Evidence map›Paper›PMID 27920281›Full record

SynthesisNeurology2016

Systematic review and statistical analysis of the integrity of 33 randomized controlled trials.

Mark J Bolland, Alison Avenell, Greg D Gamble, Andrew Grey

Abstract readSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 5 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

28 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Interventions for preventing falls in Parkinson's disease.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Pooled it
  4. Effect of vitamin K on bone mineral density and fractures in adults: an updated systematic review and meta-analysis of randomised controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
    Pooled it
  5. Pooled it
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Data integrity of 14 randomised controlled trials.European journal of obstetrics, gynecology, and reproductive biology · 2024
    Article
  12. Characteristics of baseline frequency data in spinal RCTs do not suggest widespread non-random allocation.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2023
    Article
  13. Assessing the Integrity of Clinical Trials Included in Evidence Syntheses.International journal of environmental research and public health · 2023
    Review
  14. Article
  15. Randomisation can do many things - but it cannot "fail".Significance (Oxford, England) · 2022
    Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Mark J BollandFrom the Department of Medicine (M.J.B., G.D.G., A.G.), University of Auckland, New Zealand; and Health Services Research Unit (A.A.), University of Aberdeen, Foresterhill, Scotland. m.bolland@auckland.ac.nz.
Alison AvenellFrom the Department of Medicine (M.J.B., G.D.G., A.G.), University of Auckland, New Zealand; and Health Services Research Unit (A.A.), University of Aberdeen, Foresterhill, Scotland.
Greg D GambleFrom the Department of Medicine (M.J.B., G.D.G., A.G.), University of Auckland, New Zealand; and Health Services Research Unit (A.A.), University of Aberdeen, Foresterhill, Scotland.
Andrew GreyFrom the Department of Medicine (M.J.B., G.D.G., A.G.), University of Auckland, New Zealand; and Health Services Research Unit (A.A.), University of Aberdeen, Foresterhill, Scotland.

Funding

Chief Scientist Office HSRU1
6 · The paper itself

Abstract

backgroundStatistical techniques can investigate data integrity in randomized controlled trials (RCTs). We systematically reviewed and analyzed all human RCTs undertaken by a group of researchers, about which concerns have been raised.

methodsWe compared observed distributions of p values for between-groups differences in baseline variables, for standardized sample means for continuous baseline variables, and for differences in treatment group participant numbers with the expected distributions. We assessed productivity, recruitment rates, outcome data, textual consistency, and ethical oversight.

resultsThe researchers were remarkably productive, publishing 33 RCTs over 15 years involving large numbers of older patients with substantial comorbidity, recruited over very short periods. Treatment groups were improbably similar. The distribution of p values for differences in baseline characteristics differed markedly from the expected uniform distribution (p = 5.2 × 10

conclusionsA systematic approach using statistical techniques to assess randomization outcomes can evaluate data integrity, in this case suggesting these RCT results may be unreliable.

Indexed as

Data Interpretation, StatisticalData AccuracyHumansMeta-Analysis as TopicRandomized Controlled Trials as Topic

Identifiers

PMID27920281

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.