Evidence map›Paper›PMID 28646416›Full record

Trial reportThe patient2017

Assessing Preference-Based Outcome Measures for Overactive Bladder: An Evaluation of Patient-Reported Outcome Data from the BESIDE Clinical Trial.

Mike Herdman, Jameel Nazir, Zalmai Hakimi, Emad Siddiqui, Moses Huang, Marco Pavesi, Scott MacDiarmid, Marcus J Drake, Nancy Devlin

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The patient, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

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

  1. Guideline
  2. Article
  3. The impact of overactive bladder on health-related quality of life in Korea: based on the results of a Korean Community Health Survey.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021
    Article
  4. Review
  5. Article
  6. [Overactive bladder-which treatment when?]Der Urologe. Ausg. A · 2017
    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

9 authors.

Mike HerdmanThe Office of Health Economics, Southside, 7th Floor, 105 Victoria Street, London, SW1E 6QT, UK. mherdman@ohe.org.
Jameel NazirAstellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR, Chertsey, UK.
Zalmai HakimiAstellas Pharma Europe B.V., Astellas Medical Affairs, Global, HEOR, Leiden, Netherlands.
Emad SiddiquiAstellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR, Chertsey, UK.
Moses HuangAstellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR, Chertsey, UK.
Marco PavesiData Management Centre, European Foundation for the study of Chronic LIver Failure (EF-CLIF), Barcelona, Spain.
Scott MacDiarmidAlliance Urology Specialists, Greensboro, USA.
Marcus J DrakeUniversity of Bristol and Bristol Urological Institute, Bristol, UK.
Nancy DevlinThe Office of Health Economics, Southside, 7th Floor, 105 Victoria Street, London, SW1E 6QT, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this study was to compare outcomes using two preference-based measures of health status (EQ-5D-5L and OAB-5D) in patients with overactive bladder (OAB) treated with solifenacin plus mirabegron or solifenacin monotherapy in the BESIDE trial.

methodsPatients with OAB who remained incontinent after 4 weeks' treatment with solifenacin 5 mg were randomized 1:1:1 to combination treatment (solifenacin 5 mg plus mirabegron [25 mg for the first 4 weeks/50 mg for the last 8 weeks]), solifenacin 5 mg, or solifenacin 10 mg. EQ-5D-5L and OAB-q were administered at baseline, weeks 4, 8, 12, and end of treatment (EoT). OAB-5D scores were derived from OAB-q results. Responder analysis was carried out using several definitions of minimally important difference.

resultsA total of 2054 patients received one or more doses of study treatment (combination, n = 694; solifenacin 5 mg, n = 684; solifenacin 10 mg, n = 676). EQ-5D-5L Index mean score changes (from baseline to EoT) were greater with combination (0.059) than with solifenacin 5 mg (0.040) and 10 mg (0.044) monotherapy, but the differences were not statistically significant. A significantly greater improvement was observed for combination on OAB-5D (0.107 vs 0.085 for 5 mg, and 0.087 for 10 mg; p ≤ 0.01). The dimensions most improved overall were anxiety/depression, pain/discomfort, and usual activities on EQ-5D-5L, and urge, urine loss, and coping on OAB-5D. The proportion of responders was significantly greater with combination compared with monotherapy using OAB-5D only.

conclusionsImprovements were observed in all study arms on both the EQ-5D-5L and OAB-5D, although only the OAB-5D showed a statistically significant benefit for combination versus solifenacin monotherapy. Combining generic and condition-specific preference-based health status measures allowed for assessment of dimensions that were particularly relevant to this patient population, while permitting comparison with outcomes from other studies, treatments, and populations via EQ-5D.

Indexed as

Patient Reported Outcome MeasuresAcetanilidesAdultAgedDouble-Blind MethodDrug Therapy, CombinationFemaleHealth StatusHumansMaleMental HealthMiddle AgedQuality of LifeSolifenacin SuccinateSurveys and QuestionnairesThiazolesAcetanilidesmirabegronSolifenacin SuccinateThiazolesUrological Agents

Identifiers

What OpenQuestion holds

Textmetadata
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.