Guidance for Reporting Outcomes in Clinical Trials: A 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 synthesize, replicate, or build on existing research findings. To facilitate harmonized reporting of outcomes in published trial protocols and reports, a new reporting standard, the Instrument for reporting of 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 synthesize 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 and citation list screening will be performed for included documents. Two trained reviewers will complete title and abstract screening. One reviewer and one verifier will independently complete full-text screening and data charting. Discrepancies will be resolved through discussion with a third reviewer. Captured trial outcome reporting guidance will be compared with candidate InsPECT items to support, refute, and 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 (e.g., frequencies) to characterize 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 standardizing trial outcome reporting. Registration details: This protocol was registered prospectively with the Open Science Framework (https://osf.io/ktg84/).

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Guidance for reporting outcomes in clinical trials: scoping review protocol

BMJ Open ◽

10.1136/bmjopen-2018-023001 ◽

2019 ◽

Vol 9 (2) ◽

pp. e023001 ◽

Cited By ~ 3

Author(s):

Nancy J Butcher ◽

Emma J Mew ◽

Leena Saeed ◽

Andrea Monsour ◽

Alyssandra Chee-a-tow ◽

...

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

Grey Literature ◽

Reference List ◽

Evidence Based ◽

Outcome Reporting ◽

Trial Outcome ◽

Trial Protocols ◽

Review Protocol ◽

Electronic Bibliographic Database

IntroductionPatients, 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 analysisWe 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 disseminationA 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.

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Sexual health and COVID-19: protocol for a scoping review

Systematic Reviews ◽

10.1186/s13643-021-01591-y ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Navin Kumar ◽

Kamila Janmohamed ◽

Kate Nyhan ◽

Laura Forastiere ◽

Wei-Hong Zhang ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Sexual Health ◽

Scoping Review ◽

Current Knowledge ◽

Grey Literature ◽

Well Being ◽

World Health ◽

Original Research ◽

Scoping Reviews

Abstract Background Global responses to the COVID-19 pandemic have exposed and exacerbated existing socioeconomic and health inequities that disproportionately affect the sexual health and well-being of many populations, including people of color, ethnic minority groups, women, and sexual and gender minority populations. Although there have been several reviews published on COVID-19 and health disparities across various populations, none has focused on sexual health. We plan to conduct a scoping review that seeks to fill several of the gaps in the current knowledge of sexual health in the COVID-19 era. Methods A scoping review focusing on sexual health and COVID-19 will be conducted. We will search (from January 2020 onwards) CINAHL, Africa-Wide Information, Web of Science Core Collection, Embase, Gender Studies Database, Gender Watch, Global Health, WHO Global Literature on Coronavirus Disease Database, WHO Global Index Medicus, PsycINFO, MEDLINE, and Sociological Abstracts. Grey literature will be identified using Disaster Lit, Google Scholar, governmental websites, and clinical trials registries (e.g., ClinicalTrial.gov, World Health Organization, International Clinical Trials Registry Platform, and International Standard Randomized Controlled Trial Number Registry). Study selection will conform to the Joanna Briggs Institute Reviewers’ Manual 2015 Methodology for JBI Scoping Reviews. Only English language, original studies will be considered for inclusion. Two reviewers will independently screen all citations, full-text articles, and abstract data. A narrative summary of findings will be conducted. Data analysis will involve quantitative (e.g., frequencies) and qualitative (e.g., content and thematic analysis) methods. Discussion Original research is urgently needed to mitigate the risks of COVID-19 on sexual health. The planned scoping review will help to address this gap. Systematic review registrations Systematic Review Registration: Open Science Framework osf/io/PRX8E

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Intersectoral approaches and integrated services in achieving the right to health for refugees upon resettlement: a scoping review protocol

BMJ Open ◽

10.1136/bmjopen-2017-016638 ◽

2017 ◽

Vol 7 (8) ◽

pp. e016638 ◽

Cited By ~ 3

Author(s):

Dena Javadi ◽

Etienne V Langlois ◽

Shirley Ho ◽

Peter Friberg ◽

Göran Tomson

Keyword(s):

Scoping Review ◽

Human Subjects ◽

Grey Literature ◽

Open Science ◽

Right To Health ◽

Refugee Health ◽

International Standards ◽

Vulnerable Groups ◽

Physical And Mental Health ◽

The Right

IntroductionGlobal insecurity and climate change are exacerbating the need for improved management of refugee resettlement services. International standards hold states responsible for the protection of the right of non-citizens to an adequate standard of physical and mental health while recognising the importance of social determinants of health. However, programmes to protect refugees’ right to health often lack coordination and monitoring. This paper describes the protocol for a scoping review to explore barriers and facilitators to the integration of health services for refugees; the content, process and actors involved in protecting refugee health; and the extent to which intersectoral approaches are leveraged to protect refugees’ right to health on resettlement, especially for vulnerable groups such as women and children.Methods and analysisPeer-reviewed (through four databases including MEDLINE, Web of Science, Global Health and PsycINFO) and grey literature were searched to identify programmes and interventions designed to promote refugee health in receiving countries. Two reviewers will screen articles and abstract data. Two frameworks for integration and intersectoral action will be applied to understand how and why certain approaches work while others do not and to identify the actors involved in achieving success at different levels of integration as defined by these frameworks.Ethics and disseminationFindings from the scoping review will be shared in relevant conferences and meetings. A brief will be created with lessons learnt from successful programmes to inform decision making in design of refugee programmes and services. Ethical approval is not required as human subjects are not involved.Trial registration numberRegistered on Open Science Framework athttps://osf.io/gt9ck/.

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Dysphagia rehabilitation following acquired brain injury, including cerebral palsy, across the lifespan: a scoping review protocol

Systematic Reviews ◽

10.1186/s13643-021-01861-9 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Rhiannon Halfpenny ◽

Alexandra Stewart ◽

Paula Kelly ◽

Eleanor Conway ◽

Christina Smith

Keyword(s):

Brain Injury ◽

Systematic Reviews ◽

Scoping Review ◽

Grey Literature ◽

Acquired Brain Injury ◽

Paediatric Population ◽

Open Science ◽

Language Therapy ◽

Dysphagia Rehabilitation ◽

Swallowing Exercises

Abstract Background Swallowing impairment (dysphagia) following brain injury can lead to life-threatening complications such as dehydration, aspiration pneumonia and acute choking episodes. In adult therapeutic practice, there is research and clinical evidence to support the use of swallowing exercises to improve swallowing physiology in dysphagia; however, the use of these exercises in treating children with dysphagia is largely unexplored. Fundamental questions remain regarding the feasibility and effectiveness of using swallowing exercises with children. This review aims to outline the published literature on exercise-based treatment methods used in the rehabilitation of dysphagia secondary to an acquired brain injury across the lifespan. This will allow the range and effects of interventions utilised to be mapped alongside differential practices between adult and child populations to be formally documented, providing the potential for discussions with clinicians about which rehabilitative interventions might be appropriate for further trial in paediatrics. Methods This study will use a scoping review framework to identify and systematically review the existing literature using Joanna Briggs Institute (JBI) and Preferred Reporting Items for Systematic Reviews (PRISMA) scoping review guidelines. Electronic databases (MEDLINE, PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine Database (AMED)), grey literature and the reference lists of key texts including systematic reviews will be searched. Information about the rehabilitation design, dosage and intensity of exercise programmes used as well as demographic information such as the age of participants and aetiology of dysphagia will be extracted. The number of articles in each area and the type of data source will be presented in a written and visual format. Comparison between the literature in adult and child populations will be discussed. Discussion This review is unique as it directly compares dysphagia rehabilitation in adults with that of a paediatric population in order to formally identify and discuss the therapeutic gaps in child dysphagia rehabilitation. The results will inform the next stage of research, looking into the current UK-based speech and language therapy practices when working with children with acquired dysphagia. Systematic review registration Open science framework osf.io/ja4dr

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Patient-centred care for addiction treatment: a scoping review protocol

BMJ Open ◽

10.1136/bmjopen-2018-024588 ◽

2018 ◽

Vol 8 (12) ◽

pp. e024588 ◽

Cited By ~ 6

Author(s):

Kirsten Marchand ◽

Scott Beaumont ◽

Jordan Westfall ◽

Scott MacDonald ◽

Scott Harrison ◽

...

Keyword(s):

Substance Use ◽

Scoping Review ◽

Addiction Treatment ◽

Grey Literature ◽

Healthcare Providers ◽

Open Science ◽

Patient Centred Care ◽

Healthcare Settings ◽

Problematic Substance Use ◽

Problematic Substance

IntroductionSubstance use disorders are chronic conditions that require a multidimensional treatment approach. Despite ongoing efforts to diversify such treatments, evidence continues to illuminate modest rates of treatment engagement and perceived barriers to treatment. Patient-centred care (PCC) is one approach that may strengthen the responsiveness of treatments for people with problematic substance use. The aim of this scoping review is to explore how the principles of PCC have been implemented and operationalised in healthcare settings for people with problematic substance use.Methods and analysisThis scoping review follows the iterative stages of the Arksey and O’Malley framework. Both empirical (from Medline, Embase, PsycINFO, CINAHL and ISI Web of Science) and grey literature references will be considered if they focused on populations with problematic substance use and described or measured PCC or one of its principles in a health-oriented context. Two reviewers will independently screen references in two successive stages of title/abstract screening and then full-text screening for references meeting title/abstract criteria. A descriptive overview, tabular and/or graphical summaries, and a directed content analysis will be carried out on extracted data. This scoping review has been registered with Open Science Framework (https://osf.io/5swvd/).Ethics and disseminationThis review will systematically examine the extent and nature of existing evidence of PCC in addiction research and clinical practice. Such evidence will contribute to the operationalisation of PCC for people with problematic substance use. A multidisciplinary team has been gathered to represent the needs of people with problematic substance use, healthcare providers and decision-makers. The team’s knowledge users will be engaged throughout this review and will participate in dissemination activities (eg, workshops, presentations, publications, reports).

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Sexual health and COVID-19: Protocol for a scoping review

10.21203/rs.3.rs-59514/v3 ◽

2021 ◽

Author(s):

Navin Kumar ◽

Kamila Janmohamed ◽

Kate Nyhan ◽

Laura Forastiere ◽

Wei-Hong Zhang ◽

...

Keyword(s):

Clinical Trials ◽

Sexual Health ◽

Scoping Review ◽

English Language ◽

Current Knowledge ◽

Grey Literature ◽

Well Being ◽

World Health ◽

Original Research ◽

Scoping Reviews

Abstract Background: Global responses to the COVID-19 pandemic have exposed and exacerbated existing socioeconomic and health inequities that disproportionately affect the sexual health and well-being of many populations, including people of color, ethnic minority groups, women, and sexual and gender minority populations. Although there have been several reviews published on COVID-19 and health disparities across various populations, none have focused on sexual health. We plan to conduct a scoping review that seeks to fill several of the gaps in the current knowledge of sexual health in the COVID-19 era.Methods: A scoping review focusing on sexual health and COVID-19 will be conducted. We will search (from January 2020 onwards) CINAHL, Africa-Wide Information, Web of Science Core Collection, Embase, Gender Studies Database, Gender Watch, Global Health, WHO Global Literature on Coronavirus Disease Database, WHO Global Index Medicus, PsycINFO, MEDLINE and Sociological Abstracts. Grey literature will be identified using Disaster Lit, Google Scholar, governmental websites and clinical trials registries (e.g. ClinicalTrial.gov, World Health Organization, International Clinical Trials Registry Platform and International Standard Randomized Con-trolled Trial Number registry). Study selection will conform to Joanna Briggs Institute Reviewers’ Manual 2015 Methodology for JBI Scoping Reviews. Only English language, original studies will be considered for inclusion. Two reviewers will independently screen all citations, full-text articles, and abstract data. A narrative summary of findings will be conducted. Data analysis will involve quantitative (e.g. frequencies) and qualitative (e.g. content and thematic analysis) methods.Discussion: Original research is urgently needed to mitigate the risks ofCOVID-19 on sexual health. The planned scoping review will help to address this gap.

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Interventions to Mitigate COVID-19 Misinformation: Protocol for a Scoping Review

10.21203/rs.3.rs-416531/v1 ◽

2021 ◽

Author(s):

Navin Kumar ◽

Nathan Walter ◽

Kate Nyhan ◽

Kaveh Khoshnood ◽

Joseph D Tucker ◽

...

Keyword(s):

Systematic Review ◽

Scoping Review ◽

English Language ◽

Current Knowledge ◽

Grey Literature ◽

Open Science ◽

Original Research ◽

Study Selection ◽

Scoping Reviews ◽

Science Framework

Abstract Background: The duration and impact of the COVID-19 pandemic depends in a large part on individual and societal actions which is influenced by the quality and salience of the information to which they are exposed. Unfortunately, COVID-19 misinformation has proliferated. To date, no systematic efforts have been made to evaluate interventions that mitigate COVID-19-related misinformation. We plan to conduct a scoping review that seeks to fill several of the gaps in the current knowledge of interventions that mitigate COVID-19-related misinformation.Methods: A scoping review focusing on interventions that mitigate COVID-19 misinformation will be conducted. We will search (from January 2020 onwards) MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science Core Collection, Africa-Wide Information, Global Health, WHO Global Literature on Coronavirus Disease Database, WHO Global Index Medicus, and Sociological Abstracts. Grey literature will be identified using Disaster Lit, Google Scholar, Open Science Framework, governmental websites and preprint servers (e.g. EuropePMC, PsyArXiv, MedRxiv, JMIR Preprints). Study selection will conform to Joanna Briggs Institute Reviewers’ Manual 2020 Methodology for JBI Scoping Reviews. Only English language, original studies will be considered for inclusion. Two reviewers will independently screen all citations, full-text articles, and abstract data. A narrative summary of findings will be conducted. Data analysis will involve quantitative (e.g. frequencies) and qualitative (e.g. content and thematic analysis) methods.Discussion: Original research is urgently needed to design interventions to mitigate COVID-19 misinformation. The planned scoping review will help to address this gap.Systematic Review registrations: Systematic Review Registration: Open Science Framework (osf/io/etw9d).

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Promoting inclusion in clinical trials—a rapid review of the literature and recommendations for action

Trials ◽

10.1186/s13063-021-05849-7 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Danielle H. Bodicoat ◽

Ash C. Routen ◽

Andrew Willis ◽

Winifred Ekezie ◽

Clare Gillies ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Cultural Competency ◽

Grey Literature ◽

Healthcare Delivery ◽

Research Process ◽

Rapid Review ◽

Advisory Panel ◽

Evidence Based ◽

Recommendations For Action

Abstract Background Without inclusion of diverse research participants, it is challenging to understand how study findings will translate into the real world. Despite this, a lack of inclusion of those from under-served groups in research is a prevailing problem due to multi-faceted barriers acting at multiple levels. Therefore, we rapidly reviewed international published literature, in relation to clinical trials, on barriers relating to inclusion, and evidence of approaches that are effective in overcoming these. Methods A rapid literature review was conducted searching PubMed for peer-reviewed articles that discussed barriers to inclusion or strategies to improve inclusion in clinical trial research published between 2010 and 2021. Grey literature articles were excluded. Results Seventy-two eligible articles were included. The main barriers identified were language and communication, lack of trust, access to trials, eligibility criteria, attitudes and beliefs, lack of knowledge around clinical trials, and logistical and practical issues. In relation to evidence-based strategies and enablers, two key themes arose: [1] a multi-faceted approach is essential [2]; no single strategy was universally effective either within or between trials. The key evidence-based strategies identified were cultural competency training, community partnerships, personalised approach, multilingual materials and staff, communication-specific strategies, increasing understanding and trust, and tackling logistical barriers. Conclusions Many of the barriers relating to inclusion are the same as those that impact trial design and healthcare delivery generally. However, the presentation of these barriers among different under-served groups may be unique to each population’s particular circumstances, background, and needs. Based on the literature, we make 15 recommendations that, if implemented, may help improve inclusion within clinical trials and clinical research more generally. The three main recommendations include improving cultural competency and sensitivity of all clinical trial staff through training and ongoing personal development, the need to establish a diverse community advisory panel for ongoing input into the research process, and increasing recruitment of staff from under-served groups. Implementation of these recommendations may help improve representation of under-served groups in clinical trials which would improve the external validity of associated findings.

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Investigating and evaluating evidence of the behavioural determinants of adherence to social distancing measures – A protocol for a scoping review of COVID-19 research

HRB Open Research ◽

10.12688/hrbopenres.13099.1 ◽

2020 ◽

Vol 3 ◽

pp. 46 ◽

Cited By ~ 2

Author(s):

Chris Noone ◽

Nikolett Warner ◽

Molly Byrne ◽

Hannah Durand ◽

Kim L. Lavoie ◽

...

Keyword(s):

Scoping Review ◽

Large Scale ◽

Best Practice ◽

Data Extraction ◽

Grey Literature ◽

Theoretical Domains Framework ◽

Open Science ◽

Quality Appraisal ◽

Social Distancing ◽

Behavioural Determinants

Background: The WHO has declared the outbreak of coronavirus disease 2019 (COVID-19) as a pandemic. With no vaccine currently available, using behavioural measures to reduce the spread of the virus within the population is an important tool in mitigating the effects of this pandemic. As such, social distancing measures are being implemented globally and have proven an effective tool in slowing the large-scale spread of the virus. Aim: This scoping review will focus on answering key questions about the state of the evidence on the behavioural determinants of adherence to social distancing measures in research on COVID-19. Methods: A scoping review will be conducted in accordance with guidelines for best practice. Literature searches will be conducted using online databases and grey literature sources. Databases will include Medline, Web of Science, Embase and PsycInfo, alongside relevant pre-print servers. Grey literature will be searched on Google Scholar. Screening, data extraction and quality appraisal will be conducted independently by two members of the research team, with any discrepancies resolved by consensus discussion and an additional team member if needed. Quality appraisal will be conducted using the Cochrane’s ROBINS-I tool, the Cochrane Risk of Bias tool, and the JBI Critical Appraisal Checklist where appropriate. Results will be analysed by mapping findings onto the Theoretical Domains Framework and visualising characteristics of the included studies using EviAtlas. This scoping review is pre-registered with Open Science Framework. Conclusions The results of this study may facilitate the systematic development of behavioural interventions to increase adherence to social distancing measures.

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What is the evidence for the impact of gardens and gardening on health and well-being: a scoping review and evidence-based logic model to guide healthcare strategy decision making on the use of gardening approaches as a social prescription

BMJ Open ◽

10.1136/bmjopen-2020-036923 ◽

2020 ◽

Vol 10 (7) ◽

pp. e036923 ◽

Cited By ~ 1

Author(s):

Michelle Howarth ◽

Alison Brettle ◽

Michael Hardman ◽

Michelle Maden

Keyword(s):

Decision Making ◽

Scoping Review ◽

Grey Literature ◽

Well Being ◽

Evidence Based ◽

Long Term Conditions ◽

Logic Models ◽

Health Strategy ◽

The Impact ◽

Health And Well Being

ObjectiveTo systematically identify and describe studies that have evaluated the impact of gardens and gardening on health and well-being. A secondary objective was to use this evidence to build evidence-based logic models to guide health strategy decision making about gardens and gardening as a non-medical, social prescription.DesignScoping review of the impact of gardens and gardening on health and well-being. Gardens include private spaces and those open to the public or part of hospitals, care homes, hospices or third sector organisations.Data sourcesA range of biomedical and health management journals was searched including Medline, CINAHL, Psychinfo, Web of Knowledge, ASSIA, Cochrane, Joanna Briggs, Greenfile, Environment Complete and a number of indicative websites were searched to locate context-specific data and grey literature. We searched from 1990 to November 2019.Eligibility criteriaWe included research studies (including systematic reviews) that assessed the effect, value or impact of any garden that met the gardening definition.Data extraction and synthesisThree reviewers jointly screened 50 records by titles and abstracts to ensure calibration. Each record title was screened independently by 2 out of 3 members of the project team and each abstract was screened by 1 member of a team of 3. Random checks on abstract and full-text screening were conducted by a fourth member of the team and any discrepancies were resolved through double-checking and discussion.ResultsFrom the 8896 papers located, a total of 77* studies was included. Over 35 validated health, well-being and functional biometric outcome measures were reported. Interventions ranged from viewing gardens, taking part in gardening or undertaking therapeutic activities. The findings demonstrated links between gardens and improved mental well-being, increased physical activity and a reduction in social isolation enabling the development of 2 logic models.ConclusionsGardens and gardening can improve the health and well-being for people with a range of health and social needs. The benefits of gardens and gardening could be used as a ‘social prescription’ globally, for people with long-term conditions (LTCs). Our logic models provide an evidence-based illustration that can guide health strategy decision making about the referral of people with LTCs to socially prescribed, non-medical interventions involving gardens and gardening.

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