Development of a core outcome domain set for clinical research on capillary malformations (the COSCAM project)

Objective.While there has been substantial progress in the development of core outcomes sets, the degree to which these are used by researchers is variable. We convened a special workshop on knowledge translation at the Outcome Measures in Rheumatology (OMERACT) 2016 with 2 main goals. The first focused on the development of a formal knowledge translation framework and the second on promoting uptake of recommended core outcome domain and instrument sets.Methods.We invited all 189 OMERACT 2016 attendees to the workshop; 86 attended, representing patient research partners (n = 15), healthcare providers/clinician researchers (n = 52), industry (n = 4), regulatory agencies (n = 4), and OMERACT fellows (n = 11). Participants were given an introduction to knowledge translation and were asked to propose and discuss recommendations for the OMERACT community to (1) strengthen stakeholder involvement in the core outcome instrument set development process, and (2) promote uptake of core outcome sets with a specific focus on the potential role of post-regulatory decision makers.Results.We developed the novel “OMERACT integrated knowledge translation” framework, which formalizes OMERACT’s knowledge translation strategies. We produced strategies to improve stakeholder engagement throughout the process of core outcome set development and created a list of creative and innovative ways to promote the uptake of OMERACT’s core outcome sets.Conclusion.The guidance provided in this paper is preliminary and is based on the views of the participants. Future work will engage OMERACT groups, “post-regulatory decision makers,” and a broad range of different stakeholders to identify and evaluate the most useful methods and processes, and to revise guidance accordingly.

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Ensuring that the outcome domains proposed for use in burns research are relevant to adult burn patients: a systematic review of qualitative research evidence

Burns & Trauma ◽

10.1093/burnst/tkaa030 ◽

2020 ◽

Vol 8 ◽

Author(s):

Jonathan Mathers ◽

Naiem Moiemen ◽

Amy Bamford ◽

Fay Gardiner ◽

Joanne Tarver

Keyword(s):

Systematic Review ◽

Qualitative Research ◽

Cognitive Skills ◽

English Language ◽

Burn Injury ◽

Sense Of Self ◽

Length Of Hospital Stay ◽

Core Outcome ◽

Qualitative Synthesis ◽

Outcome Domain

Abstract Background There have been several attempts to define core outcome domains for use in research focused on adult burns. Some have been based in expert opinion, whilst others have used primary qualitative research to understand patients’ perspectives on outcomes. To date there has not been a systematic review of qualitative research in burns to identify a comprehensive list of patient-centred outcome domains. We therefore conducted a systematic review of qualitative research studies in adult burns. Methods We searched multiple databases for English-language, peer-reviewed, qualitative research papers. We used search strategies devised using the SPIDER tool for qualitative synthesis. Our review utilized an iterative three-step approach: (1) outcome-focused coding; (2) development of descriptive accounts of outcome-relevant issues; and (3) revisiting studies and the broader theoretical literature in order to frame the review findings. Results Forty-one articles were included. We categorized papers according to their primary focus. The category with the most papers was adaptation to life following burn injury (n = 13). We defined 19 outcome domains across the 41 articles: (1) sense of self; (2) emotional and psychological morbidity; (3) sensory; (4) scarring and scar characteristics; (5) impact on relationships; (6) mobility and range of joint motion; (7) work; (8) activities of daily living and self-care; (9) treatment burden; (10) engagement in activities; (11) wound healing and infection; (12) other physical manifestations; (13) financial impact; (14) impact on spouses and family members; (15) analgesia and side effects; (16) cognitive skills; (17) length of hospital stay; (18) access to healthcare; and (19) speech and communication. We suggest that sense of self is a core concern for patients that, to date, has not been clearly conceptualized in the burns outcome domain literature. Conclusions This outcome domain framework identifies domains that are not covered in previous attempts to outline core outcome domains for adult burn research. It does so with reference to existing theoretical perspectives from the sociology and psychology of medicine. We propose that this framework can be used as a basis to ensure that outcome assessment is patient-centred. Sense of self requires further consideration as a core outcome domain.

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Defining Symptom Concepts in Chronic Subjective Tinnitus: Web-Based Discussion Forum Study (Preprint)

10.2196/preprints.14446 ◽

2019 ◽

Author(s):

Alice Hibbert ◽

Markku Vesala ◽

Micky Kerr ◽

Kathryn Fackrell ◽

Stephen Harrison ◽

...

Keyword(s):

Health Care ◽

Discussion Forum ◽

Delphi Survey ◽

Core Outcome ◽

Plain Language ◽

Web Based ◽

Core Set ◽

Outcome Domain ◽

Health Concepts ◽

The Web

BACKGROUND A minimum standard based upon consensus decision making recommends a core set of tinnitus-specific health complaints (outcome domains) that should be assessed and reported in all clinical trials as this enables comparisons to be made across studies as well as data pooling for meta-analysis. OBJECTIVE This study aimed to further clarify how the outcome domain concepts should be defined for 5 of the core set: tinnitus intrusiveness, sense of control, acceptance of tinnitus, concentration, and ability to ignore. This step requires a clear and fully elaborated definition for each outcome domain, moving from an abstract or a vague concept to an operationalized and measurable health-related construct, so that a suitable measurement instrument can then be identified. METHODS A series of 5 focus group–style semistructured discussions were conducted via a Web-based discussion forum, each open for 2 weeks and ending with a vote. The participants included 148 tinnitus experts who completed a preceding e-Delphi survey that had generated the original set of minimum standards. The participants were health care users living with tinnitus, health care professionals, clinical researchers, commercial representatives, and funders. RESULTS The Web discussions led to a revision of all 5 original plain language definitions that had been used in the preceding e-Delphi survey. Each revised definition was voted by 8 to 53 participants and reached the prespecified threshold of 70% consensus for all except tinnitus intrusiveness. Although a single definition was not agreed upon for tinnitus intrusiveness, the majority of participants shared the view that the concept should be sufficiently broad to encapsulate a range of subdomains. The examples included tinnitus awareness, unpleasantness, and impact on different aspects of everyday life. Thematic analysis of the 5 Web-based discussion threads gave important insights into expert interpretations of each core outcome domain, generating an operationalized and measurable health construct in each case. CONCLUSIONS The qualitative data gathered during the Web-based discussion forum provided an important in-depth understanding of the health concepts that had raised a debate during earlier face-to-face meetings. The descriptive summaries and definitions provide sufficient operationalization of those concepts to proceed to the second stage of core outcome set development that is to identify and evaluate suitable measurement instruments. This study supports the use of Web-based peer discussion forums in defining health concepts.

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Defining Symptom Concepts in Chronic Subjective Tinnitus: Web-Based Discussion Forum Study

Interactive Journal of Medical Research ◽

10.2196/14446 ◽

2020 ◽

Vol 9 (1) ◽

pp. e14446

Author(s):

Alice Hibbert ◽

Markku Vesala ◽

Micky Kerr ◽

Kathryn Fackrell ◽

Stephen Harrison ◽

...

Keyword(s):

Health Care ◽

Discussion Forum ◽

Delphi Survey ◽

Core Outcome ◽

Plain Language ◽

Web Based ◽

Core Set ◽

Outcome Domain ◽

Health Concepts ◽

The Web

Background A minimum standard based upon consensus decision making recommends a core set of tinnitus-specific health complaints (outcome domains) that should be assessed and reported in all clinical trials as this enables comparisons to be made across studies as well as data pooling for meta-analysis. Objective This study aimed to further clarify how the outcome domain concepts should be defined for 5 of the core set: tinnitus intrusiveness, sense of control, acceptance of tinnitus, concentration, and ability to ignore. This step requires a clear and fully elaborated definition for each outcome domain, moving from an abstract or a vague concept to an operationalized and measurable health-related construct, so that a suitable measurement instrument can then be identified. Methods A series of 5 focus group–style semistructured discussions were conducted via a Web-based discussion forum, each open for 2 weeks and ending with a vote. The participants included 148 tinnitus experts who completed a preceding e-Delphi survey that had generated the original set of minimum standards. The participants were health care users living with tinnitus, health care professionals, clinical researchers, commercial representatives, and funders. Results The Web discussions led to a revision of all 5 original plain language definitions that had been used in the preceding e-Delphi survey. Each revised definition was voted by 8 to 53 participants and reached the prespecified threshold of 70% consensus for all except tinnitus intrusiveness. Although a single definition was not agreed upon for tinnitus intrusiveness, the majority of participants shared the view that the concept should be sufficiently broad to encapsulate a range of subdomains. The examples included tinnitus awareness, unpleasantness, and impact on different aspects of everyday life. Thematic analysis of the 5 Web-based discussion threads gave important insights into expert interpretations of each core outcome domain, generating an operationalized and measurable health construct in each case. Conclusions The qualitative data gathered during the Web-based discussion forum provided an important in-depth understanding of the health concepts that had raised a debate during earlier face-to-face meetings. The descriptive summaries and definitions provide sufficient operationalization of those concepts to proceed to the second stage of core outcome set development that is to identify and evaluate suitable measurement instruments. This study supports the use of Web-based peer discussion forums in defining health concepts.

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The outcomes of Perthes’ disease

The Bone & Joint Journal ◽

10.1302/0301-620x.102b5.bjj-2020-0072 ◽

2020 ◽

Vol 102-B (5) ◽

pp. 611-617

Author(s):

Donato G. Leo ◽

Helen Jones ◽

Rebecca Murphy ◽

Justin Wei Leong ◽

Tina Gambling ◽

...

Keyword(s):

Systematic Review ◽

Clinical Research ◽

Qualitative Interviews ◽

Core Outcome Set ◽

Consensus Meeting ◽

Delphi Survey ◽

Perthes Disease ◽

Core Outcome ◽

Outcome Set ◽

Life Impact

Aims To identify a suite of the key physical, emotional, and social outcomes to be employed in clinical practice and research concerning Perthes' disease in children. Methods The study follows the guidelines of the COMET-Initiative (Core Outcome Measures in Effectiveness Trials). A systematic review of the literature was performed to identify a list of outcomes reported in previous studies, which was supplemented by a qualitative study exploring the experiences of families affected by Perthes’ disease. Collectively, these outcomes formed the basis of a Delphi survey (two rounds), where 18 patients with Perthes’ disease, 46 parents, and 36 orthopaedic surgeons rated each outcome for importance. The International Perthes Study Group (IPSG) (Dallas, Texas, USA (October 2018)) discussed outcomes that failed to reach any consensus (either ‘in’ or ‘out’) before a final consensus meeting with representatives of surgeons, patients, and parents. Results In total, 23 different outcome domains were identified from the systematic review, and a further ten from qualitative interviews. After round one of the Delphi survey, participants suggested five further outcome domains. A total of 38 outcomes were scored in round two of the Delphi. Among these, 16 outcomes were scored over the prespecified 70% threshold for importance (divided into six main categories: adverse events; life impact; resource use; pathophysiological manifestations; death; and technical considerations). Following the final consensus meeting, 14 outcomes were included in the final Core Outcome Set (COS). Conclusion Core Outcome Sets (COSs) are important to improve standardization of outcomes in clinical research and to aid communication between patients, clinicians, and funding bodies. The results of this study should be a catalyst to develop high-quality clinical research in order to determine the optimal treatments for children with Perthes’ disease. Cite this article: Bone Joint J 2020;102-B(5):611–617.

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