European Society of Coloproctology Core Outcome Set for haemorrhoidal disease: an international Delphi study among healthcare professionals

Tol, R. R. van; Kimman, Merel; Melenhorst, Jarno; Stassen, Laurents P. S.; Dirksen, Carmen D.; Breukink, Stéphanie O.

doi:10.1111/codi.14553

Cited by 35 publications

(24 citation statements)

References 33 publications

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“…In addition, the lack of uniform outcome, measurement and reporting in HD research data hampers the ability to compare studies and the creation of optimal treatment guidelines . A Core Outcome Set was recently developed in cooperation with the ESCP .…”

Section: Discussionmentioning

confidence: 99%

European Society of ColoProctology: guideline for haemorrhoidal disease

et al. 2020

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Aim The goal of this European Society of ColoProctology project was to establish a multidisciplinary, international guideline for haemorrhoidal disease (HD) and to provide guidance on the most effective (surgical) treatment for patients with HD. Methods The development process consisted of six phases. In phase one we defined the scope of the guideline. The patient population included patients with all stages of haemorrhoids. The target group for the guideline was all practitioners treating patients with haemorrhoids and, in addition, healthcare workers and patients who desired information regarding the treatment management of HD. The guideline needed to address both the diagnosis of and the therapeutic modalities for HD. Phase two consisted of the compilation of the guideline development group (GDG). All clinical members needed to have affinity with the diagnosis and treatment of haemorrhoids. Further, attention was paid to the geographical distribution of the clinicians. Each GDG member identified at least one patient in their country who could read English to comment on the draft guideline. In phase three review questions were formulated, using a reversed process, starting with possible recommendations based on the GDG’s knowledge. In phase four a literature search was performed in MEDLINE (Ovid), PubMed, Embase (Ovid) and the Cochrane Database of Systematic Reviews. The search was focused on existing systematic reviews addressing each review question, supplemented by other studies published after the time frame covered by the systematic reviews. In phase five data of the included papers were extracted by the surgical resident (RT) and checked by the methodologist (JK) and the GDG. If needed, meta‐analysis of the systematic reviews was updated by the surgical resident and the methodologist using Review Manager. During phase six the GDG members decided what recommendations could be made based on the evidence found in the literature using GRADE. Results There were six sections: (i) symptoms, diagnosis and classification; (ii) basic treatment; (iii) outpatient procedures; (iv) surgical interventions; (v) special situations; (vi) other surgical techniques. Thirty‐four recommendations were formulated. Conclusion This international, multidisciplinary guideline provides an up to date and evidence based summary of the current knowledge of the management of HD and may serve as a useful guide for patients and clinicians.

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Section: Discussionmentioning

confidence: 99%

European Society of ColoProctology: guideline for haemorrhoidal disease

et al. 2020

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“…The recent development of a core outcome set in evaluation of haemorrhoids by van Tol et al . [24] recommended that symptom outcomes should include domains of pain, itching, soiling and blood loss. The development of the outcome set included a content validity study which established relevance and comprehensiveness through both patient and expert feedback.…”

Section: Discussionmentioning

confidence: 99%

Symptom‐based scoring for haemorrhoidal disease: a systematic review

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Aim Haemorrhoidal disease can severely affect a patient's quality of life. Its classification is commonly based on morphology of the degree of prolapse; however, this does not take into account the symptoms and impact on the quality of life. The aim of this systematic review was to determine the most appropriate instruments that classify the severity of disease according to symptoms. Method A PRISMA-compliant search was conducted in December 2019 to identify studies that described the validation of a haemorrhoidal symptom score. The measurement properties of the scoring systems were assessed based on the consensus-based standards for the selection of health status measurement instruments (COSMIN) methodology for systematic reviews for patient-reported outcome measures. Results A total of 5288 articles were identified, with five articles included. Three studies developed a scoring system based on a set of core symptoms for a cohort of patients and validated the score against treatment outcomes. One study developed a disease-specific quality of life questionnaire based on symptoms to evaluate disease burden. One study combined both quality of life and symptom measures and tested measurement properties on two cohorts of patients. Only one study demonstrated satisfactory valid, reliable and responsive measurement criteria. Conclusion A single study demonstrated sufficient quality in measurement properties to be recommended for clinical use. Further studies in this area should utilize consensus-based standards for designing and reporting validation research to ensure that the appropriate evidence base is acquired if any further patient-reported outcome measures are to be recommended.

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“…The outcome measurements we chose based on the Core Outcome Set for hemorrhoid disease developed by Breukink and colleagues and the European Society of Coloproctology may improve the quality of our research and enhance the analysis of evidence. 7 A previous research indicated that the physical appearance of the postoperative anal cushions and patients' symptoms are poorly correlated, meaning anorectal visualization is not a reliable surrogate of success. 26 Our clinical experience and principal management for hemorrhoids shows that there is no need to review colonoscopy within half a year after CAES treatment.…”

Section: Discussionmentioning

confidence: 99%

“…1,5,6 However, clinical trials investigating the effectiveness of treatments for internal hemorrhoids lack uniformity of outcome measurement, which resulted in a wide variety in outcomes between studies and a debate regarding the best treatment option for each grade of internal hemorrhoids. 7…”

Section: Introductionmentioning

confidence: 99%

Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial

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et al. 2020

Clin Med Insights Gastroenterol

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Background: Cap-assisted endoscopic sclerotherapy is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. The proper length of the endoscopic injection needle is the core for performing cap-assisted endoscopic sclerotherapy well with more benefits and less complications. However, no data are currently available to guide endoscopists to consider the length of injection needle before cap-assisted endoscopic sclerotherapy. This study is designed to evaluate the efficacy and safety of cap-assisted endoscopic sclerotherapy with long or short injection needle in the treatment of internal hemorrhoids. Methods: This is a nationwide multi-center, prospective, single-blind and randomized controlled trial. Patients with grade I-II internal hemorrhoids who have failed to conservative treatments and grade III internal hemorrhoids who are not suitable for surgery or refuse surgery will be included. Participants will be randomized 1:1 into either long or short injection needle group. The primary outcome is the recurrence rate of internal hemorrhoids 24 weeks after cap-assisted endoscopic sclerotherapy. The secondary outcomes are as follows: (1) symptom severity score, (2) three-level EuroQoL five dimensions health scale scores, (3) occurrence of adverse events and severe adverse events, and (4) patients’ attitudes toward cap-assisted endoscopic sclerotherapy. Data collection will be conducted before and during operation, the 1st day, 1st week, 2nd week, and 24th week after cap-assisted endoscopic sclerotherapy. Discussion: The outcome of this study is expected to provide a practical clinical protocol of cap-assisted endoscopic sclerotherapy for patients with internal hemorrhoids and promote the use of this new endoscopic technique. Trial registration: ClinicalTrials.gov, NCT03917056. Registered on 12 April 2019.

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European Society of Coloproctology Core Outcome Set for haemorrhoidal disease: an international Delphi study among healthcare professionals

Abstract: Aim There is considerable heterogeneity in outcomes in studies reporting on the 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.

Cited by 35 publications

References 33 publications

European Society of ColoProctology: guideline for haemorrhoidal disease

European Society of ColoProctology: guideline for haemorrhoidal disease

Symptom‐based scoring for haemorrhoidal disease: a systematic review

Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial

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