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Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study.

ABSTRACT: OBJECTIVE:To improve the quality and consistency of intervention development reporting in health research. DESIGN:This was a consensus exercise consisting of two simultaneous and identical three-round e-Delphi studies (one with experts in intervention development and one with wider stakeholders including funders, journal editors and public involvement members), followed by a consensus workshop. Delphi items were systematically derived from two preceding systematic reviews and a qualitative interview study. PARTICIPANTS:Intervention developers (n=26) and wider stakeholders (n=18) from the UK, North America and Europe participated in separate e-Delphi studies. Intervention developers (n=13) and wider stakeholders (n=13) participated in a 1-day consensus workshop. RESULTS:e-Delphi participants achieved consensus on 15 reporting items. Following feedback from the consensus meeting, the final inclusion and wording of 14 items with description and explanations for each item were agreed. Items focus on context, purpose, target population, approaches, evidence, theory, guiding principles, stakeholder contribution, changes in content or format during the development process, required changes for subgroups, continuing uncertainties, and open access publication. They form the GUIDED (GUIDance for the rEporting of intervention Development) checklist, which contains a description and explanation of each item, alongside examples of good reporting. CONCLUSIONS:Consensus-based reporting guidance for intervention development in health research is now available for publishers and researchers to use. GUIDED has the potential to lead to greater transparency, and enhance quality and improve learning about intervention development research and practice.

SUBMITTER: Duncan E

PROVIDER: S-EPMC7245409 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study.

Duncan Edward E O'Cathain Alicia A Rousseau Nikki N Croot Liz L Sworn Katie K Turner Katrina M KM Yardley Lucy L Hoddinott Pat P

BMJ open 20200408 4

<h4>Objective</h4>To improve the quality and consistency of intervention development reporting in health research.<h4>Design</h4>This was a consensus exercise consisting of two simultaneous and identical three-round e-Delphi studies (one with experts in intervention development and one with wider stakeholders including funders, journal editors and public involvement members), followed by a consensus workshop. Delphi items were systematically derived from two preceding systematic reviews and a qu ...[more]

PMID: 32273313

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Project description:IntroductionMethodological studies (ie, studies that evaluate the design, conduct, analysis or reporting of other studies in health research) address various facets of health research including, for instance, data collection techniques, differences in approaches to analyses, reporting quality, adherence to guidelines or publication bias. As a result, methodological studies can help to identify knowledge gaps in the methodology of health research and strategies for improvement in research practices. Differences in methodological study names and a lack of reporting guidance contribute to lack of comparability across studies and difficulties in identifying relevant previous methodological studies. This paper outlines the methods we will use to develop an evidence-based tool-the MethodologIcal STudy reportIng Checklist-to harmonise naming conventions and improve the reporting of methodological studies.Methods and analysisWe will search for methodological studies in the Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Embase, MEDLINE, Web of Science, check reference lists and contact experts in the field. We will extract and summarise data on the study names, design and reporting features of the included methodological studies. Consensus on study terms and recommended reporting items will be achieved via video conference meetings with a panel of experts including researchers who have published methodological studies.Ethics and disseminationThe consensus study has been exempt from ethics review by the Hamilton Integrated Research Ethics Board. The results of the review and the reporting guideline will be disseminated in stakeholder meetings, conferences, peer-reviewed publications, in requests to journal editors (to endorse or make the guideline a requirement for authors), and on the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and reporting guideline websites.RegistrationWe have registered the development of the reporting guideline with the EQUATOR Network and publicly posted this project on the Open Science Framework (www.osf.io/9hgbq).

Project description:ObjectivesPeople with progressive multiple sclerosis (PwPMS) report that they recognise the benefits of activity on their physical and psychological health but need support to achieve their physical activity goals. We aimed to systematically develop a theoretically informed intervention that would enable PwPMS to more readily engage in regular physical activity.DesignWe used an intervention mapping approach to inform intervention development.SettingWe conducted semistructured interviews with PwPMS and their families/carers and physiotherapists recruited from secondary care settings.ParticipantsFourteen PwPMS with an Expanded Disability Status Scale score of between 6 and 8 and 7 of their families/carers and 13 physiotherapists and 1 physiotherapy technician participated.ResultsInterview data suggested that the development of supportive coaching relationships with physiotherapists could promote the ability of PwPMS to achieve a desirable and achievable physical activity plan. These interview data informed the prototype 'Lifestyle Exercise and Activity Package for Multiple Sclerosis' (LEAP-MS) consisting of a secure multiuser web-based platform (with an education and activity suite, interactive components enabling selection of exercises, goal setting and activity logging), up to six flexible face-to-face or web-based physiotherapy coaching sessions and remote support via an embedded web-based messaging function that all together draw on specific theory-based methods to achieve physical activity behaviour change, namely active learning, reinforcement, modelling, feedback, facilitation, goal setting and guided practice. Implementation is within a multiuser platform accessible to participants, trained physiotherapists and researchers.ConclusionsWe have followed an inclusive, systematic and transparent process to develop the LEAP-MS intervention that enables detailed description of components, context and guiding principles to inform ongoing evaluation. Importantly, PwPMS expressed the need for autonomy in developing physical activity plans. This has been achieved through the embedding of self-management principles in the design and delivery of the LEAP-MS intervention.

Project description:Built environment (BE) data in geographic information system (GIS) format are increasingly available from public agencies and private providers. These data can provide objective, low-cost BE data over large regions and are often used in public health research and surveillance. Yet challenges exist in repurposing GIS data for health research. The GIS data do not always capture desired constructs; the data can be of varying quality and completeness; and the data definitions, structures, and spatial representations are often inconsistent across sources. Using the Small Town Walkability study as an illustration, we describe (a) the range of BE characteristics measurable in a GIS that may be associated with active living, (b) the availability of these data across nine U.S. small towns, (c) inconsistencies in the GIS BE data that were available, and (d) strategies for developing accurate, complete, and consistent GIS BE data appropriate for research. Based on a conceptual framework and existing literature, objectively measurable characteristics of the BE potentially related to active living were classified under nine domains: generalized land uses, morphology, density, destinations, transportation system, traffic conditions, neighborhood behavioral conditions, economic environment, and regional location. At least some secondary GIS data were available across all nine towns for seven of the nine BE domains. Data representing high-resolution or behavioral aspects of the BE were often not available. Available GIS BE data - especially tax parcel data - often contained varying attributes and levels of detail across sources. When GIS BE data were available from multiple sources, the accuracy, completeness, and consistency of the data could be reasonable ensured for use in research. But this required careful attention to the definition and spatial representation of the BE characteristic of interest. Manipulation of the secondary source data was often required, which was facilitated through protocols.

Project description:ObjectiveRoutinely collected health data, collected for administrative and clinical purposes, without specific a priori research questions, are increasingly used for observational, comparative effectiveness, health services research, and clinical trials. The rapid evolution and availability of routinely collected data for research has brought to light specific issues not addressed by existing reporting guidelines. The aim of the present project was to determine the priorities of stakeholders in order to guide the development of the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement.MethodsTwo modified electronic Delphi surveys were sent to stakeholders. The first determined themes deemed important to include in the RECORD statement, and was analyzed using qualitative methods. The second determined quantitative prioritization of the themes based on categorization of manuscript headings. The surveys were followed by a meeting of RECORD working committee, and re-engagement with stakeholders via an online commentary period.ResultsThe qualitative survey (76 responses of 123 surveys sent) generated 10 overarching themes and 13 themes derived from existing STROBE categories. Highest-rated overall items for inclusion were: Disease/exposure identification algorithms; Characteristics of the population included in databases; and Characteristics of the data. In the quantitative survey (71 responses of 135 sent), the importance assigned to each of the compiled themes varied depending on the manuscript section to which they were assigned. Following the working committee meeting, online ranking by stakeholders provided feedback and resulted in revision of the final checklist.ConclusionsThe RECORD statement incorporated the suggestions provided by a large, diverse group of stakeholders to create a reporting checklist specific to observational research using routinely collected health data. Our findings point to unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues.

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Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study.

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Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study.

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