[Review of Reviews (Umbrella Reviews): Step-by-Step Guide]. / Revisão das Revisões (Revisões Umbrella): Guia Passo a Passo.

In recent years, as a result of the dramatic increase in the number of systematic reviews, a new type of systematic review, the 'systematic reviews of systematic reviews', also known as umbrella reviews, reviews of reviews, meta-reviews or synthesis of review, was developed. The aim of this article is to provide recommendations on how this type of systematic review should be conducted and reported to ensure its quality and usefulness. These reviews are designed to compile evidence from multiple systematic reviews of interventions into an accessible and usable document and are one of the highest levels of evidence synthesis.

Nos últimos anos, em consequência do aumento dramático do número de revisões sistemáticas, surgiu um novo tipo de revisões sistemáticas, as revi- sões sistemáticas das revisões sistemáticas, também conhecidas como umbrella reviews, reviews of reviews, meta-reviews, ou synthesis of review. O objetivo deste artigo é fornecer recomendações sobre como este tipo de revisão sistemática deve ser conduzido e relatado para garantir a sua qualidade e utilidade. Estas revisões são concebidas para compilar evidências de múltiplas revisões sistemáticas de intervenções num documento acessível e utilizável e constituem um dos níveis mais elevados de síntese de evidência.

SPEctacle Correction for the TReatment of Amblyopia (SPECTRA): study protocol for a prospective non-randomised interventional trial in adults with anisometropic/mixed mechanism amblyopia.

INTRODUCTION: Amblyopia is a neurodevelopmental vision disorder typically affecting one eye, resulting in compromised binocular function. While evidence-based treatments exist for children, there are no widely accepted treatments for adults. This trial aims to assess the efficacy of appropriate optical treatment in improving vision and visual functions in adults with amblyopia. This is hypothesised to significantly improve visual acuity of the amblyopic eye and other visual functions. METHODS AND ANALYSIS: SPEctacle Correction for the TReatment of Amblyopia is a prospective non-randomised interventional trial. The following criteria for amblyopia will be used: best corrected visual acuity (BCVA) in the amblyopic eye of 0.3 to 1.0 (inclusive) logMAR VA and in the fellow eye, 0.1 logMAR or better, with an interocular VA difference of ≥2 logMAR lines. Eligible participants aged 18-39 will receive full/near-full optical treatment requiring wear for at least half their waking hours for the trial duration. A difference of ≥1.00D spherical equivalent between a participant's current refractive correction and the study prescription is required for eligibility. Primary outcome is the change in amblyopic eye BCVA from baseline to 24-week postenrolment. Secondary outcomes include distance and near VA of both eyes, stereoacuity, contrast sensitivity, interocular suppression, angle of strabismus and fixation stability measured at monthly intervals. Visual evoked potentials will also be measured at baseline, week 12 and week 24. Treatment compliance and quality of life for all participants will be monitored.Analyses comparing baseline and week 24 will utilise pairwise comparisons. Linear mixed models will be fitted to the data for measures taken monthly. This allows estimates and inferences to be drawn from the coefficients of the model, while handling missing data. ETHICS AND DISSEMINATION: Human ethics approval was obtained from the respective ethics board of the Hong Kong Polytechnic University (HSEARS20210915002) and the University of Waterloo (#44235). The study protocol will conform to the principles of the Declaration of Helsinki. Results will be disseminated through peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: NCT05394987; clinicaltrials.org.

Seven Practical Recommendations for Designing and Conducting Qualitative Research in Medical Education.

Qualitative research seeks to provide context, nuance, and depth of understanding in regard to systems, behaviors, and/or lived experiences. As such, it plays a key role in many areas of medical education. Composed of myriad methods and methodologies, each of which may be valuable for some areas of inquiry but less so for others, qualitative research can be challenging to design, conduct, and report. This challenge can be conceptualized as ensuring that the study design, conduct, and reporting are "fit for purpose," following directly from a well-formulated research question. In this Perspective, we share seven important and practical recommendations to enhance the design and conduct of high-quality qualitative research in medical education: 1) craft a strong research question, 2) link the study design to this question, 3) assemble a team with diverse expertise, 4) prioritize information power when selecting recruitment and sampling strategies, 5) collect data carefully, 6) rigorously analyze data, and 7) disseminate results that tell a complete story.

'We can be a family again, but different than before'. A single-case study on therapeutic interventions that initiated a recovery process in a family after the disclosure of sibling sexual behavior.

Disclosures of sibling sexual behavior (SSB) usually affect all family members but there remains, however, a paucity in studies on therapeutical family interventions and how they can initiate changes in families. This study was designed to explore relational impacts of SSB disclosures, goals for therapy and interventions that helped a family initiate the recovery process after a SSB disclosure. A single case study design was used to analyze a family's long-term therapy process. Data on this N = 1 study comprised 18 interviews with involved therapists, five interviews with involved family members, therapy files, and notes on family sessions. Data was analyzed using a thematic approach. Relational traumas were experienced in broken relationships, relationships under pressure and damaged trust between family members. Therapy goals were to (1) recreate family's safety, (2) help the family process the SSB consequences and (3) restore trust and search for relationship healing. Appropriate interventions to target the goals included individual-centered psycho trauma treatment as well as interventions for the parents, the involved siblings, and the uninvolved siblings, followed by sessions between the involved siblings and with the whole family. Therapy outcomes were found in reduced individual trauma symptoms, a recreated sense of family safety, the start of relational trauma processing, and newfound forms of sibling/family relationships. This study provides a unique and comprehensive insight into a family's healing process after SSB disclosures from the perspectives of both professionals and family members. The effective interventions identified in this study may provide tools for therapists working with these families. This study may also offer greater insights into both the abusive and mutual types of SSB.

Nettle-induced Urticaria Treatment Study (NUTS): demonstrating the joy of research through a randomised, blinded, placebo-controlled trial.

The use of dock leaves to ease the discomfort of nettle stings is a well-known folk remedy in the British Isles, yet has never been tested in a clinical trial. A group of Emergency Department doctors designed and conducted the Nettle-induced Urticaria Treatment Study (NUTS) as a research training and team-building exercise to address this gap in the Emergency Medicine evidence base.

Improving Miscarriage Prevention Research: a survey exploring the expectations of service users and stakeholders (IMPRESS) - a study protocol for a UK-based survey.

INTRODUCTION: Interventional clinical trials in recurrent miscarriage use varying expected effect sizes to inform their sample size calculations. Often these are not informed by what stakeholders consider a meaningful treatment effect. Adaptive trial designs may integrate stakeholder views on trial success and futility but the criteria to inform this is lacking. This study aims to understand relevant stakeholder views of what is considered a worthwhile treatment effect for miscarriage prevention interventions and what is acceptable stopping criteria in miscarriage clinical trials. METHODS AND ANALYSIS: The study is designed as a cross-sectional online anonymous survey. The survey presents different scenarios to respondents relating to varying target differences and probability thresholds and explores success and futility criteria for clinical trials. The survey was developed with personal and public involvement (PPI) through focus groups and a PPI partner. Eligible participants will be those with a personal history of miscarriage, including partners, and healthcare professionals who manage patients who experience a miscarriage. Convenience, snowball and purposive sampling techniques will be employed to invite eligible participants to complete the survey. The survey will be accepting responses for an initial 2-week pilot to check validity, prior to being open for a further 12 weeks. Descriptive analyses and linear regression analyses will synthesise the survey results. ETHICS AND DISSEMINATION: Ethical approval was obtained from the NHS Research Ethics Committee North West-Greater Manchester East (23/NW/0322) on 30 January 2024. Informed consent will be obtained prior to survey completion. No personal identifying information will be collected. The results will be published in a relevant scientific journal and communicated through our institutional website.

EXPRESS: Randomized clinical trials and related concepts in clinical research.

Clinical research is a key factor in healthcare progress, as it contributes towards improving our knowledge on the prevention, aetiology, and treatment of different conditions.Healthcare professionals and researchers should be familiar with this specific terminology and procedures of clinical research to understand and be able to evaluate clinical trial results and make decisions using up-to-date recommendations.To do so, they must be familiar with different methodological aspects: from establishing the type of design, the study population, and the groups to be studied, to understanding the randomization and blinding processes. Additionally, when it comes to communicating the results and publishing them, it is also necessary to know how to do it adequately to ensure transparency.This work includes a description of different concepts commonly used in clinical research, particularly in the clinical trials field, in an attempt to compile different topics by providing a brief and accessible overview.

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: Manuscript Checklist.

Adequate and transparent reporting is necessary for critically appraising published research. Yet, ample evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-identified the minimum information needed to report and evaluate observational studies and clinical trials in oral health: the OHStat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The guidelines were subsequently revised by the Task Force's writing group. The guidelines draw heavily from the Consolidated Standards for Reporting Trials (CONSORT), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), and CONSORT harms guidelines and incorporate the SAMPL guidelines for reporting statistics, the CLIP principles for documenting images, and the GRADE indicating the quality of evidence. The guidelines also recommend reporting estimates in clinically meaningful units using confidence intervals, rather than relying on P values. In addition, OHStat introduces 7 new guidelines that concern the text itself, such as checking the congruence between abstract and text, structuring the discussion, and listing conclusions to make them more specific. OHStat does not replace other reporting guidelines; it incorporates those most relevant to dental research into a single document. Manuscripts using the OHStat guidelines will provide more information specific to oral health research.

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: Explanation and Elaboration.

Adequate and transparent reporting is necessary for critically appraising research. Yet, evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-empaneled a group of authors to develop methodological and statistical reporting guidelines identifying the minimum information needed to document and evaluate observational studies and clinical trials in oral health: the OHstat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The final version was subsequently approved by the Task Force in September 2021, submitted for journal review in 2022, and revised in 2023. The checklist consists of 48 guidelines: 5 for introductory information, 17 for methods, 13 for statistical analysis, 6 for results, and 7 for interpretation; 7 are specific to clinical trials. Each of these guidelines identifies relevant information, explains its importance, and often describes best practices. The checklist was published in multiple journals. The article was published simultaneously in JDR Clinical and Translational Research, the Journal of the American Dental Association, and the Journal of Oral and Maxillofacial Surgery. Completed checklists should accompany manuscripts submitted for publication to these and other oral health journals to help authors, journal editors, and reviewers verify that the manuscript provides the information necessary to adequately document and evaluate the research.

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: manuscript checklist.

Adequate and transparent reporting is necessary for critically appraising published research. Yet, ample evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-identified the minimum information needed to report and evaluate observational studies and clinical trials in oral health: the OHStat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The guidelines were subsequently revised by the Task Force's writing group. The guidelines draw heavily from the Consolidated Standards for Reporting Trials (CONSORT), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), and CONSORT harms guidelines and incorporate the SAMPL guidelines for reporting statistics, the CLIP principles for documenting images, and the GRADE indicating the quality of evidence. The guidelines also recommend reporting estimates in clinically meaningful units using confidence intervals, rather than relying on P values. In addition, OHStat introduces 7 new guidelines that concern the text itself, such as checking the congruence between abstract and text, structuring the discussion, and listing conclusions to make them more specific. OHStat does not replace other reporting guidelines; it incorporates those most relevant to dental research into a single document. Manuscripts using the OHStat guidelines will provide more information specific to oral health research.

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: explanation and elaboration.

Adequate and transparent reporting is necessary for critically appraising research. Yet, evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-empaneled a group of authors to develop methodological and statistical reporting guidelines identifying the minimum information needed to document and evaluate observational studies and clinical trials in oral health: the OHstat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The final version was subsequently approved by the Task Force in September 2021, submitted for journal review in 2022, and revised in 2023. The checklist consists of 48 guidelines: 5 for introductory information, 17 for methods, 13 for statistical analysis, 6 for results, and 7 for interpretation; 7 are specific to clinical trials. Each of these guidelines identifies relevant information, explains its importance, and often describes best practices. The checklist was published in multiple journals. The article was published simultaneously in JDR Clinical and Translational Research, the Journal of the American Dental Association, and the Journal of Oral and Maxillofacial Surgery. Completed checklists should accompany manuscripts submitted for publication to these and other oral health journals to help authors, journal editors, and reviewers verify that the manuscript provides the information necessary to adequately document and evaluate the research.

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: Manuscript Checklist.

Adequate and transparent reporting is necessary for critically appraising published research. Yet, ample evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-identified the minimum information needed to report and evaluate observational studies and clinical trials in oral health: the OHStat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The guidelines were subsequently revised by the Task Force's writing group. The guidelines draw heavily from the Consolidated Standards for Reporting Trials (CONSORT), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), and CONSORT harms guidelines and incorporate the SAMPL guidelines for reporting statistics, the CLIP principles for documenting images, and the GRADE indicating the quality of evidence. The guidelines also recommend reporting estimates in clinically meaningful units using confidence intervals, rather than relying on P values. In addition, OHStat introduces 7 new guidelines that concern the text itself, such as checking the congruence between abstract and text, structuring the discussion, and listing conclusions to make them more specific. OHStat does not replace other reporting guidelines; it incorporates those most relevant to dental research into a single document. Manuscripts using the OHStat guidelines will provide more information specific to oral health research.

Commentary: Core Descriptor Sets Using Consensus Methods Support 'Table One' Consistency.

Inconsistent reporting of patient characteristics in clinical research hampers reproducibility and limits analysis opportunities. This paper proposes condition-specific 'Core Descriptor Sets'(CDSs) comprising key factors like demographics, disease severity, comorbidities, and prognosis to standardise Table 1 reporting. Development entails stakeholder involvement, systematic identification of descriptors, value rating, and consensus-building using multiple Delphi rounds. Final agreement comes at an expert meeting. Benefits include easier cross-study comparison for example through individual patient meta-analysis, facilitated by comparison of consistently reported individual data rather than group level analysis. This may also support routine data analyses, subgroup and risk identification, and reduced research waste. CDSs describe cohorts thoroughly while minimising research burden. They are intended to enable improved clinical characterisation, personalisation, reproducibility, data sharing and knowledge building.

Adherence of SARS-CoV-2 Seroepidemiologic Studies to the ROSES-S Reporting Guideline During the COVID-19 Pandemic.

BACKGROUND: Complete reporting of seroepidemiologic studies is critical to their utility in evidence synthesis and public health decision making. The Reporting of Seroepidemiologic studies-SARS-CoV-2 (ROSES-S) guideline is a checklist that aims to improve reporting in SARS-CoV-2 seroepidemiologic studies. Adherence to the ROSES-S guideline has not yet been evaluated. OBJECTIVES: This study aims to evaluate the completeness of SARS-CoV-2 seroepidemiologic study reporting by the ROSES-S guideline during the COVID-19 pandemic, determine whether guideline publication was associated with reporting completeness, and identify study characteristics associated with reporting completeness. METHODS: A random sample from the SeroTracker living systematic review database was evaluated. For each reporting item in the guideline, the percentage of studies that were adherent was calculated, as well as median and interquartile range (IQR) adherence across all items and by item domain. Beta regression analyses were used to evaluate predictors of adherence to ROSES-S. RESULTS: One hundred and ninety-nine studies were analyzed. Median adherence was 48.1% (IQR 40.0%-55.2%) per study, with overall adherence ranging from 8.8% to 72.7%. The laboratory methods domain had the lowest median adherence (33.3% [IQR 25.0%-41.7%]). The discussion domain had the highest median adherence (75.0% [IQR 50.0%-100.0%]). Reporting adherence to ROSES-S before and after guideline publication did not significantly change. Publication source (p < 0.001), study risk of bias (p = 0.001), and sampling method (p = 0.004) were significantly associated with adherence. CONCLUSIONS: Completeness of reporting in SARS-CoV-2 seroepidemiologic studies was suboptimal. Publication of the ROSES-S guideline was not associated with changes in reporting practices. Authors should improve adherence to the ROSES-S guideline with support from stakeholders.

Issues and Solutions in Psychiatric Clinical Trial with Case Studies.

The coronavirus disease-2019 pandemic resulted in a major increase in depression and anxiety disorders worldwide, which increased the demand for mental health services. However, clinical interventions for treating mental disorders are currently insufficient to meet this growing demand. There is an urgent need to conduct scientific and standardized clinical research that are consistent with the features of mental disorders in order to deliver more effective and safer therapies in the clinic. Our study aimed to expose the challenges, complexities of study design, ethical issues, sample selection, and efficacy evaluation in clinical research for mental disorders. The reliance on subjective symptom presentation and rating scales for diagnosing mental diseases was discovered, emphasizing the lack of clear biological standards, which hampers the construction of rigorous research criteria. We underlined the possibility of psychotherapy in efficacy evaluation alongside medication treatment, proposing for a multidisciplinary approach comprising psychiatrists, neuroscientists, and statisticians. To comprehend mental disorders progression, we recommend the development of artificial intelligence integrated evaluation tools, the use of precise biomarkers, and the strengthening of longitudinal designs. In addition, we advocate for international collaboration to diversity samples and increase the dependability of findings, with the goal of improving clinical research quality in mental disorders through sample representativeness, accurate medical history gathering, and adherence to ethical principles.

Operational nursing managers' experiences of clinical supervision at a Johannesburg Hospital.

BACKGROUND:  Clinical supervision is pivotal in supporting nurses in rendering quality, safe patient care. Therefore, it is essential to understand clinical supervision from operational nursing managers' context to define existing challenges and propose suitable recommendations. OBJECTIVES:  This study aimed to explore and describe operational nursing managers' experiences of clinical supervision within the context of an academic hospital in Gauteng province and propose evidence-based practice recommendations to improve patient safety and the quality of clinical supervision. METHOD:  An exploratory, sequential, mixed-method design was used and implemented over two phases to take advantage of the strengths of both the qualitative and quantitative research designs. Unstructured individual interviews were conducted to collect data in phase one, and an adapted Manchester Clinical Supervision Scale (MCSS) questionnaire was used to collect data in phase two. RESULTS:  Operational nursing managers work in stressful conditions and environments with a gross shortage of staff and tools of the trade while being expected to deliver high-quality and safe nursing care. Of the sampled respondents, 36% (n = 17) were dissatisfied with the supervision they received, while 64% (n = 30) were indifferent in the sense that they did not think it was adequate or inadequate. CONCLUSION:  Clinical supervisors should be trained and supported in clinical supervision, with regular workshops on interpersonal relations.Contribution: A clearer understanding of clinical supervision within the hospital context and evidence-based practice recommendations to improve patient safety and the quality of clinical supervision.

Translation, Cross-Cultural Adaptation, and Validation of Measurement Instruments: A Practical Guideline for Novice Researchers.

Cross-cultural validation of self-reported measurement instruments for research is a long and complex process, which involves specific risks of bias that could affect the research process and results. Furthermore, it requires researchers to have a wide range of technical knowledge about the translation, adaptation and pre-test aspects, their purposes and options, about the different psychometric properties, and the required evidence for their assessment and knowledge about the quantitative data processing and analysis using statistical software. This article aimed: 1) identify all guidelines and recommendations for translation, cross-cultural adaptation, and validation within the healthcare sciences; 2) describe the methodological approaches established in these guidelines for conducting translation, adaptation, and cross-cultural validation; and 3) provide a practical guideline featuring various methodological options for novice researchers involved in translating, adapting, and validating measurement instruments. Forty-two guidelines on translation, adaptation, or cross-cultural validation of measurement instruments were obtained from "CINAHL with Full Text" (via EBSCO) and "MEDLINE with Full Text". A content analysis was conducted to identify the similarities and differences in the methodological approaches recommended. Bases on these similarities and differences, we proposed an eight-step guideline that includes: a) forward translation; 2) synthesis of translations; 3) back translation; 4) harmonization; 5) pre-testing; 6) field testing; 7) psychometric validation, and 8) analysis of psychometric properties. It is a practical guideline because it provides extensive and comprehensive information on the methodological approaches available to researchers. This is the first methodological literature review carried out in the healthcare sciences regarding the methodological approaches recommended by existing guidelines.

Disseminating Methods in Nursing Research.

Research methods papers are a valuable resource to researchers and clinicians that highlight novel yet effective methodologies and approaches to conducting research. Clinicians can use the knowledge generated from unique research methods to conduct quality, evidence-based practice, and quality improvement projects, and nurse researchers can benefit from the lessons learned by others to improve the rigor of future studies. This paper defines research methods papers, provides an overview of their importance, including examples from the literature, and highlights important considerations when writing and disseminating the findings of research methods.

Mitigating Racial Bias in Health Care Algorithms: Improving Fairness in Access to Supportive Housing.

Algorithms for guiding health care decisions have come under increasing scrutiny for being unfair to certain racial and ethnic groups. The authors describe their multistep process, using data from 3,465 individuals, to reduce racial and ethnic bias in an algorithm developed to identify state Medicaid beneficiaries experiencing homelessness and chronic health needs who were eligible for coordinated health care and housing supports. Through an iterative process of adjusting inputs, reviewing outputs with diverse stakeholders, and performing quality assurance, the authors developed an algorithm that achieved racial and ethnic parity in the selection of eligible Medicaid beneficiaries.

Navigating grey areas in HIV and mental health implementation science.

INTRODUCTION: Implementation science (IS) offers methods to systematically achieve the Ending the HIV Epidemic goals in the United States, as well as the global UNAIDS targets. Federal funders such as the National Institutes of Mental Health (NIMH) have invested in implementation research to achieve these goals, including supporting the AIDS Research Centres (ARCs), which focus on high-impact science in HIV and mental health (MH). To facilitate capacity building for the HIV/MH research workforce in IS, "grey areas," or areas of IS that are confusing, particularly for new investigators, should be addressed in the context of HIV/MH research. DISCUSSION: A group of IS experts affiliated with NIMH-funded ARCs convened to identify common and challenging grey areas. The group generated a preliminary list of 19 grey areas in HIV/MH-related IS. From the list, the authors developed a survey which was distributed to all ARCs to prioritize grey areas to address in this paper. ARC members across the United States (N = 60) identified priority grey areas requiring clarification. This commentary discusses topics with 40% or more endorsement. The top grey areas that ARC members identified were: (1) Differentiating implementation strategies from interventions; (2) Determining when an intervention has sufficient evidence for adaptation; (3) Integrating recipient perspectives into HIV/MH implementation research; (4) Evaluating whether an implementation strategy is evidence-based; (5) Identifying rigorous approaches for evaluating the impact of implementation strategies in the absence of a control group or randomization; and (6) Addressing innovation in HIV/MH IS grants. The commentary addresses each grey area by drawing from the existing literature (when available), providing expert guidance on addressing each in the context of HIV/MH research, and providing domestic and global HIV and HIV/MH case examples that address these grey areas. CONCLUSIONS: HIV/MH IS is key to achieving domestic and international goals for ending HIV transmission and mitigating its impact. Guidance offered in this paper can help to overcome challenges to rigorous and high-impact HIV/MH implementation research.