Telehealth-guided provider-to-provider communication to improve rural health: A systematic review.

INTRODUCTION: Telehealth may address healthcare disparities for rural populations. This systematic review assesses the use, effectiveness, and implementation of telehealth-supported provider-to-provider collaboration to improve rural healthcare. METHODS: We searched Ovid MEDLINE®, CINAHL®, EMBASE, and Cochrane CENTRAL from 1 January 2010 to 12 October 2021 for trials and observational studies of rural provider-to-provider telehealth. Abstracts and full text were dual-reviewed. We assessed the risk of bias for individual studies and strength of evidence for studies with similar outcomes. RESULTS: Seven studies of rural uptake of provider-to-provider telehealth documented increases over time but variability across geographic regions. In 97 effectiveness studies, outcomes were similar with rural provider-to-provider telehealth versus without for inpatient consultations, neonatal care, outpatient depression and diabetes, and emergency care. Better or similar results were reported for changes in rural clinician behavior, knowledge, confidence, and self-efficacy. Evidence was insufficient for other clinical uses and outcomes. Sixty-seven (67) evaluation and qualitative studies identified barriers and facilitators to implementing rural provider-to-provider telehealth. Success was linked to well-functioning technology, sufficient resources, and adequate payment. Barriers included lack of understanding of rural context and resources. Methodologic weaknesses of studies included less rigorous study designs and small samples. DISCUSSION: Rural provider-to-provider telehealth produces similar or better results versus care without telehealth. Barriers to rural provider-to-provider telehealth implementation are common to practice change but include some specific to rural adaptation and adoption. Evidence gaps are partially due to studies that do not address differences in the groups compared or do not include sufficient sample sizes.

Testing a filtering strategy for systematic reviews: evaluating work savings and recall.

Systematic reviews are extremely time-consuming. The goal of this work is to assess work savings and recall for a publication type filtering strategy that uses the output of two machine learning models, Multi-Tagger and web RCT Tagger, applied retrospectively to 10 systematic reviews on drug effectiveness. Our filtering strategy resulted in mean work savings of 33.6% and recall of 98.3%. Of 363 articles finally included in any of the systematic reviews, 7 were filtered out by our strategy, but 1 "error" was actually an article using a publication type that the SR team had not pre-specified as relevant for inclusion. Our analysis suggests that automated publication type filtering can potentially provide substantial work savings with minimal loss of included articles. Publication type filtering should be personalized for each systematic review and might be combined with other filtering or ranking methods to provide additional work savings for manual triage.

Telehealth Strategies for the Delivery of Maternal Health Care : A Rapid Review.

BACKGROUND: Telehealth strategies to supplement or replace in-person maternity care may affect maternal health outcomes. PURPOSE: To conduct a rapid review of the effectiveness and harms of telehealth strategies for maternal health care given the recent expansion of telehealth arising from the COVID-19 pandemic, and to produce an evidence map. DATA SOURCES: Systematic searches of MEDLINE, the Cochrane Library, CINAHL, Embase, and Scopus for English-language studies (January 2015 to April 2022). STUDY SELECTION: Randomized controlled trials (RCTs) and observational studies of maternal care telehealth strategies versus usual care. DATA EXTRACTION: Dual data extraction and risk-of-bias assessment of studies, with disagreements resolved through consensus. DATA SYNTHESIS: 28 RCTs and 14 observational studies (n = 44 894) were included. Maternal telehealth interventions supplemented in-person care for most studies of mental health and diabetes during pregnancy, primarily resulting in similar, and sometimes better, clinical and patient-reported outcomes versus usual care. Supplementing in-person mental health care with phone- or web-based platforms or mobile applications resulted in similar or better mental health outcomes versus in-person care. A reduced-visit prenatal care schedule using telehealth to replace in-person general maternity care for low-risk pregnancies resulted in similar clinical outcomes and higher patient satisfaction versus usual care. Overall, telehealth strategies were heterogeneous and resulted in similar obstetric and patient satisfaction outcomes. Few studies addressed disparities, health equity, or harms. LIMITATIONS: Interventions varied, and evidence was inadequate for some clinical outcomes. CONCLUSION: Replacing or supplementing in-person maternal care with telehealth generally results in similar, and sometimes better, clinical outcomes and patient satisfaction compared with in-person care. The effect on access to care, health equity, and harms is unclear. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42021276347).

Cannabis-Based Products for Chronic Pain : A Systematic Review.

BACKGROUND: Contemporary data are needed about the utility of cannabinoids in chronic pain. PURPOSE: To evaluate the benefits and harms of cannabinoids for chronic pain. DATA SOURCES: Ovid MEDLINE, PsycINFO, EMBASE, the Cochrane Library, and Scopus to January 2022. STUDY SELECTION: English-language, randomized, placebo-controlled trials and cohort studies (≥1 month duration) of cannabinoids for chronic pain. DATA EXTRACTION: Data abstraction, risk of bias, and strength of evidence assessments were dually reviewed. Cannabinoids were categorized by THC-to-CBD ratio (high, comparable, or low) and source (synthetic, extract or purified, or whole plant). DATA SYNTHESIS: Eighteen randomized, placebo-controlled trials (n = 1740) and 7 cohort studies (n = 13 095) assessed cannabinoids. Studies were primarily short term (1 to 6 months); 56% enrolled patients with neuropathic pain, with 3% to 89% female patients. Synthetic products with high THC-to-CBD ratios (>98% THC) may be associated with moderate improvement in pain severity and response (≥30% improvement) and an increased risk for sedation and are probably associated with a large increased risk for dizziness. Extracted products with high THC-to-CBD ratios (range, 3:1 to 47:1) may be associated with large increased risk for study withdrawal due to adverse events and dizziness. Sublingual spray with comparable THC-to-CBD ratio (1.1:1) probably is associated with small improvement in pain severity and overall function and may be associated with large increased risk for dizziness and sedation and moderate increased risk for nausea. Evidence for other products and outcomes, including longer-term harms, were not reported or were insufficient. LIMITATION: Variation in interventions; lack of study details, including unclear availability in the United States; and inadequate evidence for some products. CONCLUSION: Oral, synthetic cannabis products with high THC-to-CBD ratios and sublingual, extracted cannabis products with comparable THC-to-CBD ratios may be associated with short-term improvements in chronic pain and increased risk for dizziness and sedation. Studies are needed on long-term outcomes and further evaluation of product formulation effects. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. (PROSPERO: CRD42021229579).

Psychosocial Interventions for Adults With Schizophrenia: An Overview and Update of Systematic Reviews.

OBJECTIVE: The authors of this systematic review (SR) sought to provide evidence for effects of commonly used psychosocial interventions on several outcomes among adults with schizophrenia. METHODS: MEDLINE, the Cochrane Library, and PsycINFO databases were searched through July 2020. Eligible studies were SRs and trials of at least 12 weeks duration and with ≥50 participants that compared psychosocial interventions with treatment as usual among adults with schizophrenia. Study design, year, setting, country, sample size, eligibility criteria, population, clinical and intervention characteristics, results, and funding source were extracted, along with quality criteria. The evidence was evaluated on quality and strength of evidence stratified by intervention area and outcome, according to the Evidence-Based Practice Centers Methods Guide of the Agency for Healthcare Research and Quality. RESULTS: Nine SRs and 30 trials (N=23,921 patients) in 11 intervention areas were included. Trials were mostly of fair quality and had low-to-moderate strength of evidence. Compared with treatment as usual, most psychosocial interventions were more effective in improving intervention-targeted outcomes, including core illness symptoms. Compared with treatment as usual, assertive community treatment, cognitive-behavioral therapy (CBT), family interventions, psychoeducation, social skills training, supported employment, and early interventions for first-episode psychosis (FEP) improved various functional outcomes. CBT and early interventions for FEP improved quality of life. Family interventions, psychoeducation, illness self-management, and early interventions for FEP reduced relapse. CONCLUSIONS: Compared with treatment as usual, most psychosocial interventions improved functional outcomes, quality of life, and core illness symptoms, and several reduced relapse frequency among adults with schizophrenia.

Outpatient Treatment of Low-risk Pulmonary Embolism in the Era of Direct Oral Anticoagulants: A Systematic Review.

BACKGROUND: Clinical guidelines have supported outpatient treatment of low-risk pulmonary embolism (PE) since 2014, but adoption of this practice has been slow. Direct oral anticoagulant (DOAC) therapy for venous thromboembolism (VTE) is now as common as vitamin K antagonist treatment, but data are sparse regarding outcomes for patients with low-risk PE treated with DOACs as outpatients. We conducted a systematic review of literature on outcomes of outpatient management for PE, including comparisons to inpatient treatment and differences by anticoagulant class. METHODS: We searched Medline, Embase, PubMed, CENTRAL, clinicaltrials.gov, and ICTRN for studies published from January 1980 through February 2019 using a predefined strategy developed with a medical librarian. We included English-language randomized controlled trials (RCTs) and prospective nonrandomized trials (NRTs) of adult patients diagnosed with acute, symptomatic PE, and discharged from the emergency department or within 48 hours. Our primary outcome included four major adverse outcomes (all-cause mortality, PE-related mortality, recurrent VTE, and major bleeding) within 30 and 90 days. A preplanned subanalysis of high-quality studies assessed outcomes associated with different anticoagulation treatment classes. RESULTS: Our initial search identified 6,818 records, of which 12 studies (four RCT, eight NRT) with a total of 3,191 patients were included in the review. All RCTs and six NRTs were determined to have low to moderate risk of bias and were classified as high quality. Outpatients in these studies (n = 1,814) had rates of 90-day major adverse outcomes below 1%, including all-cause mortality (0.7%, 95% confidence interval [CI] = 0.4% to 1.2%), PE-related mortality (0.06%, 95% CI = 0.01% to 0.3%), recurrent VTE (0.8%, 95% CI = 0.5% to 1.4%), and major bleeding (0.8%, 95% CI = 0.5% to 1.4%). Exploratory analysis revealed no association between anticoagulant treatment class and rates of major adverse outcomes. CONCLUSION: Among patients with low-risk PE treated as outpatients, few patients experienced major adverse outcomes such as mortality, recurrent VTE, or major bleeding within 90 days.

Development of the PTSD-Repository: A Publicly Available Repository of Randomized Controlled Trials for Posttraumatic Stress Disorder.

Given the extensive research on posttraumatic stress disorder (PTSD) treatment, a single, updatable repository of data from PTSD treatment studies would be useful for clinical, research, and policy stakeholders. To meet this need, we established a preliminary dataset of abstracted PTSD trial data, which serve as the basis for the PTSD Trials Standardized Data Repository (PTSD-Repository), maintained by the National Center for PTSD (NCPTSD). We followed systematic review methods to identify published randomized controlled trials (RCTs) of PTSD interventions. We consulted with a panel of experts to determine a priori inclusion criteria, ensure that we captured all relevant studies, and identify variables for abstraction. We searched multiple databases for materials published from 1980 to 2018 and reviewed reference lists of relevant systematic reviews and clinical practice guidelines. In total, 318 RCTs of PTSD interventions that enrolled almost 25,000 participants were included. We abstracted 337 variables across all studies, including study, participant, and intervention characteristics as well as results. In the present paper, we describe our methods and define data elements included in the data tables. We explain coding challenges, identify inconsistencies in reporting across study types, and discuss ways stakeholders can use PTSD-Repository data to enhance research, education, and policy. The abstracted data are currently publicly available on the NCPTSD website and can be used for future systematic reviews and identifying research gaps and as an information resource for clinicians, patients, and family members.

Masks for Prevention of Respiratory Virus Infections, Including SARS-CoV-2, in Health Care and Community Settings : A Living Rapid Review.

BACKGROUND: Recommendations on masks for preventing coronavirus disease 2019 (COVID-19) vary. PURPOSE: To examine the effectiveness of N95, surgical, and cloth masks in community and health care settings for preventing respiratory virus infections, and effects of reuse or extended use of N95 masks. DATA SOURCES: Multiple electronic databases, including the World Health Organization COVID-19 database and medRxiv preprint server (2003 through 14 April 2020; surveillance through 2 June 2020), and reference lists. STUDY SELECTION: Randomized trials of masks and risk for respiratory virus infection, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and observational studies of mask use and coronavirus infection risk were included. New evidence will be incorporated by using living review methods. DATA EXTRACTION: One reviewer abstracted data and assessed methodological limitations; a second reviewer provided verification. DATA SYNTHESIS: 39 studies (18 randomized controlled trials and 21 observational studies; 33 867 participants) were included. No study evaluated reuse or extended use of N95 masks. Evidence on SARS-CoV-2 was limited to 2 observational studies with serious limitations. Community mask use was possibly associated with decreased risk for SARS-CoV-1 infection in observational studies. In high- or moderate-risk health care settings, observational studies found that risk for infection with SARS-CoV-1 and Middle East respiratory syndrome coronavirus probably decreased with mask use versus nonuse and possibly decreased with N95 versus surgical mask use. Randomized trials in community settings found possibly no difference between N95 versus surgical masks and probably no difference between surgical versus no mask in risk for influenza or influenza-like illness, but compliance was low. In health care settings, N95 and surgical masks were probably associated with similar risks for influenza-like illness and laboratory-confirmed viral infection; clinical respiratory illness had inconsistency. Bothersome symptoms were common. LIMITATIONS: There were few SARS-CoV-2 studies, observational studies have methodological limitations, and the review was done by using streamlined methods. CONCLUSION: Evidence on mask effectiveness for respiratory infection prevention is stronger in health care than community settings. N95 respirators might reduce SARS-CoV-1 risk versus surgical masks in health care settings, but applicability to SARS-CoV-2 is uncertain. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Updating the Comparative Evidence on Second-Generation Antipsychotic Use With Schizophrenia.

Objective: The objective of this study was to conduct a systematic review of literature comparing second-generation antipsychotics (SGAs) with each other and with first-generation antipsychotics (FGAs) in treating schizophrenia. Methods: MEDLINE, the Cochrane Library, and PsycINFO databases were searched through January 2020. Following standard methods, recent high-quality systematic reviews of each drug comparison and subsequently published primary studies were included to update the meta-analyses with any new data. Two reviewers independently conducted study selection, abstraction, and quality assessment. Results: Two systematic reviews and 29 newer trials (total of 162 trials of SGAs, N=53,861; 116 trials of SGAs versus FGAs, N=119,558) were included. Most trials were of fair quality, industry-funded, and included older SGAs and a few recently approved SGAs (asenapine, lurasidone, iloperidone, cariprazine, brexpiprazole and long-acting injection [LAI] formulations of aripiprazole and paliperidone). Older SGAs had similar effects on function, quality of life, mortality, and adverse event incidence, although clozapine improved symptoms more than most other drugs and olanzapine and risperidone were superior to some other drugs. Olanzapine, risperidone, ziprasidone, and aripiprazole performed similarly on outcomes of benefit compared with haloperidol. Risperidone LAI and olanzapine resulted in fewer withdrawals due to adverse events, but risk of diabetes increased with olanzapine. Haloperidol had greater incidence of adverse events than did olanzapine and risperidone, but similar effects on other outcomes. Conclusions: Most comparative evidence favored older SGAs, with clozapine, olanzapine, and risperidone superior on more outcomes than other SGAs. Older SGAs had similar benefits as haloperidol but with fewer adverse events.

Depression in Children and Adolescents: Evaluation and Treatment.

The prevalence of major unipolar depression in children and adolescents is increasing in the United States. In 2016, approximately 5% of 12-year-olds and 17% of 17-year-olds reported experiencing a major depressive episode in the previous 12 months. Screening for depression in adolescents 12 years and older should be conducted annually using a validated instrument, such as the Patient Health Questionnaire-9: Modified for Teens. If the diagnosis is confirmed, treatment should be initiated for persistent, moderate, and severe depression. Active support and monitoring may be sufficient for mild, self-limited depression. For more severe depression, evidence indicates greater response to treatment when psychotherapy (e.g., cognitive behavior therapy) and an antidepressant are used concurrently, compared with either treatment alone. Fluoxetine and escitalopram are the only antidepressants approved by the U.S. Food and Drug Administration for treatment of depression in children and adolescents. Fluoxetine may be used in patients older than eight years, and escitalopram may be used in patients 12 years and older. Monitoring for suicidality is necessary in children and adolescents receiving pharmacotherapy, with frequency of monitoring based on each patient's individual risk. The decision to modify treatment (add, increase, change the medication or add psychotherapy) should be made after about four to eight weeks. Consultation with or referral to a mental health subspecialist is warranted if symptoms worsen or do not improve despite treatment and for those who become a risk to themselves or others.

Updating the evidence on drugs to treat overactive bladder: a systematic review.

INTRODUCTION: Overactive bladder (OAB) is a common condition, increasing with age and affecting quality of life. While numerous OAB drugs are available, persistence is low. We evaluated evidence published since 2012 to determine if newer drugs provided better efficacy and harm profiles. METHODS: We searched MEDLINE and the Cochrane Library from 2012 to September 2018 using terms for included drugs and requested information from manufacturers of included drugs. We performed dual review of all systematic review processes, evaluated study quality, and conducted meta-analyses using random effects models. RESULTS: In addition to 31 older studies, we included 20 trials published since 2012 (N = 16,478; 4 good, 11 fair, and 5 poor quality). Where statistical differences were found, they were clinically small (reductions of < 0.5 episodes/day). Solifenacin plus mirabegron improved efficacy outcomes over monotherapy with either drug, but significantly increased constipation compared with solifenacin and dry mouth compared with mirabegron. Solifenacin reduced incontinence over mirabegron and tolterodine and urgency episodes over tolterodine. Mirabegron did not differ from tolterodine in efficacy but had significantly lower incidence of dry mouth than solifenacin or tolterodine. Fesoterodine showed significant improvements but also anticholinergic effects vs. tolterodine. Oxybutynin, solifenacin, and tolterodine had similar efficacy, but dry mouth led to greater discontinuation with oxybutynin. Blurred vision, cardiac arrhythmia, and dizziness were uncommon. CONCLUSION: New evidence confirms small, but clinically uncertain, differences among monotherapies and also between combination and monotherapy, regardless of statistical significance. While drugs mainly differed in incidence of dry mouth or constipation, none provided improved efficacy without increased harms.

Screening for Elevated Blood Lead Levels in Childhood and Pregnancy: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Elevated blood lead level is associated with serious, often irreversible, health consequences. Objective: To synthesize evidence on the effects of screening, testing, and treatment for elevated blood lead level in pregnant women and children aged 5 years and younger in the primary care setting to inform the US Preventive Services Task Force. Data Sources: Cochrane CENTRAL and Cochrane Database of Systematic Reviews (through June 2018) and Ovid MEDLINE (1946 to June 2018); surveillance through December 5, 2018. Study Selection: English-language trials and observational studies of screening for and treating elevated lead levels in asymptomatic children and pregnant women. Data Extraction and Synthesis: Independent critical appraisal and data abstraction by 2 reviewers using predefined criteria. Main Outcomes and Measures: Elevated blood lead level, morbidity, mortality, clinical prediction tools, test accuracy, adverse events. Results: A total of 24 studies (N = 11 433) were included in this review. No studies evaluated the benefits or harms of screening vs no screening in children. More than 1 positive answer on the 5-item 1991 Centers for Disease Control and Prevention (CDC) screening questionnaire was associated with a pooled sensitivity of 48% (95% CI, 31.4% to 65.6%) and specificity of 58% (95% CI, 39.9% to 74.0%) for identifying children with a venous blood lead level greater than 10 µg/dL (5 studies [n = 2265]). Adapted versions of the CDC questionnaire did not demonstrate improved accuracy. Capillary blood lead testing demonstrated sensitivity of 87% to 91% and specificity greater than 90%, compared with venous measurement (4 studies [n = 1431]). Counseling and nutritional interventions or residential lead hazard control techniques did not reduce blood lead concentrations in asymptomatic children, but studies were few and had methodological limitations (7 studies [n = 1419]). One trial (n = 780) of dimercaptosuccinic acid (DMSA) chelation therapy found reduced blood lead levels in children at 1 week to 1 year but not at 4.5 to 6 years, while another trial (n = 39) found no effect at 1 and 6 months. Seven-year follow-up assessments showed no effect on neuropsychological development, a small deficit in linear growth (height difference, 1.17 cm [95% CI, 0.41 to 1.93]), and poorer cognitive outcomes reported as the Attention and Executive Functions subscore of the Developmental Neuropsychological Assessment (unadjusted difference, -1.8 [95% CI, -4.5 to 1.0]; adjusted P = .045) in children treated with DMSA chelation. Evidence was too limited to determine the accuracy of screening questionnaires or benefits and harms of treatment in pregnant women. Conclusions and Relevance: Screening questionnaires were not accurate for identifying children with elevated blood lead levels. Chelating agents in children were not significantly associated with sustained effects on blood level levels but were associated with harms.

Pharmacologic Treatments for Sleep Disorders in Children: A Systematic Review.

Sleep problems are common in children, especially those with neurodevelopmental disorders, and can lead to consequences in behavior, functioning, and quality of life. We systematically reviewed the efficacy and harms of pharmacologic treatments for sleep disorders in children and adolescents. We searched MEDLINE, Cochrane library databases, and PsycINFO through June 2018. We included 22 placebo-controlled randomized controlled trials (1-13 weeks' duration), involving 1758 children (mean age 8.2 years). Single randomized controlled trials of zolpidem and eszopiclone in children with attention-deficit/hyperactivity disorder (ADHD) showed no improvement in sleep or ADHD ratings. Clinical Global Impression Improvement/Severity scores significantly improved with zolpidem ( P = .03 and P = .006, respectively). A single, small randomized controlled trial of diphenhydramine reported small improvements in sleep outcomes (8-10 minutes' better sleep latency and duration) after 1 week. In 19 randomized controlled trials, melatonin significantly improved sleep latency (median 28 minutes; range 11-51 minutes), sleep duration (median 33 minutes; range 14-68 minutes), and wake time after sleep onset (range 12-43 minutes), but not number of awakenings per night (range 0-2.7). Function and behavior improvement varied. Improvement in sleep was greatest in children with autism or other neurodevelopmental disorders, and smaller in adolescents and children with chronic delayed sleep onset. Adverse events were infrequent with melatonin, but more frequent than placebo in children taking eszopiclone or zolpidem. These findings show that melatonin was useful in improving some sleep outcomes in the short term, particularly those with comorbid ASD and neurodevelopmental disorders. Other drugs and outcomes are inadequately studied.

Comparative effectiveness and harms of long-acting insulins for type 1 and type 2 diabetes: A systematic review and meta-analysis.

AIM: To review evidence comparing benefits and harms of long-acting insulins in patients with type 1 and 2 diabetes. METHODS: MEDLINE and two Cochrane databases were searched during February 2018. Two authors selected studies meeting inclusion criteria and assessed their quality. Comparative studies of adult or paediatric patients with diabetes treated with insulin degludec, detemir or glargine were included. Meta-analysis was used to combine results of similar studies, and the I2 statistic calculated to assess statistical heterogeneity. RESULTS: Of 2534 citations reviewed, 70 studies met the inclusion criteria. No statistically significant differences in HbA1c were seen between any two insulins or formulations. Hypoglycaemia was less probable with degludec than with glargine, including nocturnal hypoglycaemia in type 1 (rate ratio 0.68, 95% CI 0.56-0.81) and type 2 diabetes (rate ratio 0.73, 95% CI 0.65-0.82), and severe hypoglycaemia in type 2 diabetes (relative risk 0.72, 95% CI 0.54-0.96). Patients with type 2 diabetes had higher rates of withdrawal because of adverse events when treated with detemir compared with glargine (relative risk 2.1, 95% CI 1.4-3.3). Adults taking detemir gained about 1 kg less body weight than those taking degludec (type 1) or glargine (type 2). CONCLUSIONS: No differences in glycaemic control were seen between insulin degludec, detemir and glargine. Hypoglycaemia was less probable with degludec than glargine, and patients taking detemir gained less body weight than those given degludec or glargine. In type 2 diabetes, withdrawals as a result of adverse events were more probable with detemir than glargine.

A study of the value of requesting information from drug manufacturers for systematic reviews; 9 years of experience from the drug effectiveness review project.

BACKGROUND: Systematic reviews (SRs) depend on comprehensive searches for evidence to provide balanced, accurate results. Requesting published and unpublished studies from pharmaceutical manufacturers has been proposed as a method to engage industry stakeholders and potentially reduce reporting bias. The Drug Effectiveness Review Project (DERP) has been requesting such evidence since 2003; the purpose of this study was to retrospectively evaluate the type and impact of the evidence received. METHODS: Data from "dossiers" submitted by pharmaceutical manufacturers for a set of 40 SRs conducted for DERP from July 2006 to June 2015 were retrospectively evaluated. Characteristics of data submitted in dossiers, including numbers, types, and characteristics of studies submitted and then included in DERP SRs, were abstracted. Time trends, study quality, publication status, and whether the submission represented a unique study or supplemental data to a published study were assessed. The impact of this evidence on SR conclusions was assessed using dual review. Differences were resolved through a consensus. RESULTS: Over 9 years, 160 dossiers were received, relating to 40 DERP SRs. Out of 7360 studies/datasets submitted, 2.2% (160) were included in a SR. The ratio of submitted-to-included increased over time. Most were unique studies (23% were supplemental data sets), and almost 42% of the studies were unpublished. The majority of the studies were rated fair quality, with 7.3% rated good and 14% rated poor quality by the original SR authors. Considering all literature search sources, 7.2% of all studies included in the 40 SRs came from a dossier, and 16% of dossier studies were included in a meta-analysis. The dossier studies resulted in changes to conclusions in 42% of the SRs. Out of 46 unpublished unique studies included in a SR, 25 (54%) influenced the conclusions in favor of the manufacturers drug, 8% favored a competitor drug, and 40% favored neither. In 92% of cases favoring the manufacturer's drug, the dossier study was the only evidence for that drug in a specific population or outcome. CONCLUSIONS: In SRs conducted for DERP, few studies submitted by pharmaceutical manufacturers were ultimately included in a SR. The included data helped to reduce reporting and publication bias by filling important gaps and in some cases led to altered conclusions.

Interventions to reduce inappropriate prescribing of antibiotics for acute respiratory tract infections: summary and update of a systematic review.

Objective Antibiotic overuse contributes to antibiotic resistance and adverse consequences. Acute respiratory tract infections (RTIs) are the most common reason for antibiotic prescribing in primary care, but such infections often do not require antibiotics. We summarized and updated a previously performed systematic review of interventions to reduce inappropriate use of antibiotics for acute RTIs. Methods To update the review, we searched MEDLINE®, the Cochrane Library (until January 2018), and reference lists. Two reviewers selected the studies, extracted the study data, and assessed the quality and strength of evidence. Results Twenty-six interventions were evaluated in 95 mostly fair-quality studies. The following four interventions had moderate-strength evidence of improved/reduced antibiotic prescribing and low-strength evidence of no adverse consequences: parent education (21% reduction, no increase return visits), combined patient/clinician education (7% reduction, no change in complications/satisfaction), procalcitonin testing for adults with RTIs of the lower respiratory tract (12%-72% reduction, no increased adverse consequences), and electronic decision support systems (24%-47% improvement in appropriate prescribing, 5%-9% reduction, no increased complications). Conclusions The best evidence supports use of specific educational interventions, procalcitonin testing in adults, and electronic decision support to reduce inappropriate antibiotic prescribing for acute RTIs without causing adverse consequences.

Use of patient decision aids increased younger women's reluctance to begin screening mammography: a systematic review and meta-analysis.

BACKGROUND: As breast cancer screening guidelines have changed recently, additional investigation is needed to understand changes in women's behavior after using breast cancer screening patient decision aids (BCS-PtDAs) and the potential effect on mammography utilization. This systematic review and meta-analysis sought to evaluate the effect of BCS-PtDAs on changes in women's intentions to undergo screening mammography and whether women deciding to begin or discontinue screening mammography displayed similar changes in screening intentions after using a BCS-PtDA. METHODS: We searched Medline, Scopus, PsycINFO, CENTRAL, Health and Psychosocial Instruments, Health Technology Assessment Database, PsycARTICLES, and cited references in eligible papers for randomized controlled trials (RCTs) and observational studies, published through August 24, 2016. The proportions of women who did and not intend to undergo screening and who were uncertain about undergoing screening mammography were pooled, using risk ratios (RR) and random effects. According to the protocol, RCTs or observational studies and any language were considered eligible for systematic review if they included data about women for which shared decision making is recommended. RESULTS: We ultimately included six studies with screening intention data for 2040 women. Compared to usual care, the use of BCS-PtDAs in three RCTs resulted in significantly more women deciding not to undergo screening mammography (RR 1.48 [95% CI 1.04-2.13]; P = 0.03), particularly for younger (38-50 years) women (1.77 [1.34-2.34]; P < 0.001). The use of BCS-PtDAs had a non-significant effect on the intentions of older women (69-89 years) to discontinue screening. CONCLUSIONS: The use of BCS-PtDAs increased younger women's reluctance to undergo screening for breast cancer. The implementation of such BCS-PtDAs in clinical practice would be expected to result in a 77% increase in the number of younger women (aged 38-50) who do not intend to be screened, and as a consequence, may reduce utilization of screening mammography. REGISTRATION: The protocol of this review is registered in the PROSPERO database, #CRD42016036695.

Nitrofurantoin vs other prophylactic agents in reducing recurrent urinary tract infections in adult women: a systematic review and meta-analysis.

BACKGROUND: The clinical and financial burden from bladder infections is significant. Daily antibiotic use is the recommended strategy for recurrent urinary tract infection prevention. Increasing antibiotic resistance rates, however, require immediate identification of innovative alternative prophylactic therapies. This systematic review aims to provide guidance on gaps in evidence to guide future research. OBJECTIVE: The objective of this review was to provide current pooled estimates of randomized control trials comparing the effects of nitrofurantoin vs other agents in reducing recurrent urinary tract infections in adult, nonpregnant women and assess relative adverse side effects. DATA SOURCES: Data sources included the following: MEDLINE, Jan. 1, 1946, to Jan. 31, 2015; Cochrane Central Register of Controlled Trials the Cochrane Database of Systematic Reviews, and web sites of the National Institute for Clinical Excellence, and the National Guideline Clearinghouse from 2000 to 2015. Randomized control trials of women with recurrent urinary tract infections comparing nitrofurantoin with any other treatment were included. STUDY DESIGN: A protocol for the study was developed a priori. Published guidance was followed for assessment of study quality. All meta-analyses were performed using random-effects models with Stats Direct Software. Dual review was used for all decisions and data abstraction. RESULTS: Twelve randomized control trials involving 1063 patients were included. One study that had a serious flaw was rated poor in quality, one study rated good, and the remainder fair. No significant differences in prophylactic antibiotic treatment with nitrofurantoin and norfloxacin, trimethoprim, sulfamethoxazole/trimethoprim, methamine hippurate, estriol, or cefaclor were found in clinical or microbiological cure in adult nonpregnant women with recurrent urinary tract infections (9 randomized control trials, 673 patients, relative risk ratio, 1.06; 95% confidence interval, 0.89-1.27; I2, 65%; and 12 randomized control trials, 1063 patients, relative risk ratio, 1.06; 95% confidence interval, 0.90-1.26; I2, 76%, respectively). Duration of prophylaxis also did not have a significant impact on outcomes. There was a statistically significant difference in overall adverse effects, with nitrofurantoin resulting in greater risk than other prophylactic treatments (10 randomized control trials, 948 patients, relative risk ratio, 2.17; 95% confidence interval, 1.34-3.50; I2, 61%). Overall, the majority of nitrofurantoin adverse effects were gastrointestinal, with a significant difference for withdrawals (12 randomized control trials, 1063 patients, relative risk ratio, 2.14; 95% confidence interval, 1.28-3.56; I2, 8%). CONCLUSION: Nitrofurantoin had similar efficacy but a greater risk of adverse events than other prophylactic treatments. Balancing the risks of adverse events, particularly gastrointestinal symptoms, with potential benefits of decreasing collateral ecological damage should be considered if selecting nitrofurantoin.