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Background: Screening and monitoring for chronic kidney disease (CKD) could lead to earlier interventions that improve clinical outcomes. Purpose: To summarize evidence about the benefits and harms of screening for and monitoring and treatment of CKD stages 1 to 3 in adults. Data Sources: MEDLINE (1985 through November 2011), reference lists, and expert suggestions. Study Selection: English-language, randomized, controlled trials that evaluated screening for or monitoring or treatment of CKD and that reported clinical outcomes. Data Extraction: Two reviewers assessed study characteristics and rated quality and strength of evidence. Data Synthesis: No trials evaluated screening or monitoring, and 110 evaluated treatments. Angiotensin-converting enzyme inhibitors (relative risk, 0.65 [95% CI, 0.49 to 0.88]) and angiotensin II-receptor blockers (relative risk, 0.77 [CI, 0.66 to 0.90]) reduced end-stage renal disease versus placebo, primarily in patients with diabetes who have macroalbuminuria. Angiotensin-converting enzyme inhibitors reduced mortality versus placebo (relative risk, 0.79 [CI, 0.66 to 0.96]) in patients with microalbuminuria and cardiovascular disease or high-risk diabetes. Statins and [beta]-blockers reduced mortality and cardiovascular events versus placebo or control in patients with impaired estimated glomerular filtration rate and either hyperlipidemia or congestive heart failure, respectively. Risks for mortality, end-stage renal disease, or other clinical outcomes did not significantly differ between strict and usual blood pressure control. The strength of evidence was rated high for angiotensin II-receptor blockers and statins, moderate for angiotensin-converting enzyme inhibitors and [beta]-blockers, and low for strict blood pressure control. Limitations: Evidence about outcomes was sometimes scant and derived from post hoc analyses of subgroups of patients enrolled in trials. Few trials reported or systematically collected information about adverse events. Selective reporting and publication bias were possible. Conclusion: The role of CKD screening or monitoring in improving clinical outcomes is uncertain. Evidence for CKD treatment benefit is strongest for angiotensin-converting enzyme inhibitors and angiotensin II-receptor blockers, and in patients with albuminuria combined with diabetes or cardiovascular disease. Primary Funding Source: Agency for Healthcare Research and Quality. [ABSTRACT FROM AUTHOR]

Improving colorectal cancer (CRC) screening rates represents a challenge for primary care providers. Some have argued that offering a choice of CRC screening modes to patients will improve the currently low adherence rates. Others have raised concerns that offering numerous CRC screening options in practice could overwhelm patients and thus dampen enthusiasm for screening. In this article we assemble evidence to critically evaluate the relative merit of these opposing views. We find little evidence to support the hypothesis that the number of options offered will affect adherence (either positively or negatively), or that expanding the modalities offered beyond FOBT and colonoscopy will improve patient satisfaction. Therefore, we assert future decisions about the number of CRC screening modes to offer would more productively be focused on considerations such as what benefit the health-care organization would derive from offering additional modes, and how this change would affect other critical components of a successful screening program such as timely diagnosis. In light of these organizational level considerations, we agree with the assertion made by others that a screening program limited to FOBT and colonoscopy is likely to be ideal in most settings. [ABSTRACT FROM AUTHOR]

Identifying the appropriate wheelchair for a person who needs one has implications for both disabled persons and society. For someone with severe locomotive problems, the right wheelchair can affect mobility and quality of life. However, policymakers are concerned about the increasing demand for unnecessarily elaborate chairs. The Office of Inspector General, U.S. Department of Health and Human Services, issued 4 reports between 2009 and 2011 detailing fraud and misapplication of Medicare funds for powered wheelchairs, more than a decade after similar concerns were first raised by 4 contractors who process claims for durable medical equipment. Subsequent concerns have arisen about whether some impaired persons who need wheeled mobility devices may now be inappropriately denied coverage. A transparent, evidence-based approach to wheeled mobility service delivery (the matching of mobility-impaired persons to appropriate devices and supporting services) might lessen these concerns. This review describes the process of wheeled mobility service delivery for long-term wheelchair users with complex rehabilitation needs and presents findings from a survey of the literature (published and gray) and interviews with key informants. Recommended steps in the delivery process were identified in textbooks, guidelines, and published literature. Delivery processes shared many commonalities; however, no research supports the recommended approaches. A search of bibliographic databases through March 2011 identified 24 studies that evaluated aspects of wheeled mobility service delivery. Most were observational, exploratory studies designed to determine consumer use of and satisfaction with the process. The evidence base for the effectiveness of approaches to wheeled mobility service delivery is insufficient, and additional research is needed to develop standards and guidelines. [ABSTRACT FROM AUTHOR]

Background: Clostridium difficile infection is increasing in incidence and severity. The optimal treatment is unknown. Purpose: To determine whether, among adults with C. difficile infection, treatment with certain antibiotics compared with others results in differences in initial cure, recurrence, and harms. Data Sources: MEDLINE, AMED, ClinicalTrials.gov, and Cochrane databases (search dates: inception through August 2011, limited to English-language reports); bibliography review. Study Selection: Randomized, controlled trials of adults with C. difficile infection, independent of outcomes, who were treated with medications available in the United States. Observational studies reporting strain were included. Data Extraction: Study design, inclusion and exclusion criteria, quality and strength of evidence as assessed by 2 reviewers, study definitions, and duration of treatment and follow-up. Outcomes included initial cure, recurrence, and treatment harms. Data Synthesis: 11 trials that included 1463 participants were identified. Three trials compared metronidazole with vancomycin; 8 compared metronidazole or vancomycin with another agent, combined agents, or placebo. Strain was analyzed in 1 trial and 2 cohort studies. No study comparing 2 antimicrobial agents demonstrated a statistically significant difference for initial cure; all comparisons were of low to moderate strength of evidence. Moderate-strength evidence from 1 study demonstrated that recurrence was decreased with fidaxomicin versus vancomycin (15% vs. 25%; difference, -10 percentage points [95% CI, -17 to -3 percentage points]; P = 0.005). Subgroup analysis of a single study comparing metronidazole with vancomycin for patients who have severe C. difficile infection showed no difference by intention-to-treat analysis; this was rated as insufficient-strength evidence. Harms, when reported, did not differ between treatments in any study. Limitations: Definitions of diarrhea, C. difficile infection, initial cure, and relapse varied. Some studies reported insufficient detail to allow assessment of all randomly assigned participants or of harms. Conclusion: No antimicrobial agent is clearly superior for the initial cure of C. difficile infection. Recurrence is less frequent with fidaxomicin than with vancomycin. Primary Funding Source: U.S. Department of Health and Human Services. [ABSTRACT FROM AUTHOR]

Background: Venous thromboembolism prophylaxis has been recommended for nonsurgical patients, but its effectiveness remains uncertain. Purpose: To assess the benefits and harms of prophylaxis in hospitalized adult medical patients and those with acute stroke. Data Sources: MEDLINE and the Cochrane Library from 1950 through April 2011, reference lists, and study authors. Study Selection: English-language randomized trials were included if they provided clinical outcomes and evaluated therapy with low-dose heparin or related agents or mechanical measures compared with placebo, no treatment, or other active prophylaxis in the target population. Data Extraction: Two independent investigators extracted data on study characteristics and clinical outcomes up to 120 days after randomization. The primary outcome was total mortality. Data Synthesis: In medical patients, heparin prophylaxis did not reduce total mortality but did result in fewer pulmonary embolisms (PEs) (odds ratio [OR], 0.69 [95% CI, 0.52 to 0.90], but with evidence of publication bias) and an increase in all bleeding events (risk ratio [RR], 1.34 [CI, 1.08 to 1.66]). Heparin prophylaxis had no statistically significant effect on any outcome in patients with acute stroke except for an increase in major bleeding events (OR, 1.66 [CI, 1.20 to 2.28]). When trials of medical patients and those with stroke were considered together (18 studies; 36 122 patients), heparin prophylaxis reduced the incidence of PE (OR, 0.70 [CI, 0.56 to 0.87]; absolute reduction, 3 events per 1000 patients treated [CI, 1 to 5 events]) but increased the incidence of all bleeding (RR, 1.28 [CI, 1.05 to 1.56]) and major bleeding events (OR, 1.61 [CI, 1.23 to 2.10]), with an absolute increase of 9 bleeding events per 1000 patients treated (CI, 2 to 18 events), 4 of which were major (CI, 1 to 7 events). A reduction in total mortality approached statistical significance (RR, 0.93 [CI, 0.86 to 1.00]; P = 0.056; absolute decrease, 6 deaths per 1000 patients treated [CI, 0 to 11 deaths]). No statistically significant differences in clinical outcomes were observed in the 14 trials that compared unfractionated heparin with low-molecular-weight heparin. No improvements in clinical outcomes were seen in the 3 studies of mechanical prophylaxis in patients with stroke, but more patients had lower-extremity skin damage (RR, 4.02 [CI, 2.34 to 6.91])-an increase of 39 events per 1000 patients treated (CI, 17 to 77 events). Limitation: Non-English-language studies were not included, but these were few and small. Conclusion: Heparin prophylaxis had no significant effect on mortality, may have reduced PE in medical patients and all patients combined, and led to more bleeding and major bleeding events, thus resulting in little or no net benefit. No differences in benefits or harms were found according to type of heparin used. Mechanical prophylaxis provided no benefit and resulted in clinically important harm to patients with stroke. Primary Funding Source: American College of Physicians. [ABSTRACT FROM AUTHOR]

DESCRIPTION: This guideline is an official statement of the American College of Physicians (ACP), American College of Chest Physicians (ACCP), American Thoracic Society (ATS), and European Respiratory Society (ERS). It represents an update of the 2007 ACP clinical practice guideline on diagnosis and management of stable chronic obstructive pulmonary disease (COPD) and is intended for clinicians who manage patients with COPD. This guideline addresses the value of history and physical examination for predicting airflow obstruction; the value of spirometry for screening or diagnosis of COPD; and COPD management strategies, specifically evaluation of various inhaled therapies (anticholinergics, long-acting [beta]-agonists, and corticosteroids), pulmonary rehabilitation programs, and supplemental oxygen therapy. METHODS: This guideline is based on a targeted literature update from March 2007 to December 2009 to evaluate the evidence and update the 2007 ACP clinical practice guideline on diagnosis and management of stable COPD. RECOMMENDATION 1: ACP, ACCP, ATS, and ERS recommend that spirometry should be obtained to diagnose airflow obstruction in patients with respiratory symptoms (Grade: strong recommendation, moderate-quality evidence). Spirometry should not be used to screen for airflow obstruction in individuals without respiratory symptoms (Grade: strong recommendation, moderate-quality evidence). RECOMMENDATION 2: For stable COPD patients with respiratory symptoms and FEV(1) between 60% and 80% predicted, ACP, ACCP, ATS, and ERS suggest that treatment with inhaled bronchodilators may be used (Grade: weak recommendation, low-quality evidence). RECOMMENDATION 3: For stable COPD patients with respiratory symptoms and FEV(1) <60% predicted, ACP, ACCP, ATS, and ERS recommend treatment with inhaled bronchodilators (Grade: strong recommendation, moderate-quality evidence). RECOMMENDATION 4: ACP, ACCP, ATS, and ERS recommend that clinicians prescribe monotherapy using either long-acting inhaled anticholinergics or long-acting inhaled [beta]-agonists for symptomatic patients with COPD and FEV(1) <60% predicted. (Grade: strong recommendation, moderate-quality evidence). Clinicians should base the choice of specific monotherapy on patient preference, cost, and adverse effect profile. RECOMMENDATION 5: ACP, ACCP, ATS, and ERS suggest that clinicians may administer combination inhaled therapies (long-acting inhaled anticholinergics, long-acting inhaled [beta]-agonists, or inhaled corticosteroids) for symptomatic patients with stable COPD and FEV(1)<60% predicted (Grade: weak recommendation, moderate-quality evidence). RECOMMENDATION 6: ACP, ACCP, ATS, and ERS recommend that clinicians should prescribe pulmonary rehabilitation for symptomatic patients with an FEV(1) <50% predicted (Grade: strong recommendation, moderate-quality evidence). Clinicians may consider pulmonary rehabilitation for symptomatic or exercise-limited patients with an FEV(1) >50% predicted. (Grade: weak recommendation, moderate-quality evidence). RECOMMENDATION 7: ACP, ACCP, ATS, and ERS recommend that clinicians should prescribe continuous oxygen therapy in patients with COPD who have severe resting hypoxemia (Pao(2) <=55 mm Hg or Spo(2) <=88%) (Grade: strong recommendation, moderate-quality evidence). [ABSTRACT FROM AUTHOR]

BACKGROUND: Erectile dysfunction (ED) is a common male sexual disorder. The relative benefits and harms of pharmacologic therapies for ED, as well as the value of hormonal testing in men with ED, are uncertain. PURPOSE: To evaluate the efficacy and harms of oral phosphodiesterase-5 (PDE-5) inhibitors and hormonal treatments for ED and assess the effect of measuring serum hormone levels on treatment outcomes for ED. DATA SOURCES: English-language studies from MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, PsycINFO, AMED, and SCOPUS through April 2009. Trial reference lists also were scanned. STUDY SELECTION: Randomized, controlled trials (RCTs) of oral PDE-5 inhibitors and hormonal treatment for ED, and observational studies reporting measurement of serum hormone levels, prevalence of hormonal abnormalities, or both in men with ED. DATA EXTRACTION: Two independent reviewers abstracted data on study, participant, and treatment characteristics; efficacy and harms outcomes; and prevalence of hormonal abnormalities. DATA SYNTHESIS: Data, primarily from short-term trials (

-- Increasing nurse-to-patient staffing has been recommended as a means to improve patient safety.-- In this study, researchers analyzed the savings-cost ratio of increased RN-to-patient ratios for patients in ICUs and patients in surgical and medical units based on a meta-analysis of published observational studies.-- Increased RN staffing was associated with lower hospital-related mortality and adverse patient events and generates societal net savings from avoided patient adverse events.-- This finding appears to hold in ICUs and, to some extent, in surgical units, but not in medical units.-- Hospitals do not experience sufficient monetary benefit from reduced length of stay corresponding to an increased RN staffing.-- Policy decisions about RN staffing should include cost-utility analyses. [ABSTRACT FROM AUTHOR]

RECOMMENDATION 1: In patients with respiratory symptoms, particularly dyspnea, spirometry should be performed to diagnose airflow obstruction. Spirometry should not be used to screen for airflow obstruction in asymptomatic individuals. (Grade: strong recommendation, moderate-quality evidence.) RECOMMENDATION 2: Treatment for stable chronic obstructive pulmonary disease (COPD) should be reserved for patients who have respiratory symptoms and FEV1 less than 60% predicted, as documented by spirometry. (Grade: strong recommendation, moderate-quality evidence.) RECOMMENDATION 3: Clinicians should prescribe 1 of the following maintenance monotherapies for symptomatic patients with COPD and FEV1 less than 60% predicted: long-acting inhaled beta-agonists, long-acting inhaled anticholinergics, or inhaled corticosteroids. (Grade: strong recommendation, high-quality evidence.) RECOMMENDATION 4: Clinicians may consider combination inhaled therapies for symptomatic patients with COPD and FEV1 less than 60% predicted. (Grade: weak recommendation, moderate-quality evidence.) RECOMMENDATION 5: Clinicians should prescribe oxygen therapy in patients with COPD and resting hypoxemia (Pao2 < or =55 mm Hg). (Grade: strong recommendation, moderate-quality evidence.) RECOMMENDATION 6: Clinicians should consider prescribing pulmonary rehabilitation in symptomatic individuals with COPD who have an FEV1 less than 50% predicted. (Grade: weak recommendation, moderate-quality evidence.). [ABSTRACT FROM AUTHOR]

Background: As an elective procedure, total knee arthroplasty is under scrutiny to evaluate its cost-effectiveness. In this review, we examined the available literature on total knee arthroplasty to assess the evidence regarding factors associated with better functional outcomes.Methods: A structured literature search of English-language databases was performed to identify studies of the functional outcomes of total knee arthroplasty that had been published between 1995 and April 2003. Inclusion criteria were a study of primary total knee arthroplasty, more than 100 knees in the study, provision of baseline data and rating of postoperative outcomes with a standardized symptom scale, and an experimental or quasi-experimental study design. The abstracting form included a list of potential prognostic factors, including comorbidities, radiographic evidence of joint destruction, bone loss, integrity of the extensor mechanism, range of motion, alignment, tibiofemoral angle, and ligament integrity, as well as the characteristics of the operating surgeon, such as procedure volume and experience.Results: Sixty-two studies met the criteria and were reviewed. Total knee arthroplasty was found to be associated with substantial functional improvement, with the effect sizes varying with the measure that was used. Physician-derived measures showed effect sizes of 2.35 and 3.91, whereas patient-derived measures showed smaller effect sizes (1.27 and 1.62). Few investigators used multivariate models to identify associations between outcomes and patient characteristics.Conclusions: Total knee arthroplasty is a generally effective procedure, but the current English-language literature does not support specific recommendations about which patients are most likely to benefit from it. [ABSTRACT FROM AUTHOR]

Objective: To conduct a systematic review and, where possible, quantitative meta-analysis of the existing evidence regarding the therapeutic efficacy and safety of the saw palmetto plant extract, Serenoa repens, in men with symptomatic benign prostatic hyperplasia (BPH).Data Sources: Studies were identified through the search of MEDLINE (1966-1997), EMBASE, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies.Study Selection: Randomized trials were included if participants had symptomatic BPH, the intervention was a preparation of S repens alone or in combination with other phytotherapeutic agents, a control group received placebo or other pharmacological therapies for BPH, and the treatment duration was at least 30 days.Data Extraction: Two investigators for each article (T.J.W., A.I., G.S., and R.M.) independently extracted key data on design features, subject characteristics, therapy allocation, and outcomes of the studies.Data Synthesis: A total of 18 randomized controlled trials involving 2939 men met inclusion criteria and were analyzed. Many studies did not report results in a method that permitted meta-analysis. Treatment allocation concealment was adequate in 9 studies; 16 were double-blinded. The mean study duration was 9 weeks (range, 4-48 weeks). As compared with men receiving placebo, men treated with S repens had decreased urinary tract symptom scores (weighted mean difference [WMD], -1.41 points [scale range, 0-19] [95% confidence interval (CI), -2.52 to -0.30] [n = 1 study]), nocturia (WMD, -0.76 times per evening [95% CI, -1.22 to -0.32] [n = 10 studies]), and improvement in self-rating of urinary tract symptoms; risk ratio for improvement (1.72 [95% CI, 1.21-2.44] [n = 6 studies]), and peak urine flow (WMD, 1.93 mL/s [95% CI, 0.72-3.14] [n = 8 studies]). Compared with men receiving finasteride, men treated with S repens had similar improvements in urinary tract symptom scores (WMD, 0.37 International Prostate Symptom Score points [scale range, 0-35] [95% CI, -0.45 to 1.19] [n = 2 studies]) and peak urine flow (WMD, -0.74 mL/s [95% CI, -1.66 to 0.18] [n = 2 studies]). Adverse effects due to S repens were mild and infrequent; erectile dysfunction was more frequent with finasteride (4.9%) than with S repens (1.1%; P<.001). Withdrawal rates in men assigned to placebo, S repens, or finasteride were 7%, 9%, and 11%, respectively.Conclusions: The existing literature on S repens for treatment of BPH is limited in terms of the short duration of studies and variability in study design, use of phytotherapeutic preparations, and reports of outcomes. However, the evidence suggests that S repens improves urologic symptoms and flow measures. Compared with finasteride, S repens produces similar improvement in urinary tract symptoms and urinary flow and was associated with fewer adverse treatment events. Further research is needed using standardized preparations of S repens to determine its long-term effectiveness and ability to prevent BPH complications. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To determine the efficacy and safety of treatments for nursing home residents with urinary incontinence (UI). PATIENTS AND METHODS: A systematic review was conducted of randomized controlled trials published from January 1985 through May 2008. Data sources were MEDLINE and Cochrane Library databases, proceedings of the 3rd International Consultation on Incontinence, and reference lists of retrieved clinical trials and review articles. Trials were eligible if they consisted of nursing home or long-term institutionalized residents with UI. Eligible trials compared interventions for improving UI with controls, including comparisons of UI outcomes and/or adverse events between randomized groups. RESULTS: Fourteen unique clinical trials, consisting of 1161 patients, met inclusion criteria. Treatments included antimuscarinic medications, oral estrogen plus progesterone, and behavioral interventions (eg, prompted voiding). Compared with usual care, prompted voiding alone or prompted voiding plus exercise reduced daytime incontinence and increased appropriate toileting. Efficacy outcomes indicated that neither prompted voiding plus exercise nor prompted voiding plus oral estrogen and progesterone was superior to prompted voiding alone for incontinence management. Prompted voiding plus oxybutynin slightly reduced incontinence compared with prompted voiding plus placebo. CONCLUSION: In nursing home residents with UI, prompted voiding alone and prompted voiding with exercise were associated with modest short-term improvement in daytime UI. Results do not clearly support an independent effect of exercise in improving UI. Oxybutynin may provide small additional benefit when used with prompted voiding. There appears to be no role for oral estrogen in UI treatment. Long-term clinical trials of prompted voiding alone, prompted voiding with exercise, and antimuscarinic medications should be conducted with targeted nursing home residents who have UI. These trials should include measures of UI, patient quality of life, and cost outcomes. [ABSTRACT FROM AUTHOR]

Background: Postmenopausal women commonly experience vulvovaginal, urinary, and sexual symptoms associated with genitourinary syndrome of menopause (GSM)., Purpose: To evaluate effectiveness and harms of vaginal estrogen, nonestrogen hormone therapies, and vaginal moisturizers for treatment of GSM symptoms., Data Sources: Medline, Embase, and CINAHL through 11 December 2023., Study Selection: Randomized controlled trials (RCTs) of at least 8 weeks' duration enrolling postmenopausal women with at least 1 GSM symptom and reporting effectiveness or harms of hormonal interventions or vaginal moisturizers., Data Extraction: Risk of bias and data extraction were performed by one reviewer and verified by a second reviewer. Certainty of evidence (COE) was assessed by one reviewer and verified by consensus., Data Synthesis: From 11 993 citations, 46 RCTs evaluating vaginal estrogen ( k = 22), nonestrogen hormones ( k = 16), vaginal moisturizers ( k = 4), or multiple interventions ( k = 4) were identified. Variation in populations, interventions, comparators, and outcomes precluded meta-analysis. Compared with placebo or no treatment, vaginal estrogen may improve vulvovaginal dryness, dyspareunia, most bothersome symptom, and treatment satisfaction. Compared with placebo, vaginal dehydroepiandrosterone (DHEA) may improve dryness, dyspareunia, and distress, bother, or interference from genitourinary symptoms; oral ospemifene may improve dryness, dyspareunia, and treatment satisfaction; and vaginal moisturizers may improve dryness (all low COE). Vaginal testosterone, systemic DHEA, vaginal oxytocin, and oral raloxifene or bazedoxifene may provide no benefit (low COE) or had uncertain effects (very low COE). Although studies did not report frequent serious harms, reporting was limited by short-duration studies that were insufficiently powered to evaluate infrequent serious harms., Limitations: Most studies were 12 weeks or less in duration and used heterogeneous GSM diagnostic criteria and outcome measures. Few studies enrolled women with a history of cancer., Conclusion: Vaginal estrogen, vaginal DHEA, oral ospemifene, and vaginal moisturizers may improve some GSM symptoms in the short term. Few long-term data exist on efficacy, comparative effectiveness, tolerability, and safety of GSM treatments., Primary Funding Source: Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42023400684)., Competing Interests: Disclosures: All relevant financial relationships have been mitigated. Disclosure forms are available with the article online.

Background: Women seeking nonhormonal interventions for vulvovaginal, urinary, and sexual symptoms associated with genitourinary syndrome of menopause (GSM) may seek out complementary and alternative medicine or therapies (CAMs)., Purpose: To summarize published evidence of CAMs for GSM., Data Sources: Ovid MEDLINE, EMBASE, and CINAHL from inception through 11 December 2023., Study Selection: Randomized controlled trials (RCTs) 8 weeks or more in duration that evaluated the effectiveness or harms of CAMs for postmenopausal women with GSM and reported 1 or more outcomes of interest, with sample sizes of 20 or more participants randomly assigned per group., Data Extraction: Data were abstracted by 1 reviewer and verified by a second., Data Synthesis: An evidence map approach was used to organize and describe trials. Studies were organized by type of intervention, with narrative summaries for population, study characteristics, interventions, and outcomes. Fifty-seven trials were identified that investigated 39 unique interventions. Studies were typically small ( n  < 200), and most were done in Iran ( k = 24) or other parts of Asia ( k = 9). Few trials evaluated similar combinations of populations, interventions, comparators, or outcomes. Most studies ( k = 44) examined natural products (that is, herbal or botanical supplements and vitamins), whereas fewer reported on mind and body practices ( k = 6) or educational programs ( k = 7). Most studies reported 1 or 2 GSM symptoms, mainly sexual ( k = 44) or vulvovaginal ( k = 30). Tools used to measure outcomes varied widely. Most trials reported on adverse events ( k = 33)., Limitations: Only English-language studies were used. Effect estimates, risk of bias, and certainty of evidence were not assessed., Conclusion: There is a large and heterogeneous literature of CAM interventions for GSM. Trials were small, and few were done in North America. Standardized population, intervention, comparator, and outcomes reporting in future RCTs are needed., Primary Funding Source: Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42023400684)., Competing Interests: Disclosures: Disclosure forms are available with the article online.

Real-time clinical care, policy, and research decisions need real-time evidence synthesis. However, as we found during the COVID-19 pandemic, it is challenging to rapidly address key clinical and policy questions through rigorous, relevant, and usable evidence. Our objective is to present three exemplar cases of rapid evidence synthesis products from the Veterans Healthcare Administration Evidence Synthesis Program (ESP) and, in the context of these examples, outline ESP products, challenges, and lessons learned. We faced challenges in (1) balancing scientific rigor with the speed in which evidence synthesis was needed, (2) sorting through rapidly evolving large bodies of evidence, and (3) assessing the impact of evidence synthesis products on clinical care, policy, and research. We found solutions in (1) engaging stakeholders early, (2) utilizing artificial intelligence capabilities, (3) building infrastructure to establish living reviews, and (4) planning for dissemination to maximize impact., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Introduction: Many types of prostate cancer present minimal risk to a man's lifespan or well-being, but existing terminology makes it difficult for men to distinguish these from high-risk prostate cancers. This study aims to explore whether using an alternative label for low-risk prostate cancer influences management choice and anxiety levels among Australian men and their partners., Methods and Analysis: We will run two separate studies for Australian men and Australian women with a male partner. Both studies are between-subjects factorial (3×2) randomised online hypothetical experiments. Following consent, eligible participants will be randomised 1:1:1 to three labels: 'low-risk prostate cancer, Gleason Group 1', 'low-risk prostate neoplasm' or 'low-risk prostate lesion'. Participants will then undergo a second randomisation step with 1:1 allocation to the provision of detailed information on the benefits and harms of different management choices versus the provision of less detailed information about management choices. The required sample sizes are 1290 men and 1410 women. The primary outcome is the participant choice of their preferred management strategy: no immediate treatment (prostate-specific antigen (PSA)-based monitoring or active surveillance using PSA, MRI, biopsy with delayed treatment for disease progression) versus immediate treatment (prostatectomy or radiation therapy). Secondary outcomes include preferred management choice (from the four options listed above), diagnosis anxiety, management choice anxiety and management choice at a later time point (for participants who initially choose a monitoring strategy)., Ethics and Dissemination: Ethics approval has been received from The University of Sydney Human Research Ethics Committee (2023/572). The results of the study will be published in a peer-reviewed medical journal and a plain language summary of the findings will be shared on the Wiser Healthcare publications page http://www.wiserhealthcare.org.au/category/publications/ TRIAL REGISTRATION NUMBERS: Australian New Zealand Clinical Trials Registry (ID 386701 and 386889)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Source Citation: Fazekas T, Shim SR, Basile G, et al. Magnetic resonance imaging in prostate cancer screening: a systematic review and meta-analysis. JAMA Oncol. 2024;10:745-754. 38576242., Competing Interests: Disclosures: Disclosure forms are available with the article online.

Purpose: Two randomized trials (SPCG4 and PIVOT) have compared surgery to conservative management for localized prostate cancer. The applicability of these trials to contemporary practice remains uncertain. We aimed to develop an individualized prediction model for prostate cancer mortality comparing immediate surgery at a high-volume center to active surveillance., Materials and Methods: We determined whether the relative risk of prostate cancer mortality with surgery vs observation varied by baseline risk. We then used various estimates of relative risk to estimate 15-year mortality with and without surgery using, as a predictor, risk of biochemical recurrence calculated from a model., Results: We saw no evidence that relative risk varied by baseline risk, supporting the use of a constant relative risk. Compared with observation, surgery was associated with negligible benefit for patients with Grade Group (GG) 1 disease (0.2% mortality reduction at 15 years) and small benefit for patients with GG2 with lower PSA and stage (≤5% mortality reduction). Benefit was greater (6%-9%) for patients with GG3 or GG4 though still modest, but effect estimates varied widely depending on choice of hazard ratio for surgery (6%-36% absolute risk reduction)., Conclusions: Surgery should be avoided for men with low-risk (GG1) prostate cancer and for many men with GG2 disease. Surgical benefits are greater in men with higher-risk disease. Integration of findings with a life expectancy model will allow patients to make informed treatment decisions given their oncologic risk, risk of death from other causes, and estimated effects of surgery.

Background: Newer diabetes medications may have beneficial effects on mortality, cardiovascular outcomes, and renal outcomes., Purpose: To evaluate the effectiveness, comparative effectiveness, and harms of sodium-glucose cotransporter-2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP1) agonists, dipeptidyl peptidase-4 (DPP4) inhibitors, and long-acting insulins as monotherapy or combination therapy in adults with type 2 diabetes mellitus (T2DM)., Data Sources: MEDLINE and EMBASE for randomized controlled trials (RCTs) published from 2010 through January 2023., Study Selection: RCTs lasting at least 52 weeks that included at least 500 adults with T2DM receiving eligible medications and reported any outcomes of interest., Data Extraction: Data were abstracted by 1 reviewer and verified by a second. Independent, dual assessments of risk of bias and certainty of evidence (CoE) were done., Data Synthesis: A total of 130 publications from 84 RCTs were identified. CoE was appraised using GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria for direct, indirect, and network meta-analysis (NMA); the highest CoE was reported. Compared with usual care, SGLT2 inhibitors and GLP1 agonists reduce all-cause mortality (high CoE) and major adverse cardiovascular events (MACE) (moderate to high CoE), SGLT2 inhibitors reduce progression of chronic kidney disease (CKD) and heart failure hospitalizations and GLP1 agonists reduce stroke (high CoE), and SGLT2 inhibitors reduce serious adverse events and severe hypoglycemia (high CoE). The threshold for minimally important differences, which was predefined with the American College of Physicians Clinical Guidelines Committee, was not met for these outcomes. Compared with usual care, insulin, tirzepatide, and DPP4 inhibitors do not reduce all-cause mortality (low to high CoE). Compared with insulin, SGLT2 inhibitors and GLP1 agonists reduce all-cause mortality (low to moderate CoE). Compared with DPP4 inhibitors, GLP1 agonists reduce all-cause mortality (moderate CoE). Compared with DPP4 inhibitors and sulfonylurea (SU), SGLT2 inhibitors reduce MACE (moderate to high CoE). Compared with SU and insulin, SGLT2 inhibitors and GLP1 agonists reduce severe hypoglycemia (low to high CoE)., Limitations: Infrequent direct comparisons between drugs of interest; sparse data for NMA on most outcomes; possible incoherence due to differences in baseline patient characteristics and usual care; insufficient data on predefined subgroups, including demographic subgroups, patients with prior cardiovascular disease, and treatment-naive persons., Conclusion: In adults with T2DM, SGLT2 inhibitors and GLP1 agonists (but not DPP4 inhibitors, insulin, or tirzepatide) reduce all-cause mortality and MACE compared with usual care. SGLT2 inhibitors reduce CKD progression and heart failure hospitalization and GLP1 agonists reduce stroke compared with usual care. Serious adverse events and severe hypoglycemia are less frequent with SGLT2 inhibitors and GLP1 agonists than with insulin or SU., Primary Funding Source: American College of Physicians. (PROSPERO: CRD42022322129)., Competing Interests: Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M23-1490.

Background: In the United States, costs of antidiabetes medications exceed $327 billion., Purpose: To systematically review cost-effectiveness analyses (CEAs) of newer antidiabetes medications for type 2 diabetes., Data Sources: Bibliographic databases from 1 January 2010 through 13 July 2023, limited to English., Study Selection: Nonindustry-funded CEAs, done from a U.S. perspective that estimated cost per quality-adjusted life-year (QALY) gained for newer antidiabetic medications. Two reviewers screened the literature; disagreements were resolved with a third reviewer., Data Extraction: Cost-effectiveness analyses were reviewed for treatment comparisons, model inputs, and outcomes. Risk of bias (RoB) of the CEAs was assessed using Drummond criteria and certainty of evidence (CoE) was assessed using GRADE (Grading of Recommendations Assessment, Development, and Evaluations). Certainty of evidence was determined using cost per QALY thresholds predetermined by the American College of Physicians Clinical Guidelines Committee; low (>$150 000), intermediate ($50 to $150 000), or high (<$50 000) value per QALY compared with the alternative., Data Synthesis: Nine CEAs were eligible (2 low, 1 high, and 6 some concerns RoB), evaluating glucagon-like peptide-1 agonists (GLP1a), dipeptidyl peptidase-4 inhibitors (DPP4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucose-dependent insulinotropic peptide agonist (GIP/GLP1a), and insulin. Comparators were metformin, sulfonylureas, neutral protamine Hagedorn (NPH) insulin, and others. Compared with metformin, GLP1a and SGLT2i are low value as first-line therapy (high CoE) but may be of intermediate value when added to metformin or background therapy compared with adding nothing (low CoE). Insulin analogues may be similarly effective but more expensive than NPH insulin (low CoE). The GIP/GLP1a value is uncertain (insufficient CoE)., Limitations: Cost-effectiveness analyses varied in methodological approach, assumptions, and drug comparisons. Risk of bias and GRADE method for CEAs are not well established., Conclusion: Glucagon-like peptide-1 agonists and SGLT2i are of low value as first-line therapy but may be of intermediate value when added to metformin or other background therapy compared with adding nothing. Other drugs and comparisons are of low or uncertain value. Results are sensitive to drug effectiveness and cost assumptions., Primary Funding Source: American College of Physicians. (PROSPERO: CRD42022382315)., Competing Interests: Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M23-1492.

Purpose: The purpose of this American Urological Association (AUA) Guideline amendment is to provide a useful reference on the effective evidence-based management of male lower urinary tract symptoms secondary/attributed to BPH (LUTS/BPH)., Materials and Methods: The Minnesota Evidence Review Team searched Ovid MEDLINE, the Cochrane Library, and the Agency for Healthcare Research and Quality (AHRQ) database to identify studies relevant to the management of BPH. The guideline was updated in 2023 to capture eligible literature published between September 2020 and October 2022. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions., Results: The BPH amendment resulted in changes to statements/supporting text on combination therapy, photoselective vaporization of the prostate (PVP), water vapor thermal therapy (WVTT), laser enucleation, and prostate artery embolization (PAE). A new statement on temporary implanted prostatic devices (TIPD) was added. In addition, statements on transurethral needle ablation (TUNA) and transurethral microwave thermotherapy (TUMT) were removed and information regarding these legacy technologies was added to the background section. References and the accompanying treatment algorithms were updated to align with the updated text., Conclusion: This guideline seeks to improve clinicians' ability to evaluate and treat patients with BPH/LUTS based on currently available evidence. Future studies will be essential to further support these statements to improve patient care.

Guidelines strongly recommend trauma-focused therapies to treat posttraumatic stress disorder. Implementation of cognitive processing therapy (CPT) and prolonged exposure (PE) in Veterans Health Administration (VHA) and non-VHA settings began in 2006. We conducted a systematic review of implementation facilitators and challenges and strategies to address barriers. We searched MEDLINE, Embase, PsycINFO, and CINAHL from inception until March 2021 for English-language articles. Two individuals reviewed eligibility and rated quality. Quantitative results were abstracted by one reviewer and verified by a second. Qualitative results were independently coded by two reviewers and finalized through consensus. We used RE-AIM and CFIR frameworks to synthesize findings. 29 eligible studies addressed CPT/PE, mostly conducted in VHA. Training/education with audit/feedback was the primary implementation strategy and was linked to improved provider CPT/PE perceptions and self-efficacy. Use was not widespread. Only six studies tested other implementation strategies with mixed impact. Following VHA implementation, strong support for training, perceived effectiveness for patients and benefits for clinics, and positive patient experiences and relationships with providers were reported. However, barriers persisted including perceived protocol inflexibility, complex referral processes and patient complexity and competing needs. In non-VHA settings, providers perceived fewer barriers, but few were CPT/PE trained. Across both settings, fewer studies targeted patient factors. Training/education with audit/feedback improved perceptions and the availability of CPT/PE, but not consistent use. Studies testing implementation strategies to address post-training challenges, including patient-level factors, are needed. A few studies are underway in VHA to test patient-focused and other implementation strategies. Research assessing actual vs perceived barriers in non-VHA settings is needed to elucidate unique challenges experienced., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background: Suicide is estimated to account for 1.4% of deaths worldwide, making it among the leading causes of premature death. Public health approaches to reduce suicide have the potential to reach individuals across the spectrum of suicide risk. Aims: To review the effectiveness of newer community-based or population-level suicide prevention strategies. Methods: We conducted a systematic review of literature published from January 2010 to November 2020 to evaluate the effectiveness of community- and population-level interventions. The US Center for Disease Control framework was used for grouping studies by strategy. Results: We included 56 publications that described 47 unique studies. Interventions that reduce access to lethal means, implement organizational policies and culture in police workplace settings, and involve community screening for depression may reduce suicide deaths. It is unclear if other interventions such as public awareness and education campaigns, crisis lines, and gatekeeper training prevent suicide. Evidence was inconsistent for community-based, multistrategy interventions. The most promising multistrategy intervention was the European Alliance Against Depression. Limitations: Most eligible studies were observational and many lacked concurrent control groups or adjustment for confounding variables. Conclusions: Community-based interventions that may reduce suicide deaths include reducing access to lethal means, implementing organizational policies in workplace settings, screening for depression, and the multistrategy European Alliance Against Depression Program. Evidence was unclear, inconsistent, or lacking regarding the impact of many other single- or multistrategy interventions on suicide deaths.

Cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and mindfulness-based stress reduction (MBSR) have demonstrated effectiveness for improving outcomes in chronic pain. These evidence-based psychotherapies (EBPs) remain underutilized in clinical practice, however. To identify research gaps and next steps for improving uptake of EBPs, we conducted a systematic review of patient-, provider-, and system-level barriers and facilitators of their use for chronic pain. We searched MEDLINE, Embase, PsycINFO, and CINAHL databases from inception through September 2022. Prespecified eligibility criteria included outpatient treatment of adults with chronic pain; examination of barriers and facilitators and/or evaluation of implementation strategies; conducted in the United States (US), United Kingdom (UK), Ireland, Canada or Australia; and publication in English. Two reviewers independently assessed eligibility and rated quality. We conducted a qualitative synthesis of results using a best-fit framework approach building upon domains of the Consolidated Framework for Implementation Research (CFIR). We identified 34 eligible studies (33 moderate or high quality), most (n = 28) of which addressed patient-level factors. Shared barriers across EBPs included variable patient buy-in to therapy rationale and competing responsibilities for patients; shared facilitators included positive group or patient-therapist dynamics. Most studies examining ACT and all examining MBSR assessed only group formats. No studies compared barriers, facilitators, or implementation strategies of group CBT to individual CBT, or of telehealth to in-person EBPs. Conceptual mismatches of patient knowledge and beliefs with therapy principles were largely analyzed qualitatively, and studies did not explore how these mismatches were addressed to support engagement. Future research on EBPs for chronic pain in real-world practice settings is needed to explore provider and system-level barriers and facilitators, heterogeneity of effects and uptake, and both effects and uptake of EBPs delivered in various formats, including group vs individual therapy and telehealth or asynchronous digital approaches. PERSPECTIVE: This systematic review synthesizes evidence on barriers and facilitators to uptake of cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness-based stress reduction for chronic pain. Findings can guide future implementation work to increase availability and use of evidence-based psychotherapies for treatment of chronic pain. REGISTRATION: PROSPERO number CRD42021252038., (Published by Elsevier Inc.)

Background: In adults with diabetes, diabetic foot ulcer (DFU) and amputation are common and associated with significant morbidity and mortality., Purpose: Identify tools predicting risk of DFU or amputation that are prognostically accurate and clinically feasible., Methods: We searched for systematic reviews (SRs) of tools predicting DFU or amputation published in multiple databases from initiation to January, 2023. We assessed risk of bias (ROB) and provided a narrative review of reviews describing performance characteristics (calibration and discrimination) of prognostically accurate tools. For such tools, we additionally reviewed original studies to ascertain clinical applicability and usability (variables included, score calculation, and risk categorization)., Results: We identified 3 eligible SRs predicting DFU or amputation risk. Two recent SRs (2020 and 2021) were rated as moderate and low ROB respectively. Four risk prediction models - Boyko, Martins-Mendes (simplified), Martins-Mendes (original), and PODUS 2020 had good prognostic accuracy for predicting DFU or amputation over time horizons ranging from 1- to 5-years. PODUS 2020 predicts absolute average risk (e.g., 6% risk of DFU at 2 years) and consists of 3-binary variables with a simple, summative scoring (0-4) making it feasible for clinic use. The other 3 models categorize risk subjectively (e.g., high-risk for DFU at 3 years), include 2-7 variables, and require a calculation device. No data exist to inform rescreening intervals. Furthermore, the effectiveness of targeted interventions in decreasing incidence of DFU or amputation in response to prediction scores is unknown., Conclusions: In this review of reviews, we identified 4 prognostically accurate models that predict DFU or amputation in persons with diabetes. The PODUS 2020 model, predicting absolute average DFU risk at 2 years, has the most favorable prognostic accuracy and is clinically feasible. Rescreening intervals and effectiveness of intervention based on prediction score are uncertain., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Objectives: To evaluate alternative formats of summary of findings (SoF) tables for single comparison with multiple outcomes., Study Design and Setting: We conducted a three-arm randomized controlled noninferiority trial (RCT) in the following systematic review (SR) users: researchers, clinical practice guideline developers, health care providers, policymakers, and knowledge transfer organizations to measure understanding, accessibility, satisfaction, and preference across the current grading of recommendations assessment, development, and evaluation (GRADE) SoF, an alternative GRADE SoF, or an adapted evidence-based practice center (EPC) program SoF table., Results: One Hundred Seventy-Nine participants were randomized, and 129 participants completed the RCT (n = 47 current GRADE, n = 41 alternative GRADE, n = 41 adapted EPC). Understanding the certainty of evidence and treatment effect was comparable across groups. The adapted EPC SoF table was inferior for quantifying risk and RD compared to the alternatives (<35% correct vs. >85% correct). Participants reported increased satisfaction when SoF tables presented number needed to treat (NNT), anticipated absolute effect differences, and narrative syntheses for evidence that could not be meta-analyzed. Participants reported accessibility to information as significantly better in both GRADE SoF tables, when compared with the adapted EPC SoF table. Participants preferred the alternative GRADE SoF table format., Conclusion: The alternative GRADE SoF table is a promising format for SR users preferring a comprehensive presentation of SR results for single comparisons., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Description: The purpose of this guideline from the American College of Physicians (ACP) is to present updated clinical recommendations on nonpharmacologic and pharmacologic interventions as initial and second-line treatments during the acute phase of a major depressive disorder (MDD) episode, based on the best available evidence on the comparative benefits and harms, consideration of patient values and preferences, and cost., Methods: The ACP Clinical Guidelines Committee based these recommendations on an updated systematic review of the evidence., Audience and Patient Population: The audience for this guideline includes clinicians caring for adult patients in the acute phase of MDD in ambulatory care. The patient population includes adults in the acute phase of MDD., Recommendation 1a: ACP recommends monotherapy with either cognitive behavioral therapy or a second-generation antidepressant as initial treatment in patients in the acute phase of moderate to severe major depressive disorder (strong recommendation; moderate-certainty evidence)., Recommendation 1b: ACP suggests combination therapy with cognitive behavioral therapy and a second-generation antidepressant as initial treatment in patients in the acute phase of moderate to severe major depressive disorder (conditional recommendation; low-certainty evidence). The informed decision on the options of monotherapy with cognitive behavioral therapy versus second-generation antidepressants or combination therapy should be personalized and based on discussion of potential treatment benefits, harms, adverse effect profiles, cost, feasibility, patients' specific symptoms (such as insomnia, hypersomnia, or fluctuation in appetite), comorbidities, concomitant medication use, and patient preferences., Recommendation 2: ACP suggests monotherapy with cognitive behavioral therapy as initial treatment in patients in the acute phase of mild major depressive disorder (conditional recommendation; low-certainty evidence)., Recommendation 3: ACP suggests one of the following options for patients in the acute phase of moderate to severe major depressive disorder who did not respond to initial treatment with an adequate dose of a second-generation antidepressant: • Switching to or augmenting with cognitive behavioral therapy (conditional recommendation; low-certainty evidence) • Switching to a different second-generation antidepressant or augmenting with a second pharmacologic treatment (see Clinical Considerations) (conditional recommendation; low-certainty evidence) The informed decision on the options should be personalized and based on discussion of potential treatment benefits, harms, adverse effect profiles, cost, feasibility, patients' specific symptoms (such as insomnia, hypersomnia, or fluctuation in appetite), comorbidities, concomitant medication use, and patient preferences.

Objectives: To evaluate the evidence on effects of nurse staffing in nursing homes on resident outcomes., Design: Systematic review., Setting and Participants: Studies evaluating the effects of nurse staffing levels, total staffing, or skill mix on pressure ulcers, nursing home associated infections, and pain outcomes for adult residents in US nursing homes., Methods: We searched MEDLINE, Embase, CINAHL, and the Cochrane Database for English-language articles published between January 2000 and May 2021. We also searched for gray literature and sought expert referrals. Two reviewers participated in determination of eligibility, assessment of methodological quality, and abstraction of data. Abstracted data included study design; setting and population characteristics; and resident outcomes. We rated overall certainty of evidence (very low, low, moderate, and high) for each outcome using GRADE., Results: Of 9152 unique citations, 378 articles underwent full-text review. We identified 22 eligible studies that addressed pressure ulcers (k = 15), COVID-19 cases and/or mortality (k = 4), other infections (k = 8), and moderate-severe pain among residents (k = 7); some examined multiple outcomes. Most studies (k = 17) were rated moderate or high quality. All studies were observational. Overall, registered nurse (RN) staffing was probably associated with fewer pressure ulcers (moderate certainty) and possibly fewer COVID-19 infections/mortality (low certainty), other infections (low certainty) and lower rates of moderate-severe pain (low certainty). Higher skill mix was probably associated with fewer pressure ulcers, higher resident COVID-19 infections, fewer other infections, and lower rates of moderate-severe pain (low certainty for all outcomes)., Conclusions and Implications: Higher RN staffing and skill mix may be associated with better nursing home resident outcomes, while results were mixed for total staffing. Increasing RN staffing levels and skill mix are one of a variety of approaches to improve nursing home care., (Published by Elsevier Inc.)

Objectives: We developed guidance to inform decisions regarding the inclusion of nonrandomized studies of interventions (NRSIs) in systematic reviews (SRs) of the effects of interventions., Study Design and Setting: The guidance workgroup comprised SR experts and used an informal consensus generation method., Results: Instead of recommending NRSI inclusion only if randomized controlled trials (RCTs) are insufficient to address the SR key question, different topics may require different decisions regarding NRSI inclusion. We identified important considerations to inform such decisions from topic refinement through protocol development. During topic scoping and refinement, considerations were related to the clinical decisional dilemma, adequacy of RCTs to address the key questions, risk of bias in NRSIs, and the extent to which NRSIs are likely to complement RCTs. When NRSIs are included, during SR team formation, familiarity with topic-specific data sources and advanced analytic methods for NRSIs should be considered. During protocol development, the decision regarding NRSI inclusion or exclusion should be justified, and potential implications explained. When NRSIs are included, the protocol should describe the processes for synthesizing evidence from RCTs and NRSIs and determining the overall strength of evidence., Conclusion: We identified specific considerations for decisions regarding NRSI inclusion in SRs and highlight the importance of flexibility and transparency., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Major organ complications have been reported in patients hospitalised for COVID-19; most studies lacked controls., Objective: Examine major organ damage postdischarge among adults hospitalised for COVID-19 versus non-COVID-19 controls., Data Sources: MEDLINE, Embase and Cochrane Library from 1 January 2020 to 19 May 2021., Study Eligibility Criteria: English language studies of adults discharged from hospital for COVID-19; reporting major organ damage. Single review of abstracts; independent dual review of full text., Study Appraisal and Synthesis Methods: Study quality was assessed using the Joanna Briggs Institute Appraisal Checklist for Cohort Studies. Outcome data were not pooled due to heterogeneity in populations, study designs and outcome assessment methods; findings are narratively synthesised., Results: Of 124 studies in a full evidence report, 9 included non-COVID controls and are described here. Four of the nine (three USA, one UK) used large administrative databases. Four of the remaining five studies enrolled <600 COVID-19 patients. Mean or median age ranged from 49 to 70 years with 46%-94% male and 48%-78% White race; 10%-40% had been in intensive care units. Follow-up ranged from 4 weeks to 22 weeks postdischarge. Four used hospitalised controls, three non-hospitalised controls and two were unclear. Studies used various definitions of, and methods to assess, major organ damage outcomes. While the magnitude of effect differed across studies, incident cardiac, pulmonary, liver, acute and chronic kidney, stroke, diabetes, and coagulation disorders were consistently greater in adults hospitalised for COVID-19 compared with non-COVID-19 controls., Limitations: Applicability to subgroups (age, gender, COVID-19 severity, treatment, vaccination status) and non-hospitalised patients is unknown., Conclusions and Implications of Key Findings: Postacute COVID-19 major organ damage is common and likely higher than controls. However, there is substantial uncertainty. More consistent reporting of clinical outcomes and pre-COVID health status along with careful selection of control groups are needed to address evidence gaps., Prospero Registration Number: CRD42020204788., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Care coordination (CC) interventions involve systematic strategies to address fragmentation and enhance continuity of care. However, it remains unclear whether CC can sufficiently address patient needs and improve outcomes., Methods: We searched MEDLINE, CINAHL, Embase, Cochrane Database of Systematic Reviews, AHRQ Evidence-based Practice Center, and VA Evidence Synthesis Program, from inception to September 2019. Two individuals reviewed eligibility and rated quality using modified AMSTAR 2. Eligible systematic reviews (SR) examined diverse CC interventions for community-dwelling adults with ambulatory care sensitive conditions and/or at higher risk for acute care. From eligible SR and relevant included primary studies, we abstracted the following: study and intervention characteristics; target population(s); effects on hospitalizations, emergency department (ED) visits, and/or patient experience; setting characteristics; and tools and approaches used. We also conducted semi-structured interviews with individuals who implemented CC interventions., Results: Of 2324 unique citations, 16 SR were eligible; 14 examined case management or transitional care interventions; and 2 evaluated intensive primary care models. Two SR highlighted selection for specific risk factors as important for effectiveness; one of these also indicated high intensity (e.g., more patient contacts) and/or multidisciplinary plans were key. Most SR found inconsistent effects on reducing hospitalizations or ED visits; few reported on patient experience. Effective interventions were implemented in multiple settings, including rural community hospitals, academic medical centers (in urban settings), and public hospitals serving largely poor, uninsured populations. Primary studies reported variable approaches to improve patient-provider communication, including health coaching and role-playing. SR, primary studies, and key informant interviews did not identify tools for measuring patient trust or care team integration. Sustainability of CC interventions varied and some were adapted over time., Discussion: CC interventions have inconsistent effects on reducing hospitalizations and ED visits. Future work should address how they should be adapted to different healthcare settings and which tools or approaches are most helpful for implementation., Trial Registration: PROSPERO #CRD42020156359., (© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)