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When randomized trials have addressed multiple interventions for the same health problem, network meta-analyses (NMAs) permit researchers to statistically pool data from individual studies including evidence from both direct and indirect comparisons. Grasping the significance of the results of NMAs may be very challenging. Authors may present the findings from such analyses in several numerical and graphical ways. In this paper, we discuss ranking strategies and visual depictions of rank, including the surface under the cumulative ranking (SUCRA) curve method. We present ranking approaches' merits and limitations and provide an example of how to apply the results of a NMA to clinical practice. [ABSTRACT FROM AUTHOR]

Background: Health equity concerns the absence of avoidable and unfair differences in health. Randomized controlled trials (RCTs) can provide evidence about the impact of an intervention on health equity for specific disadvantaged populations or in general populations; this is important for equity-focused decision-making. Previous work has identified a lack of adequate reporting guidelines for assessing health equity in RCTs. The objective of this study is to develop guidelines to improve the reporting of health equity considerations in RCTs, as an extension of the Consolidated Standards of Reporting Trials (CONSORT).Methods/design: A six-phase study using integrated knowledge translation governed by a study executive and advisory board will assemble empirical evidence to inform the CONSORT-equity extension. To create the guideline, the following steps are proposed: (1) develop a conceptual framework for identifying "equity-relevant trials," (2) assess empirical evidence regarding reporting of equity-relevant trials, (3) consult with global methods and content experts on how to improve reporting of health equity in RCTs, (4) collect broad feedback and prioritize items needed to improve reporting of health equity in RCTs, (5) establish consensus on the CONSORT-equity extension: the guideline for equity-relevant trials, and (6) broadly disseminate and implement the CONSORT-equity extension.Discussion: This work will be relevant to a broad range of RCTs addressing questions of effectiveness for strategies to improve practice and policy in the areas of social determinants of health, clinical care, health systems, public health, and international development, where health and/or access to health care is a primary outcome. The outcomes include a reporting guideline (CONSORT-equity extension) for equity-relevant RCTs and a knowledge translation strategy to broadly encourage its uptake and use by journal editors, authors, and funding agencies. [ABSTRACT FROM AUTHOR]

Background: Hepatic pregnancy is a rare form of abdominal pregnancy, often documented only as case reports.Case Presentation: We report here the case of a 24-year-old African woman, gravida 4 para 3, presenting with right upper quadrant pains and metrorrhagia after amenorrhea of 8 weeks 5 days. Elements in favor of the diagnosis of hepatic pregnancy were her clinical presentation, the kinetics of β-human chorionic gonadotropin titers, and the presence of a sub-hepatic mass on ultrasound. We successfully treated this patient with intramuscular methotrexate only.Conclusions: The interest of this case resides in the rarity of this condition and the therapeutic approach used. Clinicians should raise their index of suspicion for hepatic pregnancy when faced with females of reproductive age with such a clinical presentation. [ABSTRACT FROM AUTHOR]

Background: To compare the effectiveness of four surveillance strategies for detecting SARS-CoV-2 within the homeless shelter population in Hamilton, ON and assess participant adherence over time for each surveillance method., Methods: This was an open-label, cluster-randomized controlled trial conducted in eleven homeless shelters in Hamilton, Ontario, from April 2020 to January 2021. All participants who consented to the study and participated in the surveillance were eligible for testing by self-swabbing. SARS-CoV-2 detection rate as the primary outcome, number of outbreaks, adherence, and overall acceptability were assessed. All participants, which included staff and residents, underwent daily symptom surveillance conducted by shelter staff and shelters were allocated to one of three asymptomatic surveillance arms (once weekly, self-collected oral swabs (OS); once-weekly self-collected oral-nasal swab (ONS); or once-weekly nurse collected nasopharyngeal swab (NPS) or a symptomatic only SARS-CoV-2 testing arm., Results: A total of 9747 SARS-CoV-2 tests were performed on 1570 participants. There were 4527 participants allocated to oral swab collection and 4935 participants allocated to oral-nasal swab collection. For nasopharyngeal swab collection, 285 participants were assigned before this arm was discontinued. The OS group identified 5 new cases (1.1 per 1000; 95% CI 0.4-2.3), while the ONS group identified 15 new cases (3.0 per 1000; 95% CI 1.9-4.7), resulting in a Risk Ratio (RR) of 2.76 (95% CI 1.00-7.58; p = 0.040). However, the mixed-effect model did not show a significantly higher positivity rate in the ONS compared to OS (OR 1.64; 95% CI 0.76-9.14; p = 0.129). Both ONS and OS were preferred over NPS, which did not detect any cases due to low adherence. Three outbreaks were identified during the study period within the shelters, two of the outbreaks had 2 positive cases each and the third outbreak had 3 positive cases., Conclusions: The two self-collection strategies were superior and showed the best adherence, with the ONS strategy shown to be superior or non-inferior in all measures. We are now studying the operationalization of a large-scale self-collected ONS surveillance strategy in a prospective cohort study of multiple homeless shelters. Funding was provided by the Hamilton Academic Hospital Organization (HAHSO) and Research St. Joseph's - Hamilton., Trial Registration: The trial was retrospectively registered with ClinicalTrials.gov on June 18, 2020, with the identifier NCT04438070., Competing Interests: Declarations. Ethics approval: The protocol for this trial was approved by the Hamilton Integrated Research Ethics Board (HiREB), and all shelters, residents, and staff provided verbal consent for involvement in the study. The trial was also registered on ClinicalTrials.gov, under identification number NCT04438070 (18/06/2020). This cluster-randomized multi-shelter trial was conducted according to the Consolidated Standards of Reporting Trials (CONSORT). Consent to participate: Informed consent was obtained from all individual participants included in the study. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Background: As researchers and practitioners in the field of global health continue to acknowledge the ongoing impact of colonialism in their work, the call for decolonized research has increased. This has particular relevance in the field of sexual and reproductive health. Despite this recognized need, there is no singularly agreed upon definition of what it means to conduct decolonized research using decolonized methodologies. The aim of this review is to explore the approaches and methodologies used in contemporary sexual and reproductive health research aligned with decolonized systems of thinking., Methods: This review was developed and conducted in accordance with the JBI and the Extension for Scoping Reviews (PRISMA-ScR) Checklist. In January 2023, Medline (Ovid), Embase, EMCare, Global Health Database, and Web of Science were systematically searched for relevant studies. Relevant grey literature was also scanned. The screening and data extraction were conducted by four independent reviewers using an iterative approach. The findings were analyzed to uncover shared characteristics between the studies., Results: A total of 1775 articles were retrieved through our search strategy, of which 35 were included as discussing sexual health topics, and representing the principles of decolonization. Few of the included articles explicitly self-identified as decolonized literature. Common themes between studies included that most of the data collection was conducted in high-income countries, largely in North America, and the most prevalent sexual health topics were HIV/AIDs, and STIs/STDs. Most studies were qualitative, used community-based methodologies, and included some form of community advisory board., Conclusions: This scoping review identifies shared characteristics of both successes and gaps in decolonized research that may inform the methodological processes of future researchers. It emphasizes the need for more decolonized research originating in low- and middle-income countries, as well as decolonization of quantitative research methodologies. The findings also emphasize the importance of community engagement throughout the research process. A shared definition of decolonization is necessary to codify this body of work. Future researchers should focus on clearly communicating their approach in the methodology so that it can be replicated and become part of a shared definition. International Registered Report Identifier (IRRID): DERR1-10.2196/45771., Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Background: Missing outcome data can pose a serious threat to the validity of randomised clinical trial results. We aimed to study the extent of missing outcome data in randomised clinical trials of psychological interventions., Methods: We performed a retrospective study of randomised clinical trial reports of psychological interventions published in World Psychiatry, JAMA Psychiatry, Lancet Psychiatry, American Journal of Psychiatry, British Journal of Psychiatry, or Psychotherapy and Psychosomatics from 2017 to 2022. We assessed the proportion of missing outcome data, whether missing data patterns differed between types of outcomes, participants, intervention lengths, and psychological intervention types, how missing outcome data were handled in the statistical analyses, and whether trialists discussed missing outcome data in the discussion section of the manuscript., Results: We identified 182 randomised clinical trials (233 primary outcomes), of which 206 outcomes (88.4%) were assessed at high risk of bias due to missing data. The overall mean percentage of missing outcome data was 18.3% (95% confidence interval (CI): 16.7-20%) for all outcomes. The percentages of missing data were 18.9% (95% CI: 17.1-20.6%; 180 outcomes) for symptom severity scales and 1.8% (95% CI: 2.3-3.3%; 6 outcomes) for 'hard' binary outcomes. Trials including participants with borderline personality disorder had the highest percentage of missing outcome data (33.1%; 95% CI: 22.3-43.9%) compared with other psychiatric disorders. Fisher's exact test showed that intervention lengths and psychological intervention types were associated with the proportion of missing outcome data (p < 0.001), but there were no clear patterns., Conclusion: Missing outcome data is a considerable problem in randomised clinical trials of psychological interventions, and trialists should consider the corresponding methodological limitations in the design and analysis to reduce the risk of bias due to missing outcome data., Clinical Trial Registration Number: Not applicable., Competing Interests: Declarations Ethics approval and consent to participate The analyses in this study were performed on publicly available, published trial data that have already been approved by the respective ethical committees that originally assessed the included trials. Hence, it was not applicable to obtain ethical approval nor participation consent, e.g. in accordance with the Declaration of Helsinki, for this study. Consent for publication Not applicable. Competing interests The authors declare no competing interests., (© 2024. The Author(s).)

Introduction: Enteral nutrition (EN) is the recommended nutritional support in most critically ill populations. When given by feeding tube, EN may be administered either continuously or intermittently. It is unclear which approach is superior in reducing gastrointestinal complications-such as diarrhea-and meeting nutritional targets. The main objectives of this systematic review and meta-analysis are to (1) determine whether continuous or intermittent enteral nutrition is associated with higher incidence of adverse gastrointestinal outcomes, including diarrhea, and (2) determine which feeding modality is associated with reaching nutritional goals. METHODS AND ANALYSIS: This systematic review protocol is reported in accordance with guidelines from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement. We will search MEDLINE, Embase, the Cochrane Library, and the World Health Organization (WHO) International Clinical Trials Registry (ICTRP) search portal for studies comparing continuous EN and intermittent EN in critically ill patients with no date or language restrictions. Studies will be screened, selected, and extracted independently and in duplicate. We will assess the risk-of-bias assessment using the Cochrane Collaboration's Risk of Bias (RoB) 2 tool. The primary outcome will include the incidence of diarrhea; secondary outcomes include other adverse GI outcomes (nausea, vomiting, abdominal pain, and constipation), as well as reaching nutritional goals, and length of ICU and hospital stay and mortality. We will pool data using a random-effects model and assess the certainty of the evidence for each outcome using Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology., Ethics and Dissemination: Ethics approval is not required for this study as no original data will be collected. We will disseminate results through peer-reviewed publication and conference presentations., Systematic Review Registration: PROSPERO CRD42022330118., (© 2024. The Author(s).)

Background: Surgical site infections continue to be a significant challenge following colorectal surgery. These can result in extended hospital stays, hospital readmissions, increased treatment costs, and negative effects on patients' quality of life. Antibiotic prophylaxis plays a crucial role in preventing infection during surgery, specifically in preventing surgical site infections after colorectal surgery in adult patients. However, the optimal antibiotic regimen is still unclear based on current evidence. Considering the limitations of existing reviews, our goal is to conduct a comprehensive systematic review and network meta-analysis of randomized controlled trials to evaluate the comparative benefits and harms of available antibiotic prophylaxis regimens for preventing surgical site infections following colorectal surgery in adult patients., Methods: We will search the Medline, EMBASE, CINAHL, Scopus, and Cochrane Central Register of Controlled Trials databases to identify relevant randomized controlled trials. We will include trials that (1) enrolled adults who underwent colorectal surgeries and (2) randomized them to any systemic administration of antibiotic (single or combined) prophylaxis before surgery compared to an alternative systemic antibiotic (single or combined antibiotic), placebo, control, or no prophylactic treatment. Pairs of reviewers will independently assess the risk of bias among eligible trials using a modified Cochrane risk of bias instrument for randomized trials. Our outcomes of interest include the rate of surgical site infection within 30 days of surgery, hospital length of stay, 30-day mortality, and treatment-related adverse effects. We will perform a contrast-based network meta-analysis using a frequentist random-effects model assuming a common heterogeneity parameter. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach will be utilized to assess the certainty of evidence for treatment effects., Discussion: By synthesizing evidence from available RCTs, this study will provide valuable insight for clinicians, patients, and health policymakers on the most effective antibiotics for preventing surgical site infection., Systematic Review Registration: PROSPERO CRD42023434544., (© 2024. The Author(s).)

Background: Seniors with recurrent hospitalizations who are taking multiple medications including high-risk medications are at particular risk for serious adverse medication events. We will assess whether an expert Clinical Pharmacology and Toxicology (CPT) medication management intervention during hospitalization with follow-up post-discharge and communication with circle of care is feasible and can decrease drug therapy problems amongst this group., Methods: The design is a pragmatic pilot randomized trial with 1:1 patient-level concealed randomization with blinded outcome assessment and data analysis. Participants will be adults 65 years and older admitted to internal medicine services for more than 2 days, who have had at least one other hospitalization in the prior year, taking five or more chronic medications including at least one high-risk medication. The CPT intervention identifies medication targets; completes consult, including priorities for improving prescribing negotiated with the patient; starts the care plan; ensures a detailed discharge medication reconciliation and circle-of-care communication; and sees the patient at least twice after hospital discharge via virtual visits to consolidate the care plan in the community. Control group receives usual care. Primary outcomes are feasibility - recruitment, retention, costs, and clinical - number of drug therapy problems improved, with secondary outcomes examining coordination of transitions in care, quality of life, and healthcare utilization and costs. Follow-up is to 3-month posthospital discharge., Discussion: If results support feasibility of ramp-up and promising clinical outcomes, a follow-up definitive trial will be organized using a developing national platform and medication appropriateness network. Since the intervention allows a very scarce medical specialty expertise to be offered via virtual care, there is potential to improve the safety, outcomes, and cost of care widely., Trial Registration Number: ClinicalTrials.gov identifier: NCT04077281., (© 2024. The Author(s).)

Background: Engagement in care is important for people living with HIV (PLH) to achieve optimal outcomes. Several strategies have been developed to improve client flow through the HIV care cascade, specifically targeting initiation of treatment, adherence to antiretroviral therapy (ART), retention in care, and engagement in care. We have previously identified effective care cascade strategies in a systematic review. Initiation of ART could be improved by mobile health interventions, and changes in healthcare delivery. Adherence to ART could be improved by mobile health interventions, incentives, counselling, and psychotherapy. Retention in care could be improved by mobile health interventions, incentives, education, and electronic interventions. The aim of this study was to investigate barriers and facilitators to implementing these effective interventions in HIV clinics in Ontario, Canada., Methods: We conducted a sequential explanatory mixed methods study. In the quantitative strand, we administered a survey to health workers who provide care to PLH to identify barriers and facilitators. In the qualitative strand, we conducted in-depth interviews informed by the theoretical domains framework (TDF) with health workers and with PLH to explain our quantitative findings. Qualitative and quantitative data were merged to create meta-inferences., Results: Twenty health workers from 8 clinics in 9 cities in Ontario took the survey. Nine PLH and 10 health workers participated in the qualitative interviews. Clinics in Ontario implemented all the effective interventions identified from the literature for initiation of treatment, adherence to ART, and retention in care despite concerns about resources. Barriers to physical and financial access to care, the workload for tailored care, and expertise were identified by both health workers and PLH. Key facilitators were virtual care and client preparedness through education and peer support., Conclusion: Clinics in Ontario appear to implement several evidence-based strategies to improve PLH engagement. There is a need for more health workers with skills to address unique PLH needs. Virtual care is beneficial to both health workers and PLH., (© 2024. The Author(s).)

Background: Obesity is a chronic disease and is an established risk factor for other chronic diseases and mortality. Young adulthood is a period when people may be highly amenable to healthy behavior change, develop lifelong healthy behaviors, and when primary prevention of obesity may be feasible. Interventions in early adulthood have the potential for primary or primordial prevention (i.e., preventing risk factors before disease onset). The primary objective of this study is to determine the feasibility of a 6-month behavioral and educational intervention to promote healthy behaviors for obesity prevention among young adults., Methods: This is the study protocol for a pilot randomized controlled trial. Young adults (age 18-29) attending McMaster University, Hamilton, Canada, will be recruited and randomized to either the intervention or control. The intervention will include individual motivational interviewing sessions (online or in-person) with a trained interviewer plus educational materials (based on Canada's food guide and physical activity recommendations). The control group will receive educational materials only. The primary feasibility outcomes that will be evaluated as part of this pilot study include enrollment, retention (≥ 80%), data completion (≥ 80% of weights measured, and surveys completed), and participant satisfaction. Secondary clinical outcomes will include body mass index (BMI) change from baseline to 6 months, physical activity, nutrition risk, health-related quality of life mental health, and economic outcomes. Outcomes will be measured remotely using activity trackers, and online questionnaires at baseline and every 2 months. Risk stratification will be applied at baseline to identify participants at high risk of obesity (e.g., due to family or personal history). Exit questionnaires will collect data on how participants felt about the study and cost analysis will be conducted., Discussion: Our pilot randomized controlled trial will evaluate the feasibility of an obesity prevention intervention in early adulthood and will inform future larger studies for obesity prevention. The results of this study have the potential to directly contribute to the primary prevention of several types of cancer by testing an intervention that could be scalable to public health, post-secondary education, or primary care settings., Trial Registration: https://clinicaltrials.gov/ct2/show/NCT05264740 . Registered on March 3, 2022., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Local evidence is important for contextualized knowledge translation. It can be used to adapt global recommendations, to identify future research priorities and inform local policy decisions. However, there are challenges in identifying local evidence in a systematic, comprehensive, and timely manner. There is limited guidance on how to map local evidence and provide it to users in an accessible and user-friendly way. In this study, we address these issues by describing the methods for the development of a centralized database of health research evidence for Cameroon and its applications for research prioritization and decision making., Methods: We searched 10 electronic health databases and hand-searched the archives of non-indexed African and Cameroonian journals. We screened titles, abstracts, and full texts of peer reviewed journal articles published between 1999 and 2019 in English or French that assess health related outcomes in Cameroonian populations. We extracted relevant study characteristics based on a pre-established guide. We developed a coding scheme or taxonomy of content areas so that local evidence is mapped to corresponding domains and subdomains. Pairs of reviewers coded articles independently and resolved discrepancies by consensus. Moreover, we developed guidance on how to search the database, use search results to create evidence maps and conduct knowledge gap analyses., Results: The Cameroon Health Research and Evidence Database (CAMHRED) is a bilingual centralized online portal of local evidence on health in Cameroon from 1999 onwards. It currently includes 4384 studies categorized into content domains and study characteristics (design, setting, year and language of publication). The database is searchable by keywords or through a guided search. Results including abstracts, relevant study characteristics and bibliographic information are available for users to download. Upon request, guidance on how to optimize search results for applications like evidence maps and knowledge gap analyses is also available., Conclusions: CAMHRED ( https://camhred.org/ ) is a systematic, comprehensive, and centralized resource for local evidence about health in Cameroon. It is freely available to stakeholders and provides an additional resource to support their work at various levels in the research process., (© 2023. The Author(s).)

Introduction: Pilot and feasibility trials use predetermined thresholds for feasibility outcomes to decide if a larger trial is feasible. These thresholds may be derived from the literature, observational data, or clinical experience. The aim of this study was to determine empirical estimates for feasibility outcomes to inform future HIV pilot randomized trials., Methods: We conducted a methodological study of HIV clinical trials indexed in the past 5 years (2017-2021) in the PubMed database. We included trials of people living with HIV individually randomized to any type of intervention and excluded pilot trials and cluster randomized trials. Screening and data extraction were conducted in duplicate. We computed estimates for recruitment, randomization, non-compliance, lost to follow-up, discontinuation, and the proportion analyzed using a random effects meta-analysis of proportions and reported these estimates according to the following subgroups: use of medication, intervention type, trial design, income level, WHO region, participant type, comorbidities, and source of funding. We report estimates with 95% confidence intervals., Results: We identified 2122 studies in our search, of which 701 full texts were deemed relevant, but only 394 met our inclusion criteria. We found the following estimates: recruitment (64.1%; 95% CI 57.7 to 70.3; 156 trials); randomization (97.1%; 95% CI 95.8 to 98.3; 187 trials); non-compliance (3.8%; 95% CI 2.8 to 4.9; 216 trials); lost to follow-up (5.8%; 95% CI 4.9 to 6.8; 251 trials); discontinuation (6.5%; 95% CI 5.5 to 7.5; 215 trials); analyzed (94.2%; 95% CI 92.9 to 95.3; 367 trials). There were differences in estimates across most subgroups., Conclusion: These estimates may be used to inform the design of HIV pilot randomized trials with careful consideration of variations due to some of the subgroups investigated., (© 2023. The Author(s).)

Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE group is developing guidance for stakeholder engagement in the development of health and healthcare guideline development. The development of this guidance has included multiple meetings with stakeholders, including patients, payers/purchasers of health services, peer review editors, policymakers, program managers, providers, principal investigators, product makers, the public, and purchasers of health services and has identified a number of key issues. These include: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. In this paper, we discuss these issues and our plan to develop guidance to facilitate stakeholder engagement in all stages of the development of health and healthcare guideline development., (© 2023. The Author(s).)

Background: Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension., Methods: We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels., Discussion: Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences., (© 2023. The Author(s).)

Introduction: The COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public to improve health outcomes. The objective of this study is to evaluate, quantify, and compare the public's understanding, usability, satisfaction, intention to implement, and preference for different ways of presenting COVID-19 health recommendations derived from the COVID-19 Living Map of Recommendations and Gateway to Contextualization (RecMap)., Methods and Analysis: This is a protocol for a multi-method study. Through an online survey, we will conduct pragmatic allocation-concealed, blinded superiority randomized controlled trials (RCTs) in three populations to test alternative formats of presenting health recommendations: adults, parents, and youth, with at least 240 participants in each population. Prior to initiating the RCT, our interventions will have been refined with relevant stakeholder input. The intervention arm will receive a plain language recommendation (PLR) format while the control arm will receive the corresponding original recommendation format as originally published by the guideline organizations (standard language version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the recommendation formats. Each population's results will be analyzed separately. However, we are planning a meta-analysis of the results across populations. At the end of each survey, participants will be invited to participate in an optional one-on-one, virtual semi-structured interview to explore their user experience. All interviews will be transcribed and analyzed using the principles of thematic analysis and a hybrid inductive and deductive approach., Ethics and Dissemination: Through Clinical Trials Ontario, the Hamilton Integrated Research Ethics Board has reviewed and approved this protocol (Project ID: 3856). The University of Alberta has approved the parent portion of the trial (Project ID:00114894). Findings from this study will be disseminated through open-access publications in peer-reviewed journals and using social media., Trial Registration: Clinicaltrials.gov NCT05358990 . Registered on May 3, 2022., (© 2023. The Author(s).)

Background: This retrospective cohort study assessed benefits and risks of bedaquiline treatment in multidrug-resistant-tuberculosis (MDR-TB) combination therapy by evaluating safety, effectiveness, drug utilization and emergence of resistance to bedaquiline., Methods: Data were extracted from a register of South African drug-resistant-tuberculosis (DR-TB) patients (Electronic DR-TB Register [EDRWeb]) for newly diagnosed patients with MDR-TB (including pre-extensively drug-resistant [XDR]-TB and XDR-TB and excluding rifampicin-mono-resistant [RR]-TB, as these patients are by definition not multidrug-resistant), receiving either a bedaquiline-containing or non-bedaquiline-containing regimen, at 14 sites in South Africa. Total duration of treatment and follow-up was up to 30 months, including 6 months' bedaquiline treatment. WHO treatment outcomes within 6 months after end-of-treatment were assessed in both patient groups. Longer term mortality (up to 30 months from treatment start) was evaluated through matching to the South African National Vital Statistics Register. Multivariable Cox proportional hazards analyses were used to predict association between receiving a bedaquiline-containing regimen and treatment outcome., Results: Data were extracted from EDRWeb for 5981 MDR-TB patients (N = 3747 bedaquiline-treated; N = 2234 non-bedaquiline-treated) who initiated treatment between 2015 and 2017, of whom 40.7% versus 80.6% had MDR-TB. More bedaquiline-treated than non-bedaquiline-treated patients had pre-XDR-TB (27.7% versus 9.5%) and XDR-TB (31.5% versus 9.9%) per pre-2021 WHO definitions. Most patients with treatment duration data (94.3%) received bedaquiline for 6 months. Treatment success (per pre-2021 WHO definitions) was achieved in 66.9% of bedaquiline-treated and 49.4% of non-bedaquiline-treated patients. Death was reported in fewer bedaquiline-treated (15.4%) than non-bedaquiline-treated (25.6%) patients. Bedaquiline-treated patients had increased likelihood of treatment success and decreased risk of mortality versus non-bedaquiline-treated patients. In patients with evaluable drug susceptibility testing data, 3.5% of bedaquiline-susceptible isolates at baseline acquired phenotypic resistance. Few patients reported bedaquiline-related treatment-emergent adverse events (TEAEs) (1.8%), TEAE-related bedaquiline discontinuations (1.4%) and QTcF values > 500 ms (2.5%) during treatment., Conclusion: Data from this large cohort of South African patients with MDR-TB showed treatment with bedaquiline-containing regimens was associated with survival and effectiveness benefit compared with non-bedaquiline-containing regimens. No new safety signals were detected. These data are consistent with the positive risk-benefit profile of bedaquiline and warrant continued implementation in combination therapy for MDR-TB treatment., (© 2022. The Author(s).)

Background: Emerging evidence suggests that access to chiropractic care may reduce the likelihood of initiating an opioid prescription for spinal pain; however, the impact of chiropractic care for patients already prescribed opioids is uncertain. We undertook a sequential explanatory mixed methods study to evaluate the association between initiating chiropractic care and continued opioid use among adult patients attending an Ontario community health centre (CHC) and receiving opioid therapy for chronic non-cancer spinal pain., Methods: We conducted a retrospective cohort study of 210 patient records between January 1, 2014 and December 31, 2020. We used generalized estimating equations, adjusted for patient demographics, co-morbidities, visit frequency, and calendar year, to evaluate the association between receipt versus non-receipt of chiropractic services and continued opioid use (e.g., unique opioid fills, number of refills, and dosages) up to one year following the index chiropractic visit. We also completed follow-up interviews with 14 patients and nine general practitioners from the CHC and integrated these data with our quantitative findings., Results: Over 12-month follow-up, there were lower rates of opioid fills (incidence rate ratio [IRR] = 0.66; 95% confidence interval [CI], 0.52-0.83) and refills (IRR = 0.27; 95% CI, 0.17-0.42) among chiropractic recipients (n = 49) versus non-recipients (n = 161). Although patients who did and did not receive chiropractic care began the study with the same dose of opioids, recipients were less likely to be prescribed higher-dose opioids (i.e., ≥ 50 mg morphine equivalents daily) compared to non-recipients at three months (odds ratio [OR] = 0.14; 95% CI, 0.04-0.47), six months (OR = 0.14; 95% CI, 0.05-0.40), nine months (OR = 0.19; 95% CI, 0.07-0.57), and 12 months (OR = 0.22; 95% CI, 0.08-0.62). Interviews suggested that patient self-efficacy, limited effectiveness of opioids for chronic pain, stigma regarding use of opioids, and access to chiropractic treatment were important influencing factors., Conclusion: We found that continued prescription opioid use among patients with chronic non-cancer spinal pain who received chiropractic care was lower than in patients who did not receive chiropractic care. Four themes emerged in our qualitative interviews to help provide a richer understanding of this association. Randomized controlled trials are needed to establish the effect of chiropractic care on opioid use for chronic spinal pain., (© 2022. The Author(s).)

Background: The African, Caribbean, and Black (ACB) population of Ontario, Canada is comprised of individuals with diverse ethnic, cultural and linguistic backgrounds and experiences; some of whom have resided in Canada for many generations, and others who have migrated in recent decades. Even though the ACB population represents less than 3.5% of the Canadian population, this group accounts for 21.7% of all new HIV infections. It is well-documented that ACB populations, compared to the general population, experience multi-level barriers to accessing appropriate and responsive HIV services. In this paper, we present qualitative findings on the ACB population's experiences with HIV-testing, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) and obtain their perspectives on how to improve access., Methods: We conducted twelve Focus Group Discussions (FGDs), within a two-day World Café event and used socio-ecological framework and community-based participatory research (CBPR) approaches to guide this work. We meaningfully engaged ACB community members in discussions to identify barriers and facilitators to HIV testing, PEP and PrEP and how these may be addressed. The FGDs were transcribed verbatim and thematic analysis guided data interpretation. Credibility of data was established through data validation strategies such as external audit and peer-debriefing., Results: Our analyses revealed multi-level barriers that explain why ACB community members do not access HIV testing, PEP and PrEP. Fear, health beliefs, stigma and lack of information, were among the most frequently cited individual- and community-level barriers to care. Health system barriers included lack of provider awareness, issues related to cultural sensitivity and confidentiality, cost, and racism in the health care system. Participants identified multi-level strategies to address the HIV needs including community-based educational, health system and innovative inter-sectoral strategies., Conclusion: CBPR, co-led by community members, is an important strategy for identifying the multi-level individual, interpersonal, community, institutional and structural factors that increase HIV vulnerability in ACB communities, notably anti-Black systemic racism. Study findings suggest the need for targeted community-based strategies and strategies aimed at reducing health system barriers to testing and care., (© 2022. The Author(s).)

Background: Psychiatric disorders increase risk of neuropsychiatric disease and poor outcomes, yet little is known about the neuropsychiatric manifestations of COVID-19 in the psychiatric population. The primary objective is to synthesize neuropsychiatric outcomes of COVID-19 in people with preexisting psychiatric disorders., Methods: Data were collected during an ongoing review of the impact of pandemics on people with existing psychiatric disorders. All study designs and gray literature were included. Medline, PsychInfo, CINAHL, EMBASE, and MedRx were searched from inception to September 1 2020. Risk of bias was assessed using a published tool that can accommodate all study types. Two independent authors screened the studies and extracted data. Data were narratively synthesized, as there were insufficient data to meta-analyze. Evidence was appraised according to GRADE., Results: Four case reports were included, comprising 13 participants from three countries. Many large-sample, relevant papers were omitted for not reporting psychiatric history, despite reporting other comorbidities. Included participants (n = 13) were hospitalized with COVID-19 and appeared to meet criteria for delirium. Myoclonus, rigidity, and alogia were also reported. The most commonly reported preexisting psychiatric diagnoses were mood disorders, schizophrenia, and alcohol use disorder., Conclusions: People with preexisting psychiatric disorders may experience delirium, rigidity, myoclonus, and alogia during COVID-19 infection; although higher quality and longitudinal data are needed to better understand these phenomena. Relevant COVID-19 literature does not always report psychiatric history, despite heightened neuropsychiatric vulnerability within this population., Trial Registration:  PROSPERO (CRD42020179611)., (© 2021. The Author(s).)

Background: Pilot studies are essential in determining if a larger study is feasible. This is especially true when targeting populations that experience stigma and may be difficult to include in research, such as people with HIV. We sought to describe how pilot studies have been used to inform HIV clinical trials., Methods: We conducted a methodological study of pilot studies of interventions in people living with HIV published until November 25, 2020, using Medline, Embase, and Cochrane Controlled Register of Trials (CENTRAL). We extracted data on their nomenclature, primary objective, use of progression criteria, sample size, use of qualitative methods, and other contextual information (region, income, level, type of intervention, study design)., Results: Our search retrieved 10,597 studies, of which 248 were eligible. The number of pilot studies increased steadily over time. We found that 179 studies (72.2%) used the terms "pilot" or "feasibility" in their title, 65.3% tested feasibility as a primary objective, only 2% used progression criteria, 23.9% provided a sample size estimation and only 30.2% used qualitative methods., Conclusions: Pilot studies are increasingly being used to inform HIV research. However, the titles and objectives are not always consistent with piloting. The design and reporting of pilot studies in HIV could be improved., (© 2021. The Author(s).)

Background: In 2007-2012 the Mexican government launched the National HIV program and there was a major change in HIV policies implemented in 2013-2018, when efforts focused on prevention, increase in early diagnosis and timely treatment. Still, late HIV diagnosis is a major concern in Mexico due to its association with the development of AIDS development and mortality. Thus, the objectives of this study were to identify the determinants of late HIV diagnosis (i.e. CD4 count less than 200 cells/mm 3 ) in Mexico from 2008 to 2017 and to evaluate the impact of the 2013-2017 National HIV program., Methods: Using patient level data from the SALVAR database, which includes 64% of the population receiving HIV care in Mexico, an adjusted logistic model was conducted. Main study outcomes were HIV late diagnosis which was defined as CD4 count less than 200 cells/mm 3 at diagnosis., Results: The study included 106,830 individuals newly diagnosed with HIV and treated in Mexican public health facilities between 2008 and 2017 (mean age: 33 years old, 80% male). HIV late diagnosis decreased from 45 to 43% (P < 0.001) between 2008 and 2012 and 2013-2017 (i.e. before and after the implementation of the 2013-2017 policy). Multivariable logistic regressions indicated that being diagnosed between 2013 and 2017 (odds ratio [OR] = 0.96 [95% Confidence interval [CI] [0.93, 0.98]) or in health facilities specialized in HIV care (OR = 0.64 [95% CI 0.60, 0.69]) was associated with early diagnosis. Being male, older than 29 years old, diagnosed in Central East, the South region of Mexico or in high-marginalized locality increased the odds of a late diagnosis., Conclusions: The results of this study indicate that the 2013-2017 National HIV program in Mexico has been marginally successful in decreasing the proportion of individuals with late HIV diagnosis in Mexico. We identified several predictors of late diagnosis which could help establishing health policies. The main determinants for late diagnosis were being male, older than 29 years old, and being diagnosed in a Hospital or National Institute., (© 2021. The Author(s).)

Background: Mixed methods designs are increasingly used in health care research to enrich findings. However, little is known about the frequency of use of this methodology in chiropractic research, or the quality of reporting among chiropractic studies using mixed methods., Objective: To quantify the use and quality of mixed methods in chiropractic research, and explore the association of study characteristics (e.g., authorship, expertise, journal impact factor, country and year of publication) with reporting quality., Methods: We will conduct a systematic search of MEDLINE, EMBASE, CINAHL, and the Index to Chiropractic Literature to identify all chiropractic mixed methods studies published from inception of each database to December 31, 2020. Articles reporting the use of both qualitative and quantitative methods, or mixed qualitative methods, will be included. Pairs of reviewers will perform article screening, data extraction, risk of bias with the Mixed Methods Appraisal Tool (MMAT), and appraisal of reporting quality using the Good Reporting of A Mixed Methods Study (GRAMMS) guideline. We will explore the correlation between GRAMMS and MMAT scores, and construct generalized estimating equations to explore factors associated with reporting quality., Discussion: This will be the first methodological review to examine the reporting quality of published mixed methods studies involving chiropractic research. The results of our review will inform opportunities to improve reporting in chiropractic mixed methods studies. Our results will be disseminated in a peer-reviewed publication and presented publicly at conferences and as part of a doctoral thesis., (© 2021. The Author(s).)

Background: In Haiti where there are high rates of maternal and neonatal mortality, efforts to reduce mortality and improve maternal newborn child health (MNCH) must be tracked and monitored to measure their success. At a rural Haitian hospital, local surveillance efforts allowed for the capture of MNCH indicators. In March 2018, a new stand-alone maternity unit was opened, with increased staff, personnel, and physical space. We aimed to determine if the new maternity unit brought about improvements in maternal and neonatal outcomes., Methods: We conducted an interrupted time series analysis using data collected between July 2016 and October 2019 including 20 months before the opening of the maternity unit and 20 months after. We examined maternal-neonatal outcomes such as physiological (vaginal) births, caesarean birth, postpartum hemorrhage (PPH), maternal deaths, stillbirths and undesirable outcomes (eclampsia, PPH, perineal laceration, postpartum infection, maternal death or stillbirth)., Results: Immediately after the opening of the new maternity, the number of physiological births decreased by 7.0% (β = - 0.070; 95% CI: - 0.110 to - 0.029; p = 0.001) and there was an increase of 6.7% in caesarean births (β = 0.067; 95% CI: 0.026 to 0.107; p = 0.002). For all undesirable outcomes, preintervention there was an increasing trend of 1.8% (β = 0.018; 95% CI: 0.013 to 0.024; p < 0.001), an immediate 14.4% decrease after the intervention (β = - 0.144; 95% CI: - 0.255 to - 0.033; p = 0.012), and a decreasing trend of 1.8% through the postintervention period (β = - 0.018; 95% CI: - 0.026 to - 0.009; p < 0.001). No other significant level or trend changes were noted., Conclusions: The new maternity unit led to an upward trend in caesarean births yet an overall reduction in all undesirable maternal and neonatal outcomes. The new maternity unit at this rural Haitian hospital positively impacted and improved maternal and neonatal outcomes., (© 2021. The Author(s).)

Background: The expansion of access to antiretroviral therapy (ART) has been accompanied by an increase in pre-treatment drug resistance (PDR). While it is critical to monitor the increasing prevalence of PDR across countries and populations to inform optimal regimen selection, the completeness of reporting is often suboptimal, limiting the interpretation and generalizability of the results. Indeed, there is no formal guidance on how studies investigating the prevalence of drug resistance should be reported. Thus, we sought to determine the completeness of reporting in studies of PDR and the factors associated with sub-optimal reporting to ascertain the need for guidelines., Methods: As part of a systematic review on the global prevalence of PDR in key populations (men who have sex with men, sex workers, transgender people, people who inject drugs and people in prisons), we searched 10 electronic databases until January 2019. We extracted information on selected study characteristics useful for interpreting prevalence data. Data were extracted in duplicate. Analyses of variance and correlation were used to explore factors that may explain the number of items reported., Results: We found 650 studies of which 387 were screened as full text and 234 were deemed eligible. The included studies were published between 1997 and 2019 and included a median of 239 (quartile 1 = 101; quartile 3 = 778) participants. Most studies originated from high-income countries (125/234; 53.0%). Of 23 relevant data items, including study design, setting, participant sociodemographic characteristics, HIV risk factors, type of resistance test conducted, definition of resistance, the mean (standard deviation) number of items reported was 13 (2.2). We found that more items were reported in studies published more recently (r = 0.20; p < 0.002) and in studies at low risk of bias (F [2231] = 8.142; p < 0.001)., Conclusions: Incomplete reporting in studies on PDR makes characterising levels of PDR in subpopulations across countries challenging. Hence, guidelines are needed to define a minimum set of variables to be included in such studies.

Background: Pilot and feasibility studies (PAFS) often have complex objectives aimed at assessing feasibility of conducting a larger study. These may not be clear to participants in pilot studies., Methods: Here, we aimed to assess the transparency of informed consent in PAFS by investigating whether researchers communicate, through patient information leaflets and consent forms, key features of the studies. We collected this data from original versions of these documents submitted for ethics approval and the final approved documents for PAFS submitted to the Hamilton Integrated Research Ethics Board, Canada., Results: One hundred eighty-four PAFS, submitted for ethics approval from 2004 to 2020, were included, and we found that of the approved consent documents which were provided to participants, 83.2% (153) stated the terms "pilot" or "feasibility" in their title, 12% (22) stated the definition of a pilot/feasibility study, 42.4% (78) of the studies stated their intent to assess feasibility, 19.6% (36) stated the specific feasibility objectives, 1.6% (3) stated the criteria for success of the pilot study, and 0.5% (1) stated all five of these criteria. After ethics review, a small increase in transparency occurred, ranging from 1.6 to 2.8% depending on the criteria. By extracting data from the protocols of the PAFS, we found that 73.9% (136) stated intent to assess feasibility, 71.2% (131) stated specific feasibility objectives, and 33.7% (62) stated criteria for success of the study to lead to a larger study., Conclusion: The transparency of informed consent in PAFS is inadequate and needs to be specifically addressed by research ethics guidelines. Research ethics boards and researchers ought to be made aware and mindful of best practices of informed consent in the context of PAFS.

Background: Early identification of patients at risk for postoperative delirium is essential because adequate well-timed interventions could reduce the occurrence of delirium and the related detrimental outcomes., Methods: We will conduct a systematic review and individual patient data (IPD) meta-analysis of prognostic studies evaluating the predictive value of risk factors associated with an increased risk of postoperative delirium in elderly patients undergoing elective surgery. We will identify eligible studies through systematic search of MEDLINE, EMBASE, and CINAHL from their inception to May 2020. Eligible studies will enroll older adults (≥ 50 years) undergoing elective surgery and assess pre-operative prognostic risk factors for delirium and incidence of delirium measured by a trained individual using a validated delirium assessment tool. Pairs of reviewers will, independently and in duplicate, screen titles and abstracts of identified citations, review the full texts of potentially eligible studies. We will contact chief investigators of eligible studies requesting to share the IPD to a secured repository. We will use one-stage approach for IPD meta-analysis and will assess certainty of evidence using the GRADE approach., Discussion: Since we are using existing anonymized data, ethical approval is not required for this study. Our results can be used to guide clinical decisions about the most efficient way to prevent postoperative delirium in elderly patients., Systematic Review Registration: CRD42020171366 .

Background: Pilot trials often use quantitative data such as recruitment rate and retention rate to inform the design and feasibility of a larger trial. However, qualitative data such as patient, healthcare provider, and research staff perceptions of an intervention may also provide insights for a larger trial., Methods: As part of a larger study investigating the reporting of progression criteria in pilot studies, we sought to determine how often pilot studies planned to use qualitative data to inform the design and feasibility of a larger trial and the factors associated with plans to use qualitative data. We searched for protocols of pilot studies of randomized trials in PubMed between 2013 and 2017., Results: We included 227 articles. Only 92 (40.5%; 95% confidence interval [CI] 34.1-47.2) reported plans to collect qualitative data. The factors associated with collecting qualitative data were large studies (defined as sample size ≥ 60; adjusted odds ratio [aOR] 2.77; 95% CI 1.47-5.23; p = 0.002) and studies from Europe (aOR 3.86; 95% CI 1.68-8.88; p = 0.001) compared to North America and the rest of the world. Pilot trials with pharmacological interventions were less likely to plan to collect qualitative data (aOR 0.20; 95% CI 0.07-0.58; p = 0.003)., Conclusions: Qualitative data is not used enough in pilot trials. Large pilot trials, pilot trials from Europe, and pilot trials of non-pharmacological interventions are more likely to plan for qualitative data.

Background: Network meta-analysis (NMA) simultaneously synthesises direct and indirect evidence on the relative efficacy and safety of at least three treatments. A decision maker may use the coherent results of an NMA to determine which treatment is best for a given outcome. However, this evidence must be balanced across multiple outcomes. This study aims to provide a framework that permits the objective integration of the comparative effectiveness and safety of treatments across multiple outcomes., Methods: In the proposed framework, measures of each treatment's performance are plotted on its own pie chart, superimposed on another pie chart representing the performance of a hypothetical treatment that is the best across all outcomes. This creates a spie chart for each treatment, where the coverage area represents the probability a treatment ranks best overall. The angles of each sector may be adjusted to reflect the importance of each outcome to a decision maker. The framework is illustrated using two published NMA datasets comparing dietary oils and fats and psoriasis treatments. Outcome measures are plotted in terms of the surface under the cumulative ranking curve. The use of the spie chart was contrasted with that of the radar plot., Results: In the NMA comparing the effects of dietary oils and fats on four lipid biomarkers, the ease of incorporating the lipids' relative importance on spie charts was demonstrated using coefficients from a published risk prediction model on coronary heart disease. Radar plots produced two sets of areas based on the ordering of the lipids on the axes, while the spie chart only produced one set. In the NMA comparing psoriasis treatments, the areas inside spie charts containing both efficacy and safety outcomes masked critical information on the treatments' comparative safety. Plotting the areas inside spie charts of the efficacy outcomes against measures of the safety outcome facilitated simultaneous comparisons of the treatments' benefits and harms., Conclusions: The spie chart is more optimal than a radar plot for integrating the comparative effectiveness or safety of a treatment across multiple outcomes. Formal validation in the decision-making context, along with statistical comparisons with other recent approaches are required.

Background: There has been a significant increase in computed tomography (CT) utilization over the past two decades with the major challenges being a high exposure to ionizing radiation and rising cost. In this study we assess the risk of financial hardship after CT utilization and elaborate on how users adapt and cope in a sub-Saharan context with user fee for services and no national health insurance policy., Methods: We carried out a sequential explanatory mixed methods study with a quantitative hospital-based survey of CT users followed by in-depth interviews of some purposively selected participants who reported risk of financial hardship after CT utilization. Data was summarized using frequencies, percentages and 95% confidence intervals. Logistic regression was used in multivariable analysis to determine predictors of risk of financial hardship. Identified themes from in-depth interviews were categorized. Quantitative and qualitative findings were integrated., Results: A total of 372 participants were surveyed with a male to female sex ratio of 1:1.2. The mean age (standard deviation) was 52(17) years. CT scans of the head and facial bones accounted for 63% (95%CI: 59-68%) and the top three indications were suspected stroke (27% [95%CI: 22-32%]), trauma (14% [95%CI: 10-18%]) and persistent headaches (14% [95%CI: 10-18%]). Seventy-two percent (95%CI: 67-76%) of the respondents reported being at risk of financial hardship after CT utilization and predictors in the multivariable analysis were a low socioeconomic status (aOR: 0.19 [95%CI: 0.10-0.38]; p < 0.001), being unemployed or retired (aOR: 11.75 [95%CI: 2.59-53.18]; p = 0.001) and not having any form of health insurance (aOR: 3.59 [95%CI: 1.31-9.85]; p = 0.013). Coping strategies included getting financial support from family and friends, borrowing money and obtaining discounts from the hospital administration and staff., Conclusion: No health insurance ownership, being unemployed or retired and a low socioeconomic status are associated with financial hardship after CT utilization. Diverse coping strategies are utilized to lessen the financial burden, some with negative consequences. Minimizing out-of-pocket payments and/or the direct cost of CT can reduce this financial burden and improve CT access.

Background: Dextro-transposition of the great arteries (D-TGA) is the most frequent cyanotic congenital heart pathology in neonates. Surgical correction of this condition is possible using the arterial switch operation (ASO) which was first performed by Jatene in 1975., Objectives: The aim of this study was to summarise the evidence on short- (less than 1 year), medium- (1-20 years), and long-term (more than 20 years) outcomes of children with D-TGA treated with the ASO. The primary outcome was survival. Secondary outcomes were freedom from cardiac reoperations, occurrence of aortic insufficiency, pulmonary stenosis, coronary artery anomalies, neuropsychological development problems and quality of life., Methods: We searched MEDLINE, EMBASE, CINAHL, LILACS, and reference lists of included articles for studies reporting outcomes after ASO for D-TGA. Screening, data extraction and risk of bias assessment were done independently by two reviewers. We pooled data using a random-effects meta-analysis of proportions and, where not possible, outcomes were synthesized narratively. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to assess the certainty of the evidence for each outcome., Main Results: Following ASO for TGA, short-term survival was 92.0% (95% CI 91.0-93.0%; I 2 = 85.8%, 151 studies, 30,186 participants; moderate certainty evidence). Medium-term survival was 90.0% (95% CI 89.0-91.0%; I 2 = 84.3%, 133 studies; 23,686 participants, moderate certainty evidence), while long-term survival was 87.0% (95% CI 80.0-92.0 %; I 2 = 84.5%, 4 studies, 933 participants, very low certainty evidence). Evaluation of the different secondary outcomes also showed satisfactory results in the short, medium and long term. Subgroup analysis suggests slightly higher survival following ASO for TGA in the second surgical era (1998 to 2018) than in the first surgical era (1975 to 1997) in the short and medium term [93.0% (95% CI 92.0-94.0) vs 90.0% (95% CI 89.0-92.0) and 93.0% (95% CI 91.0-94.0) vs 88.0% (87.0-90.0%) respectively] but not in the long term [81.0% (95% CI 76.0-86.0%) vs 89.0% (80.0-95.0%)]., Conclusions: Pooled data from many sources suggests that the ASO for D-TGA leads to high rates of survival in the short, medium, and long term.

Background: Methodological studies - studies that evaluate the design, analysis or reporting of other research-related reports - play an important role in health research. They help to highlight issues in the conduct of research with the aim of improving health research methodology, and ultimately reducing research waste., Main Body: We provide an overview of some of the key aspects of methodological studies such as what they are, and when, how and why they are done. We adopt a "frequently asked questions" format to facilitate reading this paper and provide multiple examples to help guide researchers interested in conducting methodological studies. Some of the topics addressed include: is it necessary to publish a study protocol? How to select relevant research reports and databases for a methodological study? What approaches to data extraction and statistical analysis should be considered when conducting a methodological study? What are potential threats to validity and is there a way to appraise the quality of methodological studies?, Conclusion: Appropriate reflection and application of basic principles of epidemiology and biostatistics are required in the design and analysis of methodological studies. This paper provides an introduction for further discussion about the conduct of methodological studies.

Background: Cameroon still has relatively high maternal mortality rate (MMR) of 596/100,000 live births. Approximately 40% of births are unattended by skilled healthcare personnel with high out-of-pocket expenditures. Poor resource allocation, poorly functioning referral systems, long trekking distances to health facilities, all of which lead to low rates of use of maternal health services., Objectives: The aim of this pilot study is to explore perception and acceptability of mobile health (mhealth) and e-voucher and to determine the feasibility of conducting a large cluster randomized trial to determine the effects of combining e-vouchers and a mobile application compared with usual care in improving access to and use of maternal health services., Methods: This is a multimethod study that comprises two phases. The first phase is the development of the mobile phone app, which includes a qualitative formative study through in-depth key informant interviews and focus group discussions. The second phase is a cluster randomized control trial assessing the combination of e-vouchers and a mobile application compared with usual care in improving access to and use of maternal health services. Feasibility will be determined based on evaluating randomization, contamination, enrollment rate, complete follow up, compliance rate, success in matching data from different sources, and data completeness., Ethics and Discussion: Ethics approval has been granted, and the trial has been registered in the Pan-African Clinical Trials Registry. We will disseminate our findings through peer-reviewed manuscripts and conference presentations. Findings from this study will inform the design and conduct of a larger randomized trial., Trial Registration: PACTR201808703097367. The trial on the Pan African Clinical Trials Registry., Competing Interests: Competing interestThe authors declare that they have no competing interest., (© The Author(s) 2020.)

Background: A relatively novel method of appraisal, methodological reviews (MRs) are used to synthesize information on the methods used in health research. There are currently no guidelines available to inform the reporting of MRs., Objectives: This pilot review aimed to determine the feasibility of a full review and the need for reporting guidance for methodological reviews., Methods: Search strategy: We conducted a search of PubMed, restricted to 2017 to include the most recently published studies, using different search terms often used to describe methodological reviews: "literature survey" OR "meta-epidemiologic* review" OR "meta-epidemiologic* survey" OR "methodologic* review" OR "methodologic* survey" OR "systematic survey."Data extraction: Study characteristics including country, nomenclature, number of included studies, search strategy, a priori protocol use, and sampling methods were extracted in duplicate and summarized.Outcomes: Primary feasibility outcomes were the sensitivity and specificity of the search terms (criteria for success of feasibility set at sensitivity and specificity of ≥ 70%).Analysis: The estimates are reported as a point estimate (95% confidence interval)., Results: Two hundred thirty-six articles were retrieved and 31 were included in the final analysis. The most accurate search term was "meta-epidemiological" (sensitivity [Sn] 48.39; 95% CI 31.97-65.16; specificity [Sp] 97.56; 94.42-98.95). The majority of studies were published by authors from Canada ( n = 12, 38.7%), and Japan and USA ( n = 4, 12.9% each). The median (interquartile range [IQR]) number of included studies in the MRs was 77 (13-1127). Reporting of a search strategy was done in most studies ( n = 23, 74.2%). The use of a pre-published protocol ( n = 7, 22.6%) or a justifiable sampling method ( n = 5, 16.1%) occurred rarely., Conclusions: Using the MR nomenclature identified, it is feasible to build a comprehensive search strategy and conduct a full review. Given the variation in reporting practices and nomenclature attributed to MRs, there is a need for guidance on standardized and transparent reporting of MRs. Future guideline development would likely include stakeholders from Canada, USA, and Japan., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s). 2020.)

Introduction: Pilot and feasibility trials are conducted to determine feasibility or to collect information that would inform the design of a larger definitive trial. Clear progression criteria are required to determine if a definitive or main trial is feasible and how it should be designed. We sought to determine how often progression criteria are reported and the associated factors., Methods: We conducted a methodological review of protocols for pilot randomised trials published in three journals that publish research protocols ( BMJ Open , Trials , Pilot and Feasibility Studies ), using a PubMed search (2013-2017). We extracted bibliometric information including the country in which the study was conducted, source of funding, type of intervention, use of a primary feasibility outcome, sample size reporting, and justification. We used generalised linear models to determine the factors associated with reporting progression criteria., Results: Our search retrieved 276 articles, of which 49 were not eligible. We included 227 articles. Overall, 45/227 (19.8%; 95% confidence interval [CI] 14.8-25.6) reported progression criteria. Protocols published in more recent years were significantly associated with higher odds of reporting progression criteria (adjusted odds ratio [aOR] 1.40; 95% CI 1.03-1.92; p  = 0.034). Pilot trials from Europe (aOR 0.19; 95% CI 0.08-0.48; p  < 0.001) and the rest of the world (aOR 0.05; 95% CI 0.01-0.18; p  < 0.003) compared to North America were significantly associated with lower odds of reporting progression criteria. Journal, source of funding, sample size, intervention type, and having a primary outcome related to feasibility were not significantly associated with reporting progression criteria., Conclusion: Progression criteria are not often explicitly stated in protocols of pilot trials leaving room for varied interpretation of findings. The development of formal guidance for progression criteria in protocols of pilot trials is warranted., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s). 2019.)

Background: Information on subgroup assessments in systematic reviews (SR) of atrial fibrillation (AF) is limited. This review aims to describe subgroup analyses in AF SRs to inform the design of SRs and randomized trials as well as clinical practice., Methods: We conducted a cross sectional meta-epidemiological study of Cochrane AF reviews by searching AF (including variants) in the title, abstract, or keyword field without date or language restrictions (Issue 9; September 2018). Two reviewers independently extracted study characteristics to summarize frequency of subgroups pre-specified and conducted and report credibility of subgroup effects claimed., Results: Of 39 Cochrane reviews identified, 17 met inclusion criteria (including 168 reports of 127 randomized trials) and the majority (16; 94.1%) conducted meta-analysis of outcomes. Most (13; 76.5%) planned pre-specified subgroup analyses; 7 of which (41.2%) conducted subgroups. In these 7 reviews, 56 subgroups were planned, 17 (30.4%) conducted and 6 (10.7%) yielded subgroup effects. Variables such as co-morbid disease, stroke risk factors, prior stroke/transient ischemic attack, age, race, and sex represented 44% (24 subgroups) of all planned subgroups (8 conducted; 14.3%); however, information on covariate selection was lacking. Overall, more subgroups were planned than conducted (mean difference (95% CI) 2.3 (1.2-3.5, p < 0.001)). Of all subgroups conducted, anticoagulant characteristics comprised a third of all subgroup effects (n = 5, 35.7%). The credibility of subgroups identified (n = 14) was assessed and less than half (43%) represented one of a small number of pre-specified hypothesis and rarely were effects seen within studies (7%). Of 5 reviews that reported subgroup effects, only 3 discussed subgroup effects as part of the overall conclusions; none discussed credibility of subgroup effects., Conclusions: This meta-epidemiological review of a subset of Cochrane AF reviews suggests that planning and reporting of subgroup analyses in AF reviews can be improved to better inform clinical management. Most pre-specified subgroup analyses were not performed, important variables (such as stroke, bleeding risk, and other comorbidities) were rarely examined and credibility of subgroup effects claimed was low. Future reviews should aim to identify important subgroups in their protocols and use recommended approaches to test subgroup effects in order to better support clinical decision-making.

Background: There is some evidence that suggests misoprostol may supplement the action of oxytocin in preventing post-partum haemorrhage (PPH). The primary objective of this study was to determine the effect of the administration of 600 μg misoprostol in addition to oxytocin versus oxytocin alone, on the risk of PPH among pregnant women after delivery. The secondary objectives were to determine the effects of the above combination on maternal death and blood transfusion among pregnant women after delivery; and to determine the incidence of PPH, its case fatality, and the maternal mortality ratio in our hospital., Methods: Design and setting: Retrospective chart review of 1736 women delivering at the Regional Hospital Bamenda Cameroon, between 2015 and 2016. This was a pre versus post study following a policy change in the prevention of PPH. Exposure groups: One group received oxytocin-misoprostol (January-April 2016: period after policy change), and the second group received oxytocin-only (January-April 2015: period before policy change) after delivery., Outcomes: The primary outcome was PPH, and the secondary outcomes were maternal death and blood transfusion., Statistical Analysis: A 1:1 matching with replacement was done with the propensity score (PS). The groups were compared using PS matching with conditional logistic regression on the matched pairs as the main analysis. A sensitivity analysis was done using other PS adjustment methods and multiple regression., Results: Of the 1736 women included in this study, 1238 were matched and compared. Women who received oxytocin-misoprostol were less likely to have PPH as compared to those receiving oxytocin-only (odds ratio [OR] 0.22, 95% confidence interval [CI] 0.08, 0.59, p = 0.003). This reduced odds of PPH was upheld in the different sensitivity analyses. There were no significant differences in the odds of maternal death and the use of blood transfusions between the two groups: OR 3.91, 95% CI [0.44, 35.08], p = 0.22, and OR 0.89, 95% CI [0.14-5.63], p = 0.91, respectively. Sensitivity analyses showed similar results. The incidence of PPH was 2.9% (before adding misoprostol the incidence was 4.4% and after adding misoprostol it was 1.5%), the case fatality rate of PPH was 1.96%, and the overall maternal mortality ratio in the hospital was 293 maternal deaths/100000 life births., Conclusion: Our evidence suggests that using 600 μg misoprostol as an add-on to oxytocin in the prevention of post-partum haemorrhage significantly reduces the odds of PPH without affecting other maternal outcomes.

Background: The HIV/AIDS pandemic has struck regions, countries, and populations in different ways. With the introduction of antiretroviral drugs, people living with HIV (PLHIV) have a much better prognosis, even though there are still many new infections in young women. The role of widespread antiretroviral therapy (ART) on the incidence of HIV in young women is unknown., Methods: We will conduct a comprehensive search of MEDLINE (PubMed), Excerpta Medica database (EMBASE), Scopus, Google Scholar, Cochrane Central Register of Controlled Trials (CENTRAL), World Health Organization's (WHO's) library database, Latin American and Caribbean Health Sciences Literature (LILACS), conference abstracts, and gray literature sources to identify any relevant literature. We will include randomized and non-randomized clinical trials and cohort studies in which ART was offered to adults aged 18 and above reporting outcomes in females aged 15 to 24 years. The outcomes of interest are HIV incidence, ART initiation, adherence, retention, and viral load suppression. We will screen titles, abstracts, and the full texts of relevant articles in duplicate. Disagreements will be resolved by consensus. We will extract data on the risk of HIV infection in younger females after the use of ART in the adult population., Discussion: To our knowledge, this is the first systematic review to look at the impact of ART use among adults on HIV incidence in young women. The results of this review will be used in a modeling study to simulate the effects of using ART as an effective tool to prevent sexual transmission of HIV to young women. Our findings will inform the treatment-as-prevention (TasP) strategy to reduce new HIV infections among young women., Systematic Review Registration: The systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42018099174 .

Background: Placenta praevia refers to a placenta located in the lower segment of the uterus. This abnormal location predisposes the placenta to abnormal bleeding with an increased risk of premature labour. The merits of tocolytic drugs (tocolysis) to calm uterine contractions and prolong pregnancy in women with placenta praevia are uncertain., Objectives: The primary objective is to determine the effects of tocolysis versus no tocolysis on pregnancy prolongation. Secondary objectives include to determining the effects of tocolysis versus no tocolysis on gestational age at delivery, maternal hospitalisations, recurrent vaginal bleeding, prematurity, admissions into neonatology, and perinatal deaths., Methods: We searched MEDLINE, EMBASE, The Cochrane Central Register of Controlled Trials, reference lists of pertinent articles and trial registries for randomised controlled trials comparing tocolysis to no tocolysis or placebo in patients with placenta praevia. Risk of bias and data extraction was done independently by two reviewers. We pooled data using a random-effects model. We used the GRADE system to assess the certainty of evidence for each outcome., Main Results: There is no significant difference in pregnancy prolongation with the use of tocolysis in cases of placenta praevia (mean difference [MD] 11.51 days; 95% CI, - 1.75, 24.76; 3 trials, 253 participants; low certainty evidence). Tocolysis has no significant effect on gestational age at delivery (MD 0.33 weeks [95% CI - 1.53, 2.19]: 2 trials, 169 participants, moderate certainty evidence), birthweight (MD 0.12 kg [95% CI - 0.26, 0.5 kg]: 2 trials, 169 participants, moderate certainty evidence), risk of premature delivery (risk ratio [RR] 1.04; 95% CI 0.56, 1.94): 2 trials, 169 participants, low certainty evidence), risk of repeat vaginal bleeding (RR 1.05 [95% CI 0.73, 1.51]: 2 trials, 169 participants, moderate certainty evidence). Tocolysis has no significant effect on the risk of perinatal death (risk difference [RD]: 0.00 [95% CI - 0.04, 0.03]: 2 trials, 169 women; low certainty evidence), number of days of maternal hospitalisation (MD 0.60 days [95% CI - 0.79, 1.99]: 1 trial, 109 women; low certainty evidence), risk of fetal admissions into neonatology (RR 1.30 [95% CI 0.80, 2.12]: 1 trial, 109 participants, low certainty evidence) and on the duration of stay in neonatology units (MD 0.70 days [95% CI - 5.26, 6.66]: 1 trial, 109 participants, low certainty evidence)., Conclusion: In women with symptomatic placenta praevia, there is no significant effect on pregnancy prolongation with the use of tocolysis. Tocolysis has no significant effect on other prenatal, perinatal, neonatal and maternal outcomes among women with symptomatic placenta praevia., Systematic Review Registration: PROSPERO CRD42018091513.

Background: Sharing interim result measures by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an important issue that can affect trial integrity. Currently, it is unclear if there are demographic factors associated with sharing such information. This study's objective is to primarily explore the demographic factors associated with the DSMB sharing certain interim result measures and secondarily, explore demographic factors associated with the perceived usefulness in sharing certain interim result measures, with non-DSMB members., Methods: We conducted an online survey of members of the Society of Clinical Trials (SCT) and International Society of Clinical Biostatistics (ISCB) in 2015 asking their professional views on the DSMB sharing interim trial results, specifically the interim control event rate (IControlER), interim combined even rate (ICombinedER), adaptive conditional power (ACP) and unconditional conditional power (UCP) with non-DSMB members. Binary logistic and multiple linear regressions were used to explore if demographic factors were associated with sharing a certain interim result measure and the perceived usefulness of sharing that interim result measure, respectively. Multiple imputation (MI) was used to evaluate the impact of missing data as a sensitivity analysis., Results: Approximately 3136 (936 from SCT + ~ 2200 from ISCB) members were invited (response rate of 12%; [371/3136]. Two main findings: (1) involvement in more than 15 private industry-sponsored trials was associated with not endorsing the sharing of the IControlER (odds ratio [OR] = 2.92; 95% confidence interval [CI]: 1.31, 6.52]; p = 0.012), and (2) involvement in more than 15 private industry-sponsored trials was associated positively with an increase in the perceived usefulness in sharing the ACP by 2.35 points (beta coefficient estimate = 2.35 [95% CI: 0.45, 4.05], p = 0.017. The findings were similar after sensitivity analyses., Conclusions: An individual involved with more than 15 trials that had some form of private industry sponsorship is a demographic factor associated with NOT sharing the IControlER by the DSMB and an increased perceived usefulness in sharing the ACP at interim. Further studies are needed to evaluate for these demographic factors given the limitations of this study related to missing data. Due to some key limitations, regarding high non-response and missing data, we caution interpreting the results as definitive, but rather look at them as a first exploratory step to find potential associations for further evaluation.

Background: Senior high cost health care users (HCU) are a priority for many governments. Little research has addressed regional variation of HCU incidence and outcomes, especially among incident HCU. This study describes the regional variation in healthcare costs and mortality across Ontario's health planning districts [Local Health Integration Networks (LHIN)] among senior incident HCU and non-HCU and explores the relationship between healthcare spending and mortality., Methods: We conducted a retrospective population-based matched cohort study of incident senior HCU defined as Ontarians aged ≥66 years in the top 5% most costly healthcare users in fiscal year (FY) 2013. We matched HCU to non-HCU (1:3) based on age, sex and LHIN. Primary outcomes were LHIN-based variation in costs (total and 12 cost components) and mortality during FY2013 as measured by variance estimates derived from multi-level models. Outcomes were risk-adjusted for age, sex, ADGs, and low-income status. In a cost-mortality analysis by LHIN, risk-adjusted random effects for total costs and mortality were graphically presented together in a cost-mortality plane to identify low and high performers., Results: We studied 175,847 incident HCU and 527,541 matched non-HCU. On average, 94 out of 1000 seniors per LHIN were HCU (CV = 4.6%). The mean total costs for HCU in FY2013 were 12 times higher that of non-HCU ($29,779 vs. $2472 respectively), whereas all-cause mortality was 13.6 times greater (103.9 vs. 7.5 per 1000 seniors). Regional variation in costs and mortality was lower in senior HCU compared with non-HCU. We identified greater variability in accessing the healthcare system, but, once the patient entered the system, variation in costs was low. The traditional drivers of costs and mortality that we adjusted for played little role in driving the observed variation in HCUs' outcomes. We identified LHINs that had high mortality rates despite elevated healthcare expenditures and those that achieved lower mortality at lower costs. Some LHINs achieved low mortality at excessively high costs., Conclusions: Risk-adjusted allocation of healthcare resources to seniors in Ontario is overall similar across health districts, more so for HCU than non-HCU. Identified important variation in the cost-mortality relationship across LHINs needs to be further explored.

Background: Heart failure (HF) is a major cardiovascular disease with increasing prevalence. Thiamine deficiency occurs in 33% of patients with HF. However, the effectiveness of thiamine supplementation in HF is not known., Methods: In a placebo-controlled randomized two-period crossover feasibility trial, patients age ≥ 60 years with HF and reduced ejection fraction (HFrEF, EF ≤ 45%) will be randomized to thiamine 500 mg oral capsule once daily or placebo for 3 months, then crossed over to the other intervention after a 6-week washout period. The primary outcome is recruitment rate. Secondary outcomes include feasibility and clinical measures. Feasibility outcomes include refusal rate, retention rate, and compliance rate. Secondary clinical outcomes include left ventricular ejection fraction, peak global longitudinal strain measured by echocardiography, N-terminal prohormone of brain natriuretic peptide (NT-proBNP), New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) quality of life score, and clinical outcomes (all-cause mortality, HF hospitalizations, and HF emergency room visits)., Discussion: Thiamine is potentially a safe and low-cost treatment for older patients with HFrEF. Results from this study will inform the feasibility of a large clinical trial with clinical endpoints. The findings will be published in a peer review journal and presented at a relevant conference. This study has received full approval from the Hamilton Integrated Research Ethics Board (18-4537) and Health Canada (210603). This trial is funded by the Hamilton Health Sciences New Investigator Grant (15-387) and the McMaster/St. Peter's Hospital Chair of Aging., Trial Registration: NCT03228030 (ClinicalTrials.gov), registered July 24, 2017., Competing Interests: 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: Adolescent deliveries remain a public health problem in most developing countries. The aim of our study was to determine the prevalence, trends and outcome of adolescent deliveries in an urban setting in Cameroon. We carried out a retrospective register analysis over a 6-year period (January 2010-December 2015) at the Saint Albert Le Grand hospital Douala., Results: The overall prevalence of adolescent deliveries was 8.2% (662 out of 8056). There was a significant decrease over the 6-year period (p-trend: < 0.05). Adolescents were at higher risk of preterm deliveries (gestational age < 37 weeks; odds ratio [OR], 1.7; 95% confidence interval [CI]; 1.3-2.2; p < 0.01): low birth weight (defined as birth weight < 2650 g, OR; 1.7, CI 1.4-2.2, p < 0.01) and asphyxia at 1st minute (OR, 1.5; 95% CI 1.1-2.2; p = 0.02). There was no difference in delivery outcomes between early and late adolescents. Our results suggest that the prevalence of adolescent deliveries is lower in urban settings. Adolescent deliveries are more likely to result in adverse fetal outcomes than adult deliveries. Measures directed towards the prevention of adolescent pregnancies should be implemented to reduce neonatal morbidity and mortality.

Background: Sharing interim results by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an issue that can affect trial integrity. It is unclear what should be shared. This study assesses the views of professionals to understand what interim information should be shared at interim, with whom and why., Methods: Conducted an online survey of members of the Society of Clinical Trials (SCT) and International Society of Clinical Biostatistics (ISCB) in 2015 asking their professional views on sharing interim results. Email was used to advertise the survey and a link in the email was provided to the online survey., Results: Approximately 3136 (936 SCT members + 2200 ISCB members) members were invited. The response rate was 12% (371/3136). The majority reported the Interim Control Event Rate (IControlER) (149/237; 62.9% [95% CI, 56.7-69.0%]), Adaptive Conditional Power (ACP) (144/224; 64.3% [95% CI, 58.0%-70.6%]) and the Unconditional Conditional Power (UCP) (126/208; 60.6% [95% CI, 53.9-67.2%]) should not be shared with non-DSMB members. The majority reported that the Interim Combined Event Rate (ICombinedER) (168/262; 64.1% [95% CI, 58.0-69.9%]) should be shared with non-DSMB members particularly the steering committee (SC) because it does not unmask interim results and helps with monitoring trial progress, safety, and design assumptions., Conclusion: The IControlER and ACP are unmasking of interim results and should not be shared. The UCP is a technical measure that is potentially misleading and also should not be shared. The ICombinedER is usually known by the SC and sponsor making it easy to determine group rates if the IControlER is known. Though most respondents thought the ICombinedER should be shared with the SC as it does not unmask relative effects between groups, we do not recommend sharing the ICombinedER as it is flawed measure that can have multiple interpretations possibly suggesting that one group is performing better, worse or the same as a comparator group, leading to guesses about how groups are doing relative to one another.

Background: Prospective study protocols and registrations can play a significant role in reducing incomplete or selective reporting of primary biomedical research, because they are pre-specified blueprints which are available for the evaluation of, and comparison with, full reports. However, inconsistencies between protocols or registrations and full reports have been frequently documented. In this systematic review, which forms part of our series on the state of reporting of primary biomedical, we aimed to survey the existing evidence of inconsistencies between protocols or registrations (i.e., what was planned to be done and/or what was actually done) and full reports (i.e., what was reported in the literature); this was based on findings from systematic reviews and surveys in the literature., Methods: Electronic databases, including CINAHL, MEDLINE, Web of Science, and EMBASE, were searched to identify eligible surveys and systematic reviews. Our primary outcome was the level of inconsistency (expressed as a percentage, with higher percentages indicating greater inconsistency) between protocols or registration and full reports. We summarized the findings from the included systematic reviews and surveys qualitatively., Results: There were 37 studies (33 surveys and 4 systematic reviews) included in our analyses. Most studies (n = 36) compared protocols or registrations with full reports in clinical trials, while a single survey focused on primary studies of clinical trials and observational research. High inconsistency levels were found in outcome reporting (ranging from 14% to 100%), subgroup reporting (from 12% to 100%), statistical analyses (from 9% to 47%), and other measure comparisons. Some factors, such as outcomes with significant results, sponsorship, type of outcome and disease speciality were reported to be significantly related to inconsistent reporting., Conclusions: We found that inconsistent reporting between protocols or registrations and full reports of primary biomedical research is frequent, prevalent and suboptimal. We also identified methodological issues such as the need for consensus on measuring inconsistency across sources for trial reports, and more studies evaluating transparency and reproducibility in reporting all aspects of study design and analysis. A joint effort involving authors, journals, sponsors, regulators and research ethics committees is required to solve this problem.

Background: Evidence shows that research abstracts are commonly inconsistent with their corresponding full reports, and may mislead readers. In this scoping review, which is part of our series on the state of reporting of primary biomedical research, we summarized the evidence from systematic reviews and surveys, to investigate the current state of inconsistent abstract reporting, and to evaluate factors associated with improved reporting by comparing abstracts and their full reports., Methods: We searched EMBASE, Web of Science, MEDLINE, and CINAHL from January 1st 1996 to September 30th 2016 to retrieve eligible systematic reviews and surveys. Our primary outcome was the level of inconsistency between abstracts and corresponding full reports, which was expressed as a percentage (with a lower percentage indicating better reporting) or categorized rating (such as major/minor difference, high/medium/low inconsistency), as reported by the authors. We used medians and interquartile ranges to describe the level of inconsistency across studies. No quantitative syntheses were conducted. Data from the included systematic reviews or surveys was summarized qualitatively., Results: Seventeen studies that addressed this topic were included. The level of inconsistency was reported to have a median of 39% (interquartile range: 14% - 54%), and to range from 4% to 78%. In some studies that separated major from minor inconsistency, the level of major inconsistency ranged from 5% to 45% (median: 19%, interquartile range: 7% - 31%), which included discrepancies in specifying the study design or sample size, designating a primary outcome measure, presenting main results, and drawing a conclusion. A longer time interval between conference abstracts and the publication of full reports was found to be the only factor which was marginally or significantly associated with increased likelihood of reporting inconsistencies., Conclusions: This scoping review revealed that abstracts are frequently inconsistent with full reports, and efforts are needed to improve the consistency of abstract reporting in the primary biomedical community.

Background: A focus on equity in health can be seen in many global development goals and reports, research and international declarations. With the development of a relevant framework and methods, the Campbell and Cochrane Equity Methods Group has encouraged the application of an 'equity lens' to systematic reviews, and many organizations publish reviews intended to address health equity. The purpose of the Evidence for Equity (E4E) project was to conduct a priority-setting exercise and apply an equity lens by developing a knowledge translation product comprising summaries of systematic reviews from the Cochrane Library. E4E translates evidence from systematic reviews into 'friendly front end' summaries for policy makers., Methods: The following topic areas with high burdens of disease globally, were selected for the pilot: diabetes/obesity, HIV/AIDS, malaria, nutrition, and mental health/depression. For each topic area, a "stakeholder panel" was assembled that included policymakers and researchers. A systematic search of Cochrane reviews was conducted for each area to identify equity-relevant interventions with a meaningful impact. Panel chairs developed a rating sheet which was used by all panels to rank the importance of these interventions by: 1) Ease of Implementation; 2) Health System Requirements; 3)Universality/Generalizability/Share of Burden; and 4) Impact on Inequities/Effect on equity. The ratings of panel members were averaged for each intervention and criterion, and interventions were ordered according to the average overall ratings., Results: Stakeholder panels identified the top 10 interventions from their respective topic areas. The evidence on these interventions is being summarized with an equity focus and the results posted online, at http://methods.cochrane.org/equity/e4e-series ., Conclusions: This method provides an explicit approach to setting priorities by systematic review groups and funders for providing decision makers with evidence for the most important equity-relevant interventions.

Background: South Africa recently phased out access to free formula milk in the public sector in support of breastfeeding for women living with HIV. Few women living with HIV in South Africa choose breastfeeding and among those who do, many stop breastfeeding early. We sought to explore the feasibility of using mobile phone text messaging coupled with motivational interviewing to enhance adherence to breastfeeding practices., Methods and Design: A randomized, parallel group, single-center pilot trial. Electronic sequence generation and random allocation will be done centrally. Women of low socioeconomic status, from Cape Town, South Africa will be randomly assigned within 24 h of giving birth at a primary healthcare clinic to a structured weekly text message plus motivational interviewing and usual standard of care, using a permutation of different block sizes. Criteria for feasibility success will include: five participants recruited per week (over 12 weeks), about 75% of all eligible participants consent for study participation, complete evaluation of outcomes in at least 70% of all recruited participants, breastfeeding adherence rates of at least 70% in the intervention group, six months after delivery. Participants will be evaluated soon after giving birth and post-delivery at weeks 2, 6, 10, and 24. Primary analysis will follow the "intention-to-treat" principle. Sub-group analysis will be used to assess sub-group effects., Discussion: This pilot trial will evaluate the feasibility of conducting a larger trial on communication and support approaches to improve adherence to breastfeeding by HIV-infected women. Text messaging and motivational interviewing are simple interventions which may allow participants to access personalized adherence advice and support., Trial Registration: ClinicalTrials.gov: NCT02949713 . Registered on 26 October 2016; Pan African Clinical Trial Registry PACTR201611001855404 . Registered on 8 November 2016.