Evidence map›Paper›PMID 34168025›Full record

ArticleBMJ open2021

Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set.

Moira Cruickshank, Rumana Newlands, Jane Blazeby, Irfan Ahmed, Mohamed Bekheit, Miriam Brazzelli, Bernard Croal, Karen Innes, Craig Ramsay, Katie Gillies

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 16% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
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

10 authors at 3 institutions in 1 country.

Moira CruickshankHealth Services Research Unit, University of Aberdeen Institute of Applied Health Sciences, Aberdeen, UK.
Rumana NewlandsHealth Services Research Unit, University of Aberdeen Institute of Applied Health Sciences, Aberdeen, UK.
Jane BlazebyDepartment of Social Medicine, University of Bristol Department of Social Medicine, Bristol, UK.ORCID 0000-0002-3354-3330
Irfan AhmedDepartment of Surgery, NHS Grampian, Aberdeen, UK.
Mohamed BekheitDepartment of Surgery, NHS Grampian, Aberdeen, UK.
Miriam BrazzelliHealth Services Research Unit, University of Aberdeen Institute of Applied Health Sciences, Aberdeen, UK.ORCID 0000-0002-7576-6751
Bernard CroalClinical Biochemistry, Grampian University Hospitals NHS Trust, Aberdeen, UK.ORCID 0000-0002-6375-3507
Karen InnesHealth Services Research Unit, University of Aberdeen Institute of Applied Health Sciences, Aberdeen, UK.ORCID 0000-0001-8512-4368
Craig RamsayHealth Services Research Unit, University of Aberdeen Institute of Applied Health Sciences, Aberdeen, UK.ORCID 0000-0003-4043-7349
Katie GilliesHealth Services Research Unit, University of Aberdeen Institute of Applied Health Sciences, Aberdeen, UK k.gillies@abdn.ac.uk.ORCID 0000-0001-7890-2854
University of Aberdeen · GBNHS Grampian · GBUniversity of Bristol · GB

Funding

Chief Scientist Office HSRU1Chief Scientist Office [UK]Medical Research Council MR/K025643/1Medical Research Council MR/L01193X/1
6 · The paper itself

Abstract

backgroundMany completed trials of interventions for uncomplicated gallstone disease are not as helpful as they could be due to lack of standardisation across studies, outcome definition, collection and reporting. This heterogeneity of outcomes across studies hampers useful synthesis of primary studies and ultimately negatively impacts on decision making by all stakeholders. Core outcome sets offer a potential solution to this problem of heterogeneity and concerns over whether the 'right' outcomes are being measured. One of the first steps in core outcome set generation is to identify the range of outcomes reported (in the literature or by patients directly) that are considered important.

objectivesTo develop a systematic map that examines the variation in outcome reporting of interventions for uncomplicated symptomatic gallstone disease, and to identify other outcomes of importance to patients with gallstones not previously measured or reported in interventional studies.

resultsThe literature search identified 794 potentially relevant titles and abstracts of which 137 were deemed eligible for inclusion. A total of 129 randomised controlled trials, 4 gallstone disease specific patient-reported outcome measures (PROMs) and 8 qualitative studies were included. This was supplemented with data from 6 individual interviews, 1 focus group (n=5 participants) and analysis of 20 consultations. A total of 386 individual recorded outcomes were identified across the combined evidence: 330 outcomes (which were reported 1147 times) from trials evaluating interventions, 22 outcomes from PROMs, 17 outcomes from existing qualitative studies and 17 outcomes from primary qualitative research. Areas of overlap between the evidence sources existed but also the primary research contributed new, unreported in this context, outcomes.

conclusionsThis study took a rigorous approach to catalogue and map the outcomes of importance in gallstone disease to enhance the development of the COS 'long' list. A COS for uncomplicated gallstone disease that considers the views of all relevant stakeholders is needed.

Indexed as

CholelithiasisOutcome Assessment, Health CareFocus GroupsHumansQualitative Researchadult gastroenterologygastroenterologysurgery

Identifiers

PMID34168025
PMCPMC8231013
OpenAlexW3170144239

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.