O le tagata ma lona aiga, o le tagata ma lona fa'asinomaga (Every person belongs to a family and every family belongs to a person): Development of a parenting framework for adolescent mental wellbeing in American Samoa.

American Samoan adolescents experience a high prevalence of mental health problems, including depression, anxiety, substance use, and suicidal thoughts and behaviors. To complement existing health system efforts, family-based interventions may be a feasible, cost-effective, and relevant opportunity to promote mental health. This community-partnered, qualitative study aimed to: (1) identify potential family-related psychosocial protective factors for adolescent mental health and (2) develop a framework for a parenting program to promote adolescent mental health in American Samoa. Applying the fa'afaletui framework developed for research in Samoan communities, which emphasizes the importance of weaving a range of community member perspectives to reach consensus, semi-structured in-depth interviews with adult key informants (n=28) were conducted between October 2020 and February 2021. Results were validated through five focus groups with Samoan adolescents (n=35) between May and June 2022. Adult participants were sampled for diversity in profession, age, gender, education, and region of residence; adolescent participants were sampled for diversity in gender. Participants were recruited using personal networks and snowball sampling; adolescent participants also responded to Facebook advertising. The semi-structured interviews focused on broad topics including common mental health problems, contributors to mental illness, and potential interventions, among others. Transcripts were coded in duplicate and analyzed using deductive thematic analysis. Themes were collaboratively mapped onto an adapted fonofale model, an existing framework for Pacific Island health research. Six themes described key practices: (1) provide emotional safety and security; (2) provide physical safety and security; (3) encourage sense of self; (4) strengthen intergenerational communication skills; (5) prioritize quality time; and (6) cultivate healthy coping strategies. Participants also expressed the importance of a supportive environment grounded in culture, family and community, and caregiver mental health. These results provide an initial step to identify family-focused factors that promote adolescent mental health in American Samoa and categorize them into a framework to inform intervention development. Drawing on a collaborative and community-partnered process, these findings provide the first evidence-based framework to develop a parenting program to promote adolescent mental wellbeing and resilience in Samoan communities.

Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension.

Importance: Clinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis. Objective: To develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports. Findings: The scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18). Conclusions and Relevance: This CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension.

Importance: Complete information in a trial protocol regarding study outcomes is crucial for obtaining regulatory approvals, ensuring standardized trial conduct, reducing research waste, and providing transparency of methods to facilitate trial replication, critical appraisal, accurate reporting and interpretation of trial results, and knowledge synthesis. However, recommendations on what outcome-specific information should be included are diverse and inconsistent. To improve reporting practices promoting transparent and reproducible outcome selection, assessment, and analysis, a need for specific and harmonized guidance as to what outcome-specific information should be addressed in clinical trial protocols exists. Objective: To develop harmonized, evidence- and consensus-based standards for describing outcomes in clinical trial protocols through integration with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for outcome-specific reporting to be addressed in clinical trial protocols. Findings: The scoping review and consultation with experts identified 108 recommendations relevant to outcome-specific reporting to be addressed in trial protocols, the majority (72%) of which were not included in the SPIRIT 2013 statement. All recommendations were consolidated into 56 items for Delphi voting; after the Delphi survey process, 19 items met criteria for further evaluation at the consensus meeting and possible inclusion in the SPIRIT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 9 items that elaborate on the SPIRIT 2013 statement checklist items and are related to completely defining and justifying the choice of primary, secondary, and other outcomes (SPIRIT 2013 statement checklist item 12) prospectively in the trial protocol, defining and justifying the target difference between treatment groups for the primary outcome used in the sample size calculations (SPIRIT 2013 statement checklist item 14), describing the responsiveness of the study instruments used to assess the outcome and providing details on the outcome assessors (SPIRIT 2013 statement checklist item 18a), and describing any planned methods to account for multiplicity relating to the analyses or interpretation of the results (SPIRIT 2013 statement checklist item 20a). Conclusions and Relevance: This SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement provides 9 outcome-specific items that should be addressed in all trial protocols and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

Emergency care with lay responders in underserved populations: a systematic review.

OBJECTIVE: To assess the individual and community health effects of task shifting for emergency care in low-resource settings and underserved populations worldwide. METHODS: We systematically searched 13 databases and additional grey literature for studies published between 1984 and 2019. Eligible studies involved emergency care training for laypeople in underserved or low-resource populations, and any quantitative assessment of effects on the health of individuals or communities. We conducted duplicate assessments of study eligibility, data abstraction and quality. We synthesized findings in narrative and tabular format. FINDINGS: Of 19 308 papers retrieved, 34 studies met the inclusion criteria from low- and middle-income countries (21 studies) and underserved populations in high-income countries (13 studies). Targeted emergency conditions included trauma, burns, cardiac arrest, opioid poisoning, malaria, paediatric communicable diseases and malnutrition. Trainees included the general public, non-health-care professionals, volunteers and close contacts of at-risk populations, all trained through in-class, peer and multimodal education and public awareness campaigns. Important clinical and policy outcomes included improvements in community capacity to manage emergencies (14 studies), patient outcomes (13 studies) and community health (seven studies). While substantial effects were observed for programmes to address paediatric malaria, trauma and opioid poisoning, most studies reported modest effect sizes and two reported null results. Most studies were of weak (24 studies) or moderate quality (nine studies). CONCLUSION: First aid education and task shifting to laypeople for emergency care may reduce patient morbidity and mortality and build community capacity to manage health emergencies for a variety of emergency conditions in underserved and low-resource settings.

Primary outcome reporting in adolescent depression clinical trials needs standardization.

BACKGROUND: Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. METHODS: RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as "fully reported", "partially reported", or "not reported" for each checklist item, as applicable. RESULTS: Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6 to 17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time. CONCLUSIONS: Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed.

Selective adaptation in sound lateralization is not due to a repulsion effect.

Selective adaptation studies in dichotic sound lateralization have contributed to a three-channel model of lateralization mechanisms. They usually have employed highly-lateralized adaptor stimuli, and the expression of the selective adaptation is the perceptual shift of test tone locations away from that of the adaptor. The present study employed modestly lateralized adaptors so that any repulsion mechanism could be visualized in distorted position judgments for test tones on both sides of the adaptor stimuli. Comparison of position reports for tones lateralized using interaural time differences before and after selective adaptation provided no evidence for a repulsion effect.

"There are still broken or fragmented systems": Qualitative assessment of needs to strengthen adolescent mental health services in American Samoa.

Mental health challenges appear common among adolescents in American Samoa. There is a community-identified need to better understand the health burden and identify opportunities to strengthen the mental health system to better meet adolescent mental health needs. The goal of this qualitative study was to gather community stakeholders' perceptions of common mental health problems among adolescents in American Samoa, identify existing services for adolescent mental health, and highlight strength-based opportunities to enhance care. Using the Fa'afaletui research framework, semi-structured in-depth interviews (n = 28) were conducted between October 2020 and February 2021 using Zoom. Key informants were adults living in American Samoa, sampled for diversity in profession, age, gender, education, and region of residence. Transcripts were coded in duplicate and analysed using deductive thematic analysis. Participants reported that suicide, depression, anxiety, and post-traumatic stress disorder are the conditions of highest burden. Participants identified an impressive amount of infrastructure and community mobilization, but also limitations in these services in addressing adolescents' health needs. Four themes arose related to the need to: (1) strengthen existing infrastructure; (2) reduce barriers to treatment access; (3) improve sustainability; and (4) encourage collaboration among leaders. Policymakers should prioritize the allocation of resources to strengthen infrastructure, public education, and stakeholder collaboration to improve adolescent mental health in American Samoa.

Psychosocial family-level mediators in the intergenerational transmission of trauma: Protocol for a systematic review and meta-analysis.

INTRODUCTION: Family-level psychosocial factors appear to play a critical role in mediating the intergenerational transmission of trauma; however, no review article has quantitatively synthesized causal mechanisms across a diversity of trauma types. This study aims to systematically consolidate the epidemiological research on family-level psychosocial mediators and moderators to ultimately produce causal diagram(s) of the intergenerational transmission of trauma. METHODS: We will identify epidemiological peer-reviewed publications, dissertations, and conference abstracts that measure the impact of at least one psychosocial family-level factor mediating or moderating the relationship between parental trauma exposure and a child mental health outcome. English, French, Kinyarwanda, and Spanish articles will be eligible. We will search MEDLINE, PsycINFO, PTSDpubs, Scopus, and ProQuest Dissertations and Theses and will conduct forward citation chaining of included documents. Two reviewers will perform screening independently. We will extract reported mediators, moderators, and relevant study characteristics for included studies. Findings will be presented using narrative syntheses, descriptive analyses, mediation meta-analyses, moderating meta-analyses, and causal diagram(s), where possible. We will perform a risk of bias assessment and will assess for publication bias. DISCUSSION: The development of evidence-based causal diagram(s) would provide more detailed understanding of the paths by which the psychological impacts of trauma can be transmitted intergenerationally at the family-level. This review could provide evidence to better support interventions that interrupt the cycle of intergenerational trauma. TRIAL REGISTRATION: Systematic review registration: PROSPERO registration ID #CRD42021251053.

Socio-ecological predictors of mental health outcomes among healthcare workers during the COVID-19 pandemic in the United States.

BACKGROUND: Healthcare workers are at increased risk of adverse mental health outcomes during the COVID-19 pandemic. Studies are warranted that examine socio-ecological factors associated with these outcomes to inform interventions that support healthcare workers during future disease outbreaks. METHODS: We conducted an online cross-sectional study of healthcare workers during May 2020 to assess the socio-ecological predictors of mental health outcomes during the COVID-19 pandemic. We assessed factors at four socio-ecological levels: individual (e.g., gender), interpersonal (e.g., social support), institutional (e.g., personal protective equipment availability), and community (e.g., healthcare worker stigma). The Personal Health Questionnaire-9, Generalized Anxiety Disorder-7, Primary Care Post-Traumatic Stress Disorder, and Alcohol Use Disorders Identification Test-Concise scales assessed probable major depression (MD), generalized anxiety disorder (GAD), posttraumatic stress disorder (PTSD), and alcohol use disorder (AUD), respectively. Multivariable logistic regression models were used to assess unadjusted and adjusted associations between socio-ecological factors and mental health outcomes. RESULTS: Of the 1,092 participants, 72.0% were female, 51.9% were frontline workers, and the mean age was 40.4 years (standard deviation = 11.5). Based on cut-off scores, 13.9%, 15.6%, 22.8%, and 42.8% had probable MD, GAD, PTSD, and AUD, respectively. In the multivariable adjusted models, needing more social support was associated with significantly higher odds of probable MD, GAD, PTSD, and AUD. The significance of other factors varied across the outcomes. For example, at the individual level, female gender was associated with probable PTSD. At the institutional level, lower team cohesion was associated with probable PTSD, and difficulty following hospital policies with probable MD. At the community level, higher healthcare worker stigma was associated with probable PTSD and AUD, decreased satisfaction with the national government response with probable GAD, and higher media exposure with probable GAD and PTSD. CONCLUSIONS: These findings can inform targeted interventions that promote healthcare workers' psychological resilience during disease outbreaks.

Anticipating the long-term neurodevelopmental impact of the COVID-19 pandemic on newborns and infants: A call for research and preventive policy.

It is estimated that 116 million children were born worldwide in the first nine months of the COVID-19 pandemic. Given the critical importance of early life for neurodevelopment, and evidence suggesting that prenatal maternal stress and early childhood adversity negatively impact neurodevelopment, it is alarming that many pregnant women and new mothers are experiencing high levels of pandemic-related stress. Research and proactive mental health policy is needed to minimize the impact of the COVID-19 pandemic on the future mental health of a global cohort of newborns and infants.

Development of an international standard set of patient-centred outcome measures for overall paediatric health: a consensus process.

OBJECTIVE: To develop an Overall Pediatric Health Standard Set (OPH-SS) of outcome measures that captures what matters to young people and their families and recognising the biopsychosocial aspects of health for all children and adolescents regardless of health condition. DESIGN: A modified Delphi process. SETTING: The International Consortium for Health Outcomes Measurement convened an international Working Group (WG) comprised of 23 international experts from 12 countries in the field of paediatrics, family medicine, psychometrics as well as patient advisors. The WG participated in 11 video-conferences, through a modified Delphi process and 9 surveys between March 2018 and January 2020 consensus was reached on a final recommended health outcome standard set. By a literature review conducted in March 2018, 1136 articles were screened for clinician and patient-reported or proxy-reported outcomes. Further, 4315 clinical trials and 12 paediatric health surveys were scanned. Between November 2019 and January 2020, the final standard set was endorsed by a patient validation (n=270) and a health professional (n=51) survey. RESULTS: From a total of 63 identified outcomes, consensus was formed on a standard set of outcome measures that comprises 10 patient-reported outcomes, 5 clinician-reported measures, and 6 case-mix variables. The four developmental age-specific packages (ie, 0-5, 6-12, 13-17, 18-24 years) include either five or six measures with an average time for completion of 20 min. CONCLUSIONS: The OPH-SS is a starting point to drive value-based paediatric healthcare delivery from a global perspective for enhancing child and adolescent physical health and psychosocial well-being.

Outcome reporting recommendations for clinical trial protocols and reports: a scoping review.

BACKGROUND: Clinicians, patients, and policy-makers rely on published evidence from clinical trials to help inform decision-making. A lack of complete and transparent reporting of the investigated trial outcomes limits reproducibility of results and knowledge synthesis efforts, and contributes to outcome switching and other reporting biases. Outcome-specific extensions for the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT-Outcomes) and Consolidated Standards of Reporting Trials (CONSORT-Outcomes) reporting guidelines are under development to facilitate harmonized reporting of outcomes in trial protocols and reports. The aim of this review was to identify and synthesize existing guidance for trial outcome reporting to inform extension development. METHODS: We searched for documents published in the last 10 years that provided guidance on trial outcome reporting using: an electronic bibliographic database search (MEDLINE and the Cochrane Methodology Register); a grey literature search; and solicitation of colleagues using a snowballing approach. Two reviewers completed title and abstract screening, full-text screening, and data charting after training. Extracted trial outcome reporting guidance was compared with candidate reporting items to support, refute, or refine the items and to assess the need for the development of additional items. RESULTS: In total, 1758 trial outcome reporting recommendations were identified within 244 eligible documents. The majority of documents were published by academic journals (72%). Comparison of each recommendation with the initial list of 70 candidate items led to the development of an additional 62 items, producing 132 candidate items. The items encompassed outcome selection, definition, measurement, analysis, interpretation, and reporting of modifications between trial documents. The total number of documents supporting each candidate item ranged widely (median 5, range 0-84 documents per item), illustrating heterogeneity in the recommendations currently available for outcome reporting across a large and diverse sample of sources. CONCLUSIONS: Outcome reporting guidance for clinical trial protocols and reports lacks consistency and is spread across a large number of sources that may be challenging to access and implement in practice. Evidence and consensus-based guidance, currently in development (SPIRIT-Outcomes and CONSORT-Outcomes), may help authors adequately describe trial outcomes in protocols and reports transparently and completely to help reduce avoidable research waste.

Neurodevelopmental outcome descriptions in cohorts of extremely preterm children.

BACKGROUND AND OBJECTIVES: Caregivers and clinicians of extremely preterm infants (born before 26 weeks' gestation) depend on long-term follow-up research to inform clinical decision-making. The completeness of outcome reporting in this area is unknown. The objective of this study was to evaluate the reporting of outcome definitions, selection, measurement and analysis in existing cohort studies that report on neurodevelopmental outcomes of children born extremely preterm. METHODS: We evaluated the completeness of reporting of 'cognitive function' and 'cerebral palsy' in prospective cohort studies summarised in a meta-analysis that assessed the effect of preterm birth on school-age neurodevelopment. Outcome reporting was evaluated using a checklist of 55 items addressing outcome selection, definition, measurement, analysis, presentation and interpretation. Reporting frequencies were calculated to identify strengths and deficiencies in outcome descriptions. RESULTS: All 14 included studies reported 'cognitive function' as an outcome; nine reported both 'cognitive function' and 'cerebral palsy' as outcomes. Studies reported between 26% and 46% of the 55 outcome reporting items assessed; results were similar for 'cognitive function' and 'cerebral palsy' (on average 34% and 33% of items reported, respectively). Key methodological concepts often omitted included the reporting of masking of outcome assessors, methods used to handle missing data and stakeholder involvement in outcome selection. CONCLUSIONS: The reporting of neurodevelopmental outcomes in cohort studies of infants born extremely preterm is variable and often incomplete. This may affect stakeholders' interpretation of study results, impair knowledge synthesis efforts and limit evidence-based decision-making for this population.

Systematic scoping review identifies heterogeneity in outcomes measured in adolescent depression clinical trials.

OBJECTIVES: The objective of this review was to identify outcomes reported in adolescent major depressive disorder trials and quantify outcome heterogeneity. STUDY DESIGN AND SETTING: Three databases were searched to identify trials evaluating therapies for major depressive disorder in adolescents published from 2008 to 2017. Identified outcomes were thematically grouped and mapped into predefined outcome core areas (physiological/clinical, life impact, resource use, adverse events, and death). Outcome heterogeneity was quantified using descriptive analyses. RESULTS: Of 2,686 articles yielded from the search, 42 articles describing 32 trials were included. A total of 434 outcomes measured using 118 different outcome measurement instruments were grouped into 86 unique outcome terms. Most outcome terms mapped to the physiological/clinical core area (62%), followed by the life impact (27%). Nearly half (45%) were reported in only a single trial each. Of 18 primary outcomes reported, 13 (72%) were each only reported in a single trial. "Depressive symptom severity", reported in 30 trials (94%), was measured using 19 different outcome measurement instruments. CONCLUSION: Heterogeneity exists in the outcomes and outcome measurement instruments used in adolescent depression trials. To enable reproducibility, comparison, and synthesis of trial results, a standard set of agreed-on outcomes and methods of measurement is needed.

Outcomes reported in randomised clinical trials of major depressive disorder treatments in adolescents: a systematic scoping review protocol.

INTRODUCTION: Major depressive disorder (MDD) is a common mental health condition in adolescents. Randomised clinical trials (RCTs) are the gold standard for assessing the safety and efficacy of interventions in this population. Heterogeneity in the outcomes measured and reported between RCTs limits the ability to compare, contrast, and combine trial results in a clinically meaningful way. There is currently no core outcome set (COS) available for use in RCTs evaluating interventions in adolescents with MDD. We will conduct a systematic scoping review of outcomes reported in adolescent depression RCTs to assess the variability of trial outcomes and to inform the development of a COS for adolescent MDD. METHODS AND ANALYSIS: We will apply methods based on the Joanna Briggs Institute scoping review methods manual. RCTs evaluating any treatment intervention for adolescent MDD published in the last 10 years will be located using an electronic bibliographic database search (MEDLINE, PsycINFO and Cochrane Central Register of Controlled Trials). Title and abstract screening, full-text screening, and data charting of eligible studies will be performed in duplicate. Outcomes identified will be mapped to an outcome-domain framework. Data analysis will include summary statistics of the characteristics of the included trials and outcomes. ETHICS AND DISSEMINATION: The results of this review will inform the development of a COS for adolescent MDD. The development and implementation of a COS for RCTs evaluating interventions in adolescents with MDD promise to help reduce variability in trial outcome selection, definition, measurement and reporting, ultimately facilitating evidence synthesis that will help to identify the best treatment practices for adolescents with MDD.

Guidance for reporting outcomes in clinical trials: scoping review protocol.

INTRODUCTION: Patients, families and clinicians rely on published research to help inform treatment decisions. Without complete reporting of the outcomes studied, evidence-based clinical and policy decisions are limited and researchers cannot synthesise, replicate or build on existing research findings. To facilitate harmonised reporting of outcomes in published trial protocols and reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is under development. As one of the initial steps in the development of InsPECT, a scoping review will identify and synthesise existing guidance on the reporting of trial outcomes. METHODS AND ANALYSIS: We will apply methods based on the Joanna Briggs Institute scoping review methods manual. Documents that provide explicit guidance on trial outcome reporting will be searched for using: (1) an electronic bibliographic database search; (2) a grey literature search; and (3) solicitation of colleagues for guidance documents using a snowballing approach. Reference list screening will be performed for included documents. Search results will be divided between two trained reviewers who will complete title and abstract screening, full-text screening and data charting. Captured trial outcome reporting guidance will be compared with candidate InsPECT items to support, refute or refine InsPECT content and to assess the need for the development of additional items. Data analysis will explore common features of guidance and use quantitative measures (eg, frequencies) to characterise guidance and its sources. ETHICS AND DISSEMINATION: A paper describing the review findings will be published in a peer-reviewed journal. The results will be used to inform the InsPECT development process, helping to ensure that InsPECT provides an evidence-based tool for standardising trial outcome reporting.

Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT).

BACKGROUND: Inadequate and poor quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize, and build upon study findings and impacts evidence-based decision-making by patients, clinicians, and policy-makers. To facilitate harmonized and transparent reporting of outcomes in trial protocols and published reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is being developed. The final product will provide unique InsPECT extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines. METHODS: The InsPECT SPIRIT and CONSORT extensions will be developed in accordance with the methodological framework created by the EQUATOR (Enhancing the Quality and Transparency of Health Research Quality) Network for reporting guideline development. Development will consist of (1) the creation of an initial list of candidate outcome reporting items synthesized from expert consultations and a scoping review of existing guidance for reporting outcomes in trial protocols and reports; (2) a three-round international Delphi study to identify additional candidate items and assess candidate item importance on a 9-point Likert scale, completed by stakeholders such as trial report and protocol authors, systematic review authors, biostatisticians and epidemiologists, reporting guideline developers, clinicians, journal editors, and research ethics board representatives; and (3) an in-person expert consensus meeting to finalize the set of essential outcome reporting items for trial protocols and reports, respectively. The consensus meeting discussions will be independently facilitated and informed by the empirical evidence identified in the primary literature and through the opinions (aggregate rankings and comments) collected via the Delphi study. An integrated knowledge translation approach will be used throughout InsPECT development to facilitate implementation and dissemination, in addition to standard post-development activities. DISCUSSION: InsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes.

Defining and measuring health equity effects in research on task shifting interventions in high-income countries: a systematic review protocol.

INTRODUCTION: Task shifting interventions are intended to both deliver clinically effective treatments to reduce disease burden and address health inequities or population vulnerability. Little is known about how health equity and population vulnerability are defined and measured in research focused on task shifting. This systematic review will address the following questions: Among task shifting interventions in high-income settings that have been studied using randomised controlled trials or variants, how are health inequity or population vulnerability identified and defined? What methods and indicators are used to describe, characterise and measure the population's baseline status and the intervention's impacts on inequity and vulnerability? METHODS AND ANALYSIS: Studies were identified through database searches (MEDLINE, Embase, CINAHL, PsycINFO and Web of Science). Eligible studies will be randomised controlled trials published since 2004, conducted in high-income countries, concerning task shifting interventions to treat any disease, in any population that may face health disadvantage as defined by the PROGRESS-Plus framework (place of residence, race/ethnicity/culture/language, occupation, gender/sex, religion, social capital, socioeconomic position, age, disability, sexual orientation, other vulnerable groups). We will conduct independent and duplicate title and abstract screening, then identify related papers from the same programme of research through further database and manual searching. From each programme of research, we will extract study details, and definitions and measures of health equity or population vulnerability based on the PROGRESS-Plus framework. Two investigators will assess the quality of reporting and measurement related to health equity and vulnerability using a scale developed for this study. A narrative synthesis will highlight similarities and differences between the gathered studies and offer critical analyses and implications. ETHICS AND DISSEMINATION: This review does not involve primary data collection, does not constitute research on human subjects and is not subject to additional institutional ethics review or informed consent procedures. Dissemination will include open-access peer-reviewed publication and academic conference presentations.PROSPERO Registration Number CRD42017049959.

The global burden of fatal self-poisoning with pesticides 2006-15: Systematic review.

BACKGROUND: Agricultural pesticide poisoning is a major contributor to the global burden of suicide. Over the last decade there has been a marked decrease in the incidence of suicide worldwide. It is unclear whether pesticide poisoning still plays a significant role in the global incidence of suicide. METHODS: WHO method-specific suicide data were supplemented by a systematic review of the literature between 2006 and 2015, including searches of thirteen electronic databases and Google, citation searching and a review of reference lists and personal collections. Our primary outcome was the proportion of total suicides due to pesticide poisoning. Weighted estimates were calculated for seven WHO regional and income strata. RESULTS: We identified data from 108 countries (102 from WHO data, 6 from the literature). A conservative estimate based on these data indicates that there were approximately 110,000 pesticide self-poisoning deaths each year from 2010 to 2014, comprising 13.7% of all global suicides. A sensitivity analysis accounting for under-reporting of suicides in India resulted in an increased estimate of 168,000 pesticide self-poisoning deaths annually, that is, 19.7% of global suicides. The proportion of suicides due to pesticide self-poisoning varies considerably between regions, from 0.9% in low- and middle-income countries in the European region to 48.3% in low- and middle-income countries in the Western Pacific region. LIMITATIONS: High quality method-specific suicide data were unavailable for a number of the most populous countries, particularly in the African and Eastern Mediterranean regions. It is likely we have underestimated incidence in these regions. CONCLUSION: There appears to have been a substantial decline in fatal pesticide self-poisoning in recent years, largely driven by a reduction in overall suicide rates in China. Nonetheless, pesticide self-poisoning remains a major public health challenge, accounting for at least one-in-seven suicides globally.

Health effects of training laypeople to deliver emergency care in underserviced populations: a systematic review protocol.

INTRODUCTION: The Disease Control Priorities Project recommends emergency care training for laypersons in low-resource settings, but evidence for these interventions has not yet been systematically reviewed. This review will identify the individual and community health effects of educating laypeople to deliver prehospital emergency care interventions in low-resource settings. METHODS AND ANALYSIS: This systematic review addresses the following question: in underserviced populations and low-resource settings (P), does first aid or emergency care training or education for laypeople (I) confer any individual or community health benefit for emergency health conditions (O), in comparison with no training or other forms of education (C)? We restrict this review to studies reporting quantitatively measurable outcomes, and search 12 electronic bibliographic databases and grey literature sources. A team of expert content and methodology reviewers will conduct title and abstract screening and full-text review, using a custom-built online platform. Two investigators will independently extract methodological variables and outcomes related to patient-level morbidity and mortality and community-level effects on resilience or emergency care capacity. Two investigators will independently assess external validity, selection bias, performance bias, measurement bias, attrition bias and confounding. We will summarise the findings using a narrative approach to highlight similarities and differences between the gathered studies. ETHICS AND DISSEMINATION: Formal ethical approval is not required. RESULTS: The results will be disseminated through a peer-reviewed publication and knowledge translation strategy. REVIEW REGISTRATION NUMBER: CRD42014009685.