Evidence map›Paper›PMID 29995184›Full record

ReviewDigestive diseases and sciences2018

Placebo Rates in Randomized Controlled Trials of Pouchitis Therapy.

Jonathan Athayde, Sarah C Davies, Claire E Parker, Leonardo Guizzetti, Christopher Ma, Reena Khanna, Brian G Feagan, Vipul Jairath

Abstract readReview
PubMed Publisher
In one paragraph

Review in Digestive diseases and sciences, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.8field-weighted citation impact, top 14% 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, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. 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

8 authors at 3 institutions in 1 country.

Jonathan AthaydeDepartment of Medicine, University of Western Ontario, London, ON, Canada.
Sarah C DaviesDepartment of Medicine, University of Western Ontario, London, ON, Canada.
Claire E ParkerRobarts Clinical Trials Inc., 100 Dundas St. #200, London, ON, N6A 5B6, Canada.
Leonardo GuizzettiRobarts Clinical Trials Inc., 100 Dundas St. #200, London, ON, N6A 5B6, Canada.
Christopher MaRobarts Clinical Trials Inc., 100 Dundas St. #200, London, ON, N6A 5B6, Canada.
Reena KhannaDepartment of Medicine, University of Western Ontario, London, ON, Canada.
Brian G FeaganDepartment of Medicine, University of Western Ontario, London, ON, Canada.
Vipul JairathRobarts Clinical Trials Inc., 100 Dundas St. #200, London, ON, N6A 5B6, Canada. vjairath@uwo.ca.
Western University · CARobarts Clinical Trials · CAUniversity of Calgary · CA

Funding

CIHR
6 · The paper itself

Abstract

backgroundApproximately half of the patients with ulcerative colitis (UC) who undergo restorative proctocolectomy develop pouchitis within 10 years of surgery. Currently, there are no approved pouchitis treatments. It is important to quantify, and ultimately minimize, placebo rates to design and conduct efficient pouchitis trials.

aimsTo quantify the placebo rate observed in pouchitis randomized controlled trials (RCTs) in meta-analysis.

methodsEmbase, MEDLINE, and the Cochrane Library were searched from inception to November 3, 2017, for placebo-controlled RCTs enrolling adult UC patients with, or at risk for developing, pouchitis. A fixed-effect binomial-normal model was used to pool placebo rates on the log-odds (logit) scale. Proportions and 95% confidence intervals were reported. Outcomes of interest included development of pouchitis, induction of remission/response, and maintenance of remission/response. The Cochrane risk of bias tool was used to evaluate study quality.

resultsTwelve trials (five prevention, five induction, and two maintenance) enrolling a total of 229 placebo patients were eligible for inclusion. The pooled placebo rates for development of pouchitis and induction of response were 47% (95% CI 39-56%) and 24% (95% CI 14-37%), respectively. An insufficient number of trials prevented additional data pooling and meta-regression analysis and no consistent definitions of outcome were identified.

conclusionsNo consistent methods for measuring pouchitis disease activity or defining response and remission were identified, highlighting the need for standardized definitions of outcomes for use in pouchitis trials. Additional high-quality trials are required to evaluate existing and novel therapies in this area.

Indexed as

HumansOutcome and Process Assessment, Health CarePlacebo EffectPouchitisRandomized Controlled Trials as TopicRemission InductionPlacebo effectPouchitisTrial designUlcerative colitis

Identifiers

PMID29995184
OpenAlexW2831039945

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.