scholarly journals Guidance for reporting outcomes in clinical trials: scoping review protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e023001 ◽  
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.

scholarly journals Guidance for Reporting Outcomes in Clinical Trials: A Scoping Review Protocol

2018 ◽  
Author(s):  
Nancy J. Butcher ◽  
Emma Mew ◽  
Leena Saeed ◽  
Andrea Monsour ◽  
Alyssandra Chee-a-tow ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Scoping Review ◽  
Grey Literature ◽  
Open Science ◽  
Evidence Based ◽  
Reporting Standard ◽  
Outcome Reporting ◽  
Trial Outcome ◽  
Trial Protocols ◽  
Electronic Bibliographic Database

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/).

scholarly journals Hypnotherapy for Procedural Pain and Distress in Children: A scoping Review Protocol

Pain Medicine ◽  
2021 ◽  
Author(s):  
Daly Geagea ◽  
Zephanie Tyack ◽  
Roy Kimble ◽  
Lars Eriksson ◽  
Vince Polito ◽  
...  
Keyword(s):  
Scoping Review ◽  
Grey Literature ◽  
Cochrane Library ◽  
Procedural Pain ◽  
Future Research ◽  
Theoretical Frameworks ◽  
Eligibility Criteria ◽  
Pharmacological Agents ◽  
Review Protocol ◽  
Meta Analyses

Abstract Objective Inadequately treated pain and distress elicited by medical procedures can put children at higher risks of acute and chronic biopsychosocial sequelae. Children can benefit from hypnotherapy, a psychological tailored intervention, as an adjunct to pharmacological agents to address the multiple components of pain and distress. Despite providing evidence on the effectiveness and potential superiority of hypnotherapy to other psychological interventions, research on hypnotherapy for paediatric procedural pain and distress has been predominantly limited to oncology and needle procedures. Plus, there is a lack of reporting of intervention manuals, factors influencing hypnotic responding, pain unpleasantness outcomes, theoretical frameworks, adverse events, as well as barriers and facilitators to the feasibility of delivering the intervention and study procedures. The proposed review aims to map the range and nature of the evidence on hypnotherapy for procedural pain and distress in children to identify gaps in literature and areas requiring further investigation. Methods This review will follow the Arksey and O'Malley (2005) methodology and incorporate additional scoping review recommendations by The Joanna Briggs Institute and Preferred Reporting Items for Systematic reviews and Meta-Analyses. Relevant studies will be identified through searching published literature databases (PubMed, Cochrane Library, PsycINFO, Embase, CINAHL, Scopus and Web of Science) and grey literature in addition to hand-searching of reference lists and key journals. Two authors will independently screen titles and abstracts of search results followed by full-texts review against eligibility criteria. Conclusion Findings are anticipated to guide future research and inform the development of tailored hypnotic interventions in children.

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

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

scholarly journals Use of tabletop exercises for healthcare education: a scoping review protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e032662 ◽  
Author(s):  
Amélie Frégeau ◽  
Alexis Cournoyer ◽  
Marc-André Maheu-Cadotte ◽  
Massimiliano Iseppon ◽  
Nathalie Soucy ◽  
...  
Keyword(s):  
Scoping Review ◽  
Interprofessional Education ◽  
Healthcare Professionals ◽  
Grey Literature ◽  
Institutional Review ◽  
Kirkpatrick Model ◽  
Review Protocol ◽  
Objective Outcomes ◽  
Based Medicine ◽  
Healthcare Educators

IntroductionThere is a growing interest in developing interprofessional education (IPE) in the community of healthcare educators. Tabletop exercises (TTX) have been proposed as a mean to cultivate collaborative practice. A TTX simulates an emergent situation in an informal environment. Healthcare professionals need to take charge of this situation as a team through a discussion-based approach. As TTX are gaining in popularity, performing a review about their uses could guide educators and researchers. The aim of this scoping review is to map the uses of TTX in healthcare.Methods and analysisA search of the literature will be conducted using medical subject heading terms and keywords in PubMed, Medline, EBM Reviews (Evidence-Based Medicine Reviews), CINAHL (Cumulative Index of Nursing and Allied Health Literature), Embase and ERIC (Education Resources Information Center), along with a search of the grey literature. The search will be performed after the publication of this protocol (estimated to be January 1st 2020) and will be repeated 1 month prior to the submission for publication of the final review (estimated to be June 1st 2020). Studies reporting on TTX in healthcare and published in English or French will be included. Two reviewers will screen the articles and extract the data. The quality of the included articles will be assessed by two reviewers. To better map their uses, the varying TTX activities will be classified as performed in the context of disaster health or not, for IPE or not and using a board game or not. Moreover, following the same mapping objective, outcomes of TTX will be reported according to the Kirkpatrick model of outcomes of educational programs.Ethics and disseminationNo institutional review board approval is required for this review. Results will be submitted for publication in a peer-reviewed journal. The findings of this review will inform future efforts to TTX into the training of healthcare professionals.

scholarly journals What Are the Client, Organisational and Employee-Related Outcomes of High Quality Leadership in the Allied Health Professions? A scoping review.

2019 ◽  
Vol 14 (2) ◽  
pp. 19-30 ◽  
Author(s):  
Janice McKeever ◽  
Ted Brown
Keyword(s):  
Scoping Review ◽  
Allied Health ◽  
Grey Literature ◽  
Future Research ◽  
Reference List ◽  
High Quality ◽  
Allied Health Professionals ◽  
Consumer Expectation ◽  
Professional Groups ◽  
Modern Health Care

Background: Leadership is viewed as the panacea the complex problems in modern health care where chronic disease, contracting budgets and rising consumer expectation are challenging care provision. As the second largest workforce in Australia, Allied Health Professionals (AHP) are core contributors to health teams however they are largely absent from leadership positions and there is little evidence of their impact on client outcomes. Aim: A scoping review was carried out to synthesise evidence on the client, organisational and employee-related outcomes of high quality leadership in Allied Health. Method: A search of grey literature, peer and non-peer reviewed literature was undertaken using Embase, Emcare, SCOPUS and Psychinfo from 2010-2017. Data were sourced from journals, government reports, conference presentations and other grey literature. The reference list of key articles were hand searched for relevant research. Results: A total of 5880 articles were identified and after screening 35 articles were included for in depth review. Leadership contributed towards positive outcomes in all three domains and had influence across professional groups and services. Leaders are highly valued and respected by their teams. Allied Health leaders did not feature in any of the articles and AHP were the focus of only seven studies. The majority of articles were conference papers or case reviews that provided little robust data making it difficult to draw substantive conclusions on the outcome of AHP leadership. Conclusion: There was a lack of robust data specific to AHP leaders. Future research should attempt to gather evidence of the outcomes of AHP leadership through qualitative and quantitative means to substantiate the anecdotal evidence for high quality AHP leaders. 

Problems and Barriers related to the Use of Digital Health Applications: A Scoping Review Protocol (Preprint)

2021 ◽  
Author(s):  
Godwin Denk Giebel ◽  
Christian Speckemeier ◽  
Carina Abels ◽  
Kirstin Börchers ◽  
Jürgen Wasem ◽  
...  
Keyword(s):  
Scoping Review ◽  
Digital Health ◽  
Health Care Systems ◽  
Grey Literature ◽  
Screening Process ◽  
Care Systems ◽  
Research Findings ◽  
Review Protocol ◽  
Definition Of ◽  
Health Applications

BACKGROUND Usage of digital health applications (DHA) is increasing internationally. More and more regulatory bodies develop regulations and guidelines to enable an evidence-based and safe use. In Germany, DHA fulfilling predefined criteria (Digitale Gesundheitsanwendungen (="DiGA")) can be prescribed and are reimbursable by the German statutory health insurance scheme. Due to the increasing distribution of DHA problems and barriers should receive special attention. OBJECTIVE This study aims to identify relevant problems and barriers related to the use of DHA fulfilling the criteria of DiGA. The research done in this area will be mapped and research findings will be summarized. METHODS Conduct of the scoping review will follow published methodological frameworks and PRISMA-Scr criteria. Electronic databases (MEDLINE, EMBASE, and PsycINFO), reference lists of relevant articles and grey literature sources will be searched. Two reviewers will assess eligibility of articles by a two-stage (title/abstract and full-text) screening process. Only problems and barriers related to DHA fulfilling the criteria of DiGA are included for this research. RESULTS This scoping review serves to give an overview about the available evidence and to identify research gaps with regards to problems and barriers related to DiGA. Results are planned to be submitted to an indexed, peer-reviewed journal in the fourth quarter of 2021. CONCLUSIONS This is the first review identifying problems and barriers specifically to the use of the German definition of DiGA. Nevertheless, our findings can presumably be applied to other contexts and health care systems as well.

scholarly journals Type and use of digital technology in learning health systems: a scoping review protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e026204
Author(s):  
Lysanne Lessard ◽  
Agnes Grudniewicz ◽  
Antoine Sauré ◽  
Agnieszka Szczotka ◽  
James King ◽  
...  
Keyword(s):  
Health Systems ◽  
Scoping Review ◽  
Digital Technology ◽  
Technology Use ◽  
Data Extraction ◽  
Grey Literature ◽  
Future Research ◽  
Efficiency And Effectiveness ◽  
Ethical Approval ◽  
Review Protocol

IntroductionHealth systems in North America and Europe have been criticised for their lack of safety, efficiency and effectiveness despite rising healthcare costs. In response, healthcare leaders and researchers have articulated the need to transform current health systems into continuously and rapidly learning health systems (LHSs). While digital technology has been envisioned as providing the transformational power for LHSs by generating timely evidence and supporting best care practices, it remains to be ascertained if it is indeed playing this role in current LHS initiatives. This paper presents a protocol for a scoping review that aims at providing a comprehensive understanding of how and to what extent digital technology is used within LHSs. Results will help to identify gaps in the literature as a means to guide future research on this topic.Methods and analysisMultiple databases and grey literature will be searched with terms related to learning health systems. Records selection will be done in duplicate by two reviewers applying pre-defined inclusion and exclusion criteria. Data extraction from selected records will be done by two reviewers using a piloted data charting form. Results will be synthesised through a descriptive numerical summary and a mapping of digital technology use onto types of LHSs and phases of learning within LHSs.Ethics and disseminationEthical approval is not required for this scoping review. Preliminary results will be shared with stakeholders to account for their perspectives when drawing conclusions. Final results will be disseminated through presentations at relevant conferences and publications in peer-reviewed journals.

scholarly journals Mapping evidence on access to healthcare information by women of reproductive age in low-and-middle-income countries: scoping review protocol

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Joyce T. Shatilwe ◽  
Tivani P. Mashamba-Thompson
Keyword(s):  
Scoping Review ◽  
Full Text ◽  
Grey Literature ◽  
Relevant Literature ◽  
Access To Healthcare ◽  
Reproductive Age ◽  
Future Research ◽  
Reference List ◽  
Women Of Reproductive Age ◽  
Healthcare Information

Abstract Background Research shows that there are inadequate interventions in resource-limited settings that could enable women of reproductive age to access and use health services in those settings. The main objective of this scoping review is to map the evidence on access to healthcare information by women of reproductive age in LMICs. Method and analysis The primary search will include Google Scholar, Science Direct, PubMed, EBSCOhost (Academic search complete, CINAHL with full text, MEDLINE with full text, MEDLINE), Emerald, Embase, CDSR, PsycINFO, published and peer review journals, organisational projects, conference papers, reference list, grey literature sources, as well as reports related to this objective will be included in the study. Identified keywords will be used to search articles from the studies. The articles and abstracts will be screened by two independent reviewers (JS and TPMT). Inclusion and exclusion criteria will be considered to guide the screening. A thematic content analysis will be used to present the narrative account of the reviews, using NVivo computer software (version 11). Discussions The scoping review will focus on women of reproductive age in LMICs. We anticipate finding relevant literature on the interventions aimed at accessing health care services in LMICs. The study findings will help reveal research gaps to guide future research. Scoping review registration Not registered with PROSPERO (not needed). Protocol and registration This scoping review was not registered.

scholarly journals Mapping evidence on HIV status awareness among key and vulnerable populations in sub-Sahara Africa: a scoping review protocol

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Clement Avoka ◽  
Patience Adzordor ◽  
Vitalis Bawontuo ◽  
Diana A. Akila ◽  
Desmond Kuupiel
Keyword(s):  
Vulnerable Populations ◽  
Scoping Review ◽  
Data Extraction ◽  
Grey Literature ◽  
Public Health Issue ◽  
Future Research ◽  
Hiv Status ◽  
Data Extraction Form ◽  
Review Protocol ◽  
Immunodeficiency Syndrome

Abstract Background Human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS) continue to be a major public health issue, especially in sub-Sahara Africa (SSA). Literature shows significant HIV status awareness, testing, and treatment have generally improved among the population since the inception of the UNAIDS 90:90:90 programme. Despite this, it is possible literature gaps exist that require future research to inform in-country programmes to improve the gains post-UNAIDS 90:90:90 programme. This study, therefore, aims to synthesize literature and describe the evidence on HIV status awareness among key and vulnerable populations in SSA focusing on the first UNAIDS 90 since it is essential for treatment initiation. Method This systematic scoping review will be guided by the framework proposed by Arksey and O’Malley and improved by Levac and colleagues. Literature searches will be conducted in PubMed, SCOPUS, CINAHL, Google Scholar, and Science Direct from 2016 to 2020. A snowball approach will also be used to search for relevant articles from the reference of all included studies. This study will include both published and grey literature, articles that include HIV key and vulnerable populations, HIV status awareness, and evidence from SSA countries. Two reviewers will independently conduct the abstract and full-text article screening as well as pilot the data extraction form. Thematic content analysis and a summary of the themes and sub-themes will be reported narratively. Discussions The evidence that will be provided by this study may be useful to inform in-country programmes to improve the gains made post-UNAIDS 90:90:90 programme from 2021 onwards. This study also anticipates identifying literature gaps to guide researchers interested in this field of study in the future. Peer review journals, policy briefs, and conference platforms will be used to disseminate this study’s findings.

scholarly journals Systematic scoping review protocol for clinical prediction rules (CPRs) in the management of patients with spinal cord injuries

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025076 ◽  
Author(s):  
Blake Boggenpoel ◽  
Vuyolwethu Madasa ◽  
Tarryn Jeftha ◽  
Conran Joseph
Keyword(s):  
Spinal Cord ◽  
Scoping Review ◽  
Impact Analysis ◽  
Spinal Cord Injuries ◽  
Prediction Models ◽  
Grey Literature ◽  
Clinical Prediction ◽  
Clinical Prediction Rules ◽  
Prediction Rules ◽  
Review Protocol

IntroductionThe upsurge in the use of clinical prediction models in general medical practice is a result of evidence-based practice. However, the total number of clinical prediction rules (CPRs) currently being used or undergoing impact analysis in the management of patients who have sustained spinal cord injuries (SCIs) is unknown. This scoping review protocol will describe the current CPRs being used and highlight their possible strengths and weaknesses in SCI management.Methods and analysisArksey and O’Malley’s scoping review framework will be used. The following databases will be searched to identify relevant literature relating to the use of CPRs in the management of patients who have sustained an SCI: PubMed, Cumulative Index of Nursing and Allied Health Literature (CINAHL), ScienceDirect, EBSCOhost, Medline, OvidMedline and Google Scholar. Grey literature as well as reference lists of included studies will be searched. All studies relating to the use of CPRs in the management of patients with SCIs will be included. Literature searches and data extraction will be performed independently by two groups of reviewers.Ethics and disseminationEthical clearance is not required for this scoping review study since only secondary data sources will be used. The findings of this review will be disseminated by means of peer-reviewed publication and conference proceedings. The final paper will be submitted for publication. Results of this review will also be presented at relevant conferences and disseminated to important stakeholders such as practicing physicians within specialised spinal care facilities within South Africa.

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