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International Journal of Colorectal Disease
Published in: International Journal of Colorectal Disease 7/2017

Open Access 01-07-2017 | Clinical Study Protocol

Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study

Authors: R. R. van Tol, J. Melenhorst, C. D. Dirksen, L. P. S. Stassen, S. O. Breukink

Published in: International Journal of Colorectal Disease | Issue 7/2017

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Abstract

Purpose

Over the last decade, many studies were performed regarding treatment options for hemorrhoidal disease. Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes. However, the reported outcome measures are numerous and diverse. The heterogeneity of outcome definition in clinical trials limits transparency and paves the way for bias. The development of a core outcome set (COS) helps minimizing this problem. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease. The aim of this project is to generate a COS regarding the outcome of treatment after hemorrhoidal disease.

Methods

A Delphi study will be performed by an international steering group healthcare professionals and patients with the intention to create a standard outcome set for future clinical trials for the treatment of hemorrhoidal disease. First, a literature review will be conducted to establish which outcomes are used in clinical trials for hemorrhoidal disease. Secondly, both healthcare professionals and patients will participate in several consecutive rounds of online questionnaires and a face-to-face meeting to refine the content of the COS.

Discussion

Development of a COS for hemorrhoidal disease defines a minimum outcome-reporting standard and will improve the quality of research in the future.
Appendix
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Literature
1.
Loder PB, Kamm MA, Nicholls RJ, Phillips RK (1994) Haemorrhoids: pathology, pathophysiology and aetiology. Br J Surg 81(7):946–954CrossRefPubMed
2.
3.
Alonso-Coello P, Mills E, Heels-Ansdell D, Lopez-Yarto M, Zhou Q, Johanson JF et al (2006) Fiber for the treatment of hemorrhoids complications: a systematic review and meta-analysis. Am J Gastroenterol 101(1):181–188CrossRefPubMed
4.
Brown S, Tiernan J, Biggs K, Hind D, Shephard N, Bradburn M et al (2016) The HubBLe trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: a multicentre randomised controlled trial and health-economic evaluation. Health Technol Assess 20(88):1–150CrossRef
5.
Gaj F, Biviano I, Sportelli G, Candeloro L (2015) Rubber band ligation in treatment of hemorrhoids: our experience. Clin Ter 166(4):162–167PubMed
6.
Pakravan F, Helmes C, Baeten C (2009) Transanal open hemorrhoidopexy. Dis Colon rectum 52(3):503–506
7.
Corsale I, Rigutini M, Francioli N, Panicucci S, Mori PA, Aloise F (2014) Stapled anopexy and STARR in surgical treatment of haemorrhoidal disease. Updat Surg 66(3):217–222CrossRef
8.
Nisar PJ, Acheson AG, Neal KR, Scholefield JH (2004) Stapled hemorrhoidopexy compared with conventional hemorrhoidectomy: systematic review of randomized, controlled trials. Dis Colon rectum 47(11):1837–1845
9.
Faucheron JL, Poncet G, Voirin D, Badic B, Gangner Y (2011) Doppler-guided hemorrhoidal artery ligation and rectoanal repair (HAL-RAR) for the treatment of grade IV hemorrhoids: long-term results in 100 consecutive patients. Dis Colon rectum 54(2):226–231
10.
Hoyuela C, Carvajal F, Juvany M, Troyano D, Trias M, Martrat A et al (2016) HAL-RAR (Doppler guided haemorrhoid artery ligation with recto-anal repair) is a safe and effective procedure for haemorrhoids. Results of a prospective study after two-years follow-up. Int J Surg 28:39–44CrossRefPubMed
11.
Zagriadskii EA [Transanal Doppler-guided desarterization with mucopexy (HAL-RAR) for the treatment of hemorrhoids stage III-IV]. Khirurgiia (Mosk). 2013(4):59–64
12.
Shanmugam V, Thaha MA, Rabindranath KS, Campbell KL, Steele RJ, Loudon MA (2005) Systematic review of randomized trials comparing rubber band ligation with excisional haemorrhoidectomy. Br J Surg. 92(12):1481–1487CrossRefPubMed
13.
Watson AJ, Hudson J, Wood J, Kilonzo M, Brown SR, McDonald A et al (2016) Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial. Lancet 388(10058):2375–2385CrossRefPubMedPubMedCentral
14.
15.
Boonen A, Stucki G, Maksymowych W, Rat AC, Escorpizo R, Boers M et al (2009) The OMERACT-ICF reference group: integrating the ICF into the OMERACT process: opportunities and challenges. J Rheumatol 36(9):2057–2060
16.
Boers M, Brooks P, Strand CV, Tugwell P (1998) The OMERACT filter for outcome measures in rheumatology. J Rheumatol 25(2):198–199PubMed
17.
Prinsen CA, Vohra S, Rose MR, King-Jones S, Ishaque S, Bhaloo Z et al (2014) Core outcome measures in effectiveness trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’. Trials 15:247CrossRefPubMedPubMedCentral
18.
Steurer J (2011) The Delphi method: an efficient procedure to generate knowledge. Skelet Radiol 40(8):959–961CrossRef
19.
Sinha IP, Smyth RL, Williamson PR (2011) Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med 8(1):e1000393CrossRefPubMedPubMedCentral
20.
Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d'Agostino MA et al (2014) Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol 67(7):745–753CrossRefPubMed
21.
Ogden J, Lo J (2012) How meaningful are data from Likert scales? An evaluation of how ratings are made and the role of the response shift in the socially disadvantaged. J Health Psychol 17(3):350–361CrossRefPubMed
22.
van Laerhoven H, van der Zaag-Loonen HJ, Derkx BH (2004) A comparison of Likert scale and visual analogue scales as response options in children's questionnaires. Acta Paediatr 93(6):830–835CrossRefPubMed
23.
Schunemann HJ, Mustafa R, Brozek J, Santesso N, Alonso-Coello P, Guyatt G et al (2016) GRADE guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health. J Clin Epidemiol 76:89–98CrossRefPubMed
24.
Boulkedid R, Abdoul H, Loustau M, Sibony O, Alberti C (2011) Using and reporting the Delphi method for selecting healthcare quality indicators: a systematic review. PLoS One 6(6):e20476CrossRefPubMedPubMedCentral
Metadata
Title
Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study
Authors
R. R. van Tol
J. Melenhorst
C. D. Dirksen
L. P. S. Stassen
S. O. Breukink
Publication date
01-07-2017
Publisher
Springer Berlin Heidelberg
Published in
International Journal of Colorectal Disease / Issue 7/2017
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-017-2833-5

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