Development and evaluation of a patient decision aid for patients considering ongoing medical or surgical treatment options for ulcerative colitis using a mixed-methods approach: protocol for DISCUSS study

Abstract

IntroductionApproximately 20%–30% of patients with ulcerative colitis (UC) require surgery, the majority of these being elective due to chronic symptoms refractory to medical treatment. The decision for surgery is difficult and dependent on patient preferences. Current resources for patients considering surgery have been found not to meet minimum international standards. The overall aim of the ‘DISCUSS’ study is to develop and evaluate a new patient decision aid (PtDA) for patients considering surgery for UC created in line with international minimum standards.Methods and analysisThis is a prospective mixed-methods study of adults (18+ years) who are considering surgical intervention for UC across two regional centres in Yorkshire, UK. This study is in three stages. In stage 1 we will develop the PtDA and its content via systematic reviews and a patient questionnaire. In stage 2 we will assess the face validity of the PtDA using mixed-methods on key stakeholders using both semistructured interviews and questionnaires, following which the PtDA will be refined. In stage 3 we will assess the acceptability of using the PtDA in clinical practice. This will use a mixed-methods approach on clinicians and patients who are considering undergoing elective surgery. Questionnaires including the Preparation for Decision-Making Scale, a measure of anxiety and decisional conflict will be analysed at two timepoints using paired sample t-tests and CIs. Interviews with patients and clinicians will be analysed using thematic analysis.Ethics and disseminationResearch ethics approval from North East–Tyne & Wear South Research Ethics Committee (Ref: 19/NE/0073) and Health Research Authority approval (Ref: 257044) have been granted. Results will be published in open access peer-reviewed journals, presented in conferences and distributed through the Crohn’s and Colitis UK charity. External endorsement will be sought from the International Patient Decision Aid Standards Collaboration inventory of PtDAs.PROSPERO registration numberCRD42018115513, CRD42019126186, CRD42019125193.

Development of a Patient Decision Aid to Help People Living with Inflammatory Bowel Disease

“…17 In 2020, Baker and colleagues made a PDA in England to choose between medical or surgical treatment for patients with ulcerative colitis. 8 The importance of using PDAs for shared decision making in patients with IBD has reached such a level that today, not only PDAs are used to choose the appropriate treatment method but also it is emphasized that PDAs are used for the treatment of the complications of diseases such as perianal fistulas in patients with Crohn's disease. 18 Many of the developed PDAs have not been published, or they lack a full explanation of how they were developed.…”

“… 7 Shared decision-making is a process whereby clinicians share information about treatment options and probable outcomes with patients and empower them to make a decision based on their preferences. 8 , 9 Using PDA is one way to promote shared decision-making (SDM). PDA provides information about the decision, available treatment options, benefits and risks of each option, and ways to clarify patient values.…”

Editorial: shared decision‐making intervention in patients with Crohnʼs disease—a personalised, patient‐centred approach

“…Although a shared approach is recommended for the management of chronic conditions, few SDM tools are available for therapeutic decisions in patients with IBD, and SDM had not previously been used to treat patients with CD. 6,[8][9][10] Further, long-term randomised controlled trials and real-world studies involving a larger number of patients are needed to assess the impact of SDM on personalised treatment strategies based on risk patient stratification, and to evaluate the influence of this intervention on the natural history of CD. In addition, determining healthcare resource utilisation and cost-effectiveness of SDM in clinical practice may be of significant interest.…”

Editorial: time trends in colectomy rates for ulcerative colitis in England—mixed methods brings mixed messages? Authors' reply

“…Focusing on “colectomy‐free discharge” while relationships and jobs are lost and education is postponed is perhaps missing the wood for the trees 7,8 . Quality of life and decision‐making studies regarding UC surgery such as SOQCS and DISCUSS are welcome additions to the IBD research portfolio 9,10 . It seems as important as ever to work collaboratively across disciplines to provide appropriate medical salvage and timely surgery.…”