J. Bruin Rugge

Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force.

BACKGROUND Screening can detect prostate cancer at earlier, asymptomatic stages, when treatments might be more effective. PURPOSE To update the 2002 and 2008 U.S. Preventive Services Task Force evidence reviews on screening and treatments for prostate cancer. DATA SOURCES MEDLINE (2002 to July 2011) and the Cochrane Library Database (through second quarter of 2011). STUDY SELECTION Randomized trials of prostate-specific antigen-based screening, randomized trials and cohort studies of prostatectomy or radiation therapy versus watchful waiting, and large observational studies of perioperative harms. DATA EXTRACTION Investigators abstracted and checked study details and quality using predefined criteria. DATA SYNTHESIS Of 5 screening trials, the 2 largest and highest-quality studies reported conflicting results. One found that screening was associated with reduced prostate cancer-specific mortality compared with no screening in a subgroup of men aged 55 to 69 years after 9 years (relative risk, 0.80 [95% CI, 0.65 to 0.98]; absolute risk reduction, 0.07 percentage point). The other found no statistically significant effect after 10 years (relative risk, 1.1 [CI, 0.80 to 1.5]). After 3 or 4 screening rounds, 12% to 13% of screened men had false-positive results. Serious infections or urine retention occurred after 0.5% to 1.0% of prostate biopsies. There were 3 randomized trials and 23 cohort studies of treatments. One good-quality trial found that prostatectomy for localized prostate cancer decreased risk for prostate cancer-specific mortality compared with watchful waiting through 13 years of follow-up (relative risk, 0.62 [CI, 0.44 to 0.87]; absolute risk reduction, 6.1%). Benefits seemed to be limited to men younger than 65 years. Treating approximately 3 men with prostatectomy or 7 men with radiation therapy instead of watchful waiting would each result in 1 additional case of erectile dysfunction. Treating approximately 5 men with prostatectomy would result in 1 additional case of urinary incontinence. Prostatectomy was associated with perioperative death (about 0.5%) and cardiovascular events (0.6% to 3%), and radiation therapy was associated with bowel dysfunction. LIMITATIONS Only English-language articles were included. Few studies evaluated newer therapies. CONCLUSION Prostate-specific antigen-based screening results in small or no reduction in prostate cancer-specific mortality and is associated with harms related to subsequent evaluation and treatments, some of which may be unnecessary. PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality.

Screening and treatment of thyroid dysfunction: an evidence review for the U.S. Preventive Services Task Force.

An estimated 5% of women and 3% of men in the United States have subclinical thyroid dysfunction (1), and approximately 0.5% of the population may have undiagnosed overt thyroid disease (2, 3). Subclinical thyroid dysfunction is defined as elevated or low results on a thyroid-stimulating hormone (TSH) test (reference range, 0.45 to 4.50 mIU/L) in the setting of normal thyroid hormone levels. Overt thyroid disease is defined by the presence of abnormal thyroid hormone (free thyroxine, with or without triiodothyronine) levels (4, 5) (Table 1). In some studies, subclinical hypothyroidism is associated with increased risk for coronary artery disease (6, 7); congestive heart failure (8); and subclinical hyperthyroidism with increased risk for all-cause and coronary heart disease mortality, atrial fibrillation (9), and decreased bone density (5). Overt thyroid disease is associated with negative cardiovascular, musculoskeletal, dermatologic, gastrointestinal, and other effects, but clinical manifestations are highly variable and depend on the severity of thyroid abnormalities. Thyroid screening could identify persons with subclinical as well as undiagnosed overt thyroid dysfunction who could potentially benefit from treatment to reduce the risk for adverse health outcomes. Table 1. Classification of Thyroid Dysfunction: Biochemical Definition In 2004, the U.S. Preventive Services Task Force (USPSTF) found insufficient evidence to recommend for or against thyroid screening in asymptomatic, nonpregnant adults. Although the USPSTF concluded that subclinical hypothyroidism is a risk factor for overt thyroid disease, it found insufficient data to estimate effects of early treatment on clinical outcomes. A contemporaneous systematic review conducted for the American Thyroid Association, the American Association of Clinical Endocrinologists, and the Endocrine Society reached similar conclusions (5). Nonetheless, prescribing rates for thyroid medication in the United States have increased dramatically, from an estimated 49.8 million in 2006 to 70.5 million in 2010 (10). Among community-dwelling persons who are older than 65 years with subclinical hypothyroidism, the proportion receiving thyroid hormone has more than doubled, from 8.1% to 20.0%, between 1989 and 2005 (11). This report was commissioned by the USPSTF to update its 2004 recommendation on thyroid screening. It builds on a 2011 comparative-effectiveness review funded by the Agency for Healthcare Research and Quality (12) and previous USPSTF reviews on identification and treatment of subclinical thyroid dysfunction (1, 13). Before updating its 2004 recommendation, the USPSTF determined that in addition to subclinical thyroid dysfunction, screening could also identify undiagnosed overt thyroid disease (2, 3); therefore, the decision to screen should also consider the potential benefits and harms of identifying and treating undiagnosed overt disease. Therefore, this update differs from previous USPSTF reviews and the 2011 review in that it also addresses identification and treatment of undiagnosed overt thyroid disease. Methods Key Questions and Analytic Framework We developed a review protocol and analytic framework (Supplement 1) that included the following key questions: Supplement 1. Analytic Framework 1. Does screening for thyroid dysfunction reduce morbidity and mortality? 2. What are the harms of screening? 3. Does treating screen-detected overt or subclinical thyroid dysfunction improve: a) mortality and morbidity? or b) intermediate outcomes? 4. What are the harms of treating thyroid dysfunction detected by screening? Detailed methods and data for this review, including search strategies, inclusion criteria, abstraction and quality rating tables, and evidence on benefits and harms of treatment of subclinical hyperthyroidism, are in the full report (14). The protocol was developed using a standardized process with input from the USPSTF, experts, and the public. The analytic framework addresses direct evidence on benefits and harms of thyroid screening, as well as benefits and harms of treatment of subclinical or overt thyroid dysfunction. Data Sources and Searches A research librarian searched MEDLINE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews from 2002 to mid-July 2014 for subclinical hypothyroidism and hyperthyroidism and without a previous date limitation for overt hypothyroidism and hyperthyroidism (Supplement 2). Additional studies were identified from a review of reference lists of relevant articles and peer-review suggestions. Supplement 2. Search Strategies Study Selection Two investigators independently evaluated each study at the title or abstract and full-text article stages to determine eligibility for inclusion. We included randomized trials and observational studies of thyroid screening versus no screening in adults (excluding pregnant women) without a history of thyroid dysfunction or obvious goiter, nodules, or symptoms, following the protocol. We also included studies of treatment versus no treatment in adults with subclinical or overt thyroid dysfunction. Screening was based on TSH testing, with follow-up testing of thyroid hormone levels (free thyroxine, with or without triiodothyronine). Studies of patients with subclinical hypothyroidism due to Hashimoto thyroiditis (based on antibody testing) were included if they did not describe enrollment of symptomatic patients. Clinical outcomes were cardiovascular end points (cardiovascular disease, coronary artery disease or congestive heart failure, and atrial fibrillation); fractures; measures of quality of life or cognitive function; and harms, including those related to overreplacement (such as negative effects on bone mineral density or atrial fibrillation). Intermediate outcomes were effects on lipid levels, blood pressure, weight change, and bone mineral density. We restricted inclusion to English-language articles and excluded studies published only as abstracts. The literature flow diagram is shown in Supplement 3. Supplement 3. Literature Flow Diagram Data Abstraction and Quality Assessment One investigator abstracted details about the study design, patient population, setting, screening method, interventions, data analysis, and results, and another investigator verified data abstraction for accuracy. Two investigators independently applied criteria developed by the USPSTF to rate the quality of each study as good, fair, or poor (15, 16). Discrepancies were resolved through a consensus process. For all studies, we evaluated applicability to populations likely to be encountered in primary care screening settings. Data Synthesis and Analysis We assessed the aggregate internal validity (quality) of the body of evidence for each key question (good, fair, or poor) using methods developed by the USPSTF, on the basis of aggregate study quality, precision of estimates, consistency of results among studies, and directness of evidence (15, 16). A meta-analysis was not performed because of the methodological and clinical diversity among the included studies. Role of the Funding Source This research was funded by the Agency for Healthcare Research and Quality (AHRQ) under a contract to support the work of the USPSTF. Investigators worked with USPSTF members and AHRQ staff to develop the scope, analytic framework, and key questions. The funding source had no role in study selection, quality assessment, or data synthesis. Agency for Healthcare Research and Quality staff provided project oversight; reviewed the report to ensure that the analysis met methodological standards; and distributed the draft for peer review, including representatives of professional societies and federal agencies. The investigators are solely responsible for the content and the decision to submit the manuscript for publication. Results No study compared clinical benefits or harms in persons screened versus not screened for thyroid dysfunction (the first 2 key questions). We identified 11 trials (in 14 publications) and 1 retrospective cohort study on treatment of subclinical hypothyroidism (1731). Two studies examined treatment of subclinical hyperthyroidism but were poor-quality and evaluated intermediate outcomes (32, 33); they are discussed in the full report (14). No study addressed treatment versus no treatment of screen-detected, undiagnosed overt hypothyroidism. Three trials were rated good-quality (22, 27, 28), 6 trials (reported in 7 publications) were rated fair-quality (1821, 23, 24, 26), and 4 trials (in 5 publications) were rated poor-quality (17, 3033). The retrospective cohort study was rated fair-quality (29). Most of the poor-quality studies were characterized by poor reporting of methods (such as methods of randomization, allocation concealment, blinding, and reporting of attrition) rather than clearly inadequate methods. None of the trials were conducted in the United States. The TSH values used to diagnose subclinical thyroid dysfunction at baseline ranged from 4.1 to 11.0 mIU/L. Mean patient ages ranged from 32 years to older than 70 years. Treatment of subclinical hypothyroidism was levothyroxine using different dosing regimens. Study duration ranged from 4 to 12 months, except for the cohort study, which analyzed data with up to a 7.6-year follow-up (29). Sample sizes in the trials ranged from 14 to 120 patients; the cohort study analyzed 4735 patients (29). Whereas most studies evaluated a placebo comparator, 3 used a no-treatment comparison (18, 19, 29). Three trials (in 4 publications) specifically evaluated screen-detected populations (17, 20, 21, 27). Most other trials did not clearly report how patients were identified, other than that they were recruited from outpatient clinics. Trials generally reported that patients were newly diagnosed and excluded those with previous thyroid dysfunction or previous receipt of antithyroid medications.

Perceptions of Shared Decision Making and Decision Aids Among Rural Primary Care Clinicians

Background Shared decision making (SDM) and decision aids (DAs) increase patients’ involvement in health care decisions and enhance satisfaction with their choices. Studies of SDM and DAs have primarily occurred in academic centers and large health systems, but most primary care is delivered in smaller practices, and over 20% of Americans live in rural areas, where poverty, disease prevalence, and limited access to care may increase the need for SDM and DAs. Objective To explore perceptions and practices of rural primary care clinicians regarding SDM and DAs. Design Cross-sectional survey. Setting and Participants Primary care clinicians affiliated with the Oregon Rural Practice-based Research Network. Results Surveys were returned by 181 of 231 eligible participants (78%); 174 could be analyzed. Two-thirds of participants were physicians, 84% practiced family medicine, and 55% were male. Sixty-five percent of respondents were unfamiliar with the term shared decision making, but following definition, 97% reported that they found the approach useful for conditions with multiple treatment options. Over 90% of clinicians perceived helping patients make decisions regarding chronic pain and health behavior change as moderate/hard in difficulty. Although 69% of respondents preferred that patients play an equal role in making decisions, they estimate that this happens only 35% of the time. Time was reported as the largest barrier to engaging in SDM (63%). Respondents were receptive to using DAs to facilitate SDM in print- (95%) or web-based formats (72%), and topic preference varied by clinician specialty and decision difficulty. Conclusions Rural clinicians recognized the value of SDM and were receptive to using DAs in multiple formats. Integration of DAs to facilitate SDM in routine patient care may require addressing practice operation and reimbursement.