An Estimate of Severe Harms Due to Screening Colonoscopy: A Systematic Review.

OBJECTIVE: This study aims to comprehensively assess the direct, severe harms of screening colonoscopy in the United States. Whereas other investigators have completed systematic reviews estimating the harms of all types of colonoscopy, this analysis focuses on screening colonoscopies that had adequate follow up to avoid undercounting delayed harms. DATA SOURCES: PubMed and Embase were queried for relevant studies on screening colonoscopy harms published between January 1, 2002, and April 1, 2022. STUDY SELECTION: English-language studies of screening colonoscopy for average risk patients were included. Studies must have followed patients for adequate time post procedure, defined as 30 days after colonoscopy. MAIN OUTCOMES: The primary outcome was the number of severe bleeding events and gastrointestinal (GI) perforations within 30 days of screening colonoscopy. RESULTS: A total of 1951 studies were reviewed for inclusion; 94 were reviewed in full text. Of those reviewed in full, 6 studies, including a total of 467,139 colonoscopies, met our inclusion criteria and were included in our analysis of harms related to screening colonoscopies. The rate of severe bleeding ranged credibly from 16.4 to 36.18 per 10,000 colonoscopies; the rate of perforation ranged credibly from 7.62 to 8.50 per 10,000 colonoscopies. CONCLUSIONS: This study is the first to estimate direct harms from screening colonoscopy, including harms that occur up to 30 days after the procedure. The risk of harm subsequent to screening colonoscopy is higher than previously reported and should be discussed with patients when engaging in shared decision making.

Making the Case for Accelerated Withdrawal of Aducanumab.

The controversial approval in June 2021 by the Food and Drug Administration (FDA) of aducanumab (marketed as Aduhelm), Biogen's monoclonal antibody for patients with Alzheimer's disease, raises significant concerns for the dementia field and drug approval process, considering its lack of adequate evidence for clinical efficacy, safety issues, and cost. On 15 December 2021, an international group of clinicians, basic science experts, psychological and social science researchers, lay people with lived experience of dementia, and advocates for public health met to discuss making a recommendation for whether aducanumab's approval should be withdrawn. Attendees considered arguments both in favor of and in opposition to withdrawal and voted unanimously to recommend that the FDA withdraw its approval for aducanumab and to support the Right Care Alliance's filing of a formal Citizen Petition to this effect.

An Estimate of the US Rate of Overuse of Screening Colonoscopy: a Systematic Review.

BACKGROUND: This study aims to assess the rate at which screening colonoscopy is performed on patients younger or older than the age range specified in national guidelines, or at shorter intervals than recommended. Such non-indicated use of the procedure is considered low-value care, or overuse. This study is the first systematic review of the rate of non-indicated completed screening colonoscopy in the USA. METHODS: PubMed and Embase were queried for relevant studies on overuse of screening colonoscopy published from January 1, 2002, until January 23, 2019. English-language studies that were conducted for screening colonoscopy after 2001 for average-risk patients were included. Studies must have followed national guidelines for detecting rates of overuse. We followed methods outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and the reporting recommendations of the Meta-analysis of Observational Studies in Epidemiology group (MOOSE). RESULTS: A total of 772 papers were reviewed for inclusion; 42 were reviewed in full text. Of those reviewed, six studies met eligibility criteria, including a total of 459,503 colonoscopies of which 242,756 were screening colonoscopies. The rate of overuse ranged credibly from 17 to 25.7%. DISCUSSION: This study demonstrates that screening colonoscopy is regularly performed in the USA more often, and in populations older or younger, than recommended by national guidelines. Such overuse wastes resources and places patients at unnecessary risk of harm. Efforts to reduce non-indicated screening colonoscopy are needed.

Assessment of Overuse of Medical Tests and Treatments at US Hospitals Using Medicare Claims.

Importance: Overuse of health care services exposes patients to unnecessary risk of harm and costs. Distinguishing patterns of overuse among hospitals requires hospital-level measures across multiple services. Objective: To describe characteristics of hospitals associated with overuse of health care services in the US. Design, Setting, and Participants: This retrospective cross-sectional analysis used Medicare fee-for-service claims data for beneficiaries older than 65 years from January 1, 2015, to December 31, 2017, with a lookback of 1 year. Inpatient and outpatient services were included, and services offered at specialty and federal hospitals were excluded. Patients were from hospitals with the capacity (based on a claims filter developed for this study) to perform at least 7 of 12 investigated services. Statistical analyses were performed from July 1, 2020, to December 20, 2020. Main Outcomes and Measures: Outcomes of interest were a composite overuse score ranging from 0 (no overuse of services) to 1 (relatively high overuse of services) and characteristics of hospitals clustered by overuse rates. Twelve published low-value service algorithms were applied to the data to find overuse rates for each hospital, normalized and aggregated to a composite score and then compared across 6 hospital characteristics using multivariable regression. A k-means cluster analysis was used on normalized overuse rates to identify hospital clusters. Results: The primary analysis was performed on 2415 cohort A hospitals (ie, hospitals with capacity for 7 or more services), which included 1 263 592 patients (mean [SD] age, 72.4 [14] years; 678 549 women [53.7%]; 101 017 191 White patients [80.5%]). Head imaging for syncope was the highest-volume low-value service (377 745 patients [29.9%]), followed by coronary artery stenting for stable coronary disease (199 579 [15.8%]). The mean (SD) composite overuse score was 0.40 (0.10) points. Southern hospitals had a higher mean score than midwestern (difference in means: 0.06 [95% CI, 0.05-0.07] points; P < .001), northeast (0.08 [95% CI, 0.06-0.09] points; P < .001), and western hospitals (0.08 [95% CI, 0.07-0.10] points; P < .001). Nonprofit hospitals had a lower adjusted mean score than for-profit hospitals (-0.03 [95% CI, -0.04 to -0.02] points; P < .001). Major teaching hospitals had significantly lower adjusted mean overuse scores vs minor teaching hospitals (difference in means, -0.07 [95% CI, -0.08 to -0.06] points; P < .001) and nonteaching hospitals (-0.10 [95% CI, -0.12 to -0.09] points; P < .001). Of the 4 clusters identified, 1 was characterized by its low counts of overuse in all services except for spinal fusion; the majority of major teaching hospitals were in this cluster (164 of 223 major teaching hospitals [73.5%]). Conclusions and Relevance: This cross-sectional study used a novel measurement of hospital-associated overuse; results showed that the highest scores in this Medicare population were associated with nonteaching and for-profit hospitals, particularly in the South.

Adverse Events and Hospital-Acquired Conditions Associated With Potential Low-Value Care in Medicare Beneficiaries.

Importance: There has been insufficient research on the patient harms and costs associated with potential low-value procedures in the US Medicare population. Objective: To report the prevalence of adverse events associated with potential low-value procedures and the additional hospital length of stay (LOS) and costs. Design Setting and Participants: This is a retrospective cohort study using Medicare fee-for-service claims between January 2016 to December 2018. Participants were aged 65 years or older. Procedures were selected if they had previously published indicators of low-value care, including knee arthroscopy, spinal fusion, vertebroplasty, percutaneous coronary intervention (PCI), carotid endarterectomy, renal stenting, and hysterectomy for benign conditions. Analysis was conducted from July to December, 2020. Main Outcomes and Measures: For inpatient procedures, the number and rate of admissions with a hospital-acquired condition (HAC) or patient safety indicator event (PSIs), as well as the unadjusted and adjusted difference in mean LOS and Medicare costs between admissions with and without a HAC/PSI. For outpatient procedures, we report the number of claims where the beneficiary had an unplanned hospital admission within seven days and the number of these admissions with a HAC/PSI. Results: There were 573 351 patients included in the study, with 617 264 procedures; the mean (SD) age was 74.2 (6.7) years, with 320 637 women (55.9%), and mostly White patients (520 735; 90.8%). Among the 197 755 claims for the inpatient procedures, 231 had an HAC and 1764 had a PSI. Spinal fusion was associated with the most HACs (123 admissions) and PSIs (1015 admissions). Overall, HACs during a PCI admission were associated with the highest adjusted additional mean LOS (17.5 days; 95% CI, 10.3-23.6), with also the highest adjusted additional mean cost ($22 000; 95% CI, $9100-$32 600). There were 419 509 included outpatient procedures, and 7514 (1.8%) had an unplanned admission within 7 days. A total of 17 HACs and PSIs occurred in these admissions. Conclusions and Relevance: In this cross-sectional cohort study of Medicare fee-for-service claims, patients receiving potential low-value care were exposed to risk of unnecessary harm associated with higher cost and LOS.

Overtreatment in the United States.

BACKGROUND: Overtreatment is a cause of preventable harm and waste in health care. Little is known about clinician perspectives on the problem. In this study, physicians were surveyed on the prevalence, causes, and implications of overtreatment. METHODS: 2,106 physicians from an online community composed of doctors from the American Medical Association (AMA) masterfile participated in a survey. The survey inquired about the extent of overutilization, as well as causes, solutions, and implications for health care. Main outcome measures included: percentage of unnecessary medical care, most commonly cited reasons of overtreatment, potential solutions, and responses regarding association of profit and overtreatment. FINDINGS: The response rate was 70.1%. Physicians reported that an interpolated median of 20.6% of overall medical care was unnecessary, including 22.0% of prescription medications, 24.9% of tests, and 11.1% of procedures. The most common cited reasons for overtreatment were fear of malpractice (84.7%), patient pressure/request (59.0%), and difficulty accessing medical records (38.2%). Potential solutions identified were training residents on appropriateness criteria (55.2%), easy access to outside health records (52.0%), and more practice guidelines (51.5%). Most respondents (70.8%) believed that physicians are more likely to perform unnecessary procedures when they profit from them. Most respondents believed that de-emphasizing fee-for-service physician compensation would reduce health care utilization and costs. CONCLUSION: From the physician perspective, overtreatment is common. Efforts to address the problem should consider the causes and solutions offered by physicians.

How to survive the medical misinformation mess.

Most physicians and other healthcare professionals are unaware of the pervasiveness of poor quality clinical evidence that contributes considerably to overuse, underuse, avoidable adverse events, missed opportunities for right care and wasted healthcare resources. The Medical Misinformation Mess comprises four key problems. First, much published medical research is not reliable or is of uncertain reliability, offers no benefit to patients, or is not useful to decision makers. Second, most healthcare professionals are not aware of this problem. Third, they also lack the skills necessary to evaluate the reliability and usefulness of medical evidence. Finally, patients and families frequently lack relevant, accurate medical evidence and skilled guidance at the time of medical decision-making. Increasing the reliability of available, published evidence may not be an imminently reachable goal. Therefore, efforts should focus on making healthcare professionals, more sensitive to the limitations of the evidence, training them to do critical appraisal, and enhancing their communication skills so that they can effectively summarize and discuss medical evidence with patients to improve decision-making. Similar efforts may need to target also patients, journalists, policy makers, the lay public and other healthcare stakeholders.

Levers for addressing medical underuse and overuse: achieving high-value health care.

The preceding papers in this Series have outlined how underuse and overuse of health-care services occur within a complex system of health-care production, with a multiplicity of causes. Because poor care is ubiquitous and has considerable consequences for the health and wellbeing of billions of people around the world, remedying this problem is a morally and politically urgent task. Universal health coverage is a key step towards achieving the right care. Therefore, full consideration of potential levers of change must include an upstream perspective-ie, an understanding of the system-level factors that drive overuse and underuse, as well as the various incentives at work during a clinical encounter. One example of a system-level factor is the allocation of resources (eg, hospital beds and clinicians) to meet the needs of a local population to minimise underuse or overuse. Another example is priority setting using tools such as health technology assessment to guide the optimum diffusion of safe, effective, and cost-effective health-care services. In this Series paper we investigate a range of levers for eliminating medical underuse and overuse. Some levers could operate effectively (and be politically viable) across many different health and political systems (eg, increase patient activation with decision support) whereas other levers must be tailored to local contexts (eg, basing coverage decisions on a particular cost-effectiveness ratio). Ideally, policies must move beyond the purely incremental; that is, policies that merely tinker at the policy edges after underuse or overuse arises. In this regard, efforts to increase public awareness, mobilisation, and empowerment hold promise as universal methods to reset all other contexts and thereby enhance all other efforts to promote the right care.

Evidence for underuse of effective medical services around the world.

Underuse-the failure to use effective and affordable medical interventions-is common and responsible for substantial suffering, disability, and loss of life worldwide. Underuse occurs at every point along the treatment continuum, from populations lacking access to health care to inadequate supply of medical resources and labour, slow or partial uptake of innovations, and patients not accessing or declining them. The extent of underuse for different interventions varies by country, and is documented in countries of high, middle, and low-income, and across different types of health-care systems, payment models, and health services. Most research into underuse has focused on measuring solutions to the problem, with considerably less attention paid to its global prevalence or its consequences for patients and populations. Although focused effort and resources can overcome specific underuse problems, comparatively little is spent on work to better understand and overcome the barriers to improved uptake of effective interventions, and methods to make them affordable.

Drivers of poor medical care.

The global ubiquity of overuse and underuse of health-care resources and the gravity of resulting harms necessitate an investigation of drivers to inform potential solutions. We describe the network of influences that contribute to poor care and suggest that it is driven by factors that fall into three domains: money and finance; knowledge, bias, and uncertainty; and power and human relationships. In each domain the drivers operate at the global, national, regional, and individual level, and are modulated by the specific contexts within which they act. We discuss in detail drivers of poor care in each domain.

Evidence for overuse of medical services around the world.

Overuse, which is defined as the provision of medical services that are more likely to cause harm than good, is a pervasive problem. Direct measurement of overuse through documentation of delivery of inappropriate services is challenging given the difficulty of defining appropriate care for patients with individual preferences and needs; overuse can also be measured indirectly through examination of unwarranted geographical variations in prevalence of procedures and care intensity. Despite the challenges, the high prevalence of overuse is well documented in high-income countries across a wide range of services and is increasingly recognised in low-income countries. Overuse of unneeded services can harm patients physically and psychologically, and can harm health systems by wasting resources and deflecting investments in both public health and social spending, which is known to contribute to health. Although harms from overuse have not been well quantified and trends have not been well described, overuse is likely to be increasing worldwide.