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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 (

Study design:Systematic review.Objective:To review sexuality in persons with spinal cord injuries (SCIs), and to report the effectiveness of erectile interventions.Methods:Reports from six databases (1966–2003), selected annual proceedings (1997–2002) and manufacturer's information were screened against eligibility criteria. Included reports were abstracted and data pooled from case-series reports regarding intracavernous injections and sildenafil.Results:From 2127 unique reports evaluated, 49 were included. Male sexual dysfunction was addressed in these reports of several interventions (behavioural therapy, topical agents, intraurethral alprosatadil, intracavernous injections, vacuum tumescence devices, penile implants, sacral stimulators and oral medication). Penile injections resulted in successful erectile function in 90% (95% CI: 83%, 97%) of men. Sildenafil resulted in 79% (95% CI: 68%, 90%) success; the difference in efficacy was not statistically significant. Five case-series reports involving 363 participants with penile implants demonstrated a high satisfaction rate, but a 10% complication rate.Conclusions:A large body of evidence addressing sexuality in males focuses on erection. Penile injection, sildenafil and vacuum devices generally obviate the need for penile implants to address erectile dysfunction. Interventions may positively affect sexual activity in the short term. Long-term sexual adjustment and holistic approaches beyond erections remain to be studied. Rigorous study design and reporting, using common outcome measures, will facilitate higher quality research. This will positively impact patient care.Sponsorship:Agency for Healthcare Research and Quality, US Department of Health and Human Services, 2101 East Jefferson Street, Rockville, MD 20852, USA.Spinal Cord (2006) 44, 465–473. doi:10.1038/sj.sc.3101880; published online 29 November 2005 [ABSTRACT FROM AUTHOR]

Abstract Background There is a significant public health burden associated with substance use in Canada. The early detection and/or treatment of risky substance use has the potential to dramatically improve outcomes for those who experience harms from the non-medical use of psychoactive substances, particularly adolescents whose brains are still undergoing development. The Screening, Brief Intervention, and Referral to Treatment model is a comprehensive, integrated approach for the delivery of early intervention and treatment services for individuals experiencing substance use-related harms, as well as those who are at risk of experiencing such harm. Methods This article describes the protocol for a systematic review of the effectiveness of brief interventions as part of the Screening, Brief Intervention, and Referral to Treatment model for reducing the non-medical use of psychoactive substances. Studies will be selected in which brief interventions target non-medical psychoactive substance use (excluding alcohol, nicotine, or caffeine) among those 12 years and older who are opportunistically screened and deemed at risk of harms related to psychoactive substance use. We will include one-on-one verbal interventions and exclude non-verbal brief interventions (for example, the provision of information such as a pamphlet or online interventions) and group interventions. Primary, secondary and adverse outcomes of interest are prespecified. Randomized controlled trials will be included; non-randomized controlled trials, controlled before-after studies and interrupted time series designs will be considered in the absence of randomized controlled trials. We will search several bibliographic databases (for example, MEDLINE, EMBASE, CINAHL, PsycINFO, CORK) and search sources for grey literature. We will meta-analyze studies where possible. We will conduct subgroup analyses, if possible, according to drug class and intervention setting. Discussion This review will provide evidence on the effectiveness of brief interventions as part of the Screening, Brief Intervention, and Referral to Treatment protocol aimed at the non-medical use of psychoactive substances and may provide guidance as to where future research might be most beneficial.

Abstract Background Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting. Methods Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section. Results Two-hundred and five trials were included in the review. Of these, 15% (31/205) reported that no harms were observed during the trial period. Of the remaining 174 trials reporting any safety information, only 21% (36/174) had adequate safety reporting. For all trials, the median percentage of words devoted to the reporting of safety in the results section was 2.6. Moreover, 69% (n = 141) of all trials devoted a lesser or equal percentage of words to safety compared to author affiliations. Of the predictor variables used in regression analysis, multicenter trials had more words devoted to safety in the results section than single centre trials (P = 0.045). Conclusions An evaluation of safety reporting in the reports of CAM RCTs across 15 different CAM interventions demonstrated that the reporting of harms was largely inadequate. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement.

Abstract Background Breast cancer in women is increasingly frequent, and care is complex, onerous and expensive, all of which lend urgency to improvements in care. Quality measurement is essential to monitor effectiveness and to guide improvements in healthcare. Methods Ten databases, including Medline, were searched electronically to identify measures assessing the quality of breast cancer care in women (diagnosis, treatment, followup, documentation of care). Eligible studies measured adherence to standards of breast cancer care in women diagnosed with, or in treatment for, any histological type of adenocarcinoma of the breast. Reference lists of studies, review articles, web sites, and files of experts were searched manually. Evidence appraisal entailed dual independent assessments of data (e.g., indicators used in quality measurement). The extent of each quality indicator's scientific validation as a measure was assessed. The American Society of Clinical Oncology (ASCO) was asked to contribute quality measures under development. Results Sixty relevant reports identified 58 studies with 143 indicators assessing adherence to quality breast cancer care. A paucity of validated indicators (n = 12), most of which assessed quality of life, only permitted a qualitative data synthesis. Most quality indicators evaluated processes of care. Conclusion While some studies revealed patterns of under-use of care, all adherence data require confirmation using validated quality measures. ASCO's current development of a set of quality measures relating to breast cancer care may hold the key to conducting definitive studies.

Background and Objective: Rapid reviews have gained popularity as a pragmatic approach to synthesize evidence in a timely manner to inform decision-making in healthcare. This article provides an overview of the key concepts and methodological considerations in conducting rapid reviews, drawing from a series of recently published guidance papers by the Cochrane Rapid Reviews Methods Group., Study Design and Setting: We discuss the definition, characteristics, and potential applications of rapid reviews and the trade-offs between speed and rigor. We present a practical example of a rapid review and highlight the methodological considerations outlined in the updated Cochrane guidance, including recommendations for literature searching, study selection, data extraction, risk of bias assessment, synthesis, and assessing the certainty of evidence., Results: Rapid reviews can be a valuable tool for evidence-based decision-making, but it is essential to understand their limitations and adhere to methodological standards to ensure their validity and reliability., Conclusion: As the demand for rapid evidence synthesis continues to grow, further research is needed to refine and standardize the methods and reporting of rapid reviews., Plain Language Summary: Rapid reviews are a type of research method designed to quickly gather and summarize evidence to support decision-making in healthcare. They are particularly useful when timely information is needed, such as during a public health emergency. This article explains the key aspects of how rapid reviews are conducted, based on the latest guidance from experts. Rapid reviews involve several steps, including searching for relevant studies, selecting which studies to include, and carefully examining the quality of the evidence. Although rapid reviews are faster to complete than full systematic reviews, they still follow rigorous processes to ensure that the findings are reliable. This article also provides an example of a rapid review in action, demonstrating how these reviews can be applied in real-world situations. While rapid reviews are a powerful tool for making quick, evidence-based decisions, it is important to be aware of their limitations. Researchers must follow established methods to make sure the results are as accurate and useful as possible. As more people use rapid reviews, ongoing research is needed to improve and standardize how they are done., Competing Interests: Declaration of competing interest D. D., C. H., G. G., B. N. S., and U. G. are co-convenors of the Cochrane Rapid Reviews Methods Group., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Rapid reviews (RRs) are produced using abbreviated methods compared with standard systematic reviews (SR) to expedite the process for decision-making. This paper provides interim guidance to support the complete reporting of RRs. Recommendations emerged from a survey informed by empirical studies of RR reporting, in addition to collective experience. RR producers should use existing, robustly developed reporting guidelines as the foundation for writing RRs: notably Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 (PRISMA 2020; reporting for SRs), but also preferred reporting items for overviews of reviews (PRIOR) items (reporting for overviews of SRs) where SRs are included in the RR. In addition, a minimum set of six items were identified for RRs: three items pertaining to methods and three addressing publication ethics. Authors should be reporting what a priori-defined iterative methods were used during conduct, what distinguishes their RR from an SR, and knowledge user (eg, policymaker) involvement in the process. Explicitly reporting deviations from standard SR methods, including omitted steps, is important. The inclusion of publication ethics items reflects the predominance of non-journal published RRs: reporting an authorship byline and corresponding author, acknowledging other contributors, and reporting the use of expert peer review. As various formats may be used when packaging and presenting information to decision-makers, it is practical to think of complete reporting as across a set of explicitly linked documents made available in an open-access journal or repository that is barrier-free. We encourage feedback from the RR community of the use of these items as we look to develop a consolidated list in the development of PRISMA-RR., Competing Interests: Competing interests: BJS led the development of AMSTAR. No other authors had conflicts to declare., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Lung cancer is the leading cause of cancer deaths in Canada, and because early cancers are often asymptomatic screening aims to prevent mortality by detecting cancer earlier when treatment is more likely to be curative. These reviews will inform updated recommendations by the Canadian Task Force on Preventive Health Care on screening for lung cancer., Methods: We will update the review on the benefits and harms of screening with CT conducted for the task force in 2015 and perform de novo reviews on the comparative effects between (i) trial-based selection criteria and use of risk prediction models and (ii) trial-based nodule classification and different nodule classification systems and on patients' values and preferences. We will search Medline, Embase, and Cochrane Central (for questions on benefits and harms from 2015; comparative effects from 2012) and Medline, Scopus, and EconLit (for values and preferences from 2012) via peer-reviewed search strategies, clinical trial registries, and the reference lists of included studies and reviews. Two reviewers will screen all citations (including those in the previous review) and base inclusion decisions on consensus or arbitration by another reviewer. For benefits (i.e., all-cause and cancer-specific mortality and health-related quality of life) and harms (i.e., overdiagnosis, false positives, incidental findings, psychosocial harms from screening, and major complications and mortality from invasive procedures as a result of screening), we will include studies of adults in whom lung cancer is not suspected. We will include randomized controlled trials comparing CT screening with no screening or alternative screening modalities (e.g., chest radiography) or strategies (e.g., CT using different screening intervals, classification systems, and/or patient selection via risk models or biomarkers); non-randomized studies, including modeling studies, will be included for the comparative effects between trial-based and other selection criteria or nodule classification methods. For harms (except overdiagnosis) we will also include non-randomized and uncontrolled studies. For values and preferences, the study design may be any quantitative design that either directly or indirectly measures outcome preferences on outcomes pertaining to lung cancer screening. We will only include studies conducted in Very High Human Development Countries and having full texts in English or French. Data will be extracted by one reviewer with verification by another, with the exception of result data on mortality and cancer incidence (for calculating overdiagnosis) where duplicate extraction will occur. If two or more studies report on the same comparison and it is deemed suitable, we will pool continuous data using a mean difference or standardized mean difference, as applicable, and binary data using relative risks and a DerSimonian and Laird model unless events are rare (< 1%) where we will pool odds ratios using Peto's method or (if zero events) the reciprocal of the opposite treatment arm size correction. For pooling proportions, we will apply suitable transformation (logit or arcsine) depending on the proportions of events. If meta-analysis is not undertaken we will synthesize the data descriptively, considering clinical and methodological differences. For each outcome, two reviewers will independently assess within- and across-study risk of bias and rate the certainty of the evidence using GRADE (Grading of Recommendations Assessment, Development, and Evaluation), and reach consensus., Discussion: Since 2015, additional trials and longer follow-ups or additional data (e.g., harms, specific patient populations) from previously published trials have been published that will improve our understanding of the benefits and harms of screening. The systematic review of values and preferences will allow fulsome insights that will inform the balance of benefits and harms., Systematic Review Registration: PROSPERO CRD42022378858., (© 2024. The Author(s).)

This paper, part of the Cochrane Rapid Review Methods Group series, offers guidance on determining when to conduct a rapid review (RR) instead of a full systematic review (SR). While both review types aim to comprehensively synthesise evidence, RRs, conducted within a shorter time frame of typically 6 months or less, involve streamlined methods to expedite the process. The decision to opt for an RR depends on the urgency of the research question, resource availability and the impact on decision outcomes. The paper categorises scenarios where RRs are appropriate, including urgent decision-making, informing guidelines, assessing new technologies and identifying evidence gaps. It also outlines instances when RRs may be inappropriate, cautioning against conducting them solely for ease, quick publication or only cost-saving motives.When deciding on an RR, it is crucial to consider both conceptual and practical factors. These factors encompass the urgency of needing timely evidence, the consequences of waiting for a full SR, the potential risks associated with incomplete evidence, and the risk of not using synthesised evidence in decision-making, among other considerations. Key factors to weigh also include having a clearly defined need, a manageable scope and access to the necessary expertise. Overall, this paper aims to guide informed judgements about whether to choose an RR over an SR based on the specific research question and context. Researchers and decision-makers are encouraged to carefully weigh potential trade-offs when opting for RRs., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Competing interests: All authors have completed the ICMJE disclosure form at http://www.icmje.org/disclosure-of-interest/ and declare: support from Cochrane for the submitted work. Certain methods studies upon which some of the recommendations are based have been carried out by authors of this guidance (GG, BNS, CH, CG, VJK, and CK). UG, BNS, and MT planned and carried out the evaluation study of the interim rapid review methods guidance.

Rapid reviews (RRs) are a helpful evidence synthesis tool to support urgent and emergent decision-making in healthcare. RRs involve abbreviating systematic review methods and are conducted in a condensed timeline to meet the decision-making needs of organisations or groups that commission them. Knowledge users (KUs) are those individuals, typically patient and public partners, healthcare providers, and policy-makers, who are likely to use evidence from research, including RRs, to make informed decisions about health policies, programmes or practices. However, research suggests that KU involvement in RRs is often limited or overlooked, and few RRs include patients as KUs. Existing RR methods guidance advocates involving KUs but lacks detailed steps on how and when to do so. This paper discusses the importance of involving KUs in RRs, including patient and public involvement to ensure RRs are fit for purpose and relevant for decision-making. Opportunities to involve KUs in planning, conduct and knowledge translation of RRs are outlined. Further, this paper describes various modes of engaging KUs during the review lifecycle; key considerations researchers should be mindful of when involving distinct KU groups; and an exemplar case study demonstrating substantive involvement of patient partners and the public in developing RRs. Although involving KUs requires time, resources and expertise, researchers should strive to balance 'rapid' with meaningful KU involvement in RRs. This paper is the first in a series led by the Cochrane Rapid Reviews Methods Group to further guide general RR methods., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: To inform updated recommendations by the Canadian Task Force on Preventive Health Care on screening in a primary care setting for hypertension in adults aged 18 years and older. This protocol outlines the scope and methods for a series of systematic reviews and one overview of reviews., Methods: To evaluate the benefits and harms of screening for hypertension, the Task Force will rely on the relevant key questions from the 2021 United States Preventive Services Task Force systematic review. In addition, a series of reviews will be conducted to identify, appraise, and synthesize the evidence on (1) the association of blood pressure measurement methods and future cardiovascular (CVD)-related outcomes, (2) thresholds for discussions of treatment initiation, and (3) patient acceptability of hypertension screening methods. For the review of blood pressure measurement methods and future CVD-related outcomes, we will perform a de novo review and search MEDLINE, Embase, CENTRAL, and APA PsycInfo for randomized controlled trials, prospective or retrospective cohort studies, nested case-control studies, and within-arm analyses of intervention studies. For the thresholds for discussions of treatment initiation review, we will perform an overview of reviews and update results from a relevant 2019 UK NICE review. We will search MEDLINE, Embase, APA PsycInfo, and Epistemonikos for systematic reviews. For the acceptability review, we will perform a de novo systematic review and search MEDLINE, Embase, and APA PsycInfo for randomized controlled trials, controlled clinical trials, and observational studies with comparison groups. Websites of relevant organizations, gray literature sources, and the reference lists of included studies and reviews will be hand-searched. Title and abstract screening will be completed by two independent reviewers. Full-text screening, data extraction, risk-of-bias assessment, and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will be completed independently by two reviewers. Results from included studies will be synthesized narratively and pooled via meta-analysis when appropriate. The GRADE approach will be used to assess the certainty of evidence for outcomes., Discussion: The results of the evidence reviews will be used to inform Canadian recommendations on screening for hypertension in adults aged 18 years and older., Systematic Review Registration: This protocol is registered on PROSPERO and is available on the Open Science Framework (osf.io/8w4tz)., (© 2023. The Author(s).)

Objective: We conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious adverse events (SAEs), taking into consideration confounding and temporal biases., Methods: Electronic databases (Ovid MEDLINE ALL, Embase Classic+Embase and the Cochrane Central Register of Controlled Trials) were searched to June 2021 for observational studies assessing associations between influenza vaccination during pregnancy and maternal non-obstetric SAEs and adverse birth outcomes, including preterm birth, spontaneous abortion, stillbirth, small-for-gestational-age birth and congenital anomalies. Studies of live attenuated vaccines, single-arm cohort studies and abstract-only publications were excluded. Records were screened using a liberal accelerated approach initially, followed by a dual independent approach for full-text screening, data extraction and risk of bias assessment. Pairwise meta-analyses were conducted, where two or more studies met methodological criteria for inclusion. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess evidence certainty., Results: Of 9443 records screened, 63 studies were included. Twenty-nine studies (24 cohort and 5 case-control) evaluated seasonal influenza vaccination (trivalent and/or quadrivalent) versus no vaccination and were the focus of our prioritised syntheses; 34 studies of pandemic vaccines (2009 A/H1N1 and others), combinations of pandemic and seasonal vaccines, and seasonal versus seasonal vaccines were also reviewed. Control for confounding and temporal biases was inconsistent across studies, limiting pooling of data. Meta-analyses for preterm birth, spontaneous abortion and small-for-gestational-age birth demonstrated no significant associations with seasonal influenza vaccination. Immortal time bias was observed in a sensitivity analysis of meta-analysing risk-based preterm birth data. In descriptive summaries for stillbirth, congenital anomalies and maternal non-obstetric SAEs, no significant association with increased risk was found in any studies. All evidence was of very low certainty., Conclusions: Evidence of very low certainty suggests that seasonal influenza vaccination during pregnancy is not associated with adverse birth outcomes or maternal non-obstetric SAEs. Appropriate control of confounding and temporal biases in future studies would improve the evidence base., Competing Interests: Competing interests: BH has previously received honoraria from Eversana for methodologic advice related to the conduct of systematic reviews and meta-analysis. All remaining authors have no competing interests to declare., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: A rapid review is a form of evidence synthesis considered a resource-efficient alternative to the conventional systematic review. Despite a dramatic rise in the number of rapid reviews commissioned and conducted in response to the coronavirus disease 2019 pandemic, published evidence on the optimal methods of planning, doing, and sharing the results of these reviews is lacking. The Priority III study aimed to identify the top 10 unanswered questions on rapid review methodology to be addressed by future research., Study Design and Setting: A modified James Lind Alliance Priority Setting Partnership approach was adopted. This approach used two online surveys and a virtual prioritization workshop with patients and the public, reviewers, researchers, clinicians, policymakers, and funders to identify and prioritize unanswered questions., Results: Patients and the public, researchers, reviewers, clinicians, policymakers, and funders identified and prioritized the top 10 unanswered research questions about rapid review methodology. Priorities were identified throughout the entire review process, from stakeholder involvement and formulating the question, to the methods of a systematic review that are appropriate to use, through to the dissemination of results., Conclusion: The results of the Priority III study will inform the future research agenda on rapid review methodology. We hope this will enhance the quality of evidence produced by rapid reviews, which will ultimately inform decision-making in the context of healthcare., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: A key component of patient-oriented research is the engagement of patients as partners in the design and conduct of health research. While there is now national infrastructure and networks to support the engagement of patients as partners, there remain calls for promising practices and success stories. In particular, there remains a keen interest in evaluating the impact that patient engagement has on health research studies. We aimed to investigate the impact that patient engagement had on health research conducted in Ontario, Canada., Methods: Our sampling frame was studies that were awarded funding by the Ontario SPOR SUPPORT Unit. Semi-structured interviews were conducted with 10 principal investigators, members of research teams, and patient partners. Interviews explored the role of patient partners, the perceived impact of the patient engagement on the study, challenges faced, and advice for other researchers considering patient engagement. Data were analysed using the thematic analysis method with transcripts coded independently by two members of the study team. All coding and subsequent theme generation were discussed until consensus was achieved., Results: There was variation in the methods used to engage patients and other stakeholders, the roles that patients and stakeholders occupied, and where they had input. Interviewees discussed two major areas of impact of patient engagement on research: impact on the study about which they were being interviewed, which tended to relate to improved relevancy of the research to the study population, and impact on themselves which led to changes in their own practice or approaches to future research. Identified challenges to patient engagement included: identifying and reaching patient advisors or patient partners, time-related challenges, and maintaining engagement over the course of the research., Conclusions: There remains a need to further build out the concept of relevancy and how it may be operationalised in practice. Further, the longer-term impacts of patient engagement on researchers and research teams remains under-explored and may reveal additional elements for evaluation. Challenges to patient engagement remain, including identifying and maintaining engagement with partners that reflect the diversity of the population of interest., (© 2022. The Author(s).)

Background: Health policy-makers must often make decisions in compressed time frames and with limited resources. Hence, rapid reviews have become a pragmatic alternative to comprehensive systematic reviews. However, it is important that rapid review methods remain rigorous to support good policy development and decisions. There is currently little evidence about which streamlined steps in a rapid review are less likely to introduce unacceptable levels of uncertainty while still producing a product that remains useful to policy-makers., Methods: This paper summarizes current research describing commonly used methods and practices that are used to conduct rapid reviews and presents key considerations and options to guide methodological choices for a rapid review., Results: The most important step for a rapid review is for an experienced research team to have early and ongoing engagement with the people who have requested the review. A clear research protocol, derived from a needs assessment conducted with the requester, serves to focus the review, defines the scope of the rapid review, and guides all subsequent steps. Common recommendations for rapid review methods include tailoring the literature search in terms of databases, dates, and languages. Researchers can consider using a staged search to locate high-quality systematic reviews and then subsequently published primary studies. The approaches used for study screening and selection, data extraction, and risk-of-bias assessment should be tailored to the topic, researcher experience, and available resources. Many rapid reviews use a single reviewer for study selection, risk-of-bias assessment, or data abstraction, sometimes with partial or full verification by a second reviewer. Rapid reviews usually use a descriptive synthesis method rather than quantitative meta-analysis. Use of brief report templates and standardized production methods helps to speed final report publication., Conclusions: Researchers conducting rapid reviews need to make transparent methodological choices, informed by stakeholder input, to ensure that rapid reviews meet their intended purpose. Transparency is critical because it is unclear how or how much streamlined methods can bias the conclusions of reviews. There are not yet internationally accepted standards for conducting or reporting rapid reviews. Thus, this article proposes interim guidance for researchers who are increasingly employing these methods., (© 2022. The Author(s).)

Background: The value of rapid reviews in informing health care decisions is more evident since the onset of the coronavirus disease 2019 (COVID-19) pandemic. While systematic reviews can be completed rapidly, rapid reviews are usually a type of evidence synthesis in which components of the systematic review process may be simplified or omitted to produce information more efficiently within constraints of time, expertise, funding or any combination thereof. There is an absence of high-quality evidence underpinning some decisions about how we plan, do and share rapid reviews. We will conduct a modified James Lind Alliance Priority Setting Partnership to determine the top 10 unanswered research questions about how we plan, do and share rapid reviews in collaboration with patients, public, reviewers, researchers, clinicians, policymakers and funders. Methods: An international steering group consisting of key stakeholder perspectives (patients, the public, reviewers, researchers, clinicians, policymakers and funders) will facilitate broad reach, recruitment and participation across stakeholder groups. An initial online survey will identify stakeholders' perceptions of research uncertainties about how we plan, do and share rapid reviews. Responses will be categorised to generate a long list of questions. The list will be checked against systematic reviews published within the past three years to identify if the question is unanswered. A second online stakeholder survey will rank the long list in order of priority. Finally, a virtual consensus workshop of key stakeholders will agree on the top 10 unanswered questions. Discussion: Research prioritisation is an important means for minimising research waste and ensuring that research resources are targeted towards answering the most important questions. Identifying the top 10 rapid review methodology research priorities will help target research to improve how we plan, do and share rapid reviews and ultimately enhance the use of high-quality synthesised evidence to inform health care policy and practice., Competing Interests: Competing interests: Nikita Burke is paid in full from Evidence Synthesis Ireland, which is a capacity-building initiative funded by the Health Research Board (Ireland) and the HSC R&D Division of the Public Health Agency (Northern Ireland). Claire Beecher is paid in part from Evidence Synthesis Ireland, which is a capacity-building initiative funded by the Health Research Board (Ireland) and the HSC R&D Division of the Public Health Agency (Northern Ireland). Declan Devane is paid in part from Evidence Synthesis Ireland, which is a capacity-building initiative funded by the Health Research Board (Ireland) and the HSC R&D Division of the Public Health Agency (Northern Ireland). Andrea C. Tricco is paid in part by a Tier 2 Canada Research Chair in Knowledge Synthesis, (Copyright: © 2021 Beecher C et al.)

Introduction: Musculoskeletal injuries (MSKi) are a common challenge for those in military careers. Compared to their male peers, reports indicate that female military members and recruits are at greater risk of suffering MSKi during training and deployment. The objectives of this study were to identify the types and causes of MSKi among female military personnel and to explore the various risk factors associated with MSKi., Materials and Methods: A scoping review was conducted over a 4-month time frame of English language, peer-reviewed studies published from 1946 to 2019. Search strategies for major biomedical databases (e.g., MEDLINE; Embase Classic + Embase; and the following EBM Reviews-Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment, and the NHS Economic Evaluation Database) were developed by a senior medical information specialist and included 2,891 titles/abstracts. Study selection and data collection were designed according to the Population, Concept, and Context framework. Studies were included if the study population provided stratified data for females in a military context., Results: From a total of 2,287 citations captured from the literature searches, 168 peer-reviewed publications (144 unique studies) were eligible for inclusion. Studies were identified from across 10 countries and published between 1977 and 2019. Study designs were primarily prospective and retrospective cohorts. Most studies assessed both prevalence/incidence and risk factors for MSKi (62.50%), with few studies assessing cause (13.69%). For MSKi of female recruits compared to active female members, the prevalence was higher (19.7%-58.3% vs. 5.5%-56.6%), but the incidence (0.02%-57.7% vs. 13.5%-71.9%) was lower. The incidence of stress fractures was found to be much higher in female recruits than in active members (1.6%-23.9% vs. 2.7%). For anthropometric risk factors, increased body fat was a predictor of MSKi, but not stress fractures. For physiological risk factors for both female military groups, being less physically fit, later menarche, and having no/irregular menses were predictors of MSKi and stress fractures. For biomechanical risk factors, among female recruits, longer tibial length and femoral neck diameter increased the risk of stress fractures, and low foot arch increased risk of an ankle sprain. For female active military members, differences in shoulder rotation and bone strength were associated with risk of MSKi. For biological sex, being female compared to male was associated with an increased risk of MSKi, stress fractures, and general injuries. The consequences of experiencing MSKi for active military included limited duties, time off, and discharge. For recruits, these included missed training days, limited duty days, and release., Conclusions: This scoping review provides insight into the current state of the evidence regarding the types and causes of MSKi, as well as the factors that influence MSKi among females in the military. Future research endeavors should focus on randomized controlled trials examining training paradigms to see if women are more susceptible. The data presented in the scoping review could potentially be used to develop training strategies to mitigate some of the identified barriers that negatively impact women from pursuing careers in the military., (© The Association of Military Surgeons of the United States 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: One of the current challenges in long-term care homes (LTCH) is to identify the optimal model of care, which may include specialty physicians, nursing staff, person support workers, among others. There is currently no consensus on the complement or scope of care delivered by these providers, nor is there a repository of studies that evaluate the various models of care. We conducted a rapid scoping review to identify and map what care provider models and interventions in LTCH have been evaluated to improve quality of life, quality of care, and health outcomes of residents., Methods: We conducted this review over 10-weeks of English language, peer-reviewed studies published from 2010 onward. Search strategies for databases (e.g., MEDLINE) were run on July 9, 2020. Studies that evaluated models of provider care (e.g., direct patient care), or interventions delivered to facility, staff, and residents of LTCH were included. Study selection was performed independently, in duplicate. Mapping was performed by two reviewers, and data were extracted by one reviewer, with partial verification by a second reviewer., Results: A total of 7,574 citations were screened based on the title/abstract, 836 were reviewed at full text, and 366 studies were included. Studies were classified according to two main categories: healthcare service delivery (n = 92) and implementation strategies (n = 274). The condition/ focus of the intervention was used to further classify the interventions into subcategories. The complex nature of the interventions may have led to a study being classified in more than one category/subcategory., Conclusion: Many healthcare service interventions have been evaluated in the literature in the last decade. Well represented interventions (e.g., dementia care, exercise/mobility, optimal/appropriate medication) may present opportunities for future systematic reviews. Areas with less research (e.g., hearing care, vision care, foot care) have the potential to have an impact on balance, falls, subsequent acute care hospitalization., Competing Interests: The authors have declared that no competing interests exist.

Background: Elderberry has traditionally been used to prevent and treat respiratory problems. During the COVID-19 pandemic, there has been interest in elderberry supplements to treat or prevent illness, but also concern that elderberry might overstimulate the immune system and increase the risk of 'cytokine storm'. We aimed to determine benefits and harms of elderberry for the prevention and treatment of viral respiratory infections, and to assess the relationship between elderberry supplements and negative health impacts associated with overproduction of pro-inflammatory cytokines., Methods: We conducted a systematic review and searched six databases, four research registers, and two preprint sites for studies. Two reviewers independently assessed studies for inclusion, extracted data from studies, assessed risk of bias using Cochrane tools, and evaluated certainty of estimates using GRADE. Outcomes included new illnesses and the severity and duration of illness., Results: We screened 1187 records and included five randomized trials on elderberry for the treatment or prevention of viral respiratory illness. We did not find any studies linking elderberry to clinical inflammatory outcomes. However, we found three studies measuring production of cytokines ex vivo after ingestion of elderberry. Elderberry may not reduce the risk of developing the common cold; it may reduce the duration and severity of colds, but the evidence is uncertain. Elderberry may reduce the duration of influenza but the evidence is uncertain. Compared to oseltamivir, an elderberry-containing product may be associated with a lower risk of influenza complications and adverse events. We did not find evidence on elderberry and clinical outcomes related to inflammation. However, we found evidence that elderberry has some effect on inflammatory markers, although this effect may decline with ongoing supplementation. One small study compared elderberry to diclofenac (a nonsteroidal anti-inflammatory drug) and provided some evidence that elderberry is as effective or less effective than diclofenac in cytokine reduction over time., Conclusions: Elderberry may be a safe option for treating viral respiratory illness, and there is no evidence that it overstimulates the immune system. However, the evidence on both benefits and harms is uncertain and information from recent and ongoing studies is necessary to make firm conclusions.

Objectives: To develop methods guidance to support the conduct of rapid reviews (RRs) produced within Cochrane and beyond, in response to requests for timely evidence syntheses for decision-making purposes including urgent health issues of high priority., Study Design and Setting: Interim recommendations were informed by a scoping review of the underlying evidence, primary methods studies conducted, and a survey sent to 119 representatives from 20 Cochrane entities, who were asked to rate and rank RR methods across stages of review conduct. Discussions among those with expertise in RR methods further informed the list of recommendations with accompanying rationales provided., Results: Based on survey results from 63 respondents (53% response rate), 26 RR methods recommendations are presented for which there was a high or moderate level of agreement or scored highest in the absence of such agreement. Where possible, how recommendations align with Cochrane methods guidance for systematic reviews is highlighted., Conclusion: The Cochrane Rapid Reviews Methods Group offers new, interim guidance to support the conduct of RRs. Because best practice is limited by the lack of currently available evidence for some RR methods shortcuts taken, this guidance will need to be updated as additional abbreviated methods are evaluated., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background and Objective: Rapid reviews were first mentioned in the literature in 1997, when Best et al. described the rapid health technology assessment program in the south and west regions of England but did not provide a formal definition. More recently, the only consensus around a rapid review definition is that a formal definition does not exist. The primary aim of this work is to create a repository of existing definitions and to identify key themes, which may help the knowledge synthesis community in defining rapid review products., Methods: A systematic scoping review was performed to identify definitions used in journal-published rapid reviews written in English between 2017 and January 2019. We searched Medline, Embase Classic + Embase, PsycINFO, ERIC, Cochrane Library, CINAHL, and Web of Science on December 21, 2018. Two reviewers performed study selection and data extraction using a priori-defined methods published in a protocol. Definitions from rapid review methods articles (published from 1997 onward) identified in another scoping review were added to the results, and all definitions were thematically analyzed using NVivo. A quantitative analysis was also performed around studies cited., Results: Definitions from 216 rapid reviews and 90 rapid review methods articles were included in the thematic analysis. Eight key themes were identified: accelerated/rapid process or approach, variation in methods shortcuts, focus/depth/breadth of scope, compare and contrast to a full traditional systematic review, stakeholder rationale, resource efficiency rationale, systematic approach, bias/limitations. Secondary referencing was a common occurrence., Conclusion: Thematic analysis performed in this systematic scoping review has allowed for the creation of a suggested definition for rapid reviews that can be used to inform the systematic review community., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Genetic diagnosis provides important information for prenatal decision-making and management. Promising results from exome sequencing (ES) for genetic diagnosis in fetuses with structural anomalies are emerging. The objective of this scoping review was to identify what is known about the use of ES for genetic testing in prenatal cases with known or suspected genetic disease. A rapid scoping review was conducted over a six-week timeframe of English-language peer-reviewed studies. Search strategies for major databases (e.g., Medline) and gray literature were developed, and peer reviewed by information specialists. Identified studies were categorized and charted using tables and diagrams. Twenty-four publications were included from seven countries published between 2014 and 2019. Most commonly reported outcomes were diagnostic yields, which varied widely from 5% to 57%, and prenatal phenotype. Few studies reported clinical outcomes related to impact, decision-making, and clinical utility. Qualitative studies (n = 6) provided useful insights into patient and health-care provider experiences with ES. Findings suggest prenatal ES is beneficial, but more research is needed to better understand the clinical utility, circumstances for ideal use, feasibility, and costs of offering rapid ES as a routine option for prenatal genetic testing.

Objectives: The objective is to identify studies that have assessed methodological shortcuts for undertaking rapid reviews (RRs) and mapping these to review conduct stages and Methodological Expectations of Cochrane Intervention Reviews (MECIR) guidance., Study Design and Setting: We conducted a systematic scoping review. We searched multiple databases (e.g., MEDLINE, Embase), which were supplemented by grey literature searching. Methods were defined a priori in a published protocol., Results: Out of 1,873 records, 90 publications were divided into four RR categories: formal evaluation (n = 14), development, which included four subcategories (n = 65), comparison (n = 2), and applying reporting guidelines/critical appraisal tools (n = 3), and a systematic review surrogate category (n = 6). Four formal evaluation studies were composite evaluations, including more than one shortcut simultaneously. The remaining 10 studies evaluated viable (e.g., including English-only publications) and unviable (e.g., single-reviewer screening) shortcuts, covering five key dimensions and five 'other' (e.g., involving stakeholders) considerations while conducting a review. Because of complexities around shortcuts evaluated, only a cursory mapping to MECIR criteria was possible., Conclusion: Some methods shortcuts may be valid in the context of RRs, but limitations in the studies may limit their applicability. The results will serve to inform discussions within Cochrane regarding possible future implementation of RRs., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Rapid reviews (RRs) are useful products to healthcare policy-makers and other stakeholders, who require timely evidence. Therefore, it is important to assess how well RRs convey useful information in a format that is easy to understand so that decision-makers can make best use of evidence to inform policy and practice., Methods: We assessed a diverse sample of 103 RRs against the BRIDGE criteria, originally developed for communicating clearly to support healthcare policy-making. We modified the criteria to increase assessability and to align with RRs. We identified RRs from key database searches and through searching organisations known to produce RRs. We assessed each RR on 26 factors (e.g. organisation of information, lay language use). Results were descriptively analysed. Further, we explored differences between RRs published in journals and those published elsewhere., Results: Certain criteria were well covered across the RRs (e.g. all aimed to synthesise research evidence and all provided references of included studies). Further, most RRs provided detail on the problem or issue (96%; n = 99) and described methods to conduct the RR (91%; n = 94), while several addressed political or health systems contexts (61%; n = 63). Many RRs targeted policy-makers and key stakeholders as the intended audience (66%; n = 68), yet only 32% (n = 33) involved their tacit knowledge, while fewer (27%; n = 28) directly involved them reviewing the content of the RR. Only six RRs involved patient partners in the process. Only 23% (n = 24) of RRs were prepared in a format considered to make information easy to absorb (i.e. graded entry) and 25% (n = 26) provided specific key messages. Readability assessment indicated that the text of key RR sections would be hard to understand for an average reader (i.e. would require post-secondary education) and would take 42 (± 36) minutes to read., Conclusions: Overall, conformity of the RRs with the modified BRIDGE criteria was modest. By assessing RRs against these criteria, we now understand possible ways in which they could be improved to better meet the information needs of healthcare decision-makers and their potential for innovation as an information-packaging mechanism. The utility and validity of these items should be further explored., Protocol Availability: The protocol, published on the Open Science Framework, is available at: osf.io/68tj7.

Background: As production of rapid reviews (RRs) increases in healthcare, knowing how to efficiently convey RR evidence to various end-users is important given they are often intended to directly inform decision-making. Little is known about how often RRs are produced in the published or unpublished domains, and what and how information is structured., Objectives: To compare and contrast report format and content features of journal-published (JP) and non-journal published (NJP) RRs., Methods: JP RRs were identified from key databases, and NJP RRs were identified from a grey literature search of 148 RR producing organizations and were sampled proportionate to cluster size by organization and product type to match the JP RR group. We extracted and formally compared 'how' (i.e., visual arrangement) and 'what' information was presented., Results: We identified 103 RRs (52 JP and 51 NJP) from 2016. A higher percentage of certain features were observed in JP RRs compared to NJP RRs (e.g., reporting authors; use of a traditional journal article structure; section headers including abstract, methods, discussion, conclusions, acknowledgments, conflict of interests, and author contributions; and use of figures (e.g., Study Flow Diagram) in the main document). For NJP RRs, a higher percentage of features were observed (e.g., use non-traditional report structures; bannering of executive summary sections and appendices; use of typographic cues; and including outcome tables). NJP RRs were more than double in length versus JP RRs. Including key messages was uncommon in both groups., Conclusions: This comparative study highlights differences between JP and NJP RRs. Both groups may benefit from better use of plain language, and more clear and concise design. Alternative innovative formats and end-user preferences for content and layout should be studied further with thought given to other considerations to ensure better packaging of RR results to facilitate uptake into policy and practice., Study Registration: The full protocol is available at: https://osf.io/29xvk/., Competing Interests: The authors have declared that no competing interests exist.

Introduction: With its legalisation and regulation in Canada in 2018, the proportion of Canadians reporting cannabis use in 2019 increased substantially over the previous year, with half of new users being aged 45+ years. While use in older adults has been low historically, as those born in the 1950s and 1960s continue to age, this demographic will progressively have more liberal attitudes, prior cannabis exposure and higher use rates. However, older adults experience slower metabolism, increased likelihood of polypharmacy, cognitive decline and chronic physical/mental health problems. There is a need to enhance knowledge of the effects of cannabis use in older adults. The following question will be addressed using a scoping review approach: what evidence exists regarding beneficial and harmful effects of medical and non-medical cannabis use in adults >50 years of age? Given that beneficial and harmful effects of cannabis may be mediated by patient-level (eg, age, sex and race) and cannabis-related factors (eg, natural vs synthetic, consumption method), subgroup effects related to these and additional factors will be explored., Methods and Analysis: Methods for scoping reviews outlined by Arksey & O'Malley and the Joanna Briggs Institute will be used. A librarian designed a systematic search of the literature from database inception to June 2019. Using the OVID platform, Ovid MEDLINE will be searched, including Epub Ahead of Print and In-Process and Other Non-Indexed Citations, Embase Classic+Embase, and PsycINFO for reviews, randomised trials, non-randomised trials and observational studies of cannabis use. The Cochrane Library on Wiley will also be searched. Eligibility criteria will be older adult participants, currently using cannabis (medical or non-medical), with studies required to report a cannabis-related health outcome to be eligible. Two reviewers will screen citations and full texts, with support from artificial intelligence. Two reviewers will chart data. Tables/graphics will be used to map evidence and identify evidence gaps., Ethics and Dissemination: This research will enhance awareness of existing evidence addressing the health effects of medical and non-medical cannabis use in older adults. Findings will be disseminated through a peer-reviewed publication, conference presentations and a stakeholder meeting., Trial Registration Number: DOI 10.17605/OSF.IO/5JTAQ., Competing Interests: Competing interests: BH has previously received honoraria from Cornerstone Research Group for methodological advice related to the conduct of systematic reviews and meta-analysis., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Uptake of human papillomavirus (HPV) vaccine remains low in many countries, although the bivalent and quadrivalent HPV vaccines given as a three-dose schedule are effective in the prevention of precancerous lesions of the cervix in women. Simpler immunisation schedules, such as those with fewer doses, might reduce barriers to vaccination, as may programmes that include males., Objectives: To evaluate the efficacy, immunogenicity, and harms of different dose schedules and different types of HPV vaccines in females and males., Search Methods: We conducted electronic searches on 27 September 2018 in Ovid MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL) (in the Cochrane Library), and Ovid Embase. We also searched the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov (both 27 September 2018), vaccine manufacturer websites, and checked reference lists from an index of HPV studies and other relevant systematic reviews., Selection Criteria: We included randomised controlled trials (RCTs) with no language restriction. We considered studies if they enrolled HIV-negative males or females aged 9 to 26 years, or HIV-positive males or females of any age., Data Collection and Analysis: We used methods recommended by Cochrane. We use the term 'control' to refer to comparator products containing an adjuvant or active vaccine and 'placebo' to refer to products that contain no adjuvant or active vaccine. Most primary outcomes in this review were clinical outcomes. However, for comparisons comparing dose schedules, the included RCTs were designed to measure antibody responses (i.e. immunogenicity) as the primary outcome, rather than clinical outcomes, since it is unethical to collect cervical samples from girls under 16 years of age. We analysed immunogenicity outcomes (i.e. geometric mean titres) with ratios of means, clinical outcomes (e.g. cancer and intraepithelial neoplasia) with risk ratios or rate ratios and, for serious adverse events and deaths, we calculated odds ratios. We rated the certainty of evidence with GRADE., Main Results: We included 20 RCTs with 31,940 participants. The length of follow-up in the included studies ranged from seven months to five years. Two doses versus three doses of HPV vaccine in 9- to 15-year-old females Antibody responses after two-dose and three-dose HPV vaccine schedules were similar after up to five years of follow-up (4 RCTs, moderate- to high-certainty evidence). No RCTs collected clinical outcome data. Evidence about serious adverse events in studies comparing dose schedules was of very low-certainty owing to imprecision and indirectness (three doses 35/1159; two doses 36/1158; 4 RCTs). One death was reported in the three-dose group (1/898) and none in the two-dose group (0/899) (low-certainty evidence). Interval between doses of HPV vaccine in 9- to 14-year-old females and males Antibody responses were stronger with a longer interval (6 or 12 months) between the first two doses of HPV vaccine than a shorter interval (2 or 6 months) at up to three years of follow-up (4 RCTs, moderate- to high-certainty evidence). No RCTs collected data about clinical outcomes. Evidence about serious adverse events in studies comparing intervals was of very low-certainty, owing to imprecision and indirectness. No deaths were reported in any of the studies (0/1898, 3 RCTs, low-certainty evidence). HPV vaccination of 10- to 26-year-old males In one RCT there was moderate-certainty evidence that quadrivalent HPV vaccine, compared with control, reduced the incidence of external genital lesions (control 36 per 3081 person-years; quadrivalent 6 per 3173 person-years; rate ratio 0.16, 95% CI 0.07 to 0.38; 6254 person-years) and anogenital warts (control 28 per 2814 person-years; quadrivalent 3 per 2831 person-years; rate ratio 0.11, 95% CI 0.03 to 0.38; 5645 person-years). The quadrivalent vaccine resulted in more injection-site adverse events, such as pain or redness, than control (537 versus 601 per 1000; risk ratio (RR) 1.12, 95% CI 1.06 to 1.18, 3895 participants, high-certainty evidence). There was very low-certainty evidence from two RCTs about serious adverse events with quadrivalent vaccine (control 12/2588; quadrivalent 8/2574), and about deaths (control 11/2591; quadrivalent 3/2582), owing to imprecision and indirectness. Nonavalent versus quadrivalent vaccine in 9- to 26-year-old females and males Three RCTs were included; one in females aged 9- to 15-years (n = 600), one in females aged 16- to 26-years (n = 14,215), and one in males aged 16- to 26-years (n = 500). The RCT in 16- to 26-year-old females reported clinical outcomes. There was little to no difference in the incidence of the combined outcome of high-grade cervical epithelial neoplasia, adenocarcinoma in situ, or cervical cancer between the HPV vaccines (quadrivalent 325/6882, nonavalent 326/6871; OR 1.00, 95% CI 0.85 to 1.16; 13,753 participants; high-certainty evidence). The other two RCTs did not collect data about clinical outcomes. There were slightly more local adverse events with the nonavalent vaccine (905 per 1000) than the quadrivalent vaccine (846 per 1000) (RR 1.07, 95% CI 1.05 to 1.08; 3 RCTs, 15,863 participants; high-certainty evidence). Comparative evidence about serious adverse events in the three RCTs (nonavalent 243/8234, quadrivalent 192/7629; OR 0.60, 95% CI 0.14 to 2.61) was of low certainty, owing to imprecision and indirectness. HPV vaccination for people living with HIV Seven RCTs reported on HPV vaccines in people with HIV, with two small trials that collected data about clinical outcomes. Antibody responses were higher following vaccination with either bivalent or quadrivalent HPV vaccine than with control, and these responses could be demonstrated to have been maintained for up to 24 months in children living with HIV (low-certainty evidence). The evidence about clinical outcomes and harms for HPV vaccines in people with HIV is very uncertain (low- to very low-certainty evidence), owing to imprecision and indirectness., Authors' Conclusions: The immunogenicity of two-dose and three-dose HPV vaccine schedules, measured using antibody responses in young females, is comparable. The quadrivalent vaccine probably reduces external genital lesions and anogenital warts in males compared with control. The nonavalent and quadrivalent vaccines offer similar protection against a combined outcome of cervical, vaginal, and vulval precancer lesions or cancer. In people living with HIV, both the bivalent and quadrivalent HPV vaccines result in high antibody responses. For all comparisons of alternative HPV vaccine schedules, the certainty of the body of evidence about serious adverse events reported during the study periods was low or very low, either because the number of events was low, or the evidence was indirect, or both. Post-marketing surveillance is needed to continue monitoring harms that might be associated with HPV vaccines in the population, and this evidence will be incorporated in future updates of this review. Long-term observational studies are needed to determine the effectiveness of reduced-dose schedules against HPV-related cancer endpoints, and whether adopting these schedules improves vaccine coverage rates., (Copyright © 2019 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.)

Background: Infectious disease epidemics are a constant threat, and while we can strengthen preparedness in advance, inevitably, we will sometimes be caught unaware by novel outbreaks. To address the challenge of rapidly identifying clinical research priorities in those circumstances, we developed and piloted a protocol for carrying out a systematic, rapid research needs appraisal (RRNA) of existing evidence within 5 days in response to outbreaks globally, with the aim to inform clinical research prioritization., Methods: The protocol was derived from rapid review methodologies and optimized through effective use of pre-defined templates and global time zones. It was piloted using a Lassa fever (LF) outbreak scenario. Databases were searched from 1969 to July 2017. Systematic reviewers based in Canada, the UK, and the Philippines screened and extracted data using a systematic review software. The pilot was evaluated through internal analysis and by comparing the research priorities identified from the data, with those identified by an external LF expert panel., Results: The RRNA pilot was completed within 5 days. To accommodate the high number of articles identified, data extraction was prioritized by study design and year, and the clinical research prioritization done post-day 5. Of 118 potentially eligible articles, 52 met the data extraction criteria, of which 46 were extracted within the 5-day time frame. The RRNA team identified 19 clinical research priorities; the expert panel independently identified 21, of which 11 priorities overlapped. Each method identified a unique set of priorities, showing that combining both methods for clinical research prioritization is more robust than using either method alone., Conclusions: This pilot study shows that it is feasible to carry out a systematic RRNA within 5 days in response to a (re-) emerging outbreak to identify gaps in existing evidence, as long as sufficient resources are identified, and reviewers are experienced and trained in advance. Use of an online systematic review software and global time zones effectively optimized resources. Another 3 to 5 days are recommended for review of the extracted data and to formulate clinical research priorities. The RRNA can be used for a "Disease X" scenario and should optimally be combined with an expert panel to ensure breadth and depth of coverage of clinical research priorities.

Scoping reviews, a type of knowledge synthesis, follow a systematic approach to map evidence on a topic and identify main concepts, theories, sources, and knowledge gaps. Although more scoping reviews are being done, their methodological and reporting quality need improvement. This document presents the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist and explanation. The checklist was developed by a 24-member expert panel and 2 research leads following published guidance from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network. The final checklist contains 20 essential reporting items and 2 optional items. The authors provide a rationale and an example of good reporting for each item. The intent of the PRISMA-ScR is to help readers (including researchers, publishers, commissioners, policymakers, health care providers, guideline developers, and patients or consumers) develop a greater understanding of relevant terminology, core concepts, and key items to report for scoping reviews.

Plain English Summary: With the growing movement to engage patients in research, questions are being asked about who is engaging patients and how they are being engaged. Internationally, research groups are supporting and funding patient-oriented research studies that engage patients in the identification of research priorities and the design, conduct and uptake of research. As we move forward, we need to know what meaningful patient engagement looks like, how it benefits research and clinical practice, and what are the barriers to patient engagement?We conducted a review of the published literature looking for trials that report engaging patients in the research. We included both randomized controlled trials and non-randomized comparative trials. We looked at these trials for important study characteristics, including how patients were engaged, to better understand the practices used in trials. Importantly, we also discuss the number of trials reporting patient engagement practices relative to all published trials. We found that very few trials report any patient engagement activities even though it is widely supported by many major funding organizations. The findings of our work will advance patient-oriented research by showing how patients can be engaged and by stressing that patient engagement practices need to be better reported., Background: Patient-Oriented Research (POR) is research informed by patients and is centred on what is of importance to them. A fundamental component of POR is that patients are included as an integral part of the research process from conception to dissemination and implementation, and by extension, across the research continuum from basic research to pragmatic trials [J Comp Eff Res 2012, 1:181-94, JAMA 2012, 307:1587-8]. Since POR's inception, questions have been raised as to how best to achieve this goal.We conducted a systematic review of randomized controlled trials and non-randomized comparative trials that report engaging patients in their research. Our main goal was to describe the characteristics of published trials engaging patients in research, and to identify the extent of patient engagement activities reported in these trials., Methods: The MEDLINE®, EMBASE®, Cinahl, PsycINFO, Cochrane Methodology Registry, and Pubmed were searched from May 2011 to June 16th, 2016. Title, abstract and full text screening of all reports were conducted independently by two reviewers. Data were extracted from included trials by one reviewer and verified by a second. All trials that report patient engagement for the purposes of research were included., Results: Of the 9490 citations retrieved, 2777 were reviewed at full text, of which 23 trials were included. Out of the 23 trials, 17 were randomized control trials, and six were non-randomized comparative trials. The majority of these trials (83%, 19/23) originated in the United States and United Kingdom. The trials engaged a range of 2-24 patients/ community representatives per study. Engagement of children and minorities occurred in 13% (3/23) and 26% (6/23) of trials; respectively. Engagement was identified in the development of the research question, the selection of study outcomes, and the dissemination and implementation of results., Conclusions: The prevalence of patient engagement in patient-oriented interventional research is very poor with 23 trials reporting activities engaging patients. Research dedicated to determining the best practice for meaningful engagement is still needed, but adequate reporting measures also need to be defined., Competing Interests: Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Objective: The objective of this review was to perform a rapid evidence summary to determine the prevalence of subaneurysmal aortic aneurysms, growth rates, and risk factors that modulate growth in average-risk men aged 65 years and older. Secondary objectives were to evaluate benefits and harms of lifelong ultrasound (US) surveillance and treatment outcomes for any large aneurysms that develop in the screened population., Methods: We searched multiple databases (eg, Ovid MEDLINE, Embase Classic and Embase, and the Cochrane Library) on February 16, 2016. Using a liberal accelerated method, two reviewers screened titles and abstracts for relevance and subsequently screened full-text studies. General study characteristics (eg, country, study design, number of participants) and data (eg, number of men with subaneurysmal aortas, quality of life [QoL], mortality) were extracted. One reviewer performed data extraction and risk of bias assessments, and a second reviewer verified 100% of studies. Any disagreements were resolved by consensus., Results: The search identified 37 relevant studies ranging in size from 3 to 52,690 participants. Prevalence of subaneurysmal aortas ranged from 1.14% to 8.53%, and 55% to 88% of these men progressed to a 3.0-cm aneurysm by 5 years of follow-up. Risk factors for growth included the infrarenal aortic diameter at age 65 years, having a subaneurysmal aorta at age 65 years, and current smoking. The 36-Item Short Form Health Survey was the most commonly used tool to measure QoL, and QoL was typically lower in people with abdominal aortic aneurysm. Anxiety and depression levels did not differ significantly between comparison groups in any studies. Four studies reported on the number of men whose aorta was subaneurysmal on initial US who went on to surgery. Overall, 10% (57/547) of men initially measuring in the subaneurysmal range progressed to abdominal aortic aneurysm >5.4 cm and received elective surgery; 1% (6/547) received emergency surgery because of a ruptured aorta. Among those who did, mortality rates were much lower for elective (9.5%) vs emergency surgery (50%). Risk of bias was usually low for studies measuring prevalence and moderate and high for studies measuring psychological harms of screening and harms and benefits of surgery. Overall, using the Grading of Recommendations Assessment, Development, and Evaluation framework as guidance, the quality of the evidence was generally very low., Conclusions: Because of the limited evidence and the low quality of the existing evidence, it is not possible to determine confidently whether men with abdominal aortas measuring 2.5 to 2.9 cm should be observed in a lifelong US surveillance program., (Copyright © 2018 Society for Vascular Surgery. All rights reserved.)

Background: Guidelines for assessing methodological and reporting quality of systematic reviews (SRs) were developed to contribute to implementing evidence-based health care and the reduction of research waste. As SRs assessing a cohort of SRs is becoming more prevalent in the literature and with the increased uptake of SR evidence for decision-making, methodological quality and standard of reporting of SRs is of interest. The objective of this study is to evaluate SR adherence to the Quality of Reporting of Meta-analyses (QUOROM) and PRISMA reporting guidelines and the A Measurement Tool to Assess Systematic Reviews (AMSTAR) and Overview Quality Assessment Questionnaire (OQAQ) quality assessment tools as evaluated in methodological overviews., Methods: The Cochrane Library, MEDLINE®, and EMBASE® databases were searched from January 1990 to October 2014. Title and abstract screening and full-text screening were conducted independently by two reviewers. Reports assessing the quality or reporting of a cohort of SRs of interventions using PRISMA, QUOROM, OQAQ, or AMSTAR were included. All results are reported as frequencies and percentages of reports and SRs respectively., Results: Of the 20,765 independent records retrieved from electronic searching, 1189 reports were reviewed for eligibility at full text, of which 56 reports (5371 SRs in total) evaluating the PRISMA, QUOROM, AMSTAR, and/or OQAQ tools were included. Notable items include the following: of the SRs using PRISMA, over 85% (1532/1741) provided a rationale for the review and less than 6% (102/1741) provided protocol information. For reports using QUOROM, only 9% (40/449) of SRs provided a trial flow diagram. However, 90% (402/449) described the explicit clinical problem and review rationale in the introduction section. Of reports using AMSTAR, 30% (534/1794) used duplicate study selection and data extraction. Conversely, 80% (1439/1794) of SRs provided study characteristics of included studies. In terms of OQAQ, 37% (499/1367) of the SRs assessed risk of bias (validity) in the included studies, while 80% (1112/1387) reported the criteria for study selection., Conclusions: Although reporting guidelines and quality assessment tools exist, reporting and methodological quality of SRs are inconsistent. Mechanisms to improve adherence to established reporting guidelines and methodological assessment tools are needed to improve the quality of SRs.

Background: The methodological quality and completeness of reporting of the systematic reviews (SRs) is fundamental to optimal implementation of evidence-based health care and the reduction of research waste. Methods exist to appraise SRs yet little is known about how they are used in SRs or where there are potential gaps in research best-practice guidance materials. The aims of this study are to identify reports assessing the methodological quality (MQ) and/or reporting quality (RQ) of a cohort of SRs and to assess their number, general characteristics, and approaches to 'quality' assessment over time., Methods: The Cochrane Library, MEDLINE®, and EMBASE® were searched from January 1990 to October 16, 2014, for reports assessing MQ and/or RQ of SRs. Title, abstract, and full-text screening of all reports were conducted independently by two reviewers. Reports assessing the MQ and/or RQ of a cohort of ten or more SRs of interventions were included. All results are reported as frequencies and percentages of reports., Results: Of 20,765 unique records retrieved, 1189 of them were reviewed for full-text review, of which 76 reports were included. Eight previously published approaches to assessing MQ or reporting guidelines used as proxy to assess RQ were used in 80% (61/76) of identified reports. These included two reporting guidelines (PRISMA and QUOROM) and five quality assessment tools (AMSTAR, R-AMSTAR, OQAQ, Mulrow, Sacks) and GRADE criteria. The remaining 24% (18/76) of reports developed their own criteria. PRISMA, OQAQ, and AMSTAR were the most commonly used published tools to assess MQ or RQ. In conjunction with other approaches, published tools were used in 29% (22/76) of reports, with 36% (8/22) assessing adherence to both PRISMA and AMSTAR criteria and 26% (6/22) using QUOROM and OQAQ., Conclusions: The methods used to assess quality of SRs are diverse, and none has become universally accepted. The most commonly used quality assessment tools are AMSTAR, OQAQ, and PRISMA. As new tools and guidelines are developed to improve both the MQ and RQ of SRs, authors of methodological studies are encouraged to put thoughtful consideration into the use of appropriate tools to assess quality and reporting.