Evidence map›Paper›PMID 29284523›Full record

ArticleTrials2017

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.

Graeme K Ambler, David C Bosanquet, Lucy Brookes-Howell, Emma Thomas-Jones, Cherry-Ann Waldron, Adrian G K Edwards, Christopher P Twine

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
4.5field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Graeme K AmblerAneurin Bevan University Health Board, Royal Gwent Hospital, Cardiff Road, Newport, NP20 2UB, UK.
David C BosanquetAneurin Bevan University Health Board, Royal Gwent Hospital, Cardiff Road, Newport, NP20 2UB, UK.
Lucy Brookes-HowellCentre for Trials Research, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XW, UK.
Emma Thomas-JonesCentre for Trials Research, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XW, UK.
Cherry-Ann WaldronCentre for Trials Research, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XW, UK.
Adrian G K EdwardsDivision of Population Medicine, Cardiff University, 5th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XW, UK.
Christopher P TwineAneurin Bevan University Health Board, Royal Gwent Hospital, Cardiff Road, Newport, NP20 2UB, UK. christopher.twine@wales.nhs.uk.
Cardiff University · GBAneurin Bevan University Health Board · GBRoyal Gwent Hospital · GB

Funding

HCRW_ RFPPB-16-1198National Institute for Social Care and Health Research 1198
6 · The paper itself

Abstract

backgroundThe 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/

designWe 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 medium-term 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 meta-analyses of trial data.

trial registrationPROSPERO: CRD42017059329 . Registered on 30 March 2017. COMET: 975 . Registered on 5 April 2017.

Indexed as

Delphi TechniqueSystematic Reviews as TopicAmputation, SurgicalFocus GroupsHumansLower ExtremityOutcome Assessment, Health CarePeripheral Arterial DiseaseAmputationOutcome assessment (Healthcare)Peripheral arterial diseaseVascular surgical procedures

Identifiers

PMID29284523
PMCPMC5747272
OpenAlexW2777235138

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.