Development of a core outcome set for studies involving patients undergoing major lower limb amputation for peripheral arterial disease: study protocol for a systematic review and identification of a core outcome set using a Delphi survey

Ambler, Graeme K., Bosanquet, David C. ORCID: https://orcid.org/0000-0003-2304-0489, Brookes-Howell, Lucy ORCID: https://orcid.org/0000-0002-8263-7130, Thomas-Jones, Rachel Emma ORCID: https://orcid.org/0000-0001-7716-2786, Waldron, Cherry-Ann ORCID: https://orcid.org/0000-0001-8465-2492, Edwards, Adrian G. K. ORCID: https://orcid.org/0000-0002-6228-4446 and Twine, Christopher P. ORCID: https://orcid.org/0000-0003-0385-5760 2017. Development of a core outcome set for studies involving patients undergoing major lower limb amputation for peripheral arterial disease: study protocol for a systematic review and identification of a core outcome set using a Delphi survey. Trials 18 (1) , 628. 10.1186/s13063-017-2358-9

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Abstract

Background: The development of a standardised reporting set is important to ensure that research is directed towards the most important outcomes and that data is comparable. To ensure validity, the set must be agreed by a consensus of stakeholders including patients, healthcare professionals and lay representatives. There is currently no agreed core outcome set for patients undergoing major lower limb amputation for peripheral arterial disease (PAD) for either short- or medium-term research outcomes. By developing these sets we aim to rationalise future trial outcomes, facilitate meta-analysis and improve the quality and applicability of amputation research. Methods/design: We will undertake a comprehensive systematic review of studies of patients undergoing major lower limb amputation for PAD. Data regarding all primary and secondary outcomes reported in relevant studies will be extracted and summarised as outcome domains. We will then undertake focus groups with key stakeholders (patients, carers, health and social care workers) to collect qualitative data to identify the main short- and mediumterm research outcomes for patients undergoing major lower limb amputation. Results of the systematic review and focus groups will be combined to create a comprehensive list of potential key outcomes. Stakeholders (patients, researchers and health and social care workers) will then be polled to determine which of the outcomes are considered to be important in a general context using a three-phase Delphi process. After preliminary analysis, results will be presented at a face-to-face meeting of key stakeholders for discussion and voting on the final set of core outcomes. This project is being run in parallel with a feasibility trial assessing perineural catheters in patients undergoing lower limb amputation (the PLACEMENT trial). Full ethical approval has been granted for the study (Wales REC 3 reference number 16/WA/0353). Discussion: Core outcome sets will be developed for short- and medium-term outcomes of research involving patients undergoing major lower limb amputation for PAD. This will help with the design of future trials and facilitate metaanalyses of trial data.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	BioMed Central
ISSN:	1745-6215
Date of First Compliant Deposit:	4 January 2018
Date of Acceptance:	21 November 2017
Last Modified:	21 Jun 2024 01:05
URI:	https://orca.cardiff.ac.uk/id/eprint/107882

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