Top

Published in:

Open Access 01-12-2018 | Study protocol

Protocol for the development of a core outcome set for pelvic girdle pain, including methods for measuring the outcomes: the PGP-COS study

Authors: Francesca Wuytack, Annelie Gutke, Britt Stuge, Siv Mørkved, Christina Olsson, Hilde Stendal Robinson, Nina K. Vøllestad, Birgitta Öberg, Lena Nilsson Wikmar, Juan Jose Saldaña Mena, Valerie Smith

Published in: BMC Medical Research Methodology | Issue 1/2018

Abstract

Background

Pelvic Girdle Pain (PGP) is an important cause of disability and economic cost worldwide. There is a need for effective preventative and management strategies. Emerging studies measure a variety of outcomes rendering synthesis and translation to clinical practice difficult. A Core Outcome Set (COS) can address this problem by ensuring that data are relevant, useful and usable for making well-informed healthcare choices. The aim of this study is to develop a consensus-based PGP-COS, including agreement on methods (e.g. instruments) for measuring the construct outcomes in the COS for use in research and clinical practice. Furthermore, as there is uncertainty as to whether incorporating stakeholder interviews in addition to conducting a systematic review to determine an initial list of outcomes for the Delphi survey, or, whether using different rating scales in a Delphi survey impacts on the final COS, we propose to embed two methodological studies within the PGP-COS development process to address these questions.

Methods

The PGP-COS study will include five phases: (1) A systematic review of the literature and semi-structured interviews with 15 patients (three countries) to form the initial list of outcomes for the Delphi survey; (2) A 3-round Delphi including patients, clinicians, researchers and service providers; (3) A systematic review of methods for measuring the outcomes in the preliminary PGP-COS identified in the Delphi survey; (4) A face-to-face consensus meeting to agree on the final PGP-COS and methods for measuring the COS; (5) Global dissemination.

To address the methodological questions, we will assess the number and type of outcomes, in the final PGP-COS, that were exclusively derived from the interviews. Secondly, we will randomise Delphi survey participants to either a 5-point or 9-point importance rating scale, and examine potential differences in ‘important’ ratings between the groups.

Discussion

There is currently no COS for measuring/monitoring PGP in trials and clinical practice. A PGP-COS will ensure that relevant outcomes are measured using appropriate measurement instruments for patients with PGP globally.

Core outcome set registration

This PGP-COS was registered with COMET (Core Outcome Measures for Effectiveness Trials) in January 2017 (http://www.comet-initiative.org/studies/details/958).

Available only for authorised users

Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet (London, England). 2012;380(9859):2163–96.CrossRef

Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet (London, England). 2012;380(9859):2197–223.CrossRef

Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008;17(6):794–819.CrossRefPubMedPubMedCentral

Robinson HS, Mengshoel AM, Bjelland EK, Vollestad NK. Pelvic girdle pain, clinical tests and disability in late pregnancy. Man Ther. 2010;15(3):280–5.CrossRefPubMed

Gutke A, Ostgaard HC, Oberg B. Pelvic girdle pain and lumbar pain in pregnancy: a cohort study of the consequences in terms of health and functioning. Spine. 2006;31(5):E149–55.CrossRefPubMed

Albert H, Godskesen M, Westergaard J. Prognosis in four syndromes of pregnancy-related pelvic pain. Acta Obstet Gynecol Scand. 2001;80(6):505–10.CrossRefPubMed

Malmqvist S, Kjaermann I, Andersen K, Okland I, Larsen JP, Bronnick K. The association between pelvic girdle pain and sick leave during pregnancy; a retrospective study of a Norwegian population. BMC Pregnancy Childbirth. 2015;15:237.CrossRefPubMedPubMedCentral

Dorheim SK, Bjorvatn B, Eberhard-Gran M. Sick leave during pregnancy: a longitudinal study of rates and risk factors in a Norwegian population. BJOG. 2013;120(5):521–30.CrossRefPubMed

Mogren I. Perceived health, sick leave, psychosocial situation, and sexual life in women with low-back pain and pelvic pain during pregnancy. Acta Obstet Gynecol Scand. 2006;85(6):647–56.CrossRefPubMed

10.

Liddle SD, Pennick V. Interventions for preventing and treating low-back and pelvic pain during pregnancy. Cochrane Database Syst Rev. 2015;9:CD001139.

11.

Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132.CrossRefPubMedPubMedCentral

12.

Chiarotto A, Ra D, Terwee CB, Boers M, Buchbinder R, Corbin TP, LOP C, et al. Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J. 2015;24(6):1127–42.CrossRefPubMed

13.

Grieve S, Rsgm P, Birklein F, Brunner F, Bruehl S, Harden RN, Packham T, et al. Recommendations for a first Core outcome measurement set for complex regional PAin syndrome clinical sTudies (COMPACT). Pain. 2017;158(6):1083–90.CrossRefPubMedPubMedCentral

14.

Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, et al. The COMET Handbook: version 1.0. Trials. 2017;18(Suppl 3):280.CrossRefPubMedPubMedCentral

15.

Prinsen CA, Vohra S, Rose MR, Boers M, Tugwell P, Clarke M, et al. How to select outcome measurement instruments for outcomes included in a "Core outcome set" - a practical guideline. Trials. 2016;17(1):449.CrossRefPubMedPubMedCentral

16.

Harman NL, Bruce IA, Callery P, Tierney S, Sharif MO, O’Brien K, et al. MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2013;14:70.CrossRefPubMedPubMedCentral

17.

Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d'Agostino MA, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol. 2014;67(7):745–53.CrossRefPubMed

18.

Sinha IP, Smyth RL, Williamson PR. 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. 2011;8(1):e1000393.CrossRefPubMedPubMedCentral

19.

Ostgaard HC, Zetherstrom G, Roos-Hansson E. The posterior pelvic pain provocation test in pregnant women. Eur Spine J. 1994;3(5):258–60.CrossRefPubMed

20.

Gutke A, Er H, Zetherstrom G, Ostgaard HC. Posterior pelvic pain provocation test is negative in patients with lumbar herniated discs. Eur Spine J. 2009;18(7):1008–12.CrossRefPubMedPubMedCentral

21.

Mens JM, Huis In’t Veld YH, Pool-Goudzwaard A. The active straight leg raise test in lumbopelvic pain during pregnancy. Man Ther. 2012;17(4):364–8.CrossRefPubMed

22.

Mens JM, Pool-Goudzwaard A, Beekmans RE, Tijhuis MT. Relation between subjective and objective scores on the active straight leg raising test. Spine. 2010;35(3):336–9.CrossRefPubMed

23.

Gargon E, Gurung B, Medley N, Altman DG, Blazeby JM, Clarke M, et al. Choosing important health outcomes for comparative effectiveness research: a systematic review. PLoS One. 2014;9(6):e99111.CrossRefPubMedPubMedCentral

24.

Smail-Faugeron V, Fron Chabouis H, Durieux P, Attal JP, Muller-Bolla M, Courson F. Development of a core set of outcomes for randomized controlled trials with multiple outcomes--example of pulp treatments of primary teeth for extensive decay in children. PLoS One. 2013;8(1):e51908.CrossRefPubMedPubMedCentral

25.

Taylor WJ, Schumacher HR Jr, Baraf HS, Chapman P, Stamp L, Doherty M, et al. A modified Delphi exercise to determine the extent of consensus with OMERACT outcome domains for studies of acute and chronic gout. Ann Rheum Dis. 2008;67(6):888–91.CrossRefPubMed

26.

Smith V. Personal communication related to an ongoing COS development project in maternity care; 2017.

27.

Health Research Board - Trial Methodology Research Network. [Available from: http://www.hrb-tmrn.ie.

28.

Terwee CB, Jansma EP, Riphagen II, de Vet HCW. Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments. Qual Life Res. 2009;18(8):1115–23.CrossRefPubMedPubMedCentral

29.

Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol D, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19.CrossRefPubMedPubMedCentral

30.

Smith VA-Ohoo, Daly D, Lundgren I, Eri T, Begley C, Gross MM, et al. Protocol for the development of a salutogenic intrapartum core outcome set (SIPCOS). (1471–2288 (Electronic)).

31.

Egan AM, Galjaard S, Maresh MJA, Loeken MR, Napoli A, Anastasiou E, et al. A core outcome set for studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes. Diabetologia. 2017;60(7):1190–6.CrossRefPubMedPubMedCentral

32.

Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D, et al. Core outcome set-STAndards for reporting: the COS-STAR statement. PLoS Med. 2016;13(10):e1002148.CrossRefPubMedPubMedCentral

33.

Lodico M, Spaulding D. Voegtle K. 2nd ed. San Francisco: Jossey-Bass; 2010.

34.

MacLennan S, Williamson PR, Bekema H, Campbell M, Ramsay C, N'Dow J, et al. A core outcome set for localised prostate cancer effectiveness trials. BJU Int. 2017;120(5b):E64–e79.CrossRefPubMed

35.

Chiarotto A, Terwee CB, Deyo RA, Boers M, Lin CW, Buchbinder R, et al. A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set. Trials. 2014;15:511.CrossRefPubMedPubMedCentral

36.

Dosenovic S, Jelicic Kadic A, Jeric M, Boric M, Markovic D, Vucic K, et al. Efficacy and Safety Outcome Domains and Outcome Measures in Systematic Reviews of Neuropathic Pain Conditions. Clin J. Pain. 34(7):674–84.

Title: Protocol for the development of a core outcome set for pelvic girdle pain, including methods for measuring the outcomes: the PGP-COS study
Authors: Francesca Wuytack
Annelie Gutke
Britt Stuge
Siv Mørkved
Christina Olsson
Hilde Stendal Robinson
Nina K. Vøllestad
Birgitta Öberg
Lena Nilsson Wikmar
Juan Jose Saldaña Mena
Valerie Smith
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: BMC Medical Research Methodology / Issue 1/2018
Electronic ISSN: 1471-2288
DOI: https://doi.org/10.1186/s12874-018-0624-5

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Protocol for the development of a core outcome set for pelvic girdle pain, including methods for measuring the outcomes: the PGP-COS study

Abstract

Background

Methods

Discussion

Core outcome set registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods

Discussion

Core outcome set registration

Please log in to get access to this content

Other articles of this Issue 1/2018

A new approach for sample size calculation in cost-effectiveness studies based on value of information

Validating the use of veterans affairs tobacco health factors for assessing change in smoking status: accuracy, availability, and approach

Retention strategies in longitudinal cohort studies: a systematic review and meta-analysis

Meta-analysis of binary outcomes via generalized linear mixed models: a simulation study

Evaluation of surrogate measures of insulin sensitivity - correlation with gold standard is not enough

The generation of consensus guidelines for carrying out process evaluations in rehabilitation research