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A Prescription for Note Bloat: An Effective Progress Note Template
The widespread adoption of electronic health records (EHRs) has led to significant progress in the modernization of healthcare delivery. Ease of access has improved clinical efficiency, and digital data have allowed for point-of-care decision support tools ranging from predicting the 30-day risk of readmission to providing up-to-date guidelines for the care of various diseases.1,2 Documentation tools such as copy-forward and autopopulation increase the speed of documentation, and typed notes improve legibility and ease of note transmission.3,4
However, all of these benefits come with a potential for harm, particularly with respect to accurate and concise documentation. Many experts have described the perpetuation of false information leading to errors, copying-forward of inconsistent and outdated information, and the phenomenon of “note bloat” — physician notes that contain multiple pages of nonessential information, often leaving key aspects buried or lost.5-7 Providers seem to recognize the hazards of copy-and-paste functionality yet persist in utilizing it. In 1 survey, more than 70% of attendings and residents felt that copy and paste led to inaccurate and outdated information, yet 80% stated they would still use it.8
There is little evidence to guide institutions on ways to improve EHR documentation practices. Recent studies have shown that operative note templates improved documentation and decreased the number of missing components.9,10 In the nonoperative setting, 1 small pilot study of pediatric interns demonstrated that a bundled intervention composed of a note template and classroom teaching resulted in improvement in overall note quality and a decrease in “note clutter.”11 In a larger study of pediatric residents, a standardized and simplified note template resulted in a shorter note, although notes were completed later in the day.12 The present study seeks to build upon these efforts by investigating the effect of didactic teaching and an electronic progress note template on note quality, length, and timeliness across 4 academic internal medicine residency programs.
METHODS
Study Design
This prospective quality improvement study took place across 4 academic institutions: University of California Los Angeles (UCLA), University of California San Francisco (UCSF), University of California San Diego (UCSD), and University of Iowa, all of which use Epic EHR (Epic Corp., Madison, WI). The intervention combined brief educational conferences directed at housestaff and attendings with the implementation of an electronic progress note template. Guided by resident input, a note-writing task force at UCSF and UCLA developed a set of best practice guidelines and an aligned note template for progress notes (supplementary Appendix 1). UCSD and the University of Iowa adopted them at their respective institutions. The template’s design minimized autopopulation while encouraging providers to enter relevant data via free text fields (eg, physical exam), prompts (eg, “I have reviewed all the labs from today. Pertinent labs include…”), and drop-down menus (eg, deep vein thrombosis [DVT] prophylaxis: enoxaparin, heparin subcutaneously, etc; supplementary Appendix 2). Additionally, an inpatient checklist was included at the end of the note to serve as a reminder for key inpatient concerns and quality measures, such as Foley catheter days, discharge planning, and code status. Lectures that focused on issues with documentation in the EHR, the best practice guidelines, and a review of the note template with instructions on how to access it were presented to the housestaff. Each institution tailored the lecture to suit their culture. Housestaff were encouraged but not required to use the note template.
Selection and Grading of Progress Notes
Progress notes were eligible for the study if they were written by an intern on an internal medicine teaching service, from a patient with a hospitalization length of at least 3 days with a progress note selected from hospital day 2 or 3, and written while the patient was on the general medicine wards. The preintervention notes were authored from September 2013 to December 2013 and the postintervention notes from April 2014 to June 2014. One note was selected per patient and no more than 3 notes were selected per intern. Each institution selected the first 50 notes chronologically that met these criteria for both the preintervention and the postintervention periods, for a total of 400 notes. The note-grading tool consisted of the following 3 sections to analyze note quality: (1) a general impression of the note (eg, below average, average, above average); (2) the validated Physician Documentation Quality Instrument, 9-item version (PDQI-9) that evaluates notes on 9 domains (up to date, accurate, thorough, useful, organized, comprehensible, succinct, synthesized, internally consistent) on a Likert scale from 1 (not at all) to 5 (extremely); and (3) a note competency questionnaire based on the Accreditation Council for Graduate Medical Education competency note checklist that asked yes or no questions about best practice elements (eg, is there a relevant and focused physical exam).12
Graders were internal medicine teaching faculty involved in the study and were assigned to review notes from their respective sites by directly utilizing the EHR. Although this introduces potential for bias, it was felt that many of the grading elements required the grader to know details of the patient that would not be captured if the note was removed from the context of the EHR. Additionally, graders documented note length (number of lines of text), the time signed by the housestaff, and whether the template was used. Three different graders independently evaluated each note and submitted ratings by using Research Electronic Data Capture.13
Statistical Analysis
Means for each item on the grading tool were computed across raters for each progress note. These were summarized by institution as well as by pre- and postintervention. Cumulative logit mixed effects models were used to compare item responses between study conditions. The number of lines per note before and after the note template intervention was compared by using a mixed effects negative binomial regression model. The timestamp on each note, representing the time of day the note was signed, was compared pre- and postintervention by using a linear mixed effects model. All models included random note and rater effects, and fixed institution and intervention period effects, as well as their interaction. Inter-rater reliability of the grading tool was assessed by calculating the intraclass correlation coefficient (ICC) using the estimated variance components. Data obtained from the PDQI-9 portion were analyzed by individual components as well as by sum score combining each component. The sum score was used to generate odds ratios to assess the likelihood that postintervention notes that used the template compared to those that did not would increase PDQI-9 sum scores. Both cumulative and site-specific data were analyzed. P values < .05 were considered statistically significant. All analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC).
RESULTS
The mean general impression score significantly improved from 2.0 to 2.3 (on a 1-3 scale in which 2 is average) after the intervention (P < .001). Additionally, note quality significantly improved across each domain of the PDQI-9 (P < .001 for all domains, Table 1). The ICC was 0.245 for the general impression score and 0.143 for the PDQI-9 sum score.
Three of 4 institutions documented the number of lines per note and the time the note was signed by the intern. Mean number of lines per note decreased by 25% (361 lines preintervention, 265 lines postintervention, P < .001). Mean time signed was approximately 1 hour and 15 minutes earlier in the day (3:27
Site-specific data revealed variation between sites. Template use was 92% at UCSF, 90% at UCLA, 79% at Iowa, and 21% at UCSD. The mean general impression score significantly improved at UCSF, UCLA, and UCSD, but not at Iowa. The PDQI-9 score improved across all domains at UCSF and UCLA, 2 domains at UCSD, and 0 domains at Iowa. Documentation of pertinent labs and studies significantly improved at UCSF, UCLA, and Iowa, but not UCSD. Note length decreased at UCSF and UCLA, but not at UCSD. Notes were signed earlier at UCLA and UCSD, but not at UCSF.
When comparing postintervention notes based on template use, notes that used the template were significantly more likely to receive a higher mean impression score (odds ratio [OR] 11.95, P < .001), higher PDQI-9 sum score (OR 3.05, P < .001), be approximately 25% shorter (326 lines vs 239 lines, P < .001), and be completed approximately 1 hour and 20 minutes earlier (3:07
DISCUSSION
A bundled intervention consisting of educational lectures and a best practice progress note template significantly improved the quality, decreased the length, and resulted in earlier completion of inpatient progress notes. These findings are consistent with a prior study that demonstrated that a bundled note template intervention improved total note score and reduced note clutter.11 We saw a broad improvement in progress notes across all 9 domains of the PDQI-9, which corresponded with an improved general impression score. We also found statistically significant improvements in 7 of the 13 categories of the competency questionnaire.
Arguably the greatest impact of the intervention was shortening the documentation of labs and studies. Autopopulation can lead to the appearance of a comprehensive note; however, key data are often lost in a sea of numbers and imaging reports.6,14 Using simple prompts followed by free text such as, “I have reviewed all the labs from today. Pertinent labs include…” reduced autopopulation and reminded housestaff to identify only the key information that affected patient care for that day, resulting in a more streamlined, clear, and high-yield note.
The time spent documenting care is an important consideration for physician workflow and for uptake of any note intervention.14-18 One study from 2016 revealed that internal medicine housestaff spend more than half of an average shift using the computer, with 52% of that time spent on documentation.17 Although functions such as autopopulation and copy-forward were created as efficiency tools, we hypothesize that they may actually prolong note writing time by leading to disorganized, distended notes that are difficult to use the following day. There was concern that limiting these “efficiency functions” might discourage housestaff from using the progress note template. It was encouraging to find that postintervention notes were signed 1.3 hours earlier in the day. This study did not measure the impact of shorter notes and earlier completion time, but in theory, this could allow interns to spend more time in direct patient care and to be at lower risk of duty hour violations.19 Furthermore, while the clinical impact of this is unknown, it is possible that timely note completion may improve patient care by making notes available earlier for consultants and other members of the care team.
We found that adding an “inpatient checklist” to the progress note template facilitated a review of key inpatient concerns and quality measures. Although we did not specifically compare before-and-after documentation of all of the components of the checklist, there appeared to be improvement in the domains measured. Notably, there was a 31% increase (P < .001) in the percentage of notes documenting the “discharge plan, goals of hospitalization, or estimated length of stay.” In the surgical literature, studies have demonstrated that incorporating checklists improves patient safety, the delivery of care, and potentially shortens the length of stay.20-22 Future studies should explore the impact of adding a checklist to the daily progress note, as there may be potential to improve both process and outcome measures.
Institution-specific data provided insightful results. UCSD encountered low template use among their interns; however, they still had evidence of improvement in note quality, though not at the same level of UCLA and UCSF. Some barriers to uptake identified were as follows: (1) interns were accustomed to import labs and studies into their note to use as their rounding report, and (2) the intervention took place late in the year when interns had developed a functional writing system that they were reluctant to change. The University of Iowa did not show significant improvement in their note quality despite a relatively high template uptake. Both of these outcomes raise the possibility that in addition to the template, there were other factors at play. Perhaps because UCSF and UCLA created the best practice guidelines and template, it was a better fit for their culture and they had more institutional buy-in. Or because the educational lectures were similar, but not standardized across institutions, some lectures may have been more effective than others. However, when evaluating the postintervention notes at UCSD and Iowa, templated notes were found to be much more likely to score higher on the PDQI-9 than nontemplated notes, which serves as evidence of the efficacy of the note template.
Some of the strengths of this study include the relatively large sample size spanning 4 institutions and the use of 3 different assessment tools for grading progress note quality (general impression score, PDQI-9, and competency note questionnaire). An additional strength is our unique finding suggesting that note writing may be more efficient by removing, rather than adding, “efficiency functions.” There were several limitations of this study. Pre- and postintervention notes were examined at different points in the same academic year, thus certain domains may have improved as interns progressed in clinical skill and comfort with documentation, independent of our intervention.21 However, our analysis of postintervention notes across the same time period revealed that use of the template was strongly associated with higher quality, shorter notes and earlier completion time arguing that the effect seen was not merely intern experience. The poor interrater reliability is also a limitation. Although the PDQI-9 was previously validated, future use of the grading tool may require more rater training for calibration or more objective wording.23 The study was not blinded, and thus, bias may have falsely elevated postintervention scores; however, we attempted to minimize bias by incorporating a more objective yes/no competency questionnaire and by having each note scored by 3 graders. Other studies have attempted to address this form of bias by printing out notes and blinding the graders. This design, however, isolates the note from all other data in the medical record, making it difficult to assess domains such as accuracy and completeness. Our inclusion of objective outcomes such as note length and time of note completion help to mitigate some of the bias.
Future research can expand on the results of this study by introducing similar progress note interventions at other institutions and/or in nonacademic environments to validate the results and expand generalizability. Longer term follow-up would be useful to determine if these effects are transient or long lasting. Similarly, it would be interesting to determine if such results are sustained even after new interns start suggesting that institutional culture can be changed. Investigators could focus on similar projects to improve other notes that are particularly at a high risk for propagating false information, such as the History and Physical or Discharge Summary. Future research should also focus on outcomes data, including whether a more efficient note can allow housestaff to spend more time with patients, decrease patient length of stay, reduce clinical errors, and improve educational time for trainees. Lastly, we should determine if interventions such as this can mitigate the widespread frustrations with electronic documentation that are associated with physician and provider burnout.15,24 One would hope that the technology could be harnessed to improve provider productivity and be effectively integrated into comprehensive patient care.
Our research makes progress toward recommendations made by the American College of Physicians “to improve accuracy of information recorded and the value of information,” and develop automated tools that “enhance documentation quality without facilitating improper behaviors.”19 Institutions should consider developing internal best practices for clinical documentation and building structured note templates.19 Our research would suggest that, combined with a small educational intervention, such templates can make progress notes more accurate and succinct, make note writing more efficient, and be harnessed to improve quality metrics.
ACKNOWLEDGMENTS
The authors thank Michael Pfeffer, MD, and Sitaram Vangala, MS, for their contributions to and support of this research study and manuscript.
Disclosure: The authors declare no conflicts of interest.
1. Herzig SJ, Guess JR, Feinbloom DB, et al. Improving appropriateness of acid-suppressive medication use via computerized clinical decision support. J Hosp Med. 2015;10(1):41-45. PubMed
2. Nguyen OK, Makam AN, Clark C, et al. Predicting all-cause readmissions using electronic health record data from the entire hospitalization: Model development and comparison. J Hosp Med. 2016;11(7):473-480. PubMed
3. Donati A, Gabbanelli V, Pantanetti S, et al. The impact of a clinical information system in an intensive care unit. J Clin Monit Comput. 2008;22(1):31-36. PubMed
4. Schiff GD, Bates DW. Can electronic clinical documentation help prevent diagnostic errors? N Engl J Med. 2010;362(12):1066-1069. PubMed
5. Hartzband P, Groopman J. Off the record--avoiding the pitfalls of going electronic. N Engl J Med. 2008;358(16):1656-1658. PubMed
6. Hirschtick RE. A piece of my mind. Copy-and-paste. JAMA. 2006;295(20):2335-2336. PubMed
7. Hirschtick RE. A piece of my mind. John Lennon’s elbow. JAMA. 2012;308(5):463-464. PubMed
8. O’Donnell HC, Kaushal R, Barrón Y, Callahan MA, Adelman RD, Siegler EL. Physicians’ attitudes towards copy and pasting in electronic note writing. J Gen Intern Med. 2009;24(1):63-68. PubMed
9. Mahapatra P, Ieong E. Improving Documentation and Communication Using Operative Note Proformas. BMJ Qual Improv Rep. 2016;5(1):u209122.w3712. PubMed
10. Thomson DR, Baldwin MJ, Bellini MI, Silva MA. Improving the quality of operative notes for laparoscopic cholecystectomy: Assessing the impact of a standardized operation note proforma. Int J Surg. 2016;27:17-20. PubMed
11. Dean SM, Eickhoff JC, Bakel LA. The effectiveness of a bundled intervention to improve resident progress notes in an electronic health record. J Hosp Med. 2015;10(2):104-107. PubMed
12. Aylor M, Campbell EM, Winter C, Phillipi CA. Resident Notes in an Electronic Health Record: A Mixed-Methods Study Using a Standardized Intervention With Qualitative Analysis. Clin Pediatr (Phila). 2016;6(3):257-262.
13. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-381. PubMed
14. Chi J, Kugler J, Chu IM, et al. Medical students and the electronic health record: ‘an epic use of time’. Am J Med. 2014;127(9):891-895. PubMed
15. Martin SA, Sinsky CA. The map is not the territory: medical records and 21st century practice. Lancet. 2016;388(10055):2053-2056. PubMed
16. Oxentenko AS, Manohar CU, McCoy CP, et al. Internal medicine residents’ computer use in the inpatient setting. J Grad Med Educ. 2012;4(4):529-532. PubMed
17. Mamykina L, Vawdrey DK, Hripcsak G. How Do Residents Spend Their Shift Time? A Time and Motion Study With a Particular Focus on the Use of Computers. Acad Med. 2016;91(6):827-832. PubMed
18. Chen L, Guo U, Illipparambil LC, et al. Racing Against the Clock: Internal Medicine Residents’ Time Spent On Electronic Health Records. J Grad Med Educ. 2016;8(1):39-44. PubMed
19. Kuhn T, Basch P, Barr M, Yackel T, Physicians MICotACo. Clinical documentation in the 21st century: executive summary of a policy position paper from the American College of Physicians. Ann Intern Med. 2015;162(4):301-303. PubMed
20. Treadwell JR, Lucas S, Tsou AY. Surgical checklists: a systematic review of impacts and implementation. BMJ Qual Saf. 2014;23(4):299-318. PubMed
21. Ko HC, Turner TJ, Finnigan MA. Systematic review of safety checklists for use by medical care teams in acute hospital settings--limited evidence of effectiveness. BMC Health Serv Res. 2011;11:211. PubMed
22. Diaz-Montes TP, Cobb L, Ibeanu OA, Njoku P, Gerardi MA. Introduction of checklists at daily progress notes improves patient care among the gynecological oncology service. J Patient Saf. 2012;8(4):189-193. PubMed
23. Stetson PD, Bakken S, Wrenn JO, Siegler EL. Assessing Electronic Note Quality Using the Physician Documentation Quality Instrument (PDQI-9). Appl Clin Inform. 2012;3(2):164-174. PubMed
24. Friedberg MW, Chen PG, Van Busum KR, et al. Factors affecting physician professional satisfaction and their implications for patient care, health systems, and health policy. Santa Monica, CA: RAND Corporation; 2013. PubMed
The widespread adoption of electronic health records (EHRs) has led to significant progress in the modernization of healthcare delivery. Ease of access has improved clinical efficiency, and digital data have allowed for point-of-care decision support tools ranging from predicting the 30-day risk of readmission to providing up-to-date guidelines for the care of various diseases.1,2 Documentation tools such as copy-forward and autopopulation increase the speed of documentation, and typed notes improve legibility and ease of note transmission.3,4
However, all of these benefits come with a potential for harm, particularly with respect to accurate and concise documentation. Many experts have described the perpetuation of false information leading to errors, copying-forward of inconsistent and outdated information, and the phenomenon of “note bloat” — physician notes that contain multiple pages of nonessential information, often leaving key aspects buried or lost.5-7 Providers seem to recognize the hazards of copy-and-paste functionality yet persist in utilizing it. In 1 survey, more than 70% of attendings and residents felt that copy and paste led to inaccurate and outdated information, yet 80% stated they would still use it.8
There is little evidence to guide institutions on ways to improve EHR documentation practices. Recent studies have shown that operative note templates improved documentation and decreased the number of missing components.9,10 In the nonoperative setting, 1 small pilot study of pediatric interns demonstrated that a bundled intervention composed of a note template and classroom teaching resulted in improvement in overall note quality and a decrease in “note clutter.”11 In a larger study of pediatric residents, a standardized and simplified note template resulted in a shorter note, although notes were completed later in the day.12 The present study seeks to build upon these efforts by investigating the effect of didactic teaching and an electronic progress note template on note quality, length, and timeliness across 4 academic internal medicine residency programs.
METHODS
Study Design
This prospective quality improvement study took place across 4 academic institutions: University of California Los Angeles (UCLA), University of California San Francisco (UCSF), University of California San Diego (UCSD), and University of Iowa, all of which use Epic EHR (Epic Corp., Madison, WI). The intervention combined brief educational conferences directed at housestaff and attendings with the implementation of an electronic progress note template. Guided by resident input, a note-writing task force at UCSF and UCLA developed a set of best practice guidelines and an aligned note template for progress notes (supplementary Appendix 1). UCSD and the University of Iowa adopted them at their respective institutions. The template’s design minimized autopopulation while encouraging providers to enter relevant data via free text fields (eg, physical exam), prompts (eg, “I have reviewed all the labs from today. Pertinent labs include…”), and drop-down menus (eg, deep vein thrombosis [DVT] prophylaxis: enoxaparin, heparin subcutaneously, etc; supplementary Appendix 2). Additionally, an inpatient checklist was included at the end of the note to serve as a reminder for key inpatient concerns and quality measures, such as Foley catheter days, discharge planning, and code status. Lectures that focused on issues with documentation in the EHR, the best practice guidelines, and a review of the note template with instructions on how to access it were presented to the housestaff. Each institution tailored the lecture to suit their culture. Housestaff were encouraged but not required to use the note template.
Selection and Grading of Progress Notes
Progress notes were eligible for the study if they were written by an intern on an internal medicine teaching service, from a patient with a hospitalization length of at least 3 days with a progress note selected from hospital day 2 or 3, and written while the patient was on the general medicine wards. The preintervention notes were authored from September 2013 to December 2013 and the postintervention notes from April 2014 to June 2014. One note was selected per patient and no more than 3 notes were selected per intern. Each institution selected the first 50 notes chronologically that met these criteria for both the preintervention and the postintervention periods, for a total of 400 notes. The note-grading tool consisted of the following 3 sections to analyze note quality: (1) a general impression of the note (eg, below average, average, above average); (2) the validated Physician Documentation Quality Instrument, 9-item version (PDQI-9) that evaluates notes on 9 domains (up to date, accurate, thorough, useful, organized, comprehensible, succinct, synthesized, internally consistent) on a Likert scale from 1 (not at all) to 5 (extremely); and (3) a note competency questionnaire based on the Accreditation Council for Graduate Medical Education competency note checklist that asked yes or no questions about best practice elements (eg, is there a relevant and focused physical exam).12
Graders were internal medicine teaching faculty involved in the study and were assigned to review notes from their respective sites by directly utilizing the EHR. Although this introduces potential for bias, it was felt that many of the grading elements required the grader to know details of the patient that would not be captured if the note was removed from the context of the EHR. Additionally, graders documented note length (number of lines of text), the time signed by the housestaff, and whether the template was used. Three different graders independently evaluated each note and submitted ratings by using Research Electronic Data Capture.13
Statistical Analysis
Means for each item on the grading tool were computed across raters for each progress note. These were summarized by institution as well as by pre- and postintervention. Cumulative logit mixed effects models were used to compare item responses between study conditions. The number of lines per note before and after the note template intervention was compared by using a mixed effects negative binomial regression model. The timestamp on each note, representing the time of day the note was signed, was compared pre- and postintervention by using a linear mixed effects model. All models included random note and rater effects, and fixed institution and intervention period effects, as well as their interaction. Inter-rater reliability of the grading tool was assessed by calculating the intraclass correlation coefficient (ICC) using the estimated variance components. Data obtained from the PDQI-9 portion were analyzed by individual components as well as by sum score combining each component. The sum score was used to generate odds ratios to assess the likelihood that postintervention notes that used the template compared to those that did not would increase PDQI-9 sum scores. Both cumulative and site-specific data were analyzed. P values < .05 were considered statistically significant. All analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC).
RESULTS
The mean general impression score significantly improved from 2.0 to 2.3 (on a 1-3 scale in which 2 is average) after the intervention (P < .001). Additionally, note quality significantly improved across each domain of the PDQI-9 (P < .001 for all domains, Table 1). The ICC was 0.245 for the general impression score and 0.143 for the PDQI-9 sum score.
Three of 4 institutions documented the number of lines per note and the time the note was signed by the intern. Mean number of lines per note decreased by 25% (361 lines preintervention, 265 lines postintervention, P < .001). Mean time signed was approximately 1 hour and 15 minutes earlier in the day (3:27
Site-specific data revealed variation between sites. Template use was 92% at UCSF, 90% at UCLA, 79% at Iowa, and 21% at UCSD. The mean general impression score significantly improved at UCSF, UCLA, and UCSD, but not at Iowa. The PDQI-9 score improved across all domains at UCSF and UCLA, 2 domains at UCSD, and 0 domains at Iowa. Documentation of pertinent labs and studies significantly improved at UCSF, UCLA, and Iowa, but not UCSD. Note length decreased at UCSF and UCLA, but not at UCSD. Notes were signed earlier at UCLA and UCSD, but not at UCSF.
When comparing postintervention notes based on template use, notes that used the template were significantly more likely to receive a higher mean impression score (odds ratio [OR] 11.95, P < .001), higher PDQI-9 sum score (OR 3.05, P < .001), be approximately 25% shorter (326 lines vs 239 lines, P < .001), and be completed approximately 1 hour and 20 minutes earlier (3:07
DISCUSSION
A bundled intervention consisting of educational lectures and a best practice progress note template significantly improved the quality, decreased the length, and resulted in earlier completion of inpatient progress notes. These findings are consistent with a prior study that demonstrated that a bundled note template intervention improved total note score and reduced note clutter.11 We saw a broad improvement in progress notes across all 9 domains of the PDQI-9, which corresponded with an improved general impression score. We also found statistically significant improvements in 7 of the 13 categories of the competency questionnaire.
Arguably the greatest impact of the intervention was shortening the documentation of labs and studies. Autopopulation can lead to the appearance of a comprehensive note; however, key data are often lost in a sea of numbers and imaging reports.6,14 Using simple prompts followed by free text such as, “I have reviewed all the labs from today. Pertinent labs include…” reduced autopopulation and reminded housestaff to identify only the key information that affected patient care for that day, resulting in a more streamlined, clear, and high-yield note.
The time spent documenting care is an important consideration for physician workflow and for uptake of any note intervention.14-18 One study from 2016 revealed that internal medicine housestaff spend more than half of an average shift using the computer, with 52% of that time spent on documentation.17 Although functions such as autopopulation and copy-forward were created as efficiency tools, we hypothesize that they may actually prolong note writing time by leading to disorganized, distended notes that are difficult to use the following day. There was concern that limiting these “efficiency functions” might discourage housestaff from using the progress note template. It was encouraging to find that postintervention notes were signed 1.3 hours earlier in the day. This study did not measure the impact of shorter notes and earlier completion time, but in theory, this could allow interns to spend more time in direct patient care and to be at lower risk of duty hour violations.19 Furthermore, while the clinical impact of this is unknown, it is possible that timely note completion may improve patient care by making notes available earlier for consultants and other members of the care team.
We found that adding an “inpatient checklist” to the progress note template facilitated a review of key inpatient concerns and quality measures. Although we did not specifically compare before-and-after documentation of all of the components of the checklist, there appeared to be improvement in the domains measured. Notably, there was a 31% increase (P < .001) in the percentage of notes documenting the “discharge plan, goals of hospitalization, or estimated length of stay.” In the surgical literature, studies have demonstrated that incorporating checklists improves patient safety, the delivery of care, and potentially shortens the length of stay.20-22 Future studies should explore the impact of adding a checklist to the daily progress note, as there may be potential to improve both process and outcome measures.
Institution-specific data provided insightful results. UCSD encountered low template use among their interns; however, they still had evidence of improvement in note quality, though not at the same level of UCLA and UCSF. Some barriers to uptake identified were as follows: (1) interns were accustomed to import labs and studies into their note to use as their rounding report, and (2) the intervention took place late in the year when interns had developed a functional writing system that they were reluctant to change. The University of Iowa did not show significant improvement in their note quality despite a relatively high template uptake. Both of these outcomes raise the possibility that in addition to the template, there were other factors at play. Perhaps because UCSF and UCLA created the best practice guidelines and template, it was a better fit for their culture and they had more institutional buy-in. Or because the educational lectures were similar, but not standardized across institutions, some lectures may have been more effective than others. However, when evaluating the postintervention notes at UCSD and Iowa, templated notes were found to be much more likely to score higher on the PDQI-9 than nontemplated notes, which serves as evidence of the efficacy of the note template.
Some of the strengths of this study include the relatively large sample size spanning 4 institutions and the use of 3 different assessment tools for grading progress note quality (general impression score, PDQI-9, and competency note questionnaire). An additional strength is our unique finding suggesting that note writing may be more efficient by removing, rather than adding, “efficiency functions.” There were several limitations of this study. Pre- and postintervention notes were examined at different points in the same academic year, thus certain domains may have improved as interns progressed in clinical skill and comfort with documentation, independent of our intervention.21 However, our analysis of postintervention notes across the same time period revealed that use of the template was strongly associated with higher quality, shorter notes and earlier completion time arguing that the effect seen was not merely intern experience. The poor interrater reliability is also a limitation. Although the PDQI-9 was previously validated, future use of the grading tool may require more rater training for calibration or more objective wording.23 The study was not blinded, and thus, bias may have falsely elevated postintervention scores; however, we attempted to minimize bias by incorporating a more objective yes/no competency questionnaire and by having each note scored by 3 graders. Other studies have attempted to address this form of bias by printing out notes and blinding the graders. This design, however, isolates the note from all other data in the medical record, making it difficult to assess domains such as accuracy and completeness. Our inclusion of objective outcomes such as note length and time of note completion help to mitigate some of the bias.
Future research can expand on the results of this study by introducing similar progress note interventions at other institutions and/or in nonacademic environments to validate the results and expand generalizability. Longer term follow-up would be useful to determine if these effects are transient or long lasting. Similarly, it would be interesting to determine if such results are sustained even after new interns start suggesting that institutional culture can be changed. Investigators could focus on similar projects to improve other notes that are particularly at a high risk for propagating false information, such as the History and Physical or Discharge Summary. Future research should also focus on outcomes data, including whether a more efficient note can allow housestaff to spend more time with patients, decrease patient length of stay, reduce clinical errors, and improve educational time for trainees. Lastly, we should determine if interventions such as this can mitigate the widespread frustrations with electronic documentation that are associated with physician and provider burnout.15,24 One would hope that the technology could be harnessed to improve provider productivity and be effectively integrated into comprehensive patient care.
Our research makes progress toward recommendations made by the American College of Physicians “to improve accuracy of information recorded and the value of information,” and develop automated tools that “enhance documentation quality without facilitating improper behaviors.”19 Institutions should consider developing internal best practices for clinical documentation and building structured note templates.19 Our research would suggest that, combined with a small educational intervention, such templates can make progress notes more accurate and succinct, make note writing more efficient, and be harnessed to improve quality metrics.
ACKNOWLEDGMENTS
The authors thank Michael Pfeffer, MD, and Sitaram Vangala, MS, for their contributions to and support of this research study and manuscript.
Disclosure: The authors declare no conflicts of interest.
The widespread adoption of electronic health records (EHRs) has led to significant progress in the modernization of healthcare delivery. Ease of access has improved clinical efficiency, and digital data have allowed for point-of-care decision support tools ranging from predicting the 30-day risk of readmission to providing up-to-date guidelines for the care of various diseases.1,2 Documentation tools such as copy-forward and autopopulation increase the speed of documentation, and typed notes improve legibility and ease of note transmission.3,4
However, all of these benefits come with a potential for harm, particularly with respect to accurate and concise documentation. Many experts have described the perpetuation of false information leading to errors, copying-forward of inconsistent and outdated information, and the phenomenon of “note bloat” — physician notes that contain multiple pages of nonessential information, often leaving key aspects buried or lost.5-7 Providers seem to recognize the hazards of copy-and-paste functionality yet persist in utilizing it. In 1 survey, more than 70% of attendings and residents felt that copy and paste led to inaccurate and outdated information, yet 80% stated they would still use it.8
There is little evidence to guide institutions on ways to improve EHR documentation practices. Recent studies have shown that operative note templates improved documentation and decreased the number of missing components.9,10 In the nonoperative setting, 1 small pilot study of pediatric interns demonstrated that a bundled intervention composed of a note template and classroom teaching resulted in improvement in overall note quality and a decrease in “note clutter.”11 In a larger study of pediatric residents, a standardized and simplified note template resulted in a shorter note, although notes were completed later in the day.12 The present study seeks to build upon these efforts by investigating the effect of didactic teaching and an electronic progress note template on note quality, length, and timeliness across 4 academic internal medicine residency programs.
METHODS
Study Design
This prospective quality improvement study took place across 4 academic institutions: University of California Los Angeles (UCLA), University of California San Francisco (UCSF), University of California San Diego (UCSD), and University of Iowa, all of which use Epic EHR (Epic Corp., Madison, WI). The intervention combined brief educational conferences directed at housestaff and attendings with the implementation of an electronic progress note template. Guided by resident input, a note-writing task force at UCSF and UCLA developed a set of best practice guidelines and an aligned note template for progress notes (supplementary Appendix 1). UCSD and the University of Iowa adopted them at their respective institutions. The template’s design minimized autopopulation while encouraging providers to enter relevant data via free text fields (eg, physical exam), prompts (eg, “I have reviewed all the labs from today. Pertinent labs include…”), and drop-down menus (eg, deep vein thrombosis [DVT] prophylaxis: enoxaparin, heparin subcutaneously, etc; supplementary Appendix 2). Additionally, an inpatient checklist was included at the end of the note to serve as a reminder for key inpatient concerns and quality measures, such as Foley catheter days, discharge planning, and code status. Lectures that focused on issues with documentation in the EHR, the best practice guidelines, and a review of the note template with instructions on how to access it were presented to the housestaff. Each institution tailored the lecture to suit their culture. Housestaff were encouraged but not required to use the note template.
Selection and Grading of Progress Notes
Progress notes were eligible for the study if they were written by an intern on an internal medicine teaching service, from a patient with a hospitalization length of at least 3 days with a progress note selected from hospital day 2 or 3, and written while the patient was on the general medicine wards. The preintervention notes were authored from September 2013 to December 2013 and the postintervention notes from April 2014 to June 2014. One note was selected per patient and no more than 3 notes were selected per intern. Each institution selected the first 50 notes chronologically that met these criteria for both the preintervention and the postintervention periods, for a total of 400 notes. The note-grading tool consisted of the following 3 sections to analyze note quality: (1) a general impression of the note (eg, below average, average, above average); (2) the validated Physician Documentation Quality Instrument, 9-item version (PDQI-9) that evaluates notes on 9 domains (up to date, accurate, thorough, useful, organized, comprehensible, succinct, synthesized, internally consistent) on a Likert scale from 1 (not at all) to 5 (extremely); and (3) a note competency questionnaire based on the Accreditation Council for Graduate Medical Education competency note checklist that asked yes or no questions about best practice elements (eg, is there a relevant and focused physical exam).12
Graders were internal medicine teaching faculty involved in the study and were assigned to review notes from their respective sites by directly utilizing the EHR. Although this introduces potential for bias, it was felt that many of the grading elements required the grader to know details of the patient that would not be captured if the note was removed from the context of the EHR. Additionally, graders documented note length (number of lines of text), the time signed by the housestaff, and whether the template was used. Three different graders independently evaluated each note and submitted ratings by using Research Electronic Data Capture.13
Statistical Analysis
Means for each item on the grading tool were computed across raters for each progress note. These were summarized by institution as well as by pre- and postintervention. Cumulative logit mixed effects models were used to compare item responses between study conditions. The number of lines per note before and after the note template intervention was compared by using a mixed effects negative binomial regression model. The timestamp on each note, representing the time of day the note was signed, was compared pre- and postintervention by using a linear mixed effects model. All models included random note and rater effects, and fixed institution and intervention period effects, as well as their interaction. Inter-rater reliability of the grading tool was assessed by calculating the intraclass correlation coefficient (ICC) using the estimated variance components. Data obtained from the PDQI-9 portion were analyzed by individual components as well as by sum score combining each component. The sum score was used to generate odds ratios to assess the likelihood that postintervention notes that used the template compared to those that did not would increase PDQI-9 sum scores. Both cumulative and site-specific data were analyzed. P values < .05 were considered statistically significant. All analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC).
RESULTS
The mean general impression score significantly improved from 2.0 to 2.3 (on a 1-3 scale in which 2 is average) after the intervention (P < .001). Additionally, note quality significantly improved across each domain of the PDQI-9 (P < .001 for all domains, Table 1). The ICC was 0.245 for the general impression score and 0.143 for the PDQI-9 sum score.
Three of 4 institutions documented the number of lines per note and the time the note was signed by the intern. Mean number of lines per note decreased by 25% (361 lines preintervention, 265 lines postintervention, P < .001). Mean time signed was approximately 1 hour and 15 minutes earlier in the day (3:27
Site-specific data revealed variation between sites. Template use was 92% at UCSF, 90% at UCLA, 79% at Iowa, and 21% at UCSD. The mean general impression score significantly improved at UCSF, UCLA, and UCSD, but not at Iowa. The PDQI-9 score improved across all domains at UCSF and UCLA, 2 domains at UCSD, and 0 domains at Iowa. Documentation of pertinent labs and studies significantly improved at UCSF, UCLA, and Iowa, but not UCSD. Note length decreased at UCSF and UCLA, but not at UCSD. Notes were signed earlier at UCLA and UCSD, but not at UCSF.
When comparing postintervention notes based on template use, notes that used the template were significantly more likely to receive a higher mean impression score (odds ratio [OR] 11.95, P < .001), higher PDQI-9 sum score (OR 3.05, P < .001), be approximately 25% shorter (326 lines vs 239 lines, P < .001), and be completed approximately 1 hour and 20 minutes earlier (3:07
DISCUSSION
A bundled intervention consisting of educational lectures and a best practice progress note template significantly improved the quality, decreased the length, and resulted in earlier completion of inpatient progress notes. These findings are consistent with a prior study that demonstrated that a bundled note template intervention improved total note score and reduced note clutter.11 We saw a broad improvement in progress notes across all 9 domains of the PDQI-9, which corresponded with an improved general impression score. We also found statistically significant improvements in 7 of the 13 categories of the competency questionnaire.
Arguably the greatest impact of the intervention was shortening the documentation of labs and studies. Autopopulation can lead to the appearance of a comprehensive note; however, key data are often lost in a sea of numbers and imaging reports.6,14 Using simple prompts followed by free text such as, “I have reviewed all the labs from today. Pertinent labs include…” reduced autopopulation and reminded housestaff to identify only the key information that affected patient care for that day, resulting in a more streamlined, clear, and high-yield note.
The time spent documenting care is an important consideration for physician workflow and for uptake of any note intervention.14-18 One study from 2016 revealed that internal medicine housestaff spend more than half of an average shift using the computer, with 52% of that time spent on documentation.17 Although functions such as autopopulation and copy-forward were created as efficiency tools, we hypothesize that they may actually prolong note writing time by leading to disorganized, distended notes that are difficult to use the following day. There was concern that limiting these “efficiency functions” might discourage housestaff from using the progress note template. It was encouraging to find that postintervention notes were signed 1.3 hours earlier in the day. This study did not measure the impact of shorter notes and earlier completion time, but in theory, this could allow interns to spend more time in direct patient care and to be at lower risk of duty hour violations.19 Furthermore, while the clinical impact of this is unknown, it is possible that timely note completion may improve patient care by making notes available earlier for consultants and other members of the care team.
We found that adding an “inpatient checklist” to the progress note template facilitated a review of key inpatient concerns and quality measures. Although we did not specifically compare before-and-after documentation of all of the components of the checklist, there appeared to be improvement in the domains measured. Notably, there was a 31% increase (P < .001) in the percentage of notes documenting the “discharge plan, goals of hospitalization, or estimated length of stay.” In the surgical literature, studies have demonstrated that incorporating checklists improves patient safety, the delivery of care, and potentially shortens the length of stay.20-22 Future studies should explore the impact of adding a checklist to the daily progress note, as there may be potential to improve both process and outcome measures.
Institution-specific data provided insightful results. UCSD encountered low template use among their interns; however, they still had evidence of improvement in note quality, though not at the same level of UCLA and UCSF. Some barriers to uptake identified were as follows: (1) interns were accustomed to import labs and studies into their note to use as their rounding report, and (2) the intervention took place late in the year when interns had developed a functional writing system that they were reluctant to change. The University of Iowa did not show significant improvement in their note quality despite a relatively high template uptake. Both of these outcomes raise the possibility that in addition to the template, there were other factors at play. Perhaps because UCSF and UCLA created the best practice guidelines and template, it was a better fit for their culture and they had more institutional buy-in. Or because the educational lectures were similar, but not standardized across institutions, some lectures may have been more effective than others. However, when evaluating the postintervention notes at UCSD and Iowa, templated notes were found to be much more likely to score higher on the PDQI-9 than nontemplated notes, which serves as evidence of the efficacy of the note template.
Some of the strengths of this study include the relatively large sample size spanning 4 institutions and the use of 3 different assessment tools for grading progress note quality (general impression score, PDQI-9, and competency note questionnaire). An additional strength is our unique finding suggesting that note writing may be more efficient by removing, rather than adding, “efficiency functions.” There were several limitations of this study. Pre- and postintervention notes were examined at different points in the same academic year, thus certain domains may have improved as interns progressed in clinical skill and comfort with documentation, independent of our intervention.21 However, our analysis of postintervention notes across the same time period revealed that use of the template was strongly associated with higher quality, shorter notes and earlier completion time arguing that the effect seen was not merely intern experience. The poor interrater reliability is also a limitation. Although the PDQI-9 was previously validated, future use of the grading tool may require more rater training for calibration or more objective wording.23 The study was not blinded, and thus, bias may have falsely elevated postintervention scores; however, we attempted to minimize bias by incorporating a more objective yes/no competency questionnaire and by having each note scored by 3 graders. Other studies have attempted to address this form of bias by printing out notes and blinding the graders. This design, however, isolates the note from all other data in the medical record, making it difficult to assess domains such as accuracy and completeness. Our inclusion of objective outcomes such as note length and time of note completion help to mitigate some of the bias.
Future research can expand on the results of this study by introducing similar progress note interventions at other institutions and/or in nonacademic environments to validate the results and expand generalizability. Longer term follow-up would be useful to determine if these effects are transient or long lasting. Similarly, it would be interesting to determine if such results are sustained even after new interns start suggesting that institutional culture can be changed. Investigators could focus on similar projects to improve other notes that are particularly at a high risk for propagating false information, such as the History and Physical or Discharge Summary. Future research should also focus on outcomes data, including whether a more efficient note can allow housestaff to spend more time with patients, decrease patient length of stay, reduce clinical errors, and improve educational time for trainees. Lastly, we should determine if interventions such as this can mitigate the widespread frustrations with electronic documentation that are associated with physician and provider burnout.15,24 One would hope that the technology could be harnessed to improve provider productivity and be effectively integrated into comprehensive patient care.
Our research makes progress toward recommendations made by the American College of Physicians “to improve accuracy of information recorded and the value of information,” and develop automated tools that “enhance documentation quality without facilitating improper behaviors.”19 Institutions should consider developing internal best practices for clinical documentation and building structured note templates.19 Our research would suggest that, combined with a small educational intervention, such templates can make progress notes more accurate and succinct, make note writing more efficient, and be harnessed to improve quality metrics.
ACKNOWLEDGMENTS
The authors thank Michael Pfeffer, MD, and Sitaram Vangala, MS, for their contributions to and support of this research study and manuscript.
Disclosure: The authors declare no conflicts of interest.
1. Herzig SJ, Guess JR, Feinbloom DB, et al. Improving appropriateness of acid-suppressive medication use via computerized clinical decision support. J Hosp Med. 2015;10(1):41-45. PubMed
2. Nguyen OK, Makam AN, Clark C, et al. Predicting all-cause readmissions using electronic health record data from the entire hospitalization: Model development and comparison. J Hosp Med. 2016;11(7):473-480. PubMed
3. Donati A, Gabbanelli V, Pantanetti S, et al. The impact of a clinical information system in an intensive care unit. J Clin Monit Comput. 2008;22(1):31-36. PubMed
4. Schiff GD, Bates DW. Can electronic clinical documentation help prevent diagnostic errors? N Engl J Med. 2010;362(12):1066-1069. PubMed
5. Hartzband P, Groopman J. Off the record--avoiding the pitfalls of going electronic. N Engl J Med. 2008;358(16):1656-1658. PubMed
6. Hirschtick RE. A piece of my mind. Copy-and-paste. JAMA. 2006;295(20):2335-2336. PubMed
7. Hirschtick RE. A piece of my mind. John Lennon’s elbow. JAMA. 2012;308(5):463-464. PubMed
8. O’Donnell HC, Kaushal R, Barrón Y, Callahan MA, Adelman RD, Siegler EL. Physicians’ attitudes towards copy and pasting in electronic note writing. J Gen Intern Med. 2009;24(1):63-68. PubMed
9. Mahapatra P, Ieong E. Improving Documentation and Communication Using Operative Note Proformas. BMJ Qual Improv Rep. 2016;5(1):u209122.w3712. PubMed
10. Thomson DR, Baldwin MJ, Bellini MI, Silva MA. Improving the quality of operative notes for laparoscopic cholecystectomy: Assessing the impact of a standardized operation note proforma. Int J Surg. 2016;27:17-20. PubMed
11. Dean SM, Eickhoff JC, Bakel LA. The effectiveness of a bundled intervention to improve resident progress notes in an electronic health record. J Hosp Med. 2015;10(2):104-107. PubMed
12. Aylor M, Campbell EM, Winter C, Phillipi CA. Resident Notes in an Electronic Health Record: A Mixed-Methods Study Using a Standardized Intervention With Qualitative Analysis. Clin Pediatr (Phila). 2016;6(3):257-262.
13. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-381. PubMed
14. Chi J, Kugler J, Chu IM, et al. Medical students and the electronic health record: ‘an epic use of time’. Am J Med. 2014;127(9):891-895. PubMed
15. Martin SA, Sinsky CA. The map is not the territory: medical records and 21st century practice. Lancet. 2016;388(10055):2053-2056. PubMed
16. Oxentenko AS, Manohar CU, McCoy CP, et al. Internal medicine residents’ computer use in the inpatient setting. J Grad Med Educ. 2012;4(4):529-532. PubMed
17. Mamykina L, Vawdrey DK, Hripcsak G. How Do Residents Spend Their Shift Time? A Time and Motion Study With a Particular Focus on the Use of Computers. Acad Med. 2016;91(6):827-832. PubMed
18. Chen L, Guo U, Illipparambil LC, et al. Racing Against the Clock: Internal Medicine Residents’ Time Spent On Electronic Health Records. J Grad Med Educ. 2016;8(1):39-44. PubMed
19. Kuhn T, Basch P, Barr M, Yackel T, Physicians MICotACo. Clinical documentation in the 21st century: executive summary of a policy position paper from the American College of Physicians. Ann Intern Med. 2015;162(4):301-303. PubMed
20. Treadwell JR, Lucas S, Tsou AY. Surgical checklists: a systematic review of impacts and implementation. BMJ Qual Saf. 2014;23(4):299-318. PubMed
21. Ko HC, Turner TJ, Finnigan MA. Systematic review of safety checklists for use by medical care teams in acute hospital settings--limited evidence of effectiveness. BMC Health Serv Res. 2011;11:211. PubMed
22. Diaz-Montes TP, Cobb L, Ibeanu OA, Njoku P, Gerardi MA. Introduction of checklists at daily progress notes improves patient care among the gynecological oncology service. J Patient Saf. 2012;8(4):189-193. PubMed
23. Stetson PD, Bakken S, Wrenn JO, Siegler EL. Assessing Electronic Note Quality Using the Physician Documentation Quality Instrument (PDQI-9). Appl Clin Inform. 2012;3(2):164-174. PubMed
24. Friedberg MW, Chen PG, Van Busum KR, et al. Factors affecting physician professional satisfaction and their implications for patient care, health systems, and health policy. Santa Monica, CA: RAND Corporation; 2013. PubMed
1. Herzig SJ, Guess JR, Feinbloom DB, et al. Improving appropriateness of acid-suppressive medication use via computerized clinical decision support. J Hosp Med. 2015;10(1):41-45. PubMed
2. Nguyen OK, Makam AN, Clark C, et al. Predicting all-cause readmissions using electronic health record data from the entire hospitalization: Model development and comparison. J Hosp Med. 2016;11(7):473-480. PubMed
3. Donati A, Gabbanelli V, Pantanetti S, et al. The impact of a clinical information system in an intensive care unit. J Clin Monit Comput. 2008;22(1):31-36. PubMed
4. Schiff GD, Bates DW. Can electronic clinical documentation help prevent diagnostic errors? N Engl J Med. 2010;362(12):1066-1069. PubMed
5. Hartzband P, Groopman J. Off the record--avoiding the pitfalls of going electronic. N Engl J Med. 2008;358(16):1656-1658. PubMed
6. Hirschtick RE. A piece of my mind. Copy-and-paste. JAMA. 2006;295(20):2335-2336. PubMed
7. Hirschtick RE. A piece of my mind. John Lennon’s elbow. JAMA. 2012;308(5):463-464. PubMed
8. O’Donnell HC, Kaushal R, Barrón Y, Callahan MA, Adelman RD, Siegler EL. Physicians’ attitudes towards copy and pasting in electronic note writing. J Gen Intern Med. 2009;24(1):63-68. PubMed
9. Mahapatra P, Ieong E. Improving Documentation and Communication Using Operative Note Proformas. BMJ Qual Improv Rep. 2016;5(1):u209122.w3712. PubMed
10. Thomson DR, Baldwin MJ, Bellini MI, Silva MA. Improving the quality of operative notes for laparoscopic cholecystectomy: Assessing the impact of a standardized operation note proforma. Int J Surg. 2016;27:17-20. PubMed
11. Dean SM, Eickhoff JC, Bakel LA. The effectiveness of a bundled intervention to improve resident progress notes in an electronic health record. J Hosp Med. 2015;10(2):104-107. PubMed
12. Aylor M, Campbell EM, Winter C, Phillipi CA. Resident Notes in an Electronic Health Record: A Mixed-Methods Study Using a Standardized Intervention With Qualitative Analysis. Clin Pediatr (Phila). 2016;6(3):257-262.
13. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-381. PubMed
14. Chi J, Kugler J, Chu IM, et al. Medical students and the electronic health record: ‘an epic use of time’. Am J Med. 2014;127(9):891-895. PubMed
15. Martin SA, Sinsky CA. The map is not the territory: medical records and 21st century practice. Lancet. 2016;388(10055):2053-2056. PubMed
16. Oxentenko AS, Manohar CU, McCoy CP, et al. Internal medicine residents’ computer use in the inpatient setting. J Grad Med Educ. 2012;4(4):529-532. PubMed
17. Mamykina L, Vawdrey DK, Hripcsak G. How Do Residents Spend Their Shift Time? A Time and Motion Study With a Particular Focus on the Use of Computers. Acad Med. 2016;91(6):827-832. PubMed
18. Chen L, Guo U, Illipparambil LC, et al. Racing Against the Clock: Internal Medicine Residents’ Time Spent On Electronic Health Records. J Grad Med Educ. 2016;8(1):39-44. PubMed
19. Kuhn T, Basch P, Barr M, Yackel T, Physicians MICotACo. Clinical documentation in the 21st century: executive summary of a policy position paper from the American College of Physicians. Ann Intern Med. 2015;162(4):301-303. PubMed
20. Treadwell JR, Lucas S, Tsou AY. Surgical checklists: a systematic review of impacts and implementation. BMJ Qual Saf. 2014;23(4):299-318. PubMed
21. Ko HC, Turner TJ, Finnigan MA. Systematic review of safety checklists for use by medical care teams in acute hospital settings--limited evidence of effectiveness. BMC Health Serv Res. 2011;11:211. PubMed
22. Diaz-Montes TP, Cobb L, Ibeanu OA, Njoku P, Gerardi MA. Introduction of checklists at daily progress notes improves patient care among the gynecological oncology service. J Patient Saf. 2012;8(4):189-193. PubMed
23. Stetson PD, Bakken S, Wrenn JO, Siegler EL. Assessing Electronic Note Quality Using the Physician Documentation Quality Instrument (PDQI-9). Appl Clin Inform. 2012;3(2):164-174. PubMed
24. Friedberg MW, Chen PG, Van Busum KR, et al. Factors affecting physician professional satisfaction and their implications for patient care, health systems, and health policy. Santa Monica, CA: RAND Corporation; 2013. PubMed
© 2018 Society of Hospital Medicine
Brief preoperative score predicts postoperative complications in the elderly
Background: Elective operations have become increasingly more common in the elderly. This population is at a higher risk for postsurgical complications. Previous research into preoperative risk assessment relied on geriatricians, of whom there is a national shortage.
Study design: Prospective cohort study.
Setting: Preoperative surgery clinics at the University of Michigan Health System.
Synopsis: A total of 736 elderly patients had a preoperative Vulnerable Elders Surgical Pathways and Outcomes Assessment (VESPA) administered by a surgical physician assistant in clinic. VESPA assessed activities of daily living, history of falling or gait impairment, and depressive symptoms. Patients underwent a Mini-Cog examination and a Timed Up and Go assessment. Patients were asked whether they expected they could manage themselves alone after discharge. One in seven patients reported difficulty with one or more of the activities of daily living and one in three stated they would be unable to manage postoperative self-care alone. Overall, 25.3% of patients had geriatric or surgical complications. The VESPA score predicted postoperative complications (area under the curve, 0.76). More specifically, preexisting difficulties with activities of daily living, anticipated self-care difficulty, a Charlson Comorbidity score of 2 or greater, male sex, or higher surgical relative value units were all independently associated with postoperative complications.
Bottom line: Elderly patients at an increased risk of postoperative complications can be identified by nonphysician staff using the VESPA preoperative assessment.
Citation: Min L et al. Estimating risk of postsurgical general and geriatric complications using the VESPA preoperative tool. JAMA Surg. 2017 Aug 2. doi: 10.1001/jamasurg.2017.2635.
Dr. Hoegh is a hospitalist at the University of Colorado School of Medicine.
Background: Elective operations have become increasingly more common in the elderly. This population is at a higher risk for postsurgical complications. Previous research into preoperative risk assessment relied on geriatricians, of whom there is a national shortage.
Study design: Prospective cohort study.
Setting: Preoperative surgery clinics at the University of Michigan Health System.
Synopsis: A total of 736 elderly patients had a preoperative Vulnerable Elders Surgical Pathways and Outcomes Assessment (VESPA) administered by a surgical physician assistant in clinic. VESPA assessed activities of daily living, history of falling or gait impairment, and depressive symptoms. Patients underwent a Mini-Cog examination and a Timed Up and Go assessment. Patients were asked whether they expected they could manage themselves alone after discharge. One in seven patients reported difficulty with one or more of the activities of daily living and one in three stated they would be unable to manage postoperative self-care alone. Overall, 25.3% of patients had geriatric or surgical complications. The VESPA score predicted postoperative complications (area under the curve, 0.76). More specifically, preexisting difficulties with activities of daily living, anticipated self-care difficulty, a Charlson Comorbidity score of 2 or greater, male sex, or higher surgical relative value units were all independently associated with postoperative complications.
Bottom line: Elderly patients at an increased risk of postoperative complications can be identified by nonphysician staff using the VESPA preoperative assessment.
Citation: Min L et al. Estimating risk of postsurgical general and geriatric complications using the VESPA preoperative tool. JAMA Surg. 2017 Aug 2. doi: 10.1001/jamasurg.2017.2635.
Dr. Hoegh is a hospitalist at the University of Colorado School of Medicine.
Background: Elective operations have become increasingly more common in the elderly. This population is at a higher risk for postsurgical complications. Previous research into preoperative risk assessment relied on geriatricians, of whom there is a national shortage.
Study design: Prospective cohort study.
Setting: Preoperative surgery clinics at the University of Michigan Health System.
Synopsis: A total of 736 elderly patients had a preoperative Vulnerable Elders Surgical Pathways and Outcomes Assessment (VESPA) administered by a surgical physician assistant in clinic. VESPA assessed activities of daily living, history of falling or gait impairment, and depressive symptoms. Patients underwent a Mini-Cog examination and a Timed Up and Go assessment. Patients were asked whether they expected they could manage themselves alone after discharge. One in seven patients reported difficulty with one or more of the activities of daily living and one in three stated they would be unable to manage postoperative self-care alone. Overall, 25.3% of patients had geriatric or surgical complications. The VESPA score predicted postoperative complications (area under the curve, 0.76). More specifically, preexisting difficulties with activities of daily living, anticipated self-care difficulty, a Charlson Comorbidity score of 2 or greater, male sex, or higher surgical relative value units were all independently associated with postoperative complications.
Bottom line: Elderly patients at an increased risk of postoperative complications can be identified by nonphysician staff using the VESPA preoperative assessment.
Citation: Min L et al. Estimating risk of postsurgical general and geriatric complications using the VESPA preoperative tool. JAMA Surg. 2017 Aug 2. doi: 10.1001/jamasurg.2017.2635.
Dr. Hoegh is a hospitalist at the University of Colorado School of Medicine.
FDA grants ‘Breakthrough Therapy Designation’ for upadacitinib for atopic dermatitis
The Food and Drug Administration has granted “Breakthrough Therapy Designation” for the investigational, once-daily oral Janus kinase 1 (JAK1)-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
The Breakthrough Therapy Designation is based on positive phase 2b results announced in Sept. 2017. The study found that patients treated with upadacitinib achieved statistically significant improvements in the primary endpoint (greater mean percentage change from baseline in Eczema Area and Severity Index score) and in all skin- and itch-specific secondary endpoints across all doses (30 mg, 15mg, or 7.5 mg once-daily) at week 16, compared with placebo (P less than .05). Reduction in itch was observed within the first week and improvement in skin within the first 2 weeks (P less than .001 across all doses). Of patients receiving the 30 mg once-daily dose of upadacitinib, 50% had clear or almost clear skin, according to a press release. There were 42 patients in each of the three treatment groups and 41 patients in the placebo group in this randomized, double-blind, parallel-group study sponsored by AbbVie, which discovered and developed upadacitinib.
The phase 3 clinical program is expected to begin in the first half of 2018, according to AbbVie. Any additional information on the clinical trials for upadacitinib is available at clinicaltrials.gov.
SOURCE: Prnewswire.com.
The Food and Drug Administration has granted “Breakthrough Therapy Designation” for the investigational, once-daily oral Janus kinase 1 (JAK1)-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
The Breakthrough Therapy Designation is based on positive phase 2b results announced in Sept. 2017. The study found that patients treated with upadacitinib achieved statistically significant improvements in the primary endpoint (greater mean percentage change from baseline in Eczema Area and Severity Index score) and in all skin- and itch-specific secondary endpoints across all doses (30 mg, 15mg, or 7.5 mg once-daily) at week 16, compared with placebo (P less than .05). Reduction in itch was observed within the first week and improvement in skin within the first 2 weeks (P less than .001 across all doses). Of patients receiving the 30 mg once-daily dose of upadacitinib, 50% had clear or almost clear skin, according to a press release. There were 42 patients in each of the three treatment groups and 41 patients in the placebo group in this randomized, double-blind, parallel-group study sponsored by AbbVie, which discovered and developed upadacitinib.
The phase 3 clinical program is expected to begin in the first half of 2018, according to AbbVie. Any additional information on the clinical trials for upadacitinib is available at clinicaltrials.gov.
SOURCE: Prnewswire.com.
The Food and Drug Administration has granted “Breakthrough Therapy Designation” for the investigational, once-daily oral Janus kinase 1 (JAK1)-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
The Breakthrough Therapy Designation is based on positive phase 2b results announced in Sept. 2017. The study found that patients treated with upadacitinib achieved statistically significant improvements in the primary endpoint (greater mean percentage change from baseline in Eczema Area and Severity Index score) and in all skin- and itch-specific secondary endpoints across all doses (30 mg, 15mg, or 7.5 mg once-daily) at week 16, compared with placebo (P less than .05). Reduction in itch was observed within the first week and improvement in skin within the first 2 weeks (P less than .001 across all doses). Of patients receiving the 30 mg once-daily dose of upadacitinib, 50% had clear or almost clear skin, according to a press release. There were 42 patients in each of the three treatment groups and 41 patients in the placebo group in this randomized, double-blind, parallel-group study sponsored by AbbVie, which discovered and developed upadacitinib.
The phase 3 clinical program is expected to begin in the first half of 2018, according to AbbVie. Any additional information on the clinical trials for upadacitinib is available at clinicaltrials.gov.
SOURCE: Prnewswire.com.
Our fascination with medication compliance
As a forensic psychiatrist, I follow news relating to mental illness and crime. Like many of the judges and lawyers with whom I work, the media appear to have an obsession with medication compliance in those with mental illness. Being “off medications” has become a threatening term suggestive of unbridled impulsivity and violence – a term that can explain any behavior, implying that without medication, humans are routinely capable of all things without warning.
The year 2018 already has provided two stark examples of this phenomenon. During the first week of the year, two articles with the following headlines were published: “ ‘He was off his meds’: Son charged in mother’s murder”1 and “A man lost his life in the subway after telling a teen off of his medication to ‘get away.’ ”2 Those two articles describe awful events that, as the headlines suggest, are best explained by a lack of compliance with a psychotropic medication regimen.
“A man lost his life in the subway after telling a teen off of his medication to ‘get away’ ” reports on a 65-year-old man who was pushed onto New York’s subway tracks after interacting with an 18-year-old who “did not take medication that day for his mental illness.” This article provides some limited details on the state of mind of the defendant, indicating that he had been “talking to himself.” However, to reinforce the message, the article informs the reader that he had been prescribed three psychotropics – insinuating a multiplier effect for the role of noncompliance. Furthermore, the article implies that missing a single day of psychotropics is an explanation for the incident.
The media routinely use this bias in favor of the medication explanation in its analysis – or lack thereof – of violent behavior in people with mental illness. Recent stories include a man killing his nephew3 and a man killing his girlfriend4, and both were incidents apparently best explained by medication noncompliance. Another story reports of police officers who were charged with assault after an altercation with a patient with mental illness led to the patient’s death. In the latter case, the article suggests that the simple fact that the victim had been acting erratically warrants the comment that he was “likely was off his medications.”
My work in the jail system also has been tainted by this overreliance on the unquestioned dogma of medication compliance. Discussions pertaining to punishment and privileges of inmates with mental illness often would lead to the question: “Is he taking his meds?” I have witnessed countless times when crucial decisions about placement in solitary confinement were predicated on questions of medication compliance. My answer was always the same: “Why does it matter? If the inmate is following the rules and behaving respectfully, how does taking a pill provide more important information?”
What was once thought to be a predictor of relapse risk, despite limited evidence, has become the outcome itself. As a society, we have falsely equated mental illness with violence; we have furthermore falsely equated remission and safety with medication compliance. The consequences of those beliefs are severe as we have limited attention, and our focus on medications blinds us to much clearer risk factors. 5
The court system is equally riveted with this question. Judges and lawyers associate medication compliance with legal competency, safety in probation or parole, and general well-being. I have witnessed agitated patients being reprimanded for their lack of medication adherence, leaving me to remind lawyers that the patient has been compliant. Conversely, patients are congratulated for their medication adherence when appearing well, until I remind the lawyers that the patient missed his last two visits for long-acting injectables.
As our field is reconciling new evidence questioning the long-term role of antipsychotics in schizophrenia, I am questioning whether society has accepted their value as a foregone conclusion. Lex Wunderink, MD, PhD, and his associates challenged accepted dogma when conducting a long-term, randomized trial of antipsychotics, in which patients on a dose reduction and discontinuation arm did better at 7 years than the patients on the continuation arm.6 The then National Institute of Mental Health director, Thomas Insel, MD, wrote in his blog that for some schizophrenia patients, “remaining on medication long term might impede a full return to wellness.”7
A Cochrane review of the literature found that, over time, antipsychotics had a diminishing effect on relapse prevention. After 2 years, the effect approached zero.8 In 2016, Nancy L. Sohler, PhD, and her colleagues looked at the literature on antipsychotic use in longer trials. The data were of poor quality and inconclusive.9 However, stories in the popular press suggest that the best explanation for violent behavior in the mentally ill population is medication noncompliance.
Inextricably bound up with this dogma regarding noncompliance is the incorporation of the pharmaceutical industry into mainstream psychiatry. The promise of psychopharmacology to treat mental illness was adopted in a wholesale manner for financial and practical reasons as well as a desperate optimism to relieve seemingly intractable problems. Sadly, the failure of psychopharmacology to produce on said promises has not produced a backlash. Instead, there is a doubling down on this belief, which can be seen, for example, in the creation of Abilify MyCite – with its promise to keep clinicians informed about their patients’ medication compliance.10 The alternative to this prescribing culture would be an attentive reckoning of the ongoing limitations inherent in the treatment of those with mental illness. If noncompliance cannot explain violence in people with mental illness, we are left with the same complex and subtle issues surrounding violence that frustrate easy journalistic explanations, and relatively cheap and easy interventions for the care of this population. It feels better and is more cost effective to blame the patients for not fitting our biological models by being drug nonresponders or noncompliant.
Blaming pills is facile. It is tangible and easier to measure than looking into someone’s mind. Psychiatrists have promoted this idea by teaching the public about chemical imbalances and by focusing on medication management. However, when the consequences are as severe as placing people in solitary confinement or explaining murder, the evidence needs to be equally solid as the severity of the punishment. This must start with psychiatrists reeducating the public on the role, the power, and the limitations of psychotropics.
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre mentors residents on projects, including reduction in the use of solitary confinement of patients with mental illness and examination of the mentally ill offender. Dr. Badre can be reached at Badremd.com.
References
1. Worcester Patch. Jan. 2, 2018.
2. Rare News. Jan. 4, 2018.
3. WTSP.com. Dec. 31, 2017.
4. Wavy.com, Dec. 20, 2017.
5. U.S. Attorney General. 2016. U.S. Department of Justice Report and Recommendations Concerning the Use of Restrictive Housing.
6. JAMA Psychiatry. 2013 Sep;70(9):913-20.
7. Blogpost, by Thomas Insel, MD. Aug. 28, 2013.
8. Cochrane Database Syst Rev. 2012 May 16. doi: 10.1002/14651858.CD008016.pub2.
9. Am J Orthopsychiatry. 2016;86(5):477-85.
10. New York Times. Nov. 13, 2017.
As a forensic psychiatrist, I follow news relating to mental illness and crime. Like many of the judges and lawyers with whom I work, the media appear to have an obsession with medication compliance in those with mental illness. Being “off medications” has become a threatening term suggestive of unbridled impulsivity and violence – a term that can explain any behavior, implying that without medication, humans are routinely capable of all things without warning.
The year 2018 already has provided two stark examples of this phenomenon. During the first week of the year, two articles with the following headlines were published: “ ‘He was off his meds’: Son charged in mother’s murder”1 and “A man lost his life in the subway after telling a teen off of his medication to ‘get away.’ ”2 Those two articles describe awful events that, as the headlines suggest, are best explained by a lack of compliance with a psychotropic medication regimen.
“A man lost his life in the subway after telling a teen off of his medication to ‘get away’ ” reports on a 65-year-old man who was pushed onto New York’s subway tracks after interacting with an 18-year-old who “did not take medication that day for his mental illness.” This article provides some limited details on the state of mind of the defendant, indicating that he had been “talking to himself.” However, to reinforce the message, the article informs the reader that he had been prescribed three psychotropics – insinuating a multiplier effect for the role of noncompliance. Furthermore, the article implies that missing a single day of psychotropics is an explanation for the incident.
The media routinely use this bias in favor of the medication explanation in its analysis – or lack thereof – of violent behavior in people with mental illness. Recent stories include a man killing his nephew3 and a man killing his girlfriend4, and both were incidents apparently best explained by medication noncompliance. Another story reports of police officers who were charged with assault after an altercation with a patient with mental illness led to the patient’s death. In the latter case, the article suggests that the simple fact that the victim had been acting erratically warrants the comment that he was “likely was off his medications.”
My work in the jail system also has been tainted by this overreliance on the unquestioned dogma of medication compliance. Discussions pertaining to punishment and privileges of inmates with mental illness often would lead to the question: “Is he taking his meds?” I have witnessed countless times when crucial decisions about placement in solitary confinement were predicated on questions of medication compliance. My answer was always the same: “Why does it matter? If the inmate is following the rules and behaving respectfully, how does taking a pill provide more important information?”
What was once thought to be a predictor of relapse risk, despite limited evidence, has become the outcome itself. As a society, we have falsely equated mental illness with violence; we have furthermore falsely equated remission and safety with medication compliance. The consequences of those beliefs are severe as we have limited attention, and our focus on medications blinds us to much clearer risk factors. 5
The court system is equally riveted with this question. Judges and lawyers associate medication compliance with legal competency, safety in probation or parole, and general well-being. I have witnessed agitated patients being reprimanded for their lack of medication adherence, leaving me to remind lawyers that the patient has been compliant. Conversely, patients are congratulated for their medication adherence when appearing well, until I remind the lawyers that the patient missed his last two visits for long-acting injectables.
As our field is reconciling new evidence questioning the long-term role of antipsychotics in schizophrenia, I am questioning whether society has accepted their value as a foregone conclusion. Lex Wunderink, MD, PhD, and his associates challenged accepted dogma when conducting a long-term, randomized trial of antipsychotics, in which patients on a dose reduction and discontinuation arm did better at 7 years than the patients on the continuation arm.6 The then National Institute of Mental Health director, Thomas Insel, MD, wrote in his blog that for some schizophrenia patients, “remaining on medication long term might impede a full return to wellness.”7
A Cochrane review of the literature found that, over time, antipsychotics had a diminishing effect on relapse prevention. After 2 years, the effect approached zero.8 In 2016, Nancy L. Sohler, PhD, and her colleagues looked at the literature on antipsychotic use in longer trials. The data were of poor quality and inconclusive.9 However, stories in the popular press suggest that the best explanation for violent behavior in the mentally ill population is medication noncompliance.
Inextricably bound up with this dogma regarding noncompliance is the incorporation of the pharmaceutical industry into mainstream psychiatry. The promise of psychopharmacology to treat mental illness was adopted in a wholesale manner for financial and practical reasons as well as a desperate optimism to relieve seemingly intractable problems. Sadly, the failure of psychopharmacology to produce on said promises has not produced a backlash. Instead, there is a doubling down on this belief, which can be seen, for example, in the creation of Abilify MyCite – with its promise to keep clinicians informed about their patients’ medication compliance.10 The alternative to this prescribing culture would be an attentive reckoning of the ongoing limitations inherent in the treatment of those with mental illness. If noncompliance cannot explain violence in people with mental illness, we are left with the same complex and subtle issues surrounding violence that frustrate easy journalistic explanations, and relatively cheap and easy interventions for the care of this population. It feels better and is more cost effective to blame the patients for not fitting our biological models by being drug nonresponders or noncompliant.
Blaming pills is facile. It is tangible and easier to measure than looking into someone’s mind. Psychiatrists have promoted this idea by teaching the public about chemical imbalances and by focusing on medication management. However, when the consequences are as severe as placing people in solitary confinement or explaining murder, the evidence needs to be equally solid as the severity of the punishment. This must start with psychiatrists reeducating the public on the role, the power, and the limitations of psychotropics.
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre mentors residents on projects, including reduction in the use of solitary confinement of patients with mental illness and examination of the mentally ill offender. Dr. Badre can be reached at Badremd.com.
References
1. Worcester Patch. Jan. 2, 2018.
2. Rare News. Jan. 4, 2018.
3. WTSP.com. Dec. 31, 2017.
4. Wavy.com, Dec. 20, 2017.
5. U.S. Attorney General. 2016. U.S. Department of Justice Report and Recommendations Concerning the Use of Restrictive Housing.
6. JAMA Psychiatry. 2013 Sep;70(9):913-20.
7. Blogpost, by Thomas Insel, MD. Aug. 28, 2013.
8. Cochrane Database Syst Rev. 2012 May 16. doi: 10.1002/14651858.CD008016.pub2.
9. Am J Orthopsychiatry. 2016;86(5):477-85.
10. New York Times. Nov. 13, 2017.
As a forensic psychiatrist, I follow news relating to mental illness and crime. Like many of the judges and lawyers with whom I work, the media appear to have an obsession with medication compliance in those with mental illness. Being “off medications” has become a threatening term suggestive of unbridled impulsivity and violence – a term that can explain any behavior, implying that without medication, humans are routinely capable of all things without warning.
The year 2018 already has provided two stark examples of this phenomenon. During the first week of the year, two articles with the following headlines were published: “ ‘He was off his meds’: Son charged in mother’s murder”1 and “A man lost his life in the subway after telling a teen off of his medication to ‘get away.’ ”2 Those two articles describe awful events that, as the headlines suggest, are best explained by a lack of compliance with a psychotropic medication regimen.
“A man lost his life in the subway after telling a teen off of his medication to ‘get away’ ” reports on a 65-year-old man who was pushed onto New York’s subway tracks after interacting with an 18-year-old who “did not take medication that day for his mental illness.” This article provides some limited details on the state of mind of the defendant, indicating that he had been “talking to himself.” However, to reinforce the message, the article informs the reader that he had been prescribed three psychotropics – insinuating a multiplier effect for the role of noncompliance. Furthermore, the article implies that missing a single day of psychotropics is an explanation for the incident.
The media routinely use this bias in favor of the medication explanation in its analysis – or lack thereof – of violent behavior in people with mental illness. Recent stories include a man killing his nephew3 and a man killing his girlfriend4, and both were incidents apparently best explained by medication noncompliance. Another story reports of police officers who were charged with assault after an altercation with a patient with mental illness led to the patient’s death. In the latter case, the article suggests that the simple fact that the victim had been acting erratically warrants the comment that he was “likely was off his medications.”
My work in the jail system also has been tainted by this overreliance on the unquestioned dogma of medication compliance. Discussions pertaining to punishment and privileges of inmates with mental illness often would lead to the question: “Is he taking his meds?” I have witnessed countless times when crucial decisions about placement in solitary confinement were predicated on questions of medication compliance. My answer was always the same: “Why does it matter? If the inmate is following the rules and behaving respectfully, how does taking a pill provide more important information?”
What was once thought to be a predictor of relapse risk, despite limited evidence, has become the outcome itself. As a society, we have falsely equated mental illness with violence; we have furthermore falsely equated remission and safety with medication compliance. The consequences of those beliefs are severe as we have limited attention, and our focus on medications blinds us to much clearer risk factors. 5
The court system is equally riveted with this question. Judges and lawyers associate medication compliance with legal competency, safety in probation or parole, and general well-being. I have witnessed agitated patients being reprimanded for their lack of medication adherence, leaving me to remind lawyers that the patient has been compliant. Conversely, patients are congratulated for their medication adherence when appearing well, until I remind the lawyers that the patient missed his last two visits for long-acting injectables.
As our field is reconciling new evidence questioning the long-term role of antipsychotics in schizophrenia, I am questioning whether society has accepted their value as a foregone conclusion. Lex Wunderink, MD, PhD, and his associates challenged accepted dogma when conducting a long-term, randomized trial of antipsychotics, in which patients on a dose reduction and discontinuation arm did better at 7 years than the patients on the continuation arm.6 The then National Institute of Mental Health director, Thomas Insel, MD, wrote in his blog that for some schizophrenia patients, “remaining on medication long term might impede a full return to wellness.”7
A Cochrane review of the literature found that, over time, antipsychotics had a diminishing effect on relapse prevention. After 2 years, the effect approached zero.8 In 2016, Nancy L. Sohler, PhD, and her colleagues looked at the literature on antipsychotic use in longer trials. The data were of poor quality and inconclusive.9 However, stories in the popular press suggest that the best explanation for violent behavior in the mentally ill population is medication noncompliance.
Inextricably bound up with this dogma regarding noncompliance is the incorporation of the pharmaceutical industry into mainstream psychiatry. The promise of psychopharmacology to treat mental illness was adopted in a wholesale manner for financial and practical reasons as well as a desperate optimism to relieve seemingly intractable problems. Sadly, the failure of psychopharmacology to produce on said promises has not produced a backlash. Instead, there is a doubling down on this belief, which can be seen, for example, in the creation of Abilify MyCite – with its promise to keep clinicians informed about their patients’ medication compliance.10 The alternative to this prescribing culture would be an attentive reckoning of the ongoing limitations inherent in the treatment of those with mental illness. If noncompliance cannot explain violence in people with mental illness, we are left with the same complex and subtle issues surrounding violence that frustrate easy journalistic explanations, and relatively cheap and easy interventions for the care of this population. It feels better and is more cost effective to blame the patients for not fitting our biological models by being drug nonresponders or noncompliant.
Blaming pills is facile. It is tangible and easier to measure than looking into someone’s mind. Psychiatrists have promoted this idea by teaching the public about chemical imbalances and by focusing on medication management. However, when the consequences are as severe as placing people in solitary confinement or explaining murder, the evidence needs to be equally solid as the severity of the punishment. This must start with psychiatrists reeducating the public on the role, the power, and the limitations of psychotropics.
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre mentors residents on projects, including reduction in the use of solitary confinement of patients with mental illness and examination of the mentally ill offender. Dr. Badre can be reached at Badremd.com.
References
1. Worcester Patch. Jan. 2, 2018.
2. Rare News. Jan. 4, 2018.
3. WTSP.com. Dec. 31, 2017.
4. Wavy.com, Dec. 20, 2017.
5. U.S. Attorney General. 2016. U.S. Department of Justice Report and Recommendations Concerning the Use of Restrictive Housing.
6. JAMA Psychiatry. 2013 Sep;70(9):913-20.
7. Blogpost, by Thomas Insel, MD. Aug. 28, 2013.
8. Cochrane Database Syst Rev. 2012 May 16. doi: 10.1002/14651858.CD008016.pub2.
9. Am J Orthopsychiatry. 2016;86(5):477-85.
10. New York Times. Nov. 13, 2017.
Putting a number on biologic DMARD costs
Annual medical costs for patients with rheumatoid arthritis were almost three times higher for those who used biologic disease-modifying antirheumatic drugs (bDMARDs), compared with those who used any treatment regimen, according to meta-analysis of 12 studies conducted since bDMARDs were introduced in 1999.
RA patients who used bDMARDs had an average direct cost of $36,053 per year, which was 2.9 times higher than the $12,509 in annual direct medical costs for all RA patients on any treatment regimen. Proportionately, the difference was even greater for RA-specific care, with the annual cost of bDMARD care ($20,262) 5.4 times higher than that of all treatment regimens ($3,723), reported Andrew Hresko and his associates at Brigham and Women’s Hospital, Boston.
Funding for the study was supported through a grant from the National Institutes of Health. Mr. Hresko was supported by a fellowship from Tufts University. One of his associates receives research support from grants to his hospital from Amgen, Pfizer, Eli Lilly, AstraZeneca, Genentech, Bristol Myers Squibb, and Corrona. The third investigator is now an employee of Amgen but was not during the study.
SOURCE: Hresko A et al. Arthritis Care Res. 2018 Jan 5. doi: 10.1002/acr.23512.
Annual medical costs for patients with rheumatoid arthritis were almost three times higher for those who used biologic disease-modifying antirheumatic drugs (bDMARDs), compared with those who used any treatment regimen, according to meta-analysis of 12 studies conducted since bDMARDs were introduced in 1999.
RA patients who used bDMARDs had an average direct cost of $36,053 per year, which was 2.9 times higher than the $12,509 in annual direct medical costs for all RA patients on any treatment regimen. Proportionately, the difference was even greater for RA-specific care, with the annual cost of bDMARD care ($20,262) 5.4 times higher than that of all treatment regimens ($3,723), reported Andrew Hresko and his associates at Brigham and Women’s Hospital, Boston.
Funding for the study was supported through a grant from the National Institutes of Health. Mr. Hresko was supported by a fellowship from Tufts University. One of his associates receives research support from grants to his hospital from Amgen, Pfizer, Eli Lilly, AstraZeneca, Genentech, Bristol Myers Squibb, and Corrona. The third investigator is now an employee of Amgen but was not during the study.
SOURCE: Hresko A et al. Arthritis Care Res. 2018 Jan 5. doi: 10.1002/acr.23512.
Annual medical costs for patients with rheumatoid arthritis were almost three times higher for those who used biologic disease-modifying antirheumatic drugs (bDMARDs), compared with those who used any treatment regimen, according to meta-analysis of 12 studies conducted since bDMARDs were introduced in 1999.
RA patients who used bDMARDs had an average direct cost of $36,053 per year, which was 2.9 times higher than the $12,509 in annual direct medical costs for all RA patients on any treatment regimen. Proportionately, the difference was even greater for RA-specific care, with the annual cost of bDMARD care ($20,262) 5.4 times higher than that of all treatment regimens ($3,723), reported Andrew Hresko and his associates at Brigham and Women’s Hospital, Boston.
Funding for the study was supported through a grant from the National Institutes of Health. Mr. Hresko was supported by a fellowship from Tufts University. One of his associates receives research support from grants to his hospital from Amgen, Pfizer, Eli Lilly, AstraZeneca, Genentech, Bristol Myers Squibb, and Corrona. The third investigator is now an employee of Amgen but was not during the study.
SOURCE: Hresko A et al. Arthritis Care Res. 2018 Jan 5. doi: 10.1002/acr.23512.
FROM ARTHRITIS CARE & RESEARCH
Finance Committee votes on Azar HHS nomination
With a Senate Finance Committee vote of 15 to 12, Alex Azar’s nomination for secretary of Health & Human Services has been sent to the full Senate for consideration.
Finance Committee Chairman Orrin Hatch (R-Utah) said at a Jan. 17 hearing that “by any objective account, Mr. Azar is very well qualified for this important position. He has close to two decades of experience, the right expertise, and sound judgment.”
Most recently, Mr. Azar served as president of Eli Lilly’s U.S. operations from 2012 to 2017 after joining the company in 2007. His drug industry ties have raised concerns that the agency’s regulatory actions would be favorable to pharmaceutical manufacturers at the expense of patients. However, at his confirmation hearing, Mr. Azar noted that he would be willing to investigate government drug price negotiations for Medicare Part B drugs.
The top Democrat on the Finance Committee, Sen. Ron Wyden (D-Ore.) voted against Mr. Azar’s nomination, noting that President Trump “famously said, his words, in the 2016 campaign, ‘price-hiking drug companies were getting away with murder.’ The President has now nominated a drug company executive with a documented history of raising drug prices.”
Sen. Wyden noted that prices of many commonly prescribed drugs “more than doubled under [Mr. Azar’s] watch” while no drugs saw a decline in pricing.
With a Senate Finance Committee vote of 15 to 12, Alex Azar’s nomination for secretary of Health & Human Services has been sent to the full Senate for consideration.
Finance Committee Chairman Orrin Hatch (R-Utah) said at a Jan. 17 hearing that “by any objective account, Mr. Azar is very well qualified for this important position. He has close to two decades of experience, the right expertise, and sound judgment.”
Most recently, Mr. Azar served as president of Eli Lilly’s U.S. operations from 2012 to 2017 after joining the company in 2007. His drug industry ties have raised concerns that the agency’s regulatory actions would be favorable to pharmaceutical manufacturers at the expense of patients. However, at his confirmation hearing, Mr. Azar noted that he would be willing to investigate government drug price negotiations for Medicare Part B drugs.
The top Democrat on the Finance Committee, Sen. Ron Wyden (D-Ore.) voted against Mr. Azar’s nomination, noting that President Trump “famously said, his words, in the 2016 campaign, ‘price-hiking drug companies were getting away with murder.’ The President has now nominated a drug company executive with a documented history of raising drug prices.”
Sen. Wyden noted that prices of many commonly prescribed drugs “more than doubled under [Mr. Azar’s] watch” while no drugs saw a decline in pricing.
With a Senate Finance Committee vote of 15 to 12, Alex Azar’s nomination for secretary of Health & Human Services has been sent to the full Senate for consideration.
Finance Committee Chairman Orrin Hatch (R-Utah) said at a Jan. 17 hearing that “by any objective account, Mr. Azar is very well qualified for this important position. He has close to two decades of experience, the right expertise, and sound judgment.”
Most recently, Mr. Azar served as president of Eli Lilly’s U.S. operations from 2012 to 2017 after joining the company in 2007. His drug industry ties have raised concerns that the agency’s regulatory actions would be favorable to pharmaceutical manufacturers at the expense of patients. However, at his confirmation hearing, Mr. Azar noted that he would be willing to investigate government drug price negotiations for Medicare Part B drugs.
The top Democrat on the Finance Committee, Sen. Ron Wyden (D-Ore.) voted against Mr. Azar’s nomination, noting that President Trump “famously said, his words, in the 2016 campaign, ‘price-hiking drug companies were getting away with murder.’ The President has now nominated a drug company executive with a documented history of raising drug prices.”
Sen. Wyden noted that prices of many commonly prescribed drugs “more than doubled under [Mr. Azar’s] watch” while no drugs saw a decline in pricing.
REPORTING FROM A SENATE FINANCE COMMITTEE HEARING
Mood changes reported in cases of methotrexate use for dermatologic disease
, said Trisha Bhat and Carrie C. Coughlin, MD, both of Washington University, St. Louis.
Neurotoxicity with low-dose methotrexate often has been described when used to treat rheumatologic disease, the investigators said, but not in the dermatologic literature – although CNS symptoms such as dizziness and headache have been described in both.
An 8-year-old girl with psoriasis vulgaris and no prior psychiatric history began weekly subcutaneous methotrexate 12.5 mg (0.23 mg/kg) with folic acid supplementation 6 days per week after failing topical therapy. Her parents noticed severe irritability right away and fluctuating mood changes over the next 2 months. At first, she was angry and unsettled, with depressed mood; her irritability became less frequent later, but she said she wanted to hurt someone else. After stopping methotrexate, her mood returned to normal within 2 weeks.
It is unclear how methotrexate affects mood, but recent evidence suggests that abnormalities in synaptic plasticity are involved in mood changes, and there is evidence that mice treated with methotrexate show changes in synaptic plasticity. Methotrexate also increases extracellular adenosine, which affects neuronal excitability and synaptic plasticity, Ms. Bhat and Dr. Coughlin observed. Methotrexate also affects glucose metabolism in rats, and regional metabolic disturbances occur in a number of psychiatric disorders.
Read more at Pediatric Dermatology (2018 Jan 9. doi: 10.1111/pde.13406).
, said Trisha Bhat and Carrie C. Coughlin, MD, both of Washington University, St. Louis.
Neurotoxicity with low-dose methotrexate often has been described when used to treat rheumatologic disease, the investigators said, but not in the dermatologic literature – although CNS symptoms such as dizziness and headache have been described in both.
An 8-year-old girl with psoriasis vulgaris and no prior psychiatric history began weekly subcutaneous methotrexate 12.5 mg (0.23 mg/kg) with folic acid supplementation 6 days per week after failing topical therapy. Her parents noticed severe irritability right away and fluctuating mood changes over the next 2 months. At first, she was angry and unsettled, with depressed mood; her irritability became less frequent later, but she said she wanted to hurt someone else. After stopping methotrexate, her mood returned to normal within 2 weeks.
It is unclear how methotrexate affects mood, but recent evidence suggests that abnormalities in synaptic plasticity are involved in mood changes, and there is evidence that mice treated with methotrexate show changes in synaptic plasticity. Methotrexate also increases extracellular adenosine, which affects neuronal excitability and synaptic plasticity, Ms. Bhat and Dr. Coughlin observed. Methotrexate also affects glucose metabolism in rats, and regional metabolic disturbances occur in a number of psychiatric disorders.
Read more at Pediatric Dermatology (2018 Jan 9. doi: 10.1111/pde.13406).
, said Trisha Bhat and Carrie C. Coughlin, MD, both of Washington University, St. Louis.
Neurotoxicity with low-dose methotrexate often has been described when used to treat rheumatologic disease, the investigators said, but not in the dermatologic literature – although CNS symptoms such as dizziness and headache have been described in both.
An 8-year-old girl with psoriasis vulgaris and no prior psychiatric history began weekly subcutaneous methotrexate 12.5 mg (0.23 mg/kg) with folic acid supplementation 6 days per week after failing topical therapy. Her parents noticed severe irritability right away and fluctuating mood changes over the next 2 months. At first, she was angry and unsettled, with depressed mood; her irritability became less frequent later, but she said she wanted to hurt someone else. After stopping methotrexate, her mood returned to normal within 2 weeks.
It is unclear how methotrexate affects mood, but recent evidence suggests that abnormalities in synaptic plasticity are involved in mood changes, and there is evidence that mice treated with methotrexate show changes in synaptic plasticity. Methotrexate also increases extracellular adenosine, which affects neuronal excitability and synaptic plasticity, Ms. Bhat and Dr. Coughlin observed. Methotrexate also affects glucose metabolism in rats, and regional metabolic disturbances occur in a number of psychiatric disorders.
Read more at Pediatric Dermatology (2018 Jan 9. doi: 10.1111/pde.13406).
FROM PEDIATRIC DERMATOLOGY
FDA grants priority review to CAR T-cell therapy for DLBCL
The Food and Drug Administration has granted a priority review for the CAR T-cell therapy tisagenlecleucel suspension, formerly CTL019, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapsed after autologous stem cell transplant.
The current application is based on a 6-month primary analysis from the single-arm, phase 2 JULIET clinical trial in adult patients with relapsed or refractory diffuse large B-cell lymphoma. According to results presented at ASH 2017, among 81 patients followed for at least 3 months before data cutoff, best overall response rate was 53%, and 40% had a complete response. Cytokine release syndrome (all grades) occurred in 58% of infused patients. Other grade 3 or 4 adverse events included neurologic toxicities, cytopenias lasting more than 28 days, infections, and febrile neutropenia.
Tisagenlecleucel suspension is marketed as Kymriah by Novartis.
The Food and Drug Administration has granted a priority review for the CAR T-cell therapy tisagenlecleucel suspension, formerly CTL019, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapsed after autologous stem cell transplant.
The current application is based on a 6-month primary analysis from the single-arm, phase 2 JULIET clinical trial in adult patients with relapsed or refractory diffuse large B-cell lymphoma. According to results presented at ASH 2017, among 81 patients followed for at least 3 months before data cutoff, best overall response rate was 53%, and 40% had a complete response. Cytokine release syndrome (all grades) occurred in 58% of infused patients. Other grade 3 or 4 adverse events included neurologic toxicities, cytopenias lasting more than 28 days, infections, and febrile neutropenia.
Tisagenlecleucel suspension is marketed as Kymriah by Novartis.
The Food and Drug Administration has granted a priority review for the CAR T-cell therapy tisagenlecleucel suspension, formerly CTL019, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapsed after autologous stem cell transplant.
The current application is based on a 6-month primary analysis from the single-arm, phase 2 JULIET clinical trial in adult patients with relapsed or refractory diffuse large B-cell lymphoma. According to results presented at ASH 2017, among 81 patients followed for at least 3 months before data cutoff, best overall response rate was 53%, and 40% had a complete response. Cytokine release syndrome (all grades) occurred in 58% of infused patients. Other grade 3 or 4 adverse events included neurologic toxicities, cytopenias lasting more than 28 days, infections, and febrile neutropenia.
Tisagenlecleucel suspension is marketed as Kymriah by Novartis.
FDA approves injection treatment for low-risk APL
The Food and Drug Administration announced the approval of arsenic trioxide injection (Trisenox) in combination with tretinoin for the treatment of adults with newly diagnosed, low-risk acute promyelocytic leukemia (APL) characterized by t(15;17) translocation or PML/RAR-alpha gene expression.
The expanded indication was granted by the FDA on Jan. 12 after priority review. It is based on published studies and a review of Teva’s global safety database for arsenic trioxide.
A recent randomized, phase 3 trial compared tretinoin plus arsenic trioxide with tretinoin plus chemotherapy as first-line treatment for APL (J Clin Oncol. 2017 Feb 20;35[6]:605-12). It found that 100% of 127 patients in the tretinoin plus arsenic trioxide arm achieved complete remission, compared with 97% of 136 patients in the tretinoin plus chemotherapy arm. After a median follow-up of 40.6 months, the event-free survival at 50 months for patients in the tretinoin/arsenic trioxide arm was 97.3% vs. 80% for tretinoin/chemotherapy (P = .001).
The arsenic trioxide injection carries a boxed warning for differentiation syndrome and cardiac conduction abnormalities.
The Food and Drug Administration announced the approval of arsenic trioxide injection (Trisenox) in combination with tretinoin for the treatment of adults with newly diagnosed, low-risk acute promyelocytic leukemia (APL) characterized by t(15;17) translocation or PML/RAR-alpha gene expression.
The expanded indication was granted by the FDA on Jan. 12 after priority review. It is based on published studies and a review of Teva’s global safety database for arsenic trioxide.
A recent randomized, phase 3 trial compared tretinoin plus arsenic trioxide with tretinoin plus chemotherapy as first-line treatment for APL (J Clin Oncol. 2017 Feb 20;35[6]:605-12). It found that 100% of 127 patients in the tretinoin plus arsenic trioxide arm achieved complete remission, compared with 97% of 136 patients in the tretinoin plus chemotherapy arm. After a median follow-up of 40.6 months, the event-free survival at 50 months for patients in the tretinoin/arsenic trioxide arm was 97.3% vs. 80% for tretinoin/chemotherapy (P = .001).
The arsenic trioxide injection carries a boxed warning for differentiation syndrome and cardiac conduction abnormalities.
The Food and Drug Administration announced the approval of arsenic trioxide injection (Trisenox) in combination with tretinoin for the treatment of adults with newly diagnosed, low-risk acute promyelocytic leukemia (APL) characterized by t(15;17) translocation or PML/RAR-alpha gene expression.
The expanded indication was granted by the FDA on Jan. 12 after priority review. It is based on published studies and a review of Teva’s global safety database for arsenic trioxide.
A recent randomized, phase 3 trial compared tretinoin plus arsenic trioxide with tretinoin plus chemotherapy as first-line treatment for APL (J Clin Oncol. 2017 Feb 20;35[6]:605-12). It found that 100% of 127 patients in the tretinoin plus arsenic trioxide arm achieved complete remission, compared with 97% of 136 patients in the tretinoin plus chemotherapy arm. After a median follow-up of 40.6 months, the event-free survival at 50 months for patients in the tretinoin/arsenic trioxide arm was 97.3% vs. 80% for tretinoin/chemotherapy (P = .001).
The arsenic trioxide injection carries a boxed warning for differentiation syndrome and cardiac conduction abnormalities.
Clinical rule decreased pediatric trauma CT scans
ORLANDO – A according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
With values for five clinical variables, the prediction rule would eliminate the need to subject some patients to unwarranted radiation exposure, which has become a growing health and financial concern for medical institutions.
“CT utilization rates in pediatric blunt trauma are very high, at a rate of 40%-60%, despite a relatively low incidence of intra-abdominal injury after abdominal trauma,” according to presenter Chase A. Arbra, MD, of the department of surgery at the Medical University of South Carolina, Charleston. “With increasing concerns regarding the cost and radiation exposure in children, our group is focusing on research to safely avoid these unnecessary scans.”
The rule, developed by the Pediatric Surgery Research Collaborative (PedSRC), evaluates abdominal wall trauma and tenderness, complaint of abdominal pain, aspartate aminotransferase level greater than 200 U/L, abnormal pancreatic enzymes, and abnormal chest x-rays to determine a patient’s risk of having an intra-abdominal injury (IAI). If none of the five variables in a patient is abnormal, the finding is considered negative and the patient is considered to be at very low risk for having an IAI or an IAI requiring acute intervention (IAI-I).
Investigators studied 2,435 pediatric blunt trauma patients with all five clinical variables documented within 6 hours of arrival, using data gathered from the Pediatric Emergency Care Applied Research Network.
Patients were an average of 9.4 years old, with an IAI rate of 9.7% (n = 235) and an IAI-I rate of 2.5% (n = 60); 61.1% of the patients had a CT scan.
Prediction sensitivity of the method was 97.5% for IAI and 100% for IAI-I, said Dr. Arbra. Negative predictive value for the model was 99.3% for IAI and 100% for IAI-I.
Patients who were found to have aspartate aminotransferase level greater than 200 U/L were at the highest risk of IAI (52.6%) and IAI-I (11.9%), according to investigators. One-third of the test population was found to be at very low risk after using the prediction model, according to Dr. Arbra, with 46.8% of them still undergoing a CT scan. Of those tested, six patients had IAI that was not predicted by the model, three of whom were intubated. Because CT scans were not required and there was no follow-up after discharge, investigators are not able to determine if any minor IAI was missed.
Despite these limitations, the highly sensitive rule shows great promise, according to Dr. Arbra.
“Patients with 0-5 variables, even patients who were involved in a high impact mechanism, could potentially forgo CT scans safely.”
A closer look at the 26 patients who only had abdominal pain showed that only 1 had IAI, suggesting that patients with only abdominal pain could be safely observed with only serial exams, according to Dr. Arbra.
Investigators plan to conduct a prospective study that will include older patients.
Dr. Arbra concluded, “The rule could potentially help centers to determine who could avoid imaging prior to transfer and potentially could one day be used to see who could be discharged.”
Dr. Arbra reported no relevant financial disclosures.
SOURCE: Arbra CA. EAST Scientific Assembly 2018, paper #7.
ORLANDO – A according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
With values for five clinical variables, the prediction rule would eliminate the need to subject some patients to unwarranted radiation exposure, which has become a growing health and financial concern for medical institutions.
“CT utilization rates in pediatric blunt trauma are very high, at a rate of 40%-60%, despite a relatively low incidence of intra-abdominal injury after abdominal trauma,” according to presenter Chase A. Arbra, MD, of the department of surgery at the Medical University of South Carolina, Charleston. “With increasing concerns regarding the cost and radiation exposure in children, our group is focusing on research to safely avoid these unnecessary scans.”
The rule, developed by the Pediatric Surgery Research Collaborative (PedSRC), evaluates abdominal wall trauma and tenderness, complaint of abdominal pain, aspartate aminotransferase level greater than 200 U/L, abnormal pancreatic enzymes, and abnormal chest x-rays to determine a patient’s risk of having an intra-abdominal injury (IAI). If none of the five variables in a patient is abnormal, the finding is considered negative and the patient is considered to be at very low risk for having an IAI or an IAI requiring acute intervention (IAI-I).
Investigators studied 2,435 pediatric blunt trauma patients with all five clinical variables documented within 6 hours of arrival, using data gathered from the Pediatric Emergency Care Applied Research Network.
Patients were an average of 9.4 years old, with an IAI rate of 9.7% (n = 235) and an IAI-I rate of 2.5% (n = 60); 61.1% of the patients had a CT scan.
Prediction sensitivity of the method was 97.5% for IAI and 100% for IAI-I, said Dr. Arbra. Negative predictive value for the model was 99.3% for IAI and 100% for IAI-I.
Patients who were found to have aspartate aminotransferase level greater than 200 U/L were at the highest risk of IAI (52.6%) and IAI-I (11.9%), according to investigators. One-third of the test population was found to be at very low risk after using the prediction model, according to Dr. Arbra, with 46.8% of them still undergoing a CT scan. Of those tested, six patients had IAI that was not predicted by the model, three of whom were intubated. Because CT scans were not required and there was no follow-up after discharge, investigators are not able to determine if any minor IAI was missed.
Despite these limitations, the highly sensitive rule shows great promise, according to Dr. Arbra.
“Patients with 0-5 variables, even patients who were involved in a high impact mechanism, could potentially forgo CT scans safely.”
A closer look at the 26 patients who only had abdominal pain showed that only 1 had IAI, suggesting that patients with only abdominal pain could be safely observed with only serial exams, according to Dr. Arbra.
Investigators plan to conduct a prospective study that will include older patients.
Dr. Arbra concluded, “The rule could potentially help centers to determine who could avoid imaging prior to transfer and potentially could one day be used to see who could be discharged.”
Dr. Arbra reported no relevant financial disclosures.
SOURCE: Arbra CA. EAST Scientific Assembly 2018, paper #7.
ORLANDO – A according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
With values for five clinical variables, the prediction rule would eliminate the need to subject some patients to unwarranted radiation exposure, which has become a growing health and financial concern for medical institutions.
“CT utilization rates in pediatric blunt trauma are very high, at a rate of 40%-60%, despite a relatively low incidence of intra-abdominal injury after abdominal trauma,” according to presenter Chase A. Arbra, MD, of the department of surgery at the Medical University of South Carolina, Charleston. “With increasing concerns regarding the cost and radiation exposure in children, our group is focusing on research to safely avoid these unnecessary scans.”
The rule, developed by the Pediatric Surgery Research Collaborative (PedSRC), evaluates abdominal wall trauma and tenderness, complaint of abdominal pain, aspartate aminotransferase level greater than 200 U/L, abnormal pancreatic enzymes, and abnormal chest x-rays to determine a patient’s risk of having an intra-abdominal injury (IAI). If none of the five variables in a patient is abnormal, the finding is considered negative and the patient is considered to be at very low risk for having an IAI or an IAI requiring acute intervention (IAI-I).
Investigators studied 2,435 pediatric blunt trauma patients with all five clinical variables documented within 6 hours of arrival, using data gathered from the Pediatric Emergency Care Applied Research Network.
Patients were an average of 9.4 years old, with an IAI rate of 9.7% (n = 235) and an IAI-I rate of 2.5% (n = 60); 61.1% of the patients had a CT scan.
Prediction sensitivity of the method was 97.5% for IAI and 100% for IAI-I, said Dr. Arbra. Negative predictive value for the model was 99.3% for IAI and 100% for IAI-I.
Patients who were found to have aspartate aminotransferase level greater than 200 U/L were at the highest risk of IAI (52.6%) and IAI-I (11.9%), according to investigators. One-third of the test population was found to be at very low risk after using the prediction model, according to Dr. Arbra, with 46.8% of them still undergoing a CT scan. Of those tested, six patients had IAI that was not predicted by the model, three of whom were intubated. Because CT scans were not required and there was no follow-up after discharge, investigators are not able to determine if any minor IAI was missed.
Despite these limitations, the highly sensitive rule shows great promise, according to Dr. Arbra.
“Patients with 0-5 variables, even patients who were involved in a high impact mechanism, could potentially forgo CT scans safely.”
A closer look at the 26 patients who only had abdominal pain showed that only 1 had IAI, suggesting that patients with only abdominal pain could be safely observed with only serial exams, according to Dr. Arbra.
Investigators plan to conduct a prospective study that will include older patients.
Dr. Arbra concluded, “The rule could potentially help centers to determine who could avoid imaging prior to transfer and potentially could one day be used to see who could be discharged.”
Dr. Arbra reported no relevant financial disclosures.
SOURCE: Arbra CA. EAST Scientific Assembly 2018, paper #7.
REPORTING FROM EAST 2018
Key clinical point: New prediction model successfully identified patients with intra-abdominal injury (IAI) and IAI patients who require acute intervention (IAI-I).
Major finding: The test had a negative predictive value of 99.3% in IAI patients and 100% in IAI-I patients when either had no abnormalities.
Study details: Prospective study of 2,345 pediatric patients with IAI or IAI-I, the data for which was collected from the Pediatric Emergency Care Applied Research Network.
Disclosures: Dr. Arbra reported no relevant financial disclosures.
Source: Arbra CA. EAST Scientific Assembly 2018, paper #7.