Recently Published Projects

Published on June 27, 2021
Management of Primary Headache During Pregnancy
52 Studies • 4 Key Questions • 52 Extraction Forms
Project created on June 27, 2021
Last updated on June 27, 2021
Objectives: This systematic review will assess the prevention and treatment of primary headache during pregnancy, postpartum, and breastfeeding.
Published on June 27, 2021
Management of Acute Diverticulitis
81 Studies • 4 Key Questions • 81 Extraction Forms
Project created on June 27, 2021
Last updated on June 27, 2021
Objectives: Purpose of the Review The American College of Physicians (ACP) nominated the topic of management of acute diverticulitis to the Agency for Healthcare Research and Quality for systematic review. 45, 46 The ACP develops guidelines based on the needs of its members and the internal medicine community.47 The scope of the current systematic review was developed to support the ACP in its effort to create a new clinical practice guideline that will address diagnosis and staging of acute diverticulitis, nonsurgical treatment of acute diverticulitis, colorectal cancer screening in people with a history of diverticulitis, and interventions to prevent recurrence of acute diverticulitis. Specifically, (1) the systematic review will summarize existing systematic reviews on the test accuracy of CT imaging for diagnosis and staging of acute diverticulitis and conduct a de novo review of harms related to false positive, false negative, and incidental findings on CT imaging for suspected acute diverticulitis; (2) it will address effectiveness, comparative effectiveness, and harms of hospitalization for acute uncomplicated diverticulitis, antibiotics use for acute complicated or uncomplicated diverticulitis, and interventional radiology techniques for acute complicated diverticulitis; (3) it will review the benefits and harms of colonoscopy in people with a history of diverticulitis; and (4) it will evaluate pharmacologic, nonpharmacologic, and elective surgical interventions to prevent recurrent diverticulitis. Of note, this review will not evaluate the need for, or the choice of, surgery for the patient with acute diverticulitis. The intended audience includes guideline developers, clinicians and other providers of care for patients with diverticulitis, healthcare policy makers, and patients.
Published on June 27, 2021
Medication Use for the Risk Reduction of Primary Breast Cancer in Women: A Systematic Review for the U.S. Preventive Services Task Force [Entered Retrospectively]
82 Studies • 4 Key Questions • 82 Extraction Forms
Project created on June 27, 2021
Last updated on June 27, 2021
Objectives: Background: Medications to reduce breast cancer risk are an effective prevention intervention for women at increased risk, although medications also cause adverse effects. Purpose: To update the 2013 U.S. Preventive Services Task Force (USPSTF) systematic review on the use of medications to reduce the risk of primary breast cancer. Data Sources: Searches included the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, EMBASE, and MEDLINE (January 1, 2013 to February 1, 2019); and manual review of reference lists. Studies published before 2013 were identified from prior systematic reviews for the USPSTF. Study Selection: Discriminatory accuracy studies of breast cancer risk assessment methods; double-blind, placebo-controlled or head-to-head randomized controlled trials (RCT) of tamoxifen, raloxifene, and aromatase inhibitors for primary prevention of breast cancer that enrolled women without preexisting breast cancer; and RCTs and observational studies of harms of medications. Data Extraction: One investigator abstracted data on study methods; setting; population characteristics; eligibility criteria; interventions; numbers enrolled and lost to followup; method of outcome ascertainment; and results for each outcome and a second investigator checked abstractions for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF. Data Synthesis (Results): Eighteen risk models evaluated in 25 studies had generally low discriminatory accuracy in predicting the probability of breast cancer in an individual (c-statistics 0.55 to 0.65). Most models performed only slightly better than age alone as a risk predictor. No studies evaluated optimal ages or frequencies of risk assessment. In placebo-controlled trials, tamoxifen (risk ratio [RR] 0.69; 95% confidence interval [CI], 0.59 to 0.84; 7 fewer cases per 1000 women over 5 years of use [95% CI, 4 to 12]; 4 trials), raloxifene (RR 0.44; 95% CI, 0.24 to 0.80; 9 fewer cases [95% CI, 3 to 15]; 2 trials), and the aromatase inhibitors exemestane and anastrozole (RR 0.45; 95% CI, 0.26 to 0.70; 16 fewer cases [95% CI, 8 to 24]; 2 trials) reduced invasive breast cancer. Risk for invasive breast cancer was higher for raloxifene than tamoxifen in the Study of Tamoxifen And Raloxifene (STAR) head-to-head trial (RR, 1.24; 95% CI, 1.05 to 1.47) after long-term followup. Effects did not differ by age of initiation or duration of use (3 to 5 years), although these effects were not directly compared. Risk reduction persisted at least 8 years after discontinuation in tamoxifen trials with long-term followup. All medications reduced estrogen receptor positive, but not estrogen receptor negative invasive breast cancer; tamoxifen reduced noninvasive cancer in two trials; and breast-cancer specific and all-cause mortality were not reduced. In placebo-controlled trials, raloxifene (RR 0.61; 95% CI, 0.53 to 0.73; 2 trials) reduced vertebral fractures; tamoxifen reduced nonvertebral fractures in the National Surgical Adjuvant Breast and Bowel Project (NSABP P-1) trial (RR 0.66; 95% CI, 0.45 to 0.98); while the aromatase inhibitors had no effect on fractures. Tamoxifen and raloxifene had similar effects on reducing fractures at multiple vertebral and nonvertebral sites in the STAR head-to-head trial. In placebo-controlled trials, tamoxifen (RR 1.93; 95% CI, 1.33 to 2.68; 4 trials) and raloxifene (RR 1.56; 95% CI, 1.11 to 2.60; 2 trials) increased thromboembolic events, while aromatase inhibitors did not. Raloxifene caused fewer thromboembolic events (RR 0.75; 95% CI, 0.60 to 0.93) than tamoxifen in the STAR head-to-head trial. Tamoxifen, raloxifene, and aromatase inhibitors did not increase coronary heart disease events or strokes. In placebo-controlled trials, tamoxifen increased endometrial cancer (RR 2.25; 95% CI, 1.17 to 4.41; 3 trials), while raloxifene and aromatase inhibitors did not. In the STAR head-to-head trial, raloxifene caused fewer cases of endometrial cancer (RR 0.55; 95% CI, 0.36 to 0.83) and endometrial hyperplasia (RR 0.19; 95% CI, 0.12 to 0.29), and fewer hysterectomies (RR 0.45; 95% CI, 0.37 to 0.54) than tamoxifen. Tamoxifen increased cataracts (RR 1.22; 95% CI, 1.08 to 1.48; 3 trials) and cataract surgery compared with placebo, while raloxifene and aromatase inhibitors did not. Risks for thromboembolic events and endometrial cancer with tamoxifen were higher for older compared with younger women and returned to normal after discontinuation. All medications caused adverse effects, such as vasomotor or musculoskeletal symptoms, that varied by medication. Risks for invasive cancer were generally reduced in all population subgroups evaluated based on menopausal status (pre and postmenopausal); family history of breast cancer; body mass index categories; modified Gail model risk categories; and age at menarche, parity, or age at first live birth, although results varied. Tamoxifen and anastrozole had larger effects in reducing invasive breast cancer in women with previous breast lesions (lobular carcinoma in situ, atypical ductal hyperplasia, or atypical lobular hyperplasia). Limitations: Trials were limited by clinical heterogeneity related to different medications, exposure durations, eligibility criteria, adherence, and ascertainment of outcomes. No trials compared timing and duration directly. Long-term followup data were lacking from most trials, and followup was particularly short for the aromatase inhibitors. Trials were not designed for subgroup comparisons and analysis of differences may be underpowered. Conclusions: Tamoxifen, raloxifene, and the aromatase inhibitors exemestane and anastrozole reduce invasive breast cancer in women without preexisting breast cancer, but also cause adverse effects that vary by medication. Tamoxifen and raloxifene increase thromboembolic events and tamoxifen increases endometrial cancer and cataracts. Identifying candidates for therapy is complicated by risk stratification methods that demonstrate low accuracy.
Published on June 27, 2021
Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA1/2-Related Cancer in Women: A Systematic Review for the U.S. Preventive Services Task Force [Entered Retrospectively]
110 Studies • 5 Key Questions • 110 Extraction Forms
Project created on June 27, 2021
Last updated on June 27, 2021
Objectives: Background: Pathogenic mutations in breast cancer susceptibility genes BRCA1 and BRCA2 increase risks for breast, ovarian, fallopian tube, and peritoneal cancer in women; interventions reduce risk in mutation carriers. Purpose: To update the 2013 U.S. Preventive Services Task Force review on benefits and harms of risk assessment, genetic counseling, and genetic testing for BRCA1/2-related cancer in women. Data Sources: Cochrane libraries; MEDLINE, PsycINFO, EMBASE (January 1, 2013 to March 6, 2019 for updates; January 1, 1994 to March 6, 2019 for new key questions and populations); reference lists. Study Selection: Discriminatory accuracy studies, randomized controlled trials (RCTs), and observational studies of women without recently diagnosed BRCA1/2-related cancer. Data Extraction: Data on study methods; setting; population characteristics; eligibility criteria; interventions; numbers enrolled and lost to followup; outcome ascertainment; and results were abstracted. Two reviewers independently assessed study quality. Data Synthesis (Results): 103 studies (110 articles) were included. No studies evaluated the effectiveness of risk assessment, genetic counseling, and genetic testing in reducing incidence and mortality of BRCA1/2-related cancer. Fourteen studies of 10 risk assessment tools to guide referrals to genetic counseling demonstrated moderate to high accuracy (area under the receiver operating characteristic curve 0.68 to 0.96). No studies determined optimal ages, frequencies, or harms of risk assessment. Twenty-eight studies indicated genetic counseling is associated with reduced breast cancer worry, anxiety, and depression; increased understanding of risk; and decreased intention for testing. A RCT showed that population-based testing of Ashkenazi Jews detected more BRCA1/2 mutations than family-history based testing, while measures of anxiety, depression, distress, uncertainty, and quality of life were similar between groups; clinical outcomes were not evaluated. Twenty studies indicated breast cancer worry and anxiety were higher after testing for women with positive results and lower for others, and understanding of risk was higher. No RCTs evaluated the effectiveness of intensive screening for breast or ovarian cancer in mutation carriers. In observational studies, false-positive rates, additional imaging, and benign biopsies were higher with magnetic resonance imaging than mammography. In eight RCTs, tamoxifen (risk ratio [RR], 0.69; 95% confidence interval [CI], 0.59 to 0.84; 4 trials), raloxifene (RR, 0.44 95% CI, 0.24 to 0.80; 2 trials), and aromatase inhibitors (RR, 0.45 95% CI, 0.26 to 0.70; 2 trials) were associated with lower risks of invasive breast cancer compared with placebo; results were not specific to mutation carriers. Adverse effects included venous thromboembolic events for tamoxifen and raloxifene; endometrial cancer and cataracts for tamoxifen; and vasomotor, musculoskeletal, and other symptoms for all medications. In observational studies, mastectomy was associated with 90 to 100 percent reduction in breast cancer incidence and 81 to 100 percent reduction in breast cancer mortality; oophorectomy or salpingo-oophorectomy was associated with 69 to 100 percent reduction in ovarian cancer; complications were common with mastectomy. Limitations: Including only English-language articles and studies applicable to the United States; varying number, quality, and applicability of studies; and few studies of untested women previously treated for BRCA1/2-related cancer. Conclusions: Risk assessment, genetic counseling, and genetic testing to reduce BRCA1/2-cancer incidence and mortality as a prevention service has not been directly evaluated by current research. Risk assessment with familial risk tools accurately identifies high-risk women for genetic counseling. Genetic counseling reduces breast cancer worry, anxiety, and depression; increases understanding of risk; and decreases intention for mutation testing, while testing improves accuracy of understanding of risk. The effectiveness of intensive screening is not known, but it increases false-positive results and procedures. Risk-reducing medications and surgery are associated with reduced breast and ovarian cancer, but also have adverse effects. Evidence gaps relevant to prevention remain and additional studies are needed to better inform clinical practice.
Published on June 27, 2021
Achieving Health Equity in Preventive Services
82 Studies • 5 Key Questions • 82 Extraction Forms
Project created on June 27, 2021
Last updated on June 27, 2021
Objectives: To summarize research on achieving health equity in ten preventive services for cancer, cardiovascular disease, and diabetes in adults for a National Institutes of Health Pathways to Prevention Workshop by identifying the effects of impediments and barriers that create disparities and the effectiveness of interventions to reduce them.