Evidence map›Paper›PMID 35006311›Full record

SynthesisInternational urogynecology journal2022

Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS).

Reem Moussa, Maria Patricia Rada, Constantin Durnea, Gabriele Falconi, Cornelia Betschart, Jorge Milhem Haddad, Philip Sedgwick, Stergios K Doumouchtsis, CHORUS: An International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health (i-chorus.org)

Open access · hybridAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in International urogynecology journal, 2022. 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
2.4field-weighted citation impact, top 11% 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, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Review
  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

9 authors at 6 institutions in 8 countries.

Reem MoussaInstitute of Medical and Biomedical Education, St George's University of London, London, UK.
Maria Patricia Rada2nd Department of Obstetrics-Gynaecology, "luliu Hatieganu", University of Medicine and Pharmacy, Cluj-Napoca, Romania.
Constantin DurneaDepartment of Obstetrics and Gynaecology, Luton and Dunstable University Hospital NHS Foundation Trust, Luton, UK.
Gabriele FalconiComplex Operative Unit of Gynecology, Fondazione Policlinico Tor Vergata University Hospital, Rome, Italy.
Cornelia BetschartUniversity Hospital and University of Zurich, Zurich, Switzerland.
Jorge Milhem HaddadHospital das Clinicas da Faculdade de Medicina da, Universidade de São Paulo, São Paulo, Brazil.
Philip SedgwickInstitute of Medical and Biomedical Education, St George's University of London, London, UK.
Stergios K DoumouchtsisInstitute of Medical and Biomedical Education, St George's University of London, London, UK. sdoumouc@sgul.ac.uk.ORCID http://orcid.org/0000-0002-0404-6335
CHORUS: An International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health (i-chorus.org)
St George's, University of London · GBHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRIuliu Hațieganu University of Medicine and Pharmacy · ROLuton and Dunstable University Hospital NHS Foundation Trust · GBPoliclinico Tor Vergata · ITUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introduction and hypothesisEvidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS).

methodsRCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores.

resultsThirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman's rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality.

conclusionsDevelopment of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.

Indexed as

Urinary Bladder, OveractiveUrinary IncontinenceAdultFemaleHumansMuscarinic AntagonistsOutcome Assessment, Health CareRandomized Controlled Trials as TopicTreatment OutcomeMuscarinic AntagonistsLUTSOutcomesOveractive bladder; core outcome setPelvic floor disordersUrgency urinary incontinenceUrinary incontinenceUrinary urgency

Identifiers

PMID35006311
PMCPMC9120103
OpenAlexW4205988220

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.