Cauda Equina Syndrome Core Outcome Set (CESCOS): An international patient and healthcare professional consensus for research studies

English version

Autoři: Nisaharan Srikandarajah ^aff001; Adam Noble ^aff002; Simon Clark ^aff003; Martin Wilby ^aff003; Brian J. C. Freeman ^aff004; Michael G. Fehlings ^aff005; Paula R. Williamson ^aff006; Tony Marson ^aff001
Působiště autorů: Institute of Translational Medicine, University of Liverpool, Liverpool, Merseyside, United Kingdom ^aff001; Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Liverpool, Merseyside, United Kingdom ^aff002; Department of Spinal Surgery, The Walton Centre NHS Foundation Trust, Liverpool, Merseyside, United Kingdom ^aff003; Department of Spinal Surgery, Royal Adelaide Hospital, University of Adelaide, Adelaide, Australia ^aff004; Division of Neurosurgery and Spine Program, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada ^aff005; MRC North West Hub for Trials Methodology Research, Institute of Translational Medicine, University of Liverpool, Liverpool, Merseyside, United Kingdom ^aff006
Vyšlo v časopise: PLoS ONE 15(1)
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pone.0225907

Souhrn

Background

Cauda Equina Syndrome (CES) is an emergency condition that requires acute intervention and can lead to permanent neurological deficit in working age adults. A Core Outcome Set (COS) is the minimum set of outcomes that should be reported by a research study within a specific disease area. There is significant heterogeneity in outcome reporting for CES, which does not allow data synthesis between studies. The hypothesis is that a COS for CES can be developed for future research studies using patients and healthcare professionals (HCPs) as key stakeholders.

Methods and findings

Qualitative semi-structured interviews with CES patients were audio-recorded, transcribed and analysed using NVivo to identify the outcomes of importance. These were combined with the outcomes obtained from a published systematic literature review of CES patients. The outcomes were grouped into a list of 37, for rating through two rounds of an international Delphi survey according to pre-set criteria. The Delphi survey had an overall response rate of 63% and included 172 participants (104 patients, 68 HCPs) from 14 countries who completed both rounds. Thirteen outcomes reached consensus at the end of the Delphi survey and there was no attrition bias detected. The results were discussed at an international consensus meeting attended by 34 key stakeholders (16 patients and 18 HCPs) from 8 countries. A further three outcomes were agreed to be included. There was no selection bias detected at the consensus meeting. There are 16 outcomes in total in the CESCOS.

Discussion

This is the first study in the literature that has determined the core outcomes in CES using a transparent international consensus process involving healthcare professionals and CES patients as key stakeholders. This COS is recommended as the most important outcomes to be reported in any research study investigating CES outcomes and will allow evidence synthesis in CES.

Klíčová slova:

Lower back pain – Quality of life – Emotions – Sensory perception – Bladder – Myalgia – Pain sensation – Echinococcosis

Zdroje

1. Germon T, Ahuja S, Casey AT, Todd NV, Rai A. British Association of Spine Surgeons standards of care for cauda equina syndrome. Spine J. 2015;15(3 Suppl):S2–4. doi: 10.1016/j.spinee.2015.01.006 25708139.

2. Kostuik JP. Controversies in cauda equina syndrome and lumbar disk herniation. Current Opinion in Orthopaedics. 1993;4(2):125–8.

3. Gardner A, Gardner E, Morley T. Cauda equina syndrome: A review of the current clinical and medico-legal position. Eur Spine J. 2011;20(5):690–7. doi: 10.1007/s00586-010-1668-3 21193933.

4. Gitelman A, Hishmeh S, Morelli BN, Joseph SA Jr, Casden A, Kuflik P, et al. Cauda equina syndrome: a comprehensive review. Am J Orthop (Belle Mead NJ). 2008;37(11):556–62.

5. Gleave JR, Macfarlane R. Cauda equina syndrome: what is the relationship between timing of surgery and outcome? Br J Neurosurg. 2002;16(4):325–8. doi: 10.1080/0268869021000032887 12389883.

6. Srikandarajah N, Boissaud-Cooke MA, Clark S, Wilby MJ. Does early surgical decompression in cauda equina syndrome improve bladder outcome? Spine (03622436). 2015;40(8):580–3. doi: 10.1097/BRS.0000000000000813 109721571. Language: English. Entry Date: 20150923. Revision Date: 20160228. Publication Type: journal article. Journal Subset: Allied Health.

7. Daniels EW, Gordon Z, French K, Ahn UM, Ahn NU. Review of medicolegal cases for cauda equina syndrome: what factors lead to an adverse outcome for the provider? Orthopedics. 2012;35(3):200–. doi: 10.3928/01477447-20120222-15 104482517. Language: English. Entry Date: 20120803. Revision Date: 20170411. Publication Type: journal article.

8. Korse NS, Jacobs WC, Elzevier HW, Vleggeert-Lankamp CL. Complaints of micturition, defecation and sexual function in cauda equina syndrome due to lumbar disk herniation: a systematic review. Eur Spine J. 2013;22(5):1019–29. doi: 10.1007/s00586-012-2601-8 23238848.

9. Srikandarajah N, Wilby M, Clark S, Noble A, Williamson P, Marson T. Outcomes Reported After Surgery for Cauda Equina Syndrome: A Systematic Literature Review. Spine. 2018;43(17):E1005. doi: 10.1097/BRS.0000000000002605 29432394

10. 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(1):132.

11. Kirkham JJ, Gargon E, Clarke M, Williamson PR. Can a core outcome set improve the quality of systematic reviews?–a survey of the Co-ordinating Editors of Cochrane Review Groups. Trials. 2013;14(1):21.

12. 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 medicine. 2016;13(10):e1002148. doi: 10.1371/journal.pmed.1002148 27755541

13. Srikandarajah N, Noble A, Wilby M, Clark S, Williamson P, Marson T. Protocol for the development of a core outcome set for cauda equina syndrome: systematic literature review, qualitative interviews, Delphi survey and consensus meeting. BMJ Open. 2019 (In Press). Epub In Press.

14. Renzetti CM, Lee RM. Researching sensitive topics. London: Sage. 1993.

15. Dodd S, Clarke M, Becker L, Mavergames C, Fish R, Williamson PR. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. Journal of clinical epidemiology. 2018;96:84–92. doi: 10.1016/j.jclinepi.2017.12.020 29288712

16. Collins D. Pretesting survey instruments: an overview of cognitive methods. Quality of life research. 2003;12(3):229–38. doi: 10.1023/a:1023254226592 12769135

17. Drennan J. Cognitive interviewing: verbal data in the design and pretesting of questionnaires. Journal of advanced nursing. 2003;42(1):57–63. doi: 10.1046/j.1365-2648.2003.02579.x 12641812

18. Keeley T, Khan H, Pinfold V, Williamson P, Mathers J, Davies L, et al. Core outcome sets for use in effectiveness trials involving people with bipolar and schizophrenia in a community-based setting (PARTNERS2): study protocol for the development of two core outcome sets. Trials. 2015;16(1):47.

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

20. Blazeby J, Macefield R, Blencowe N, Jacobs M, McNair A, Sprangers M, et al. Core information set for oesophageal cancer surgery. British Journal of Surgery. 2015;102(8):936–43. doi: 10.1002/bjs.9840 25980524

21. Fish R, Sanders C, Adams R, Brewer J, Brookes ST, DeNardo J, et al. A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus. The Lancet Gastroenterology & Hepatology. 2018;3(12):865–73.

22. Biggane AM, Brading L, Ravaud P, Young B, Williamson PR. Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys. Trials. 2018;19(1):113. doi: 10.1186/s13063-018-2493-y 29454368

23. Ahn UM, Ahn NU, Buchowski JM, Garrett ES, Sieber AN, Kostuik JP. Cauda equina syndrome secondary to lumbar disc herniation. Spine. 2000;25(12):1515–22. doi: 10.1097/00007632-200006150-00010 10851100.

24. Jones JE, Jones LL, Keeley TJ, Calvert MJ, Mathers J. A review of patient and carer participation and the use of qualitative research in the development of core outcome sets. PLoS ONE. 2017;12(3):e0172937. doi: 10.1371/journal.pone.0172937 28301485

25. Balasubramanian K, Kalsi P, Greenough CG, Seetharam MPK. Reliability of clinical assessment in diagnosing cauda equina syndrome. Br J Neurosurg. 2010;24(4):383–6. doi: 10.3109/02688697.2010.505987 20726746.

26. Brookes ST, Macefield RC, Williamson PR, McNair AG, Potter S, Blencowe NS, et al. Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development. Trials. 2016;17(1):409. doi: 10.1186/s13063-016-1479-x 27534622

27. Korse NS, Veldman AB, Peul WC, Vleggeert-Lankamp CL. The long term outcome of micturition, defecation and sexual function after spinal surgery for cauda equina syndrome. PLoS ONE. 2017;12(4):e0175987. doi: 10.1371/journal.pone.0175987 28423044

28. 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. doi: 10.1186/s13063-016-1555-2 27618914

29. Kirkham JJ, Clarke M, Williamson PR. A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials. gov: findings from a review of randomised controlled trials of rheumatoid arthritis. Bmj. 2017;357:j2262. doi: 10.1136/bmj.j2262 28515234

30. Woodfield J, Hoeritzauer I, Jamjoom AA, Pronin S, Srikandarajah N, Poon M, et al. Understanding cauda equina syndrome: protocol for a UK multicentre prospective observational cohort study. BMJ open. 2018;8(12):e025230. doi: 10.1136/bmjopen-2018-025230 30552283