Dataset Information

Protocol for the development of the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline: checklist of items for reporting pharmacogenetic studies.

ABSTRACT:

Introduction

Large sample sizes are often required to detect statistically significant associations between pharmacogenetic markers and treatment response. Meta-analysis may be performed to synthesise data from several studies, increasing sample size and consequently power to detect significant genetic effects. However, performing robust synthesis of data from pharmacogenetic studies is often challenging due to poor reporting of key data in study reports. There is currently no guideline for the reporting of pharmacogenetic studies. The aim of this project is to develop the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline. The STROPS guideline will facilitate the conduct of high-quality meta-analyses and thus improve the power to detect genetic associations.

Methods and analysis

We will establish a preliminary checklist of reporting items to be considered for inclusion in the guideline. We will then conduct a Delphi survey of key stakeholder groups to gain consensus opinion on which reporting items to include in the final guideline. The Delphi survey will consist of two rounds: the first round will invite participants to score items from the preliminary checklist and to suggest additional relevant items; the second round will provide feedback from the previous round and invite participants to re-score the items. Following the second round, we will summarise the distribution of scores for each item, stratified by stakeholder group. The Steering Committee for the project and representatives from the key stakeholder groups will meet to consider the results of the Delphi survey and to finalise the list of reporting items. We will then draft, pilot-test and publish the STROPS reporting guideline and accompanying explanatory document.

Ethics and dissemination

The University of Liverpool Ethics Committee has confirmed ethical approval for this study (reference: 3586). Dissemination activities will include presenting the reporting guideline at conferences relevant to pharmacogenetic research.

SUBMITTER: Richardson M

PROVIDER: S-EPMC6629424 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

Protocol for the development of the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline: checklist of items for reporting pharmacogenetic studies.

Richardson Marty M Kirkham Jamie J JJ Dwan Kerry M KM Sloan Derek J DJ Davies Geraint G Jorgensen Andrea A

BMJ open 20190711 7

<h4>Introduction</h4>Large sample sizes are often required to detect statistically significant associations between pharmacogenetic markers and treatment response. Meta-analysis may be performed to synthesise data from several studies, increasing sample size and consequently power to detect significant genetic effects. However, performing robust synthesis of data from pharmacogenetic studies is often challenging due to poor reporting of key data in study reports. There is currently no guideline ...[more]

PMID: 31300508

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Project description:IntroductionStrengthening the reporting of observational studies in epidemiology (STROBE) coined in 2007, highlighted the importance of improving the quality of observational research by providing an item checklist in order to avoid inadequate reporting of research. However, currently there are no reporting guidelines specific to surgical cohort studies, which have an extremely important role within the surgical literature. The recent development of surgery specific guidelines has underscored how surgical and procedural interventions require additional detail for readers to have a complete, clear, transparent and reproducible understanding. The objective of this research is to conduct a Delphi consensus exercise to develop the STROCSS guideline (Strengthening the Reporting of Cohort Studies in Surgery).Methods and analysisCurrent guidelines for case series (PROCESS), Cohort Studies (STROBE) and randomised controlled trials (CONSORT) will be analysed to compile items to form baseline material for developing cohort guidelines in the Delphi consensus exercise. The Delphi questionnaire will be administered via Google Forms and conducted using standard Delphi Methodology. Surgeons and individuals with significant experience of reviewing cohort studies as well as those with experience in developing reporting guidelines will be invited to participate. In the first round, existing items from PROCESS and STROBE will be put forward and participants will be invited to augment them or contribute further items for consideration. The provisional guidelines will then be updated in successive rounds using the nine-point Likert scale as proposed by the Grading Recommendations, Assessment, Development, and Evaluations (GRADE) working group. This process will be used to agree Standard definitions for the outcomes.DisseminationThe work will be published in a peer-reviewed journal and presented at national and international meetings. Findings will be disseminated to interested parties, and journals will be encouraged to endorse the reporting guidelines.

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

Project description:IntroductionDe novo (new) guideline development methods are well described and supported by numerous examples, including comprehensive checklists. However, alternative guideline development methods, which draw from existing up to date, high quality clinical practice guidelines instead of re-inventing the wheel, have not been adopted so readily, despite the potential efficiencies of such methods compared to de novo development. In Africa, guideline quality and rigour of development, especially for prehospital care, remains poor. This paper firstly describes the opinions of international guideline experts on the African Federation for Emergency Medicine guideline project, and secondly updates a framework for South African prehospital guideline development.MethodsWe conducted a qualitative study of expert reviews of an evidence-based guideline development project led by the African Federation for Emergency Medicine in 2016 for prehospital care in South Africa. We purposefully sampled key international and regional guideline experts from a range of organisations. Comments and voice memos, following a terms of reference guide, were thematically analysed through manual coding.ResultsA total of seven experts gave feedback. Key themes revolved around existing international clinical practice guidelines not being enough to cover context specific evidence, blurring of guideline responsibilities and output, and transparency of guideline decisions and conflicts of interest. We showcase three fit-for-purpose guideline development approaches and provide an updated alternative guideline development roadmap for low-resource settings.ConclusionIn order to create clinical practice guidelines that clinicians trust and use on a daily basis to change lives, guideline developers need rigorous yet pragmatic approaches that are responsive to end-user needs. Reflecting on the African Federation for Emergency Medicine prehospital guideline development project in 2016, this paper presents key guiding themes to strengthen guideline development in low- and middle-income countries and other low-resource settings and provides an updated hybrid guideline development approach.

Project description:IntroductionStandards for Reporting of Diagnostic Accuracy Study (STARD) was developed to improve the completeness and transparency of reporting in studies investigating diagnostic test accuracy. However, its current form, STARD 2015 does not address the issues and challenges raised by artificial intelligence (AI)-centred interventions. As such, we propose an AI-specific version of the STARD checklist (STARD-AI), which focuses on the reporting of AI diagnostic test accuracy studies. This paper describes the methods that will be used to develop STARD-AI.Methods and analysisThe development of the STARD-AI checklist can be distilled into six stages. (1) A project organisation phase has been undertaken, during which a Project Team and a Steering Committee were established; (2) An item generation process has been completed following a literature review, a patient and public involvement and engagement exercise and an online scoping survey of international experts; (3) A three-round modified Delphi consensus methodology is underway, which will culminate in a teleconference consensus meeting of experts; (4) Thereafter, the Project Team will draft the initial STARD-AI checklist and the accompanying documents; (5) A piloting phase among expert users will be undertaken to identify items which are either unclear or missing. This process, consisting of surveys and semistructured interviews, will contribute towards the explanation and elaboration document and (6) On finalisation of the manuscripts, the group's efforts turn towards an organised dissemination and implementation strategy to maximise end-user adoption.Ethics and disseminationEthical approval has been granted by the Joint Research Compliance Office at Imperial College London (reference number: 19IC5679). A dissemination strategy will be aimed towards five groups of stakeholders: (1) academia, (2) policy, (3) guidelines and regulation, (4) industry and (5) public and non-specific stakeholders. We anticipate that dissemination will take place in Q3 of 2021.

Dataset Information

Protocol for the development of the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline: checklist of items for reporting pharmacogenetic studies.

Introduction

Methods and analysis

Ethics and dissemination

Publications

Protocol for the development of the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline: checklist of items for reporting pharmacogenetic studies.

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