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Editor's Note: This article is a reprint of a previously published article. For citation purposes, please use the original publication details: Harris RP, Helfand M, Woolf SH, et al. Current methods of the U.S. Preventive Services Task Force: a review of the process. Am J Prev Med. 2001;20(3S):21-35. The U.S. Preventive Services Task Force (USPSTF/Task Force) represents one of several efforts to take a more evidence-based approach to the development of clinical practice guidelines. As methods have matured for assembling and reviewing evidence and for translating evidence into guidelines, so too have the methods of the USPSTF. This paper summarizes the current methods of the third USPSTF, supported by the Agency for Healthcare Research and Quality (AHRQ) and two of the AHRQ Evidence-based Practice Centers (EPCs). The Task Force limits the topics it reviews to those conditions that cause a large burden of suffering to society and that also have available a potentially effective preventive service. It focuses its reviews on the questions and evidence most critical to making a recommendation. It uses analytic frameworks to specify the linkages and key questions connecting the preventive service with health outcomes. These linkages, together with explicit inclusion criteria, guide the literature searches for admissible evidence. Once assembled, admissible evidence is reviewed at three strata: (1) the individual study, (2) the body of evidence concerning a single linkage in the analytic framework, and (3) the body of evidence concerning the entire preventive service. For each stratum, the Task Force uses explicit criteria as general guidelines to assign one of three grades of evidence: good, fair, or poor. Good or fair quality evidence for the entire preventive service must include studies of sufficient design and quality to provide an unbroken chain of evidence-supported linkages, generalizable to the general primary care population, that connect the preventive service with health outcomes. Poor evidence contains a formidable break in the evidence chain such that the connection between the preventive service and health outcomes is uncertain. For services supported by overall good or fair evidence, the Task Force uses outcomes tables to help categorize the magnitude of benefits, harms, and net benefit from implementation of the preventive service into one of four categories: substantial, moderate, small, or zero/negative. The Task Force uses its assessment of the evidence and magnitude of net benefit to make a recommendation, coded as a letter: from A (strongly recommended) to D (recommend against). It gives an I recommendation in situations in which the evidence is insufficient to determine net benefit. The third Task Force and the EPCs will continue to examine a variety of methodologic issues and document work group progress in future communications.

Changing circumstances may alter the benefit and risk profile of screening programmes. Fabienne G Ropers and colleagues propose a framework for re-evaluation to ensure continued public benefit

This chapter focuses on problems and possibilities for rational decision-making about screening. Some policy and individual decisions about screening are rational, and some are not. According to the model of rational decision-making developed at the beginning of this chapter, decision-makers should first understand the scientific evidence for benefits, harms, and costs of screening in the specific situation of interest. Many decisions made about screening, on both individual and policy levels, are not rational, often because the decision-makers are ill informed or because the actual perceptions and values of those affected were not used in making the decision. It has presented a model of rational decision-making, and explored the problems and possibilities of such a model in deciding about screening. The public and individuals need alternative sources of information about screening. In conclusion, the intuitive appeal of screening sometimes makes decision-making difficult. .

Importance Type 2 diabetes is common and is a leading cause of morbidity and disability. Objective To review the evidence on screening for prediabetes and diabetes to inform the US Preventive Services Task Force (USPSTF). Data Sources PubMed/MEDLINE, Cochrane Library, and trial registries through September 2019; references; and experts; literature surveillance through May 21, 2021. Study Selection English-language controlled studies evaluating screening or interventions for prediabetes or diabetes that was screen detected or recently diagnosed. Data Extraction and Synthesis Dual review of abstracts, full-text articles, and study quality; qualitative synthesis of findings; meta-analyses conducted when at least 3 similar studies were available. Main Outcomes and Measures Mortality, cardiovascular morbidity, diabetes-related morbidity, development of diabetes, quality of life, and harms. Results The review included 89 publications (N = 68 882). Two randomized clinical trials (RCTs) (25 120 participants) found no significant difference between screening and control groups for all-cause or cause-specific mortality at 10 years. For harms (eg, anxiety or worry), the trials reported no significant differences between screening and control groups. For recently diagnosed (not screen-detected) diabetes, 5 RCTs (5138 participants) were included. In the UK Prospective Diabetes Study, health outcomes were improved with intensive glucose control with sulfonylureas or insulin. For example, for all-cause mortality the relative risk (RR) was 0.87 (95% CI, 0.79 to 0.96) over 20 years (10-year posttrial assessment). For overweight persons, intensive glucose control with metformin improved health outcomes at the 10-year follow-up (eg, all-cause mortality: RR, 0.64 [95% CI, 0.45 to 0.91]), and benefits were maintained longer term. Lifestyle interventions (most involving >360 minutes) for obese or overweight persons with prediabetes were associated with reductions in the incidence of diabetes (23 RCTs; pooled RR, 0.78 [95% CI, 0.69 to 0.88]). Lifestyle interventions were also associated with improved intermediate outcomes, such as reduced weight, body mass index, systolic blood pressure, and diastolic blood pressure (pooled weighted mean difference, −1.7 mm Hg [95% CI, −2.6 to −0.8] and −1.2 mm Hg [95% CI, −2.0 to −0.4], respectively). Metformin was associated with a significant reduction in diabetes incidence (pooled RR, 0.73 [95% CI, 0.64 to 0.83]) and reduction in weight and body mass index. Conclusions and Relevance Trials of screening for diabetes found no significant mortality benefit but had insufficient data to assess other health outcomes; evidence on harms of screening was limited. For persons with recently diagnosed (not screen-detected) diabetes, interventions improved health outcomes; for obese or overweight persons with prediabetes, interventions were associated with reduced incidence of diabetes and improvement in other intermediate outcomes.

Rigorous evidence about the broad range of harms that might be experienced by a patient in the course of testing and treatment is sparse. We aimed to generate recommendations for how researchers might more comprehensively evaluate potential harms of healthcare interventions, to allow clinicians and patients to better include this evidence in clinical decision-making. We propose seven domains of harms of tests and treatments that are relevant to patients: (1) physical impairment, (2) psychological distress, (3) social disruption, (4) disruption in connection to healthcare, (5) labeling, (6) financial impact, and (7) treatment burden. These domains will include a range of severity of harms and variation in timing after testing or treatment, attributable to the service itself or a resulting care cascade. Although some new measures may be needed, diverse data and tools are available to allow the assessment of harms comprehensively across these domains. We encourage researchers to evaluate harms in sub-populations, since the harms experienced may differ importantly by demographics, social determinants, presence of comorbid illness, psychological state, and other characteristics. Regulators, funders, and editors might require either assessment or reporting of harms in each domain or require justification for inclusion and exclusion of different domains. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-06597-9.

Background: In their landmark report on the “Principles and Practice of Screening for Disease” (1968), Wilson and Jungner noted that the practice of screening is just as important for securing beneficial outcomes and avoiding harms as the formulation of principles. Many jurisdictions have since established various kinds of “screening governance organizations” to provide oversight of screening practice. Yet to date there has been relatively little reflection on the nature and organization of screening governance itself, or on how different governance arrangements affect the way screening is implemented and perceived and the balance of benefits and harms it delivers. Methods: An international expert policy workshop convened by Sturdy, Miller and Hogarth. Results: While effective governance is essential to promote beneficial screening practices and avoid attendant harms, screening governance organizations face enduring challenges. These challenges are social and ethical as much as technical. Evidence-based adjudication of the benefits and harms of population screening must take account of factors that inform the production and interpretation of evidence, including the divergent professional, financial and personal commitments of stakeholders. Similarly, when planning and overseeing organized screening programs, screening governance organizations must persuade or compel multiple stakeholders to work together to a common end. Screening governance organizations in different jurisdictions vary widely in how they are constituted, how they relate to other interested organizations and actors, and what powers and authority they wield. Yet we know little about how these differences affect the way screening is implemented, and with what consequences. Conclusions: Systematic research into how screening governance is organized in different jurisdictions would facilitate policy learning to address enduring challenges. Even without such research, informal exchange and sharing of experiences between screening governance organizations can deliver invaluable insights into the social as well as the technical aspects of governance.

Background. Concerns have been raised about both over- and underutilization of colorectal cancer (CRC) screening in older patients and the need to align screening behavior with likelihood of net benefit. Objective. The purpose of this study was to test a novel use of a patient decision aid (PtDA) to promote appropriate CRC screening in older adults. Methods. A total of 424 patients ages 70 to 84 y who were not up to date with CRC screening participated in a double-blinded randomized controlled trial of a PtDA targeted to older adults making decisions about whether to undergo CRC screening from March 2012 to February 2015. Intervention. Patients were randomized to a targeted PtDA or an attention control. The PtDA was designed to facilitate individualized decision making—helping patients understand the potential risks, benefits, and uncertainties of CRC screening given advanced age, health state, preferences, and values. Outcomes. Two composite outcomes, appropriate CRC screening behavior 6 mo after the index visit and appropriate screening intent immediately after the visit, were defined as completed screening or intent for patients in good health, discussion about screening with their provider for patients in intermediate health, and no screening or intent for patients in poor health. Health state was determined by age and Charlson Comorbidity Index. Results. Four hundred twelve (97%) and 421 (99%) patients were analyzed for the primary and secondary outcomes, respectively. Appropriate screening behavior at 6 mo was higher in the intervention group (55% v. 45%, P = 0.023) as was appropriate screening intent following the provider visit (61% v. 47%, P = 0.003). Limitations. The study took place in a single geographic region. The appropriate CRC screening classification system used in this study has not been formally validated. Conclusions. A PtDA for older adults promoted appropriate CRC screening behavior and intent. Trial Registration: Clinicaltrials.gov, registration number NCT01575990. https://clinicaltrials.gov/ct2/show/NCT01575990?term=epic-d&rank=1

Christine E Kistler,1 Maihan Vu,2 Anne Sutkowi-Hemstreet,3 Ziya Gizlice,4 Russell P Harris,5 Noel T Brewer,6 Carmen L Lewis,7 Rowena J Dolor,8 Colleen Barclay,5 Stacey L Sheridan9 1Department of Family Medicine, School of Medicine, 2Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, 3Napa County Office of Education, Napa, CA, 4Biostatistical Support Unit, Center for Health Promotion and Disease Prevention, 5Cecil G Sheps Center for Health Services Research, 6Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, 7Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, 8Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, 9Reaching for High Value Care Team, Chapel Hill, NC, USA Background: Primary-care providers may contribute to the use of low-value cancer screening. Objective: We sought to examine circumstances under which primary-care providers would discuss and recommend two types of cancer screening services across a spectrum of net benefit and other factors known to influence screening. Patients and methods: This was a cross sectional survey of 126 primary-care providers in 24 primary-care clinics in the US. Participants completed surveys with two hypothetical screening scenarios for prostate or colorectal cancer (CRC). Patients in the scenarios varied by age and screening-request status. For each scenario, providers indicated whether they would discuss and recommend screening. Providers also reported on their screening attitudes and the influence of other factors known to affect screening (short patient visits, worry about lawsuits, clinical reminders/performance measures, and screening guidelines). We examined associations between providers’ attitudes and their screening recommendations for hypothetical 90-year-olds (the lowest-value screening). Results: Providers reported they would discuss cancer screening more often than they would recommend it (P

In an accompanying article, Hofmann (Am J Epidemiol. 2019;188(10):1812–1817) seeks to clarify the concept of overdiagnosis by screening. He makes a helpful suggestion to reconnect diagnosis with patient suffering, pointing out the underlying issue in overdiagnosis of prognostic uncertainty. He then divides prognostic uncertainty into developmental and progression uncertainty, using a categorical model of disease progression through indicators to manifest disease. This model could be improved by considering the heterogeneity of patient-condition combinations. This leads to an understanding of the probabilistic nature of the connection between any indicator in a specific individual and patient suffering. The model also needs to consider the time span over which the patient-condition combination leads to patient suffering. I propose a simpler approach that goes further to focus not only on overdiagnosis but also on the broader problem of diagnosis without benefit and diagnosis without net benefit. This makes measurement easier and focuses attention where it belongs: on the harm caused by overly aggressive screening programs.

The primary goal of cancer screening is early detection of cancer to reduce cancer-specific mortality and morbidity. The benefits of screening in older adults are uncertain due to paucity of evidence. Extrapolating data from younger populations, evidence suggests that the benefit occurs years later from the time of initial screening and therefore may not be applicable in those older adults with limited life expectancy. Contrast this with the harms of screening, which are more immediate and increase with age and comorbidities. An individualized approach to cancer screening takes these factors into consideration, allowing for thoughtful decision making for older adults.

The U.S. Preventive Services Task Force (USPSTF) is an independent body of experts who make evidence-based recommendations about clinical preventive services using a transparent and objective process. Developing recommendations on a clinical preventive service requires evidence of its effect on health outcomes. Health outcomes are symptoms, functional levels, and conditions that affect a patient's quantity or quality of life and are measured by assessments of physical or psychologic well-being. Intermediate outcomes are pathologic, physiologic, psychologic, social, or behavioral measures related to a preventive service. Given the frequent lack of evidence on health outcomes, the USPSTF uses evidence on intermediate outcomes when appropriate. The ultimate goal is to determine precisely a consistent relationship between the direction and magnitude of change in an intermediate outcome with a predictable resultant direction and magnitude of change in the health outcomes. The USPSTF reviewed its historical use of intermediate outcomes, reviewed methods of other evidence-based guideline-making bodies, consulted with other experts, and reviewed scientific literature. Most important were the established criteria for causation, tenets of evidence-based medicine, and consistency with its current standards. Studies that follow participants over time following early treatment, stratify patients according to treatment response, and adjust for important confounders can provide useful information about the association between intermediate and health outcomes. However, such studies remain susceptible to residual confounding. The USPSTF will exercise great caution when making a recommendation that depends on the evidence linking intermediate and health outcomes because of inherent evidence limitations.

Since the 1980s, the U.S. Preventive Services Task Force (USPSTF) has developed and used rigorous methods to make evidence-based recommendations about preventive services to promote health and well-being for all Americans. Recommendations are based on the evidence of magnitude of net benefit (benefits minus harms). Expert opinion is not substituted when evidence is lacking. Evidence gaps are common. Few preventive services are supported by high-quality studies that directly and comprehensively determine the overall magnitude of benefits and harms in the same study. When assessing the body of evidence, studies may not have been conducted in primary care settings, studies may not have sufficiently included populations of interest, and long-term outcomes may not have been directly assessed. When direct evidence is not available, the USPSTF uses the methodologies of applicability to determine whether evidence can be generalized to an asymptomatic primary care population; coherence to link bodies of evidence and create an indirect evidence pathway; extrapolation to make inferences across the indirect evidence pathway, extend evidence to populations not specifically studied, consider service delivery intervals, and infer long-term outcomes; and conceptual bounding to set theoretical lower or upper limits for plausible benefits or harms. The USPSTF extends the evidence only so far as to maintain at least moderate certainty that its findings are preserved. This manuscript details with examples of how the USPSTF uses these methods to make recommendations that truly reflect the evidence.

The United States Preventive Services Task Force (USPSTF) issued recommendations for older, heavy lifetime smokers to complete annual low-dose computed tomography (LDCT) scans of the chest as screening for lung cancer. The USPSTF recommends and the Centers for Medicare and Medicaid Services require shared decision making using a decision aid for lung cancer screening with annual LDCT. Little is known about how decision aids affect screening knowledge, preferences, and behavior. Thus, we tested a lung cancer screening decision aid video in screening-eligible primary care patients. We conducted a single-group study with surveys before and after decision aid viewing and medical record review at 3 months. Participants were active patients of a large US academic primary care practice who were current or former smokers, ages 55–80 years, and eligible for screening based on current screening guidelines. Outcomes assessed pre-post decision aid viewing were screening-related knowledge score (9 items about screening-related harms of false positives and overdiagnosis, likelihood of benefit; score range = 0–9) and preference (preferred screening vs. not). Screening behavior measures, assessed via chart review, included provider visits, screening discussion, LDCT ordering, and LDCT completion within 3 months. Among 50 participants, knowledge increased from pre- to post-decision aid viewing (mean = 2.6 vs. 5.5, difference = 2.8; 95% CI 2.1, 3.6, p

Updated guidelines on breast cancer screening have been published by several major organisations over the past five years. Recommendations vary regarding both age range, screening interval, and even on whether breast screening should be offered at all. The variation between recommendations reflects substantial differences in estimates of the major benefit (breast cancer mortality reduction) and the major harm (overdiagnosis). Estimates vary considerably among randomised trials, as well as observational studies: from no benefit to large reductions, and from no overdiagnosis to substantial levels. The estimates vary according to the methodology of the randomised trials, and the design of the observational studies. Guideline recommendations reflect the choice of evidence informing them. While there are well-developed tools to deal with randomised trials in guideline work, these are not always used, or they may not be followed as recommended. Further, results of trials performed decades ago may no longer be applicable. For observational studies, the framework for inclusion in guidelines is not similarly well-developed and there are methodological concerns specific to screening interventions, such as small effects in absolute terms. There is a need for agreement on a hierarchy of observational study designs to quantify the major benefit and harm of cancer screening. This review provides a summary of recent guidelines on breast cancer screening and their major strengths and weaknesses, as well as a short overview of the major strengths and limitations of observational study designs. There is a need for agreement on a hierarchy of observational study designs in this field.

Importance Lung cancer is the leading cause of cancer-related death in the US. Objective To review the evidence on screening for lung cancer with low-dose computed tomography (LDCT) to inform the US Preventive Services Task Force (USPSTF). Data sources MEDLINE, Cochrane Library, and trial registries through May 2019; references; experts; and literature surveillance through November 20, 2020. Study selection English-language studies of screening with LDCT, accuracy of LDCT, risk prediction models, or treatment for early-stage lung cancer. Data extraction and synthesis Dual review of abstracts, full-text articles, and study quality; qualitative synthesis of findings. Data were not pooled because of heterogeneity of populations and screening protocols. Main outcomes and measures Lung cancer incidence, lung cancer mortality, all-cause mortality, test accuracy, and harms. Results This review included 223 publications. Seven randomized clinical trials (RCTs) (N = 86 486) evaluated lung cancer screening with LDCT; the National Lung Screening Trial (NLST, N = 53 454) and Nederlands-Leuvens Longkanker Screenings Onderzoek (NELSON, N = 15 792) were the largest RCTs. Participants were more likely to benefit than the US screening-eligible population (eg, based on life expectancy). The NLST found a reduction in lung cancer mortality (incidence rate ratio [IRR], 0.85 [95% CI, 0.75-0.96]; number needed to screen [NNS] to prevent 1 lung cancer death, 323 over 6.5 years of follow-up) with 3 rounds of annual LDCT screening compared with chest radiograph for high-risk current and former smokers aged 55 to 74 years. NELSON found a reduction in lung cancer mortality (IRR, 0.75 [95% CI, 0.61-0.90]; NNS to prevent 1 lung cancer death of 130 over 10 years of follow-up) with 4 rounds of LDCT screening with increasing intervals compared with no screening for high-risk current and former smokers aged 50 to 74 years. Harms of screening included radiation-induced cancer, false-positive results leading to unnecessary tests and invasive procedures, overdiagnosis, incidental findings, and increases in distress. For every 1000 persons screened in the NLST, false-positive results led to 17 invasive procedures (number needed to harm, 59) and fewer than 1 person having a major complication. Overdiagnosis estimates varied greatly (0%-67% chance that a lung cancer was overdiagnosed). Incidental findings were common, and estimates varied widely (4.4%-40.7% of persons screened). Conclusions and relevance Screening high-risk persons with LDCT can reduce lung cancer mortality but also causes false-positive results leading to unnecessary tests and invasive procedures, overdiagnosis, incidental findings, increases in distress, and, rarely, radiation-induced cancers. Most studies reviewed did not use current nodule evaluation protocols, which might reduce false-positive results and invasive procedures for false-positive results.

Background: In their landmark report on the “Principles and Practice of Screening for Disease” (1968), Wilson and Jungner noted that the practice of screening is just as important for securing beneficial outcomes and avoiding harms as the formulation of principles. Many jurisdictions have since established various kinds of “screening governance organizations” to provide oversight of screening practice. Yet to date there has been relatively little reflection on the nature and organization of screening governance itself, or on how different governance arrangements affect the way screening is implemented and perceived and the balance of benefits and harms it delivers. Methods: An international expert policy workshop convened by Sturdy, Miller and Hogarth. Results: While effective governance is essential to promote beneficial screening practices and avoid attendant harms, screening governance organizations face enduring challenges. These challenges are social and ethical as much as technical. Evidence-based adjudication of the benefits and harms of population screening must take account of factors that inform the production and interpretation of evidence, including the divergent professional, financial and personal commitments of stakeholders. Similarly, when planning and overseeing organized screening programs, screening governance organizations must persuade or compel multiple stakeholders to work together to a common end. Screening governance organizations in different jurisdictions vary widely in how they are constituted, how they relate to other interested organizations and actors, and what powers and authority they wield. Yet we know little about how these differences affect the way screening is implemented, and with what consequences. Conclusions: Systematic research into how screening governance is organized in different jurisdictions would facilitate policy learning to address enduring challenges. Even without such research, informal exchange and sharing of experiences between screening governance organizations can deliver invaluable insights into the social as well as the technical aspects of governance.

Background: Appropriate colorectal cancer screening in older adults should be aligned with the likelihood of net benefit. In general, patient decision aids improve knowledge and values clarity, but in older adults, they may also help patients identify their individual likelihood of benefit and foster individualized decision-making. We report on the design of a randomized clinical trial to understand the effects of a patient decision aid on appropriate colorectal cancer screening. This report includes a description of the baseline characteristics of participants. Methods: English-speaking primary care patients aged 70–84 years who were not currently up to date with screening were recruited into a randomized clinical trial comparing a tailored colorectal cancer screening decision aid with an attention control. The intervention group received a decision aid that included a values clarification exercise and individualized decision-making worksheet, while the control group received an educational pamphlet on safe driving behaviors. The primary outcome was appropriate screening at 6 months based on chart review. We used a composite measure to define appropriate screening as screening for participants in good health, a discussion about screening for patients in intermediate health, and no screening for patients in poor health. Health state was objectively determined using patients’ Charlson Comorbidity Index score and age. Results: A total of 14 practices in central North Carolina participated as part of a practice-based research network. In total, 424 patients were recruited to participate and completed a baseline visit. Overall, 79% of participants were White and 58% female, with a mean age of 76.8 years. Patient characteristics between groups were similar by age, gender, race, education, insurance coverage, or work status. Overall, 70% had some college education or more, 57% were married, and virtually all had Medicare insurance (90%). The three primary medical conditions among the cohort were a history of diabetes, pneumonia, and cancer (28%, 26%, and 21%, respectively). Conclusion: We designed a randomized clinical trial to test a novel use of a patient decision aid to promote appropriate colorectal cancer screening and have recruited a diverse study population that seems similar between the intervention and control groups. The study should be able to determine the ability of a patient decision aid to increase individualized and appropriate colorectal cancer screening.

Introduction Groups making recommendations need evidence about whether preventive services improve health outcomes (HOs). When such evidence is not available, groups may choose to evaluate evidence about effects on intermediate outcomes (IOs) and the link between IOs and HOs. This paper aims to describe considerations for assessing the evidence linking changes in IOs to changes in HOs. Methods Working definitions of IOs, HOs, and other outcomes were developed. All current U.S. Preventive Services Task Force (USPSTF) recommendations through April 2016 were examined to identify how evidence of the IO–HO link was gathered and the criteria that appeared to be used to determine the adequacy of the evidence. Methods of other expert and recommendation-making groups were also examined. Results Forty-four USPSTF recommendations involved a relevant IO–HO link. The approaches used most commonly to gather evidence about the link were selected review (19 of 44, 43%) and systematic review (12 of 44, 27%). Some key considerations when assessing the adequacy of evidence about the IO–HO link include adjustment for confounding, proximity of the IO to the HO in the causal pathway, and independence of IO–HO relationship from specific treatments. Conclusions Considerations were identified for recommendation-making groups to use when gathering and assessing the adequacy of evidence about the IO–HO link. Using a standard set of written principles could improve the transparency of assessments of the IO–HO link, especially if used together with judgment in a reasoned conjecture and refutation process. Ideally, the process would result in an estimate of the magnitude of change in HOs that is expected for specified changes in IOs.

New guidelines from the American Gastroenterological Association on the management of incidental pancreatic cysts recommend less aggressive evaluation than previous recommendations from other group...

Importance Many adverse health outcomes are associated with obstructive sleep apnea (OSA). Objective To review primary care–relevant evidence on screening adults for OSA, test accuracy, and treatment of OSA, to inform the US Preventive Services Task Force. Data Sources MEDLINE, Cochrane Library, EMBASE, and trial registries through October 2015, references, and experts, with surveillance of the literature through October 5, 2016. Study Selection English-language randomized clinical trials (RCTs); studies evaluating accuracy of screening questionnaires or prediction tools, diagnostic accuracy of portable monitors, or association between apnea-hypopnea index (AHI) and health outcomes among community-based participants. Data Extraction and Synthesis Two investigators independently reviewed abstracts and full-text articles. When multiple similar studies were available, random-effects meta-analyses were conducted. Main Outcomes and Measures Sensitivity, specificity, area under the curve (AUC), AHI, Epworth Sleepiness Scale (ESS) scores, blood pressure, mortality, cardiovascular events, motor vehicle crashes, quality of life, and harms. Results A total of 110 studies were included (N = 46 188). No RCTs compared screening with no screening. In 2 studies (n = 702), the screening accuracy of the multivariable apnea prediction score followed by home portable monitor testing for detecting severe OSA syndrome (AHI ≥30 and ESS score >10) was AUC 0.80 (95% CI, 0.78 to 0.82) and 0.83 (95% CI, 0.77 to 0.90), respectively, but the studies oversampled high-risk participants and those with OSA and OSA syndrome. No studies prospectively evaluated screening tools to report calibration or clinical utility for improving health outcomes. Meta-analysis found that continuous positive airway pressure (CPAP) compared with sham was significantly associated with reduction of AHI (weighted mean difference [WMD], −33.8 [95% CI, −42.0 to −25.6]; 13 trials, 543 participants), excessive sleepiness assessed by ESS score (WMD, −2.0 [95% CI, −2.6 to −1.4]; 22 trials, 2721 participants), diurnal systolic blood pressure (WMD, −2.4 points [95% CI, −3.9 to −0.9]; 15 trials, 1190 participants), and diurnal diastolic blood pressure (WMD, −1.3 points [95% CI, −2.2 to −0.4]; 15 trials, 1190 participants). CPAP was associated with modest improvement in sleep-related quality of life (Cohen d, 0.28 [95% CI, 0.14 to 0.42]; 13 trials, 2325 participants). Mandibular advancement devices (MADs) and weight loss programs were also associated with reduced AHI and excessive sleepiness. Common adverse effects of CPAP and MADs included oral or nasal dryness, irritation, and pain, among others. In cohort studies, there was a consistent association between AHI and all-cause mortality. Conclusions and Relevance There is uncertainty about the accuracy or clinical utility of all potential screening tools. Multiple treatments for OSA reduce AHI, ESS scores, and blood pressure. Trials of CPAP and other treatments have not established whether treatment reduces mortality or improves most other health outcomes, except for modest improvement in sleep-related quality of life.

The economics of installing solar photovoltaics (PV) is significantly affected by the customer’s offer for grid-supplied electricity. In the deregulated retail electricity market in Victoria, Australia, these offers vary widely. This analysis finds median payback periods for PV installation in Victoria of 12 years, using current PV costs and the median of all retail offers. But the payback period ranges between 6 and 19 years on different offers. Median payback periods reduce to 8 years if feed-in rates are increased by 5 cents per kWh and reduce further to 7 years if fixed daily charges in retail tariffs are converted into variable charges.

Objective To systematically review the observational evidence concerning the effect of screening on breast cancer mortality in actual populations of women ages 50–69 years. Methods We searched MEDLINE and multiple reference lists for relevant cohort and ecologic studies. At least 2 authors reviewed abstracts and full texts of studies meeting eligibility criteria. We rated each accepted study on standard quality criteria and developed a Summary Evidence Table. Results Seventeen studies met eligibility criteria. Five studies found no to small effect of screening (0–12% relative risk reduction [RRR] in breast cancer mortality), 4 found a large effect (greater than 33% RRR), and 8 found a moderate effect (13% to 33% reduction). The authors found concerns about quality in all studies. There was insufficient evidence to determine whether the effectiveness of screening is decreasing over time. Conclusions Current observational evidence shows that breast cancer screening in actual populations of women ages 50 to 69 reduces breast cancer mortality; the magnitude of the effect is probably smaller than predicted in the randomized controlled trials. Because the magnitude may change (either increase or decrease) in the future, further ecologic studies are needed. The methodology and infrastructure for these studies should be improved.

Objective. To examine the effects of a community-based intervention on decisions about prostate-specific antigen (PSA) screening using multiple measures of informed decision making (IDM). Data Sources/Study Setting. Nonequivalent control group time series design collecting primary data in late 2004 and 2005. Study Design. We developed a multimodal intervention designed to convey the medical uncertainty about the benefits of PSA screening and early treatment and the limited predictive ability of both the PSA test and pathological specimens collected from prostate biopsy. We examined (1) patients' recognition that there is a decision to be made about PSA screening, (2) prostate cancer knowledge levels, (3) their preferred and actual levels of participation in decision making about screening at three points in time, and (4) screening decision. Data Collection. Baseline data collection occurred in community-based organizations. These organizations served as recruiting sources and as sites for the intervention. We collected follow-up data by mail with telephone reminders. Principal Findings. Our intervention was associated with greater recognition of the PSA test as a decision to be made, levels of knowledge, both preferred and actual levels of involvement in decision making, but did not have an impact on the screening decision. Conclusions. Community-based interventions can influence key measures of IDM about PSA screening.

The National Lung Screening Trial (NLST) is a randomized multicenter study comparing low-dose helical computed tomography (CT) with chest radiography in the screening of older current and former heavy smokers for early detection of lung cancer, which is the leading cause of cancer-related death in the United States. Five-year survival rates approach 70% with surgical resection of stage IA disease; however, more than 75% of individuals have incurable locally advanced or metastatic disease, the latter having a 5-year survival of less than 5%. It is plausible that treatment should be more effective and the likelihood of death decreased if asymptomatic lung cancer is detected through screening early enough in its preclinical phase. For these reasons, there is intense interest and intuitive appeal in lung cancer screening with low-dose CT. The use of survival as the determinant of screening effectiveness is, however, confounded by the well-described biases of lead time, length, and overdiagnosis. Despite previous attempts, no test has been shown to reduce lung cancer mortality, an endpoint that circumvents screening biases and provides a definitive measure of benefit when assessed in a randomized controlled trial that enables comparison of mortality rates between screened individuals and a control group that does not undergo the screening intervention of interest. The NLST is such a trial. The rationale for and design of the NLST are presented.

The randomized controlled trials (RCTs) of breast cancer screening were conducted 20–50 years in the past. Since that time, such critical factors as women’s risk, screening technology, and breast cancer treatment have all evolved. This makes us less certain that we can trust the RCTs to inform decision makers of the benefits and harms of screening in today’s world. Because of several important inherent problems of RCTs, many have turned to observational studies to provide evidence relevant to the current day. Unfortunately, observational studies also have important limitations that make us question their results. There are ways, however, to improve the validity and reliability of observational studies. An international team of independent experts should develop standards for trustworthy observational studies of screening that can then be carried out in an ongoing way to monitor the benefits and harms of screening.

Importance Healthcare overuse, the delivery of low-value services, is increasingly recognized as a critical problem. However, little is known about the comparative effectiveness of alternate formats for presenting benefits and harms information to patients as a strategy to reduce overuse. Objective To examine the effect of different benefits and harms presentations on patients’ intentions to accept low-value or potentially low-value screening services (prostate cancer screening in men ages 50-69 years; osteoporosis screening in low-risk women ages 50-64 years; or colorectal cancer screening in men and women ages 76-85 years). Design, Setting, and Participants Randomized clinical trial of 775 individuals eligible to receive information about any 1 of the 3 screening services and scheduled for a visit with their clinician. Participants were randomized to 1 of 4 intervention arms that differed in terms of presentation format: words, numbers, numbers plus narrative, and numbers plus framed presentation. The trial was conducted from September 2012 to June 2014 at 2 family medicine and 2 internal medicine practices affiliated with the Duke Primary Care Research Consortium. The data were analyzed between May and September of 2015. Interventions One-page evidence-based decision support sheets on each of the 3 screening services, with benefits and harms information presented in 1 of 4 formats: words, numbers, numbers plus narratives, or numbers plus a framed presentation. Main Outcomes and Measures The primary outcome was change in intention to accept screening (on a response scale from 1 to 5). Our secondary outcomes included general and disease-specific knowledge, perceived risk and consequences of disease, screening attitudes, perceived net benefit of screening, values clarity, and self-efficacy for screening. Results We enrolled and randomly allocated 775 individuals, aged 50 to 85 years, to 1 of 4 intervention arms: 195 to words, 192 to numbers, 196 to narrative, and 192 to framed formats. Intentions to accept screening were high before the intervention and change in intentions did not differ across intervention arms (words, −0.07; numbers, −0.05; numbers plus narrative, −0.12; numbers plus framed presentation, −0.02; P = .57 for all comparisons). Change in other outcomes also showed no difference across intervention arms. Results were similar when stratified by screening service. Conclusions and Relevance Single, brief, written decision support interventions, such as the ones in this study, are unlikely to be sufficient to change intentions for screening. Alternate and additional interventions are needed to reduce overused screening services. Trial Registration clinicaltrials.gov Identifier:NCT01694784

The US Preventive Services Task Force (USPSTF) concludes that the evidence is insufficient to recommend for or against routine use of brief, formal screening instruments in primary care to detect speech and language delay in children up to 5 years of age (I recommendation; see Appendix 1). Speech and language delay affects 5% to 8% of preschool children, often persists into the school years, and may be associated with lowered school performance and psychosocial problems. The USPSTF found insufficient evidence that brief, formal screening instruments that are suitable for use in primary care for assessing speech and language development can accurately identify children who would benefit from further evaluation and intervention. Fair evidence suggests that interventions can improve the results of short-term assessments of speech and language skills; however, no studies have assessed long-term outcomes. Furthermore, no studies have assessed any additional benefits that may be gained by treating children who are identified through brief, formal screening who would not be identified by addressing clinical or parental concerns. No studies have addressed the potential harms of screening or interventions for speech and language delays, such as labeling, parental anxiety, or unnecessary evaluation and intervention. Thus, the USPSTF could not determine the balance of benefits and harms of using brief, formal screening instruments to screen for speech and language delay in the primary care setting. Address correspondence to Ned Calonge, MD, MPH, US Preventive Services Task Force, Agency for Healthcare Research and Quality, 540 Gaither Rd, Rockville, MD 20850. E-mail: uspstf{at}ahrq.gov

Shared decision making is a process in which patients are involved as active partners with the clinician in clarifying acceptable medical options and in choosing a preferred course of clinical care. Shared decision making offers a way of individualizing recommendations, according to patients' special needs and preferences, when some patients may benefit from an intervention but others may not. This paper clarifies how the U.S. Preventive Services Task Force (USPSTF) envisions the application of shared decision making in the execution of screening and chemoprevention. Unlike conventional USPSTF reports, this paper is neither a systematic review nor a formal recommendation. Instead, it is a concept paper that includes a commentary on the current thinking and evidence regarding shared decision making. Although the USPSTF does not endorse a specific style of decision making, it does encourage informed and joint decisions. This means that patients should be informed about preventive services before they are performed, and that the patient-clinician partnership is central to decision making. The USPSTF suggests that clinicians inform patients about preventive services for which there is clear evidence of net benefit, and, if time permits, about other services with high visibility or special individual importance. Clinicians should make sure that balanced, evidence-based information about the service (including the potential benefits and harms, alternatives, and uncertainties) is available to the patient if needed. For preventive services for which the balance of potential benefits and harms is a close call, or for which the evidence is insufficient to guide a decision for or against screening, clinicians should additionally assist patients in determining whether individual characteristics and personal preferences favor performing or not performing the preventive service. The USPSTF believes that clinicians generally have no obligation to initiate discussion about services that have either no benefit or net harm. Nonetheless, clinicians should be prepared to explain why these services are discouraged and should consider a proactive discussion for services with high visibility or special individual importance or for services for which new evidence has prompted withdrawal of previous recommendations.

Objective To systematically review the evidence for screening for gestational diabetes mellitus (GDM). Data sources We established eligibility criteria for relevant studies. We systematically searched MEDLINE and the Cochrane Collaboration Library for studies meeting eligibility criteria. We supplemented this search with further studies identified from reference lists of reviews. Methods of study selection Two reviewers examined each article for eligibility. A single reviewer abstracted relevant data from the included articles; a second reviewer checked the abstractions. We graded the quality of the articles according to criteria developed by the U.S. Preventive Services Task Force. Tabulation, integration, and results No well-conducted, randomized, controlled trial provides direct evidence for the health benefits of screening for GDM. The evidence is unclear regarding the optimal screening and reference diagnostic test for GDM. The impact of hyperglycemia on adverse maternal and neonatal health outcomes is probably continuous. Although insulin therapy decreases the incidence of fetal macrosomia for those women with more severe degrees of hyperglycemia, the magnitude of any effect on maternal and neonatal health outcomes is not clear. The evidence is insufficient to determine the magnitude of health benefit for any treatment among the large number of women with GDM at milder degrees of hyperglycemia. We found limited evidence regarding the potential adverse effects of screening for GDM. Conclusion Because of the lack of high-quality evidence concerning critical issues, we are unable to determine the extent to which screening has an important impact on maternal and neonatal health outcomes. A randomized, controlled trial of screening is necessary to answer the many remaining questions.

Objective To determine the optimal method for quantifying and monitoring overdiagnosis in cancer screening over time. Design Systematic review of primary research studies of any design that quantified overdiagnosis from screening for nine types of cancer. We used explicit criteria to critically appraise individual studies and assess strength of the body of evidence for each study design (double blinded review), and assessed the potential for each study design to accurately quantify and monitor overdiagnosis over time. Data sources PubMed and Embase up to 28 February 2014; hand searching of systematic reviews. Eligibility criteria for selecting studies English language studies of any design that quantified overdiagnosis for any of nine common cancers (prostate, breast, lung, colorectal, melanoma, bladder, renal, thyroid, and uterine); excluded case series, case reports, and reviews that only reported results of other studies. Results 52 studies met the inclusion criteria. We grouped studies into four methodological categories: (1) follow-up of a well designed randomized controlled trial (n=3), which has low risk of bias but may not be generalizable and is not suitable for monitoring; (2) pathological or imaging studies (n=8), drawing conclusions about overdiagnosis by examining biological characteristics of cancers, a simple design limited by the uncertain assumption that the measured characteristics are highly correlated with disease progression; (3) modeling studies (n=21), which can be done in a shorter time frame but require complex mathematical equations simulating the natural course of screen detected cancer, the fundamental unknown question; and (4) ecological and cohort studies (n=20), which are suitable for monitoring over time but are limited by a lack of agreed standards, by variable data quality, by inadequate follow-up time, and by the potential for population level confounders. Some ecological and cohort studies, however, have addressed these potential weaknesses in reasonable ways. Conclusions Well conducted ecological and cohort studies in multiple settings are the most appropriate approach for quantifying and monitoring overdiagnosis in cancer screening programs. To support this work, we need internationally agreed standards for ecological and cohort studies and a multinational team of unbiased researchers to perform ongoing analysis.

ObjectiveA potential psychological harm of screening is unexpected diagnosis—labelling. We need to know the frequency and severity of this harm to make informed decisions about screening. We asked whether current evidence allows an estimate of any psychological harm of labelling. As case studies, we used two conditions for which screening is common: prostate cancer (PCa) and abdominal aortic aneurysm (AAA).DesignSystematic review with narrative synthesis.Data sources and eligibility criteriaWe searched the English language literature in PubMed, PsychINFO and Cumulative Index of Nursing and Allied Health Literature (CINAHL) for research of any design published between 1 January 2002 and 23 January 2017 that provided valid data about the psychological state of people recently diagnosed with early stage PCa or AAA. Two authors independently used explicit criteria to review and critically appraise all studies for bias, applicability and the extent to which it provided evidence about the frequency and severity of harm from labelling.Results35 quantitative studies (30 of PCa and 5 of AAA) met our criteria, 17 (48.6%) of which showed possible or definite psychological harm from labelling. None of these studies, however, had either appropriate measures or relevant comparisons to estimate the frequency and severity of psychological harm. Four PCa and three AAA qualitative studies all showed clear evidence of at least moderate psychological harm from labelling. Seven population-based studies found increased suicide in patients recently diagnosed with PCa.ConclusionsAlthough qualitative and population-based studies show that at least moderate psychological harm due to screening for PCa and AAA does occur, the current quantitative evidence is insufficient to allow a more precise estimation of frequency and severity. More sensitive measures and improved research designs are needed to fully characterise this harm. In the meantime, clinicians and recommendation panels should be aware of the occurrence of this harm.

BACKGROUND: Systematic reviews for the US Preventive Services Task Force have found less high-quality evidence on psychological than physical harms of screening. To understand the extent of evidence on psychological harms, we developed an evidence map that quantifies the distribution of evidence on psychological harms for five adult screening services. We also note gaps in the literature and make recommendations for future research. METHODS: We systematically searched PubMed, PsycInfo, and CINAHL from 2002 to 2012 for studies of any research design that assessed the burden or frequency of psychological harm associated with screening for: prostate and lung cancers, osteoporosis, abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS). We also searched for studies that estimated rates of overdiagnosis (a marker for unnecessary labeling). We included studies published in English and used dual independent review to determine study inclusion and to abstract information on design, types of measures, and outcomes assessed. RESULTS: Sixty-eight studies assessing psychological harms met our criteria; 62 % concerned prostate cancer and 16 % concerned lung cancer. Evidence was scant for the other three screening services. Overall, only about one-third of the studies used both longitudinal designs and condition-specific measures (ranging from 0 % for AAA and CAS to 78 % for lung cancer), which can provide the best evidence on harms. An additional 20 studies that met our criteria estimated rates of overdiagnosis in lung or prostate cancer. No studies estimated overdiagnosis for the non-cancer screening services. DISCUSSION: Evidence on psychological harms varied markedly across screening services in number and potential usefulness. We found important evidence gaps for all five screening services. The evidence that we have on psychological harms is inadequate in number of studies and in research design and measures. Future research should focus more clearly on the evidence that we need for decision making about screening.

Approximately 10% of ischemic strokes are caused by carotid artery stenosis (CAS). Estimated prevalence of asymptomatic CAS is 1%.To evaluate evidence on screening and treating asymptomatic adults for CAS.MEDLINE, the Cochrane Library, EMBASE, and trial registries through September 2013; MEDLINE through March 2014 for trials.Good- or fair-quality trials of screening, carotid endarterectomy (CEA), or stenting compared with medical therapy or of intensification of medical therapy; systematic reviews; multi-institution studies reporting harms; and externally validated risk-stratification tools.Dual extraction and quality assessment.No trials compared screening with no screening or stenting with medical therapy or assessed intensification of medical therapy, and no externally validated, reliable risk-stratification tools were found. Given the specificity of ultrasonography (range, 88% to 94% for CAS ≥ 50% to ≥ 70%), its use in low-prevalence populations would yield many false-positive results. Absolute reduction of nonperioperative strokes was 5.5% (95% CI, 3.9% to 7.0%; 3 trials; 5223 participants) over approximately 5 years for CEA compared with medical therapy. The 30-day rates of stroke or death after CEA in trials and cohort studies were 2.4% (CI, 1.7% to 3.1%; 6 trials; 3435 participants) and 3.3% (CI, 2.7% to 3.9%; 7 studies; 17474 participants), respectively. Other harms of interventions included myocardial infarction, nerve injury, and hematoma.Trials may have overestimated benefits and used highly selected surgeons. Medical therapy used in trials was outdated, and stroke rates have declined in recent decades. Harms may have been underreported.Current evidence does not establish incremental overall benefit of CEA, stenting, or intensification of medical therapy. Potential for overall benefit is limited by low prevalence and harms.Agency for Healthcare Research and Quality.

Description: The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the utility of screening pelvic examination for the detection of pathology in asymptomatic, nonpregnant, adult women. Methods: This guideline is based on a systematic review of the published literature in the English language from 1946 through January 2014 identified using MEDLINE and hand-searching. Evaluated outcomes include morbidity; mortality; and harms, including overdiagnosis, overtreatment, diagnostic procedure–related harms, fear, anxiety, embarrassment, pain, and discomfort. The target audience for this guideline includes all clinicians, and the target patient population includes asymptomatic, nonpregnant, adult women. This guideline grades the evidence and recommendations using the ACP’s clinical practice guidelines grading system. Recommendation: ACP recommends against performing screening pelvic examination in asymptomatic, nonpregnant, adult women (strong recommendation, moderate-quality evidence).

In recent years, there has been a growing interest in reducing the overuse of healthcare services. However, little is known about how patients conceptualize the benefits and harms of overused screening tests or how patients make decisions regarding these tests.To determine how patients think about the harms and benefits of overused screening tests and how they consider these and other factors when making decisions.Semi-structured, qualitative interviews.The study comprised 50 patients, ages 50-84, who had previously received or not received any of four overused screening services: 1) prostate cancer screening (men ages 50-69), 2) colon cancer screening (men and women ages 76-85), 3) osteoporosis screening (low-risk women ages 50-64), or 4) cardiovascular disease screening (low-risk men and women ages 50-85).We conducted a thematic analysis, using a hybrid inductive-deductive approach. Two independent coders analyzed interview transcriptions to identify themes and exemplifying quotes.Many patients could not name a harm of screening. When they did name harms, patients often focused on only the harms of the screening test itself and rarely mentioned harms further along the screening cascade (e.g., from follow-up testing and treatment). In contrast, patients could easily name benefits of screening, although many seemed to misunderstand or overestimate the magnitude of the benefits. Furthermore, patients described many additional factors they considered when making screening decisions, including their clinicians' recommendations, their age, family or friends' experiences with disease, and insurance coverage.This study highlights the need to help adults recognize and understand the benefits and harms of screening and make appropriate decisions about overused screening tests.

To assess the validity of retrospective medical chart review as a method of classifying prostate-specific antigen (PSA) tests as screening or diagnostic services, we reviewed PSA tests ordered at a university hospital ( n = 95). PSA tests were reviewed by four raters: medicine resident (RES), oncologist (ONC), urologist (UR), medicine attending (GM)−and the physician who ordered the PSA test (ATTEND) using predefined standardized criteria. Agreement rates by individual rater and ATTEND were 0.79 (GM), 0.80 (ONC), 0.74 (UR), 0.83 (RES), for a composite percent agreement of 0.79. ATTEND incorrectly classified seven tests; exclusion of these tests raised agreement rates to 0.86 (GM), 0.86 (ONC), 0.80 (UR), 0.90 (RES), for a group composite percent agreement of 0.86. Of note, two raters had higher agreement rates when evaluating screening PSA tests than when evaluating diagnostic PSA tests. Standardized criteria applied to medical charts provide a valid method of retrospectively classifying PSA tests.

Studies of the effectiveness of breast cancer screening for women in their forties show that the probabil- ity of benefit is relatively small and, for some women, may be outweighed by the probability of harm. Thus, screening for breast cancer in this age group is a "close call" on which reasonable women may disagree. Many women in their forties, however, are being screened. We suggest that few truly understand the issues involved in this decision. In this paper, we examine the potential benefits and harms of breast cancer screening for women ages 40-49 and consider a strategy for helping women make informed decisions about screening: shared decision making. Shared decision making involves framing breast cancer screening as a decision that could reasonably be decided either for or against screening; giving the patient evidence-based information about the decision in an understandable format; and assisting the pa- tient to use her values to close on a decision. We believe that this approach will eventually become the standard of care not only for breast cancer screening for women in their forties, but for older women (and other issues), as well.