian | 2 | 6.7 | 1 | 3.7 |
| Black | 0 | 0.0 | 2 | 7.4 |
| White | 26 | 86.7 | 22 | 81.5 |
| Prefer not to say | 1 | 3.3 | 1 | 3.7 |
| >1 race | 1 | 3.3 | 1 | 3.7 |
| Ethnicity | ||||
| Hispanic/Latino | 2 | 6.7 | 1 | 3.7 |
| Not Hispanic/Latino | 23 | 76.7 | 25 | 92.6 |
| Prefer not to say | 5 | 16.7 | 1 | 3.7 |
| Sex | ||||
| F | 16 | 53.3 | 25 | 92.6 |
| M | 14 | 46.7 | 2 | 7.4 |
| Practice setting | ||||
| Medical | 21 | 70.0 | 22 | 81.5 |
| Surgical | 9 | 30.0 | 5 | 18.5 |
| Among physicians only, experience level | ||||
| Intern | 7 | 23.3 | ||
| Senior resident | 7 | 23.3 | ||
| Attending physician | 16 | 53.3 | ||
| Among attending physicians only, no. of years practicing | ||||
| <5 | 8 | 50.0 | ||
| 5<10 | 3 | 18.8 | ||
| 10 | 5 | 31.3 | ||
| Among nurses only, no. of years practicing | ||||
| <1 | 5 | 18.5 | ||
| 1<2 | 5 | 18.5 | ||
| 2<5 | 9 | 33.3 | ||
| 5<10 | 4 | 14.8 | ||
| 10<20 | 1 | 3.7 | ||
| 20 | 3 | 11.1 | ||
| Recruitment method | ||||
| Cared for patient with false‐positive score | 10 | 33.3 | 14 | 51.9 |
| Cared for patient with false‐negative score | 13 | 43.3 | 10 | 37.0 |
| Randomly selected to ensure data saturation for surgical settings | 7 | 23.3 | 3 | 11.1 |
Thematic Analysis
We provide the final themes, associated subthemes, and representative quotations below, with additional supporting quotations in Table 3. Because CHOP's MET is named the Critical Assessment Team, the term CAT appears in some quotations.
|
| Theme 1: The EWS facilitates patient safety by alerting nurses and physicians to concerning vital sign changes and prompting them to think critically about the possibility of deterioration. |
| I think [the EWS] helps us to be focused and gives us definite criteria to look for if there is an issue or change. It hopefully gives us a head start if there is going to be a change. They have a way of tracking it with the different color‐coding system they use Like, Oh geez, the heart rate is a little bit higher, that changes the color from yellow to orange, then I have to let the charge nurse know because that is a change from where they were earlier it kind of organizes it, I feel like, from where it was before. (medical nurse with 23 years of experience) |
| I think for myself, as a new clinician, one of our main goals is to help judge sick versus not sick. So to have a concrete system for thinking about that is helpful. (medical intern) |
| I think [the EWS] can help put things together for us. When you are really busy, you don't always get to focus on a lot of details. It is like another red flag to say you might have not realized that the child's heart rates went up further, but now here's some evidence that they did. (medical senior resident) |
| I think that the ability to use the EWS to watch the progression of a patient over time is really helpful. I've had a few patients that have gotten sicker from a respiratory standpoint. We can have multiple on the floor at the same time, and what's nice is that sometimes nurses have been able to come to me and we can really see through the score that we are at the point where a higher level of care is needed, whereas, in the old system, without that, we would have had to essentially wait for true clinical decompensation before the ICU would have been involved. I think that does help to deliver better care. (medical senior resident) |
| Theme 2: The EWS provides less‐experienced nurses with helpful age‐based reference ranges for vital signs that they use when caring for hospitalized children. |
| Sometimes you just write down the vitals and maybe you are not really thinking, and then when you go to do the EWS you looked at the score and it's really off in their age range. It kind of gives you 1 more step to recognize that there's a problem. (medical nurse with <1 year of experience) |
| I see the role [of the EWS] more broadly as a guide of where your patient should fall with their vital signs according to their age. I think that has been the biggest help for me, to be able to visualize, I have a 3‐year‐old; this is where they should be for their respiratory rate or heart rate. I think it has been good to be able to see that they are falling within the range appropriate for their age. (surgical nurse with 9 years of experience) |
| Theme 3: The EWS provides concrete evidence of clinical changes in the form of a score. This empowers nurses to overcome escalation barriers and communicate their concerns, helping them take action to rescue their deteriorating patients. |
| The times when I think the EWS helped me out the most are when there is a little bit of disagreement maybe the doctors and the nurses don't see eye‐to‐eye on how the patient is doing and so a higher score can sometimes be a way to say, I know there is nothing specifically going on, but if you take a look at the EWSs they are turning up very significantly. That might be enough to at least get a second opinion on that patient or to start some kind of change in their care. (medical nurse with <1 year of experience) |
| If we have the EWS to back us up, we can use that to say, Look, I don't feel comfortable with this patient, the EWS is 7 and I know you are saying they are okay, but I would feel more comfortable calling. Having that protocol in place I feel like it really gives us a voice it kind of gives us the, not that they don't trust us, but if they say, Oh, I think the child is fine but if I tell them Look, their EWS is an 8 or a 9, they are like, Oh, okay. It is not just you freaking out. There is an issue. (medical nurse with 3 years of experience) |
| I think that since it has been instituted nursing is coming to residents more than they did beforehand Can you reassess this patient? Do you think that we should call CAT? I think that it encourages residents to reevaluate patients at times when things are changing, and quicker than it did without the system in place. (medical senior resident) |
| I view [the EWS] as a tool, like if I have someone managing my patients when I am on service this would be a good tool because it mandates the nurses to notify and it also mandates the residents to understand what's going on. I think that was done on purpose. (medical attending physician in practice for 8 years) |
| Theme 4: In some patients, the EWS may not help with decision‐making. These include patients who are very stable and have a low likelihood of deterioration, and patients with abnormal physiology at baseline who consistently have very high EWSs. |
| The patient I took care of in this situation was a really sick kid to begin with, and it wasn't so much they were concerned about his EWS because, unless there was a really serious event, he would probably be staying on our floor anyway in some cases we just have some really sick kids whose scores may constantly be high all the time, so it wouldn't be helpful for the doctors or us to really bring it up. (medical nurse with 1 year of experience) |
Of note, after interviewing 9 surgeons, we found that they were not very familiar with the EWS and had little to say either positively or negatively about the system. For example, when asked what they thought about the EWS, a surgical intern said, I have no idea. I don't have enough experience with it. This is probably the first time that I ever had anybody telling me that the system is in place. Therefore, surgeons did not contribute meaningfully to the themes below.
Theme 1: The EWS facilitates patient safety by alerting nurses and physicians to concerning vital sign changes and prompting them to think critically about the possibility of deterioration
Nurses and physicians frequently discussed the direct role of the EWS in revealing changes consistent with early signs of deterioration. A medical nurse with <1 year of experience said, The higher the number gets, the more it sets off a red flag to you to kind of keep an eye on certain things. They are just as important as taking a set of vitals. When asked if the EWS had ever helped to identify deterioration, a medical attending physician in practice for 5 years said, I think sometimes we will blow off, so to speak, certain things, but when you look at the numbers and you see a big [EWS] change versus if you were [just] looking at individual vital signs, then yeah, I think it has made a difference.
Nurses and physicians also discussed the role of the EWSs in prompting them to closely examine individual vital signs and think critically about whether or not a patient is exhibiting early signs of deterioration. A surgical nurse with <1 year of experience said, Sometimes I feel like if you want things to be okay you can kind of write them off, but when you have to write [the EWS] down it kind of jogs you to think, maybe something is going on or maybe someone else needs to know about this. A medical senior resident commented, I think it has alerted me earlier to changes in vital signs that I might not necessarily have known. I think there are nurses that use it and they see that there is an elevation and they call you about it. Then it makes me go back and look through and see what their vital signs are and if it happens in timewe only go through and look at everyone's vital signs about twice a dayit can be very helpful.
Theme 2: The EWS provides less‐experienced nurses with helpful age‐based reference ranges for vital signs that they use when caring for hospitalized children
Although this theme did not appear among physicians, nurses frequently noted that they referred to the scoring sheet as a reference for vital signs appropriate for hospitalized children. A surgical nurse with <1 year of experience said, In nursing school, I mostly dealt with adults. So, to figure out the different ranges for normal vital signs, it helps to have it listed on paper so I can see, 'Oh, I didn't realize that this 10‐year‐old's heart rate is higher than it should be.' A medical nurse with 14 years of experience cited the benefits for less‐experienced nurses, noting, [The EWS helps] newer nurses who don't know the ranges. Where it's Oh, my kid's blood pressure is 81 [mm Hg] over something, then they can look at their age and say, Oh, that is completely normal for a 2‐month‐old. But [before the EWS] there was nowhere to look to see the ranges. Unless you were [Pediatric Advanced Life Support] certified where you would know that stuff, there was a lot of anxiety related to vital signs.
Theme 3: The EWS provides concrete evidence of clinical changes in the form of a score. This empowers nurses to overcome escalation barriers and communicate their concerns, helping them take action to rescue their deteriorating patients
Nurses and physicians often described the role of the EWS as a source of objective evidence that a patient was exhibiting a concerning change. They shared the ways in which the EWS was used to convey concerns, noting most commonly that this was used as a communication tool by nurses to raise their concerns with physicians. A medical nurse with 23 years of experience said, [With the EWS] you feel like you have concrete evidence. It's not just a feeling [that] they are not looking as well as they were it feels scientific. Building upon this concept, a medical attending physician in practice for 2 years said, The EWS is a number that certainly gives people a sense of Here's the data behind why I am really coming to you and insisting on this. It is not calling and saying, I just have a bad feeling, it is, I have a bad feeling and his EWS has gone to a 9.
Theme 4: In some patients, the EWS may not help with decision making. These include patients who are very stable and have a low likelihood of deterioration, patients with abnormal physiology at baseline who consistently have very high EWSs, and patients experiencing neurologic deterioration
Nurses and physicians described some patient scenarios in which the EWS may not help with decision making. Discussing postoperative patients, a surgical nurse with 1 year of experience said, I love doing [the EWS] for some patients. I think it makes perfect sense. Then there are some patients [for whom] I am doing it just to do it because they are only here for 24 hours. They are completely stable. They never had 1 vital sign that was even a little bit off. It's kind of like we are just filling it out to fill it out. Commenting on patients at the other end of the spectrum, a medical attending physician in practice for 2 years said, [The EWS] can be a useful composite tool, but for specialty patients with abnormal baselines, I think it is much more a question of making sure you pay attention to the specific changes, whether it is the EWS or heart rate or vital signs or pain score or any of those things. A final area in which nurses and physicians identified weaknesses in the EWS surrounded neurologic deterioration. Specifically, nurses and physicians described experiences when the EWS increased minimally or not at all in patients with sudden seizures or concerning mental status changes that warranted escalation of care.
DISCUSSION
This study is the first to analyze viewpoints on the mechanisms by which EWSs impact decision making among physicians and nurses who had recently experienced score failures. Our study, performed in a children's hospital, builds upon the findings of related studies performed in hospitals that care primarily for adults.[23, 24, 25, 26, 27, 28] Andrews and Waterman found that nurses consider the utility of EWSs to extend beyond detecting deterioration by providing quantifiable evidence, packaged in the form of a score that improves communication between nurses and physicians.[23] Mackintosh and colleagues found that a RRS that included an EWS helped to formalize the way nurses and physicians understand deterioration, enable them to overcome hierarchical boundaries through structured discussions, and empower them to call for help.[24] In a quasi‐experimental study, McDonnell and colleagues found that an EWS improved self‐assessed knowledge, skills, and confidence of nursing staff to detect and manage deteriorating patients.[25] In addition, we describe novel findings, including the use of EWS parameters as reference ranges independent of the score, and specific situations when the EWS fails to support decision making. The weaknesses we identified could be used to drive EWS optimization for low‐risk patients who are stable as well as higher‐risk patients with abnormal baseline physiology and those at risk of neurologic deterioration.
This study has several limitations. Although the interviewers were not involved in RRS operations, it is possible that social desirability bias influenced responses. Next, we identified a knowledge gap among surgeons, and they contributed minimally to our findings. This is most likely because (1) surgical patients deteriorate on the wards less often than medical patients in our hospital, so surgeons are rarely presented with EWSs; (2) surgeons spend less time on the wards compared with medical physicians; and (3) surgical residents rotate in short blocks interspersed with rotations at other hospitals and may be less engaged in hospital safety initiatives.
CONCLUSIONS
Although EWSs perform only marginally well as statistical tools to predict clinical deterioration, nurses and physicians who recently experienced score failures described substantial benefits in using them to help identify deteriorating patients and transcend barriers to escalation of care by serving as objective communication tools. Combining an EWS with a clinician's judgment may result in a system better equipped to respond to deterioration than previous EWS studies focused on their test characteristics alone suggest. Future research should seek to compare and prospectively evaluate the clinical effectiveness of EWSs in real‐world settings.
Acknowledgments
Disclosures: This project was funded by the Pennsylvania Health Research Formula Fund Award (awarded to Keren and Bonafide) and the CHOP Nursing Research and Evidence‐Based Practice Award (awarded to Roberts). The funders did not influence the study design; the collection, analysis, or interpretation of data; the writing of the report; or the decision to submit the article for publication. The authors have no other conflicts to report.
- Institute for Healthcare Improvement. Overview of the Institute for Healthcare Improvement Five Million Lives Campaign. Available at: http://www.ihi.org/offerings/Initiatives/PastStrategicInitiatives/5MillionLivesCampaign/Pages/default.aspx. Accessed June 21, 2012.
- UK National Institute for Health and Clinical Excellence (NICE). Acutely Ill Patients in Hospital: Recognition of and Response to Acute Illness in Adults in Hospital. Available at: http://publications.nice.org.uk/acutely‐ill‐patients‐in‐hospital‐cg50. Published July 2007. Accessed June 21, 2012.
- , , , et al. Findings of the first consensus conference on medical emergency teams. Crit Care Med. 2006; 34(9):2463–2478.
- . Detecting and managing deterioration in children. Paediatr Nurs. 2005;17(1):32–35.
- , , , , , . Sensitivity of the Pediatric Early Warning Score to identify patient deterioration. Pediatrics. 2010;125(4):e763–e769.
- , , . Promoting care for acutely ill children—development and evaluation of a paediatric early warning tool. Intensive Crit Care Nurs. 2006;22(2):73–81.
- , , , . Prospective cohort study to test the predictability of the Cardiff and Vale paediatric early warning system. Arch Dis Child. 2009;94(8):602–606.
- , , . The Pediatric Early Warning System Score: a severity of illness score to predict urgent medical need in hospitalized children. J Crit Care. 2006;21(3):271–278.
- , , . Development and initial validation of the Bedside Paediatric Early Warning System score. Crit Care. 2009;13(4):R135.
- , , , et al. Multi‐centre validation of the Bedside Paediatric Early Warning System Score: a severity of illness score to detect evolving critical illness in hospitalized children. Crit Care. 2011;15(4):R184.
- , . Evaluation of a paediatric early warning tool—claims unsubstantiated. Intensive Crit Care Nurs. 2006;22(6):315–316.
- , , , et al. Development of a pragmatic measure for evaluating and optimizing rapid response systems. Pediatrics. 2012;129(4):e874–e881.
- , , , et al. Implementation of a multicenter rapid response system in pediatric academic hospitals is effective. Pediatrics. 2011;128(1):72–78.
- , , , , . Rapid response teams: a systematic review and meta‐analysis. Arch Intern Med. 2010;170(1):18–26.
- , , , et al. Implementation of a medical emergency team in a large pediatric teaching hospital prevents respiratory and cardiopulmonary arrests outside the intensive care unit. Pediatr Crit Care Med. 2007;8(3):236–246.
- , , , et al. Transition from a traditional code team to a medical emergency team and categorization of cardiopulmonary arrests in a children's center. Arch Pediatr Adolesc Med. 2008;162(2):117–122.
- , , , et al. Effect of a rapid response team on hospital‐wide mortality and code rates outside the ICU in a children's hospital. JAMA. 2007;298(19):2267–2274.
- , . Reduction of hospital mortality and of preventable cardiac arrest and death on introduction of a pediatric medical emergency team. Pediatr Crit Care Med. 2009;10(3):306–312.
- , , , et al. Implementation and impact of a rapid response team in a children's hospital. Jt Comm J Qual Patient Saf. 2007;33(7):418–425.
- , , . How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59–82.
- . Different approaches in grounded theory. In: Bryant A, Charmaz K, eds. The Sage Handbook of Grounded Theory. Los Angeles, CA: Sage; 2007:191–213.
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- , . Packaging: a grounded theory of how to report physiological deterioration effectively. J Adv Nurs. 2005;52(5):473–481.
- , , . Understanding how rapid response systems may improve safety for the acutely ill patient: learning from the frontline. BMJ Qual Saf. 2012;21(2):135–144.
- , , , , , . A before and after study assessing the impact of a new model for recognizing and responding to early signs of deterioration in an acute hospital. J Adv Nurs. 2013;69(1):41–52.
- , . Overcoming gendered and professional hierarchies in order to facilitate escalation of care in emergency situations: the role of standardised communication protocols. Soc Sci Med. 2010;71(9):1683–1686.
- , , , , . Defining impact of a rapid response team: qualitative study with nurses, physicians and hospital administrators. BMJ Qual Saf. 2012;21(5):391–398.
- , , , , . Leading successful rapid response teams: a multisite implementation evaluation. J Nurs Adm. 2009;39(4):176–181.
Thousands of hospitals have recently implemented rapid response systems (RRSs), attempting to reduce mortality outside of intensive care units (ICUs).[1, 2] These systems have 2 clinical components, a response (efferent) arm and an identification (afferent) arm.[3] The response arm is usually composed of a medical emergency team (MET) that responds to calls for urgent assistance. The identification arm includes tools to help clinicians recognize patients who require assistance from the MET. In many hospitals, the identification arm includes an early warning score (EWS). In pediatric patients, EWSs assign point values to vital signs that fall outside of age‐based ranges, among other clinical observations. They then generate a total score intended to help clinicians identify patients exhibiting early signs of deterioration.[4, 5, 6, 7, 8, 9, 10, 11]
When experimentally applied to vital sign datasets, the test characteristics of pediatric EWSs in detecting clinical deterioration are highly variable across studies, with major tradeoffs between sensitivity, specificity, and predictive values that differ by outcome, score, and cut‐point (Table 1). This reflects the difficulty of identifying deteriorating patients using only objective measures. However, in real‐world settings, EWSs are used by clinicians in conjunction with their clinical judgment. We hypothesized that EWSs have benefits that extend beyond their ability to predict deterioration, and thus have value not demonstrated by test characteristics alone. In order to further explore this issue, we aimed to qualitatively evaluate mechanisms beyond their statistical ability to predict deterioration by which physicians and nurses use EWSs to support their decision making.
| Score and Citation | Outcome Measure | Score Cut‐point | Sens | Spec | PPV | NPV |
|---|---|---|---|---|---|---|
| ||||||
| Brighton Paediatric Early Warning Score[5] | RRT or code blue call | 4 | 86% | NR | NR | NR |
| Bristol Paediatric Early Warning Tool[6, 11] | Escalation to higher level of care | 1 | ER | ER | 63% | NR |
| Cardiff and Vale Paediatric Early Warning System[7] | Respiratory or cardiac arrest, HDU/ICU admission, or death | 1 | 89% | 64% | 2% | >99% |
| Bedside Paediatric Early Warning System score, original version[8] | Code blue call | 5 | 78% | 95% | 4% | NR |
| Bedside Paediatric Early Warning System score, simplified version[9] | Urgent ICU admission without a code blue call | 8 | 82% | 93% | NR | NR |
| Bedside Paediatric Early Warning System score, simplified version[10] | Urgent ICU admission or code blue call | 7 | 64% | 91% | 9% | NR |
METHODS
Overview
As 1 component of a larger study, we conducted semistructured interviews with nurses and physicians at The Children's Hospital of Philadelphia (CHOP) between May and October 2011. In separate subprojects using the same participants, the larger study also aimed to identify residual barriers to calling for urgent assistance and assess the role of families in the recognition of deterioration and MET activation.
Setting
The Children's Hospital of Philadelphia is an urban, tertiary‐care pediatric hospital with 504 beds. Surgical patients hospitalized outside of ICUs are cared for by surgeons and surgical nurses without pediatrician co‐management. Implementation of a RRS was prompted by serious safety events in which clinical deterioration was either not recognized or was recognized and not escalated. Prior to RRS implementation, a code blue team could be activated for patients in immediate need of resuscitation, or, for less‐urgent needs, a pediatric ICU fellow could be paged by physicians for informal consults.
A multidisciplinary team developed and pilot‐tested the RRS, then implemented it hospital‐wide in February 2010. Representing an aspect of a multipronged approach to improve safety culture, the RRS consisted of (1) an EWS based upon Parshuram's Bedside Paediatric Early Warning System,[8, 9, 10] calculated by hand on a paper form (see online supplementary content) at the same frequency as vital signs (usually every 4 hours), and (2) a 30‐minute response MET available for activation by any clinician for any concern, 24 hours per day, 7 days per week. Escalation guidelines included a prompt to activate the MET for a score that increased to the red zone (9). For concerns that could not wait 30 minutes, any hospital employee could activate the immediate‐response code blue team.
Utilization of the RRS at CHOP is high, with 23 calls to the MET per day and a combined MET/code‐blue team call rate of 27.8 per 1000 admissions.[12] Previously reported pediatric call rates range from 2.8 to 44.0, with a median of 9.6 per 1000 admissions across 6 studies.[13, 14, 15, 16, 17, 18, 19] Since implementation, there has been a statistically significant net reduction in critical deterioration events (unpublished data).
Participants
We recruited nurses and physicians who had recently cared for children age 18 years on general medical or surgical wards with false‐negative or false‐positive EWSs (instances when the score failed to predict deterioration). Recruitment ceased when we reached thematic data saturation (a qualitative research term for the point at which no new themes emerge with additional interviews).[20]
Data Collection
Through a detailed review of the relevant literature and consultation with experts, we developed a semistructured interview guide (see online supplementary content) to elicit nurses' and physicians' viewpoints regarding the mechanisms by which they use EWSs to support their decision making.
Experienced qualitative research scientists (F.K.B. and J.H.H.) trained 2 study interviewers (B.P. and K.M.T.). In order to minimize social‐desirability bias, the interviewers were not clinicians and were not involved in RRS operations. Each interview was recorded, professionally transcribed, and imported into NVivo 8.0 software for analysis (QSR International, Melbourne, Australia).
Data Analysis
We coded the interviews inductively, without using a predetermined set of themes. This approach is known as grounded theory methodology.[21] Two team members coded each interview independently. They then reviewed their coding together and discussed discrepancies until reaching consensus. In weekly meetings while the interviews were ongoing, we compared newly collected data with themes that had previously emerged in order to guide further thematic development and refinement (the constant comparative method).[22] After all of the interviews were completed and consensus had been reached for each individual interview, the study team convened a series of additional meetings to further refine and finalize the themes.
Human Subjects
The CHOP Institutional Review Board approved this study. All participants provided written informed consent.
RESULTS
Participants
We recruited 27 nurses and 30 physicians before reaching thematic data saturation. Because surgical patients are underrepresented relative to medical patients among the population with false‐positive and false‐negative scores in our hospital, this included 3 randomly selected surgical nurses and 7 randomly selected surgical physicians recruited to ensure thematic data saturation for surgical settings. Characteristics of the participants are displayed in Table 2.
| Physicians (n=30) | Nurses (n=27) | |||
|---|---|---|---|---|
| ||||
| N | % | N | % | |
| Race | ||||
| Asian | 2 | 6.7 | 1 | 3.7 |
| Black | 0 | 0.0 | 2 | 7.4 |
| White | 26 | 86.7 | 22 | 81.5 |
| Prefer not to say | 1 | 3.3 | 1 | 3.7 |
| >1 race | 1 | 3.3 | 1 | 3.7 |
| Ethnicity | ||||
| Hispanic/Latino | 2 | 6.7 | 1 | 3.7 |
| Not Hispanic/Latino | 23 | 76.7 | 25 | 92.6 |
| Prefer not to say | 5 | 16.7 | 1 | 3.7 |
| Sex | ||||
| F | 16 | 53.3 | 25 | 92.6 |
| M | 14 | 46.7 | 2 | 7.4 |
| Practice setting | ||||
| Medical | 21 | 70.0 | 22 | 81.5 |
| Surgical | 9 | 30.0 | 5 | 18.5 |
| Among physicians only, experience level | ||||
| Intern | 7 | 23.3 | ||
| Senior resident | 7 | 23.3 | ||
| Attending physician | 16 | 53.3 | ||
| Among attending physicians only, no. of years practicing | ||||
| <5 | 8 | 50.0 | ||
| 5<10 | 3 | 18.8 | ||
| 10 | 5 | 31.3 | ||
| Among nurses only, no. of years practicing | ||||
| <1 | 5 | 18.5 | ||
| 1<2 | 5 | 18.5 | ||
| 2<5 | 9 | 33.3 | ||
| 5<10 | 4 | 14.8 | ||
| 10<20 | 1 | 3.7 | ||
| 20 | 3 | 11.1 | ||
| Recruitment method | ||||
| Cared for patient with false‐positive score | 10 | 33.3 | 14 | 51.9 |
| Cared for patient with false‐negative score | 13 | 43.3 | 10 | 37.0 |
| Randomly selected to ensure data saturation for surgical settings | 7 | 23.3 | 3 | 11.1 |
Thematic Analysis
We provide the final themes, associated subthemes, and representative quotations below, with additional supporting quotations in Table 3. Because CHOP's MET is named the Critical Assessment Team, the term CAT appears in some quotations.
|
| Theme 1: The EWS facilitates patient safety by alerting nurses and physicians to concerning vital sign changes and prompting them to think critically about the possibility of deterioration. |
| I think [the EWS] helps us to be focused and gives us definite criteria to look for if there is an issue or change. It hopefully gives us a head start if there is going to be a change. They have a way of tracking it with the different color‐coding system they use Like, Oh geez, the heart rate is a little bit higher, that changes the color from yellow to orange, then I have to let the charge nurse know because that is a change from where they were earlier it kind of organizes it, I feel like, from where it was before. (medical nurse with 23 years of experience) |
| I think for myself, as a new clinician, one of our main goals is to help judge sick versus not sick. So to have a concrete system for thinking about that is helpful. (medical intern) |
| I think [the EWS] can help put things together for us. When you are really busy, you don't always get to focus on a lot of details. It is like another red flag to say you might have not realized that the child's heart rates went up further, but now here's some evidence that they did. (medical senior resident) |
| I think that the ability to use the EWS to watch the progression of a patient over time is really helpful. I've had a few patients that have gotten sicker from a respiratory standpoint. We can have multiple on the floor at the same time, and what's nice is that sometimes nurses have been able to come to me and we can really see through the score that we are at the point where a higher level of care is needed, whereas, in the old system, without that, we would have had to essentially wait for true clinical decompensation before the ICU would have been involved. I think that does help to deliver better care. (medical senior resident) |
| Theme 2: The EWS provides less‐experienced nurses with helpful age‐based reference ranges for vital signs that they use when caring for hospitalized children. |
| Sometimes you just write down the vitals and maybe you are not really thinking, and then when you go to do the EWS you looked at the score and it's really off in their age range. It kind of gives you 1 more step to recognize that there's a problem. (medical nurse with <1 year of experience) |
| I see the role [of the EWS] more broadly as a guide of where your patient should fall with their vital signs according to their age. I think that has been the biggest help for me, to be able to visualize, I have a 3‐year‐old; this is where they should be for their respiratory rate or heart rate. I think it has been good to be able to see that they are falling within the range appropriate for their age. (surgical nurse with 9 years of experience) |
| Theme 3: The EWS provides concrete evidence of clinical changes in the form of a score. This empowers nurses to overcome escalation barriers and communicate their concerns, helping them take action to rescue their deteriorating patients. |
| The times when I think the EWS helped me out the most are when there is a little bit of disagreement maybe the doctors and the nurses don't see eye‐to‐eye on how the patient is doing and so a higher score can sometimes be a way to say, I know there is nothing specifically going on, but if you take a look at the EWSs they are turning up very significantly. That might be enough to at least get a second opinion on that patient or to start some kind of change in their care. (medical nurse with <1 year of experience) |
| If we have the EWS to back us up, we can use that to say, Look, I don't feel comfortable with this patient, the EWS is 7 and I know you are saying they are okay, but I would feel more comfortable calling. Having that protocol in place I feel like it really gives us a voice it kind of gives us the, not that they don't trust us, but if they say, Oh, I think the child is fine but if I tell them Look, their EWS is an 8 or a 9, they are like, Oh, okay. It is not just you freaking out. There is an issue. (medical nurse with 3 years of experience) |
| I think that since it has been instituted nursing is coming to residents more than they did beforehand Can you reassess this patient? Do you think that we should call CAT? I think that it encourages residents to reevaluate patients at times when things are changing, and quicker than it did without the system in place. (medical senior resident) |
| I view [the EWS] as a tool, like if I have someone managing my patients when I am on service this would be a good tool because it mandates the nurses to notify and it also mandates the residents to understand what's going on. I think that was done on purpose. (medical attending physician in practice for 8 years) |
| Theme 4: In some patients, the EWS may not help with decision‐making. These include patients who are very stable and have a low likelihood of deterioration, and patients with abnormal physiology at baseline who consistently have very high EWSs. |
| The patient I took care of in this situation was a really sick kid to begin with, and it wasn't so much they were concerned about his EWS because, unless there was a really serious event, he would probably be staying on our floor anyway in some cases we just have some really sick kids whose scores may constantly be high all the time, so it wouldn't be helpful for the doctors or us to really bring it up. (medical nurse with 1 year of experience) |
Of note, after interviewing 9 surgeons, we found that they were not very familiar with the EWS and had little to say either positively or negatively about the system. For example, when asked what they thought about the EWS, a surgical intern said, I have no idea. I don't have enough experience with it. This is probably the first time that I ever had anybody telling me that the system is in place. Therefore, surgeons did not contribute meaningfully to the themes below.
Theme 1: The EWS facilitates patient safety by alerting nurses and physicians to concerning vital sign changes and prompting them to think critically about the possibility of deterioration
Nurses and physicians frequently discussed the direct role of the EWS in revealing changes consistent with early signs of deterioration. A medical nurse with <1 year of experience said, The higher the number gets, the more it sets off a red flag to you to kind of keep an eye on certain things. They are just as important as taking a set of vitals. When asked if the EWS had ever helped to identify deterioration, a medical attending physician in practice for 5 years said, I think sometimes we will blow off, so to speak, certain things, but when you look at the numbers and you see a big [EWS] change versus if you were [just] looking at individual vital signs, then yeah, I think it has made a difference.
Nurses and physicians also discussed the role of the EWSs in prompting them to closely examine individual vital signs and think critically about whether or not a patient is exhibiting early signs of deterioration. A surgical nurse with <1 year of experience said, Sometimes I feel like if you want things to be okay you can kind of write them off, but when you have to write [the EWS] down it kind of jogs you to think, maybe something is going on or maybe someone else needs to know about this. A medical senior resident commented, I think it has alerted me earlier to changes in vital signs that I might not necessarily have known. I think there are nurses that use it and they see that there is an elevation and they call you about it. Then it makes me go back and look through and see what their vital signs are and if it happens in timewe only go through and look at everyone's vital signs about twice a dayit can be very helpful.
Theme 2: The EWS provides less‐experienced nurses with helpful age‐based reference ranges for vital signs that they use when caring for hospitalized children
Although this theme did not appear among physicians, nurses frequently noted that they referred to the scoring sheet as a reference for vital signs appropriate for hospitalized children. A surgical nurse with <1 year of experience said, In nursing school, I mostly dealt with adults. So, to figure out the different ranges for normal vital signs, it helps to have it listed on paper so I can see, 'Oh, I didn't realize that this 10‐year‐old's heart rate is higher than it should be.' A medical nurse with 14 years of experience cited the benefits for less‐experienced nurses, noting, [The EWS helps] newer nurses who don't know the ranges. Where it's Oh, my kid's blood pressure is 81 [mm Hg] over something, then they can look at their age and say, Oh, that is completely normal for a 2‐month‐old. But [before the EWS] there was nowhere to look to see the ranges. Unless you were [Pediatric Advanced Life Support] certified where you would know that stuff, there was a lot of anxiety related to vital signs.
Theme 3: The EWS provides concrete evidence of clinical changes in the form of a score. This empowers nurses to overcome escalation barriers and communicate their concerns, helping them take action to rescue their deteriorating patients
Nurses and physicians often described the role of the EWS as a source of objective evidence that a patient was exhibiting a concerning change. They shared the ways in which the EWS was used to convey concerns, noting most commonly that this was used as a communication tool by nurses to raise their concerns with physicians. A medical nurse with 23 years of experience said, [With the EWS] you feel like you have concrete evidence. It's not just a feeling [that] they are not looking as well as they were it feels scientific. Building upon this concept, a medical attending physician in practice for 2 years said, The EWS is a number that certainly gives people a sense of Here's the data behind why I am really coming to you and insisting on this. It is not calling and saying, I just have a bad feeling, it is, I have a bad feeling and his EWS has gone to a 9.
Theme 4: In some patients, the EWS may not help with decision making. These include patients who are very stable and have a low likelihood of deterioration, patients with abnormal physiology at baseline who consistently have very high EWSs, and patients experiencing neurologic deterioration
Nurses and physicians described some patient scenarios in which the EWS may not help with decision making. Discussing postoperative patients, a surgical nurse with 1 year of experience said, I love doing [the EWS] for some patients. I think it makes perfect sense. Then there are some patients [for whom] I am doing it just to do it because they are only here for 24 hours. They are completely stable. They never had 1 vital sign that was even a little bit off. It's kind of like we are just filling it out to fill it out. Commenting on patients at the other end of the spectrum, a medical attending physician in practice for 2 years said, [The EWS] can be a useful composite tool, but for specialty patients with abnormal baselines, I think it is much more a question of making sure you pay attention to the specific changes, whether it is the EWS or heart rate or vital signs or pain score or any of those things. A final area in which nurses and physicians identified weaknesses in the EWS surrounded neurologic deterioration. Specifically, nurses and physicians described experiences when the EWS increased minimally or not at all in patients with sudden seizures or concerning mental status changes that warranted escalation of care.
DISCUSSION
This study is the first to analyze viewpoints on the mechanisms by which EWSs impact decision making among physicians and nurses who had recently experienced score failures. Our study, performed in a children's hospital, builds upon the findings of related studies performed in hospitals that care primarily for adults.[23, 24, 25, 26, 27, 28] Andrews and Waterman found that nurses consider the utility of EWSs to extend beyond detecting deterioration by providing quantifiable evidence, packaged in the form of a score that improves communication between nurses and physicians.[23] Mackintosh and colleagues found that a RRS that included an EWS helped to formalize the way nurses and physicians understand deterioration, enable them to overcome hierarchical boundaries through structured discussions, and empower them to call for help.[24] In a quasi‐experimental study, McDonnell and colleagues found that an EWS improved self‐assessed knowledge, skills, and confidence of nursing staff to detect and manage deteriorating patients.[25] In addition, we describe novel findings, including the use of EWS parameters as reference ranges independent of the score, and specific situations when the EWS fails to support decision making. The weaknesses we identified could be used to drive EWS optimization for low‐risk patients who are stable as well as higher‐risk patients with abnormal baseline physiology and those at risk of neurologic deterioration.
This study has several limitations. Although the interviewers were not involved in RRS operations, it is possible that social desirability bias influenced responses. Next, we identified a knowledge gap among surgeons, and they contributed minimally to our findings. This is most likely because (1) surgical patients deteriorate on the wards less often than medical patients in our hospital, so surgeons are rarely presented with EWSs; (2) surgeons spend less time on the wards compared with medical physicians; and (3) surgical residents rotate in short blocks interspersed with rotations at other hospitals and may be less engaged in hospital safety initiatives.
CONCLUSIONS
Although EWSs perform only marginally well as statistical tools to predict clinical deterioration, nurses and physicians who recently experienced score failures described substantial benefits in using them to help identify deteriorating patients and transcend barriers to escalation of care by serving as objective communication tools. Combining an EWS with a clinician's judgment may result in a system better equipped to respond to deterioration than previous EWS studies focused on their test characteristics alone suggest. Future research should seek to compare and prospectively evaluate the clinical effectiveness of EWSs in real‐world settings.
Acknowledgments
Disclosures: This project was funded by the Pennsylvania Health Research Formula Fund Award (awarded to Keren and Bonafide) and the CHOP Nursing Research and Evidence‐Based Practice Award (awarded to Roberts). The funders did not influence the study design; the collection, analysis, or interpretation of data; the writing of the report; or the decision to submit the article for publication. The authors have no other conflicts to report.
Thousands of hospitals have recently implemented rapid response systems (RRSs), attempting to reduce mortality outside of intensive care units (ICUs).[1, 2] These systems have 2 clinical components, a response (efferent) arm and an identification (afferent) arm.[3] The response arm is usually composed of a medical emergency team (MET) that responds to calls for urgent assistance. The identification arm includes tools to help clinicians recognize patients who require assistance from the MET. In many hospitals, the identification arm includes an early warning score (EWS). In pediatric patients, EWSs assign point values to vital signs that fall outside of age‐based ranges, among other clinical observations. They then generate a total score intended to help clinicians identify patients exhibiting early signs of deterioration.[4, 5, 6, 7, 8, 9, 10, 11]
When experimentally applied to vital sign datasets, the test characteristics of pediatric EWSs in detecting clinical deterioration are highly variable across studies, with major tradeoffs between sensitivity, specificity, and predictive values that differ by outcome, score, and cut‐point (Table 1). This reflects the difficulty of identifying deteriorating patients using only objective measures. However, in real‐world settings, EWSs are used by clinicians in conjunction with their clinical judgment. We hypothesized that EWSs have benefits that extend beyond their ability to predict deterioration, and thus have value not demonstrated by test characteristics alone. In order to further explore this issue, we aimed to qualitatively evaluate mechanisms beyond their statistical ability to predict deterioration by which physicians and nurses use EWSs to support their decision making.
| Score and Citation | Outcome Measure | Score Cut‐point | Sens | Spec | PPV | NPV |
|---|---|---|---|---|---|---|
| ||||||
| Brighton Paediatric Early Warning Score[5] | RRT or code blue call | 4 | 86% | NR | NR | NR |
| Bristol Paediatric Early Warning Tool[6, 11] | Escalation to higher level of care | 1 | ER | ER | 63% | NR |
| Cardiff and Vale Paediatric Early Warning System[7] | Respiratory or cardiac arrest, HDU/ICU admission, or death | 1 | 89% | 64% | 2% | >99% |
| Bedside Paediatric Early Warning System score, original version[8] | Code blue call | 5 | 78% | 95% | 4% | NR |
| Bedside Paediatric Early Warning System score, simplified version[9] | Urgent ICU admission without a code blue call | 8 | 82% | 93% | NR | NR |
| Bedside Paediatric Early Warning System score, simplified version[10] | Urgent ICU admission or code blue call | 7 | 64% | 91% | 9% | NR |
METHODS
Overview
As 1 component of a larger study, we conducted semistructured interviews with nurses and physicians at The Children's Hospital of Philadelphia (CHOP) between May and October 2011. In separate subprojects using the same participants, the larger study also aimed to identify residual barriers to calling for urgent assistance and assess the role of families in the recognition of deterioration and MET activation.
Setting
The Children's Hospital of Philadelphia is an urban, tertiary‐care pediatric hospital with 504 beds. Surgical patients hospitalized outside of ICUs are cared for by surgeons and surgical nurses without pediatrician co‐management. Implementation of a RRS was prompted by serious safety events in which clinical deterioration was either not recognized or was recognized and not escalated. Prior to RRS implementation, a code blue team could be activated for patients in immediate need of resuscitation, or, for less‐urgent needs, a pediatric ICU fellow could be paged by physicians for informal consults.
A multidisciplinary team developed and pilot‐tested the RRS, then implemented it hospital‐wide in February 2010. Representing an aspect of a multipronged approach to improve safety culture, the RRS consisted of (1) an EWS based upon Parshuram's Bedside Paediatric Early Warning System,[8, 9, 10] calculated by hand on a paper form (see online supplementary content) at the same frequency as vital signs (usually every 4 hours), and (2) a 30‐minute response MET available for activation by any clinician for any concern, 24 hours per day, 7 days per week. Escalation guidelines included a prompt to activate the MET for a score that increased to the red zone (9). For concerns that could not wait 30 minutes, any hospital employee could activate the immediate‐response code blue team.
Utilization of the RRS at CHOP is high, with 23 calls to the MET per day and a combined MET/code‐blue team call rate of 27.8 per 1000 admissions.[12] Previously reported pediatric call rates range from 2.8 to 44.0, with a median of 9.6 per 1000 admissions across 6 studies.[13, 14, 15, 16, 17, 18, 19] Since implementation, there has been a statistically significant net reduction in critical deterioration events (unpublished data).
Participants
We recruited nurses and physicians who had recently cared for children age 18 years on general medical or surgical wards with false‐negative or false‐positive EWSs (instances when the score failed to predict deterioration). Recruitment ceased when we reached thematic data saturation (a qualitative research term for the point at which no new themes emerge with additional interviews).[20]
Data Collection
Through a detailed review of the relevant literature and consultation with experts, we developed a semistructured interview guide (see online supplementary content) to elicit nurses' and physicians' viewpoints regarding the mechanisms by which they use EWSs to support their decision making.
Experienced qualitative research scientists (F.K.B. and J.H.H.) trained 2 study interviewers (B.P. and K.M.T.). In order to minimize social‐desirability bias, the interviewers were not clinicians and were not involved in RRS operations. Each interview was recorded, professionally transcribed, and imported into NVivo 8.0 software for analysis (QSR International, Melbourne, Australia).
Data Analysis
We coded the interviews inductively, without using a predetermined set of themes. This approach is known as grounded theory methodology.[21] Two team members coded each interview independently. They then reviewed their coding together and discussed discrepancies until reaching consensus. In weekly meetings while the interviews were ongoing, we compared newly collected data with themes that had previously emerged in order to guide further thematic development and refinement (the constant comparative method).[22] After all of the interviews were completed and consensus had been reached for each individual interview, the study team convened a series of additional meetings to further refine and finalize the themes.
Human Subjects
The CHOP Institutional Review Board approved this study. All participants provided written informed consent.
RESULTS
Participants
We recruited 27 nurses and 30 physicians before reaching thematic data saturation. Because surgical patients are underrepresented relative to medical patients among the population with false‐positive and false‐negative scores in our hospital, this included 3 randomly selected surgical nurses and 7 randomly selected surgical physicians recruited to ensure thematic data saturation for surgical settings. Characteristics of the participants are displayed in Table 2.
| Physicians (n=30) | Nurses (n=27) | |||
|---|---|---|---|---|
| ||||
| N | % | N | % | |
| Race | ||||
| Asian | 2 | 6.7 | 1 | 3.7 |
| Black | 0 | 0.0 | 2 | 7.4 |
| White | 26 | 86.7 | 22 | 81.5 |
| Prefer not to say | 1 | 3.3 | 1 | 3.7 |
| >1 race | 1 | 3.3 | 1 | 3.7 |
| Ethnicity | ||||
| Hispanic/Latino | 2 | 6.7 | 1 | 3.7 |
| Not Hispanic/Latino | 23 | 76.7 | 25 | 92.6 |
| Prefer not to say | 5 | 16.7 | 1 | 3.7 |
| Sex | ||||
| F | 16 | 53.3 | 25 | 92.6 |
| M | 14 | 46.7 | 2 | 7.4 |
| Practice setting | ||||
| Medical | 21 | 70.0 | 22 | 81.5 |
| Surgical | 9 | 30.0 | 5 | 18.5 |
| Among physicians only, experience level | ||||
| Intern | 7 | 23.3 | ||
| Senior resident | 7 | 23.3 | ||
| Attending physician | 16 | 53.3 | ||
| Among attending physicians only, no. of years practicing | ||||
| <5 | 8 | 50.0 | ||
| 5<10 | 3 | 18.8 | ||
| 10 | 5 | 31.3 | ||
| Among nurses only, no. of years practicing | ||||
| <1 | 5 | 18.5 | ||
| 1<2 | 5 | 18.5 | ||
| 2<5 | 9 | 33.3 | ||
| 5<10 | 4 | 14.8 | ||
| 10<20 | 1 | 3.7 | ||
| 20 | 3 | 11.1 | ||
| Recruitment method | ||||
| Cared for patient with false‐positive score | 10 | 33.3 | 14 | 51.9 |
| Cared for patient with false‐negative score | 13 | 43.3 | 10 | 37.0 |
| Randomly selected to ensure data saturation for surgical settings | 7 | 23.3 | 3 | 11.1 |
Thematic Analysis
We provide the final themes, associated subthemes, and representative quotations below, with additional supporting quotations in Table 3. Because CHOP's MET is named the Critical Assessment Team, the term CAT appears in some quotations.
|
| Theme 1: The EWS facilitates patient safety by alerting nurses and physicians to concerning vital sign changes and prompting them to think critically about the possibility of deterioration. |
| I think [the EWS] helps us to be focused and gives us definite criteria to look for if there is an issue or change. It hopefully gives us a head start if there is going to be a change. They have a way of tracking it with the different color‐coding system they use Like, Oh geez, the heart rate is a little bit higher, that changes the color from yellow to orange, then I have to let the charge nurse know because that is a change from where they were earlier it kind of organizes it, I feel like, from where it was before. (medical nurse with 23 years of experience) |
| I think for myself, as a new clinician, one of our main goals is to help judge sick versus not sick. So to have a concrete system for thinking about that is helpful. (medical intern) |
| I think [the EWS] can help put things together for us. When you are really busy, you don't always get to focus on a lot of details. It is like another red flag to say you might have not realized that the child's heart rates went up further, but now here's some evidence that they did. (medical senior resident) |
| I think that the ability to use the EWS to watch the progression of a patient over time is really helpful. I've had a few patients that have gotten sicker from a respiratory standpoint. We can have multiple on the floor at the same time, and what's nice is that sometimes nurses have been able to come to me and we can really see through the score that we are at the point where a higher level of care is needed, whereas, in the old system, without that, we would have had to essentially wait for true clinical decompensation before the ICU would have been involved. I think that does help to deliver better care. (medical senior resident) |
| Theme 2: The EWS provides less‐experienced nurses with helpful age‐based reference ranges for vital signs that they use when caring for hospitalized children. |
| Sometimes you just write down the vitals and maybe you are not really thinking, and then when you go to do the EWS you looked at the score and it's really off in their age range. It kind of gives you 1 more step to recognize that there's a problem. (medical nurse with <1 year of experience) |
| I see the role [of the EWS] more broadly as a guide of where your patient should fall with their vital signs according to their age. I think that has been the biggest help for me, to be able to visualize, I have a 3‐year‐old; this is where they should be for their respiratory rate or heart rate. I think it has been good to be able to see that they are falling within the range appropriate for their age. (surgical nurse with 9 years of experience) |
| Theme 3: The EWS provides concrete evidence of clinical changes in the form of a score. This empowers nurses to overcome escalation barriers and communicate their concerns, helping them take action to rescue their deteriorating patients. |
| The times when I think the EWS helped me out the most are when there is a little bit of disagreement maybe the doctors and the nurses don't see eye‐to‐eye on how the patient is doing and so a higher score can sometimes be a way to say, I know there is nothing specifically going on, but if you take a look at the EWSs they are turning up very significantly. That might be enough to at least get a second opinion on that patient or to start some kind of change in their care. (medical nurse with <1 year of experience) |
| If we have the EWS to back us up, we can use that to say, Look, I don't feel comfortable with this patient, the EWS is 7 and I know you are saying they are okay, but I would feel more comfortable calling. Having that protocol in place I feel like it really gives us a voice it kind of gives us the, not that they don't trust us, but if they say, Oh, I think the child is fine but if I tell them Look, their EWS is an 8 or a 9, they are like, Oh, okay. It is not just you freaking out. There is an issue. (medical nurse with 3 years of experience) |
| I think that since it has been instituted nursing is coming to residents more than they did beforehand Can you reassess this patient? Do you think that we should call CAT? I think that it encourages residents to reevaluate patients at times when things are changing, and quicker than it did without the system in place. (medical senior resident) |
| I view [the EWS] as a tool, like if I have someone managing my patients when I am on service this would be a good tool because it mandates the nurses to notify and it also mandates the residents to understand what's going on. I think that was done on purpose. (medical attending physician in practice for 8 years) |
| Theme 4: In some patients, the EWS may not help with decision‐making. These include patients who are very stable and have a low likelihood of deterioration, and patients with abnormal physiology at baseline who consistently have very high EWSs. |
| The patient I took care of in this situation was a really sick kid to begin with, and it wasn't so much they were concerned about his EWS because, unless there was a really serious event, he would probably be staying on our floor anyway in some cases we just have some really sick kids whose scores may constantly be high all the time, so it wouldn't be helpful for the doctors or us to really bring it up. (medical nurse with 1 year of experience) |
Of note, after interviewing 9 surgeons, we found that they were not very familiar with the EWS and had little to say either positively or negatively about the system. For example, when asked what they thought about the EWS, a surgical intern said, I have no idea. I don't have enough experience with it. This is probably the first time that I ever had anybody telling me that the system is in place. Therefore, surgeons did not contribute meaningfully to the themes below.
Theme 1: The EWS facilitates patient safety by alerting nurses and physicians to concerning vital sign changes and prompting them to think critically about the possibility of deterioration
Nurses and physicians frequently discussed the direct role of the EWS in revealing changes consistent with early signs of deterioration. A medical nurse with <1 year of experience said, The higher the number gets, the more it sets off a red flag to you to kind of keep an eye on certain things. They are just as important as taking a set of vitals. When asked if the EWS had ever helped to identify deterioration, a medical attending physician in practice for 5 years said, I think sometimes we will blow off, so to speak, certain things, but when you look at the numbers and you see a big [EWS] change versus if you were [just] looking at individual vital signs, then yeah, I think it has made a difference.
Nurses and physicians also discussed the role of the EWSs in prompting them to closely examine individual vital signs and think critically about whether or not a patient is exhibiting early signs of deterioration. A surgical nurse with <1 year of experience said, Sometimes I feel like if you want things to be okay you can kind of write them off, but when you have to write [the EWS] down it kind of jogs you to think, maybe something is going on or maybe someone else needs to know about this. A medical senior resident commented, I think it has alerted me earlier to changes in vital signs that I might not necessarily have known. I think there are nurses that use it and they see that there is an elevation and they call you about it. Then it makes me go back and look through and see what their vital signs are and if it happens in timewe only go through and look at everyone's vital signs about twice a dayit can be very helpful.
Theme 2: The EWS provides less‐experienced nurses with helpful age‐based reference ranges for vital signs that they use when caring for hospitalized children
Although this theme did not appear among physicians, nurses frequently noted that they referred to the scoring sheet as a reference for vital signs appropriate for hospitalized children. A surgical nurse with <1 year of experience said, In nursing school, I mostly dealt with adults. So, to figure out the different ranges for normal vital signs, it helps to have it listed on paper so I can see, 'Oh, I didn't realize that this 10‐year‐old's heart rate is higher than it should be.' A medical nurse with 14 years of experience cited the benefits for less‐experienced nurses, noting, [The EWS helps] newer nurses who don't know the ranges. Where it's Oh, my kid's blood pressure is 81 [mm Hg] over something, then they can look at their age and say, Oh, that is completely normal for a 2‐month‐old. But [before the EWS] there was nowhere to look to see the ranges. Unless you were [Pediatric Advanced Life Support] certified where you would know that stuff, there was a lot of anxiety related to vital signs.
Theme 3: The EWS provides concrete evidence of clinical changes in the form of a score. This empowers nurses to overcome escalation barriers and communicate their concerns, helping them take action to rescue their deteriorating patients
Nurses and physicians often described the role of the EWS as a source of objective evidence that a patient was exhibiting a concerning change. They shared the ways in which the EWS was used to convey concerns, noting most commonly that this was used as a communication tool by nurses to raise their concerns with physicians. A medical nurse with 23 years of experience said, [With the EWS] you feel like you have concrete evidence. It's not just a feeling [that] they are not looking as well as they were it feels scientific. Building upon this concept, a medical attending physician in practice for 2 years said, The EWS is a number that certainly gives people a sense of Here's the data behind why I am really coming to you and insisting on this. It is not calling and saying, I just have a bad feeling, it is, I have a bad feeling and his EWS has gone to a 9.
Theme 4: In some patients, the EWS may not help with decision making. These include patients who are very stable and have a low likelihood of deterioration, patients with abnormal physiology at baseline who consistently have very high EWSs, and patients experiencing neurologic deterioration
Nurses and physicians described some patient scenarios in which the EWS may not help with decision making. Discussing postoperative patients, a surgical nurse with 1 year of experience said, I love doing [the EWS] for some patients. I think it makes perfect sense. Then there are some patients [for whom] I am doing it just to do it because they are only here for 24 hours. They are completely stable. They never had 1 vital sign that was even a little bit off. It's kind of like we are just filling it out to fill it out. Commenting on patients at the other end of the spectrum, a medical attending physician in practice for 2 years said, [The EWS] can be a useful composite tool, but for specialty patients with abnormal baselines, I think it is much more a question of making sure you pay attention to the specific changes, whether it is the EWS or heart rate or vital signs or pain score or any of those things. A final area in which nurses and physicians identified weaknesses in the EWS surrounded neurologic deterioration. Specifically, nurses and physicians described experiences when the EWS increased minimally or not at all in patients with sudden seizures or concerning mental status changes that warranted escalation of care.
DISCUSSION
This study is the first to analyze viewpoints on the mechanisms by which EWSs impact decision making among physicians and nurses who had recently experienced score failures. Our study, performed in a children's hospital, builds upon the findings of related studies performed in hospitals that care primarily for adults.[23, 24, 25, 26, 27, 28] Andrews and Waterman found that nurses consider the utility of EWSs to extend beyond detecting deterioration by providing quantifiable evidence, packaged in the form of a score that improves communication between nurses and physicians.[23] Mackintosh and colleagues found that a RRS that included an EWS helped to formalize the way nurses and physicians understand deterioration, enable them to overcome hierarchical boundaries through structured discussions, and empower them to call for help.[24] In a quasi‐experimental study, McDonnell and colleagues found that an EWS improved self‐assessed knowledge, skills, and confidence of nursing staff to detect and manage deteriorating patients.[25] In addition, we describe novel findings, including the use of EWS parameters as reference ranges independent of the score, and specific situations when the EWS fails to support decision making. The weaknesses we identified could be used to drive EWS optimization for low‐risk patients who are stable as well as higher‐risk patients with abnormal baseline physiology and those at risk of neurologic deterioration.
This study has several limitations. Although the interviewers were not involved in RRS operations, it is possible that social desirability bias influenced responses. Next, we identified a knowledge gap among surgeons, and they contributed minimally to our findings. This is most likely because (1) surgical patients deteriorate on the wards less often than medical patients in our hospital, so surgeons are rarely presented with EWSs; (2) surgeons spend less time on the wards compared with medical physicians; and (3) surgical residents rotate in short blocks interspersed with rotations at other hospitals and may be less engaged in hospital safety initiatives.
CONCLUSIONS
Although EWSs perform only marginally well as statistical tools to predict clinical deterioration, nurses and physicians who recently experienced score failures described substantial benefits in using them to help identify deteriorating patients and transcend barriers to escalation of care by serving as objective communication tools. Combining an EWS with a clinician's judgment may result in a system better equipped to respond to deterioration than previous EWS studies focused on their test characteristics alone suggest. Future research should seek to compare and prospectively evaluate the clinical effectiveness of EWSs in real‐world settings.
Acknowledgments
Disclosures: This project was funded by the Pennsylvania Health Research Formula Fund Award (awarded to Keren and Bonafide) and the CHOP Nursing Research and Evidence‐Based Practice Award (awarded to Roberts). The funders did not influence the study design; the collection, analysis, or interpretation of data; the writing of the report; or the decision to submit the article for publication. The authors have no other conflicts to report.
- Institute for Healthcare Improvement. Overview of the Institute for Healthcare Improvement Five Million Lives Campaign. Available at: http://www.ihi.org/offerings/Initiatives/PastStrategicInitiatives/5MillionLivesCampaign/Pages/default.aspx. Accessed June 21, 2012.
- UK National Institute for Health and Clinical Excellence (NICE). Acutely Ill Patients in Hospital: Recognition of and Response to Acute Illness in Adults in Hospital. Available at: http://publications.nice.org.uk/acutely‐ill‐patients‐in‐hospital‐cg50. Published July 2007. Accessed June 21, 2012.
- , , , et al. Findings of the first consensus conference on medical emergency teams. Crit Care Med. 2006; 34(9):2463–2478.
- . Detecting and managing deterioration in children. Paediatr Nurs. 2005;17(1):32–35.
- , , , , , . Sensitivity of the Pediatric Early Warning Score to identify patient deterioration. Pediatrics. 2010;125(4):e763–e769.
- , , . Promoting care for acutely ill children—development and evaluation of a paediatric early warning tool. Intensive Crit Care Nurs. 2006;22(2):73–81.
- , , , . Prospective cohort study to test the predictability of the Cardiff and Vale paediatric early warning system. Arch Dis Child. 2009;94(8):602–606.
- , , . The Pediatric Early Warning System Score: a severity of illness score to predict urgent medical need in hospitalized children. J Crit Care. 2006;21(3):271–278.
- , , . Development and initial validation of the Bedside Paediatric Early Warning System score. Crit Care. 2009;13(4):R135.
- , , , et al. Multi‐centre validation of the Bedside Paediatric Early Warning System Score: a severity of illness score to detect evolving critical illness in hospitalized children. Crit Care. 2011;15(4):R184.
- , . Evaluation of a paediatric early warning tool—claims unsubstantiated. Intensive Crit Care Nurs. 2006;22(6):315–316.
- , , , et al. Development of a pragmatic measure for evaluating and optimizing rapid response systems. Pediatrics. 2012;129(4):e874–e881.
- , , , et al. Implementation of a multicenter rapid response system in pediatric academic hospitals is effective. Pediatrics. 2011;128(1):72–78.
- , , , , . Rapid response teams: a systematic review and meta‐analysis. Arch Intern Med. 2010;170(1):18–26.
- , , , et al. Implementation of a medical emergency team in a large pediatric teaching hospital prevents respiratory and cardiopulmonary arrests outside the intensive care unit. Pediatr Crit Care Med. 2007;8(3):236–246.
- , , , et al. Transition from a traditional code team to a medical emergency team and categorization of cardiopulmonary arrests in a children's center. Arch Pediatr Adolesc Med. 2008;162(2):117–122.
- , , , et al. Effect of a rapid response team on hospital‐wide mortality and code rates outside the ICU in a children's hospital. JAMA. 2007;298(19):2267–2274.
- , . Reduction of hospital mortality and of preventable cardiac arrest and death on introduction of a pediatric medical emergency team. Pediatr Crit Care Med. 2009;10(3):306–312.
- , , , et al. Implementation and impact of a rapid response team in a children's hospital. Jt Comm J Qual Patient Saf. 2007;33(7):418–425.
- , , . How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59–82.
- . Different approaches in grounded theory. In: Bryant A, Charmaz K, eds. The Sage Handbook of Grounded Theory. Los Angeles, CA: Sage; 2007:191–213.
- , . The Discovery of Grounded Theory: Strategies for Qualitative Research. New York, NY: Aldine De Gruyter; 1967.
- , . Packaging: a grounded theory of how to report physiological deterioration effectively. J Adv Nurs. 2005;52(5):473–481.
- , , . Understanding how rapid response systems may improve safety for the acutely ill patient: learning from the frontline. BMJ Qual Saf. 2012;21(2):135–144.
- , , , , , . A before and after study assessing the impact of a new model for recognizing and responding to early signs of deterioration in an acute hospital. J Adv Nurs. 2013;69(1):41–52.
- , . Overcoming gendered and professional hierarchies in order to facilitate escalation of care in emergency situations: the role of standardised communication protocols. Soc Sci Med. 2010;71(9):1683–1686.
- , , , , . Defining impact of a rapid response team: qualitative study with nurses, physicians and hospital administrators. BMJ Qual Saf. 2012;21(5):391–398.
- , , , , . Leading successful rapid response teams: a multisite implementation evaluation. J Nurs Adm. 2009;39(4):176–181.
- Institute for Healthcare Improvement. Overview of the Institute for Healthcare Improvement Five Million Lives Campaign. Available at: http://www.ihi.org/offerings/Initiatives/PastStrategicInitiatives/5MillionLivesCampaign/Pages/default.aspx. Accessed June 21, 2012.
- UK National Institute for Health and Clinical Excellence (NICE). Acutely Ill Patients in Hospital: Recognition of and Response to Acute Illness in Adults in Hospital. Available at: http://publications.nice.org.uk/acutely‐ill‐patients‐in‐hospital‐cg50. Published July 2007. Accessed June 21, 2012.
- , , , et al. Findings of the first consensus conference on medical emergency teams. Crit Care Med. 2006; 34(9):2463–2478.
- . Detecting and managing deterioration in children. Paediatr Nurs. 2005;17(1):32–35.
- , , , , , . Sensitivity of the Pediatric Early Warning Score to identify patient deterioration. Pediatrics. 2010;125(4):e763–e769.
- , , . Promoting care for acutely ill children—development and evaluation of a paediatric early warning tool. Intensive Crit Care Nurs. 2006;22(2):73–81.
- , , , . Prospective cohort study to test the predictability of the Cardiff and Vale paediatric early warning system. Arch Dis Child. 2009;94(8):602–606.
- , , . The Pediatric Early Warning System Score: a severity of illness score to predict urgent medical need in hospitalized children. J Crit Care. 2006;21(3):271–278.
- , , . Development and initial validation of the Bedside Paediatric Early Warning System score. Crit Care. 2009;13(4):R135.
- , , , et al. Multi‐centre validation of the Bedside Paediatric Early Warning System Score: a severity of illness score to detect evolving critical illness in hospitalized children. Crit Care. 2011;15(4):R184.
- , . Evaluation of a paediatric early warning tool—claims unsubstantiated. Intensive Crit Care Nurs. 2006;22(6):315–316.
- , , , et al. Development of a pragmatic measure for evaluating and optimizing rapid response systems. Pediatrics. 2012;129(4):e874–e881.
- , , , et al. Implementation of a multicenter rapid response system in pediatric academic hospitals is effective. Pediatrics. 2011;128(1):72–78.
- , , , , . Rapid response teams: a systematic review and meta‐analysis. Arch Intern Med. 2010;170(1):18–26.
- , , , et al. Implementation of a medical emergency team in a large pediatric teaching hospital prevents respiratory and cardiopulmonary arrests outside the intensive care unit. Pediatr Crit Care Med. 2007;8(3):236–246.
- , , , et al. Transition from a traditional code team to a medical emergency team and categorization of cardiopulmonary arrests in a children's center. Arch Pediatr Adolesc Med. 2008;162(2):117–122.
- , , , et al. Effect of a rapid response team on hospital‐wide mortality and code rates outside the ICU in a children's hospital. JAMA. 2007;298(19):2267–2274.
- , . Reduction of hospital mortality and of preventable cardiac arrest and death on introduction of a pediatric medical emergency team. Pediatr Crit Care Med. 2009;10(3):306–312.
- , , , et al. Implementation and impact of a rapid response team in a children's hospital. Jt Comm J Qual Patient Saf. 2007;33(7):418–425.
- , , . How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59–82.
- . Different approaches in grounded theory. In: Bryant A, Charmaz K, eds. The Sage Handbook of Grounded Theory. Los Angeles, CA: Sage; 2007:191–213.
- , . The Discovery of Grounded Theory: Strategies for Qualitative Research. New York, NY: Aldine De Gruyter; 1967.
- , . Packaging: a grounded theory of how to report physiological deterioration effectively. J Adv Nurs. 2005;52(5):473–481.
- , , . Understanding how rapid response systems may improve safety for the acutely ill patient: learning from the frontline. BMJ Qual Saf. 2012;21(2):135–144.
- , , , , , . A before and after study assessing the impact of a new model for recognizing and responding to early signs of deterioration in an acute hospital. J Adv Nurs. 2013;69(1):41–52.
- , . Overcoming gendered and professional hierarchies in order to facilitate escalation of care in emergency situations: the role of standardised communication protocols. Soc Sci Med. 2010;71(9):1683–1686.
- , , , , . Defining impact of a rapid response team: qualitative study with nurses, physicians and hospital administrators. BMJ Qual Saf. 2012;21(5):391–398.
- , , , , . Leading successful rapid response teams: a multisite implementation evaluation. J Nurs Adm. 2009;39(4):176–181.
Copyright © 2013 Society of Hospital Medicine
Bumps
People hate bumps.
Bumps are ugly. Bumps are nasty. Bumps bother.
Seeing bumps makes people frown. Touching bumps makes them shudder.
Bumps on toads. Bumps on potatoes. Bumps on trees.
But especially bumps on skin – on faces, on lips, on tongues, on genitals. Bumps almost anywhere.
Bumps bother the people who have them. They especially agitate other people who have to look at them, so they point out the bumps and make it perfectly plain how bumps make them feel:
• "My wife says, ‘When are you going to get that disgusting red spot off your neck?’" (About a hemangioma.)
• "My kids say, ‘Dad, when are you getting that gross thing off your back?’" (About an epidermoid cyst.)
• "That black spot on your back – have you had that looked at?" (A doctor – not a dermatologist, of course – asks a patient about a dermal nevus you’ve been reassuring that patient about for years.)
"Just leave those skin tags on your neck alone," you say.
"But they’re nasty! Can’t you take them off?"
"I suggest you leave the cyst alone. Removing it would require surgery."
"But I hate it!"
Even nonverbal observers can call attention to bumps. More than one nursing mother has had me remove a mole from her breast, even though it’s been there without changing for a long time, because "the baby keeps grabbing at it."
But once the people who see bumps can talk, it’s open bump season. My wife had a blue nevus removed from her cheek many years ago. She recalls that she did it because our youngest son, about 8 years old at the time, kept pointing to her cheek and saying, "Blue nevus! Blue nevus!" (Yes, he could be irritating then, but no, he wasn’t diagnostically precocious – I’d told him what it was.)
That son now has three children of his own, so he can look to his own parenting challenges, not to mention his own blemishes.
The loaded words people apply to their bumps – ugly, disgusting, gross, nasty – are not the ones you’d expect, and they have nothing to do with histology or malignant potential. But if you listen for these words, you’ll hear them as often as I do.
Some of my bumpy conversations are droll in unexpected ways. Last week, for instance, Seth came in for his annual physical.
"I have these two things under my left arm," he said, pointing to a pair of skin tags.
"Do they bother you?" I asked.
"They bother my kids," he said. "Adam and Melissa keep pointing at them. They call them Fred."
"Fred? What do they call the other one?"
"Also Fred."
"Did you know," I asked him, "that all little thingies hanging off the body are male? People always say, ‘Can’t you get rid of those little guys?’ "
"I didn’t know that," said Seth.
"You see what you can learn at the dermatologist’s office?" I said. "If you want, I can make your kids happy and get rid of Fred. Both of him."
"Sure," said Seth. I loaded up my electric needle. I don’t play video games. Who needs when you have a Hyfrecator? Soon Fred was vaporized. BLAMMM! So was Fred. KAPOWW!
"Seth," I said, "if Dr. Seuss had written a book about dermatology, he might have called it ‘Bye, Bye, Fred’ and it may have gone like this":
See Fred.
Fred bled.
Fred bled red.
Fred bled red in bed.
Zap, Fred! Pow, Fred!
Now Fred is dead.
Sayonara, Fred.
Go ahead, moles, warts, skin tags, bumps of all kinds. Make my day.
Dr. Rockoff practices dermatology in Brookline, Mass. To respond to this column, e-mail him at our editorial offices at [email protected].
People hate bumps.
Bumps are ugly. Bumps are nasty. Bumps bother.
Seeing bumps makes people frown. Touching bumps makes them shudder.
Bumps on toads. Bumps on potatoes. Bumps on trees.
But especially bumps on skin – on faces, on lips, on tongues, on genitals. Bumps almost anywhere.
Bumps bother the people who have them. They especially agitate other people who have to look at them, so they point out the bumps and make it perfectly plain how bumps make them feel:
• "My wife says, ‘When are you going to get that disgusting red spot off your neck?’" (About a hemangioma.)
• "My kids say, ‘Dad, when are you getting that gross thing off your back?’" (About an epidermoid cyst.)
• "That black spot on your back – have you had that looked at?" (A doctor – not a dermatologist, of course – asks a patient about a dermal nevus you’ve been reassuring that patient about for years.)
"Just leave those skin tags on your neck alone," you say.
"But they’re nasty! Can’t you take them off?"
"I suggest you leave the cyst alone. Removing it would require surgery."
"But I hate it!"
Even nonverbal observers can call attention to bumps. More than one nursing mother has had me remove a mole from her breast, even though it’s been there without changing for a long time, because "the baby keeps grabbing at it."
But once the people who see bumps can talk, it’s open bump season. My wife had a blue nevus removed from her cheek many years ago. She recalls that she did it because our youngest son, about 8 years old at the time, kept pointing to her cheek and saying, "Blue nevus! Blue nevus!" (Yes, he could be irritating then, but no, he wasn’t diagnostically precocious – I’d told him what it was.)
That son now has three children of his own, so he can look to his own parenting challenges, not to mention his own blemishes.
The loaded words people apply to their bumps – ugly, disgusting, gross, nasty – are not the ones you’d expect, and they have nothing to do with histology or malignant potential. But if you listen for these words, you’ll hear them as often as I do.
Some of my bumpy conversations are droll in unexpected ways. Last week, for instance, Seth came in for his annual physical.
"I have these two things under my left arm," he said, pointing to a pair of skin tags.
"Do they bother you?" I asked.
"They bother my kids," he said. "Adam and Melissa keep pointing at them. They call them Fred."
"Fred? What do they call the other one?"
"Also Fred."
"Did you know," I asked him, "that all little thingies hanging off the body are male? People always say, ‘Can’t you get rid of those little guys?’ "
"I didn’t know that," said Seth.
"You see what you can learn at the dermatologist’s office?" I said. "If you want, I can make your kids happy and get rid of Fred. Both of him."
"Sure," said Seth. I loaded up my electric needle. I don’t play video games. Who needs when you have a Hyfrecator? Soon Fred was vaporized. BLAMMM! So was Fred. KAPOWW!
"Seth," I said, "if Dr. Seuss had written a book about dermatology, he might have called it ‘Bye, Bye, Fred’ and it may have gone like this":
See Fred.
Fred bled.
Fred bled red.
Fred bled red in bed.
Zap, Fred! Pow, Fred!
Now Fred is dead.
Sayonara, Fred.
Go ahead, moles, warts, skin tags, bumps of all kinds. Make my day.
Dr. Rockoff practices dermatology in Brookline, Mass. To respond to this column, e-mail him at our editorial offices at [email protected].
People hate bumps.
Bumps are ugly. Bumps are nasty. Bumps bother.
Seeing bumps makes people frown. Touching bumps makes them shudder.
Bumps on toads. Bumps on potatoes. Bumps on trees.
But especially bumps on skin – on faces, on lips, on tongues, on genitals. Bumps almost anywhere.
Bumps bother the people who have them. They especially agitate other people who have to look at them, so they point out the bumps and make it perfectly plain how bumps make them feel:
• "My wife says, ‘When are you going to get that disgusting red spot off your neck?’" (About a hemangioma.)
• "My kids say, ‘Dad, when are you getting that gross thing off your back?’" (About an epidermoid cyst.)
• "That black spot on your back – have you had that looked at?" (A doctor – not a dermatologist, of course – asks a patient about a dermal nevus you’ve been reassuring that patient about for years.)
"Just leave those skin tags on your neck alone," you say.
"But they’re nasty! Can’t you take them off?"
"I suggest you leave the cyst alone. Removing it would require surgery."
"But I hate it!"
Even nonverbal observers can call attention to bumps. More than one nursing mother has had me remove a mole from her breast, even though it’s been there without changing for a long time, because "the baby keeps grabbing at it."
But once the people who see bumps can talk, it’s open bump season. My wife had a blue nevus removed from her cheek many years ago. She recalls that she did it because our youngest son, about 8 years old at the time, kept pointing to her cheek and saying, "Blue nevus! Blue nevus!" (Yes, he could be irritating then, but no, he wasn’t diagnostically precocious – I’d told him what it was.)
That son now has three children of his own, so he can look to his own parenting challenges, not to mention his own blemishes.
The loaded words people apply to their bumps – ugly, disgusting, gross, nasty – are not the ones you’d expect, and they have nothing to do with histology or malignant potential. But if you listen for these words, you’ll hear them as often as I do.
Some of my bumpy conversations are droll in unexpected ways. Last week, for instance, Seth came in for his annual physical.
"I have these two things under my left arm," he said, pointing to a pair of skin tags.
"Do they bother you?" I asked.
"They bother my kids," he said. "Adam and Melissa keep pointing at them. They call them Fred."
"Fred? What do they call the other one?"
"Also Fred."
"Did you know," I asked him, "that all little thingies hanging off the body are male? People always say, ‘Can’t you get rid of those little guys?’ "
"I didn’t know that," said Seth.
"You see what you can learn at the dermatologist’s office?" I said. "If you want, I can make your kids happy and get rid of Fred. Both of him."
"Sure," said Seth. I loaded up my electric needle. I don’t play video games. Who needs when you have a Hyfrecator? Soon Fred was vaporized. BLAMMM! So was Fred. KAPOWW!
"Seth," I said, "if Dr. Seuss had written a book about dermatology, he might have called it ‘Bye, Bye, Fred’ and it may have gone like this":
See Fred.
Fred bled.
Fred bled red.
Fred bled red in bed.
Zap, Fred! Pow, Fred!
Now Fred is dead.
Sayonara, Fred.
Go ahead, moles, warts, skin tags, bumps of all kinds. Make my day.
Dr. Rockoff practices dermatology in Brookline, Mass. To respond to this column, e-mail him at our editorial offices at [email protected].
You need a time clock
Every medical office, even the smallest, should have a time clock, and there are two very good reasons why. The obvious one is for stamping employee time cards. This is essential, even if all your employees are paid weekly or semiweekly rather than by the hour.
In most states, any employee who works more than 40 hours in any given week must be paid overtime wages. Employees know this, and disgruntled ones have been known to file complaints stating that they had worked hundreds of hours of unpaid overtime. This may be completely untrue, but labor boards almost invariably side with employees in such disputes – unless the employer can produce time records to disprove the claim. A time clock is cheap insurance against such headaches.
For hourly wage employees, time records are even more important, obviously because you only want to pay them for the hours they work. If you are paying your part-timers for the number of hours they should be working, without documenting how many hours they actually work, you could be paying for a lot of nonwork. Employees have little incentive to arrive on time or to stay the entire length of their shift, if they know they are being paid for a set number of hours anyway. And they certainly will balk at staying late if they can’t count on being paid for the extra time.
Time clocks also work to the advantage of your employees, since they will be paid for all the time they work. In fact, if any employees object to being asked to punch in every day, point out that they will be assured of payment for fractional time worked past their usual hours – time which until now may have gone unpaid.
The second – possibly more important – reason to have a time clock is to punch in your patients. A time clock is a great tool in the endless struggle to run your practice on time.
As each patient arrives, have your receptionist time-stamp the "encounter form" that goes back with the patient’s chart. As you take each chart off the door and enter the room, one glance at the time stamp will tell you exactly how long that patient has been waiting.
Now you no longer have to guess how far behind you are – and you’ll have an answer for the curmudgeon who walked in 15 minutes ago, but insists he’s been sitting there for 2 hours.
Time/attendance systems range from simple and cheap to complex and expensive. Many of the newer mechanical clocks will automatically calculate time between punches and total work time, and these can be configured for weekly, biweekly, semimonthly or monthly pay periods. Some will automatically deduct meal breaks from the totals. However, remember that you can only exclude meal breaks from compensable time when an employee is completely relieved of work duties for at least 1 uninterrupted half-hour.
If you have a problem with "buddy punching" (employees punching in or out for each other), some clocks are equipped to recognize fingerprints or hand contours.
There are also electronic timing systems, both web-based and in-house, which can be deployed across a local computer network. These systems will print time sheets with employee hours and earnings calculated, and some will even interface with financial software such as QuickBooks and other third party payroll services.
One popular Web-based system is Count Me In, which has the fingerprint option, and also allows you to restrict clocking in or out to those IP addresses that you authorize. The system prevents employees from punching in from home, or a vacation house, or a distant casino. Other examples of cloud-based systems: Time Card Manager, Time Force, and Time America. PHP Timeclock is a free, open-source download – though setting it up on your server will require some technical expertise.
As always, I have no financial interest in any product or service discussed in this column. Whether you go the mechanical or electronic route, make sure that the system you choose has security measures in place to prevent anyone from altering the displayed time at will. You need to be reasonably certain that your time stamps have not been fudged.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J.
Every medical office, even the smallest, should have a time clock, and there are two very good reasons why. The obvious one is for stamping employee time cards. This is essential, even if all your employees are paid weekly or semiweekly rather than by the hour.
In most states, any employee who works more than 40 hours in any given week must be paid overtime wages. Employees know this, and disgruntled ones have been known to file complaints stating that they had worked hundreds of hours of unpaid overtime. This may be completely untrue, but labor boards almost invariably side with employees in such disputes – unless the employer can produce time records to disprove the claim. A time clock is cheap insurance against such headaches.
For hourly wage employees, time records are even more important, obviously because you only want to pay them for the hours they work. If you are paying your part-timers for the number of hours they should be working, without documenting how many hours they actually work, you could be paying for a lot of nonwork. Employees have little incentive to arrive on time or to stay the entire length of their shift, if they know they are being paid for a set number of hours anyway. And they certainly will balk at staying late if they can’t count on being paid for the extra time.
Time clocks also work to the advantage of your employees, since they will be paid for all the time they work. In fact, if any employees object to being asked to punch in every day, point out that they will be assured of payment for fractional time worked past their usual hours – time which until now may have gone unpaid.
The second – possibly more important – reason to have a time clock is to punch in your patients. A time clock is a great tool in the endless struggle to run your practice on time.
As each patient arrives, have your receptionist time-stamp the "encounter form" that goes back with the patient’s chart. As you take each chart off the door and enter the room, one glance at the time stamp will tell you exactly how long that patient has been waiting.
Now you no longer have to guess how far behind you are – and you’ll have an answer for the curmudgeon who walked in 15 minutes ago, but insists he’s been sitting there for 2 hours.
Time/attendance systems range from simple and cheap to complex and expensive. Many of the newer mechanical clocks will automatically calculate time between punches and total work time, and these can be configured for weekly, biweekly, semimonthly or monthly pay periods. Some will automatically deduct meal breaks from the totals. However, remember that you can only exclude meal breaks from compensable time when an employee is completely relieved of work duties for at least 1 uninterrupted half-hour.
If you have a problem with "buddy punching" (employees punching in or out for each other), some clocks are equipped to recognize fingerprints or hand contours.
There are also electronic timing systems, both web-based and in-house, which can be deployed across a local computer network. These systems will print time sheets with employee hours and earnings calculated, and some will even interface with financial software such as QuickBooks and other third party payroll services.
One popular Web-based system is Count Me In, which has the fingerprint option, and also allows you to restrict clocking in or out to those IP addresses that you authorize. The system prevents employees from punching in from home, or a vacation house, or a distant casino. Other examples of cloud-based systems: Time Card Manager, Time Force, and Time America. PHP Timeclock is a free, open-source download – though setting it up on your server will require some technical expertise.
As always, I have no financial interest in any product or service discussed in this column. Whether you go the mechanical or electronic route, make sure that the system you choose has security measures in place to prevent anyone from altering the displayed time at will. You need to be reasonably certain that your time stamps have not been fudged.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J.
Every medical office, even the smallest, should have a time clock, and there are two very good reasons why. The obvious one is for stamping employee time cards. This is essential, even if all your employees are paid weekly or semiweekly rather than by the hour.
In most states, any employee who works more than 40 hours in any given week must be paid overtime wages. Employees know this, and disgruntled ones have been known to file complaints stating that they had worked hundreds of hours of unpaid overtime. This may be completely untrue, but labor boards almost invariably side with employees in such disputes – unless the employer can produce time records to disprove the claim. A time clock is cheap insurance against such headaches.
For hourly wage employees, time records are even more important, obviously because you only want to pay them for the hours they work. If you are paying your part-timers for the number of hours they should be working, without documenting how many hours they actually work, you could be paying for a lot of nonwork. Employees have little incentive to arrive on time or to stay the entire length of their shift, if they know they are being paid for a set number of hours anyway. And they certainly will balk at staying late if they can’t count on being paid for the extra time.
Time clocks also work to the advantage of your employees, since they will be paid for all the time they work. In fact, if any employees object to being asked to punch in every day, point out that they will be assured of payment for fractional time worked past their usual hours – time which until now may have gone unpaid.
The second – possibly more important – reason to have a time clock is to punch in your patients. A time clock is a great tool in the endless struggle to run your practice on time.
As each patient arrives, have your receptionist time-stamp the "encounter form" that goes back with the patient’s chart. As you take each chart off the door and enter the room, one glance at the time stamp will tell you exactly how long that patient has been waiting.
Now you no longer have to guess how far behind you are – and you’ll have an answer for the curmudgeon who walked in 15 minutes ago, but insists he’s been sitting there for 2 hours.
Time/attendance systems range from simple and cheap to complex and expensive. Many of the newer mechanical clocks will automatically calculate time between punches and total work time, and these can be configured for weekly, biweekly, semimonthly or monthly pay periods. Some will automatically deduct meal breaks from the totals. However, remember that you can only exclude meal breaks from compensable time when an employee is completely relieved of work duties for at least 1 uninterrupted half-hour.
If you have a problem with "buddy punching" (employees punching in or out for each other), some clocks are equipped to recognize fingerprints or hand contours.
There are also electronic timing systems, both web-based and in-house, which can be deployed across a local computer network. These systems will print time sheets with employee hours and earnings calculated, and some will even interface with financial software such as QuickBooks and other third party payroll services.
One popular Web-based system is Count Me In, which has the fingerprint option, and also allows you to restrict clocking in or out to those IP addresses that you authorize. The system prevents employees from punching in from home, or a vacation house, or a distant casino. Other examples of cloud-based systems: Time Card Manager, Time Force, and Time America. PHP Timeclock is a free, open-source download – though setting it up on your server will require some technical expertise.
As always, I have no financial interest in any product or service discussed in this column. Whether you go the mechanical or electronic route, make sure that the system you choose has security measures in place to prevent anyone from altering the displayed time at will. You need to be reasonably certain that your time stamps have not been fudged.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J.
Interferon-free regimen cures 100% of hard-to-treat hepatitis C
ATLANTA – Adding ledipasvir to sofosbuvir and ribavirin produced sustained virological responses 12 weeks after therapy in 100% of treatment-naive and prior nonresponder patients with chronic hepatitis C genotype 1 in the ELECTRON trial.
"Certainly adding a second direct-acting antiviral agent, ledipasvir, increases the efficacy of sofosbuvir plus ribavirin," Dr. Edward Gane said at the Conference on Retroviruses and Opportunistic Infections.
Three-quarters of the roughly 170 million people infected with hepatitis C virus (HCV) worldwide have genotype 1, the most difficult strain to treat.
Current treatment includes triple therapy with a protease inhibitor plus peginterferon and ribavirin for 24-48 weeks, but PI-based therapy is limited by complex dosing regimens, the potential for resistance, and lower responses in prior nonresponders, explained Dr. Gane of Auckland Clinical Studies in New Zealand.
The investigators hypothesized that combining two direct-acting antivirals with a different mechanism would enhance response.
At last year’s CROI meeting, Dr. Gane reported that treatment with the nucleotide NS5B inhibitor sofosbuvir (formerly known as GS-7977) and ribavirin alone led to early viral load suppression, but relapses within 4 weeks of stopping treatment resulted in 12-week posttreatment sustained virological response (SVR12) rates of 84% among treatment-naive patients and only 10% among previous interferon-based therapy null responders.
In the current arm of the trial, the NS5A inhibitor ledipasvir (formerly known as GS-5885) was added to sofosbuvir and weight-based ribavirin, all for 12 weeks, in 25 noncirrhotic treatment-naive and 9 null responders, defined by less than a 2-log reduction in HCV RNA after 12 weeks of peginterferon and ribavirin.
The majority of treatment-naive and null responders were genotype 1a (80% and 89%) and had high baseline HCV RNA loads (mean 5.9 log10 IU/mL and 6.9 log10 IU/mL). The more favorable IL28B genotype CC genotype was present in 36% of treatment-naive patients, but in no null responders. The patients median age was 48; 94% were white.
Early on–treatment viral suppression was very rapid, with all treatment-naive patients and all but one prior null responder having an undetectable viral load at week 4, Dr. Gane said. This patient’s load was on the threshold at week 4 and became undetectable by week 5, resulting in SVR12 rates of 100% in both groups.
No viral breakthroughs were observed, and all patients achieved an end-of-treatment response.
Unlike the earlier arm of the trial, however, both groups maintained undetectable HCV viral loads at 4 and 12 weeks after therapy, he said.
The triple combination was well tolerated and safe. Three serious adverse events occurred, but none were treatment related. One patient had to stop therapy at week 8 due to the event, but subsequently achieved SVR24. The most common adverse events were anemia (20%), depression (8%), and headache (4%), and all were in treatment-naive patients.
Grade 3 laboratory abnormalities occurred in 52% of the treatment-naive and 22% of null responders. No grade 4 abnormalities were seen, Dr. Gane said.
Ledipasvir and sofosbuvir have been combined into a single fixed-dose tablet and is being evaluated in phase III studies in patients with cirrhosis and to determine whether there is a need for ribavirin, he said. Additional studies are also underway to explore shorter durations of therapy.
ELECTRON was sponsored by Gilead Sciences. Dr. Gane reported ties with Gilead, Janssen-Cilag, Novartis, Pharmasset, Roche and Vertex.
 |
| Dr. Steven L. Flamm |
These results of the phaseII ELECTRON trial arm testing the all-oral regimen of sofosbuvir (NS5b polymerase inhibitor), ledipasvir (NS5a inhibitor) and weight-based ribavirin in patients with chronic HCV genotype 1 (without cirrhosis) adds to the recent number of stunning reports describing all-oral treatment regimens for chronic HCV. Such therapeutic approaches offer the promise of tolerable regimens that have outstanding efficacy and may have few or no contraindications to therapy.
It is unclear if patients with cirrhosis will respond as well as noncirrhotic patients did in ELECTRON and whether or not ribavirin is needed; phase III trials are currently underway to address these issues. If the phase II results are replicated in these phase III trials and if the medications are available to all patients who have chronic HCV genotype 1, this type of a regimen could represent the “apocalypse moment” for HCV, an age during which the most common type of HCV worldwide (genotype 1) is largely eliminated.
Steven L. Flamm, M.D., is chief of transplant hepatology and is professor of medicine in the division of gastroenterology and hepatology at Northwestern University Feinberg School of Medicine, Chicago. He disclosed receiving research support from Gilead and serving as an advisor to the company.
|
| Dr. Steven L. Flamm |
These results of the phaseII ELECTRON trial arm testing the all-oral regimen of sofosbuvir (NS5b polymerase inhibitor), ledipasvir (NS5a inhibitor) and weight-based ribavirin in patients with chronic HCV genotype 1 (without cirrhosis) adds to the recent number of stunning reports describing all-oral treatment regimens for chronic HCV. Such therapeutic approaches offer the promise of tolerable regimens that have outstanding efficacy and may have few or no contraindications to therapy.
It is unclear if patients with cirrhosis will respond as well as noncirrhotic patients did in ELECTRON and whether or not ribavirin is needed; phase III trials are currently underway to address these issues. If the phase II results are replicated in these phase III trials and if the medications are available to all patients who have chronic HCV genotype 1, this type of a regimen could represent the “apocalypse moment” for HCV, an age during which the most common type of HCV worldwide (genotype 1) is largely eliminated.
Steven L. Flamm, M.D., is chief of transplant hepatology and is professor of medicine in the division of gastroenterology and hepatology at Northwestern University Feinberg School of Medicine, Chicago. He disclosed receiving research support from Gilead and serving as an advisor to the company.
|
| Dr. Steven L. Flamm |
These results of the phaseII ELECTRON trial arm testing the all-oral regimen of sofosbuvir (NS5b polymerase inhibitor), ledipasvir (NS5a inhibitor) and weight-based ribavirin in patients with chronic HCV genotype 1 (without cirrhosis) adds to the recent number of stunning reports describing all-oral treatment regimens for chronic HCV. Such therapeutic approaches offer the promise of tolerable regimens that have outstanding efficacy and may have few or no contraindications to therapy.
It is unclear if patients with cirrhosis will respond as well as noncirrhotic patients did in ELECTRON and whether or not ribavirin is needed; phase III trials are currently underway to address these issues. If the phase II results are replicated in these phase III trials and if the medications are available to all patients who have chronic HCV genotype 1, this type of a regimen could represent the “apocalypse moment” for HCV, an age during which the most common type of HCV worldwide (genotype 1) is largely eliminated.
Steven L. Flamm, M.D., is chief of transplant hepatology and is professor of medicine in the division of gastroenterology and hepatology at Northwestern University Feinberg School of Medicine, Chicago. He disclosed receiving research support from Gilead and serving as an advisor to the company.
ATLANTA – Adding ledipasvir to sofosbuvir and ribavirin produced sustained virological responses 12 weeks after therapy in 100% of treatment-naive and prior nonresponder patients with chronic hepatitis C genotype 1 in the ELECTRON trial.
"Certainly adding a second direct-acting antiviral agent, ledipasvir, increases the efficacy of sofosbuvir plus ribavirin," Dr. Edward Gane said at the Conference on Retroviruses and Opportunistic Infections.
Three-quarters of the roughly 170 million people infected with hepatitis C virus (HCV) worldwide have genotype 1, the most difficult strain to treat.
Current treatment includes triple therapy with a protease inhibitor plus peginterferon and ribavirin for 24-48 weeks, but PI-based therapy is limited by complex dosing regimens, the potential for resistance, and lower responses in prior nonresponders, explained Dr. Gane of Auckland Clinical Studies in New Zealand.
The investigators hypothesized that combining two direct-acting antivirals with a different mechanism would enhance response.
At last year’s CROI meeting, Dr. Gane reported that treatment with the nucleotide NS5B inhibitor sofosbuvir (formerly known as GS-7977) and ribavirin alone led to early viral load suppression, but relapses within 4 weeks of stopping treatment resulted in 12-week posttreatment sustained virological response (SVR12) rates of 84% among treatment-naive patients and only 10% among previous interferon-based therapy null responders.
In the current arm of the trial, the NS5A inhibitor ledipasvir (formerly known as GS-5885) was added to sofosbuvir and weight-based ribavirin, all for 12 weeks, in 25 noncirrhotic treatment-naive and 9 null responders, defined by less than a 2-log reduction in HCV RNA after 12 weeks of peginterferon and ribavirin.
The majority of treatment-naive and null responders were genotype 1a (80% and 89%) and had high baseline HCV RNA loads (mean 5.9 log10 IU/mL and 6.9 log10 IU/mL). The more favorable IL28B genotype CC genotype was present in 36% of treatment-naive patients, but in no null responders. The patients median age was 48; 94% were white.
Early on–treatment viral suppression was very rapid, with all treatment-naive patients and all but one prior null responder having an undetectable viral load at week 4, Dr. Gane said. This patient’s load was on the threshold at week 4 and became undetectable by week 5, resulting in SVR12 rates of 100% in both groups.
No viral breakthroughs were observed, and all patients achieved an end-of-treatment response.
Unlike the earlier arm of the trial, however, both groups maintained undetectable HCV viral loads at 4 and 12 weeks after therapy, he said.
The triple combination was well tolerated and safe. Three serious adverse events occurred, but none were treatment related. One patient had to stop therapy at week 8 due to the event, but subsequently achieved SVR24. The most common adverse events were anemia (20%), depression (8%), and headache (4%), and all were in treatment-naive patients.
Grade 3 laboratory abnormalities occurred in 52% of the treatment-naive and 22% of null responders. No grade 4 abnormalities were seen, Dr. Gane said.
Ledipasvir and sofosbuvir have been combined into a single fixed-dose tablet and is being evaluated in phase III studies in patients with cirrhosis and to determine whether there is a need for ribavirin, he said. Additional studies are also underway to explore shorter durations of therapy.
ELECTRON was sponsored by Gilead Sciences. Dr. Gane reported ties with Gilead, Janssen-Cilag, Novartis, Pharmasset, Roche and Vertex.
ATLANTA – Adding ledipasvir to sofosbuvir and ribavirin produced sustained virological responses 12 weeks after therapy in 100% of treatment-naive and prior nonresponder patients with chronic hepatitis C genotype 1 in the ELECTRON trial.
"Certainly adding a second direct-acting antiviral agent, ledipasvir, increases the efficacy of sofosbuvir plus ribavirin," Dr. Edward Gane said at the Conference on Retroviruses and Opportunistic Infections.
Three-quarters of the roughly 170 million people infected with hepatitis C virus (HCV) worldwide have genotype 1, the most difficult strain to treat.
Current treatment includes triple therapy with a protease inhibitor plus peginterferon and ribavirin for 24-48 weeks, but PI-based therapy is limited by complex dosing regimens, the potential for resistance, and lower responses in prior nonresponders, explained Dr. Gane of Auckland Clinical Studies in New Zealand.
The investigators hypothesized that combining two direct-acting antivirals with a different mechanism would enhance response.
At last year’s CROI meeting, Dr. Gane reported that treatment with the nucleotide NS5B inhibitor sofosbuvir (formerly known as GS-7977) and ribavirin alone led to early viral load suppression, but relapses within 4 weeks of stopping treatment resulted in 12-week posttreatment sustained virological response (SVR12) rates of 84% among treatment-naive patients and only 10% among previous interferon-based therapy null responders.
In the current arm of the trial, the NS5A inhibitor ledipasvir (formerly known as GS-5885) was added to sofosbuvir and weight-based ribavirin, all for 12 weeks, in 25 noncirrhotic treatment-naive and 9 null responders, defined by less than a 2-log reduction in HCV RNA after 12 weeks of peginterferon and ribavirin.
The majority of treatment-naive and null responders were genotype 1a (80% and 89%) and had high baseline HCV RNA loads (mean 5.9 log10 IU/mL and 6.9 log10 IU/mL). The more favorable IL28B genotype CC genotype was present in 36% of treatment-naive patients, but in no null responders. The patients median age was 48; 94% were white.
Early on–treatment viral suppression was very rapid, with all treatment-naive patients and all but one prior null responder having an undetectable viral load at week 4, Dr. Gane said. This patient’s load was on the threshold at week 4 and became undetectable by week 5, resulting in SVR12 rates of 100% in both groups.
No viral breakthroughs were observed, and all patients achieved an end-of-treatment response.
Unlike the earlier arm of the trial, however, both groups maintained undetectable HCV viral loads at 4 and 12 weeks after therapy, he said.
The triple combination was well tolerated and safe. Three serious adverse events occurred, but none were treatment related. One patient had to stop therapy at week 8 due to the event, but subsequently achieved SVR24. The most common adverse events were anemia (20%), depression (8%), and headache (4%), and all were in treatment-naive patients.
Grade 3 laboratory abnormalities occurred in 52% of the treatment-naive and 22% of null responders. No grade 4 abnormalities were seen, Dr. Gane said.
Ledipasvir and sofosbuvir have been combined into a single fixed-dose tablet and is being evaluated in phase III studies in patients with cirrhosis and to determine whether there is a need for ribavirin, he said. Additional studies are also underway to explore shorter durations of therapy.
ELECTRON was sponsored by Gilead Sciences. Dr. Gane reported ties with Gilead, Janssen-Cilag, Novartis, Pharmasset, Roche and Vertex.
AT CROI 2013
Major finding: Sustained virological response rates 12 weeks posttreatment were 100% in treatment-naive and prior null responders.
Data source: In an arm of the ELECTRON trial, the NS5A inhibitor ledipasvir (formerly known as GS-5885) was added to sofosbuvir and weight-based ribavirin, all for 12 weeks, in 25 noncirrhotic treatment-naive and 9 null responders.
Disclosures: ELECTRON was sponsored by Gilead Sciences. Dr. Gane reported ties with Gilead, Janssen-Cilag, Novartis, Pharmasset, Roche and Vertex.
FDA again rejects rivaroxaban for ACS
Credit: CDC
For a second time, the FDA has decided against approving rivaroxaban (Xarelto) to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS).
The agency has issued a complete response letter to the drug’s makers, Janssen Pharmaceuticals.
The contents of the letter are not publicly known, but representatives at Janssen have said they “are evaluating the letter and will respond to the agency’s questions.”
This is not the first time the FDA has raised questions about the use of rivaroxaban in ACS. Last June, the agency issued a complete response letter requesting additional information on the drug.
A month before that, an FDA review committee had expressed concerns about missing follow-up data from the ATLAS ACS 2 TIMI 51 trial (JL Mega et al, NEJM, 2012).
So in September, Janssen supplied the FDA with data on the patients who had withdrawn from trial. The company was able to confirm the vital status information for 843 (63%) of the 1338 trial participants who previously had unknown vital status.
Of those 843 patients, 37 had died. The company said the deaths were equally distributed among the treatment groups—rivaroxaban at 2.5 mg, rivaroxaban at 5 mg, and placebo.
“We remain confident in the robustness and results of the ATLAS ACS 2 TIMI 51 trial, evidenced by a significant reduction in cardiovascular events, including a clinically important decrease in cardiovascular death . . . ,” said Christopher Nessel, Vice President at Janssen.
“While we saw an increase in major bleeding, there was no increase in fatal bleeding. We will continue to work with the FDA to address their questions.”
Rivaroxaban is already approved by the FDA to treat and prevent the recurrence of deep vein thrombosis and pulmonary embolism, as thromboprophylaxis in patients who have undergone knee or hip replacement surgery, as well as to reduce the risk of stroke in patients with non-valvular atrial fibrillation. 
Credit: CDC
For a second time, the FDA has decided against approving rivaroxaban (Xarelto) to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS).
The agency has issued a complete response letter to the drug’s makers, Janssen Pharmaceuticals.
The contents of the letter are not publicly known, but representatives at Janssen have said they “are evaluating the letter and will respond to the agency’s questions.”
This is not the first time the FDA has raised questions about the use of rivaroxaban in ACS. Last June, the agency issued a complete response letter requesting additional information on the drug.
A month before that, an FDA review committee had expressed concerns about missing follow-up data from the ATLAS ACS 2 TIMI 51 trial (JL Mega et al, NEJM, 2012).
So in September, Janssen supplied the FDA with data on the patients who had withdrawn from trial. The company was able to confirm the vital status information for 843 (63%) of the 1338 trial participants who previously had unknown vital status.
Of those 843 patients, 37 had died. The company said the deaths were equally distributed among the treatment groups—rivaroxaban at 2.5 mg, rivaroxaban at 5 mg, and placebo.
“We remain confident in the robustness and results of the ATLAS ACS 2 TIMI 51 trial, evidenced by a significant reduction in cardiovascular events, including a clinically important decrease in cardiovascular death . . . ,” said Christopher Nessel, Vice President at Janssen.
“While we saw an increase in major bleeding, there was no increase in fatal bleeding. We will continue to work with the FDA to address their questions.”
Rivaroxaban is already approved by the FDA to treat and prevent the recurrence of deep vein thrombosis and pulmonary embolism, as thromboprophylaxis in patients who have undergone knee or hip replacement surgery, as well as to reduce the risk of stroke in patients with non-valvular atrial fibrillation.
Credit: CDC
For a second time, the FDA has decided against approving rivaroxaban (Xarelto) to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS).
The agency has issued a complete response letter to the drug’s makers, Janssen Pharmaceuticals.
The contents of the letter are not publicly known, but representatives at Janssen have said they “are evaluating the letter and will respond to the agency’s questions.”
This is not the first time the FDA has raised questions about the use of rivaroxaban in ACS. Last June, the agency issued a complete response letter requesting additional information on the drug.
A month before that, an FDA review committee had expressed concerns about missing follow-up data from the ATLAS ACS 2 TIMI 51 trial (JL Mega et al, NEJM, 2012).
So in September, Janssen supplied the FDA with data on the patients who had withdrawn from trial. The company was able to confirm the vital status information for 843 (63%) of the 1338 trial participants who previously had unknown vital status.
Of those 843 patients, 37 had died. The company said the deaths were equally distributed among the treatment groups—rivaroxaban at 2.5 mg, rivaroxaban at 5 mg, and placebo.
“We remain confident in the robustness and results of the ATLAS ACS 2 TIMI 51 trial, evidenced by a significant reduction in cardiovascular events, including a clinically important decrease in cardiovascular death . . . ,” said Christopher Nessel, Vice President at Janssen.
“While we saw an increase in major bleeding, there was no increase in fatal bleeding. We will continue to work with the FDA to address their questions.”
Rivaroxaban is already approved by the FDA to treat and prevent the recurrence of deep vein thrombosis and pulmonary embolism, as thromboprophylaxis in patients who have undergone knee or hip replacement surgery, as well as to reduce the risk of stroke in patients with non-valvular atrial fibrillation.
The Heart Team
Although to many, the concept of Heart Teams, as examined in Mitchel L. Zoler’s article, "Heart teams inch into routine cardiac practice," seem novel, such collaborations were the norm at the dawn of cardiac surgery.
Beginning with the surgical approach to valvular and, later, coronary vascular surgery, the interaction between cardiac physiologists (as they were called then), coronary angiographers, and cardiac surgeons in deciding where and when to operate was often difficult and contentious. Cardiac surgery was a high-risk procedure, and the outcomes were uncertain. Over the last 50 years we have come a long way and much of what we do is almost commonplace, as frequently performed as a cholecystectomy or appendectomy and with similar risks. Over time, we have become casual with our decision-making process. Both cardiologists and cardiac surgeons have staked out their own therapeutic parameters. Specialty society guidelines have provided important boundaries within which we can and should operate.
At the same time, we continue to push the envelope to identify therapeutic targets and technologies. We have developed complex interventional and surgical procedures and have applied them to older and sicker patient populations. New technology has opened avenues of therapy that we could not have imagined at the inception of interventional cardiology and cardiac surgery.
The advanced interventional surgical approach now requires even greater interaction with more special players in both cardiology and surgery. Although the modern cardiology practice is built on everyday procedures that provide the platform on which we treat a variety of cardiac issues that commonly do not require ongoing group interactions, the new treatment options require a more interactive and collegial environment. It is in this domain that the Heart Team has an important role and has found success. It was re-initiated as a result of the development of the transcatheter aortic valve implantation, which requires close cardiology and surgical interaction. It has expanded as a team approach to the treatment choices in the care of patients with structural heart disease.
Definitions of the boundaries of the new therapies raise important economic and professional challenges. The Heart Team as currently organized provides the framework of that discourse. To some, it will represent an inconvenience and an obstruction to their individual professional performance: The requirement to participate in a structured interaction is just one more barrier to the daily performance of their skills. To others, it will provide an important process that will improve performance: It is an opportunity to coordinate the different skills required for the advance treatments and, more importantly, it represents a forum to educate not only the current participants but also the physician, nurses, and technicians for the future. The discussion and planning for the surgical approach for a particular patient provides a dynamic discussion of the therapeutic options and the important decisions about appropriateness of the procedure. This interactive learning process is critical to the interdisciplinary training of all present and future players.
The growth of cardiovascular therapy has led to the construction of large stand-alone units or sections within hospitals identified as heart centers or institutes. The creation of these facilities provides the professional structure and financial environment to create the Heart Team and answer some of the issues raised in the article in this issue. Initially devised as a combination of marketing and professional associations, they now can provide the educational and scientific structure of the Heart Team.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Although to many, the concept of Heart Teams, as examined in Mitchel L. Zoler’s article, "Heart teams inch into routine cardiac practice," seem novel, such collaborations were the norm at the dawn of cardiac surgery.
Beginning with the surgical approach to valvular and, later, coronary vascular surgery, the interaction between cardiac physiologists (as they were called then), coronary angiographers, and cardiac surgeons in deciding where and when to operate was often difficult and contentious. Cardiac surgery was a high-risk procedure, and the outcomes were uncertain. Over the last 50 years we have come a long way and much of what we do is almost commonplace, as frequently performed as a cholecystectomy or appendectomy and with similar risks. Over time, we have become casual with our decision-making process. Both cardiologists and cardiac surgeons have staked out their own therapeutic parameters. Specialty society guidelines have provided important boundaries within which we can and should operate.
At the same time, we continue to push the envelope to identify therapeutic targets and technologies. We have developed complex interventional and surgical procedures and have applied them to older and sicker patient populations. New technology has opened avenues of therapy that we could not have imagined at the inception of interventional cardiology and cardiac surgery.
The advanced interventional surgical approach now requires even greater interaction with more special players in both cardiology and surgery. Although the modern cardiology practice is built on everyday procedures that provide the platform on which we treat a variety of cardiac issues that commonly do not require ongoing group interactions, the new treatment options require a more interactive and collegial environment. It is in this domain that the Heart Team has an important role and has found success. It was re-initiated as a result of the development of the transcatheter aortic valve implantation, which requires close cardiology and surgical interaction. It has expanded as a team approach to the treatment choices in the care of patients with structural heart disease.
Definitions of the boundaries of the new therapies raise important economic and professional challenges. The Heart Team as currently organized provides the framework of that discourse. To some, it will represent an inconvenience and an obstruction to their individual professional performance: The requirement to participate in a structured interaction is just one more barrier to the daily performance of their skills. To others, it will provide an important process that will improve performance: It is an opportunity to coordinate the different skills required for the advance treatments and, more importantly, it represents a forum to educate not only the current participants but also the physician, nurses, and technicians for the future. The discussion and planning for the surgical approach for a particular patient provides a dynamic discussion of the therapeutic options and the important decisions about appropriateness of the procedure. This interactive learning process is critical to the interdisciplinary training of all present and future players.
The growth of cardiovascular therapy has led to the construction of large stand-alone units or sections within hospitals identified as heart centers or institutes. The creation of these facilities provides the professional structure and financial environment to create the Heart Team and answer some of the issues raised in the article in this issue. Initially devised as a combination of marketing and professional associations, they now can provide the educational and scientific structure of the Heart Team.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Although to many, the concept of Heart Teams, as examined in Mitchel L. Zoler’s article, "Heart teams inch into routine cardiac practice," seem novel, such collaborations were the norm at the dawn of cardiac surgery.
Beginning with the surgical approach to valvular and, later, coronary vascular surgery, the interaction between cardiac physiologists (as they were called then), coronary angiographers, and cardiac surgeons in deciding where and when to operate was often difficult and contentious. Cardiac surgery was a high-risk procedure, and the outcomes were uncertain. Over the last 50 years we have come a long way and much of what we do is almost commonplace, as frequently performed as a cholecystectomy or appendectomy and with similar risks. Over time, we have become casual with our decision-making process. Both cardiologists and cardiac surgeons have staked out their own therapeutic parameters. Specialty society guidelines have provided important boundaries within which we can and should operate.
At the same time, we continue to push the envelope to identify therapeutic targets and technologies. We have developed complex interventional and surgical procedures and have applied them to older and sicker patient populations. New technology has opened avenues of therapy that we could not have imagined at the inception of interventional cardiology and cardiac surgery.
The advanced interventional surgical approach now requires even greater interaction with more special players in both cardiology and surgery. Although the modern cardiology practice is built on everyday procedures that provide the platform on which we treat a variety of cardiac issues that commonly do not require ongoing group interactions, the new treatment options require a more interactive and collegial environment. It is in this domain that the Heart Team has an important role and has found success. It was re-initiated as a result of the development of the transcatheter aortic valve implantation, which requires close cardiology and surgical interaction. It has expanded as a team approach to the treatment choices in the care of patients with structural heart disease.
Definitions of the boundaries of the new therapies raise important economic and professional challenges. The Heart Team as currently organized provides the framework of that discourse. To some, it will represent an inconvenience and an obstruction to their individual professional performance: The requirement to participate in a structured interaction is just one more barrier to the daily performance of their skills. To others, it will provide an important process that will improve performance: It is an opportunity to coordinate the different skills required for the advance treatments and, more importantly, it represents a forum to educate not only the current participants but also the physician, nurses, and technicians for the future. The discussion and planning for the surgical approach for a particular patient provides a dynamic discussion of the therapeutic options and the important decisions about appropriateness of the procedure. This interactive learning process is critical to the interdisciplinary training of all present and future players.
The growth of cardiovascular therapy has led to the construction of large stand-alone units or sections within hospitals identified as heart centers or institutes. The creation of these facilities provides the professional structure and financial environment to create the Heart Team and answer some of the issues raised in the article in this issue. Initially devised as a combination of marketing and professional associations, they now can provide the educational and scientific structure of the Heart Team.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Improving Family Engagement During FCR
A growing body of literature suggests that patient‐ and family‐centered care can improve patient outcomes[1, 2, 3, 4, 5] as well as patient, family, and provider satisfaction.[6, 7, 8, 9, 10] Engaging patients and families as a way to improve the quality and safety of care has been widely endorsed by leading healthcare organizations,[11, 12, 13] including the Institute of Medicine.[14] In the pediatric inpatient setting, family‐centered rounds (FCR), defined as bedside rounds in which the patient and family share in the control of the management plan as well as in the evaluation of the process itself,[15] potentially provide a consistent venue for family engagement and are recommended by the American Academy of Pediatrics as standard practice.[13]
According to a recent study by Mittal et al.,[16] FCR are the most common type of rounds practiced among pediatric hospitalists surveyed in the United States and Canada. Despite this widespread shift from rounding in a conference room to the bedside with patients and families, there exist only a few studies that provide specific recommendations on conducting FCR.[15, 17, 18] This research has been limited, primarily focusing how rounds are conducted, and further investigation is needed to identify the impact of other processes and elements within the hospital work system that may also affect family engagement during rounds.
The objectives of this study were to: 1) identify strategies to enhance family engagement during FCR drawing from the viewpoints of the various stakeholders on rounds, and 2) characterize these strategies into known elements of hospital work systems and rounding processes using a recognized human factors engineering approach, The Systems Engineering Initiative for Patient Safety (SEIPS) model.[19] According to the SEIPS model, barriers and facilitators to family engagement during FCR are likely embedded in the design of the hospital work systems and rounding process; therefore, we hypothesized that strategies that influence engagement will target all work system and process elements. This work is part of a larger study in which, after prioritization of this group of strategies based on feasibility and sustainability, a bundle of best practices for conducting FCR will be developed, implemented, and evaluated.
METHODS
Study Design
Semistructured interviews using the stimulated recall approach[20, 21] were conducted to understand the cognitive processes of families and healthcare team (HCT) members during FCR. This qualitative study design allowed us to capture comprehensive information from the perspectives of a diverse group of stakeholders on strategies for improving family engagement during FCR.
Setting and Participants
This study was conducted at a children's hospital in Wisconsin, where FCR were initiated in 2007 with the transition to a new hospital facility. The expectation is that FCR are conducted daily with the family and the patient's HCT, consisting of at least an attending physician and nurse. Typically, multiple residents, interns, and medical students are present along with a combination of other providers, including consulting subspecialists, a fellow, nurse practitioner, respiratory therapist, or pharmacist. When this study was conducted, attendees received little to no formal training regarding their role on FCR. As part of a larger study, English‐speaking patients and/or families admitted to 1 of 4 inpatient services (2 hospitalist, 1 pulmonary, and 1 hematology/oncology), and their associated HCT members were enrolled and their bedside rounds were video recorded. A purposive sampling technique[22, 23] was employed, recruiting interviewees that represented the various groups of stakeholders of rounds, including parents, children, attending physicians, resident physicians, medical students, and nurses. For child interviews, we restricted selection to children aged 8 to 17 years to ensure the ability to understand the interviewing process and provide feedback. Families were consented and children were assented. The University of Wisconsin‐Madison Health Sciences Institutional Review Board approved this study.
Interviews and analysis occurred concurrently in an iterative process, informing each other. Thus, recruitment continued until we reached theoretical saturation,[24, 25] the point at which additional interviews did not provide new information or further conceptual development.
Study Procedures
All interviews were conducted by trained researchers, who used the same semistructured interview guide. During each interview, the interviewee was instructed to watch his/her own rounding video and pause when noticing something that made it easy (facilitator) or hard (barrier) to engage the family. Every time the interviewee paused the video to describe what was noticed, the interviewer then asked follow‐up, open‐ended questions to solicit specific information that focused on strategies for enhancing family engagement during FCR. For instance, if the issue identified was a barrier, the interviewer asked, What would you have wanted to happen differently? and if the issue identified was a facilitator, the interviewer asked, How could we ensure that would happen for everyone? The interviewee rewound the video as needed. If the interviewee had not stopped the video by the halfway point, the interviewer would pause the video and review the instructions. After the interviewee had viewed and commented on the entire rounding video, an opportunity was offered to reflect on other factors that influence family engagement during rounds, and additional questions were asked as necessary to fully understand the interviewee's views. All interviews were audio recorded and personal identifiers were removed prior to data analysis.
Data Analysis
Two research assistants reviewed the audio recordings and identified all instances related to strategies for improving family engagement during FCR. There was no screening of strategies (ie, if an interviewee suggested a strategy was related to improving family engagement, it was categorized as such). To ensure intercoder reliability, these assistants, under the supervision of a researcher (L.D.), reviewed the coding process together, held consensus meetings, and crosschecked interviews for coding consensus. A researcher (A.X.) transcribed all strategy‐related instances, which were then reviewed by two additional researchers (M.K., P.C.). To organize, sort, and code the data, interview transcripts were imported in the NVivo qualitative data analysis software (QSR International, Doncaster, Victoria, Australia). The research group then performed a qualitative content analysis of the transcripts[26] and categorized the strategies in an iterative process (information provided on request).
To ensure that all strategies remained conceptually similar within categories, the constant comparative method[27, 28] was applied to the coding process. This involved comparing: 1) strategy‐related instances from the same participants, 2) strategy‐related instances from different participants in the same groups, 3) strategy‐related instances from different participants in different groups, 4) a coded strategy with other coded strategies, 5) coded strategies with categories, and 6) a category with other categories. A strategy‐related instance could be coded under more than one strategy or category. For instance, one interviewee said conducting things that can be done without family beforehand, and presenting and reviewing the plan with family. This was coded under both the strategy conducting rounds in another location without family and then at the bedside with family in the location of FCR category and the strategy focusing presentation on assessment and plan in the communication style category.
RESULTS
A total of 37 interviews were conducted with 11 parents, 4 children, and 22 HCT members (8 attending physicians, 6 resident physicians, 5 medical students, and 3 nurses) in 24 videos of rounding sessions. The duration of the interviews ranged from 30 to 60 minutes.
A total of 338 separate instances related to strategies for improving family engagement on FCR were identified and sorted into 21 categories. Using the SEIPS model, these categories were organized into 2 themes: the work system and process of FCR (Figure 1). Of the 21 categories, 12 were mentioned by both families (parents and/or children) and HCT members and 9 were solely mentioned by the HCT.
Work System of FCR
Table 1 shows the categories of strategies related to the 5 elements of the FCR work system.[29, 30] Illustrative quotes from the interviews (Q) are presented in Table 2.
| Work System Elements | Categories | Strategies | P (11) | C (4) | Att. (8) | Res. (6) | MS (5) | RN (3) |
|---|---|---|---|---|---|---|---|---|
| ||||||||
| People | 1. Size and composition of HCT | Have a smaller HCT conduct FCR | X | X | X | X | ||
| Ensure all relevant disciplines present on FCR | X | X | X | X | X | |||
| Task | 2. Roles and duties of HCT members | Define roles/duties of HCT members on FCR | X | X | ||||
| Organization | 3. Timing and scheduling of FCR | Schedule FCR, inform participants beforehand | X | X | X | |||
| 4. Training of HCT for FCR | Train HCT on how to present on FCR | X | X | |||||
| Environment | 5. Location of FCR | At bedside with family and patient | X | X | ||||
| In another location with HCT, then at bedside | X | X | X | X | ||||
| In another location with family but without child | X | |||||||
| 6. Positioning of HCT members on FCR | Sit down with family | X | X | X | X | X | ||
| Stand close to or in a semicircle around family | X | X | X | X | X | |||
| Tools and technologies | 7. Use of computers on FCR | Use computer to support family interaction | X | X | X | X | ||
| Don't use a computer | X | X | ||||||
|
| Q1: I'm intimidated to ask a question. It seems like there are too many peopleI like a smaller group. (P5) |
| Q2: Sometimes rounds are the only time that the parents are there to see the entire teamso in that way, including [the entire team] at the rounds makes more sense. (MS1) |
| Q3: There needs to be much more clear roles about who is supposed to do what, and it should be predictable. (Att.2) |
| Q4: ([T]iming of rounds) is a huge source of frustration for families. If [physicians] know in which order they will go for patients, they can call our charge nurse or unit clerk or page nurses with that information. (RN1) |
| Q5: ([W]ith a notice of the rounding schedule), I can be ahead of time, trying to think of questions. (P10) |
| Q6: [I]t would be really nice to see somebody do a presentation in a medical eye's version and then also in the family‐centered version. (MS5) |
| Q7: [H]aving the medical students practice with the senior residentis a good way of doing it. (Res.4) |
| Q8: [M]aybe some small groups where you practice this among students. (MS5) |
| Q9: It would be better to be in the room for communication. (Att.1) |
| Q10: You could have sort of hallway rounds, which is much more medical oriented, and inside‐the‐room rounds, which is much more talking with the parent. (P1) |
| Q11: [H]ave sit‐down rounds with parents and families. (Res.5) |
| Q12: I've seen some attending physicians who sat down. I think that could be helpful to be on the same level as the patient and family. (Res.2) |
| Q13: [M]aybe formation of semicircle or something like that, where we can see everybody a little more clearly, I think that would be very helpful. (P10) |
| Q14: I find the presence of a computer incredibly offensive and obstructivewhen you are supposed to be able to interact with the patient. (Att.6) |
| Q15: One of the things I started doing is having one of the other resident physicians have the computer, so just relying on them to do the orders, and me just being there mainly for being the presenter of rounds. (Res.4) |
People
Two seemingly contradictory strategies were proposed. Some interviewees suggested a smaller HCT with members most familiar to the family (Q1), whereas other interviewees stressed the need to involve different relevant disciplines (eg, social worker, nutritionist) during rounds (Q2).
Tasks
Both attending and resident physicians emphasized the importance of defining the role of each HCT member before rounding (Q3). Interviewees also suggested these roles should be explained to families, ideally at admission.
Organization
Many interviewees suggested the need to consistently schedule rounds (Q4) and to inform families and nurses of the schedule so all parties could plan ahead (Q5). Some resident physicians and medical students recommended training of learners on how to give a family‐centered presentation using methods such as role modeling (Q6) and practicing with the senior resident physician (Q7) or in small groups (Q8).
Environment
Some interviewees suggested conducting rounds in patient rooms (Q9). Others suggested conducting rounds first in another location (eg, hallway) without the family and then going to the bedside to round with the family (Q10). There were also interviewees who suggested conducting rounds in another location (eg, conference room) with the family (Q11). When conducting rounds in the patient room, some interviewees suggested that some HCT members (eg, attending and senior resident physicians) could sit down with the family (Q12), with the rest of the HCT standing close to the family in a semicircle (Q13).
Tools and Technologies
Some interviewees thought that conversation with families could be negatively affected by the use of computers, and therefore suggested not using them on FCR (Q14). Alternatively, other interviewees considered computers a tool to facilitate the interaction between the HCT and families, such as showing x‐rays or lab values. Several interviewees suggested that computers should not be positioned to block eye contact between HCT members and families; therefore, only HCT members not presenting should use computers (Q15).
Process of FCR
Table 3 shows the categories of strategies related to the process of FCR, which were categorized into 3 phases. Illustrative quotes are presented in Table 4.
| Process Phases | Categories | Strategies | P (11) | C (4) | Att. (8) | Res. (6) | MS (5) | RN (3) |
|---|---|---|---|---|---|---|---|---|
| ||||||||
| Before FCR | 8. HCT preparation | Collect and prepare pertinent information | X | X | X | X | ||
| 9. Family preparation | Orient family to rounding process | X | X | X | X | X | ||
| Build relationship with family | X | X | X | |||||
| Ask family for permission and preferences | X | X | X | |||||
| During FCR | 10. Introduction and explanation of FCR | Introduce HCT and family to each other | X | X | X | X | X | |
| Explain interactive rounding process | X | X | X | |||||
| 11. Active involvement of nurse | Giving nurse opportunity to actively participate | X | X | |||||
| 12. Communication with family | Give family opportunity to actively participate | X | X | X | X | X | X | |
| Address family's questions/concerns | X | X | X | X | X | |||
| Explain tests, findings and results to family | X | X | X | X | X | |||
| Confirm family understanding | X | X | X | |||||
| 13. Giving presentation | Restructure the presentation | X | X | |||||
| Shorten the presentation | X | X | X | |||||
| Focus presentation on assessment and plan | X | X | X | X | X | |||
| Summarize plan for family | X | X | X | |||||
| Avoid discussion of sensitive topics | X | X | X | |||||
| 14. Communication style | Present in a conversational manner | X | X | X | ||||
| Use an engaging communication style | X | X | X | X | X | |||
| 15. Language used | Use qualitative language | X | X | X | ||||
| Use plain language | X | X | X | X | X | |||
| 16. Performing physical exam | Pause and confirm physical exam | X | ||||||
| 17. Managing distractions | Minimize distractions and interruptions | X | X | X | X | X | X | |
| 18. Senior physician leading/role modeling | Attending/senior resident physician should lead, direct and be a role model on FCR rounds | X | X | |||||
| 19. Teaching | Ask family permission and involve in teaching | X | X | |||||
| 20. Customizing FCR for family | Adapt rounds to family's needs | X | X | X | X | |||
| After FCR | 21. Following up with family | HCT members follow up with family | X | X | X | |||
|
| Q1: [Medical students and residents] actually had a chance to do a quick round, an abbreviated presentation to put together an outline of what we're going to talk about before we even do it. (MS2) |
| Q2: I would like to know exactly what's going onbefore I walk in. (Att.6) |
| Q3: [T]he nurse did give me the fore‐warning that rounds would be coming and it was usually like a group of 8 to 10so I was prepared for that. (P7) |
| Q4: What went well is that I had already connected with this mom and the daughter prior to this rounding encounter. (Res.3) |
| Q5: [Y]ou could ask the patient or the parents if they want the child there. (P3) |
| Q6: [Families] really want to know what your role is on the team. (Att.5) |
| Q7: I guess it would be easier to figure out who you need to direct questions to. (P3) |
| Q8: [L]etting the family anticipate what rounding is going to be like and when the opportunity is going to come up to talk. I think that can help. (Res.2) |
| Q9: I think the decision making is probably the most critical partthere is really no substitute for [families] being involved in the decisionwithout a lot of medical conversation and analysis. (P1) |
| Q10: The family was proactive enough to ask questions, but they were never really given entrance to ask questions.No one had said do you have any questions?' (Res.4) |
| Q11: It is really important for the doctors to listen to them, to know that they are the parents and they know their children best. (RN3) |
| Q12: I think sometimes when you are teaching, some of the information could potentially be scary to the family. What I would hope is letting the family feel like they are part of the education process. (Res.2) |
| Q13: Sometimes nurses are asked initially, do you have anything to add,' which I think is a good way to startbecause we have probably the most current and updated information. (RN1) |
| Q14: When I was talking about the physical exam partmaybe at that point, if I could just stop talking, we couldconfirm that exam. (Res.3) |
| Q15: It's distracting if different groups have individual discussions when you are trying to keep the group focused on this particular patient for rounds. (Att.7) |
| Q16: It's just the basic thing that I try to tell residents. I do this hopefully at least once every time I am on services with the team. (Att.1) |
| Q17: ([C]hanging rounds depending on the families) would be the ideal situationthinking about what's helpful for a family. (Att.6) |
| Q18: What I usually see when things work well after we leave is that the nurse can still stick around the family. (Res.4) |
| Q19: [T]he students have to go back in the afternoon to talk with the family about what the treatment point is and answer any questions. (MS2) |
Before FCR
To engage families during FCR, many interviewees suggested that both the HCT and families need preparation. HCT members suggested that medical students should collect up‐to‐date patient information and review it with the senior resident physicians (Q1) to reach a consensus before starting FCR (Q2). To prepare families for rounds, parents and HCT members suggested that the HCT should orient families to the rounding process (Q3), build relationships with families (Q4), and ask for their permission and preference regarding participation in rounds (Q5).
During FCR
A number of strategies focused on the beginning of rounds. Parents, children, and HCT members stressed the need to introduce HCT members by role (Q6) and inform families to whom to direct questions (Q7). It was also suggested that parents introduce themselves to the team. Some interviewees recommended that the HCT explain the rounding process to families at this time (Q8).
Interviewees recommended strategies related to communication between the HCT and families during rounds. Many interviewees suggested restructuring and shortening the presentation by focusing on the assessment and plan (Q9). According to all interviewees, the HCT should present in a conversational manner and use an engaging communication style (eg, smiling, making eye contact, using appropriate humor) and appropriate language (eg, qualitative trend instead of numbers, plain language instead of medical jargon) to communicate with families. To ensure families understanding, HCT members should encourage and address their questions and concerns (Q10). In addition, families should be given the opportunity to provide information (eg, patient history and overnight events) and to express their opinions about the plan (Q11). If teaching is done during rounds, the HCT should involve families and ask for permission (Q12).
Other strategies on rounds were suggested, such as giving nurses the opportunity to actively participate (Q13), pausing and confirming physical exam findings (Q14), minimizing distractions and interruptions (Q15), attending and/or senior resident physicians leading and being role models for FCR (Q16), and adapting rounds to families' needs (Q17).
After FCR
Some HCT members talked about the importance of following up with families after rounds. Specifically, suggestions that nurses could stay with families immediately after rounds (Q18) were made, whereas physicians could return to families later in the day (Q19).
DISCUSSION
Using recognized qualitative systems engineering methods, we identified a broad range of strategies for enhancing family engagement on FCR from the perspectives of a diverse group of stakeholders on rounds and described how these strategies target known fundamental elements in both the hospital work system and rounding process. We highlight recommendations on the content and style of communication during rounds with families, but also introduce more complex system‐wide elements that likely play a role in family engagement, such as the composition of the HCT; organization and environment of rounds; tools and technologies used; and preparation of the HCT, families, and patients beforehand.
Our research both confirms and builds upon practices previously described in the FCR literature.[17, 31, 32] In a case report by Muething et al.,[17] recommendations were developed using a series of plan‐do‐study‐act cycles to determine the components needed to conduct FCR. These components included: 1) determining family preference prior to rounds, 2) defining HCT roles, 3) introducing HCT to family and explaining the purpose of rounds, 4) describing what is shared and how it is said on rounds, 5) describing the contribution of families, nurses, and ancillary staff, and 6) providing teaching recommendations to senior physicians on rounds. All of these components are suggested by one or more of the participants in our study. In addition, our research identifies a variety of new work system‐related strategies, such as scheduling rounds, using computers appropriately on rounds, and providing training of HCT members beforehand.
Of particular interest was the discordance between strategies mentioned by families and the various members of the HCT. Although HCT members mentioned all identified strategies, families were interested in certain ones. Regarding the structure of FCR, families showed particular interest in HCT composition, timing and scheduling of rounds, location of rounds, and positioning of the HCT. In comparison, families did not mention the importance of the roles and duties of HCT members, HCT preparation for rounds, and use of computers during rounds. With respect to the FCR process, families stressed the importance of family preparation beforehand, introduction and explanation of rounds at the beginning, presentation style and communication style, customization, and management of distractions during rounds. None of the families, however, mentioned the rest of the strategies, including HCT preparation before rounds, involvement of the nurse, teaching and performing the physical exam, the role of the attending and senior resident roles during rounds, and following up with the family after rounds. These different perspectives are likely, in part, inherent to the different roles and experiences of parents and HCT members. For example, parents' knowledge of what goes on in the hospital outside of FCR, such as orientation and preparation of HCT members for rounds, is relatively limited. Future research using methods to evaluate and prioritize strategies as well as understanding reasons for contradicting strategies is warranted.
We recognize that, although family engagement is recommended as a critical component of care, strategies to improve engagement may be in direct opposition to other goals of the HCT. For example, some of our participants suggest having a smaller team may be more beneficial for family engagement on rounds. In some settings, it may be feasible to have a small team; however, in institutions that accommodate a large number of learners, excluding students from the teaching opportunity of rounds may actually compromise educational experiences. In patients with chronic and/or complex care, a larger multidisciplinary team may better facilitate information exchange among disciplines and expedite discharge planning. Moreover, one might speculate that it may not be that the size affects family engagement as much as the composition of the team, especially if tailored to the needs of the patient. For example, a large team consisting of primarily physicians and trainees may not be as engaging as the same sized team with one attending physician and a respiratory therapist, case manager, and consulting subspecialist. Finding a balance between engaging families, teaching learners, and maintaining efficiency is paramount and needs to be studied further.
This study has several limitations. Our data are from a single academic children's hospital, which may limit generalizability due to a small sampling of multiple stakeholders on different services, our specific patient population, HCT composition and roles, and teaching needs. However, we face similar barriers to engaging families during rounds as those published from both another single institution[17] and a national sampling of pediatric hospitalists.[16] Furthermore, our recommended strategies to address the FCR process are supported by prior work.[17] Because this study was voluntary, our interviewees were likely more engaged participants in general. Specifically, the viewpoints of engaged families and HCT members may not represent the viewpoints of those who are less engaged or supportive of FCR. We did not enroll nonEnglish‐speaking patients and families, which is a potential direction for future research. In our interviews, we also relied solely on the perceptions of rounding participants, rather than those of outside observers or researchers, which may only provide a partial perspective of potential strategies to improve family engagement. Last, this qualitative research approach does not provide quantitative information regarding whether certain strategies are preferred by a majority of participants, which we hope to address in future research.
This work is part of a larger study that aims to implement a bundle of these strategies after stakeholder prioritization based on impact on family engagement, feasibility, and sustainability. We plan to systematically evaluate the implementation process of these strategies and measure their impact on family engagement and, ultimately, patient safety. One or more of these strategies could be implemented in a similar manner at other hospitals depending on specific institutional needs.
In conclusion, as recently reflected by Barry et al. in The New England Journal of Medicine, Although talk about patient‐centered care is ubiquitous in modern health care, one of the greatest challenges of turning the rhetoric into reality continues to be routinely engaging patients in decision making.[33] FCR provide a crucial opportunity for family involvement in daily care decisions in the pediatric inpatient setting. This study highlights the importance of prior work defining the components of involving families in this process, while emphasizing new systems‐based strategies that further facilitate the expectation of family engagement in the care of hospitalized children.
Disclosures
This work was funded through an Agency for Healthcare Research and Quality Health Services Research Dissemination and Demonstration Grant, R18 HS018680, and also supported by the Arthur Vining Davis Foundation and the National Patient Safety Foundation through the James S. Todd Memorial Research Award. Funding organizations did not contribute to the design and conduct of study; collection, management, analysis, and interpretation of data; or preparation, review, or approval of the manuscript. The authors report no conflicts of interest.
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A growing body of literature suggests that patient‐ and family‐centered care can improve patient outcomes[1, 2, 3, 4, 5] as well as patient, family, and provider satisfaction.[6, 7, 8, 9, 10] Engaging patients and families as a way to improve the quality and safety of care has been widely endorsed by leading healthcare organizations,[11, 12, 13] including the Institute of Medicine.[14] In the pediatric inpatient setting, family‐centered rounds (FCR), defined as bedside rounds in which the patient and family share in the control of the management plan as well as in the evaluation of the process itself,[15] potentially provide a consistent venue for family engagement and are recommended by the American Academy of Pediatrics as standard practice.[13]
According to a recent study by Mittal et al.,[16] FCR are the most common type of rounds practiced among pediatric hospitalists surveyed in the United States and Canada. Despite this widespread shift from rounding in a conference room to the bedside with patients and families, there exist only a few studies that provide specific recommendations on conducting FCR.[15, 17, 18] This research has been limited, primarily focusing how rounds are conducted, and further investigation is needed to identify the impact of other processes and elements within the hospital work system that may also affect family engagement during rounds.
The objectives of this study were to: 1) identify strategies to enhance family engagement during FCR drawing from the viewpoints of the various stakeholders on rounds, and 2) characterize these strategies into known elements of hospital work systems and rounding processes using a recognized human factors engineering approach, The Systems Engineering Initiative for Patient Safety (SEIPS) model.[19] According to the SEIPS model, barriers and facilitators to family engagement during FCR are likely embedded in the design of the hospital work systems and rounding process; therefore, we hypothesized that strategies that influence engagement will target all work system and process elements. This work is part of a larger study in which, after prioritization of this group of strategies based on feasibility and sustainability, a bundle of best practices for conducting FCR will be developed, implemented, and evaluated.
METHODS
Study Design
Semistructured interviews using the stimulated recall approach[20, 21] were conducted to understand the cognitive processes of families and healthcare team (HCT) members during FCR. This qualitative study design allowed us to capture comprehensive information from the perspectives of a diverse group of stakeholders on strategies for improving family engagement during FCR.
Setting and Participants
This study was conducted at a children's hospital in Wisconsin, where FCR were initiated in 2007 with the transition to a new hospital facility. The expectation is that FCR are conducted daily with the family and the patient's HCT, consisting of at least an attending physician and nurse. Typically, multiple residents, interns, and medical students are present along with a combination of other providers, including consulting subspecialists, a fellow, nurse practitioner, respiratory therapist, or pharmacist. When this study was conducted, attendees received little to no formal training regarding their role on FCR. As part of a larger study, English‐speaking patients and/or families admitted to 1 of 4 inpatient services (2 hospitalist, 1 pulmonary, and 1 hematology/oncology), and their associated HCT members were enrolled and their bedside rounds were video recorded. A purposive sampling technique[22, 23] was employed, recruiting interviewees that represented the various groups of stakeholders of rounds, including parents, children, attending physicians, resident physicians, medical students, and nurses. For child interviews, we restricted selection to children aged 8 to 17 years to ensure the ability to understand the interviewing process and provide feedback. Families were consented and children were assented. The University of Wisconsin‐Madison Health Sciences Institutional Review Board approved this study.
Interviews and analysis occurred concurrently in an iterative process, informing each other. Thus, recruitment continued until we reached theoretical saturation,[24, 25] the point at which additional interviews did not provide new information or further conceptual development.
Study Procedures
All interviews were conducted by trained researchers, who used the same semistructured interview guide. During each interview, the interviewee was instructed to watch his/her own rounding video and pause when noticing something that made it easy (facilitator) or hard (barrier) to engage the family. Every time the interviewee paused the video to describe what was noticed, the interviewer then asked follow‐up, open‐ended questions to solicit specific information that focused on strategies for enhancing family engagement during FCR. For instance, if the issue identified was a barrier, the interviewer asked, What would you have wanted to happen differently? and if the issue identified was a facilitator, the interviewer asked, How could we ensure that would happen for everyone? The interviewee rewound the video as needed. If the interviewee had not stopped the video by the halfway point, the interviewer would pause the video and review the instructions. After the interviewee had viewed and commented on the entire rounding video, an opportunity was offered to reflect on other factors that influence family engagement during rounds, and additional questions were asked as necessary to fully understand the interviewee's views. All interviews were audio recorded and personal identifiers were removed prior to data analysis.
Data Analysis
Two research assistants reviewed the audio recordings and identified all instances related to strategies for improving family engagement during FCR. There was no screening of strategies (ie, if an interviewee suggested a strategy was related to improving family engagement, it was categorized as such). To ensure intercoder reliability, these assistants, under the supervision of a researcher (L.D.), reviewed the coding process together, held consensus meetings, and crosschecked interviews for coding consensus. A researcher (A.X.) transcribed all strategy‐related instances, which were then reviewed by two additional researchers (M.K., P.C.). To organize, sort, and code the data, interview transcripts were imported in the NVivo qualitative data analysis software (QSR International, Doncaster, Victoria, Australia). The research group then performed a qualitative content analysis of the transcripts[26] and categorized the strategies in an iterative process (information provided on request).
To ensure that all strategies remained conceptually similar within categories, the constant comparative method[27, 28] was applied to the coding process. This involved comparing: 1) strategy‐related instances from the same participants, 2) strategy‐related instances from different participants in the same groups, 3) strategy‐related instances from different participants in different groups, 4) a coded strategy with other coded strategies, 5) coded strategies with categories, and 6) a category with other categories. A strategy‐related instance could be coded under more than one strategy or category. For instance, one interviewee said conducting things that can be done without family beforehand, and presenting and reviewing the plan with family. This was coded under both the strategy conducting rounds in another location without family and then at the bedside with family in the location of FCR category and the strategy focusing presentation on assessment and plan in the communication style category.
RESULTS
A total of 37 interviews were conducted with 11 parents, 4 children, and 22 HCT members (8 attending physicians, 6 resident physicians, 5 medical students, and 3 nurses) in 24 videos of rounding sessions. The duration of the interviews ranged from 30 to 60 minutes.
A total of 338 separate instances related to strategies for improving family engagement on FCR were identified and sorted into 21 categories. Using the SEIPS model, these categories were organized into 2 themes: the work system and process of FCR (Figure 1). Of the 21 categories, 12 were mentioned by both families (parents and/or children) and HCT members and 9 were solely mentioned by the HCT.
Work System of FCR
Table 1 shows the categories of strategies related to the 5 elements of the FCR work system.[29, 30] Illustrative quotes from the interviews (Q) are presented in Table 2.
| Work System Elements | Categories | Strategies | P (11) | C (4) | Att. (8) | Res. (6) | MS (5) | RN (3) |
|---|---|---|---|---|---|---|---|---|
| ||||||||
| People | 1. Size and composition of HCT | Have a smaller HCT conduct FCR | X | X | X | X | ||
| Ensure all relevant disciplines present on FCR | X | X | X | X | X | |||
| Task | 2. Roles and duties of HCT members | Define roles/duties of HCT members on FCR | X | X | ||||
| Organization | 3. Timing and scheduling of FCR | Schedule FCR, inform participants beforehand | X | X | X | |||
| 4. Training of HCT for FCR | Train HCT on how to present on FCR | X | X | |||||
| Environment | 5. Location of FCR | At bedside with family and patient | X | X | ||||
| In another location with HCT, then at bedside | X | X | X | X | ||||
| In another location with family but without child | X | |||||||
| 6. Positioning of HCT members on FCR | Sit down with family | X | X | X | X | X | ||
| Stand close to or in a semicircle around family | X | X | X | X | X | |||
| Tools and technologies | 7. Use of computers on FCR | Use computer to support family interaction | X | X | X | X | ||
| Don't use a computer | X | X | ||||||
|
| Q1: I'm intimidated to ask a question. It seems like there are too many peopleI like a smaller group. (P5) |
| Q2: Sometimes rounds are the only time that the parents are there to see the entire teamso in that way, including [the entire team] at the rounds makes more sense. (MS1) |
| Q3: There needs to be much more clear roles about who is supposed to do what, and it should be predictable. (Att.2) |
| Q4: ([T]iming of rounds) is a huge source of frustration for families. If [physicians] know in which order they will go for patients, they can call our charge nurse or unit clerk or page nurses with that information. (RN1) |
| Q5: ([W]ith a notice of the rounding schedule), I can be ahead of time, trying to think of questions. (P10) |
| Q6: [I]t would be really nice to see somebody do a presentation in a medical eye's version and then also in the family‐centered version. (MS5) |
| Q7: [H]aving the medical students practice with the senior residentis a good way of doing it. (Res.4) |
| Q8: [M]aybe some small groups where you practice this among students. (MS5) |
| Q9: It would be better to be in the room for communication. (Att.1) |
| Q10: You could have sort of hallway rounds, which is much more medical oriented, and inside‐the‐room rounds, which is much more talking with the parent. (P1) |
| Q11: [H]ave sit‐down rounds with parents and families. (Res.5) |
| Q12: I've seen some attending physicians who sat down. I think that could be helpful to be on the same level as the patient and family. (Res.2) |
| Q13: [M]aybe formation of semicircle or something like that, where we can see everybody a little more clearly, I think that would be very helpful. (P10) |
| Q14: I find the presence of a computer incredibly offensive and obstructivewhen you are supposed to be able to interact with the patient. (Att.6) |
| Q15: One of the things I started doing is having one of the other resident physicians have the computer, so just relying on them to do the orders, and me just being there mainly for being the presenter of rounds. (Res.4) |
People
Two seemingly contradictory strategies were proposed. Some interviewees suggested a smaller HCT with members most familiar to the family (Q1), whereas other interviewees stressed the need to involve different relevant disciplines (eg, social worker, nutritionist) during rounds (Q2).
Tasks
Both attending and resident physicians emphasized the importance of defining the role of each HCT member before rounding (Q3). Interviewees also suggested these roles should be explained to families, ideally at admission.
Organization
Many interviewees suggested the need to consistently schedule rounds (Q4) and to inform families and nurses of the schedule so all parties could plan ahead (Q5). Some resident physicians and medical students recommended training of learners on how to give a family‐centered presentation using methods such as role modeling (Q6) and practicing with the senior resident physician (Q7) or in small groups (Q8).
Environment
Some interviewees suggested conducting rounds in patient rooms (Q9). Others suggested conducting rounds first in another location (eg, hallway) without the family and then going to the bedside to round with the family (Q10). There were also interviewees who suggested conducting rounds in another location (eg, conference room) with the family (Q11). When conducting rounds in the patient room, some interviewees suggested that some HCT members (eg, attending and senior resident physicians) could sit down with the family (Q12), with the rest of the HCT standing close to the family in a semicircle (Q13).
Tools and Technologies
Some interviewees thought that conversation with families could be negatively affected by the use of computers, and therefore suggested not using them on FCR (Q14). Alternatively, other interviewees considered computers a tool to facilitate the interaction between the HCT and families, such as showing x‐rays or lab values. Several interviewees suggested that computers should not be positioned to block eye contact between HCT members and families; therefore, only HCT members not presenting should use computers (Q15).
Process of FCR
Table 3 shows the categories of strategies related to the process of FCR, which were categorized into 3 phases. Illustrative quotes are presented in Table 4.
| Process Phases | Categories | Strategies | P (11) | C (4) | Att. (8) | Res. (6) | MS (5) | RN (3) |
|---|---|---|---|---|---|---|---|---|
| ||||||||
| Before FCR | 8. HCT preparation | Collect and prepare pertinent information | X | X | X | X | ||
| 9. Family preparation | Orient family to rounding process | X | X | X | X | X | ||
| Build relationship with family | X | X | X | |||||
| Ask family for permission and preferences | X | X | X | |||||
| During FCR | 10. Introduction and explanation of FCR | Introduce HCT and family to each other | X | X | X | X | X | |
| Explain interactive rounding process | X | X | X | |||||
| 11. Active involvement of nurse | Giving nurse opportunity to actively participate | X | X | |||||
| 12. Communication with family | Give family opportunity to actively participate | X | X | X | X | X | X | |
| Address family's questions/concerns | X | X | X | X | X | |||
| Explain tests, findings and results to family | X | X | X | X | X | |||
| Confirm family understanding | X | X | X | |||||
| 13. Giving presentation | Restructure the presentation | X | X | |||||
| Shorten the presentation | X | X | X | |||||
| Focus presentation on assessment and plan | X | X | X | X | X | |||
| Summarize plan for family | X | X | X | |||||
| Avoid discussion of sensitive topics | X | X | X | |||||
| 14. Communication style | Present in a conversational manner | X | X | X | ||||
| Use an engaging communication style | X | X | X | X | X | |||
| 15. Language used | Use qualitative language | X | X | X | ||||
| Use plain language | X | X | X | X | X | |||
| 16. Performing physical exam | Pause and confirm physical exam | X | ||||||
| 17. Managing distractions | Minimize distractions and interruptions | X | X | X | X | X | X | |
| 18. Senior physician leading/role modeling | Attending/senior resident physician should lead, direct and be a role model on FCR rounds | X | X | |||||
| 19. Teaching | Ask family permission and involve in teaching | X | X | |||||
| 20. Customizing FCR for family | Adapt rounds to family's needs | X | X | X | X | |||
| After FCR | 21. Following up with family | HCT members follow up with family | X | X | X | |||
|
| Q1: [Medical students and residents] actually had a chance to do a quick round, an abbreviated presentation to put together an outline of what we're going to talk about before we even do it. (MS2) |
| Q2: I would like to know exactly what's going onbefore I walk in. (Att.6) |
| Q3: [T]he nurse did give me the fore‐warning that rounds would be coming and it was usually like a group of 8 to 10so I was prepared for that. (P7) |
| Q4: What went well is that I had already connected with this mom and the daughter prior to this rounding encounter. (Res.3) |
| Q5: [Y]ou could ask the patient or the parents if they want the child there. (P3) |
| Q6: [Families] really want to know what your role is on the team. (Att.5) |
| Q7: I guess it would be easier to figure out who you need to direct questions to. (P3) |
| Q8: [L]etting the family anticipate what rounding is going to be like and when the opportunity is going to come up to talk. I think that can help. (Res.2) |
| Q9: I think the decision making is probably the most critical partthere is really no substitute for [families] being involved in the decisionwithout a lot of medical conversation and analysis. (P1) |
| Q10: The family was proactive enough to ask questions, but they were never really given entrance to ask questions.No one had said do you have any questions?' (Res.4) |
| Q11: It is really important for the doctors to listen to them, to know that they are the parents and they know their children best. (RN3) |
| Q12: I think sometimes when you are teaching, some of the information could potentially be scary to the family. What I would hope is letting the family feel like they are part of the education process. (Res.2) |
| Q13: Sometimes nurses are asked initially, do you have anything to add,' which I think is a good way to startbecause we have probably the most current and updated information. (RN1) |
| Q14: When I was talking about the physical exam partmaybe at that point, if I could just stop talking, we couldconfirm that exam. (Res.3) |
| Q15: It's distracting if different groups have individual discussions when you are trying to keep the group focused on this particular patient for rounds. (Att.7) |
| Q16: It's just the basic thing that I try to tell residents. I do this hopefully at least once every time I am on services with the team. (Att.1) |
| Q17: ([C]hanging rounds depending on the families) would be the ideal situationthinking about what's helpful for a family. (Att.6) |
| Q18: What I usually see when things work well after we leave is that the nurse can still stick around the family. (Res.4) |
| Q19: [T]he students have to go back in the afternoon to talk with the family about what the treatment point is and answer any questions. (MS2) |
Before FCR
To engage families during FCR, many interviewees suggested that both the HCT and families need preparation. HCT members suggested that medical students should collect up‐to‐date patient information and review it with the senior resident physicians (Q1) to reach a consensus before starting FCR (Q2). To prepare families for rounds, parents and HCT members suggested that the HCT should orient families to the rounding process (Q3), build relationships with families (Q4), and ask for their permission and preference regarding participation in rounds (Q5).
During FCR
A number of strategies focused on the beginning of rounds. Parents, children, and HCT members stressed the need to introduce HCT members by role (Q6) and inform families to whom to direct questions (Q7). It was also suggested that parents introduce themselves to the team. Some interviewees recommended that the HCT explain the rounding process to families at this time (Q8).
Interviewees recommended strategies related to communication between the HCT and families during rounds. Many interviewees suggested restructuring and shortening the presentation by focusing on the assessment and plan (Q9). According to all interviewees, the HCT should present in a conversational manner and use an engaging communication style (eg, smiling, making eye contact, using appropriate humor) and appropriate language (eg, qualitative trend instead of numbers, plain language instead of medical jargon) to communicate with families. To ensure families understanding, HCT members should encourage and address their questions and concerns (Q10). In addition, families should be given the opportunity to provide information (eg, patient history and overnight events) and to express their opinions about the plan (Q11). If teaching is done during rounds, the HCT should involve families and ask for permission (Q12).
Other strategies on rounds were suggested, such as giving nurses the opportunity to actively participate (Q13), pausing and confirming physical exam findings (Q14), minimizing distractions and interruptions (Q15), attending and/or senior resident physicians leading and being role models for FCR (Q16), and adapting rounds to families' needs (Q17).
After FCR
Some HCT members talked about the importance of following up with families after rounds. Specifically, suggestions that nurses could stay with families immediately after rounds (Q18) were made, whereas physicians could return to families later in the day (Q19).
DISCUSSION
Using recognized qualitative systems engineering methods, we identified a broad range of strategies for enhancing family engagement on FCR from the perspectives of a diverse group of stakeholders on rounds and described how these strategies target known fundamental elements in both the hospital work system and rounding process. We highlight recommendations on the content and style of communication during rounds with families, but also introduce more complex system‐wide elements that likely play a role in family engagement, such as the composition of the HCT; organization and environment of rounds; tools and technologies used; and preparation of the HCT, families, and patients beforehand.
Our research both confirms and builds upon practices previously described in the FCR literature.[17, 31, 32] In a case report by Muething et al.,[17] recommendations were developed using a series of plan‐do‐study‐act cycles to determine the components needed to conduct FCR. These components included: 1) determining family preference prior to rounds, 2) defining HCT roles, 3) introducing HCT to family and explaining the purpose of rounds, 4) describing what is shared and how it is said on rounds, 5) describing the contribution of families, nurses, and ancillary staff, and 6) providing teaching recommendations to senior physicians on rounds. All of these components are suggested by one or more of the participants in our study. In addition, our research identifies a variety of new work system‐related strategies, such as scheduling rounds, using computers appropriately on rounds, and providing training of HCT members beforehand.
Of particular interest was the discordance between strategies mentioned by families and the various members of the HCT. Although HCT members mentioned all identified strategies, families were interested in certain ones. Regarding the structure of FCR, families showed particular interest in HCT composition, timing and scheduling of rounds, location of rounds, and positioning of the HCT. In comparison, families did not mention the importance of the roles and duties of HCT members, HCT preparation for rounds, and use of computers during rounds. With respect to the FCR process, families stressed the importance of family preparation beforehand, introduction and explanation of rounds at the beginning, presentation style and communication style, customization, and management of distractions during rounds. None of the families, however, mentioned the rest of the strategies, including HCT preparation before rounds, involvement of the nurse, teaching and performing the physical exam, the role of the attending and senior resident roles during rounds, and following up with the family after rounds. These different perspectives are likely, in part, inherent to the different roles and experiences of parents and HCT members. For example, parents' knowledge of what goes on in the hospital outside of FCR, such as orientation and preparation of HCT members for rounds, is relatively limited. Future research using methods to evaluate and prioritize strategies as well as understanding reasons for contradicting strategies is warranted.
We recognize that, although family engagement is recommended as a critical component of care, strategies to improve engagement may be in direct opposition to other goals of the HCT. For example, some of our participants suggest having a smaller team may be more beneficial for family engagement on rounds. In some settings, it may be feasible to have a small team; however, in institutions that accommodate a large number of learners, excluding students from the teaching opportunity of rounds may actually compromise educational experiences. In patients with chronic and/or complex care, a larger multidisciplinary team may better facilitate information exchange among disciplines and expedite discharge planning. Moreover, one might speculate that it may not be that the size affects family engagement as much as the composition of the team, especially if tailored to the needs of the patient. For example, a large team consisting of primarily physicians and trainees may not be as engaging as the same sized team with one attending physician and a respiratory therapist, case manager, and consulting subspecialist. Finding a balance between engaging families, teaching learners, and maintaining efficiency is paramount and needs to be studied further.
This study has several limitations. Our data are from a single academic children's hospital, which may limit generalizability due to a small sampling of multiple stakeholders on different services, our specific patient population, HCT composition and roles, and teaching needs. However, we face similar barriers to engaging families during rounds as those published from both another single institution[17] and a national sampling of pediatric hospitalists.[16] Furthermore, our recommended strategies to address the FCR process are supported by prior work.[17] Because this study was voluntary, our interviewees were likely more engaged participants in general. Specifically, the viewpoints of engaged families and HCT members may not represent the viewpoints of those who are less engaged or supportive of FCR. We did not enroll nonEnglish‐speaking patients and families, which is a potential direction for future research. In our interviews, we also relied solely on the perceptions of rounding participants, rather than those of outside observers or researchers, which may only provide a partial perspective of potential strategies to improve family engagement. Last, this qualitative research approach does not provide quantitative information regarding whether certain strategies are preferred by a majority of participants, which we hope to address in future research.
This work is part of a larger study that aims to implement a bundle of these strategies after stakeholder prioritization based on impact on family engagement, feasibility, and sustainability. We plan to systematically evaluate the implementation process of these strategies and measure their impact on family engagement and, ultimately, patient safety. One or more of these strategies could be implemented in a similar manner at other hospitals depending on specific institutional needs.
In conclusion, as recently reflected by Barry et al. in The New England Journal of Medicine, Although talk about patient‐centered care is ubiquitous in modern health care, one of the greatest challenges of turning the rhetoric into reality continues to be routinely engaging patients in decision making.[33] FCR provide a crucial opportunity for family involvement in daily care decisions in the pediatric inpatient setting. This study highlights the importance of prior work defining the components of involving families in this process, while emphasizing new systems‐based strategies that further facilitate the expectation of family engagement in the care of hospitalized children.
Disclosures
This work was funded through an Agency for Healthcare Research and Quality Health Services Research Dissemination and Demonstration Grant, R18 HS018680, and also supported by the Arthur Vining Davis Foundation and the National Patient Safety Foundation through the James S. Todd Memorial Research Award. Funding organizations did not contribute to the design and conduct of study; collection, management, analysis, and interpretation of data; or preparation, review, or approval of the manuscript. The authors report no conflicts of interest.
A growing body of literature suggests that patient‐ and family‐centered care can improve patient outcomes[1, 2, 3, 4, 5] as well as patient, family, and provider satisfaction.[6, 7, 8, 9, 10] Engaging patients and families as a way to improve the quality and safety of care has been widely endorsed by leading healthcare organizations,[11, 12, 13] including the Institute of Medicine.[14] In the pediatric inpatient setting, family‐centered rounds (FCR), defined as bedside rounds in which the patient and family share in the control of the management plan as well as in the evaluation of the process itself,[15] potentially provide a consistent venue for family engagement and are recommended by the American Academy of Pediatrics as standard practice.[13]
According to a recent study by Mittal et al.,[16] FCR are the most common type of rounds practiced among pediatric hospitalists surveyed in the United States and Canada. Despite this widespread shift from rounding in a conference room to the bedside with patients and families, there exist only a few studies that provide specific recommendations on conducting FCR.[15, 17, 18] This research has been limited, primarily focusing how rounds are conducted, and further investigation is needed to identify the impact of other processes and elements within the hospital work system that may also affect family engagement during rounds.
The objectives of this study were to: 1) identify strategies to enhance family engagement during FCR drawing from the viewpoints of the various stakeholders on rounds, and 2) characterize these strategies into known elements of hospital work systems and rounding processes using a recognized human factors engineering approach, The Systems Engineering Initiative for Patient Safety (SEIPS) model.[19] According to the SEIPS model, barriers and facilitators to family engagement during FCR are likely embedded in the design of the hospital work systems and rounding process; therefore, we hypothesized that strategies that influence engagement will target all work system and process elements. This work is part of a larger study in which, after prioritization of this group of strategies based on feasibility and sustainability, a bundle of best practices for conducting FCR will be developed, implemented, and evaluated.
METHODS
Study Design
Semistructured interviews using the stimulated recall approach[20, 21] were conducted to understand the cognitive processes of families and healthcare team (HCT) members during FCR. This qualitative study design allowed us to capture comprehensive information from the perspectives of a diverse group of stakeholders on strategies for improving family engagement during FCR.
Setting and Participants
This study was conducted at a children's hospital in Wisconsin, where FCR were initiated in 2007 with the transition to a new hospital facility. The expectation is that FCR are conducted daily with the family and the patient's HCT, consisting of at least an attending physician and nurse. Typically, multiple residents, interns, and medical students are present along with a combination of other providers, including consulting subspecialists, a fellow, nurse practitioner, respiratory therapist, or pharmacist. When this study was conducted, attendees received little to no formal training regarding their role on FCR. As part of a larger study, English‐speaking patients and/or families admitted to 1 of 4 inpatient services (2 hospitalist, 1 pulmonary, and 1 hematology/oncology), and their associated HCT members were enrolled and their bedside rounds were video recorded. A purposive sampling technique[22, 23] was employed, recruiting interviewees that represented the various groups of stakeholders of rounds, including parents, children, attending physicians, resident physicians, medical students, and nurses. For child interviews, we restricted selection to children aged 8 to 17 years to ensure the ability to understand the interviewing process and provide feedback. Families were consented and children were assented. The University of Wisconsin‐Madison Health Sciences Institutional Review Board approved this study.
Interviews and analysis occurred concurrently in an iterative process, informing each other. Thus, recruitment continued until we reached theoretical saturation,[24, 25] the point at which additional interviews did not provide new information or further conceptual development.
Study Procedures
All interviews were conducted by trained researchers, who used the same semistructured interview guide. During each interview, the interviewee was instructed to watch his/her own rounding video and pause when noticing something that made it easy (facilitator) or hard (barrier) to engage the family. Every time the interviewee paused the video to describe what was noticed, the interviewer then asked follow‐up, open‐ended questions to solicit specific information that focused on strategies for enhancing family engagement during FCR. For instance, if the issue identified was a barrier, the interviewer asked, What would you have wanted to happen differently? and if the issue identified was a facilitator, the interviewer asked, How could we ensure that would happen for everyone? The interviewee rewound the video as needed. If the interviewee had not stopped the video by the halfway point, the interviewer would pause the video and review the instructions. After the interviewee had viewed and commented on the entire rounding video, an opportunity was offered to reflect on other factors that influence family engagement during rounds, and additional questions were asked as necessary to fully understand the interviewee's views. All interviews were audio recorded and personal identifiers were removed prior to data analysis.
Data Analysis
Two research assistants reviewed the audio recordings and identified all instances related to strategies for improving family engagement during FCR. There was no screening of strategies (ie, if an interviewee suggested a strategy was related to improving family engagement, it was categorized as such). To ensure intercoder reliability, these assistants, under the supervision of a researcher (L.D.), reviewed the coding process together, held consensus meetings, and crosschecked interviews for coding consensus. A researcher (A.X.) transcribed all strategy‐related instances, which were then reviewed by two additional researchers (M.K., P.C.). To organize, sort, and code the data, interview transcripts were imported in the NVivo qualitative data analysis software (QSR International, Doncaster, Victoria, Australia). The research group then performed a qualitative content analysis of the transcripts[26] and categorized the strategies in an iterative process (information provided on request).
To ensure that all strategies remained conceptually similar within categories, the constant comparative method[27, 28] was applied to the coding process. This involved comparing: 1) strategy‐related instances from the same participants, 2) strategy‐related instances from different participants in the same groups, 3) strategy‐related instances from different participants in different groups, 4) a coded strategy with other coded strategies, 5) coded strategies with categories, and 6) a category with other categories. A strategy‐related instance could be coded under more than one strategy or category. For instance, one interviewee said conducting things that can be done without family beforehand, and presenting and reviewing the plan with family. This was coded under both the strategy conducting rounds in another location without family and then at the bedside with family in the location of FCR category and the strategy focusing presentation on assessment and plan in the communication style category.
RESULTS
A total of 37 interviews were conducted with 11 parents, 4 children, and 22 HCT members (8 attending physicians, 6 resident physicians, 5 medical students, and 3 nurses) in 24 videos of rounding sessions. The duration of the interviews ranged from 30 to 60 minutes.
A total of 338 separate instances related to strategies for improving family engagement on FCR were identified and sorted into 21 categories. Using the SEIPS model, these categories were organized into 2 themes: the work system and process of FCR (Figure 1). Of the 21 categories, 12 were mentioned by both families (parents and/or children) and HCT members and 9 were solely mentioned by the HCT.
Work System of FCR
Table 1 shows the categories of strategies related to the 5 elements of the FCR work system.[29, 30] Illustrative quotes from the interviews (Q) are presented in Table 2.
| Work System Elements | Categories | Strategies | P (11) | C (4) | Att. (8) | Res. (6) | MS (5) | RN (3) |
|---|---|---|---|---|---|---|---|---|
| ||||||||
| People | 1. Size and composition of HCT | Have a smaller HCT conduct FCR | X | X | X | X | ||
| Ensure all relevant disciplines present on FCR | X | X | X | X | X | |||
| Task | 2. Roles and duties of HCT members | Define roles/duties of HCT members on FCR | X | X | ||||
| Organization | 3. Timing and scheduling of FCR | Schedule FCR, inform participants beforehand | X | X | X | |||
| 4. Training of HCT for FCR | Train HCT on how to present on FCR | X | X | |||||
| Environment | 5. Location of FCR | At bedside with family and patient | X | X | ||||
| In another location with HCT, then at bedside | X | X | X | X | ||||
| In another location with family but without child | X | |||||||
| 6. Positioning of HCT members on FCR | Sit down with family | X | X | X | X | X | ||
| Stand close to or in a semicircle around family | X | X | X | X | X | |||
| Tools and technologies | 7. Use of computers on FCR | Use computer to support family interaction | X | X | X | X | ||
| Don't use a computer | X | X | ||||||
|
| Q1: I'm intimidated to ask a question. It seems like there are too many peopleI like a smaller group. (P5) |
| Q2: Sometimes rounds are the only time that the parents are there to see the entire teamso in that way, including [the entire team] at the rounds makes more sense. (MS1) |
| Q3: There needs to be much more clear roles about who is supposed to do what, and it should be predictable. (Att.2) |
| Q4: ([T]iming of rounds) is a huge source of frustration for families. If [physicians] know in which order they will go for patients, they can call our charge nurse or unit clerk or page nurses with that information. (RN1) |
| Q5: ([W]ith a notice of the rounding schedule), I can be ahead of time, trying to think of questions. (P10) |
| Q6: [I]t would be really nice to see somebody do a presentation in a medical eye's version and then also in the family‐centered version. (MS5) |
| Q7: [H]aving the medical students practice with the senior residentis a good way of doing it. (Res.4) |
| Q8: [M]aybe some small groups where you practice this among students. (MS5) |
| Q9: It would be better to be in the room for communication. (Att.1) |
| Q10: You could have sort of hallway rounds, which is much more medical oriented, and inside‐the‐room rounds, which is much more talking with the parent. (P1) |
| Q11: [H]ave sit‐down rounds with parents and families. (Res.5) |
| Q12: I've seen some attending physicians who sat down. I think that could be helpful to be on the same level as the patient and family. (Res.2) |
| Q13: [M]aybe formation of semicircle or something like that, where we can see everybody a little more clearly, I think that would be very helpful. (P10) |
| Q14: I find the presence of a computer incredibly offensive and obstructivewhen you are supposed to be able to interact with the patient. (Att.6) |
| Q15: One of the things I started doing is having one of the other resident physicians have the computer, so just relying on them to do the orders, and me just being there mainly for being the presenter of rounds. (Res.4) |
People
Two seemingly contradictory strategies were proposed. Some interviewees suggested a smaller HCT with members most familiar to the family (Q1), whereas other interviewees stressed the need to involve different relevant disciplines (eg, social worker, nutritionist) during rounds (Q2).
Tasks
Both attending and resident physicians emphasized the importance of defining the role of each HCT member before rounding (Q3). Interviewees also suggested these roles should be explained to families, ideally at admission.
Organization
Many interviewees suggested the need to consistently schedule rounds (Q4) and to inform families and nurses of the schedule so all parties could plan ahead (Q5). Some resident physicians and medical students recommended training of learners on how to give a family‐centered presentation using methods such as role modeling (Q6) and practicing with the senior resident physician (Q7) or in small groups (Q8).
Environment
Some interviewees suggested conducting rounds in patient rooms (Q9). Others suggested conducting rounds first in another location (eg, hallway) without the family and then going to the bedside to round with the family (Q10). There were also interviewees who suggested conducting rounds in another location (eg, conference room) with the family (Q11). When conducting rounds in the patient room, some interviewees suggested that some HCT members (eg, attending and senior resident physicians) could sit down with the family (Q12), with the rest of the HCT standing close to the family in a semicircle (Q13).
Tools and Technologies
Some interviewees thought that conversation with families could be negatively affected by the use of computers, and therefore suggested not using them on FCR (Q14). Alternatively, other interviewees considered computers a tool to facilitate the interaction between the HCT and families, such as showing x‐rays or lab values. Several interviewees suggested that computers should not be positioned to block eye contact between HCT members and families; therefore, only HCT members not presenting should use computers (Q15).
Process of FCR
Table 3 shows the categories of strategies related to the process of FCR, which were categorized into 3 phases. Illustrative quotes are presented in Table 4.
| Process Phases | Categories | Strategies | P (11) | C (4) | Att. (8) | Res. (6) | MS (5) | RN (3) |
|---|---|---|---|---|---|---|---|---|
| ||||||||
| Before FCR | 8. HCT preparation | Collect and prepare pertinent information | X | X | X | X | ||
| 9. Family preparation | Orient family to rounding process | X | X | X | X | X | ||
| Build relationship with family | X | X | X | |||||
| Ask family for permission and preferences | X | X | X | |||||
| During FCR | 10. Introduction and explanation of FCR | Introduce HCT and family to each other | X | X | X | X | X | |
| Explain interactive rounding process | X | X | X | |||||
| 11. Active involvement of nurse | Giving nurse opportunity to actively participate | X | X | |||||
| 12. Communication with family | Give family opportunity to actively participate | X | X | X | X | X | X | |
| Address family's questions/concerns | X | X | X | X | X | |||
| Explain tests, findings and results to family | X | X | X | X | X | |||
| Confirm family understanding | X | X | X | |||||
| 13. Giving presentation | Restructure the presentation | X | X | |||||
| Shorten the presentation | X | X | X | |||||
| Focus presentation on assessment and plan | X | X | X | X | X | |||
| Summarize plan for family | X | X | X | |||||
| Avoid discussion of sensitive topics | X | X | X | |||||
| 14. Communication style | Present in a conversational manner | X | X | X | ||||
| Use an engaging communication style | X | X | X | X | X | |||
| 15. Language used | Use qualitative language | X | X | X | ||||
| Use plain language | X | X | X | X | X | |||
| 16. Performing physical exam | Pause and confirm physical exam | X | ||||||
| 17. Managing distractions | Minimize distractions and interruptions | X | X | X | X | X | X | |
| 18. Senior physician leading/role modeling | Attending/senior resident physician should lead, direct and be a role model on FCR rounds | X | X | |||||
| 19. Teaching | Ask family permission and involve in teaching | X | X | |||||
| 20. Customizing FCR for family | Adapt rounds to family's needs | X | X | X | X | |||
| After FCR | 21. Following up with family | HCT members follow up with family | X | X | X | |||
|
| Q1: [Medical students and residents] actually had a chance to do a quick round, an abbreviated presentation to put together an outline of what we're going to talk about before we even do it. (MS2) |
| Q2: I would like to know exactly what's going onbefore I walk in. (Att.6) |
| Q3: [T]he nurse did give me the fore‐warning that rounds would be coming and it was usually like a group of 8 to 10so I was prepared for that. (P7) |
| Q4: What went well is that I had already connected with this mom and the daughter prior to this rounding encounter. (Res.3) |
| Q5: [Y]ou could ask the patient or the parents if they want the child there. (P3) |
| Q6: [Families] really want to know what your role is on the team. (Att.5) |
| Q7: I guess it would be easier to figure out who you need to direct questions to. (P3) |
| Q8: [L]etting the family anticipate what rounding is going to be like and when the opportunity is going to come up to talk. I think that can help. (Res.2) |
| Q9: I think the decision making is probably the most critical partthere is really no substitute for [families] being involved in the decisionwithout a lot of medical conversation and analysis. (P1) |
| Q10: The family was proactive enough to ask questions, but they were never really given entrance to ask questions.No one had said do you have any questions?' (Res.4) |
| Q11: It is really important for the doctors to listen to them, to know that they are the parents and they know their children best. (RN3) |
| Q12: I think sometimes when you are teaching, some of the information could potentially be scary to the family. What I would hope is letting the family feel like they are part of the education process. (Res.2) |
| Q13: Sometimes nurses are asked initially, do you have anything to add,' which I think is a good way to startbecause we have probably the most current and updated information. (RN1) |
| Q14: When I was talking about the physical exam partmaybe at that point, if I could just stop talking, we couldconfirm that exam. (Res.3) |
| Q15: It's distracting if different groups have individual discussions when you are trying to keep the group focused on this particular patient for rounds. (Att.7) |
| Q16: It's just the basic thing that I try to tell residents. I do this hopefully at least once every time I am on services with the team. (Att.1) |
| Q17: ([C]hanging rounds depending on the families) would be the ideal situationthinking about what's helpful for a family. (Att.6) |
| Q18: What I usually see when things work well after we leave is that the nurse can still stick around the family. (Res.4) |
| Q19: [T]he students have to go back in the afternoon to talk with the family about what the treatment point is and answer any questions. (MS2) |
Before FCR
To engage families during FCR, many interviewees suggested that both the HCT and families need preparation. HCT members suggested that medical students should collect up‐to‐date patient information and review it with the senior resident physicians (Q1) to reach a consensus before starting FCR (Q2). To prepare families for rounds, parents and HCT members suggested that the HCT should orient families to the rounding process (Q3), build relationships with families (Q4), and ask for their permission and preference regarding participation in rounds (Q5).
During FCR
A number of strategies focused on the beginning of rounds. Parents, children, and HCT members stressed the need to introduce HCT members by role (Q6) and inform families to whom to direct questions (Q7). It was also suggested that parents introduce themselves to the team. Some interviewees recommended that the HCT explain the rounding process to families at this time (Q8).
Interviewees recommended strategies related to communication between the HCT and families during rounds. Many interviewees suggested restructuring and shortening the presentation by focusing on the assessment and plan (Q9). According to all interviewees, the HCT should present in a conversational manner and use an engaging communication style (eg, smiling, making eye contact, using appropriate humor) and appropriate language (eg, qualitative trend instead of numbers, plain language instead of medical jargon) to communicate with families. To ensure families understanding, HCT members should encourage and address their questions and concerns (Q10). In addition, families should be given the opportunity to provide information (eg, patient history and overnight events) and to express their opinions about the plan (Q11). If teaching is done during rounds, the HCT should involve families and ask for permission (Q12).
Other strategies on rounds were suggested, such as giving nurses the opportunity to actively participate (Q13), pausing and confirming physical exam findings (Q14), minimizing distractions and interruptions (Q15), attending and/or senior resident physicians leading and being role models for FCR (Q16), and adapting rounds to families' needs (Q17).
After FCR
Some HCT members talked about the importance of following up with families after rounds. Specifically, suggestions that nurses could stay with families immediately after rounds (Q18) were made, whereas physicians could return to families later in the day (Q19).
DISCUSSION
Using recognized qualitative systems engineering methods, we identified a broad range of strategies for enhancing family engagement on FCR from the perspectives of a diverse group of stakeholders on rounds and described how these strategies target known fundamental elements in both the hospital work system and rounding process. We highlight recommendations on the content and style of communication during rounds with families, but also introduce more complex system‐wide elements that likely play a role in family engagement, such as the composition of the HCT; organization and environment of rounds; tools and technologies used; and preparation of the HCT, families, and patients beforehand.
Our research both confirms and builds upon practices previously described in the FCR literature.[17, 31, 32] In a case report by Muething et al.,[17] recommendations were developed using a series of plan‐do‐study‐act cycles to determine the components needed to conduct FCR. These components included: 1) determining family preference prior to rounds, 2) defining HCT roles, 3) introducing HCT to family and explaining the purpose of rounds, 4) describing what is shared and how it is said on rounds, 5) describing the contribution of families, nurses, and ancillary staff, and 6) providing teaching recommendations to senior physicians on rounds. All of these components are suggested by one or more of the participants in our study. In addition, our research identifies a variety of new work system‐related strategies, such as scheduling rounds, using computers appropriately on rounds, and providing training of HCT members beforehand.
Of particular interest was the discordance between strategies mentioned by families and the various members of the HCT. Although HCT members mentioned all identified strategies, families were interested in certain ones. Regarding the structure of FCR, families showed particular interest in HCT composition, timing and scheduling of rounds, location of rounds, and positioning of the HCT. In comparison, families did not mention the importance of the roles and duties of HCT members, HCT preparation for rounds, and use of computers during rounds. With respect to the FCR process, families stressed the importance of family preparation beforehand, introduction and explanation of rounds at the beginning, presentation style and communication style, customization, and management of distractions during rounds. None of the families, however, mentioned the rest of the strategies, including HCT preparation before rounds, involvement of the nurse, teaching and performing the physical exam, the role of the attending and senior resident roles during rounds, and following up with the family after rounds. These different perspectives are likely, in part, inherent to the different roles and experiences of parents and HCT members. For example, parents' knowledge of what goes on in the hospital outside of FCR, such as orientation and preparation of HCT members for rounds, is relatively limited. Future research using methods to evaluate and prioritize strategies as well as understanding reasons for contradicting strategies is warranted.
We recognize that, although family engagement is recommended as a critical component of care, strategies to improve engagement may be in direct opposition to other goals of the HCT. For example, some of our participants suggest having a smaller team may be more beneficial for family engagement on rounds. In some settings, it may be feasible to have a small team; however, in institutions that accommodate a large number of learners, excluding students from the teaching opportunity of rounds may actually compromise educational experiences. In patients with chronic and/or complex care, a larger multidisciplinary team may better facilitate information exchange among disciplines and expedite discharge planning. Moreover, one might speculate that it may not be that the size affects family engagement as much as the composition of the team, especially if tailored to the needs of the patient. For example, a large team consisting of primarily physicians and trainees may not be as engaging as the same sized team with one attending physician and a respiratory therapist, case manager, and consulting subspecialist. Finding a balance between engaging families, teaching learners, and maintaining efficiency is paramount and needs to be studied further.
This study has several limitations. Our data are from a single academic children's hospital, which may limit generalizability due to a small sampling of multiple stakeholders on different services, our specific patient population, HCT composition and roles, and teaching needs. However, we face similar barriers to engaging families during rounds as those published from both another single institution[17] and a national sampling of pediatric hospitalists.[16] Furthermore, our recommended strategies to address the FCR process are supported by prior work.[17] Because this study was voluntary, our interviewees were likely more engaged participants in general. Specifically, the viewpoints of engaged families and HCT members may not represent the viewpoints of those who are less engaged or supportive of FCR. We did not enroll nonEnglish‐speaking patients and families, which is a potential direction for future research. In our interviews, we also relied solely on the perceptions of rounding participants, rather than those of outside observers or researchers, which may only provide a partial perspective of potential strategies to improve family engagement. Last, this qualitative research approach does not provide quantitative information regarding whether certain strategies are preferred by a majority of participants, which we hope to address in future research.
This work is part of a larger study that aims to implement a bundle of these strategies after stakeholder prioritization based on impact on family engagement, feasibility, and sustainability. We plan to systematically evaluate the implementation process of these strategies and measure their impact on family engagement and, ultimately, patient safety. One or more of these strategies could be implemented in a similar manner at other hospitals depending on specific institutional needs.
In conclusion, as recently reflected by Barry et al. in The New England Journal of Medicine, Although talk about patient‐centered care is ubiquitous in modern health care, one of the greatest challenges of turning the rhetoric into reality continues to be routinely engaging patients in decision making.[33] FCR provide a crucial opportunity for family involvement in daily care decisions in the pediatric inpatient setting. This study highlights the importance of prior work defining the components of involving families in this process, while emphasizing new systems‐based strategies that further facilitate the expectation of family engagement in the care of hospitalized children.
Disclosures
This work was funded through an Agency for Healthcare Research and Quality Health Services Research Dissemination and Demonstration Grant, R18 HS018680, and also supported by the Arthur Vining Davis Foundation and the National Patient Safety Foundation through the James S. Todd Memorial Research Award. Funding organizations did not contribute to the design and conduct of study; collection, management, analysis, and interpretation of data; or preparation, review, or approval of the manuscript. The authors report no conflicts of interest.
- , , , et al. The impact of patient‐centered care on outcomes. J Fam Pract. 2000;49:796–804.
- , , , et al. Observational study of effect of patient centredness and positive approach on outcomes of general practice consultations. BMJ. 2001;323:908–911.
- , , . Improvement in the family‐centered medical home enhances outcomes for children and youth with special healthcare needs. J Ambul Care Manage. 2009;32:188–196.
- , , . Associations of family‐centered care with health care outcomes for children with special health care needs. Matern Child Health J. 2011;15:794–805.
- , , , , Can a patient‐centered medical home lead to better patient outcomes? The quality implications of Geisinger's ProvenHealth Navigator. Am J Med Qual. 2012;27:210–216.
- , , . Perceptions of health care providers' communication: relationships between patient‐centered communication and satisfaction. Health Commun. 2004;16:363–383.
- , . Satisfaction with care and ease of using health care services among parents of children with special health care needs: the roles of race/ethnicity, insurance, language, and adequacy of family‐centered care. Pediatrics. 2006;117:1184–1196.
- , , , . A randomized, controlled trial of bedside versus conference‐room case presentation in a pediatric intensive care unit. Pediatrics. 2007;120:275–280.
- , , , , . Effect of patient‐centered care on patient satisfaction and quality of care. J Nurs Care Qual. 2008;23:316–321.
- , , . Implementing family‐centered rounds: pediatric residents' perceptions. Clin Pediatr (Phila) 2010;49:228–234.
- ACGME Program Requirements for Graduate Medical Education in Pediatrics. 2007. Available at: http://www.acgme.org/acWebsite/downloads/RRC_progReq320_pediatrics_07012007.pdf. Accessed February 10, 2012.
- Speak up: prevent errors in your child's care. 2011. The Joint Commission Web site. Available at: http://www.jointcommission.org/Speak_Up_Prevent_Errors_in_Your_Childs_Care/. Accessed May 11, 2012.
- Patient‐ and family‐centered care and the pediatrician's role. Pediatrics. 2012;129:394–404.
- Committee on Quality of Health Care in America, Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: The National Academies Press; 2001.
- , , , . Defining family‐centered rounds. Teach Learn Med. 2007;19:319–322.
- , , , et al. Family‐centered rounds on pediatric wards: A PRIS network survey of US and Canadian hospitalists. Pediatrics. 2010;126:37–43.
- , , , , . Family‐centered bedside rounds: a new approach to patient care and teaching. Pediatrics. 2007;119:829–832.
- , , , . Parental responses to involvement in rounds on a pediatric inpatient unit at a teaching hospital: a qualitative study. Acad Med. 2008;83:292–297.
- , , , et al. Work system design for patient safety: the SEIPS model. Qual Saf Health Care. 2006;15:i50–i58.
- , . IPR—a validated model for the 1990s and beyond. Couns Psychol. 1990;18:436–440.
- , . Auto‐ and allo‐confrontation as tools for reflective activities. Appl Ergon. 2004;35:531–540.
- . Qualitative Research and Evaluation Methods. 3rd ed. Thousand Oaks, CA: Sage Publications; 2002.
- , . Doing Qualitative Research. 2nd ed. Thousand Oaks, CA: Sage Publications; 1999.
- . Sample size in qualitative research. Res Nurs Health. 1995;18:179–183.
- , . Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory. Newbury Park, CA: Sage Publications; 1998.
- , . Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004;24:105–112.
- . A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Qual Quant. 2002;36:391–409.
- . Theoretical Sensitivity: Advances in the Methodology of Grounded Theory. Mill Valley, CA: Sociology Press; 1978.
- , . Balance theory of job design. In: Karwowski W, ed. International Encyclopedia of Ergonomics and Human Factors. London: Taylor 2000:1181–1184.
- , . A balance theory of job design for stress reduction. Int J Ind Ergon. 1989;4:67–79.
- Institute for Patient‐ and Family‐Centered Care. Applying patient‐ and family‐centered concepts to bedside rounds. 2010. Available at: http://www.ipfcc.org/advance/topics/PH_RD_Applying_PFCC_Rounds_012009.pdf. Accessed May 11, 2012.
- . A fundamental shift: family‐centered rounds in an academic medical center. Hospitalist. 2006;10:45–46.
- , Shared decision making—pinnacle of patient‐centered care. N Engl J Med. 2012;366:780–781.
- , , , et al. The impact of patient‐centered care on outcomes. J Fam Pract. 2000;49:796–804.
- , , , et al. Observational study of effect of patient centredness and positive approach on outcomes of general practice consultations. BMJ. 2001;323:908–911.
- , , . Improvement in the family‐centered medical home enhances outcomes for children and youth with special healthcare needs. J Ambul Care Manage. 2009;32:188–196.
- , , . Associations of family‐centered care with health care outcomes for children with special health care needs. Matern Child Health J. 2011;15:794–805.
- , , , , Can a patient‐centered medical home lead to better patient outcomes? The quality implications of Geisinger's ProvenHealth Navigator. Am J Med Qual. 2012;27:210–216.
- , , . Perceptions of health care providers' communication: relationships between patient‐centered communication and satisfaction. Health Commun. 2004;16:363–383.
- , . Satisfaction with care and ease of using health care services among parents of children with special health care needs: the roles of race/ethnicity, insurance, language, and adequacy of family‐centered care. Pediatrics. 2006;117:1184–1196.
- , , , . A randomized, controlled trial of bedside versus conference‐room case presentation in a pediatric intensive care unit. Pediatrics. 2007;120:275–280.
- , , , , . Effect of patient‐centered care on patient satisfaction and quality of care. J Nurs Care Qual. 2008;23:316–321.
- , , . Implementing family‐centered rounds: pediatric residents' perceptions. Clin Pediatr (Phila) 2010;49:228–234.
- ACGME Program Requirements for Graduate Medical Education in Pediatrics. 2007. Available at: http://www.acgme.org/acWebsite/downloads/RRC_progReq320_pediatrics_07012007.pdf. Accessed February 10, 2012.
- Speak up: prevent errors in your child's care. 2011. The Joint Commission Web site. Available at: http://www.jointcommission.org/Speak_Up_Prevent_Errors_in_Your_Childs_Care/. Accessed May 11, 2012.
- Patient‐ and family‐centered care and the pediatrician's role. Pediatrics. 2012;129:394–404.
- Committee on Quality of Health Care in America, Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: The National Academies Press; 2001.
- , , , . Defining family‐centered rounds. Teach Learn Med. 2007;19:319–322.
- , , , et al. Family‐centered rounds on pediatric wards: A PRIS network survey of US and Canadian hospitalists. Pediatrics. 2010;126:37–43.
- , , , , . Family‐centered bedside rounds: a new approach to patient care and teaching. Pediatrics. 2007;119:829–832.
- , , , . Parental responses to involvement in rounds on a pediatric inpatient unit at a teaching hospital: a qualitative study. Acad Med. 2008;83:292–297.
- , , , et al. Work system design for patient safety: the SEIPS model. Qual Saf Health Care. 2006;15:i50–i58.
- , . IPR—a validated model for the 1990s and beyond. Couns Psychol. 1990;18:436–440.
- , . Auto‐ and allo‐confrontation as tools for reflective activities. Appl Ergon. 2004;35:531–540.
- . Qualitative Research and Evaluation Methods. 3rd ed. Thousand Oaks, CA: Sage Publications; 2002.
- , . Doing Qualitative Research. 2nd ed. Thousand Oaks, CA: Sage Publications; 1999.
- . Sample size in qualitative research. Res Nurs Health. 1995;18:179–183.
- , . Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory. Newbury Park, CA: Sage Publications; 1998.
- , . Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004;24:105–112.
- . A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Qual Quant. 2002;36:391–409.
- . Theoretical Sensitivity: Advances in the Methodology of Grounded Theory. Mill Valley, CA: Sociology Press; 1978.
- , . Balance theory of job design. In: Karwowski W, ed. International Encyclopedia of Ergonomics and Human Factors. London: Taylor 2000:1181–1184.
- , . A balance theory of job design for stress reduction. Int J Ind Ergon. 1989;4:67–79.
- Institute for Patient‐ and Family‐Centered Care. Applying patient‐ and family‐centered concepts to bedside rounds. 2010. Available at: http://www.ipfcc.org/advance/topics/PH_RD_Applying_PFCC_Rounds_012009.pdf. Accessed May 11, 2012.
- . A fundamental shift: family‐centered rounds in an academic medical center. Hospitalist. 2006;10:45–46.
- , Shared decision making—pinnacle of patient‐centered care. N Engl J Med. 2012;366:780–781.
Copyright © 2013 Society of Hospital Medicine
Quetiapine for the Treatment of Delirium
Delirium is an acute fluctuation in mental status that includes symptoms of inattention, disorganized thinking, and altered level of consciousness occurring over a short time period.[1] Prevalence of delirium ranges from 10% to 30% in the hospitalized medically ill and ranges from 40% to 60% in intensive care unit (ICU) patients who are not receiving mechanical ventilation.[2, 3] Patients experience delirium more often if they are of older age; have dementia, cancer, or acquired immune deficiency syndrome; have undergone surgery; are terminally ill; or have received multiple psychoactive medications, particularly benzodiazepines or opioids.[3, 4, 5, 6, 7] Delirium is associated with high rates of morbidity and mortality,[8] with patients more likely to develop complications such as pneumonia, decubitus ulcers, and long‐term cognitive deficits.[9, 10, 11, 12] These complications, in turn, lead to longer hospital stays and increased costs of care.[13, 14] Currently, there are no antipsychotics approved by the US Food and Drug Administration for the treatment of delirium.
Both the 2002 American Society of Critical Care Medicine[12] and the 2004 American Psychiatric Association guidelines[15] on delirium recommend haloperidol as the antipsychotic of choice due to its potent tranquilizing effect, lack of active metabolites, and limited anticholinergic and sedating side effects. However, when given intravenously or at high cumulative doses (generally >35 mg/day), haloperidol has been shown to cause QT interval prolongation potentially leading to torsades de pointes and sudden cardiac death.[15] Recent research in delirium treatment has focused on the second‐generation antipsychotics, and these studies have reported positive findings,[16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29] although no significant differences have been found compared to haloperidol.[16, 17, 18, 22, 23, 24] Systematic reviews have also failed to show a significant difference in efficacy or safety between second‐generation and first‐generation antipsychotics and unfortunately report a number of limitations including poor study designs, small sample sizes, lack of a placebo control group, exclusion of ICU patients, and weak primary outcomes.[8, 30, 31, 32] Attempting to correct for a number of these limitations, recent research with quetiapine has reported promising results in 2 controlled studies.[19, 20]
Quetiapine is a second‐generation antipsychotic with a very low affinity for dopamine receptors and a very high affinity for serotonin receptors.[33, 34] Additionally, quetiapine has a high affinity for histamine and 1‐adrenergic receptors, but a very low affinity for M1 muscarinic receptors.[34] This mechanism of action may allow quetiapine to effectively treat delirium and provide sedation without causing significant extrapyramidal side effects associated with potent dopamine receptor antagonism or precipitating delirium through muscarinic receptor antagonism. Quetiapine has a rapid absorption and a short half‐life (36 hours), giving it a quick onset of action and a fast elimination from the body.[35] Unlike haloperidol, it is only available in oral dosage forms, but can be crushed to administer via enteral tube. Common reported adverse effects include somnolence, hypotension, and dizziness. Although quetiapine has been shown to prolong QTc, Harrigan et al. reported a mean increase in QTc from baseline of 5.7 msec; there was no significant effect on this change in the presence of a metabolic inhibitor, ketoconazole.[36] The mean change in QTc from baseline with quetiapine was lower than the change reported with oral haloperidol, 5.7 msec compared to 7.1 msec, respectively. No statistical comparison was performed between these 2 drugs on this measure. Quetiapine does carry a black box warning for increased mortality in elderly patients with dementia‐related psychosis.[35] However, this risk has also been found with first‐generation antipsychotics.[37, 38, 39] A recent study found this risk of sudden cardiac death extended to adult users of both first‐ and second‐generation antipsychotics.[40] In contrast, Elie et al. found no increased risk of mortality in elderly patients with delirium receiving antipsychoticsover 90% were prescribed either haloperidol or risperidonein their nested case‐controlled study.[41] Quetiapine has demonstrated some benefit with limited side effects in studies utilizing antipsychotics for the treatment of delirium. The purpose of this review was to evaluate the role of quetiapine for the treatment of delirium.
LITERATURE REVIEW
We performed an English‐language literature search of MEDLINE and Embase databases to identify journal articles published between January 1960 and December 2012. Keywords included quetiapine, second‐generation antipsychotic, atypical antipsychotic, delirium, and agitation. The search was limited to English‐language articles and adult subjects (>18 years). Based on our review of abstracts, we included both controlled and noncontrolled trials as long as treatment of delirium was the primary focus. We eliminated case reports, foreign language articles, and poster presentations. We identified 8 trials[19, 20, 24, 25, 26, 27, 28, 29] that included 2 double‐blind, randomized, placebo‐controlled trials, which are described in the text below.[19, 20] Six other trials, 5 open‐label[25, 26, 27, 28, 29] and 1 retrospective cohort,[24] are described in Table 1.
| Study | Study Design | No. of Patients Included in Analyses | Patient Type | Treatment | Baseline Delirium Scores | Quetiapine Dose (mg/day) (MeanSD) | Efficacy Measures | Results | Side Effects |
|---|---|---|---|---|---|---|---|---|---|
| |||||||||
| Schwartz et al. (2000)[24] | RC | 22 | General hospital | Quetiapine or haloperidol flexible dose | DRS score 20.9 Q; 18.5 H | 211.4 Q; 3.4 H | >50% improvement in DRS scores | 10/11 in each treatment group had >50% improvement in DRS scores | EPS 2/11 H and 0/11 Q; mild‐to‐moderate sedation 0/11 H and 2/11 Q |
| Pae et al. (2004)[25] | OL | 22 | Neurosurgery and orthopedic surgery and oncology | Flexible dose quetiapine | DRS‐R‐98 21.83.2 and CGI‐s 4.90.8 | 127.172.2 | DRS‐R‐98 and CGI‐s score reduction | DRS‐R‐98 9.33.8 (P<0.0001) and CGI‐s 2.11.1 (P<0.0001) reduction from baseline; 19/22 (86.3%) and 17/22 (77.3%) showed >50% score reduction for DRS‐R‐98 and CGI‐s, respectively | EPS none; sedation requiring discontinuation 2; mild sedation 3; serious side effects none |
| Maneeton et al. (2007)[26] | OL | 17 | General hospital | Quetiapine 25100 mg/day in 1 or 2 divided doses | DRS 24.53.2 and CGI‐s 4.90.9 | 45.728.7 | 50% reduction in DRS scores | 15/17 (88.2%) had 50% reduction in DRS score; all DRS and CGI‐s scores on days 17 of the 7‐day treatment course were significantly lower than baseline scores | EPS tremor 2; hypotension 2; daytime sleepiness 13; nightmare 3; dry mouth 2; nausea 1 |
| Kim et al. (2003)[27] | OL | 12 (all male and age 64 years) | General hospital | Quetiapine 25 mg BID and increased by 25 mg every 2 days until patient maximally stabilized | DRS 18.256.05; MMSE 14.505.90; CGI‐s 3.000.43; CDT 3.25 2.77 | 93.7523.31 | Reduction in DRS, MMSE, CGI‐s, or CDT scores | All scores were statistically significantly improved from baseline; DRS at end of study 0.631.21 (P=0.03) | No dropouts due to side effects; EPS none; sedation 2; vivid dreams 1 |
| Sasaki et al. (2003)[28] | OL | 12 | General hospital | Quetiapine started at 25 or 50 mg/day and titrated to maximal clinical effect | DRS‐J 18.14.2 | 44.931.0 | Remission was DRS‐J score <12 (cutoff for delirium) and resolution of delirium symptoms | Remission occurred in all patients; mean DRS‐J score was reduced to 9.31.6 after remission | No statistically significant change from baseline in EPS; no excessive daytime sedation, anticholinergic effects, vital sign, or lab parameter changes |
| Lee et al. (2005)[29] | OL | 31 | Neurosurgery and orthopedic surgery, internal medicine, neurology and rehabilitation medicine | Flexible dose quetiapine or amisulpride | DRS‐R‐98 10.14.1 Q and 10.54.1 A | 11385.5 Q; 156.497.5 A | Reduction in DRS‐R‐98 score | DRS‐R‐98 scores significantly reduced from baseline in both groups with 3.52.6 Q (P=0.001) and 3.51.4 A (P=0.000); no difference between groups (P=0.842); 12 (80%) Q and 13 (81.3%) A had >50% reduction in DRS‐R‐98 score | No serious side effects; dropouts 5 Q and 4 A; oversedation 1 Q and 1 A; patient withdrawal 2 Q and 1 A; no statistical differences in total sleep time P=0.767 or quality of sleep P=0.984 |
Randomized Controlled Trials
Tahir et al. published a double‐blind, randomized, placebo‐controlled trial examining the efficacy and tolerability of quetiapine in the treatment of delirium.[19] Inclusion criteria were a Diagnostic and Statistical Manual of Mental Disorders‐IV diagnosis of delirium and a Delirium Rating Scale Revised 98 (DRS‐R‐98) total score of at least 15, indicating the presence of delirium. Subjects were excluded for major preexisting cognitive deficits, alcohol withdrawal, preexisting psychosis, substance dependence, inability to comply with the constraints of the trial, and concurrent medications that interact with quetiapine.
Forty‐two general medicine subjects were enrolled and randomized in the study with no difference in baseline characteristics. Patients received either placebo or quetiapine 25 mg once daily. Doses were titrated by 25 mg daily to a maximum daily dose of 175 mg in divided doses. The primary end point was DRS‐R‐98 total mean score assessed on days 1, 2, 3, 4, 7, and 10, with follow‐up assessment on day 30. Secondary outcome measures were Mini‐Mental State Examination (MMSE), the Brief Psychiatric Rating Scale, and the Clinical Global Improvement Scale. Tolerability was assessed using the Abnormal Involuntary Movements Scale and by clinical examination.
No differences in total mean DRS‐R‐98 score at individual time points reached statistical significance, but these scores improved more quickly in the quetiapine group than placebo. The secondary outcome of rate of delirium improvement on severity score did reach statistical significance; differences on mean severity scores were 0.8270.37 (P=0.026), suggesting that severity scores improved 82% more quickly than placebo. There were no significant differences between groups for any of the other secondary outcomes. Seven patients died within 30 days of entering the study (4 in the quetiapine group and 3 in the placebo group) due to serious medical conditions and not due to study medication as determined through clinical review. One patient withdrew from quetiapine due to sedation. Results of this study are limited by a small sample size, as it was underpowered to detect a statistically significant difference in the primary outcome. Other limitations include subjects who were older, with mean age of 84 years, which may have prevented titration of quetiapine, and subjects with minor cognitive deficits were included, which may have reduced the impact of treatment on the study outcomes. Additionally, strict criteria for exclusion kept those patients most likely to develop delirium from being included, limiting the studies external validity. Finally, the use of DRS‐R‐98 mean total and severity scores is subject to error as outliers in the mean could potentially skew the results.
Devlin et al. investigated the efficacy and safety of quetiapine for ICU delirium in critically ill patients in a double‐blind, randomized, placebo‐controlled trial.[20] Inclusion criteria were an Intensive Care Delirium Screening Checklist Score (ICDSC) >4, which indicates the presence of delirium, an order for as‐needed haloperidol, and tolerating enteral nutrition. Patients were excluded if they had a complicating neurologic condition, current treatment with dexmedetomidine or with medications that interact with quetiapine, baseline QTc interval >500, pregnancy, or poor prognosis. Thirty‐six critically ill subjects were randomized with no significant differences in baseline characteristics including exposure to fentanyl, haloperidol, and benzodiazepines, and in particular, midazolam. If the subject received at least 1 dose of as‐needed haloperidol in the previous 24 hours, then either placebo or quetiapine was given. Quetiapine was initiated at 50 mg every 12 hours and titrated up by 50 mg every 12 hours to a maximum dose of 200 mg every 12 hours. Patients could receive intravenous haloperidol, 1 to 10 mg up to every 2 hours as needed. The primary outcome was time to first resolution of delirium defined as time from administration of the first dose of study drug until an ICDSC <3 was first detected, indicating an absence of delirium. Secondary outcomes were total hours in delirium, total hours spent deeply sedated (Sedation‐Agitation Scale [SAS] <2) or agitated (SAS >5), episodes of subject‐initiated device removal, use of haloperidol therapy including total dose in milligrams, number of doses and number of days of therapy, the use of sedatives (converted to midazolam equivalents) and analgesics, duration of study‐drug administration, average daily and maximum study‐drug dose, length of mechanical ventilation, duration of both ICU and hospital stay, hospital mortality, and disposition of subjects after hospital discharge. Safety measures were total number of adverse and serious adverse events, episodes of somnolence, incidence of extrapyramidal symptoms, and episodes of QTc interval prolongation.
The time to first resolution of delirium was shorter with quetiapine compared to placebo (median [interquartile range]: 1.0 [0.53.0] vs 4.5 days [2.0‐7.0]; P=0.001). Resolution of delirium occurred at least once in all quetiapine patients and in 78% of placebo patients (P=0.05). Statistical significance with quetiapine was reached on the following secondary end points: time spent in delirium (36 [1287] vs 120 hours [60195], P=0.006); shorter duration of study drug (102 [84168] vs 186 hours [108228], P=0.04); lower daily study drug dose (110 [88191] vs 210 mg [116293], P=0.01); less upregulation of the study medication dose (200 [100313] vs 375 mg [25400], P=0.02); fewer hours of agitation (6 [038] vs 36 hours [1166], P=0.02); shorter duration of haloperidol therapy (3 [24] vs 4 days [38], P=0.05); and fewer days of fentanyl (0 [03] vs 4 days [19], P=0.03). There were no significant differences between groups for any other secondary outcomes. As‐needed haloperidol use in the quetiapine versus the placebo group was lower but not statistically significant (1.9 vs 4.3 mg per day; P=0.26). Two main limitations were a small sample size and strict exclusion criteria. Additionally, the primary end point of time to first resolution of delirium may be interpreted as a less rigorous measure, because there is no standard definition for delirium resolution, and delirium is a condition that waxes and wanes on its own.
A post hoc analysis by Devlin et al. was conducted on the above study to compare duration and time to first resolution of 10 delirium symptoms in 29 patients.[21] Symptoms included agitation, decreased level of consciousness, inattention, disorientation, hallucinations/delusions, hyperactivity, hypoactivity, inappropriate speech or mood, sleep/wake cycle disturbance, and symptom fluctuation. Only symptom fluctuation (P=0.009), time to first resolution of symptom fluctuation (P=0.004), time with inattention (47 vs 78 hours, P=0.025), and time with symptom fluctuation (47 vs 89 hours; P =0.04) reached statistical significance with quetiapine compared to placebo. However, quetiapine subjects had a longer time to resolution of agitation (3 vs 1 day, P=0.04) and hyperactivity (5 vs 1 day, P<0.04). The authors attribute these findings to the higher use of as‐needed haloperidol in the placebo group (1.9 vs 4.3 mg per day, P=0.26). These results may also be due to a limitation in the study design, which self‐selected for agitation delirium by requiring the use of as‐needed haloperidol as inclusion criteria, as symptoms of agitation would be more likely to receive as‐needed haloperidol doses. In addition, subjects were allowed to receive 1 to 10 mg of haloperidol up to every 2 hours as needed, but there is no discussion of controlling total daily haloperidol dose in each group in the study. Although 1.9 versus 4.3 mg per day is neither statistically nor likely clinically significant, haloperidol is a treatment for delirium, so the study design would be stronger if quetiapine could be directly compared to an equivalent daily dose of haloperidol or if both groups received the same daily dose of haloperidol. Study results are also limited by the nature of a post hoc analysis, missing documentation for individual delirium symptoms, symptoms of delirium not being well characterized and subjective, and delay in enrollment of subjects.
Noncontrolled Trials
Six additional trials are included in the table of this review including 5 open label trials and 1 retrospective cohort study.[24, 25, 26, 27, 28, 29] Schwartz and Masand[24] and Lee et al.[29] compared the efficacy of quetiapine to haloperidol and amisulpride, a second‐generation antipsychotic unavailable in the United States, respectively. In a retrospective cohort of 22 general hospital patients, Schwartz and Masand found quetiapine (average dose, 211.4 mg/day) was as efficacious as haloperidol (average dose, 3.4 mg/day) in improving delirium rating scale (DRS) scores by more than 50% in 10/11 subjects in each group. Lee et al. also found quetiapine (average dose, 113.0 mg/day) to be equally efficacious to amisulpride (156.4 mg/day) in statistically significantly improving DRS‐R‐98 scores in 31 neurosurgery, orthopedic surgery, internal medicine, neurology, and rehabilitation medicine patients. Four open‐label studies tested the efficacy of flexible doses of quetiapine in a total of 63 general hospital, neurosurgery, orthopedic surgery, and oncology patients.[25, 26, 27, 28] Pae et al.,[25] Maneeton et al.,[26] and Kim et al.[27] found that quetiapine statistically significantly reduced DRS‐R‐98, Clinical Global Impression Scale‐Severity, DRS, MMSE, and Clock Drawing Test scores from baseline. Sasaki et al.[28] found all 12 general hospital patients in their study reached remission with an average daily quetiapine dose of 44.9 mg/day. Although these studies have a limited level of evidence due to their small sample sizes, study designs, and heterogeneous subjects, they do still suggest that quetiapine may effectively treat delirium in various patient populations.
DISCUSSION
Although the role of quetiapine for the treatment of delirium continues to develop, the studies evaluated here suggest that quetiapine may be effective and safe for this usage. Resolution of delirium from baseline was shown in all studies. Quetiapine resolved symptoms of delirium more quickly than placebo and had equal efficacy to other antipsychotics, haloperidol and amisulpride. Quetiapine may be most useful for patients with symptom fluctuation as opposed to agitation and hyperactivity or in those patients who may not tolerate haloperidol well. Both randomized control and open‐label trials found a low incidence of adverse effects with quetiapine. There were fewer incidences of QT prolongation and extrapyramidal symptoms, but higher a rate of somnolence with quetiapine compared to other antipsychotics in these trials. However, none of these differences in adverse effects reached statistical significance.
Drawing definitive conclusions about the efficacy of quetiapine in the treatment of delirium is difficult due to multiple study limitations. First, the body of literature is small, with only 2 randomized controlled trials, both of which had limitations. Tahir et al.[19] was underpowered and found no statistically significant difference in the primary end point, DRS‐R‐98 total mean score. Devlin et al.[20] tested the primary end point of time to first resolution of delirium, which may be interpreted as a less rigorous measure because there is no standard definition for delirium resolution. Furthermore, both randomized controlled and observational trials tested the efficacy of quetiapine using different tests, making comparison between these trials difficult. All studies included in this review were carried out in small patient populations, with the largest trial having 42 subjects, and had highly restrictive exclusion criteria limiting the generalizability of the study population to the general hospital population. Although most of the patients included in these studies are general hospital populations, Devlin et al. was performed in critically ill patients, which creates the additional limitation of having heterogeneous study populations. Last, superiority of any 1 antipsychotic is not possible given that none of these studies have done a head‐to‐head comparison of quetiapine with another atypical antipsychotic.
Given the comparable efficacy and safety of antipsychotics, cost is a relevant factor in treatment decisions. Haloperidol is supplied as either a suspension for injection or a tablet. One vial of 5 mg/mL haloperidol is $8.32. Haloperidol 5 mg tablets are approximately $0.29 each, whereas 25 mg tablets of quetiapine are approximately $3.53 each. However, these prices are for consumers and will vary depending on institutional contracts.[42]
CONCLUSION
Quetiapine appears to be an effective and safe agent for the treatment of delirium in both general medicine and ICU patients. Superiority of quetiapine over other antipsychotics for hospital‐associated delirium has not been shown due to limitations in quality and quantity of data. Large, randomized, double‐blind, active control studies with longer study durations are needed to elucidate the efficacy and niche of quetiapine in the treatment of delirium.
Acknowledgment
Disclosure: Nothing to report.
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Delirium is an acute fluctuation in mental status that includes symptoms of inattention, disorganized thinking, and altered level of consciousness occurring over a short time period.[1] Prevalence of delirium ranges from 10% to 30% in the hospitalized medically ill and ranges from 40% to 60% in intensive care unit (ICU) patients who are not receiving mechanical ventilation.[2, 3] Patients experience delirium more often if they are of older age; have dementia, cancer, or acquired immune deficiency syndrome; have undergone surgery; are terminally ill; or have received multiple psychoactive medications, particularly benzodiazepines or opioids.[3, 4, 5, 6, 7] Delirium is associated with high rates of morbidity and mortality,[8] with patients more likely to develop complications such as pneumonia, decubitus ulcers, and long‐term cognitive deficits.[9, 10, 11, 12] These complications, in turn, lead to longer hospital stays and increased costs of care.[13, 14] Currently, there are no antipsychotics approved by the US Food and Drug Administration for the treatment of delirium.
Both the 2002 American Society of Critical Care Medicine[12] and the 2004 American Psychiatric Association guidelines[15] on delirium recommend haloperidol as the antipsychotic of choice due to its potent tranquilizing effect, lack of active metabolites, and limited anticholinergic and sedating side effects. However, when given intravenously or at high cumulative doses (generally >35 mg/day), haloperidol has been shown to cause QT interval prolongation potentially leading to torsades de pointes and sudden cardiac death.[15] Recent research in delirium treatment has focused on the second‐generation antipsychotics, and these studies have reported positive findings,[16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29] although no significant differences have been found compared to haloperidol.[16, 17, 18, 22, 23, 24] Systematic reviews have also failed to show a significant difference in efficacy or safety between second‐generation and first‐generation antipsychotics and unfortunately report a number of limitations including poor study designs, small sample sizes, lack of a placebo control group, exclusion of ICU patients, and weak primary outcomes.[8, 30, 31, 32] Attempting to correct for a number of these limitations, recent research with quetiapine has reported promising results in 2 controlled studies.[19, 20]
Quetiapine is a second‐generation antipsychotic with a very low affinity for dopamine receptors and a very high affinity for serotonin receptors.[33, 34] Additionally, quetiapine has a high affinity for histamine and 1‐adrenergic receptors, but a very low affinity for M1 muscarinic receptors.[34] This mechanism of action may allow quetiapine to effectively treat delirium and provide sedation without causing significant extrapyramidal side effects associated with potent dopamine receptor antagonism or precipitating delirium through muscarinic receptor antagonism. Quetiapine has a rapid absorption and a short half‐life (36 hours), giving it a quick onset of action and a fast elimination from the body.[35] Unlike haloperidol, it is only available in oral dosage forms, but can be crushed to administer via enteral tube. Common reported adverse effects include somnolence, hypotension, and dizziness. Although quetiapine has been shown to prolong QTc, Harrigan et al. reported a mean increase in QTc from baseline of 5.7 msec; there was no significant effect on this change in the presence of a metabolic inhibitor, ketoconazole.[36] The mean change in QTc from baseline with quetiapine was lower than the change reported with oral haloperidol, 5.7 msec compared to 7.1 msec, respectively. No statistical comparison was performed between these 2 drugs on this measure. Quetiapine does carry a black box warning for increased mortality in elderly patients with dementia‐related psychosis.[35] However, this risk has also been found with first‐generation antipsychotics.[37, 38, 39] A recent study found this risk of sudden cardiac death extended to adult users of both first‐ and second‐generation antipsychotics.[40] In contrast, Elie et al. found no increased risk of mortality in elderly patients with delirium receiving antipsychoticsover 90% were prescribed either haloperidol or risperidonein their nested case‐controlled study.[41] Quetiapine has demonstrated some benefit with limited side effects in studies utilizing antipsychotics for the treatment of delirium. The purpose of this review was to evaluate the role of quetiapine for the treatment of delirium.
LITERATURE REVIEW
We performed an English‐language literature search of MEDLINE and Embase databases to identify journal articles published between January 1960 and December 2012. Keywords included quetiapine, second‐generation antipsychotic, atypical antipsychotic, delirium, and agitation. The search was limited to English‐language articles and adult subjects (>18 years). Based on our review of abstracts, we included both controlled and noncontrolled trials as long as treatment of delirium was the primary focus. We eliminated case reports, foreign language articles, and poster presentations. We identified 8 trials[19, 20, 24, 25, 26, 27, 28, 29] that included 2 double‐blind, randomized, placebo‐controlled trials, which are described in the text below.[19, 20] Six other trials, 5 open‐label[25, 26, 27, 28, 29] and 1 retrospective cohort,[24] are described in Table 1.
| Study | Study Design | No. of Patients Included in Analyses | Patient Type | Treatment | Baseline Delirium Scores | Quetiapine Dose (mg/day) (MeanSD) | Efficacy Measures | Results | Side Effects |
|---|---|---|---|---|---|---|---|---|---|
| |||||||||
| Schwartz et al. (2000)[24] | RC | 22 | General hospital | Quetiapine or haloperidol flexible dose | DRS score 20.9 Q; 18.5 H | 211.4 Q; 3.4 H | >50% improvement in DRS scores | 10/11 in each treatment group had >50% improvement in DRS scores | EPS 2/11 H and 0/11 Q; mild‐to‐moderate sedation 0/11 H and 2/11 Q |
| Pae et al. (2004)[25] | OL | 22 | Neurosurgery and orthopedic surgery and oncology | Flexible dose quetiapine | DRS‐R‐98 21.83.2 and CGI‐s 4.90.8 | 127.172.2 | DRS‐R‐98 and CGI‐s score reduction | DRS‐R‐98 9.33.8 (P<0.0001) and CGI‐s 2.11.1 (P<0.0001) reduction from baseline; 19/22 (86.3%) and 17/22 (77.3%) showed >50% score reduction for DRS‐R‐98 and CGI‐s, respectively | EPS none; sedation requiring discontinuation 2; mild sedation 3; serious side effects none |
| Maneeton et al. (2007)[26] | OL | 17 | General hospital | Quetiapine 25100 mg/day in 1 or 2 divided doses | DRS 24.53.2 and CGI‐s 4.90.9 | 45.728.7 | 50% reduction in DRS scores | 15/17 (88.2%) had 50% reduction in DRS score; all DRS and CGI‐s scores on days 17 of the 7‐day treatment course were significantly lower than baseline scores | EPS tremor 2; hypotension 2; daytime sleepiness 13; nightmare 3; dry mouth 2; nausea 1 |
| Kim et al. (2003)[27] | OL | 12 (all male and age 64 years) | General hospital | Quetiapine 25 mg BID and increased by 25 mg every 2 days until patient maximally stabilized | DRS 18.256.05; MMSE 14.505.90; CGI‐s 3.000.43; CDT 3.25 2.77 | 93.7523.31 | Reduction in DRS, MMSE, CGI‐s, or CDT scores | All scores were statistically significantly improved from baseline; DRS at end of study 0.631.21 (P=0.03) | No dropouts due to side effects; EPS none; sedation 2; vivid dreams 1 |
| Sasaki et al. (2003)[28] | OL | 12 | General hospital | Quetiapine started at 25 or 50 mg/day and titrated to maximal clinical effect | DRS‐J 18.14.2 | 44.931.0 | Remission was DRS‐J score <12 (cutoff for delirium) and resolution of delirium symptoms | Remission occurred in all patients; mean DRS‐J score was reduced to 9.31.6 after remission | No statistically significant change from baseline in EPS; no excessive daytime sedation, anticholinergic effects, vital sign, or lab parameter changes |
| Lee et al. (2005)[29] | OL | 31 | Neurosurgery and orthopedic surgery, internal medicine, neurology and rehabilitation medicine | Flexible dose quetiapine or amisulpride | DRS‐R‐98 10.14.1 Q and 10.54.1 A | 11385.5 Q; 156.497.5 A | Reduction in DRS‐R‐98 score | DRS‐R‐98 scores significantly reduced from baseline in both groups with 3.52.6 Q (P=0.001) and 3.51.4 A (P=0.000); no difference between groups (P=0.842); 12 (80%) Q and 13 (81.3%) A had >50% reduction in DRS‐R‐98 score | No serious side effects; dropouts 5 Q and 4 A; oversedation 1 Q and 1 A; patient withdrawal 2 Q and 1 A; no statistical differences in total sleep time P=0.767 or quality of sleep P=0.984 |
Randomized Controlled Trials
Tahir et al. published a double‐blind, randomized, placebo‐controlled trial examining the efficacy and tolerability of quetiapine in the treatment of delirium.[19] Inclusion criteria were a Diagnostic and Statistical Manual of Mental Disorders‐IV diagnosis of delirium and a Delirium Rating Scale Revised 98 (DRS‐R‐98) total score of at least 15, indicating the presence of delirium. Subjects were excluded for major preexisting cognitive deficits, alcohol withdrawal, preexisting psychosis, substance dependence, inability to comply with the constraints of the trial, and concurrent medications that interact with quetiapine.
Forty‐two general medicine subjects were enrolled and randomized in the study with no difference in baseline characteristics. Patients received either placebo or quetiapine 25 mg once daily. Doses were titrated by 25 mg daily to a maximum daily dose of 175 mg in divided doses. The primary end point was DRS‐R‐98 total mean score assessed on days 1, 2, 3, 4, 7, and 10, with follow‐up assessment on day 30. Secondary outcome measures were Mini‐Mental State Examination (MMSE), the Brief Psychiatric Rating Scale, and the Clinical Global Improvement Scale. Tolerability was assessed using the Abnormal Involuntary Movements Scale and by clinical examination.
No differences in total mean DRS‐R‐98 score at individual time points reached statistical significance, but these scores improved more quickly in the quetiapine group than placebo. The secondary outcome of rate of delirium improvement on severity score did reach statistical significance; differences on mean severity scores were 0.8270.37 (P=0.026), suggesting that severity scores improved 82% more quickly than placebo. There were no significant differences between groups for any of the other secondary outcomes. Seven patients died within 30 days of entering the study (4 in the quetiapine group and 3 in the placebo group) due to serious medical conditions and not due to study medication as determined through clinical review. One patient withdrew from quetiapine due to sedation. Results of this study are limited by a small sample size, as it was underpowered to detect a statistically significant difference in the primary outcome. Other limitations include subjects who were older, with mean age of 84 years, which may have prevented titration of quetiapine, and subjects with minor cognitive deficits were included, which may have reduced the impact of treatment on the study outcomes. Additionally, strict criteria for exclusion kept those patients most likely to develop delirium from being included, limiting the studies external validity. Finally, the use of DRS‐R‐98 mean total and severity scores is subject to error as outliers in the mean could potentially skew the results.
Devlin et al. investigated the efficacy and safety of quetiapine for ICU delirium in critically ill patients in a double‐blind, randomized, placebo‐controlled trial.[20] Inclusion criteria were an Intensive Care Delirium Screening Checklist Score (ICDSC) >4, which indicates the presence of delirium, an order for as‐needed haloperidol, and tolerating enteral nutrition. Patients were excluded if they had a complicating neurologic condition, current treatment with dexmedetomidine or with medications that interact with quetiapine, baseline QTc interval >500, pregnancy, or poor prognosis. Thirty‐six critically ill subjects were randomized with no significant differences in baseline characteristics including exposure to fentanyl, haloperidol, and benzodiazepines, and in particular, midazolam. If the subject received at least 1 dose of as‐needed haloperidol in the previous 24 hours, then either placebo or quetiapine was given. Quetiapine was initiated at 50 mg every 12 hours and titrated up by 50 mg every 12 hours to a maximum dose of 200 mg every 12 hours. Patients could receive intravenous haloperidol, 1 to 10 mg up to every 2 hours as needed. The primary outcome was time to first resolution of delirium defined as time from administration of the first dose of study drug until an ICDSC <3 was first detected, indicating an absence of delirium. Secondary outcomes were total hours in delirium, total hours spent deeply sedated (Sedation‐Agitation Scale [SAS] <2) or agitated (SAS >5), episodes of subject‐initiated device removal, use of haloperidol therapy including total dose in milligrams, number of doses and number of days of therapy, the use of sedatives (converted to midazolam equivalents) and analgesics, duration of study‐drug administration, average daily and maximum study‐drug dose, length of mechanical ventilation, duration of both ICU and hospital stay, hospital mortality, and disposition of subjects after hospital discharge. Safety measures were total number of adverse and serious adverse events, episodes of somnolence, incidence of extrapyramidal symptoms, and episodes of QTc interval prolongation.
The time to first resolution of delirium was shorter with quetiapine compared to placebo (median [interquartile range]: 1.0 [0.53.0] vs 4.5 days [2.0‐7.0]; P=0.001). Resolution of delirium occurred at least once in all quetiapine patients and in 78% of placebo patients (P=0.05). Statistical significance with quetiapine was reached on the following secondary end points: time spent in delirium (36 [1287] vs 120 hours [60195], P=0.006); shorter duration of study drug (102 [84168] vs 186 hours [108228], P=0.04); lower daily study drug dose (110 [88191] vs 210 mg [116293], P=0.01); less upregulation of the study medication dose (200 [100313] vs 375 mg [25400], P=0.02); fewer hours of agitation (6 [038] vs 36 hours [1166], P=0.02); shorter duration of haloperidol therapy (3 [24] vs 4 days [38], P=0.05); and fewer days of fentanyl (0 [03] vs 4 days [19], P=0.03). There were no significant differences between groups for any other secondary outcomes. As‐needed haloperidol use in the quetiapine versus the placebo group was lower but not statistically significant (1.9 vs 4.3 mg per day; P=0.26). Two main limitations were a small sample size and strict exclusion criteria. Additionally, the primary end point of time to first resolution of delirium may be interpreted as a less rigorous measure, because there is no standard definition for delirium resolution, and delirium is a condition that waxes and wanes on its own.
A post hoc analysis by Devlin et al. was conducted on the above study to compare duration and time to first resolution of 10 delirium symptoms in 29 patients.[21] Symptoms included agitation, decreased level of consciousness, inattention, disorientation, hallucinations/delusions, hyperactivity, hypoactivity, inappropriate speech or mood, sleep/wake cycle disturbance, and symptom fluctuation. Only symptom fluctuation (P=0.009), time to first resolution of symptom fluctuation (P=0.004), time with inattention (47 vs 78 hours, P=0.025), and time with symptom fluctuation (47 vs 89 hours; P =0.04) reached statistical significance with quetiapine compared to placebo. However, quetiapine subjects had a longer time to resolution of agitation (3 vs 1 day, P=0.04) and hyperactivity (5 vs 1 day, P<0.04). The authors attribute these findings to the higher use of as‐needed haloperidol in the placebo group (1.9 vs 4.3 mg per day, P=0.26). These results may also be due to a limitation in the study design, which self‐selected for agitation delirium by requiring the use of as‐needed haloperidol as inclusion criteria, as symptoms of agitation would be more likely to receive as‐needed haloperidol doses. In addition, subjects were allowed to receive 1 to 10 mg of haloperidol up to every 2 hours as needed, but there is no discussion of controlling total daily haloperidol dose in each group in the study. Although 1.9 versus 4.3 mg per day is neither statistically nor likely clinically significant, haloperidol is a treatment for delirium, so the study design would be stronger if quetiapine could be directly compared to an equivalent daily dose of haloperidol or if both groups received the same daily dose of haloperidol. Study results are also limited by the nature of a post hoc analysis, missing documentation for individual delirium symptoms, symptoms of delirium not being well characterized and subjective, and delay in enrollment of subjects.
Noncontrolled Trials
Six additional trials are included in the table of this review including 5 open label trials and 1 retrospective cohort study.[24, 25, 26, 27, 28, 29] Schwartz and Masand[24] and Lee et al.[29] compared the efficacy of quetiapine to haloperidol and amisulpride, a second‐generation antipsychotic unavailable in the United States, respectively. In a retrospective cohort of 22 general hospital patients, Schwartz and Masand found quetiapine (average dose, 211.4 mg/day) was as efficacious as haloperidol (average dose, 3.4 mg/day) in improving delirium rating scale (DRS) scores by more than 50% in 10/11 subjects in each group. Lee et al. also found quetiapine (average dose, 113.0 mg/day) to be equally efficacious to amisulpride (156.4 mg/day) in statistically significantly improving DRS‐R‐98 scores in 31 neurosurgery, orthopedic surgery, internal medicine, neurology, and rehabilitation medicine patients. Four open‐label studies tested the efficacy of flexible doses of quetiapine in a total of 63 general hospital, neurosurgery, orthopedic surgery, and oncology patients.[25, 26, 27, 28] Pae et al.,[25] Maneeton et al.,[26] and Kim et al.[27] found that quetiapine statistically significantly reduced DRS‐R‐98, Clinical Global Impression Scale‐Severity, DRS, MMSE, and Clock Drawing Test scores from baseline. Sasaki et al.[28] found all 12 general hospital patients in their study reached remission with an average daily quetiapine dose of 44.9 mg/day. Although these studies have a limited level of evidence due to their small sample sizes, study designs, and heterogeneous subjects, they do still suggest that quetiapine may effectively treat delirium in various patient populations.
DISCUSSION
Although the role of quetiapine for the treatment of delirium continues to develop, the studies evaluated here suggest that quetiapine may be effective and safe for this usage. Resolution of delirium from baseline was shown in all studies. Quetiapine resolved symptoms of delirium more quickly than placebo and had equal efficacy to other antipsychotics, haloperidol and amisulpride. Quetiapine may be most useful for patients with symptom fluctuation as opposed to agitation and hyperactivity or in those patients who may not tolerate haloperidol well. Both randomized control and open‐label trials found a low incidence of adverse effects with quetiapine. There were fewer incidences of QT prolongation and extrapyramidal symptoms, but higher a rate of somnolence with quetiapine compared to other antipsychotics in these trials. However, none of these differences in adverse effects reached statistical significance.
Drawing definitive conclusions about the efficacy of quetiapine in the treatment of delirium is difficult due to multiple study limitations. First, the body of literature is small, with only 2 randomized controlled trials, both of which had limitations. Tahir et al.[19] was underpowered and found no statistically significant difference in the primary end point, DRS‐R‐98 total mean score. Devlin et al.[20] tested the primary end point of time to first resolution of delirium, which may be interpreted as a less rigorous measure because there is no standard definition for delirium resolution. Furthermore, both randomized controlled and observational trials tested the efficacy of quetiapine using different tests, making comparison between these trials difficult. All studies included in this review were carried out in small patient populations, with the largest trial having 42 subjects, and had highly restrictive exclusion criteria limiting the generalizability of the study population to the general hospital population. Although most of the patients included in these studies are general hospital populations, Devlin et al. was performed in critically ill patients, which creates the additional limitation of having heterogeneous study populations. Last, superiority of any 1 antipsychotic is not possible given that none of these studies have done a head‐to‐head comparison of quetiapine with another atypical antipsychotic.
Given the comparable efficacy and safety of antipsychotics, cost is a relevant factor in treatment decisions. Haloperidol is supplied as either a suspension for injection or a tablet. One vial of 5 mg/mL haloperidol is $8.32. Haloperidol 5 mg tablets are approximately $0.29 each, whereas 25 mg tablets of quetiapine are approximately $3.53 each. However, these prices are for consumers and will vary depending on institutional contracts.[42]
CONCLUSION
Quetiapine appears to be an effective and safe agent for the treatment of delirium in both general medicine and ICU patients. Superiority of quetiapine over other antipsychotics for hospital‐associated delirium has not been shown due to limitations in quality and quantity of data. Large, randomized, double‐blind, active control studies with longer study durations are needed to elucidate the efficacy and niche of quetiapine in the treatment of delirium.
Acknowledgment
Disclosure: Nothing to report.
Delirium is an acute fluctuation in mental status that includes symptoms of inattention, disorganized thinking, and altered level of consciousness occurring over a short time period.[1] Prevalence of delirium ranges from 10% to 30% in the hospitalized medically ill and ranges from 40% to 60% in intensive care unit (ICU) patients who are not receiving mechanical ventilation.[2, 3] Patients experience delirium more often if they are of older age; have dementia, cancer, or acquired immune deficiency syndrome; have undergone surgery; are terminally ill; or have received multiple psychoactive medications, particularly benzodiazepines or opioids.[3, 4, 5, 6, 7] Delirium is associated with high rates of morbidity and mortality,[8] with patients more likely to develop complications such as pneumonia, decubitus ulcers, and long‐term cognitive deficits.[9, 10, 11, 12] These complications, in turn, lead to longer hospital stays and increased costs of care.[13, 14] Currently, there are no antipsychotics approved by the US Food and Drug Administration for the treatment of delirium.
Both the 2002 American Society of Critical Care Medicine[12] and the 2004 American Psychiatric Association guidelines[15] on delirium recommend haloperidol as the antipsychotic of choice due to its potent tranquilizing effect, lack of active metabolites, and limited anticholinergic and sedating side effects. However, when given intravenously or at high cumulative doses (generally >35 mg/day), haloperidol has been shown to cause QT interval prolongation potentially leading to torsades de pointes and sudden cardiac death.[15] Recent research in delirium treatment has focused on the second‐generation antipsychotics, and these studies have reported positive findings,[16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29] although no significant differences have been found compared to haloperidol.[16, 17, 18, 22, 23, 24] Systematic reviews have also failed to show a significant difference in efficacy or safety between second‐generation and first‐generation antipsychotics and unfortunately report a number of limitations including poor study designs, small sample sizes, lack of a placebo control group, exclusion of ICU patients, and weak primary outcomes.[8, 30, 31, 32] Attempting to correct for a number of these limitations, recent research with quetiapine has reported promising results in 2 controlled studies.[19, 20]
Quetiapine is a second‐generation antipsychotic with a very low affinity for dopamine receptors and a very high affinity for serotonin receptors.[33, 34] Additionally, quetiapine has a high affinity for histamine and 1‐adrenergic receptors, but a very low affinity for M1 muscarinic receptors.[34] This mechanism of action may allow quetiapine to effectively treat delirium and provide sedation without causing significant extrapyramidal side effects associated with potent dopamine receptor antagonism or precipitating delirium through muscarinic receptor antagonism. Quetiapine has a rapid absorption and a short half‐life (36 hours), giving it a quick onset of action and a fast elimination from the body.[35] Unlike haloperidol, it is only available in oral dosage forms, but can be crushed to administer via enteral tube. Common reported adverse effects include somnolence, hypotension, and dizziness. Although quetiapine has been shown to prolong QTc, Harrigan et al. reported a mean increase in QTc from baseline of 5.7 msec; there was no significant effect on this change in the presence of a metabolic inhibitor, ketoconazole.[36] The mean change in QTc from baseline with quetiapine was lower than the change reported with oral haloperidol, 5.7 msec compared to 7.1 msec, respectively. No statistical comparison was performed between these 2 drugs on this measure. Quetiapine does carry a black box warning for increased mortality in elderly patients with dementia‐related psychosis.[35] However, this risk has also been found with first‐generation antipsychotics.[37, 38, 39] A recent study found this risk of sudden cardiac death extended to adult users of both first‐ and second‐generation antipsychotics.[40] In contrast, Elie et al. found no increased risk of mortality in elderly patients with delirium receiving antipsychoticsover 90% were prescribed either haloperidol or risperidonein their nested case‐controlled study.[41] Quetiapine has demonstrated some benefit with limited side effects in studies utilizing antipsychotics for the treatment of delirium. The purpose of this review was to evaluate the role of quetiapine for the treatment of delirium.
LITERATURE REVIEW
We performed an English‐language literature search of MEDLINE and Embase databases to identify journal articles published between January 1960 and December 2012. Keywords included quetiapine, second‐generation antipsychotic, atypical antipsychotic, delirium, and agitation. The search was limited to English‐language articles and adult subjects (>18 years). Based on our review of abstracts, we included both controlled and noncontrolled trials as long as treatment of delirium was the primary focus. We eliminated case reports, foreign language articles, and poster presentations. We identified 8 trials[19, 20, 24, 25, 26, 27, 28, 29] that included 2 double‐blind, randomized, placebo‐controlled trials, which are described in the text below.[19, 20] Six other trials, 5 open‐label[25, 26, 27, 28, 29] and 1 retrospective cohort,[24] are described in Table 1.
| Study | Study Design | No. of Patients Included in Analyses | Patient Type | Treatment | Baseline Delirium Scores | Quetiapine Dose (mg/day) (MeanSD) | Efficacy Measures | Results | Side Effects |
|---|---|---|---|---|---|---|---|---|---|
| |||||||||
| Schwartz et al. (2000)[24] | RC | 22 | General hospital | Quetiapine or haloperidol flexible dose | DRS score 20.9 Q; 18.5 H | 211.4 Q; 3.4 H | >50% improvement in DRS scores | 10/11 in each treatment group had >50% improvement in DRS scores | EPS 2/11 H and 0/11 Q; mild‐to‐moderate sedation 0/11 H and 2/11 Q |
| Pae et al. (2004)[25] | OL | 22 | Neurosurgery and orthopedic surgery and oncology | Flexible dose quetiapine | DRS‐R‐98 21.83.2 and CGI‐s 4.90.8 | 127.172.2 | DRS‐R‐98 and CGI‐s score reduction | DRS‐R‐98 9.33.8 (P<0.0001) and CGI‐s 2.11.1 (P<0.0001) reduction from baseline; 19/22 (86.3%) and 17/22 (77.3%) showed >50% score reduction for DRS‐R‐98 and CGI‐s, respectively | EPS none; sedation requiring discontinuation 2; mild sedation 3; serious side effects none |
| Maneeton et al. (2007)[26] | OL | 17 | General hospital | Quetiapine 25100 mg/day in 1 or 2 divided doses | DRS 24.53.2 and CGI‐s 4.90.9 | 45.728.7 | 50% reduction in DRS scores | 15/17 (88.2%) had 50% reduction in DRS score; all DRS and CGI‐s scores on days 17 of the 7‐day treatment course were significantly lower than baseline scores | EPS tremor 2; hypotension 2; daytime sleepiness 13; nightmare 3; dry mouth 2; nausea 1 |
| Kim et al. (2003)[27] | OL | 12 (all male and age 64 years) | General hospital | Quetiapine 25 mg BID and increased by 25 mg every 2 days until patient maximally stabilized | DRS 18.256.05; MMSE 14.505.90; CGI‐s 3.000.43; CDT 3.25 2.77 | 93.7523.31 | Reduction in DRS, MMSE, CGI‐s, or CDT scores | All scores were statistically significantly improved from baseline; DRS at end of study 0.631.21 (P=0.03) | No dropouts due to side effects; EPS none; sedation 2; vivid dreams 1 |
| Sasaki et al. (2003)[28] | OL | 12 | General hospital | Quetiapine started at 25 or 50 mg/day and titrated to maximal clinical effect | DRS‐J 18.14.2 | 44.931.0 | Remission was DRS‐J score <12 (cutoff for delirium) and resolution of delirium symptoms | Remission occurred in all patients; mean DRS‐J score was reduced to 9.31.6 after remission | No statistically significant change from baseline in EPS; no excessive daytime sedation, anticholinergic effects, vital sign, or lab parameter changes |
| Lee et al. (2005)[29] | OL | 31 | Neurosurgery and orthopedic surgery, internal medicine, neurology and rehabilitation medicine | Flexible dose quetiapine or amisulpride | DRS‐R‐98 10.14.1 Q and 10.54.1 A | 11385.5 Q; 156.497.5 A | Reduction in DRS‐R‐98 score | DRS‐R‐98 scores significantly reduced from baseline in both groups with 3.52.6 Q (P=0.001) and 3.51.4 A (P=0.000); no difference between groups (P=0.842); 12 (80%) Q and 13 (81.3%) A had >50% reduction in DRS‐R‐98 score | No serious side effects; dropouts 5 Q and 4 A; oversedation 1 Q and 1 A; patient withdrawal 2 Q and 1 A; no statistical differences in total sleep time P=0.767 or quality of sleep P=0.984 |
Randomized Controlled Trials
Tahir et al. published a double‐blind, randomized, placebo‐controlled trial examining the efficacy and tolerability of quetiapine in the treatment of delirium.[19] Inclusion criteria were a Diagnostic and Statistical Manual of Mental Disorders‐IV diagnosis of delirium and a Delirium Rating Scale Revised 98 (DRS‐R‐98) total score of at least 15, indicating the presence of delirium. Subjects were excluded for major preexisting cognitive deficits, alcohol withdrawal, preexisting psychosis, substance dependence, inability to comply with the constraints of the trial, and concurrent medications that interact with quetiapine.
Forty‐two general medicine subjects were enrolled and randomized in the study with no difference in baseline characteristics. Patients received either placebo or quetiapine 25 mg once daily. Doses were titrated by 25 mg daily to a maximum daily dose of 175 mg in divided doses. The primary end point was DRS‐R‐98 total mean score assessed on days 1, 2, 3, 4, 7, and 10, with follow‐up assessment on day 30. Secondary outcome measures were Mini‐Mental State Examination (MMSE), the Brief Psychiatric Rating Scale, and the Clinical Global Improvement Scale. Tolerability was assessed using the Abnormal Involuntary Movements Scale and by clinical examination.
No differences in total mean DRS‐R‐98 score at individual time points reached statistical significance, but these scores improved more quickly in the quetiapine group than placebo. The secondary outcome of rate of delirium improvement on severity score did reach statistical significance; differences on mean severity scores were 0.8270.37 (P=0.026), suggesting that severity scores improved 82% more quickly than placebo. There were no significant differences between groups for any of the other secondary outcomes. Seven patients died within 30 days of entering the study (4 in the quetiapine group and 3 in the placebo group) due to serious medical conditions and not due to study medication as determined through clinical review. One patient withdrew from quetiapine due to sedation. Results of this study are limited by a small sample size, as it was underpowered to detect a statistically significant difference in the primary outcome. Other limitations include subjects who were older, with mean age of 84 years, which may have prevented titration of quetiapine, and subjects with minor cognitive deficits were included, which may have reduced the impact of treatment on the study outcomes. Additionally, strict criteria for exclusion kept those patients most likely to develop delirium from being included, limiting the studies external validity. Finally, the use of DRS‐R‐98 mean total and severity scores is subject to error as outliers in the mean could potentially skew the results.
Devlin et al. investigated the efficacy and safety of quetiapine for ICU delirium in critically ill patients in a double‐blind, randomized, placebo‐controlled trial.[20] Inclusion criteria were an Intensive Care Delirium Screening Checklist Score (ICDSC) >4, which indicates the presence of delirium, an order for as‐needed haloperidol, and tolerating enteral nutrition. Patients were excluded if they had a complicating neurologic condition, current treatment with dexmedetomidine or with medications that interact with quetiapine, baseline QTc interval >500, pregnancy, or poor prognosis. Thirty‐six critically ill subjects were randomized with no significant differences in baseline characteristics including exposure to fentanyl, haloperidol, and benzodiazepines, and in particular, midazolam. If the subject received at least 1 dose of as‐needed haloperidol in the previous 24 hours, then either placebo or quetiapine was given. Quetiapine was initiated at 50 mg every 12 hours and titrated up by 50 mg every 12 hours to a maximum dose of 200 mg every 12 hours. Patients could receive intravenous haloperidol, 1 to 10 mg up to every 2 hours as needed. The primary outcome was time to first resolution of delirium defined as time from administration of the first dose of study drug until an ICDSC <3 was first detected, indicating an absence of delirium. Secondary outcomes were total hours in delirium, total hours spent deeply sedated (Sedation‐Agitation Scale [SAS] <2) or agitated (SAS >5), episodes of subject‐initiated device removal, use of haloperidol therapy including total dose in milligrams, number of doses and number of days of therapy, the use of sedatives (converted to midazolam equivalents) and analgesics, duration of study‐drug administration, average daily and maximum study‐drug dose, length of mechanical ventilation, duration of both ICU and hospital stay, hospital mortality, and disposition of subjects after hospital discharge. Safety measures were total number of adverse and serious adverse events, episodes of somnolence, incidence of extrapyramidal symptoms, and episodes of QTc interval prolongation.
The time to first resolution of delirium was shorter with quetiapine compared to placebo (median [interquartile range]: 1.0 [0.53.0] vs 4.5 days [2.0‐7.0]; P=0.001). Resolution of delirium occurred at least once in all quetiapine patients and in 78% of placebo patients (P=0.05). Statistical significance with quetiapine was reached on the following secondary end points: time spent in delirium (36 [1287] vs 120 hours [60195], P=0.006); shorter duration of study drug (102 [84168] vs 186 hours [108228], P=0.04); lower daily study drug dose (110 [88191] vs 210 mg [116293], P=0.01); less upregulation of the study medication dose (200 [100313] vs 375 mg [25400], P=0.02); fewer hours of agitation (6 [038] vs 36 hours [1166], P=0.02); shorter duration of haloperidol therapy (3 [24] vs 4 days [38], P=0.05); and fewer days of fentanyl (0 [03] vs 4 days [19], P=0.03). There were no significant differences between groups for any other secondary outcomes. As‐needed haloperidol use in the quetiapine versus the placebo group was lower but not statistically significant (1.9 vs 4.3 mg per day; P=0.26). Two main limitations were a small sample size and strict exclusion criteria. Additionally, the primary end point of time to first resolution of delirium may be interpreted as a less rigorous measure, because there is no standard definition for delirium resolution, and delirium is a condition that waxes and wanes on its own.
A post hoc analysis by Devlin et al. was conducted on the above study to compare duration and time to first resolution of 10 delirium symptoms in 29 patients.[21] Symptoms included agitation, decreased level of consciousness, inattention, disorientation, hallucinations/delusions, hyperactivity, hypoactivity, inappropriate speech or mood, sleep/wake cycle disturbance, and symptom fluctuation. Only symptom fluctuation (P=0.009), time to first resolution of symptom fluctuation (P=0.004), time with inattention (47 vs 78 hours, P=0.025), and time with symptom fluctuation (47 vs 89 hours; P =0.04) reached statistical significance with quetiapine compared to placebo. However, quetiapine subjects had a longer time to resolution of agitation (3 vs 1 day, P=0.04) and hyperactivity (5 vs 1 day, P<0.04). The authors attribute these findings to the higher use of as‐needed haloperidol in the placebo group (1.9 vs 4.3 mg per day, P=0.26). These results may also be due to a limitation in the study design, which self‐selected for agitation delirium by requiring the use of as‐needed haloperidol as inclusion criteria, as symptoms of agitation would be more likely to receive as‐needed haloperidol doses. In addition, subjects were allowed to receive 1 to 10 mg of haloperidol up to every 2 hours as needed, but there is no discussion of controlling total daily haloperidol dose in each group in the study. Although 1.9 versus 4.3 mg per day is neither statistically nor likely clinically significant, haloperidol is a treatment for delirium, so the study design would be stronger if quetiapine could be directly compared to an equivalent daily dose of haloperidol or if both groups received the same daily dose of haloperidol. Study results are also limited by the nature of a post hoc analysis, missing documentation for individual delirium symptoms, symptoms of delirium not being well characterized and subjective, and delay in enrollment of subjects.
Noncontrolled Trials
Six additional trials are included in the table of this review including 5 open label trials and 1 retrospective cohort study.[24, 25, 26, 27, 28, 29] Schwartz and Masand[24] and Lee et al.[29] compared the efficacy of quetiapine to haloperidol and amisulpride, a second‐generation antipsychotic unavailable in the United States, respectively. In a retrospective cohort of 22 general hospital patients, Schwartz and Masand found quetiapine (average dose, 211.4 mg/day) was as efficacious as haloperidol (average dose, 3.4 mg/day) in improving delirium rating scale (DRS) scores by more than 50% in 10/11 subjects in each group. Lee et al. also found quetiapine (average dose, 113.0 mg/day) to be equally efficacious to amisulpride (156.4 mg/day) in statistically significantly improving DRS‐R‐98 scores in 31 neurosurgery, orthopedic surgery, internal medicine, neurology, and rehabilitation medicine patients. Four open‐label studies tested the efficacy of flexible doses of quetiapine in a total of 63 general hospital, neurosurgery, orthopedic surgery, and oncology patients.[25, 26, 27, 28] Pae et al.,[25] Maneeton et al.,[26] and Kim et al.[27] found that quetiapine statistically significantly reduced DRS‐R‐98, Clinical Global Impression Scale‐Severity, DRS, MMSE, and Clock Drawing Test scores from baseline. Sasaki et al.[28] found all 12 general hospital patients in their study reached remission with an average daily quetiapine dose of 44.9 mg/day. Although these studies have a limited level of evidence due to their small sample sizes, study designs, and heterogeneous subjects, they do still suggest that quetiapine may effectively treat delirium in various patient populations.
DISCUSSION
Although the role of quetiapine for the treatment of delirium continues to develop, the studies evaluated here suggest that quetiapine may be effective and safe for this usage. Resolution of delirium from baseline was shown in all studies. Quetiapine resolved symptoms of delirium more quickly than placebo and had equal efficacy to other antipsychotics, haloperidol and amisulpride. Quetiapine may be most useful for patients with symptom fluctuation as opposed to agitation and hyperactivity or in those patients who may not tolerate haloperidol well. Both randomized control and open‐label trials found a low incidence of adverse effects with quetiapine. There were fewer incidences of QT prolongation and extrapyramidal symptoms, but higher a rate of somnolence with quetiapine compared to other antipsychotics in these trials. However, none of these differences in adverse effects reached statistical significance.
Drawing definitive conclusions about the efficacy of quetiapine in the treatment of delirium is difficult due to multiple study limitations. First, the body of literature is small, with only 2 randomized controlled trials, both of which had limitations. Tahir et al.[19] was underpowered and found no statistically significant difference in the primary end point, DRS‐R‐98 total mean score. Devlin et al.[20] tested the primary end point of time to first resolution of delirium, which may be interpreted as a less rigorous measure because there is no standard definition for delirium resolution. Furthermore, both randomized controlled and observational trials tested the efficacy of quetiapine using different tests, making comparison between these trials difficult. All studies included in this review were carried out in small patient populations, with the largest trial having 42 subjects, and had highly restrictive exclusion criteria limiting the generalizability of the study population to the general hospital population. Although most of the patients included in these studies are general hospital populations, Devlin et al. was performed in critically ill patients, which creates the additional limitation of having heterogeneous study populations. Last, superiority of any 1 antipsychotic is not possible given that none of these studies have done a head‐to‐head comparison of quetiapine with another atypical antipsychotic.
Given the comparable efficacy and safety of antipsychotics, cost is a relevant factor in treatment decisions. Haloperidol is supplied as either a suspension for injection or a tablet. One vial of 5 mg/mL haloperidol is $8.32. Haloperidol 5 mg tablets are approximately $0.29 each, whereas 25 mg tablets of quetiapine are approximately $3.53 each. However, these prices are for consumers and will vary depending on institutional contracts.[42]
CONCLUSION
Quetiapine appears to be an effective and safe agent for the treatment of delirium in both general medicine and ICU patients. Superiority of quetiapine over other antipsychotics for hospital‐associated delirium has not been shown due to limitations in quality and quantity of data. Large, randomized, double‐blind, active control studies with longer study durations are needed to elucidate the efficacy and niche of quetiapine in the treatment of delirium.
Acknowledgment
Disclosure: Nothing to report.
- American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: APA; 1994.
- American Psychiatric Association. Practice guideline for the treatment of patients with delirium. Am J Psychiatry. 1999;156:1–20.
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- , , , , , . Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non‐ventilated patients. Crit Care. 2005;9:R375–R381.
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- , . A double‐blind trial of risperdone and haloperidol for the treatment of delirium. Psychosomatics. 2004;45:297–301.
- , , , . Olanzapine vs haloperidol: treating delirium in a critical care setting. Intensive Care Med. 2004;30:444–449.
- , , , et al. Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: the MIND randomized, placebo‐controlled trial. Crit Care Med. 2010;38:428–437.
- , , , et al. A randomized controlled trial of quetiapine versus placebo in the treatment of delirium. Psychosom Res. 2010;69:485–490.
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- , , , et al. Impact of quetiapine on resolution of individual delirium symptoms in critically ill patients with delirium: a post‐hoc analysis of a double‐blind, randomized, placebo‐controlled study. Critical Care. 2011;15:R215.
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- , , , , . A pilot trial of quetiapine for the treatment of patients with delirium. Hum Psychopharmacol Clin Exp. 2004;19:125–127.
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- , , , . Treatment of delirium in older adults with quetiapine. J Geriatr Psychiatry Neurol. 2003;16:29–31.
- , , , et al. A prospective, open‐label, flexible‐dose study of quetiapine in the treatment of delirium. J Clin Psychiatry. 2003;64:1316–1321.
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- , , , et al. Pharmacological management of delirium in hospitalized adults‐a systematic evidence review. J Gen Intern Med. 2009;24:848–853.
- , , . Systematic review of antipsychotics for the treatment of hospital‐associated delirium in medically or surgically ill patients. Ann Pharmacother. 2006;40:1966–1973.
- , , , . Atypical antipsychotics versus haloperidol for treatment of delirium in acutely ill patients. Pharmacotherapy. 2007;27:588–594.
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- , . Seroquel: biochemical profile of a potential atypical antipsychotic. Psychopharmacology. 1993;112:285–292.
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- , , , et al. Risk of death in elderly users of conventional vs. atypical antipsychotic medications. N Engl J Med. 2005;353:2335–2341.
- , , , , . Atypical antipsychotic drugs and the risk of sudden cardiac death. N Engl J Med. 2009;360:225–235.
- , , , , , . A retrospective, exploratory, secondary analysis of the association between antipsychotic use and mortality in elderly patients with delirium. Int Psychogeriatr. 2009;21(3):588–592.
- Walgreens Co. Price your drugs Available at: http://www.walgreens.com/pharmacy/psc/drugpricing/psc_drug_pricing.jsp. Accessed December 17, 2012.
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- , . Delirium in cancer patients. Int Psychogeriatr. 1991;3:333–336.
- . Organic mental disorders caused by HIV: update on early‐diagnosis and treatment. Am J Psychiatry. 1990;147:696–710.
- . Post‐operative delirium. Int Psychogeriatr. 1991;3:325–332.
- , , . Delirium in terminally ill cancer patients. Am J Psychiatry. 1983;140:1048–1050.
- , , . Antipsychotics in the treatment of delirium: a systematic review. J Clin Psychiatry. 2007;68:11–21.
- , , , et al. Acute confusional states in the hospitalized elderly: incidence, risk factors and complications [abstract]. Clin Res. 1989;37:524A.
- , . Prognosis of delirium in elderly hospital patients. CMAJ. 1993;149:41–46.
- , , . Duration of delirium shortened by the correction of electrolyte imbalance. Jpn J Psychiatry Neurol. 1988;42:81–88.
- , , , et al. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002;30:119–141.
- , , , , , . Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non‐ventilated patients. Crit Care. 2005;9:R375–R381.
- , , , et al. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004;32:955–962.
- Cook IA: Guideline Watch: Practice Guideline for the Treatment of Patients With Delirium. Arlington, VA:American Psychiatric Association, 2004. Available at: http://www.psych.org/psych_pract/treatg/pg/prac_guide.cfm. Accessed March 5, 2012.
- , . A double‐blind trial of risperdone and haloperidol for the treatment of delirium. Psychosomatics. 2004;45:297–301.
- , , , . Olanzapine vs haloperidol: treating delirium in a critical care setting. Intensive Care Med. 2004;30:444–449.
- , , , et al. Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: the MIND randomized, placebo‐controlled trial. Crit Care Med. 2010;38:428–437.
- , , , et al. A randomized controlled trial of quetiapine versus placebo in the treatment of delirium. Psychosom Res. 2010;69:485–490.
- , , , et al. Efficacy and safety of quetiapine in critically ill patients with delirium: a prospective, multicenter, randomized, double‐blind, placebo‐controlled pilot study. Crit Care Med. 2010;38:419–427.
- , , , et al. Impact of quetiapine on resolution of individual delirium symptoms in critically ill patients with delirium: a post‐hoc analysis of a double‐blind, randomized, placebo‐controlled study. Critical Care. 2011;15:R215.
- , . Olanzapine in the treatment of delirium. Psychosomatics. 1998;39:422–430.
- , , . Comparative efficacy study of haloperidol, olanzapine and risperidone in delirium. J Psychosom Res. 2011;71:277–281.
- , . Treatment of delirium with quetiapine. J Clin Psychiatry. 2000;2:10–12.
- , , , , . A pilot trial of quetiapine for the treatment of patients with delirium. Hum Psychopharmacol Clin Exp. 2004;19:125–127.
- , , . An open‐label study of quetiapine for delirium. J Med Assoc Thai. 2007;10:2158–2163.
- , , , . Treatment of delirium in older adults with quetiapine. J Geriatr Psychiatry Neurol. 2003;16:29–31.
- , , , et al. A prospective, open‐label, flexible‐dose study of quetiapine in the treatment of delirium. J Clin Psychiatry. 2003;64:1316–1321.
- , , , et al. Amisulpride versus quetiapine for the treatment of delirium: a randomized, open prospective study. Int Clin Psychopharmacol. 2005;20:311–314.
- , , , et al. Pharmacological management of delirium in hospitalized adults‐a systematic evidence review. J Gen Intern Med. 2009;24:848–853.
- , , . Systematic review of antipsychotics for the treatment of hospital‐associated delirium in medically or surgically ill patients. Ann Pharmacother. 2006;40:1966–1973.
- , , , . Atypical antipsychotics versus haloperidol for treatment of delirium in acutely ill patients. Pharmacotherapy. 2007;27:588–594.
- , , . Delirium: prevention, treatment, and outcome studies. J Geriatr Psychiatry Neurol. 1998;11:126–137.
- , . Seroquel: biochemical profile of a potential atypical antipsychotic. Psychopharmacology. 1993;112:285–292.
- Seroquel [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2011.
- , , , et al. A randomized evaluation of the effects of six antipsychotic agents on QTc, in the absence and presence of metabolic inhibition. J Clin Psychopharmacol. 2004;24:62–69.
- , , , et al. Mortality risk in patients with dementia treated with antipsychotics versus other psychiatric medications. Am J Psychiatry. 2007;164:1568–1576.
- , , , et al. Antipsychotic drug use and mortality in older adults with dementia. Ann Intern Med. 2007;146:775–786.
- , , , et al. Risk of death in elderly users of conventional vs. atypical antipsychotic medications. N Engl J Med. 2005;353:2335–2341.
- , , , , . Atypical antipsychotic drugs and the risk of sudden cardiac death. N Engl J Med. 2009;360:225–235.
- , , , , , . A retrospective, exploratory, secondary analysis of the association between antipsychotic use and mortality in elderly patients with delirium. Int Psychogeriatr. 2009;21(3):588–592.
- Walgreens Co. Price your drugs Available at: http://www.walgreens.com/pharmacy/psc/drugpricing/psc_drug_pricing.jsp. Accessed December 17, 2012.
Erratum
The author list for the following article, Survey of Overnight Academic Hospitalist Supervision of Trainees, by Jeanne M. Farnan, Alfred Burger, Romsai T. Boonyasai, Luci Leykum, Rebecca Harrison, Julie Machulsky, Vikas Parekh, Bradley A. Sharpe, Anneliese M. Schleyer and Vineet M. Arora, for the SGIM Housestaff Oversight Subcommittee that published in Volume 7, Issue 7, pages 521523 of the Journal of Hospital Medicine contained an error in the spelling of an author name. Romsai T. Boonayasai should be corrected to Romsai T. Boonyasai.
The author list for the following article, Survey of Overnight Academic Hospitalist Supervision of Trainees, by Jeanne M. Farnan, Alfred Burger, Romsai T. Boonyasai, Luci Leykum, Rebecca Harrison, Julie Machulsky, Vikas Parekh, Bradley A. Sharpe, Anneliese M. Schleyer and Vineet M. Arora, for the SGIM Housestaff Oversight Subcommittee that published in Volume 7, Issue 7, pages 521523 of the Journal of Hospital Medicine contained an error in the spelling of an author name. Romsai T. Boonayasai should be corrected to Romsai T. Boonyasai.
The author list for the following article, Survey of Overnight Academic Hospitalist Supervision of Trainees, by Jeanne M. Farnan, Alfred Burger, Romsai T. Boonyasai, Luci Leykum, Rebecca Harrison, Julie Machulsky, Vikas Parekh, Bradley A. Sharpe, Anneliese M. Schleyer and Vineet M. Arora, for the SGIM Housestaff Oversight Subcommittee that published in Volume 7, Issue 7, pages 521523 of the Journal of Hospital Medicine contained an error in the spelling of an author name. Romsai T. Boonayasai should be corrected to Romsai T. Boonyasai.
ONLINE EXCLUSIVE: TKTK
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