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Nursing home litigation: A vicious cycle
Nursing home neglect/abuse is growing fast, and so is related litigation. Cases typically involve wrongful death, decubitus ulcers, dehydration, malnutrition, sepsis, and falls.1 The financial burden nursing homes face in defending numerous lawsuits diverts funds that could be used to improve the quality of care.2
The families of victims of nursing home abuse/neglect often pursue lawsuits to get nursing homes to provide better quality of care to their residents. This can be difficult for nursing homes to achieve when they have to pour their financial resources into defending lawsuits. Historically, nursing home abuse/ neglect has been addressed by governmental regulation.3 Although victims and their families should not be deprived of their Seventh Amendment right, perhaps stricter government regulation is a more efficient means of addressing this problem.4
Mohammed Muqeet Adnan, MD
Huma Adnan, JD
Syed Amer, MD
Usman Bhutta, MD
Oklahoma City, Okla
1. Wunderlich GS, Kohler PO, eds. Improving the Quality of Long-Term Care. Washington, DC: National Academies Press; 2001.
2. Bourdon T, Doubin S. Long Term Care: General Liability and Professional Liability, Actuarial Analysis. New York, NY: Aon Risk Solutions; 2002.
3. Kapp MB. Quality of care and quality of life in nursing facilities: What’s regulation got to do with it? McGeorge Law Rev. 2000;31: 707-731.
4. Hemp SH. The right to a remedy: When should an abused nursing home resident sue? Elder Law J. 1994;2:195-224.
Nursing home neglect/abuse is growing fast, and so is related litigation. Cases typically involve wrongful death, decubitus ulcers, dehydration, malnutrition, sepsis, and falls.1 The financial burden nursing homes face in defending numerous lawsuits diverts funds that could be used to improve the quality of care.2
The families of victims of nursing home abuse/neglect often pursue lawsuits to get nursing homes to provide better quality of care to their residents. This can be difficult for nursing homes to achieve when they have to pour their financial resources into defending lawsuits. Historically, nursing home abuse/ neglect has been addressed by governmental regulation.3 Although victims and their families should not be deprived of their Seventh Amendment right, perhaps stricter government regulation is a more efficient means of addressing this problem.4
Mohammed Muqeet Adnan, MD
Huma Adnan, JD
Syed Amer, MD
Usman Bhutta, MD
Oklahoma City, Okla
Nursing home neglect/abuse is growing fast, and so is related litigation. Cases typically involve wrongful death, decubitus ulcers, dehydration, malnutrition, sepsis, and falls.1 The financial burden nursing homes face in defending numerous lawsuits diverts funds that could be used to improve the quality of care.2
The families of victims of nursing home abuse/neglect often pursue lawsuits to get nursing homes to provide better quality of care to their residents. This can be difficult for nursing homes to achieve when they have to pour their financial resources into defending lawsuits. Historically, nursing home abuse/ neglect has been addressed by governmental regulation.3 Although victims and their families should not be deprived of their Seventh Amendment right, perhaps stricter government regulation is a more efficient means of addressing this problem.4
Mohammed Muqeet Adnan, MD
Huma Adnan, JD
Syed Amer, MD
Usman Bhutta, MD
Oklahoma City, Okla
1. Wunderlich GS, Kohler PO, eds. Improving the Quality of Long-Term Care. Washington, DC: National Academies Press; 2001.
2. Bourdon T, Doubin S. Long Term Care: General Liability and Professional Liability, Actuarial Analysis. New York, NY: Aon Risk Solutions; 2002.
3. Kapp MB. Quality of care and quality of life in nursing facilities: What’s regulation got to do with it? McGeorge Law Rev. 2000;31: 707-731.
4. Hemp SH. The right to a remedy: When should an abused nursing home resident sue? Elder Law J. 1994;2:195-224.
1. Wunderlich GS, Kohler PO, eds. Improving the Quality of Long-Term Care. Washington, DC: National Academies Press; 2001.
2. Bourdon T, Doubin S. Long Term Care: General Liability and Professional Liability, Actuarial Analysis. New York, NY: Aon Risk Solutions; 2002.
3. Kapp MB. Quality of care and quality of life in nursing facilities: What’s regulation got to do with it? McGeorge Law Rev. 2000;31: 707-731.
4. Hemp SH. The right to a remedy: When should an abused nursing home resident sue? Elder Law J. 1994;2:195-224.
Are these CAD study findings too good to be true?
I read with interest “A way to reverse CAD?” by Esselstyn et al (J Fam Pract. 2014;63:356-364,364a,364b) on the effects of a plant-based nutrition program on the incidence of cardiac events in patients with cardiovascular disease (CVD). If found to be effective in subsequent studies, this intervention could have tremendous clinical implications for patients. However, the article left me with many questions and concerns.
One of my concerns is that the article was written in a promotional, not scientific, tone. Although no potential conflicts of interest were reported, the lead author has published books on the topic from which he could profit. Even if one were to disregard these concerns, several methodological issues remain.
Specifically, Esselstyn et al report that over a mean 3.7 years of follow-up, 89% of patients were compliant to the program, defined as avoidance of all meat, fish, dairy, and added oils. Frankly, this statistic isn’t believable because the “compliant” patients undoubtedly consumed these products on occasion during this period. More likely, compliance was assessed by a simple Yes or No response over the phone; expectation bias would strongly influence patient reporting in this situation.
In addition, there’s no comparison of disease severity, prior interventions, weight loss, assessment of optimized medical management, or follow-up duration between the 2 groups. The differences in events reported in this study may be explained by unreported confounders.
The authors should be congratulated for presenting this work, but overall, the reporting is inadequate to form any scientific conclusions. The data lead to more questions than answers.
Larry E. Miller, PhD
Asheville, NC
Esselstyn et al report an extraordinary recurrent event rate of 0.6% among 177 patients with established cardiovascular disease who adhered to a plant-based diet for approximately 44 months. These results are so remarkable that several questions come to mind. Why didn’t the editors of The Journal of Family Practice offer any commentary on a revolutionary intervention that appears to cure cardiovascular disease? Why aren’t these results being reported and commented upon in the lay media? Why didn’t the journal note Dr. Esselstyn’s potential conflict of interest as an author who profits from the sale of books that advocate a plant-based diet?
I am glad to see studies that look at nutritional interventions getting equal billing with those funded by pharmaceutical companies, but publishing this report without comment certainly leads a reader to believe that the editors and peer reviewers accept this study at face value, and that physicians might practice accordingly.
David A. Silverstein, MD
Buffalo, NY
Authors' response:
We agree with the major point of Dr. Miller’s comments—this safe, inexpensive, and effective diet works so well at reducing coronary and other vascular disease that it raises more questions than answers, and deserves study by other groups. There was no intent to obscure the senior author’s 2007 book, Prevent and Reverse Heart Disease1; as it is mentioned in the article, a copy of the book was provided to each study participant, and it was listed among the references.
We agree that using standardized, validated instruments to evaluate dietary intake, such as food frequency questionnaires or 3- to 7-day food records, would provide more scientifically sound methodology, but we were able to assess several key features of the diet, including the 2 key ones, abstinence from animal food intake and avoidance of all oils, without such tools. Most patients transitioned to the whole foods plant-based diet from the meat and processed foods dietary pattern, with only a few eating ovo-lacto or lacto-vegetarian diets before participating in the study.
Regarding disease severity, 44 participants had a prior myocardial infarction and 119 had a prior percutaneous coronary intervention or coronary artery bypass graft surgery. Twenty-seven were scheduled for intervention that was unnecessary after they adopted the program. The frustration of current cardiovascular therapy and the potential of plant-based nutrition are succinctly expressed in our recent series of case reports.2
Caldwell B. Esselstyn Jr, MD
Mladen Golubic, MD, PhD
Michael F. Roizen, MD
Lyndhurst, Ohio
1. Esselstyn CB Jr. Prevent and Reverse Heart Disease. New York, New York: Penguin Group; 2007.
2. Esselstyn CB, Golubic M. The nutritional reversal of cardiovascular disease—fact or fiction? Three case reports. Exp Clin Cardiol. 2014;20:1901-1908.
I read with interest “A way to reverse CAD?” by Esselstyn et al (J Fam Pract. 2014;63:356-364,364a,364b) on the effects of a plant-based nutrition program on the incidence of cardiac events in patients with cardiovascular disease (CVD). If found to be effective in subsequent studies, this intervention could have tremendous clinical implications for patients. However, the article left me with many questions and concerns.
One of my concerns is that the article was written in a promotional, not scientific, tone. Although no potential conflicts of interest were reported, the lead author has published books on the topic from which he could profit. Even if one were to disregard these concerns, several methodological issues remain.
Specifically, Esselstyn et al report that over a mean 3.7 years of follow-up, 89% of patients were compliant to the program, defined as avoidance of all meat, fish, dairy, and added oils. Frankly, this statistic isn’t believable because the “compliant” patients undoubtedly consumed these products on occasion during this period. More likely, compliance was assessed by a simple Yes or No response over the phone; expectation bias would strongly influence patient reporting in this situation.
In addition, there’s no comparison of disease severity, prior interventions, weight loss, assessment of optimized medical management, or follow-up duration between the 2 groups. The differences in events reported in this study may be explained by unreported confounders.
The authors should be congratulated for presenting this work, but overall, the reporting is inadequate to form any scientific conclusions. The data lead to more questions than answers.
Larry E. Miller, PhD
Asheville, NC
Esselstyn et al report an extraordinary recurrent event rate of 0.6% among 177 patients with established cardiovascular disease who adhered to a plant-based diet for approximately 44 months. These results are so remarkable that several questions come to mind. Why didn’t the editors of The Journal of Family Practice offer any commentary on a revolutionary intervention that appears to cure cardiovascular disease? Why aren’t these results being reported and commented upon in the lay media? Why didn’t the journal note Dr. Esselstyn’s potential conflict of interest as an author who profits from the sale of books that advocate a plant-based diet?
I am glad to see studies that look at nutritional interventions getting equal billing with those funded by pharmaceutical companies, but publishing this report without comment certainly leads a reader to believe that the editors and peer reviewers accept this study at face value, and that physicians might practice accordingly.
David A. Silverstein, MD
Buffalo, NY
Authors' response:
We agree with the major point of Dr. Miller’s comments—this safe, inexpensive, and effective diet works so well at reducing coronary and other vascular disease that it raises more questions than answers, and deserves study by other groups. There was no intent to obscure the senior author’s 2007 book, Prevent and Reverse Heart Disease1; as it is mentioned in the article, a copy of the book was provided to each study participant, and it was listed among the references.
We agree that using standardized, validated instruments to evaluate dietary intake, such as food frequency questionnaires or 3- to 7-day food records, would provide more scientifically sound methodology, but we were able to assess several key features of the diet, including the 2 key ones, abstinence from animal food intake and avoidance of all oils, without such tools. Most patients transitioned to the whole foods plant-based diet from the meat and processed foods dietary pattern, with only a few eating ovo-lacto or lacto-vegetarian diets before participating in the study.
Regarding disease severity, 44 participants had a prior myocardial infarction and 119 had a prior percutaneous coronary intervention or coronary artery bypass graft surgery. Twenty-seven were scheduled for intervention that was unnecessary after they adopted the program. The frustration of current cardiovascular therapy and the potential of plant-based nutrition are succinctly expressed in our recent series of case reports.2
Caldwell B. Esselstyn Jr, MD
Mladen Golubic, MD, PhD
Michael F. Roizen, MD
Lyndhurst, Ohio
I read with interest “A way to reverse CAD?” by Esselstyn et al (J Fam Pract. 2014;63:356-364,364a,364b) on the effects of a plant-based nutrition program on the incidence of cardiac events in patients with cardiovascular disease (CVD). If found to be effective in subsequent studies, this intervention could have tremendous clinical implications for patients. However, the article left me with many questions and concerns.
One of my concerns is that the article was written in a promotional, not scientific, tone. Although no potential conflicts of interest were reported, the lead author has published books on the topic from which he could profit. Even if one were to disregard these concerns, several methodological issues remain.
Specifically, Esselstyn et al report that over a mean 3.7 years of follow-up, 89% of patients were compliant to the program, defined as avoidance of all meat, fish, dairy, and added oils. Frankly, this statistic isn’t believable because the “compliant” patients undoubtedly consumed these products on occasion during this period. More likely, compliance was assessed by a simple Yes or No response over the phone; expectation bias would strongly influence patient reporting in this situation.
In addition, there’s no comparison of disease severity, prior interventions, weight loss, assessment of optimized medical management, or follow-up duration between the 2 groups. The differences in events reported in this study may be explained by unreported confounders.
The authors should be congratulated for presenting this work, but overall, the reporting is inadequate to form any scientific conclusions. The data lead to more questions than answers.
Larry E. Miller, PhD
Asheville, NC
Esselstyn et al report an extraordinary recurrent event rate of 0.6% among 177 patients with established cardiovascular disease who adhered to a plant-based diet for approximately 44 months. These results are so remarkable that several questions come to mind. Why didn’t the editors of The Journal of Family Practice offer any commentary on a revolutionary intervention that appears to cure cardiovascular disease? Why aren’t these results being reported and commented upon in the lay media? Why didn’t the journal note Dr. Esselstyn’s potential conflict of interest as an author who profits from the sale of books that advocate a plant-based diet?
I am glad to see studies that look at nutritional interventions getting equal billing with those funded by pharmaceutical companies, but publishing this report without comment certainly leads a reader to believe that the editors and peer reviewers accept this study at face value, and that physicians might practice accordingly.
David A. Silverstein, MD
Buffalo, NY
Authors' response:
We agree with the major point of Dr. Miller’s comments—this safe, inexpensive, and effective diet works so well at reducing coronary and other vascular disease that it raises more questions than answers, and deserves study by other groups. There was no intent to obscure the senior author’s 2007 book, Prevent and Reverse Heart Disease1; as it is mentioned in the article, a copy of the book was provided to each study participant, and it was listed among the references.
We agree that using standardized, validated instruments to evaluate dietary intake, such as food frequency questionnaires or 3- to 7-day food records, would provide more scientifically sound methodology, but we were able to assess several key features of the diet, including the 2 key ones, abstinence from animal food intake and avoidance of all oils, without such tools. Most patients transitioned to the whole foods plant-based diet from the meat and processed foods dietary pattern, with only a few eating ovo-lacto or lacto-vegetarian diets before participating in the study.
Regarding disease severity, 44 participants had a prior myocardial infarction and 119 had a prior percutaneous coronary intervention or coronary artery bypass graft surgery. Twenty-seven were scheduled for intervention that was unnecessary after they adopted the program. The frustration of current cardiovascular therapy and the potential of plant-based nutrition are succinctly expressed in our recent series of case reports.2
Caldwell B. Esselstyn Jr, MD
Mladen Golubic, MD, PhD
Michael F. Roizen, MD
Lyndhurst, Ohio
1. Esselstyn CB Jr. Prevent and Reverse Heart Disease. New York, New York: Penguin Group; 2007.
2. Esselstyn CB, Golubic M. The nutritional reversal of cardiovascular disease—fact or fiction? Three case reports. Exp Clin Cardiol. 2014;20:1901-1908.
1. Esselstyn CB Jr. Prevent and Reverse Heart Disease. New York, New York: Penguin Group; 2007.
2. Esselstyn CB, Golubic M. The nutritional reversal of cardiovascular disease—fact or fiction? Three case reports. Exp Clin Cardiol. 2014;20:1901-1908.
Errata
The author listing for the Clinical Inquiry, “What is the best imaging method for patients with a presumed acute stroke?” (J Fam Pract. 2014;63:36-37) incorrectly listed Leilani St. Anna, MLIS, AHIP as one of the authors. It should have read: Roya Sadeghi, MD, and Jon Neher, MD (Valley Family Medicine Residency, Renton, Wash), and Sarah Safranek, MLIS (University of Washington Health Sciences Library, Seattle).
The article “4 EKG abnormalities: What are the lifesaving diagnoses?” (J Fam Pract. 2014;63:368-375) incorrectly stated that ventricular fibrillation was one of 4 arrhythmias associated with Wolff-Parkinson-White syndrome that should be treated with synchronized cardioversion. In fact, an unstable patient with ventricular fibrillation should receive defibrillation—not synchronized cardioversion. The passage, which appeared on page 373, has been corrected in the online edition of the article.
The author listing for the Clinical Inquiry, “What is the best imaging method for patients with a presumed acute stroke?” (J Fam Pract. 2014;63:36-37) incorrectly listed Leilani St. Anna, MLIS, AHIP as one of the authors. It should have read: Roya Sadeghi, MD, and Jon Neher, MD (Valley Family Medicine Residency, Renton, Wash), and Sarah Safranek, MLIS (University of Washington Health Sciences Library, Seattle).
The article “4 EKG abnormalities: What are the lifesaving diagnoses?” (J Fam Pract. 2014;63:368-375) incorrectly stated that ventricular fibrillation was one of 4 arrhythmias associated with Wolff-Parkinson-White syndrome that should be treated with synchronized cardioversion. In fact, an unstable patient with ventricular fibrillation should receive defibrillation—not synchronized cardioversion. The passage, which appeared on page 373, has been corrected in the online edition of the article.
The author listing for the Clinical Inquiry, “What is the best imaging method for patients with a presumed acute stroke?” (J Fam Pract. 2014;63:36-37) incorrectly listed Leilani St. Anna, MLIS, AHIP as one of the authors. It should have read: Roya Sadeghi, MD, and Jon Neher, MD (Valley Family Medicine Residency, Renton, Wash), and Sarah Safranek, MLIS (University of Washington Health Sciences Library, Seattle).
The article “4 EKG abnormalities: What are the lifesaving diagnoses?” (J Fam Pract. 2014;63:368-375) incorrectly stated that ventricular fibrillation was one of 4 arrhythmias associated with Wolff-Parkinson-White syndrome that should be treated with synchronized cardioversion. In fact, an unstable patient with ventricular fibrillation should receive defibrillation—not synchronized cardioversion. The passage, which appeared on page 373, has been corrected in the online edition of the article.
To improve our patients’ health, look beyond reducing readmissions
In this issue of the Cleveland Clinic Journal of Medicine, Drs. Ayache, Boyaji, and Pile share evidence-based strategies for reducing the risk of readmission for patients with acute exacerbations of chronic obstructive pulmonary disease (COPD).1 They emphasize standardizing practice by combining effective clinical management with appropriate patient education, communication, and postdischarge follow-up.
Reducing the rate of preventable hospital readmissions (as well as avoiding admissions in the first place) is the right thing to do for the patient. Moreover, broader adoption of the strategies that they outline in their article will be critical to the success of health care organizations in improving patient outcomes and navigating a rapidly evolving landscape of reimbursement and reporting changes associated with the Centers for Medicare and Medicaid Services (CMS) Readmissions Reduction Program. Hospital readmission rates, while imperfect measures of the quality of care, demonstrate opportunities to optimize transitions of care. Success in our efforts to improve the health of our patients will likely be aligned with reductions in preventable admissions and improved attention to care coordination.
HOSPITALS ARE PENALIZED FOR EXCESSIVE READMISSION RATES
With nearly 20% of Medicare beneficiaries being rehospitalized within 30 days of discharge, at a cost of $17 billion annually,2 Congress enacted the Hospital Readmissions Reduction Program3 as part of the Affordable Care Act (ACA) in 2012. The Centers for Medicare and Medicaid Services (CMS) had already been reporting the readmission rates for heart failure, acute myocardial infarction, and pneumonia since 2009 (www.medicare.gov/hospitalcompare). Building on this work, the Affordable Care Act implemented financial penalties against hospitals that had excessive rates of readmissions for these conditions.
The Affordable Care Act put 1% of a hospital’s Medicare base payment at risk for all inpatient diagnoses in 2013—not just the three listed here. The risk is 2% in 2014 and will rise to 3% in 2015. In its first year, more than 2,200 United States hospitals were penalized a total of approximately $280 million because of readmission rates above the national mean. Nearly 10% of hospitals incurred the maximum 1% penalty, and about 30% paid no penalty.
The Secretary of the Department of Health and Human Services has the authority to extend the Readmissions Reduction Program to additional high-volume or high-expenditure conditions, and the department has announced it will expand the program in October 2014 (fiscal year 2015) to include two additional conditions: elective hip or knee replacement and COPD.4 In both cases, CMS began by publicly reporting these rates before including them in the program. Additional readmission measures, including those for stroke and hospital-wide all-cause readmissions, are also publicly reported and receive increased attention but are not yet included in the Readmissions Reduction Program.
UNFAIRLY PENALIZING THOSE THAT SERVE THE POOR
Avoidable causes of readmissions include hospital-acquired infections and complications, inadequate medication reconciliation and management, poor communication and coordination of care among the members of the health care team, and suboptimal care transitions.5 But other important drivers of readmissions are outside of a hospital’s direct control. These include mental illness, lack of social support, and poverty.6
A criticism of the Readmissions Reduction Program is that it disproportionately penalizes hospitals that serve the poorest patients.7 Currently, CMS readmission risk models do not adjust for socioeconomic factors. Further, CMS responds to these concerns by noting that it does not want different outcome standards for poor patients, and that adjusting for these factors may conceal potential health care disparities in disadvantaged populations.
NEW MISSION FOR HOSPITALS: MITIGATE SOCIOECONOMIC BARRIERS
Effective programs to reduce hospital readmissions must address the clinical interventions and patient education needs in the COPD discharge checklist discussed by Ayache et al, but must also attempt to mitigate social disadvantages that drive up readmissions for patients at highest risk.
Are hospitals in a position to do this? Too often, it is assumed that patients have access to medications, transportation to follow-up appointments, and social support. Early identification of patients at highest risk of being affected by lack of these factors and innovative solutions for mitigating these risks are important considerations in our efforts to reduce hospital readmissions.
HOW MANY READMISSIONS ARE TRULY PREVENTABLE?
Experts disagree on how many readmissions are truly preventable. Readmission rates for the sickest patients treated at tertiary or academic medical centers may reflect high-quality care in well-managed patients who otherwise would have died during the index admission.8
In early studies, the Medicare Payment Advisory Commission estimated that up to three-quarters of readmissions are preventable.9 In contrast, studies that used clinical instead of administrative data suggest preventable readmissions make up as little as 12% of total readmissions.10
Regardless of the actual percentage, Medicare’s risk-adjustment model relies exclusively on administrative data that do not fully account for nonpreventable factors and do not completely address unrelated or planned rehospitalizations. CMS is attempting to address these issues with an expanded readmission algorithm that excludes more planned and unrelated readmissions from the penalty calculation.
Ironically, the current structure of the Readmissions Reduction Program does little to address its intended goal of eliminating the perverse financial incentives for hospitals and physicians to readmit patients. Payments are still episode-based and reward readmissions. The $280 million that CMS expects to receive from the program this year covers less than 5% of the nearly $12 billion attributed to preventable rehospitalizations.11
WHAT PATIENTS NEED, NOT WHAT SUITS PROVIDERS
Hospital readmission rates are publicly reported, but it is shortsighted to think about readmissions outside of the broader context of the “medical home.” One must consider the role of primary care providers before and after an index admission in addition to the role of postacute care providers for some patients after discharge. Neither is directly affected by the current penalty program, but both are critical to effective solutions and optimizing value-oriented care.
Readmission rates are suboptimal measures, as they address presumed failures of hospital transitions rather than measuring care coordination and providing meaningful incentives to coordinate care. Yes, there is much to do to ensure effective transitions from the hospital to home or postacute settings. But to truly transform health care and deliver value, shouldn’t we strive to redesign the work flow around what patients need rather than what suits providers?
This effort should focus on managing the conditions that bring patients to the hospital. Medical homes and optimizing chronic disease care can play pivotal roles in improving quality and reducing costs. Coordination of care and disease-management programs have led to cost reductions of 30% or more12 and have reduced admission rates by more than 10%.13 While the nation waits for health care reimbursement models to better reward patient quality outcomes and population health while reducing costs, we can use measures such as the Agency for Healthcare Research and Quality’s Prevention Quality Indicators to identify early interventions in the ambulatory care setting that can prevent admissions, complications, and exacerbation of disease.
Payers should also experiment with and promote innovative bundled-payment models such as Geisinger Health System’s ProvenCare program, which sets a fixed price for surgical procedures and up to 90 days of posthospital care, including readmission. These warranty-like programs overcome financial incentives to readmit patients in Medicare’s volume-based diagnosis-related group payment system.5
Re-engineering the delivery of care requires realigning resources to improve efficiency and effectiveness. In the short term, hospitals that successfully reduce readmission rates can expect reduced net reimbursements, as the penalties currently do not exceed the lost revenue of readmissions.
Reducing preventable readmissions is the right thing to do, but not all hospitalizations and rehospitalizations are avoidable. Many readmissions reflect appropriate and necessary care. The relentless focus on the readmission rate diverts attention and resources from more proactive solutions and innovative approaches for increasing health care safety, quality outcomes, and value.
Hospitals are caught between the volume and value paradigms. Payment programs that reward proactive disease management and care coordination will do the most to reduce health care costs and improve the quality of care. Hospitals have a responsibility to efficiently and effectively manage acute care and optimize handoffs to the next provider. Medicare’s payment policies do not do enough today to align the financial and quality-of-care incentives.
- Ayache MB, Boyaji S, Pile J. Can we reduce the risk of readmission for a patient with an exacerbation of COPD? Cleve Clin J Med 2014; 81:525–527.
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med 2009; 360:1418–1428.
- Department of Health and Human Services. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2012 Rates; Hospitals’ FTE Resident Caps for Graduate Medical Education Payment; Final Rule. Federal Register 2011; 76:51475–51846. www.gpo.gov/fdsys/pkg/FR-2011-08-18/pdf/2011-19719.pdf. Accessed August 5, 2014.
- Department of Health and Human Services. Medicare program; hospital inpatient prospective payment systems for acute care hospitals and the long term care; hospital prospective payment system and fiscal year 2014 rates; quality reporting requirements for specific providers; hospital conditions of participation; payment policies related to patient status; final rule. Federal Register 2013; 78:50495–51040. www.gpo.gov/fdsys/pkg/FR-2013-08-19/pdf/2013-18956.pdf. Accessed August 5, 2014.
- Berenson RA, Paulus RA, Kalman NS. Medicare’s readmissions-reduction program—a positive alternative. N Engl J Med 2012; 366:1364–1366.
- Joynt KE, Jha AK. Thirty-day readmissions—truth and consequences. N Engl J Med 2012; 366:1366–1369.
- Rau J. Medicare to penalize 2,217 hospitals for excess readmissions. Kaiser Health News 2012. www.kaiserhealthnews.org/stories/2012/august/13/medicare-hospitals-readmissions-penalties.aspx. Accessed August 5, 2014.
- Gorodeski EZ, Starling RC, Blackstone EH. Are all readmissions bad readmissions? N Engl J Med 2010; 363:297–298.
- Medicare Payment Advisory Commission. Report to the Congress: Promoting Greater Efficiency in Medicare, June 2007. www.medpac.gov/documents/jun07_entirereport.pdf. Accessed August 5, 2014.
- van Walraven C, Bennett C, Jennings A, Austin PC, Forster AJ. Proportion of hospital readmissions deemed avoidable: a systematic review. CMAJ 2011; 183:E391–E402.
- CMS Fee For Service IPPS Payment File, Fiscal Year 2014. cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Downloads/FY_14_FR_Impact_File.zip. Accessed August 5, 2014.
- Dartmouth Medical School Center for the Evaluative Clinical Sciences. The Dartmouth Atlas of Health Care, 2006. www.dartmouthat-las.org/downloads/atlases/2006_Chronic_Care_Atlas.pdf. Accessed August 5, 2014.
- Gold W, Kongstvedt P. How broadening DM’s focus helped shrink one plan’s costs. Managed Care 2003. www.managedcaremag.com/archives/0311/0311.minnesota.html. Accessed August 5, 2014.
In this issue of the Cleveland Clinic Journal of Medicine, Drs. Ayache, Boyaji, and Pile share evidence-based strategies for reducing the risk of readmission for patients with acute exacerbations of chronic obstructive pulmonary disease (COPD).1 They emphasize standardizing practice by combining effective clinical management with appropriate patient education, communication, and postdischarge follow-up.
Reducing the rate of preventable hospital readmissions (as well as avoiding admissions in the first place) is the right thing to do for the patient. Moreover, broader adoption of the strategies that they outline in their article will be critical to the success of health care organizations in improving patient outcomes and navigating a rapidly evolving landscape of reimbursement and reporting changes associated with the Centers for Medicare and Medicaid Services (CMS) Readmissions Reduction Program. Hospital readmission rates, while imperfect measures of the quality of care, demonstrate opportunities to optimize transitions of care. Success in our efforts to improve the health of our patients will likely be aligned with reductions in preventable admissions and improved attention to care coordination.
HOSPITALS ARE PENALIZED FOR EXCESSIVE READMISSION RATES
With nearly 20% of Medicare beneficiaries being rehospitalized within 30 days of discharge, at a cost of $17 billion annually,2 Congress enacted the Hospital Readmissions Reduction Program3 as part of the Affordable Care Act (ACA) in 2012. The Centers for Medicare and Medicaid Services (CMS) had already been reporting the readmission rates for heart failure, acute myocardial infarction, and pneumonia since 2009 (www.medicare.gov/hospitalcompare). Building on this work, the Affordable Care Act implemented financial penalties against hospitals that had excessive rates of readmissions for these conditions.
The Affordable Care Act put 1% of a hospital’s Medicare base payment at risk for all inpatient diagnoses in 2013—not just the three listed here. The risk is 2% in 2014 and will rise to 3% in 2015. In its first year, more than 2,200 United States hospitals were penalized a total of approximately $280 million because of readmission rates above the national mean. Nearly 10% of hospitals incurred the maximum 1% penalty, and about 30% paid no penalty.
The Secretary of the Department of Health and Human Services has the authority to extend the Readmissions Reduction Program to additional high-volume or high-expenditure conditions, and the department has announced it will expand the program in October 2014 (fiscal year 2015) to include two additional conditions: elective hip or knee replacement and COPD.4 In both cases, CMS began by publicly reporting these rates before including them in the program. Additional readmission measures, including those for stroke and hospital-wide all-cause readmissions, are also publicly reported and receive increased attention but are not yet included in the Readmissions Reduction Program.
UNFAIRLY PENALIZING THOSE THAT SERVE THE POOR
Avoidable causes of readmissions include hospital-acquired infections and complications, inadequate medication reconciliation and management, poor communication and coordination of care among the members of the health care team, and suboptimal care transitions.5 But other important drivers of readmissions are outside of a hospital’s direct control. These include mental illness, lack of social support, and poverty.6
A criticism of the Readmissions Reduction Program is that it disproportionately penalizes hospitals that serve the poorest patients.7 Currently, CMS readmission risk models do not adjust for socioeconomic factors. Further, CMS responds to these concerns by noting that it does not want different outcome standards for poor patients, and that adjusting for these factors may conceal potential health care disparities in disadvantaged populations.
NEW MISSION FOR HOSPITALS: MITIGATE SOCIOECONOMIC BARRIERS
Effective programs to reduce hospital readmissions must address the clinical interventions and patient education needs in the COPD discharge checklist discussed by Ayache et al, but must also attempt to mitigate social disadvantages that drive up readmissions for patients at highest risk.
Are hospitals in a position to do this? Too often, it is assumed that patients have access to medications, transportation to follow-up appointments, and social support. Early identification of patients at highest risk of being affected by lack of these factors and innovative solutions for mitigating these risks are important considerations in our efforts to reduce hospital readmissions.
HOW MANY READMISSIONS ARE TRULY PREVENTABLE?
Experts disagree on how many readmissions are truly preventable. Readmission rates for the sickest patients treated at tertiary or academic medical centers may reflect high-quality care in well-managed patients who otherwise would have died during the index admission.8
In early studies, the Medicare Payment Advisory Commission estimated that up to three-quarters of readmissions are preventable.9 In contrast, studies that used clinical instead of administrative data suggest preventable readmissions make up as little as 12% of total readmissions.10
Regardless of the actual percentage, Medicare’s risk-adjustment model relies exclusively on administrative data that do not fully account for nonpreventable factors and do not completely address unrelated or planned rehospitalizations. CMS is attempting to address these issues with an expanded readmission algorithm that excludes more planned and unrelated readmissions from the penalty calculation.
Ironically, the current structure of the Readmissions Reduction Program does little to address its intended goal of eliminating the perverse financial incentives for hospitals and physicians to readmit patients. Payments are still episode-based and reward readmissions. The $280 million that CMS expects to receive from the program this year covers less than 5% of the nearly $12 billion attributed to preventable rehospitalizations.11
WHAT PATIENTS NEED, NOT WHAT SUITS PROVIDERS
Hospital readmission rates are publicly reported, but it is shortsighted to think about readmissions outside of the broader context of the “medical home.” One must consider the role of primary care providers before and after an index admission in addition to the role of postacute care providers for some patients after discharge. Neither is directly affected by the current penalty program, but both are critical to effective solutions and optimizing value-oriented care.
Readmission rates are suboptimal measures, as they address presumed failures of hospital transitions rather than measuring care coordination and providing meaningful incentives to coordinate care. Yes, there is much to do to ensure effective transitions from the hospital to home or postacute settings. But to truly transform health care and deliver value, shouldn’t we strive to redesign the work flow around what patients need rather than what suits providers?
This effort should focus on managing the conditions that bring patients to the hospital. Medical homes and optimizing chronic disease care can play pivotal roles in improving quality and reducing costs. Coordination of care and disease-management programs have led to cost reductions of 30% or more12 and have reduced admission rates by more than 10%.13 While the nation waits for health care reimbursement models to better reward patient quality outcomes and population health while reducing costs, we can use measures such as the Agency for Healthcare Research and Quality’s Prevention Quality Indicators to identify early interventions in the ambulatory care setting that can prevent admissions, complications, and exacerbation of disease.
Payers should also experiment with and promote innovative bundled-payment models such as Geisinger Health System’s ProvenCare program, which sets a fixed price for surgical procedures and up to 90 days of posthospital care, including readmission. These warranty-like programs overcome financial incentives to readmit patients in Medicare’s volume-based diagnosis-related group payment system.5
Re-engineering the delivery of care requires realigning resources to improve efficiency and effectiveness. In the short term, hospitals that successfully reduce readmission rates can expect reduced net reimbursements, as the penalties currently do not exceed the lost revenue of readmissions.
Reducing preventable readmissions is the right thing to do, but not all hospitalizations and rehospitalizations are avoidable. Many readmissions reflect appropriate and necessary care. The relentless focus on the readmission rate diverts attention and resources from more proactive solutions and innovative approaches for increasing health care safety, quality outcomes, and value.
Hospitals are caught between the volume and value paradigms. Payment programs that reward proactive disease management and care coordination will do the most to reduce health care costs and improve the quality of care. Hospitals have a responsibility to efficiently and effectively manage acute care and optimize handoffs to the next provider. Medicare’s payment policies do not do enough today to align the financial and quality-of-care incentives.
In this issue of the Cleveland Clinic Journal of Medicine, Drs. Ayache, Boyaji, and Pile share evidence-based strategies for reducing the risk of readmission for patients with acute exacerbations of chronic obstructive pulmonary disease (COPD).1 They emphasize standardizing practice by combining effective clinical management with appropriate patient education, communication, and postdischarge follow-up.
Reducing the rate of preventable hospital readmissions (as well as avoiding admissions in the first place) is the right thing to do for the patient. Moreover, broader adoption of the strategies that they outline in their article will be critical to the success of health care organizations in improving patient outcomes and navigating a rapidly evolving landscape of reimbursement and reporting changes associated with the Centers for Medicare and Medicaid Services (CMS) Readmissions Reduction Program. Hospital readmission rates, while imperfect measures of the quality of care, demonstrate opportunities to optimize transitions of care. Success in our efforts to improve the health of our patients will likely be aligned with reductions in preventable admissions and improved attention to care coordination.
HOSPITALS ARE PENALIZED FOR EXCESSIVE READMISSION RATES
With nearly 20% of Medicare beneficiaries being rehospitalized within 30 days of discharge, at a cost of $17 billion annually,2 Congress enacted the Hospital Readmissions Reduction Program3 as part of the Affordable Care Act (ACA) in 2012. The Centers for Medicare and Medicaid Services (CMS) had already been reporting the readmission rates for heart failure, acute myocardial infarction, and pneumonia since 2009 (www.medicare.gov/hospitalcompare). Building on this work, the Affordable Care Act implemented financial penalties against hospitals that had excessive rates of readmissions for these conditions.
The Affordable Care Act put 1% of a hospital’s Medicare base payment at risk for all inpatient diagnoses in 2013—not just the three listed here. The risk is 2% in 2014 and will rise to 3% in 2015. In its first year, more than 2,200 United States hospitals were penalized a total of approximately $280 million because of readmission rates above the national mean. Nearly 10% of hospitals incurred the maximum 1% penalty, and about 30% paid no penalty.
The Secretary of the Department of Health and Human Services has the authority to extend the Readmissions Reduction Program to additional high-volume or high-expenditure conditions, and the department has announced it will expand the program in October 2014 (fiscal year 2015) to include two additional conditions: elective hip or knee replacement and COPD.4 In both cases, CMS began by publicly reporting these rates before including them in the program. Additional readmission measures, including those for stroke and hospital-wide all-cause readmissions, are also publicly reported and receive increased attention but are not yet included in the Readmissions Reduction Program.
UNFAIRLY PENALIZING THOSE THAT SERVE THE POOR
Avoidable causes of readmissions include hospital-acquired infections and complications, inadequate medication reconciliation and management, poor communication and coordination of care among the members of the health care team, and suboptimal care transitions.5 But other important drivers of readmissions are outside of a hospital’s direct control. These include mental illness, lack of social support, and poverty.6
A criticism of the Readmissions Reduction Program is that it disproportionately penalizes hospitals that serve the poorest patients.7 Currently, CMS readmission risk models do not adjust for socioeconomic factors. Further, CMS responds to these concerns by noting that it does not want different outcome standards for poor patients, and that adjusting for these factors may conceal potential health care disparities in disadvantaged populations.
NEW MISSION FOR HOSPITALS: MITIGATE SOCIOECONOMIC BARRIERS
Effective programs to reduce hospital readmissions must address the clinical interventions and patient education needs in the COPD discharge checklist discussed by Ayache et al, but must also attempt to mitigate social disadvantages that drive up readmissions for patients at highest risk.
Are hospitals in a position to do this? Too often, it is assumed that patients have access to medications, transportation to follow-up appointments, and social support. Early identification of patients at highest risk of being affected by lack of these factors and innovative solutions for mitigating these risks are important considerations in our efforts to reduce hospital readmissions.
HOW MANY READMISSIONS ARE TRULY PREVENTABLE?
Experts disagree on how many readmissions are truly preventable. Readmission rates for the sickest patients treated at tertiary or academic medical centers may reflect high-quality care in well-managed patients who otherwise would have died during the index admission.8
In early studies, the Medicare Payment Advisory Commission estimated that up to three-quarters of readmissions are preventable.9 In contrast, studies that used clinical instead of administrative data suggest preventable readmissions make up as little as 12% of total readmissions.10
Regardless of the actual percentage, Medicare’s risk-adjustment model relies exclusively on administrative data that do not fully account for nonpreventable factors and do not completely address unrelated or planned rehospitalizations. CMS is attempting to address these issues with an expanded readmission algorithm that excludes more planned and unrelated readmissions from the penalty calculation.
Ironically, the current structure of the Readmissions Reduction Program does little to address its intended goal of eliminating the perverse financial incentives for hospitals and physicians to readmit patients. Payments are still episode-based and reward readmissions. The $280 million that CMS expects to receive from the program this year covers less than 5% of the nearly $12 billion attributed to preventable rehospitalizations.11
WHAT PATIENTS NEED, NOT WHAT SUITS PROVIDERS
Hospital readmission rates are publicly reported, but it is shortsighted to think about readmissions outside of the broader context of the “medical home.” One must consider the role of primary care providers before and after an index admission in addition to the role of postacute care providers for some patients after discharge. Neither is directly affected by the current penalty program, but both are critical to effective solutions and optimizing value-oriented care.
Readmission rates are suboptimal measures, as they address presumed failures of hospital transitions rather than measuring care coordination and providing meaningful incentives to coordinate care. Yes, there is much to do to ensure effective transitions from the hospital to home or postacute settings. But to truly transform health care and deliver value, shouldn’t we strive to redesign the work flow around what patients need rather than what suits providers?
This effort should focus on managing the conditions that bring patients to the hospital. Medical homes and optimizing chronic disease care can play pivotal roles in improving quality and reducing costs. Coordination of care and disease-management programs have led to cost reductions of 30% or more12 and have reduced admission rates by more than 10%.13 While the nation waits for health care reimbursement models to better reward patient quality outcomes and population health while reducing costs, we can use measures such as the Agency for Healthcare Research and Quality’s Prevention Quality Indicators to identify early interventions in the ambulatory care setting that can prevent admissions, complications, and exacerbation of disease.
Payers should also experiment with and promote innovative bundled-payment models such as Geisinger Health System’s ProvenCare program, which sets a fixed price for surgical procedures and up to 90 days of posthospital care, including readmission. These warranty-like programs overcome financial incentives to readmit patients in Medicare’s volume-based diagnosis-related group payment system.5
Re-engineering the delivery of care requires realigning resources to improve efficiency and effectiveness. In the short term, hospitals that successfully reduce readmission rates can expect reduced net reimbursements, as the penalties currently do not exceed the lost revenue of readmissions.
Reducing preventable readmissions is the right thing to do, but not all hospitalizations and rehospitalizations are avoidable. Many readmissions reflect appropriate and necessary care. The relentless focus on the readmission rate diverts attention and resources from more proactive solutions and innovative approaches for increasing health care safety, quality outcomes, and value.
Hospitals are caught between the volume and value paradigms. Payment programs that reward proactive disease management and care coordination will do the most to reduce health care costs and improve the quality of care. Hospitals have a responsibility to efficiently and effectively manage acute care and optimize handoffs to the next provider. Medicare’s payment policies do not do enough today to align the financial and quality-of-care incentives.
- Ayache MB, Boyaji S, Pile J. Can we reduce the risk of readmission for a patient with an exacerbation of COPD? Cleve Clin J Med 2014; 81:525–527.
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med 2009; 360:1418–1428.
- Department of Health and Human Services. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2012 Rates; Hospitals’ FTE Resident Caps for Graduate Medical Education Payment; Final Rule. Federal Register 2011; 76:51475–51846. www.gpo.gov/fdsys/pkg/FR-2011-08-18/pdf/2011-19719.pdf. Accessed August 5, 2014.
- Department of Health and Human Services. Medicare program; hospital inpatient prospective payment systems for acute care hospitals and the long term care; hospital prospective payment system and fiscal year 2014 rates; quality reporting requirements for specific providers; hospital conditions of participation; payment policies related to patient status; final rule. Federal Register 2013; 78:50495–51040. www.gpo.gov/fdsys/pkg/FR-2013-08-19/pdf/2013-18956.pdf. Accessed August 5, 2014.
- Berenson RA, Paulus RA, Kalman NS. Medicare’s readmissions-reduction program—a positive alternative. N Engl J Med 2012; 366:1364–1366.
- Joynt KE, Jha AK. Thirty-day readmissions—truth and consequences. N Engl J Med 2012; 366:1366–1369.
- Rau J. Medicare to penalize 2,217 hospitals for excess readmissions. Kaiser Health News 2012. www.kaiserhealthnews.org/stories/2012/august/13/medicare-hospitals-readmissions-penalties.aspx. Accessed August 5, 2014.
- Gorodeski EZ, Starling RC, Blackstone EH. Are all readmissions bad readmissions? N Engl J Med 2010; 363:297–298.
- Medicare Payment Advisory Commission. Report to the Congress: Promoting Greater Efficiency in Medicare, June 2007. www.medpac.gov/documents/jun07_entirereport.pdf. Accessed August 5, 2014.
- van Walraven C, Bennett C, Jennings A, Austin PC, Forster AJ. Proportion of hospital readmissions deemed avoidable: a systematic review. CMAJ 2011; 183:E391–E402.
- CMS Fee For Service IPPS Payment File, Fiscal Year 2014. cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Downloads/FY_14_FR_Impact_File.zip. Accessed August 5, 2014.
- Dartmouth Medical School Center for the Evaluative Clinical Sciences. The Dartmouth Atlas of Health Care, 2006. www.dartmouthat-las.org/downloads/atlases/2006_Chronic_Care_Atlas.pdf. Accessed August 5, 2014.
- Gold W, Kongstvedt P. How broadening DM’s focus helped shrink one plan’s costs. Managed Care 2003. www.managedcaremag.com/archives/0311/0311.minnesota.html. Accessed August 5, 2014.
- Ayache MB, Boyaji S, Pile J. Can we reduce the risk of readmission for a patient with an exacerbation of COPD? Cleve Clin J Med 2014; 81:525–527.
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med 2009; 360:1418–1428.
- Department of Health and Human Services. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2012 Rates; Hospitals’ FTE Resident Caps for Graduate Medical Education Payment; Final Rule. Federal Register 2011; 76:51475–51846. www.gpo.gov/fdsys/pkg/FR-2011-08-18/pdf/2011-19719.pdf. Accessed August 5, 2014.
- Department of Health and Human Services. Medicare program; hospital inpatient prospective payment systems for acute care hospitals and the long term care; hospital prospective payment system and fiscal year 2014 rates; quality reporting requirements for specific providers; hospital conditions of participation; payment policies related to patient status; final rule. Federal Register 2013; 78:50495–51040. www.gpo.gov/fdsys/pkg/FR-2013-08-19/pdf/2013-18956.pdf. Accessed August 5, 2014.
- Berenson RA, Paulus RA, Kalman NS. Medicare’s readmissions-reduction program—a positive alternative. N Engl J Med 2012; 366:1364–1366.
- Joynt KE, Jha AK. Thirty-day readmissions—truth and consequences. N Engl J Med 2012; 366:1366–1369.
- Rau J. Medicare to penalize 2,217 hospitals for excess readmissions. Kaiser Health News 2012. www.kaiserhealthnews.org/stories/2012/august/13/medicare-hospitals-readmissions-penalties.aspx. Accessed August 5, 2014.
- Gorodeski EZ, Starling RC, Blackstone EH. Are all readmissions bad readmissions? N Engl J Med 2010; 363:297–298.
- Medicare Payment Advisory Commission. Report to the Congress: Promoting Greater Efficiency in Medicare, June 2007. www.medpac.gov/documents/jun07_entirereport.pdf. Accessed August 5, 2014.
- van Walraven C, Bennett C, Jennings A, Austin PC, Forster AJ. Proportion of hospital readmissions deemed avoidable: a systematic review. CMAJ 2011; 183:E391–E402.
- CMS Fee For Service IPPS Payment File, Fiscal Year 2014. cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Downloads/FY_14_FR_Impact_File.zip. Accessed August 5, 2014.
- Dartmouth Medical School Center for the Evaluative Clinical Sciences. The Dartmouth Atlas of Health Care, 2006. www.dartmouthat-las.org/downloads/atlases/2006_Chronic_Care_Atlas.pdf. Accessed August 5, 2014.
- Gold W, Kongstvedt P. How broadening DM’s focus helped shrink one plan’s costs. Managed Care 2003. www.managedcaremag.com/archives/0311/0311.minnesota.html. Accessed August 5, 2014.
Aggression and angry outbursts
Introduction
Aggressive behavior is one of the most common child psychiatric symptoms for which parents seek help. The difficulty with managing aggressive behavior is determining whether it is out of the ordinary from typical child development and then assessing the causes of the behavior before tackling the tough job of intervening. The following case is typical of what might present to the pediatrics office and provides a few ideas for the assessment and management of aggressive behavior.
Case summary
Dakota is a 6-year-old boy who presents for a well-child check with his father, Joe. Dakota is just finishing his kindergarten year, and the teachers have expressed concerns about his behavior in the classroom and on the playground. They note that he is often irritable and touchy, and that he will frequently have aggressive outbursts, particularly when asked to do something that he doesn’t like. He will often interrupt other children’s games, and will force children to play by his rules with a threat of, or occasional use of, hitting. In the classroom, he has been removed multiple times to the principal’s office, where he will go only with marked reluctance. He has been noted by his teachers to have difficulty attending to the classroom instructions, and frequently removes himself during circle time. They allow him to do this to avoid a power struggle. Similarly, Joe notes that the entire family is "walking on eggshells" because they never know what might set him off. They’ve tried "everything," including time out, sticker charts, and spanking, but with little effect. Joe says that he was "just like Dakota" when he was a child, and that he was "straightened out" in the Army. He wonders if some kind of boot camp or "scared straight" program would help Dakota learn his lesson.
Discussion
Diagnosis. Irritability and aggression are common manifestations of multiple child psychiatric conditions. While it’s easy to jump to the conclusion that the patient has oppositional-defiant disorder (ODD) or conduct disorder (CD) and move straight to treatment, care must be taken to evaluate common causes and co-occurring disorders that might change the treatment plan.
The differential diagnosis includes a primary mood disorder like depression, other disruptive behavior disorders such as attention-deficit/hyperactivity disorder (ADHD), a primary anxiety disorder, posttraumatic stress disorder, a learning or language disorder, and/or intellectual disability. One also must determine whether the aggression exhibited is greater than that shown by other boys his age. For this reason, the use of a scale that has normative values by age and sex makes sense. Having a standardized instrument filled out by parents and by the teachers also will help give an indication of how he is performing in multiple settings. Using a broad-based instrument that also covers mood, anxiety, and attention problems can be a quick and useful way to examine what type of co-occurring symptoms are present.
Aggression, while a heritable trait, also has a significant component from the environment. It is important to see how much of the aggression is being "caught, not taught" in the family setting. Querying as to the general level of negative, coercive parenting can be performed quickly by asking for a description of how the last outburst was managed – what the precipitant, the course, and the outcome were. Frequently, with ODD in particular, you will find a cycle of escalating threats and illogical consequences that serve to reinforce, rather than to reduce, aggressive and oppositional behavior. Practically, while the busy pediatrician may be able to manage some of this screening in a well-child check, it is likely that a separate appointment will be needed to go over the results of the screening instruments and to more fully assess the parenting environment.
At the scheduled visit designed to specifically assess the aggression:
• Make sure that both the parents and the child see this as a family-based problem. A treatment alliance with both parties is necessary to get the buy-in for any type of intervention that will occur.
• Assess the level of impairment. Are these outbursts severe only at home? In the school setting? With other people such as coaches or health care providers?
• Review the broadband screening instruments from multiple settings to make sure that this is a primary disruptive behavior disorder and not something else, particularly ADHD or a mood disorder, which will need to be managed differently.
• Determine if the aggressive behavior is impulsive/reactive or if it is planned/predatory. Is there remorse afterward (about the action, as opposed to remorse about being caught)? Lack of remorse could be an indicator of callous-unemotional traits, which have a worse prognosis.
Pearl: When asking about aggressive outbursts, make sure to concentrate not just on the outburst, but on the behavior and mood between outbursts. If the mood between outbursts is chronically irritable or sad, this might indicate a mood disorder rather than a primary disruptive behavior disorder.
Treatment. Treatment for aggressive behavior really calls for an "all hands on deck" family-based intervention. Parenting interventions will work best when the parents themselves are as healthy as they can be. Working with them to ensure that aggressive behavior, substance abuse, or anxiety is adequately treated through referral is an important step.
Next, the parenting interventions should involve those best informed by evidence-based practice, which typically include components of reducing the cycle of reinforcing aggressive behavior, noticing and rewarding prosocial behavior, and ceasing corporal punishment and replacing it with predictable, logical consequences for aggressive behavior. There are several excellent programs that therapists can use with parents, and referring to a therapist working with an evidence-based treatment program makes sense. There is a table listing parent management training packages that can be found in the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for ODD (J. Am. Acad. Child. Adolesc. Psychiatry 2007;46:126-41).
Wellness interventions such as ensuring hydration and adequate caloric intake can make a difference in the management of aggression. It’s harder to maintain control when you are concentrating on the grumbling of your stomach. Further, using exercise and sports as an intervention allows children to channel some of their negative aggressive impulses into positive, prosocial activities.
Pharmacotherapy is not indicated for ODD or CD, except to target co-occurring symptoms. For example, treatment of ADHD or anxiety can quite successfully reduce impulsive or reactive aggression, and can make it easier to treat the ODD or CD through parent management techniques. In very severe cases of aggression, treatment with other agents such as mood stabilizers or antipsychotics might be indicated, but this would likely be implemented only in consultation with a child and adolescent psychiatrist.
Finally, there is little to no evidence for a mock incarceration or boot camp approach with children who exhibit oppositional behavior. In fact, it’s very possible that these kinds of programs can make the behaviors worse (J. Am. Acad. Child Adolesc. Psychiatry 1999;38:1320-1; "Aggression and Antisocial Behavior in Children and Adolescents: Research and Treatment" [New York: The Guilford Press, 2002]).
When to consult? Uncomplicated aggressive behavior can be managed by the primary care team with consultation from a therapist using evidence-based approaches. If there is poor treatment response, or if the aggression is severe enough to cause serious physical injury, or if there is concern for a cycling mood disorder (such as bipolar disorder – a topic for a later column), then consultation with a child psychiatrist is likely appropriate.
Dr. Althoff is an associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Dr. Althoff has received grants/research support from the National Institute of Mental Health, the National Institute of General Medical Sciences, and the Klingenstein Third Generation Foundation, and honoraria from the Oakstone General Publishing for CME presentations.
Introduction
Aggressive behavior is one of the most common child psychiatric symptoms for which parents seek help. The difficulty with managing aggressive behavior is determining whether it is out of the ordinary from typical child development and then assessing the causes of the behavior before tackling the tough job of intervening. The following case is typical of what might present to the pediatrics office and provides a few ideas for the assessment and management of aggressive behavior.
Case summary
Dakota is a 6-year-old boy who presents for a well-child check with his father, Joe. Dakota is just finishing his kindergarten year, and the teachers have expressed concerns about his behavior in the classroom and on the playground. They note that he is often irritable and touchy, and that he will frequently have aggressive outbursts, particularly when asked to do something that he doesn’t like. He will often interrupt other children’s games, and will force children to play by his rules with a threat of, or occasional use of, hitting. In the classroom, he has been removed multiple times to the principal’s office, where he will go only with marked reluctance. He has been noted by his teachers to have difficulty attending to the classroom instructions, and frequently removes himself during circle time. They allow him to do this to avoid a power struggle. Similarly, Joe notes that the entire family is "walking on eggshells" because they never know what might set him off. They’ve tried "everything," including time out, sticker charts, and spanking, but with little effect. Joe says that he was "just like Dakota" when he was a child, and that he was "straightened out" in the Army. He wonders if some kind of boot camp or "scared straight" program would help Dakota learn his lesson.
Discussion
Diagnosis. Irritability and aggression are common manifestations of multiple child psychiatric conditions. While it’s easy to jump to the conclusion that the patient has oppositional-defiant disorder (ODD) or conduct disorder (CD) and move straight to treatment, care must be taken to evaluate common causes and co-occurring disorders that might change the treatment plan.
The differential diagnosis includes a primary mood disorder like depression, other disruptive behavior disorders such as attention-deficit/hyperactivity disorder (ADHD), a primary anxiety disorder, posttraumatic stress disorder, a learning or language disorder, and/or intellectual disability. One also must determine whether the aggression exhibited is greater than that shown by other boys his age. For this reason, the use of a scale that has normative values by age and sex makes sense. Having a standardized instrument filled out by parents and by the teachers also will help give an indication of how he is performing in multiple settings. Using a broad-based instrument that also covers mood, anxiety, and attention problems can be a quick and useful way to examine what type of co-occurring symptoms are present.
Aggression, while a heritable trait, also has a significant component from the environment. It is important to see how much of the aggression is being "caught, not taught" in the family setting. Querying as to the general level of negative, coercive parenting can be performed quickly by asking for a description of how the last outburst was managed – what the precipitant, the course, and the outcome were. Frequently, with ODD in particular, you will find a cycle of escalating threats and illogical consequences that serve to reinforce, rather than to reduce, aggressive and oppositional behavior. Practically, while the busy pediatrician may be able to manage some of this screening in a well-child check, it is likely that a separate appointment will be needed to go over the results of the screening instruments and to more fully assess the parenting environment.
At the scheduled visit designed to specifically assess the aggression:
• Make sure that both the parents and the child see this as a family-based problem. A treatment alliance with both parties is necessary to get the buy-in for any type of intervention that will occur.
• Assess the level of impairment. Are these outbursts severe only at home? In the school setting? With other people such as coaches or health care providers?
• Review the broadband screening instruments from multiple settings to make sure that this is a primary disruptive behavior disorder and not something else, particularly ADHD or a mood disorder, which will need to be managed differently.
• Determine if the aggressive behavior is impulsive/reactive or if it is planned/predatory. Is there remorse afterward (about the action, as opposed to remorse about being caught)? Lack of remorse could be an indicator of callous-unemotional traits, which have a worse prognosis.
Pearl: When asking about aggressive outbursts, make sure to concentrate not just on the outburst, but on the behavior and mood between outbursts. If the mood between outbursts is chronically irritable or sad, this might indicate a mood disorder rather than a primary disruptive behavior disorder.
Treatment. Treatment for aggressive behavior really calls for an "all hands on deck" family-based intervention. Parenting interventions will work best when the parents themselves are as healthy as they can be. Working with them to ensure that aggressive behavior, substance abuse, or anxiety is adequately treated through referral is an important step.
Next, the parenting interventions should involve those best informed by evidence-based practice, which typically include components of reducing the cycle of reinforcing aggressive behavior, noticing and rewarding prosocial behavior, and ceasing corporal punishment and replacing it with predictable, logical consequences for aggressive behavior. There are several excellent programs that therapists can use with parents, and referring to a therapist working with an evidence-based treatment program makes sense. There is a table listing parent management training packages that can be found in the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for ODD (J. Am. Acad. Child. Adolesc. Psychiatry 2007;46:126-41).
Wellness interventions such as ensuring hydration and adequate caloric intake can make a difference in the management of aggression. It’s harder to maintain control when you are concentrating on the grumbling of your stomach. Further, using exercise and sports as an intervention allows children to channel some of their negative aggressive impulses into positive, prosocial activities.
Pharmacotherapy is not indicated for ODD or CD, except to target co-occurring symptoms. For example, treatment of ADHD or anxiety can quite successfully reduce impulsive or reactive aggression, and can make it easier to treat the ODD or CD through parent management techniques. In very severe cases of aggression, treatment with other agents such as mood stabilizers or antipsychotics might be indicated, but this would likely be implemented only in consultation with a child and adolescent psychiatrist.
Finally, there is little to no evidence for a mock incarceration or boot camp approach with children who exhibit oppositional behavior. In fact, it’s very possible that these kinds of programs can make the behaviors worse (J. Am. Acad. Child Adolesc. Psychiatry 1999;38:1320-1; "Aggression and Antisocial Behavior in Children and Adolescents: Research and Treatment" [New York: The Guilford Press, 2002]).
When to consult? Uncomplicated aggressive behavior can be managed by the primary care team with consultation from a therapist using evidence-based approaches. If there is poor treatment response, or if the aggression is severe enough to cause serious physical injury, or if there is concern for a cycling mood disorder (such as bipolar disorder – a topic for a later column), then consultation with a child psychiatrist is likely appropriate.
Dr. Althoff is an associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Dr. Althoff has received grants/research support from the National Institute of Mental Health, the National Institute of General Medical Sciences, and the Klingenstein Third Generation Foundation, and honoraria from the Oakstone General Publishing for CME presentations.
Introduction
Aggressive behavior is one of the most common child psychiatric symptoms for which parents seek help. The difficulty with managing aggressive behavior is determining whether it is out of the ordinary from typical child development and then assessing the causes of the behavior before tackling the tough job of intervening. The following case is typical of what might present to the pediatrics office and provides a few ideas for the assessment and management of aggressive behavior.
Case summary
Dakota is a 6-year-old boy who presents for a well-child check with his father, Joe. Dakota is just finishing his kindergarten year, and the teachers have expressed concerns about his behavior in the classroom and on the playground. They note that he is often irritable and touchy, and that he will frequently have aggressive outbursts, particularly when asked to do something that he doesn’t like. He will often interrupt other children’s games, and will force children to play by his rules with a threat of, or occasional use of, hitting. In the classroom, he has been removed multiple times to the principal’s office, where he will go only with marked reluctance. He has been noted by his teachers to have difficulty attending to the classroom instructions, and frequently removes himself during circle time. They allow him to do this to avoid a power struggle. Similarly, Joe notes that the entire family is "walking on eggshells" because they never know what might set him off. They’ve tried "everything," including time out, sticker charts, and spanking, but with little effect. Joe says that he was "just like Dakota" when he was a child, and that he was "straightened out" in the Army. He wonders if some kind of boot camp or "scared straight" program would help Dakota learn his lesson.
Discussion
Diagnosis. Irritability and aggression are common manifestations of multiple child psychiatric conditions. While it’s easy to jump to the conclusion that the patient has oppositional-defiant disorder (ODD) or conduct disorder (CD) and move straight to treatment, care must be taken to evaluate common causes and co-occurring disorders that might change the treatment plan.
The differential diagnosis includes a primary mood disorder like depression, other disruptive behavior disorders such as attention-deficit/hyperactivity disorder (ADHD), a primary anxiety disorder, posttraumatic stress disorder, a learning or language disorder, and/or intellectual disability. One also must determine whether the aggression exhibited is greater than that shown by other boys his age. For this reason, the use of a scale that has normative values by age and sex makes sense. Having a standardized instrument filled out by parents and by the teachers also will help give an indication of how he is performing in multiple settings. Using a broad-based instrument that also covers mood, anxiety, and attention problems can be a quick and useful way to examine what type of co-occurring symptoms are present.
Aggression, while a heritable trait, also has a significant component from the environment. It is important to see how much of the aggression is being "caught, not taught" in the family setting. Querying as to the general level of negative, coercive parenting can be performed quickly by asking for a description of how the last outburst was managed – what the precipitant, the course, and the outcome were. Frequently, with ODD in particular, you will find a cycle of escalating threats and illogical consequences that serve to reinforce, rather than to reduce, aggressive and oppositional behavior. Practically, while the busy pediatrician may be able to manage some of this screening in a well-child check, it is likely that a separate appointment will be needed to go over the results of the screening instruments and to more fully assess the parenting environment.
At the scheduled visit designed to specifically assess the aggression:
• Make sure that both the parents and the child see this as a family-based problem. A treatment alliance with both parties is necessary to get the buy-in for any type of intervention that will occur.
• Assess the level of impairment. Are these outbursts severe only at home? In the school setting? With other people such as coaches or health care providers?
• Review the broadband screening instruments from multiple settings to make sure that this is a primary disruptive behavior disorder and not something else, particularly ADHD or a mood disorder, which will need to be managed differently.
• Determine if the aggressive behavior is impulsive/reactive or if it is planned/predatory. Is there remorse afterward (about the action, as opposed to remorse about being caught)? Lack of remorse could be an indicator of callous-unemotional traits, which have a worse prognosis.
Pearl: When asking about aggressive outbursts, make sure to concentrate not just on the outburst, but on the behavior and mood between outbursts. If the mood between outbursts is chronically irritable or sad, this might indicate a mood disorder rather than a primary disruptive behavior disorder.
Treatment. Treatment for aggressive behavior really calls for an "all hands on deck" family-based intervention. Parenting interventions will work best when the parents themselves are as healthy as they can be. Working with them to ensure that aggressive behavior, substance abuse, or anxiety is adequately treated through referral is an important step.
Next, the parenting interventions should involve those best informed by evidence-based practice, which typically include components of reducing the cycle of reinforcing aggressive behavior, noticing and rewarding prosocial behavior, and ceasing corporal punishment and replacing it with predictable, logical consequences for aggressive behavior. There are several excellent programs that therapists can use with parents, and referring to a therapist working with an evidence-based treatment program makes sense. There is a table listing parent management training packages that can be found in the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for ODD (J. Am. Acad. Child. Adolesc. Psychiatry 2007;46:126-41).
Wellness interventions such as ensuring hydration and adequate caloric intake can make a difference in the management of aggression. It’s harder to maintain control when you are concentrating on the grumbling of your stomach. Further, using exercise and sports as an intervention allows children to channel some of their negative aggressive impulses into positive, prosocial activities.
Pharmacotherapy is not indicated for ODD or CD, except to target co-occurring symptoms. For example, treatment of ADHD or anxiety can quite successfully reduce impulsive or reactive aggression, and can make it easier to treat the ODD or CD through parent management techniques. In very severe cases of aggression, treatment with other agents such as mood stabilizers or antipsychotics might be indicated, but this would likely be implemented only in consultation with a child and adolescent psychiatrist.
Finally, there is little to no evidence for a mock incarceration or boot camp approach with children who exhibit oppositional behavior. In fact, it’s very possible that these kinds of programs can make the behaviors worse (J. Am. Acad. Child Adolesc. Psychiatry 1999;38:1320-1; "Aggression and Antisocial Behavior in Children and Adolescents: Research and Treatment" [New York: The Guilford Press, 2002]).
When to consult? Uncomplicated aggressive behavior can be managed by the primary care team with consultation from a therapist using evidence-based approaches. If there is poor treatment response, or if the aggression is severe enough to cause serious physical injury, or if there is concern for a cycling mood disorder (such as bipolar disorder – a topic for a later column), then consultation with a child psychiatrist is likely appropriate.
Dr. Althoff is an associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Dr. Althoff has received grants/research support from the National Institute of Mental Health, the National Institute of General Medical Sciences, and the Klingenstein Third Generation Foundation, and honoraria from the Oakstone General Publishing for CME presentations.
Big Data: The Paradigm Shift Needed to Revolutionize Musculoskeletal Clinical Research
One year ago, we wrote an editorial in The American Journal of Orthopedics on missing data.1 This year, data is once again the focus of our editorial but from a
different perspective. Rather than focus on the problems of incomplete data, we want to talk about the possibilities of collecting all data through advanced technology, a phenomenon better known as “Big Data.”
New Technology
The factors driving Big Data’s ascendency are the digitalization of useful data, increased means to gather digitalized data, and cheaper analytic power.2 Computer behemoth IBM claims that 90% of the data in the world today has been created in the last 2 years alone.3 Big Data is not just an industry buzzword; it is already an industry in itself. Revenue from Big Data reached $18 billion in 2013 and is predicted to rise to $50 billion in the next 5 years.4 While it is easy to see how Internet companies like Amazon can both collect and use all of the data they receive from customers (to suggest their next purchase, for example), it might be less easy to see how Big Data concepts can be applied to clinical research.
Health Care
Electronic data records are propelling the development of pools of information in health care. Almost half of all hospitals in the United States are participating in health information exchanges (HIEs).5 When these sources of data pools are integrated, the information collected can be used in a powerful way. For example, the health maintenance organization Kaiser Permanente uses a new computer system that drives data exchange between medical facilities. Patient benefits include improved outcomes of cardiovascular disease, and an estimated $1 billion has been saved due to reduced office visits and laboratory tests.5
Contemporary Studies
Let’s quickly consider how we currently conduct clinical studies. Because we do not usually collect data from the entire population, contemporary clinical studies offer only a snapshot of a subsection of patients. The results from this sample are then usually extrapolated to the general population. This was fine when there were insurmountable technological and logistical issues. So instead of trying to
collect data from everyone in the population of interest, we select a sample of patients and expend our energy on controlling for the suboptimal methods we currently employ, techniques which are the best ones available to us.
What are the consequences of all this? Those of us in clinical research are usually very concerned about dealing with confounding factors: selection bias, adjusting for missing data, controlling for errors, and so on. We can also see how imprecise our current methods are by how often a scientific manuscript ends with a call for larger-scale research. Indeed, a scientific research paper that does not list the study’s limitations is often regarded with suspicion, a telling indictment of the problems we expect to encounter in clinical research.
So what has historically been the best current solution to overcome these challenges? A meta-analysis of randomized controlled trials sits atop the evidence pyramid as being the best level of evidence. However, even the use of meta-analyses can be problematic. One group of researchers found that in 2005 and 2008, respectively, 18% and 30% of orthopedic meta-analyses had major to extensive flaws in their methodology.6 Indeed, implicit in the use of a meta-analysis is a criticism that our current studies with their limited sample sizes do not tell the whole story.
Paradigm Shift
We are in the middle of a paradigm shift in the way we can collect and analyze data. Our focus until now has been on identifying a causal relationship in our studies. New technology which allows for large-scale data collection and analysis means that we can now collect ALL patient data, in other words N = all. When you can collect all data, the why (causality) something is happening becomes less
important than the what (correlation) is happening.7 Studies will therefore begin to focus on effectiveness in the real world as opposed to measurements taken under the ideal (or nearly ideal) conditions of efficacy.
All of this is going to have implications, the greatest of which is the change in mindset that we are going to have to go through. How we conduct our studies and what their focus is will both change and expand. For example, the Mini-Sentinel project uses preexisting electronic health care data from multiple sources to monitor the safety of medical products that are regulated by the US Food and
Drug Administration (FDA). This FDA-sponsored initiative, which only began in 2008, had already collected data on 178 million individuals by July 2014.8
Since we cannot ignore Big Data, we must do what we can to ensure that its potential is harnessed to reduce costs and improve patient outcomes. Given the potential of using electronic clinical data, it is also necessary to strike a note of caution. We have to keep uppermost in mind that new technologies like Big Data can unsettle a lot of people. A central tenet of clinical research is that patient data belong to the patient. Robust and transparent processes need to be developed to ensure that patients do not feel compromised in any way by their data being used in such new and widespread methods. The need to rethink and implement safeguards is already being addressed. For example, the university-associated Regenstrief Institute does not pass along even deidentified data to their Big Data industry partner.9
However, we need to also be cognizant of the fact that society is changing in the way people use and regard their own information. Patient-reported data is already being shared among patients online, for both common and rare diseases. The data are also richer and can go beyond the usual outcomes that are recorded to give a bigger picture, eg, why patients are not adhering to treatment regimens.10
In summary, it is our earnest belief that if the health care industry can embrace the concept of Big Data and utilize it properly, our patients and medical practices will be all the better for it.
References
1. Helfet DL, Hanson BP, De Faoite D. Publish or perish; but what, when,
and how? Am J Orthop. 2013;42(9):399-400.
2. Nash DB. Harnessing the power of big data in healthcare. Am Health
Drug Benefits. 2014;7(2):69-70.
3. What is big data? IBM website. http://www-01.ibm.com/software/data/
bigdata/what-is-big-data.html. Accessed July 22, 2014.
4. Upbin B. Visualizing the big data industrial complex. Forbes website.
http://www.forbes.com/sites/bruceupbin/2013/08/30/visualizing-thebig-
data-industrial-complex-infographic/. Published August 30, 2013. Accessed July 22, 2014.
5. Kayyali B, Knott D, Van Kuiken S. The big-data revolution in US health
care: accelerating value and innovation. McKinsey & Company website.
http://www.mckinsey.com/insights/health_systems_and_services/
the_big-data_revolution_in_us_health_care. Published January 2013.
Accessed July 22, 2014.
6. Dijkman BG, Abouali JA, Kooistra BW, et al. Twenty years of meta-analyses
in orthopaedic surgery: has quality kept up with quantity? J Bone Joint Surg Am. 2010;92(1):48-57.
7. Cukier K, Mayer-Schonberger V. Big Data: A Revolution That Will Transform
How We Live, Work, and Think. New York, NY: Eamon Dolan/Houghton Mifflin Harcourt; 2013.
8. Mini-Sentinel distributed data “at a glance.” Mini-Sentinel website.
http://www.mini-sentinel.org/about_us/MSDD_At-a-Glance.aspx. Accessed July 22, 2014.
9. Jain SH, Rosenblatt M, Duke J. Is big data the new frontier for academic-
industry collaboration? JAMA. 2014;311(21):2171-2172.
10. Okun S, McGraw D, Stang P, et al. Making the case for continuous
learning from routinely collected data. Institute of Medicine website.
http://www.iom.edu/Global/Perspectives/2013/~/media/Files/
Perspectives-Files/2013/Discussion-Papers/VSRT-MakingtheCase.pdf. Published April 15, 2013. Accessed July 22, 2014.
One year ago, we wrote an editorial in The American Journal of Orthopedics on missing data.1 This year, data is once again the focus of our editorial but from a
different perspective. Rather than focus on the problems of incomplete data, we want to talk about the possibilities of collecting all data through advanced technology, a phenomenon better known as “Big Data.”
New Technology
The factors driving Big Data’s ascendency are the digitalization of useful data, increased means to gather digitalized data, and cheaper analytic power.2 Computer behemoth IBM claims that 90% of the data in the world today has been created in the last 2 years alone.3 Big Data is not just an industry buzzword; it is already an industry in itself. Revenue from Big Data reached $18 billion in 2013 and is predicted to rise to $50 billion in the next 5 years.4 While it is easy to see how Internet companies like Amazon can both collect and use all of the data they receive from customers (to suggest their next purchase, for example), it might be less easy to see how Big Data concepts can be applied to clinical research.
Health Care
Electronic data records are propelling the development of pools of information in health care. Almost half of all hospitals in the United States are participating in health information exchanges (HIEs).5 When these sources of data pools are integrated, the information collected can be used in a powerful way. For example, the health maintenance organization Kaiser Permanente uses a new computer system that drives data exchange between medical facilities. Patient benefits include improved outcomes of cardiovascular disease, and an estimated $1 billion has been saved due to reduced office visits and laboratory tests.5
Contemporary Studies
Let’s quickly consider how we currently conduct clinical studies. Because we do not usually collect data from the entire population, contemporary clinical studies offer only a snapshot of a subsection of patients. The results from this sample are then usually extrapolated to the general population. This was fine when there were insurmountable technological and logistical issues. So instead of trying to
collect data from everyone in the population of interest, we select a sample of patients and expend our energy on controlling for the suboptimal methods we currently employ, techniques which are the best ones available to us.
What are the consequences of all this? Those of us in clinical research are usually very concerned about dealing with confounding factors: selection bias, adjusting for missing data, controlling for errors, and so on. We can also see how imprecise our current methods are by how often a scientific manuscript ends with a call for larger-scale research. Indeed, a scientific research paper that does not list the study’s limitations is often regarded with suspicion, a telling indictment of the problems we expect to encounter in clinical research.
So what has historically been the best current solution to overcome these challenges? A meta-analysis of randomized controlled trials sits atop the evidence pyramid as being the best level of evidence. However, even the use of meta-analyses can be problematic. One group of researchers found that in 2005 and 2008, respectively, 18% and 30% of orthopedic meta-analyses had major to extensive flaws in their methodology.6 Indeed, implicit in the use of a meta-analysis is a criticism that our current studies with their limited sample sizes do not tell the whole story.
Paradigm Shift
We are in the middle of a paradigm shift in the way we can collect and analyze data. Our focus until now has been on identifying a causal relationship in our studies. New technology which allows for large-scale data collection and analysis means that we can now collect ALL patient data, in other words N = all. When you can collect all data, the why (causality) something is happening becomes less
important than the what (correlation) is happening.7 Studies will therefore begin to focus on effectiveness in the real world as opposed to measurements taken under the ideal (or nearly ideal) conditions of efficacy.
All of this is going to have implications, the greatest of which is the change in mindset that we are going to have to go through. How we conduct our studies and what their focus is will both change and expand. For example, the Mini-Sentinel project uses preexisting electronic health care data from multiple sources to monitor the safety of medical products that are regulated by the US Food and
Drug Administration (FDA). This FDA-sponsored initiative, which only began in 2008, had already collected data on 178 million individuals by July 2014.8
Since we cannot ignore Big Data, we must do what we can to ensure that its potential is harnessed to reduce costs and improve patient outcomes. Given the potential of using electronic clinical data, it is also necessary to strike a note of caution. We have to keep uppermost in mind that new technologies like Big Data can unsettle a lot of people. A central tenet of clinical research is that patient data belong to the patient. Robust and transparent processes need to be developed to ensure that patients do not feel compromised in any way by their data being used in such new and widespread methods. The need to rethink and implement safeguards is already being addressed. For example, the university-associated Regenstrief Institute does not pass along even deidentified data to their Big Data industry partner.9
However, we need to also be cognizant of the fact that society is changing in the way people use and regard their own information. Patient-reported data is already being shared among patients online, for both common and rare diseases. The data are also richer and can go beyond the usual outcomes that are recorded to give a bigger picture, eg, why patients are not adhering to treatment regimens.10
In summary, it is our earnest belief that if the health care industry can embrace the concept of Big Data and utilize it properly, our patients and medical practices will be all the better for it.
References
1. Helfet DL, Hanson BP, De Faoite D. Publish or perish; but what, when,
and how? Am J Orthop. 2013;42(9):399-400.
2. Nash DB. Harnessing the power of big data in healthcare. Am Health
Drug Benefits. 2014;7(2):69-70.
3. What is big data? IBM website. http://www-01.ibm.com/software/data/
bigdata/what-is-big-data.html. Accessed July 22, 2014.
4. Upbin B. Visualizing the big data industrial complex. Forbes website.
http://www.forbes.com/sites/bruceupbin/2013/08/30/visualizing-thebig-
data-industrial-complex-infographic/. Published August 30, 2013. Accessed July 22, 2014.
5. Kayyali B, Knott D, Van Kuiken S. The big-data revolution in US health
care: accelerating value and innovation. McKinsey & Company website.
http://www.mckinsey.com/insights/health_systems_and_services/
the_big-data_revolution_in_us_health_care. Published January 2013.
Accessed July 22, 2014.
6. Dijkman BG, Abouali JA, Kooistra BW, et al. Twenty years of meta-analyses
in orthopaedic surgery: has quality kept up with quantity? J Bone Joint Surg Am. 2010;92(1):48-57.
7. Cukier K, Mayer-Schonberger V. Big Data: A Revolution That Will Transform
How We Live, Work, and Think. New York, NY: Eamon Dolan/Houghton Mifflin Harcourt; 2013.
8. Mini-Sentinel distributed data “at a glance.” Mini-Sentinel website.
http://www.mini-sentinel.org/about_us/MSDD_At-a-Glance.aspx. Accessed July 22, 2014.
9. Jain SH, Rosenblatt M, Duke J. Is big data the new frontier for academic-
industry collaboration? JAMA. 2014;311(21):2171-2172.
10. Okun S, McGraw D, Stang P, et al. Making the case for continuous
learning from routinely collected data. Institute of Medicine website.
http://www.iom.edu/Global/Perspectives/2013/~/media/Files/
Perspectives-Files/2013/Discussion-Papers/VSRT-MakingtheCase.pdf. Published April 15, 2013. Accessed July 22, 2014.
One year ago, we wrote an editorial in The American Journal of Orthopedics on missing data.1 This year, data is once again the focus of our editorial but from a
different perspective. Rather than focus on the problems of incomplete data, we want to talk about the possibilities of collecting all data through advanced technology, a phenomenon better known as “Big Data.”
New Technology
The factors driving Big Data’s ascendency are the digitalization of useful data, increased means to gather digitalized data, and cheaper analytic power.2 Computer behemoth IBM claims that 90% of the data in the world today has been created in the last 2 years alone.3 Big Data is not just an industry buzzword; it is already an industry in itself. Revenue from Big Data reached $18 billion in 2013 and is predicted to rise to $50 billion in the next 5 years.4 While it is easy to see how Internet companies like Amazon can both collect and use all of the data they receive from customers (to suggest their next purchase, for example), it might be less easy to see how Big Data concepts can be applied to clinical research.
Health Care
Electronic data records are propelling the development of pools of information in health care. Almost half of all hospitals in the United States are participating in health information exchanges (HIEs).5 When these sources of data pools are integrated, the information collected can be used in a powerful way. For example, the health maintenance organization Kaiser Permanente uses a new computer system that drives data exchange between medical facilities. Patient benefits include improved outcomes of cardiovascular disease, and an estimated $1 billion has been saved due to reduced office visits and laboratory tests.5
Contemporary Studies
Let’s quickly consider how we currently conduct clinical studies. Because we do not usually collect data from the entire population, contemporary clinical studies offer only a snapshot of a subsection of patients. The results from this sample are then usually extrapolated to the general population. This was fine when there were insurmountable technological and logistical issues. So instead of trying to
collect data from everyone in the population of interest, we select a sample of patients and expend our energy on controlling for the suboptimal methods we currently employ, techniques which are the best ones available to us.
What are the consequences of all this? Those of us in clinical research are usually very concerned about dealing with confounding factors: selection bias, adjusting for missing data, controlling for errors, and so on. We can also see how imprecise our current methods are by how often a scientific manuscript ends with a call for larger-scale research. Indeed, a scientific research paper that does not list the study’s limitations is often regarded with suspicion, a telling indictment of the problems we expect to encounter in clinical research.
So what has historically been the best current solution to overcome these challenges? A meta-analysis of randomized controlled trials sits atop the evidence pyramid as being the best level of evidence. However, even the use of meta-analyses can be problematic. One group of researchers found that in 2005 and 2008, respectively, 18% and 30% of orthopedic meta-analyses had major to extensive flaws in their methodology.6 Indeed, implicit in the use of a meta-analysis is a criticism that our current studies with their limited sample sizes do not tell the whole story.
Paradigm Shift
We are in the middle of a paradigm shift in the way we can collect and analyze data. Our focus until now has been on identifying a causal relationship in our studies. New technology which allows for large-scale data collection and analysis means that we can now collect ALL patient data, in other words N = all. When you can collect all data, the why (causality) something is happening becomes less
important than the what (correlation) is happening.7 Studies will therefore begin to focus on effectiveness in the real world as opposed to measurements taken under the ideal (or nearly ideal) conditions of efficacy.
All of this is going to have implications, the greatest of which is the change in mindset that we are going to have to go through. How we conduct our studies and what their focus is will both change and expand. For example, the Mini-Sentinel project uses preexisting electronic health care data from multiple sources to monitor the safety of medical products that are regulated by the US Food and
Drug Administration (FDA). This FDA-sponsored initiative, which only began in 2008, had already collected data on 178 million individuals by July 2014.8
Since we cannot ignore Big Data, we must do what we can to ensure that its potential is harnessed to reduce costs and improve patient outcomes. Given the potential of using electronic clinical data, it is also necessary to strike a note of caution. We have to keep uppermost in mind that new technologies like Big Data can unsettle a lot of people. A central tenet of clinical research is that patient data belong to the patient. Robust and transparent processes need to be developed to ensure that patients do not feel compromised in any way by their data being used in such new and widespread methods. The need to rethink and implement safeguards is already being addressed. For example, the university-associated Regenstrief Institute does not pass along even deidentified data to their Big Data industry partner.9
However, we need to also be cognizant of the fact that society is changing in the way people use and regard their own information. Patient-reported data is already being shared among patients online, for both common and rare diseases. The data are also richer and can go beyond the usual outcomes that are recorded to give a bigger picture, eg, why patients are not adhering to treatment regimens.10
In summary, it is our earnest belief that if the health care industry can embrace the concept of Big Data and utilize it properly, our patients and medical practices will be all the better for it.
References
1. Helfet DL, Hanson BP, De Faoite D. Publish or perish; but what, when,
and how? Am J Orthop. 2013;42(9):399-400.
2. Nash DB. Harnessing the power of big data in healthcare. Am Health
Drug Benefits. 2014;7(2):69-70.
3. What is big data? IBM website. http://www-01.ibm.com/software/data/
bigdata/what-is-big-data.html. Accessed July 22, 2014.
4. Upbin B. Visualizing the big data industrial complex. Forbes website.
http://www.forbes.com/sites/bruceupbin/2013/08/30/visualizing-thebig-
data-industrial-complex-infographic/. Published August 30, 2013. Accessed July 22, 2014.
5. Kayyali B, Knott D, Van Kuiken S. The big-data revolution in US health
care: accelerating value and innovation. McKinsey & Company website.
http://www.mckinsey.com/insights/health_systems_and_services/
the_big-data_revolution_in_us_health_care. Published January 2013.
Accessed July 22, 2014.
6. Dijkman BG, Abouali JA, Kooistra BW, et al. Twenty years of meta-analyses
in orthopaedic surgery: has quality kept up with quantity? J Bone Joint Surg Am. 2010;92(1):48-57.
7. Cukier K, Mayer-Schonberger V. Big Data: A Revolution That Will Transform
How We Live, Work, and Think. New York, NY: Eamon Dolan/Houghton Mifflin Harcourt; 2013.
8. Mini-Sentinel distributed data “at a glance.” Mini-Sentinel website.
http://www.mini-sentinel.org/about_us/MSDD_At-a-Glance.aspx. Accessed July 22, 2014.
9. Jain SH, Rosenblatt M, Duke J. Is big data the new frontier for academic-
industry collaboration? JAMA. 2014;311(21):2171-2172.
10. Okun S, McGraw D, Stang P, et al. Making the case for continuous
learning from routinely collected data. Institute of Medicine website.
http://www.iom.edu/Global/Perspectives/2013/~/media/Files/
Perspectives-Files/2013/Discussion-Papers/VSRT-MakingtheCase.pdf. Published April 15, 2013. Accessed July 22, 2014.
But I’m Sick! Where’s My Script?
The approach of fall brings changes in weather and the start of school and (often) new jobs—with the requisite associated illnesses. Exposure to new germs makes us vulnerable to “catching everything.” Prime candidates for this phenomenon are children just entering school, who are magnets for the myriad pathogens lurking in classrooms and are quite adept at carrying them home to “share” with the family! As a result, upper respiratory infections (URIs) are common at this time of year.
With symptoms ranging from rhinorrhea, pharyngitis, and cough to difficulty breathing and fatigue, URIs are among the most frequent reasons for visits to health care providers and a leading cause of missed school or work in the United States.1 The combination of bothersome symptoms and lost productivity is often the impetus for a request for antibiotics. Distressingly, these requests all too frequently result in unnecessary—and inappropriate—prescriptions.
Why is this a big deal? According to the World Health Organization, bacterial infections, including respiratory tract and hospital-acquired infections, are becoming increasingly resistant to first-choice antibiotics. This places both individual patients and society at risk for severe infections acquired in either health care facilities or the community.2
In the US alone, each year there are at least 2 million antibiotic-resistant infections, with more than 20,000 deaths as a result.3 Among the major causes of resistance are overuse and misuse of antibiotics. Data indicate that 50% of hospitalized patients who are given antibiotics will receive unnecessary or redundant therapy, resulting in overuse. In the primary care setting, antibiotic overuse is associated with antibiotic resistance at the individual patient level.3 What is most concerning is that “the presence of antibiotic-resistant bacteria is greatest during the month following a patient’s antibiotic use and may persist for up to 12 months.”3
The Global Antibiotic Resistance Partnership has identified four major reasons for inappropriate antibiotic prescribing and overuse. Although the particular findings came from a study in India, I submit that two of the reasons are applicable to the US: patients’ expectations and the lack of awareness about the inappropriate use of antibiotics and its associated risks.4
Since the early 1980s, global efforts have attempted to address these issues and provide solutions, which include judicious use of antibiotics in an attempt to stem the rising tide of bacterial resistance. The Alliance for the Prudent Use of Antibiotics, affiliated with Tufts University School of Medicine, has devoted 30-plus years to research, education, and public policy advocacy on this topic.5 The CDC has an ongoing public service campaign, Get Smart About Antibiotics, to educate the general public about when antibiotics are appropriate and when they are not. And yet …
Not surprisingly, antibiotic overuse occurs most often among patients with common respiratory ailments. We as clinicians know that URIs caused by viruses are self-limited and thus require no specific treatment—especially not antibiotics. Yet, perhaps for the following reasons—the patient doesn’t want to “suffer” with the URI (which lasts between three and 14 days) or insists that he/she only gets better when taking antibiotics, or it is simply easier to concede than spend the extra time to explain why an antibiotic is not indicated (or effective) for viral infections—we write the prescription. Thus, we contribute to the problem.
We, as health care professionals, know better. We are armed with not only education and information that tells us when we should not prescribe an antibiotic, but also, increasingly, with recommendations and admonitions not to do it. These include
• One of the goals of Healthy People 2020 is to “increase immunization rates and reduce preventable infectious diseases.”6 Goal IID-6 is specific: “Reduce the number of courses of antibiotics prescribed for the sole diagnosis of the common cold.”6
• The Institute of Medicine has identified six key issues that must be addressed in today’s health care systems, including safety and effectiveness of care. Safety involves “avoiding injuries to patients from the care that is intended to help them.”7 Surely avoiding inappropriate use of antibiotics qualifies.
I’m not suggesting we should never prescribe antibiotics; we all know there are instances in which it is absolutely appropriate: in patients who are immunocompromised and in cases when we suspect strep throat, bacterial sinusitis, or epiglottitis. When we have these clinical suspicions, we need to obtain cultures to confirm them. And if treatment is the right course, we should prescribe the right antibiotic at the right dose for the right duration and be familiar with regional resistance trends.3
We—as primary care providers—can easily mitigate the global threat of antibiotic-resistant bacteria if we encourage symptomatic therapy for URIs: those simple, “tried and true” treatments. We know them, our patients know them, and just in case we forget, we have seasonal commercials to remind us. The treatment for the average URI is simple: Rest in bed, drink plenty of fluids, and take nonprescription medications to attenuate symptoms such as fever or myalgia. (For helpful patient education, see “When Patients Ask for Antibiotics, Arm Them With Handouts”)
We must base our decision whether to treat common URI complaints with antibiotics on sound clinical findings. Take the time to explain to your patients those findings and educate them about appropriate use of antibiotics. Moreover, when the clinical findings do not support the need for an antibiotic, tell your patients, “I’m not saying you aren’t sick; I’m telling you that you don’t need antibiotics for your illness!” Remind patients that they will get better, as one colleague of mine always said, “in seven days with, or in a week without, antibiotics.”’
So, when you must, write the prescription. But please: Prescribe “tincture of time.”
REFERENCES
1. Johns Hopkins. Upper respiratory infection (URI or common cold). www.hopkinsmed icine.org/healthlibrary/conditions/pediatrics/upper_respiratory_infection_uri_or_common_cold_90,P02966/. Accessed August 14, 2014.
2. World Health Organization. Antimicrobial resistance. www.who.int/mediacentre/fact sheets/fs194/en/. Accessed August 14, 2014.
3. CDC. Delivering smart care for patients: all healthcare providers play a role. www.cdc.gov/getsmart/healthcare/factsheets/hc_pro viders.html. Accessed August 14, 2014.
4. Global Antibiotic Resistance Partnership (GARP) India Working Group. Rationalizing antibiotic use to limit antibiotic resistance in India. Indian J Med Res. 2011;134(3):281-294.
5. Alliance for the Prudent Use of Antibiotics. www.tufts.edu/med/apua/about_us/what_we_do.shtml. Accessed August 14, 2014.
6. United States Department of Health and Human Services. Immunization and infectious disease. www.healthypeople.gov/2020/
topicsobjectives2020/overview.aspx?
topicid=23. Accessed August 14, 2014.
7. The Institute of Medicine. An agenda for crossing the chasm. In: Crossing the Quality Chasm: A New Health System for the 21st Century. 2001:5-6. http://books.nap.edu/openbook.php?record_id=10027&page=5. Accessed August 14, 2014.
The approach of fall brings changes in weather and the start of school and (often) new jobs—with the requisite associated illnesses. Exposure to new germs makes us vulnerable to “catching everything.” Prime candidates for this phenomenon are children just entering school, who are magnets for the myriad pathogens lurking in classrooms and are quite adept at carrying them home to “share” with the family! As a result, upper respiratory infections (URIs) are common at this time of year.
With symptoms ranging from rhinorrhea, pharyngitis, and cough to difficulty breathing and fatigue, URIs are among the most frequent reasons for visits to health care providers and a leading cause of missed school or work in the United States.1 The combination of bothersome symptoms and lost productivity is often the impetus for a request for antibiotics. Distressingly, these requests all too frequently result in unnecessary—and inappropriate—prescriptions.
Why is this a big deal? According to the World Health Organization, bacterial infections, including respiratory tract and hospital-acquired infections, are becoming increasingly resistant to first-choice antibiotics. This places both individual patients and society at risk for severe infections acquired in either health care facilities or the community.2
In the US alone, each year there are at least 2 million antibiotic-resistant infections, with more than 20,000 deaths as a result.3 Among the major causes of resistance are overuse and misuse of antibiotics. Data indicate that 50% of hospitalized patients who are given antibiotics will receive unnecessary or redundant therapy, resulting in overuse. In the primary care setting, antibiotic overuse is associated with antibiotic resistance at the individual patient level.3 What is most concerning is that “the presence of antibiotic-resistant bacteria is greatest during the month following a patient’s antibiotic use and may persist for up to 12 months.”3
The Global Antibiotic Resistance Partnership has identified four major reasons for inappropriate antibiotic prescribing and overuse. Although the particular findings came from a study in India, I submit that two of the reasons are applicable to the US: patients’ expectations and the lack of awareness about the inappropriate use of antibiotics and its associated risks.4
Since the early 1980s, global efforts have attempted to address these issues and provide solutions, which include judicious use of antibiotics in an attempt to stem the rising tide of bacterial resistance. The Alliance for the Prudent Use of Antibiotics, affiliated with Tufts University School of Medicine, has devoted 30-plus years to research, education, and public policy advocacy on this topic.5 The CDC has an ongoing public service campaign, Get Smart About Antibiotics, to educate the general public about when antibiotics are appropriate and when they are not. And yet …
Not surprisingly, antibiotic overuse occurs most often among patients with common respiratory ailments. We as clinicians know that URIs caused by viruses are self-limited and thus require no specific treatment—especially not antibiotics. Yet, perhaps for the following reasons—the patient doesn’t want to “suffer” with the URI (which lasts between three and 14 days) or insists that he/she only gets better when taking antibiotics, or it is simply easier to concede than spend the extra time to explain why an antibiotic is not indicated (or effective) for viral infections—we write the prescription. Thus, we contribute to the problem.
We, as health care professionals, know better. We are armed with not only education and information that tells us when we should not prescribe an antibiotic, but also, increasingly, with recommendations and admonitions not to do it. These include
• One of the goals of Healthy People 2020 is to “increase immunization rates and reduce preventable infectious diseases.”6 Goal IID-6 is specific: “Reduce the number of courses of antibiotics prescribed for the sole diagnosis of the common cold.”6
• The Institute of Medicine has identified six key issues that must be addressed in today’s health care systems, including safety and effectiveness of care. Safety involves “avoiding injuries to patients from the care that is intended to help them.”7 Surely avoiding inappropriate use of antibiotics qualifies.
I’m not suggesting we should never prescribe antibiotics; we all know there are instances in which it is absolutely appropriate: in patients who are immunocompromised and in cases when we suspect strep throat, bacterial sinusitis, or epiglottitis. When we have these clinical suspicions, we need to obtain cultures to confirm them. And if treatment is the right course, we should prescribe the right antibiotic at the right dose for the right duration and be familiar with regional resistance trends.3
We—as primary care providers—can easily mitigate the global threat of antibiotic-resistant bacteria if we encourage symptomatic therapy for URIs: those simple, “tried and true” treatments. We know them, our patients know them, and just in case we forget, we have seasonal commercials to remind us. The treatment for the average URI is simple: Rest in bed, drink plenty of fluids, and take nonprescription medications to attenuate symptoms such as fever or myalgia. (For helpful patient education, see “When Patients Ask for Antibiotics, Arm Them With Handouts”)
We must base our decision whether to treat common URI complaints with antibiotics on sound clinical findings. Take the time to explain to your patients those findings and educate them about appropriate use of antibiotics. Moreover, when the clinical findings do not support the need for an antibiotic, tell your patients, “I’m not saying you aren’t sick; I’m telling you that you don’t need antibiotics for your illness!” Remind patients that they will get better, as one colleague of mine always said, “in seven days with, or in a week without, antibiotics.”’
So, when you must, write the prescription. But please: Prescribe “tincture of time.”
REFERENCES
1. Johns Hopkins. Upper respiratory infection (URI or common cold). www.hopkinsmed icine.org/healthlibrary/conditions/pediatrics/upper_respiratory_infection_uri_or_common_cold_90,P02966/. Accessed August 14, 2014.
2. World Health Organization. Antimicrobial resistance. www.who.int/mediacentre/fact sheets/fs194/en/. Accessed August 14, 2014.
3. CDC. Delivering smart care for patients: all healthcare providers play a role. www.cdc.gov/getsmart/healthcare/factsheets/hc_pro viders.html. Accessed August 14, 2014.
4. Global Antibiotic Resistance Partnership (GARP) India Working Group. Rationalizing antibiotic use to limit antibiotic resistance in India. Indian J Med Res. 2011;134(3):281-294.
5. Alliance for the Prudent Use of Antibiotics. www.tufts.edu/med/apua/about_us/what_we_do.shtml. Accessed August 14, 2014.
6. United States Department of Health and Human Services. Immunization and infectious disease. www.healthypeople.gov/2020/
topicsobjectives2020/overview.aspx?
topicid=23. Accessed August 14, 2014.
7. The Institute of Medicine. An agenda for crossing the chasm. In: Crossing the Quality Chasm: A New Health System for the 21st Century. 2001:5-6. http://books.nap.edu/openbook.php?record_id=10027&page=5. Accessed August 14, 2014.
The approach of fall brings changes in weather and the start of school and (often) new jobs—with the requisite associated illnesses. Exposure to new germs makes us vulnerable to “catching everything.” Prime candidates for this phenomenon are children just entering school, who are magnets for the myriad pathogens lurking in classrooms and are quite adept at carrying them home to “share” with the family! As a result, upper respiratory infections (URIs) are common at this time of year.
With symptoms ranging from rhinorrhea, pharyngitis, and cough to difficulty breathing and fatigue, URIs are among the most frequent reasons for visits to health care providers and a leading cause of missed school or work in the United States.1 The combination of bothersome symptoms and lost productivity is often the impetus for a request for antibiotics. Distressingly, these requests all too frequently result in unnecessary—and inappropriate—prescriptions.
Why is this a big deal? According to the World Health Organization, bacterial infections, including respiratory tract and hospital-acquired infections, are becoming increasingly resistant to first-choice antibiotics. This places both individual patients and society at risk for severe infections acquired in either health care facilities or the community.2
In the US alone, each year there are at least 2 million antibiotic-resistant infections, with more than 20,000 deaths as a result.3 Among the major causes of resistance are overuse and misuse of antibiotics. Data indicate that 50% of hospitalized patients who are given antibiotics will receive unnecessary or redundant therapy, resulting in overuse. In the primary care setting, antibiotic overuse is associated with antibiotic resistance at the individual patient level.3 What is most concerning is that “the presence of antibiotic-resistant bacteria is greatest during the month following a patient’s antibiotic use and may persist for up to 12 months.”3
The Global Antibiotic Resistance Partnership has identified four major reasons for inappropriate antibiotic prescribing and overuse. Although the particular findings came from a study in India, I submit that two of the reasons are applicable to the US: patients’ expectations and the lack of awareness about the inappropriate use of antibiotics and its associated risks.4
Since the early 1980s, global efforts have attempted to address these issues and provide solutions, which include judicious use of antibiotics in an attempt to stem the rising tide of bacterial resistance. The Alliance for the Prudent Use of Antibiotics, affiliated with Tufts University School of Medicine, has devoted 30-plus years to research, education, and public policy advocacy on this topic.5 The CDC has an ongoing public service campaign, Get Smart About Antibiotics, to educate the general public about when antibiotics are appropriate and when they are not. And yet …
Not surprisingly, antibiotic overuse occurs most often among patients with common respiratory ailments. We as clinicians know that URIs caused by viruses are self-limited and thus require no specific treatment—especially not antibiotics. Yet, perhaps for the following reasons—the patient doesn’t want to “suffer” with the URI (which lasts between three and 14 days) or insists that he/she only gets better when taking antibiotics, or it is simply easier to concede than spend the extra time to explain why an antibiotic is not indicated (or effective) for viral infections—we write the prescription. Thus, we contribute to the problem.
We, as health care professionals, know better. We are armed with not only education and information that tells us when we should not prescribe an antibiotic, but also, increasingly, with recommendations and admonitions not to do it. These include
• One of the goals of Healthy People 2020 is to “increase immunization rates and reduce preventable infectious diseases.”6 Goal IID-6 is specific: “Reduce the number of courses of antibiotics prescribed for the sole diagnosis of the common cold.”6
• The Institute of Medicine has identified six key issues that must be addressed in today’s health care systems, including safety and effectiveness of care. Safety involves “avoiding injuries to patients from the care that is intended to help them.”7 Surely avoiding inappropriate use of antibiotics qualifies.
I’m not suggesting we should never prescribe antibiotics; we all know there are instances in which it is absolutely appropriate: in patients who are immunocompromised and in cases when we suspect strep throat, bacterial sinusitis, or epiglottitis. When we have these clinical suspicions, we need to obtain cultures to confirm them. And if treatment is the right course, we should prescribe the right antibiotic at the right dose for the right duration and be familiar with regional resistance trends.3
We—as primary care providers—can easily mitigate the global threat of antibiotic-resistant bacteria if we encourage symptomatic therapy for URIs: those simple, “tried and true” treatments. We know them, our patients know them, and just in case we forget, we have seasonal commercials to remind us. The treatment for the average URI is simple: Rest in bed, drink plenty of fluids, and take nonprescription medications to attenuate symptoms such as fever or myalgia. (For helpful patient education, see “When Patients Ask for Antibiotics, Arm Them With Handouts”)
We must base our decision whether to treat common URI complaints with antibiotics on sound clinical findings. Take the time to explain to your patients those findings and educate them about appropriate use of antibiotics. Moreover, when the clinical findings do not support the need for an antibiotic, tell your patients, “I’m not saying you aren’t sick; I’m telling you that you don’t need antibiotics for your illness!” Remind patients that they will get better, as one colleague of mine always said, “in seven days with, or in a week without, antibiotics.”’
So, when you must, write the prescription. But please: Prescribe “tincture of time.”
REFERENCES
1. Johns Hopkins. Upper respiratory infection (URI or common cold). www.hopkinsmed icine.org/healthlibrary/conditions/pediatrics/upper_respiratory_infection_uri_or_common_cold_90,P02966/. Accessed August 14, 2014.
2. World Health Organization. Antimicrobial resistance. www.who.int/mediacentre/fact sheets/fs194/en/. Accessed August 14, 2014.
3. CDC. Delivering smart care for patients: all healthcare providers play a role. www.cdc.gov/getsmart/healthcare/factsheets/hc_pro viders.html. Accessed August 14, 2014.
4. Global Antibiotic Resistance Partnership (GARP) India Working Group. Rationalizing antibiotic use to limit antibiotic resistance in India. Indian J Med Res. 2011;134(3):281-294.
5. Alliance for the Prudent Use of Antibiotics. www.tufts.edu/med/apua/about_us/what_we_do.shtml. Accessed August 14, 2014.
6. United States Department of Health and Human Services. Immunization and infectious disease. www.healthypeople.gov/2020/
topicsobjectives2020/overview.aspx?
topicid=23. Accessed August 14, 2014.
7. The Institute of Medicine. An agenda for crossing the chasm. In: Crossing the Quality Chasm: A New Health System for the 21st Century. 2001:5-6. http://books.nap.edu/openbook.php?record_id=10027&page=5. Accessed August 14, 2014.
Kegel exercises
The prevalence of urinary incontinence is 17%-55% among older women and 12%-42% among younger and middle-aged women. Only 45% of women with at least weekly symptoms seek medical care to address their symptoms.
For most of us, offering conservative measures is the most reasonable approach when women present. Pelvic floor muscle training, sometimes referred to as Kegel exercises, is usually one of the first things we discuss. Many women have heard this spiel before and may report having tried but not benefited from the exercises. This real or perceived lack of benefit may be related to either poor adherence or lack of efficacy.
In theory, pelvic floor muscle training builds strength and improves muscle tone, enhances conscious awareness of muscle groups, and increases perineal support by lifting pelvic viscera. But do clinical trial data support the use of pelvic muscle training for reducing urinary incontinence?
Dr. O. Celiker Tosun of Dokuz Eylül University, Izmir, Turkey, and colleagues published the results of a randomized clinical trial evaluating the effectiveness of an individually prescribed 12-week home-based pelvic floor muscle exercise program (Clin. Rehabil. 2014 Aug. 20 [doi:10.1177/0269215514546768]). Women with stress or mixed urinary incontinence were selected from a urogynecology clinic and randomized to pelvic floor muscle training (65 patients) or a control condition (65 patients).
The pelvic floor muscle training group had significant improvement in their symptoms of urinary incontinence and pelvic floor muscle strength, compared with the control group. Symptoms of urinary incontinence were significantly decreased in the training group.
This study is important because it demonstrates the utility of pelvic floor muscle training exercises under ideal circumstances.
However, the intervention provided in this study was intense and sophisticated – and it will be difficult, if not impossible, for most of us to replicate. A physiotherapist provided the training over a 12-week period, with 30-minute sessions three times a week for the first 2 weeks. Women also kept a training diary. Adherence to the protocol was 89% in the training group.
This is very different from the handout on Kegel’s we might be giving to our patients – with adherence to recommendations likely approaching 0%.
But now that we have these data, perhaps we can talk to our female patients more consistently and convincingly about the utility of this approach for reducing incontinence. If we are lucky and have a women’s health clinic with access to this type of expertise, this might be another option – at least before we refer them for higher-risk surgical procedures.
Dr. Ebbert is professor of medicine and a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. They should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
The prevalence of urinary incontinence is 17%-55% among older women and 12%-42% among younger and middle-aged women. Only 45% of women with at least weekly symptoms seek medical care to address their symptoms.
For most of us, offering conservative measures is the most reasonable approach when women present. Pelvic floor muscle training, sometimes referred to as Kegel exercises, is usually one of the first things we discuss. Many women have heard this spiel before and may report having tried but not benefited from the exercises. This real or perceived lack of benefit may be related to either poor adherence or lack of efficacy.
In theory, pelvic floor muscle training builds strength and improves muscle tone, enhances conscious awareness of muscle groups, and increases perineal support by lifting pelvic viscera. But do clinical trial data support the use of pelvic muscle training for reducing urinary incontinence?
Dr. O. Celiker Tosun of Dokuz Eylül University, Izmir, Turkey, and colleagues published the results of a randomized clinical trial evaluating the effectiveness of an individually prescribed 12-week home-based pelvic floor muscle exercise program (Clin. Rehabil. 2014 Aug. 20 [doi:10.1177/0269215514546768]). Women with stress or mixed urinary incontinence were selected from a urogynecology clinic and randomized to pelvic floor muscle training (65 patients) or a control condition (65 patients).
The pelvic floor muscle training group had significant improvement in their symptoms of urinary incontinence and pelvic floor muscle strength, compared with the control group. Symptoms of urinary incontinence were significantly decreased in the training group.
This study is important because it demonstrates the utility of pelvic floor muscle training exercises under ideal circumstances.
However, the intervention provided in this study was intense and sophisticated – and it will be difficult, if not impossible, for most of us to replicate. A physiotherapist provided the training over a 12-week period, with 30-minute sessions three times a week for the first 2 weeks. Women also kept a training diary. Adherence to the protocol was 89% in the training group.
This is very different from the handout on Kegel’s we might be giving to our patients – with adherence to recommendations likely approaching 0%.
But now that we have these data, perhaps we can talk to our female patients more consistently and convincingly about the utility of this approach for reducing incontinence. If we are lucky and have a women’s health clinic with access to this type of expertise, this might be another option – at least before we refer them for higher-risk surgical procedures.
Dr. Ebbert is professor of medicine and a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. They should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
The prevalence of urinary incontinence is 17%-55% among older women and 12%-42% among younger and middle-aged women. Only 45% of women with at least weekly symptoms seek medical care to address their symptoms.
For most of us, offering conservative measures is the most reasonable approach when women present. Pelvic floor muscle training, sometimes referred to as Kegel exercises, is usually one of the first things we discuss. Many women have heard this spiel before and may report having tried but not benefited from the exercises. This real or perceived lack of benefit may be related to either poor adherence or lack of efficacy.
In theory, pelvic floor muscle training builds strength and improves muscle tone, enhances conscious awareness of muscle groups, and increases perineal support by lifting pelvic viscera. But do clinical trial data support the use of pelvic muscle training for reducing urinary incontinence?
Dr. O. Celiker Tosun of Dokuz Eylül University, Izmir, Turkey, and colleagues published the results of a randomized clinical trial evaluating the effectiveness of an individually prescribed 12-week home-based pelvic floor muscle exercise program (Clin. Rehabil. 2014 Aug. 20 [doi:10.1177/0269215514546768]). Women with stress or mixed urinary incontinence were selected from a urogynecology clinic and randomized to pelvic floor muscle training (65 patients) or a control condition (65 patients).
The pelvic floor muscle training group had significant improvement in their symptoms of urinary incontinence and pelvic floor muscle strength, compared with the control group. Symptoms of urinary incontinence were significantly decreased in the training group.
This study is important because it demonstrates the utility of pelvic floor muscle training exercises under ideal circumstances.
However, the intervention provided in this study was intense and sophisticated – and it will be difficult, if not impossible, for most of us to replicate. A physiotherapist provided the training over a 12-week period, with 30-minute sessions three times a week for the first 2 weeks. Women also kept a training diary. Adherence to the protocol was 89% in the training group.
This is very different from the handout on Kegel’s we might be giving to our patients – with adherence to recommendations likely approaching 0%.
But now that we have these data, perhaps we can talk to our female patients more consistently and convincingly about the utility of this approach for reducing incontinence. If we are lucky and have a women’s health clinic with access to this type of expertise, this might be another option – at least before we refer them for higher-risk surgical procedures.
Dr. Ebbert is professor of medicine and a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. They should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
Antidepressants and Youths: What we’ve learned in the decade since the black box
Ten years ago, the Food and Drug Administration required that all antidepressants carry a severe black box warning to alert prescribers to the possibility that these medications could cause worsening suicidal thoughts and behavior. A decade later, this issue had faded from the public eye and the media headlines. Nevertheless, research into their use has continued, and antidepressants continue to be prescribed. Have things changed since all the attention in the past? The results may be surprising.
Although there are undoubtedly different views, here is my summary of the five key points with direct implications for pediatricians:
1. The risk of suicide due to antidepressants was overstated. Subsequent analyses from additional clinical trials comparing suicidal thoughts or behavior between youths taking antidepressants versus placebo have increasingly struggled to find that "signal" related to active drug. Perhaps more importantly, several other studies that have examined actual suicides and/or suicide attempts from large databases have not shown links to the taking of antidepressants and, if anything, have suggested that untreated depression poses a greater risk (BMJ 2014;348:g3596). It is worth repeating that there still has never been an actual suicide in any of the antidepressant trials.
2. The efficacy of antidepressants also was overstated. As people began to examine more closely the issue of suicidal behavior and antidepressants, it became evident that there was much more data on this than was obvious from published studies. Many more trials of depression and antidepressants were performed, usually funded by pharmaceutical companies, and many of these trials did not show that antidepressants were superior to placebo (N. Engl. J. Med. 2008;358:252-60). As opposed to the positive trials, however, the negative ones tended not to be published or featured. Overall, it seems that about 60% of depressed children and adolescents respond to antidepressant medication, compared with 50% who respond to placebo.
3. The prescribing of antidepressants is making a comeback. After the 2004 warnings, the number of antidepressant prescriptions dropped. Since around 2008, however, the rate of antidepressant prescribing has increased again, although not at 2004 levels, according to some studies.
4. Antidepressants don’t work by fixing a serotonin "chemical imbalance." Although it is true that antidepressants result in more serotonin being available in brain synapses acutely, depression is not caused by a simple serotonin deficit. Medications likely work by changing the expression of certain genes that relate to how strongly particular brain pathways are connected. This process may explain why antidepressants take time to be effective.
5. Antidepressants actually work better for youths with anxiety rather than depression. More promising results with antidepressants have been found for children with anxiety disorder and obsessive-compulsive disorder (N. Engl. J. Med. 2008;359:2753-66). Although cognitive-behavior therapy remains the recommended first-line intervention for children with anxiety disorders, antidepressants have been shown to be effective both alone and in combination with cognitive-behavior therapy.
There is still much to learn. Children and adolescents who are extremely irritable, unmotivated, and at times suicidal are a diverse group of people whose difficulties can arise from many factors that deserve investigation. When it comes to antidepressants, it appears that both the amount of risk and the amount of benefit associated with this class of medications may be less than what was believed a decade ago.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych. Dr. Rettew said he had no financial disclosures relevant to this article.
Ten years ago, the Food and Drug Administration required that all antidepressants carry a severe black box warning to alert prescribers to the possibility that these medications could cause worsening suicidal thoughts and behavior. A decade later, this issue had faded from the public eye and the media headlines. Nevertheless, research into their use has continued, and antidepressants continue to be prescribed. Have things changed since all the attention in the past? The results may be surprising.
Although there are undoubtedly different views, here is my summary of the five key points with direct implications for pediatricians:
1. The risk of suicide due to antidepressants was overstated. Subsequent analyses from additional clinical trials comparing suicidal thoughts or behavior between youths taking antidepressants versus placebo have increasingly struggled to find that "signal" related to active drug. Perhaps more importantly, several other studies that have examined actual suicides and/or suicide attempts from large databases have not shown links to the taking of antidepressants and, if anything, have suggested that untreated depression poses a greater risk (BMJ 2014;348:g3596). It is worth repeating that there still has never been an actual suicide in any of the antidepressant trials.
2. The efficacy of antidepressants also was overstated. As people began to examine more closely the issue of suicidal behavior and antidepressants, it became evident that there was much more data on this than was obvious from published studies. Many more trials of depression and antidepressants were performed, usually funded by pharmaceutical companies, and many of these trials did not show that antidepressants were superior to placebo (N. Engl. J. Med. 2008;358:252-60). As opposed to the positive trials, however, the negative ones tended not to be published or featured. Overall, it seems that about 60% of depressed children and adolescents respond to antidepressant medication, compared with 50% who respond to placebo.
3. The prescribing of antidepressants is making a comeback. After the 2004 warnings, the number of antidepressant prescriptions dropped. Since around 2008, however, the rate of antidepressant prescribing has increased again, although not at 2004 levels, according to some studies.
4. Antidepressants don’t work by fixing a serotonin "chemical imbalance." Although it is true that antidepressants result in more serotonin being available in brain synapses acutely, depression is not caused by a simple serotonin deficit. Medications likely work by changing the expression of certain genes that relate to how strongly particular brain pathways are connected. This process may explain why antidepressants take time to be effective.
5. Antidepressants actually work better for youths with anxiety rather than depression. More promising results with antidepressants have been found for children with anxiety disorder and obsessive-compulsive disorder (N. Engl. J. Med. 2008;359:2753-66). Although cognitive-behavior therapy remains the recommended first-line intervention for children with anxiety disorders, antidepressants have been shown to be effective both alone and in combination with cognitive-behavior therapy.
There is still much to learn. Children and adolescents who are extremely irritable, unmotivated, and at times suicidal are a diverse group of people whose difficulties can arise from many factors that deserve investigation. When it comes to antidepressants, it appears that both the amount of risk and the amount of benefit associated with this class of medications may be less than what was believed a decade ago.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych. Dr. Rettew said he had no financial disclosures relevant to this article.
Ten years ago, the Food and Drug Administration required that all antidepressants carry a severe black box warning to alert prescribers to the possibility that these medications could cause worsening suicidal thoughts and behavior. A decade later, this issue had faded from the public eye and the media headlines. Nevertheless, research into their use has continued, and antidepressants continue to be prescribed. Have things changed since all the attention in the past? The results may be surprising.
Although there are undoubtedly different views, here is my summary of the five key points with direct implications for pediatricians:
1. The risk of suicide due to antidepressants was overstated. Subsequent analyses from additional clinical trials comparing suicidal thoughts or behavior between youths taking antidepressants versus placebo have increasingly struggled to find that "signal" related to active drug. Perhaps more importantly, several other studies that have examined actual suicides and/or suicide attempts from large databases have not shown links to the taking of antidepressants and, if anything, have suggested that untreated depression poses a greater risk (BMJ 2014;348:g3596). It is worth repeating that there still has never been an actual suicide in any of the antidepressant trials.
2. The efficacy of antidepressants also was overstated. As people began to examine more closely the issue of suicidal behavior and antidepressants, it became evident that there was much more data on this than was obvious from published studies. Many more trials of depression and antidepressants were performed, usually funded by pharmaceutical companies, and many of these trials did not show that antidepressants were superior to placebo (N. Engl. J. Med. 2008;358:252-60). As opposed to the positive trials, however, the negative ones tended not to be published or featured. Overall, it seems that about 60% of depressed children and adolescents respond to antidepressant medication, compared with 50% who respond to placebo.
3. The prescribing of antidepressants is making a comeback. After the 2004 warnings, the number of antidepressant prescriptions dropped. Since around 2008, however, the rate of antidepressant prescribing has increased again, although not at 2004 levels, according to some studies.
4. Antidepressants don’t work by fixing a serotonin "chemical imbalance." Although it is true that antidepressants result in more serotonin being available in brain synapses acutely, depression is not caused by a simple serotonin deficit. Medications likely work by changing the expression of certain genes that relate to how strongly particular brain pathways are connected. This process may explain why antidepressants take time to be effective.
5. Antidepressants actually work better for youths with anxiety rather than depression. More promising results with antidepressants have been found for children with anxiety disorder and obsessive-compulsive disorder (N. Engl. J. Med. 2008;359:2753-66). Although cognitive-behavior therapy remains the recommended first-line intervention for children with anxiety disorders, antidepressants have been shown to be effective both alone and in combination with cognitive-behavior therapy.
There is still much to learn. Children and adolescents who are extremely irritable, unmotivated, and at times suicidal are a diverse group of people whose difficulties can arise from many factors that deserve investigation. When it comes to antidepressants, it appears that both the amount of risk and the amount of benefit associated with this class of medications may be less than what was believed a decade ago.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych. Dr. Rettew said he had no financial disclosures relevant to this article.
ADHD boundaries with normal behavior
Case summary
Dylan is a bright and lively 10-year-old boy who has always been energetic and passionate. His parents have celebrated his exuberance but now have become concerned that there is "something more," after his teacher has needed to remove him from class for several episodes of impulsive and disruptive behavior. Further history reveals that, compared with his classmates, he can be quite distractible and often needs a lot of prompting and redirection to complete his work. Dylan is an intelligent child who has always managed to do well in school despite some longstanding challenges with attention. His performance has slipped somewhat as the academic load increases, although not to the point that he is in jeopardy of being held back.
At home, Dylan enjoys playing outside but also is drawn to video games, an activity that seems to hold his attention well. His parents get frustrated with needing to repeat requests several times and having to remind him to be quieter in the house.
Discussion
Attention-deficit/hyperactivity disorder, like all other psychiatric disorders, is defined in binary terms as being present or not-present. Nonetheless, it has become abundantly clear from research studies that the symptoms exist dimensionally and are normally distributed in a manner such as height. As such, diagnosing ADHD is analogous to diagnosing someone as being tall. Given this reality, how does a clinician figure out when a child really "has" a disorder, versus the behavior being "just" part of normal behavior?
All of the diagnostic criteria for ADHD include behaviors that at age-appropriate levels are considered completely normal. To qualify as a symptom that is present, the behaviors have to occur "often" and be inappropriate to the child’s developmental level. These subjective judgments about moving targets make drawing the line difficult for clinicians. Most children are well within normal limits and others are clearly beyond them, yet that leaves a sizable group somewhere in that middle "gray zone."
Making matters more complicated is the increasing but still insufficient evidence suggesting that this dimensionality exists when it comes to the underlying neurobiology of ADHD as well. In other words, the genes, environmental factors, brain regions, neurotransmitters, etc., that determine why a child has an average attention span or activity level are the same ones involved in ADHD. Such a revelation, however, in no way should be interpreted as ADHD being not "real," any more than other dimensional nonpsychiatric conditions (hypertension, hyperlipidemia).
This continuum of behaviors, however, does present a real diagnostic challenge. The inconvenient reality is that there really may not be any "true" rate of ADHD at 5%, 7%, or more recently, 11%. Many people make much of assessing whether or not there is associated impairment with the behaviors, but the truth of the matter is that impairment itself is dimensional.
Thus, we need to appreciate the complexities and limitations of this challenging diagnosis without throwing up our hands in frustration and giving up. After all, these problems can get significantly better with treatment. Here are a few tips to consider.
1. In making an ADHD diagnosis, use quantitative rating scales that appreciate this dimensional nature. Ideally, these instruments should be standardized by age and sex so that, for example, scores of 8-year-old boys can be compared to those of other 8-year-old boys. Don’t feel compelled to come up with a diagnosis on the spot if this procedure takes a little time in getting input from multiple people (parents, teachers, self-report).
2. Don’t stop investigating just because you arrive at an ADHD diagnosis. There are many factors that can result in a child struggling with these behaviors. Poor sleep, excessive screen time, inadequate nutrition, suboptimal parenting practices, exposures to lead and other substances, and lack of exercise are some factors that can underlie these problems. Correcting them can often make a big difference and in some cases can obviate the need for medication.
3. Approach a dimensional diagnosis with dimensional treatment. Just as many patients with borderline levels of hypertension or borderline glucose levels might be recommended to try nonpharmacological interventions first, the same principle can be applied to ADHD. Parent behavioral management, skills training, and addressing potential causes or exacerbating causes described in No. 2 can all provide important benefits.
The bottom line here, in my view, is to appreciate and respect the inherent blurriness of these boundaries without it leading to clinical paralysis. Children who struggle with inattention and hyperactivity are well known to be at risk for a variety of negative outcomes. Pediatricians have a large number of options to help these children that have been shown to be effective and can be individually tailored to each specific case.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych.
Case summary
Dylan is a bright and lively 10-year-old boy who has always been energetic and passionate. His parents have celebrated his exuberance but now have become concerned that there is "something more," after his teacher has needed to remove him from class for several episodes of impulsive and disruptive behavior. Further history reveals that, compared with his classmates, he can be quite distractible and often needs a lot of prompting and redirection to complete his work. Dylan is an intelligent child who has always managed to do well in school despite some longstanding challenges with attention. His performance has slipped somewhat as the academic load increases, although not to the point that he is in jeopardy of being held back.
At home, Dylan enjoys playing outside but also is drawn to video games, an activity that seems to hold his attention well. His parents get frustrated with needing to repeat requests several times and having to remind him to be quieter in the house.
Discussion
Attention-deficit/hyperactivity disorder, like all other psychiatric disorders, is defined in binary terms as being present or not-present. Nonetheless, it has become abundantly clear from research studies that the symptoms exist dimensionally and are normally distributed in a manner such as height. As such, diagnosing ADHD is analogous to diagnosing someone as being tall. Given this reality, how does a clinician figure out when a child really "has" a disorder, versus the behavior being "just" part of normal behavior?
All of the diagnostic criteria for ADHD include behaviors that at age-appropriate levels are considered completely normal. To qualify as a symptom that is present, the behaviors have to occur "often" and be inappropriate to the child’s developmental level. These subjective judgments about moving targets make drawing the line difficult for clinicians. Most children are well within normal limits and others are clearly beyond them, yet that leaves a sizable group somewhere in that middle "gray zone."
Making matters more complicated is the increasing but still insufficient evidence suggesting that this dimensionality exists when it comes to the underlying neurobiology of ADHD as well. In other words, the genes, environmental factors, brain regions, neurotransmitters, etc., that determine why a child has an average attention span or activity level are the same ones involved in ADHD. Such a revelation, however, in no way should be interpreted as ADHD being not "real," any more than other dimensional nonpsychiatric conditions (hypertension, hyperlipidemia).
This continuum of behaviors, however, does present a real diagnostic challenge. The inconvenient reality is that there really may not be any "true" rate of ADHD at 5%, 7%, or more recently, 11%. Many people make much of assessing whether or not there is associated impairment with the behaviors, but the truth of the matter is that impairment itself is dimensional.
Thus, we need to appreciate the complexities and limitations of this challenging diagnosis without throwing up our hands in frustration and giving up. After all, these problems can get significantly better with treatment. Here are a few tips to consider.
1. In making an ADHD diagnosis, use quantitative rating scales that appreciate this dimensional nature. Ideally, these instruments should be standardized by age and sex so that, for example, scores of 8-year-old boys can be compared to those of other 8-year-old boys. Don’t feel compelled to come up with a diagnosis on the spot if this procedure takes a little time in getting input from multiple people (parents, teachers, self-report).
2. Don’t stop investigating just because you arrive at an ADHD diagnosis. There are many factors that can result in a child struggling with these behaviors. Poor sleep, excessive screen time, inadequate nutrition, suboptimal parenting practices, exposures to lead and other substances, and lack of exercise are some factors that can underlie these problems. Correcting them can often make a big difference and in some cases can obviate the need for medication.
3. Approach a dimensional diagnosis with dimensional treatment. Just as many patients with borderline levels of hypertension or borderline glucose levels might be recommended to try nonpharmacological interventions first, the same principle can be applied to ADHD. Parent behavioral management, skills training, and addressing potential causes or exacerbating causes described in No. 2 can all provide important benefits.
The bottom line here, in my view, is to appreciate and respect the inherent blurriness of these boundaries without it leading to clinical paralysis. Children who struggle with inattention and hyperactivity are well known to be at risk for a variety of negative outcomes. Pediatricians have a large number of options to help these children that have been shown to be effective and can be individually tailored to each specific case.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych.
Case summary
Dylan is a bright and lively 10-year-old boy who has always been energetic and passionate. His parents have celebrated his exuberance but now have become concerned that there is "something more," after his teacher has needed to remove him from class for several episodes of impulsive and disruptive behavior. Further history reveals that, compared with his classmates, he can be quite distractible and often needs a lot of prompting and redirection to complete his work. Dylan is an intelligent child who has always managed to do well in school despite some longstanding challenges with attention. His performance has slipped somewhat as the academic load increases, although not to the point that he is in jeopardy of being held back.
At home, Dylan enjoys playing outside but also is drawn to video games, an activity that seems to hold his attention well. His parents get frustrated with needing to repeat requests several times and having to remind him to be quieter in the house.
Discussion
Attention-deficit/hyperactivity disorder, like all other psychiatric disorders, is defined in binary terms as being present or not-present. Nonetheless, it has become abundantly clear from research studies that the symptoms exist dimensionally and are normally distributed in a manner such as height. As such, diagnosing ADHD is analogous to diagnosing someone as being tall. Given this reality, how does a clinician figure out when a child really "has" a disorder, versus the behavior being "just" part of normal behavior?
All of the diagnostic criteria for ADHD include behaviors that at age-appropriate levels are considered completely normal. To qualify as a symptom that is present, the behaviors have to occur "often" and be inappropriate to the child’s developmental level. These subjective judgments about moving targets make drawing the line difficult for clinicians. Most children are well within normal limits and others are clearly beyond them, yet that leaves a sizable group somewhere in that middle "gray zone."
Making matters more complicated is the increasing but still insufficient evidence suggesting that this dimensionality exists when it comes to the underlying neurobiology of ADHD as well. In other words, the genes, environmental factors, brain regions, neurotransmitters, etc., that determine why a child has an average attention span or activity level are the same ones involved in ADHD. Such a revelation, however, in no way should be interpreted as ADHD being not "real," any more than other dimensional nonpsychiatric conditions (hypertension, hyperlipidemia).
This continuum of behaviors, however, does present a real diagnostic challenge. The inconvenient reality is that there really may not be any "true" rate of ADHD at 5%, 7%, or more recently, 11%. Many people make much of assessing whether or not there is associated impairment with the behaviors, but the truth of the matter is that impairment itself is dimensional.
Thus, we need to appreciate the complexities and limitations of this challenging diagnosis without throwing up our hands in frustration and giving up. After all, these problems can get significantly better with treatment. Here are a few tips to consider.
1. In making an ADHD diagnosis, use quantitative rating scales that appreciate this dimensional nature. Ideally, these instruments should be standardized by age and sex so that, for example, scores of 8-year-old boys can be compared to those of other 8-year-old boys. Don’t feel compelled to come up with a diagnosis on the spot if this procedure takes a little time in getting input from multiple people (parents, teachers, self-report).
2. Don’t stop investigating just because you arrive at an ADHD diagnosis. There are many factors that can result in a child struggling with these behaviors. Poor sleep, excessive screen time, inadequate nutrition, suboptimal parenting practices, exposures to lead and other substances, and lack of exercise are some factors that can underlie these problems. Correcting them can often make a big difference and in some cases can obviate the need for medication.
3. Approach a dimensional diagnosis with dimensional treatment. Just as many patients with borderline levels of hypertension or borderline glucose levels might be recommended to try nonpharmacological interventions first, the same principle can be applied to ADHD. Parent behavioral management, skills training, and addressing potential causes or exacerbating causes described in No. 2 can all provide important benefits.
The bottom line here, in my view, is to appreciate and respect the inherent blurriness of these boundaries without it leading to clinical paralysis. Children who struggle with inattention and hyperactivity are well known to be at risk for a variety of negative outcomes. Pediatricians have a large number of options to help these children that have been shown to be effective and can be individually tailored to each specific case.
Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych.