Evidence map›Paper›PMID 33963945›Full record

SynthesisTechniques in coloproctology2021

Heterogeneity in outcome selection, definition and measurement in studies assessing the treatment of cryptoglandular anal fistula: findings from a systematic review.

A J H M Machielsen, N Iqbal, M L Kimman, K Sahnan, S O Adegbola, G Kane, R Woodcock, J Kleijnen, U Grossi, S O Breukink and 1 more

Abstract readSystematic Review
In one paragraph

Synthesis in Techniques in coloproctology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Observational
  3. Article
  4. Article
  5. The Songdo consensus: Development of minimum reporting standards for studies of intervention in idiopathic anal fistula using a modified nominal group technique.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2025
    Article
  6. Article
  7. Article
  8. The development of a cryptoglandular anal fistula quality of life scale (AF-QoL).Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2024
    Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Review
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

11 authors.

A J H M Machielsen *Department of Surgery and Colorectal Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands.
N Iqbal *Robin Phillips' Fistula Research Unit, St Mark's Hospital, London, UK. niqbal@doctors.org.uk.ORCID 0000-0003-3264-7362
M L KimmanDepartment of Clinical Epidemiology and Medical Technology Assessment, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre+, Maastricht, The Netherlands.
K SahnanRobin Phillips' Fistula Research Unit, St Mark's Hospital, London, UK.
S O AdegbolaRobin Phillips' Fistula Research Unit, St Mark's Hospital, London, UK.
G Kane, Belfast, UK.
R Woodcock, London, UK.
J KleijnenDepartment of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.
U GrossiTertiary Referral Pelvic Floor and Incontinence Centre, Regional Hospital Treviso, Treviso, Italy.
S O BreukinkDepartment of Surgery and Colorectal Surgery, Nutrim School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, Grow School for Oncology and Developmental Biology, Maastricht, The Netherlands.
P J TozerRobin Phillips' Fistula Research Unit, St Mark's Hospital, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment for cryptoglandular anal fistula (AF) is challenging and a lack of uniform outcomes in the literature prevents direct comparison of treatments. This can be addressed by developing a core outcome set, a standardised set of outcomes reported in all interventional studies for a specific condition. The aim of this systematic review is to assess the range of outcomes, their definitions, and the measurement instruments currently utilised in interventional studies for adult patients with AF. This will inform the development of an AF core outcome set.

methodsMedline, Embase and The Cochrane Library were searched to identify all patient- and clinician-reported outcomes in studies assessing medical, surgical or combination treatment of adult patients with AF published from January 2008 to May 2020. The resulting outcomes were categorized according to the Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to better understand their distribution.

resultsIn total, 155 studies were included, 552 outcomes were extracted, with a median of three outcomes (interquartile range 2-5) per study. Only 25% of studies demonstrated high-quality outcome reporting. The outcomes were merged into 52 unique outcomes and structured into four core areas and 14 domains, with the majority in the domain of physiological or clinical (gastrointestinal) outcomes. The most commonly reported outcomes were healing (77%), incontinence (63%), and recurrence (40%), with no single outcome assessed across all studies. There was a wide variation in outcome definitions and measurement instruments used.

conclusionsThere is substantial heterogeneity in outcomes, definitions, and measurement instruments reported in interventional studies for cryptoglandular anal fistula. This emphasises the need for standardised outcome reporting and measurement.

Indexed as

Rectal FistulaAdultHumansRecurrenceTreatment OutcomeCore outcome setCryptoglandular anal fistulaOutcome assessmentSystematic review

Identifiers

PMID33963945
PMCPMC8187216

What OpenQuestion holds

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Registered trials

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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.