Core Outcome Measures in Effectiveness Trials

European Society of Coloproctology (ESCP) Core Outcome Set (COS) for haemorrhoidal disease: An international Delphi Study among healthcare professionals.

General Information

Abstract:
AIM: There is considerable heterogeneity in outcomes in studies reporting on treatment of haemorrhoidal disease (HD). The aim of this study was to develop a Core Outcome Set (COS) for HD in cooperation with the European Society of Coloproctology (ESCP).

METHOD: A Delphi study was performed according to the OMERACT methodology. In total 38 healthcare professionals and 30 patients were invited to the panel. Previously, 10 outcome Domains and 59 Outcomes were identified through a systematic literature review. In this study these Domains and Outcomes were created into one questionnaire for healthcare professionals and a separate questionnaire for patients. Sequential questionnaire rounds prioritizing the Domains and Outcomes were conducted. Panel members were asked to rate the appropriateness of each Domain and Outcome on a 9-point Likert scale. During a face-to-face meeting, healthcare professionals agreed on the primary and secondary endpoints of the COS for HD. Finally, a short survey was sent to the healthcare professionals in order to reach consensus on how the chosen endpoints should be assessed and at which time points.

RESULTS: The response rate in questionnaire round 1 for healthcare professionals was 44.7% (n=17). Sixteen out of seventeen healthcare professionals also completed the questionnaire in round 2. The response rate for the patient questionnaire was 60% (n=18). Seventeen healthcare professionals participated in the face-to-face meeting. The questionnaire rounds did not result in a clear-cut selection of primary and secondary endpoints. Most Domains and Outcomes were considered important and only three Outcomes were excluded. During the face-to-face meeting, agreement was reached to select the Domain 'symptoms' as primary endpoints, and 'complications', 'recurrence' and 'patient satisfaction' as secondary endpoints in the COS for HD. Furthermore, consensus was reached that the Domain 'symptoms' should be a Patient Reported Outcome Measure and include the Outcomes 'pain' and 'prolapse', 'itching', 'soiling' and 'blood loss'. The Domain 'complications' should include the Outcomes 'incontinence', 'abscess', 'urinary retention', 'anal stenosis' and 'fistula'. Consensus was reached to use 'reappearance of initial symptoms' as reported by the patient to define recurrence. During an additional short survey, consensus was reached that 'incontinence' should be assessed by the Wexner Fecal Incontinence Score, 'abscess' by physical examination, 'urinary retention' by ultrasonography, 'anal stenosis' by physical examination, and 'fistula' by physical examination and MR imaging if inconclusive. During follow-up, the Outcome 'symptoms' should be assessed at baseline, 7 days, 6 weeks and one year post-procedure. The Outcomes 'abscess' and 'urinary retention' should be assessed 7 days post-procedure and 'incontinence', 'anal stenosis' and 'fistula' one year post-procedure.

CONCLUSIONS: We developed the first European Society of Coloproctology (ESCP) Core Outcome Set for haemorrhoidal disease based on an international Delphi study among healthcare professionals. The next step is to incorporate the patients' perspective in the COS. Use of this COS may improve the quality and uniformity of future research and enhance the analysis of evidence. This article is protected by copyright. All rights reserved.

Authors:
van Tol RR, Kimman ML, Melenhorst J, Stassen LPS, Dirksen CD, Breukink SO; Members of the steering group are co-authors of this study and can be found under the heading Collaborators.

Publication

Journal:
Colorectal Disease
Volume:
Issue:
Pages:
-
Year:
2019
DOI:
Further Study Information

Date:
December 2014 - June 2016
Funding source(s):

Health Area

Disease Category
Gastroenterology

Disease Name
Haemorrhoids

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Consensus meeting
Delphi process
Systematic review

A Delphi study was performed according to the OMERACT methodology. In total 38 healthcare professionals and 30 patients were invited to the panel. Previously, 10 outcome Domains and 59 Outcomes were identified through a systematic literature review. In this study these Domains and Outcomes were created into one questionnaire for healthcare professionals and a separate questionnaire for patients. Sequential questionnaire rounds prioritizing the Domains and Outcomes were conducted. Panel members were asked to rate the appropriateness of each Domain and Outcome on a 9-point Likert scale. During a face-to-face meeting, healthcare professionals agreed on the primary and secondary endpoints of the COS for HD. Finally, a short survey was sent to the healthcare professionals in order to reach consensus on how the chosen endpoints should be assessed and at which time points.


Stakeholders Involved

Clinical experts
Consumers (patients)

Study Type

COS for clinical trials or clinical research

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