Evidence map›Paper›PMID 27678540›Full record

ArticleBMJ open2016

Exclusion of patients with concomitant chronic conditions in ongoing randomised controlled trials targeting 10 common chronic conditions and registered at ClinicalTrials.gov: a systematic review of registration details.

Céline Buffel du Vaure, Agnès Dechartres, Constance Battin, Philippe Ravaud, Isabelle Boutron

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 9 pooled it
5.2field-weighted citation impact, top 4% 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

53 citing papers in PubMed, 9 syntheses or guidelines pooled it, 128 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Multimorbidity in randomized controlled trials of behavioral interventions: A systematic review.Health psychology : official journal of the Division of Health Psychology, American Psychological Association · 2019
    Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Asthma and Multimorbidity Amongst Ethnic Minority Groups in High Income Countries.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2026
    Review
  14. Article
  15. Are physical activity, sleep, and joint pain associated with physical function and quality of life in individuals with multimorbidity? A cross-sectional analysis of the MOBILIZE trial.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Article
  16. Article
  17. Article
  18. Observational
  19. Article
  20. Molecular Morbidity Score-Can MicroRNAs Assess the Burden of Disease?International journal of molecular sciences · 2024
    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

5 authors at 4 institutions in 2 countries.

Céline Buffel du VaureFaculté de Médecine, Département de médecine générale, Université Paris Descartes, Sorbonne Paris Cité, Paris, France Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France METHODS Team, Epidemiology and Statistics Sorbonne Paris Cité Research Center UMR 1153, INSERM, Paris, France.
Agnès DechartresFaculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France METHODS Team, Epidemiology and Statistics Sorbonne Paris Cité Research Center UMR 1153, INSERM, Paris, France Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Epidémiologie Clinique, Paris, France French Cochrane Center, Paris, France.
Constance BattinMETHODS Team, Epidemiology and Statistics Sorbonne Paris Cité Research Center UMR 1153, INSERM, Paris, France.
Philippe RavaudFaculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France METHODS Team, Epidemiology and Statistics Sorbonne Paris Cité Research Center UMR 1153, INSERM, Paris, France Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Epidémiologie Clinique, Paris, France French Cochrane Center, Paris, France Department of Epidemiology, Columbia University Mailman School of Public Health, New York, New York, USA.
Isabelle BoutronFaculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France METHODS Team, Epidemiology and Statistics Sorbonne Paris Cité Research Center UMR 1153, INSERM, Paris, France Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Epidémiologie Clinique, Paris, France French Cochrane Center, Paris, France.
Sorbonne Paris Cité · FRAssistance Publique – Hôpitaux de Paris · FRInserm · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo systematically assess registration details of ongoing randomised controlled trials (RCTs) targeting 10 common chronic conditions and registered at ClinicalTrials.gov and to determine the prevalence of (1) trial records excluding patients with concomitant chronic condition(s) and (2) those specifically targeting patients with concomitant chronic conditions.

designSystematic review of trial registration records. DATA SOURCES: ClinicalTrials.gov register. STUDY SELECTION: All ongoing RCTs registered from 1 January 2014 to 31 January 2015 that assessed an intervention targeting adults with coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease, painful condition, depression and dementia with a target sample size ≥100. DATA EXTRACTION: From the trial registration records, 2 researchers independently recorded the trial characteristics and the number of exclusion criteria and determined whether patients with concomitant chronic conditions were excluded or specifically targeted.

resultsAmong 319 ongoing RCTs, despite the high prevalence of the concomitant chronic conditions, patients with these conditions were excluded in 251 trials (79%). For example, although 91% of patients with CHD had a concomitant chronic condition, 69% of trials targeting such patients excluded patients with concomitant chronic condition(s). When considering the co-occurrence of 2 chronic conditions, 31% of patients with chronic pain also had depression, but 58% of the trials targeting patients with chronic pain excluded patients with depression. Only 37 trials (12%) assessed interventions specifically targeting patients with concomitant chronic conditions; 31 (84%) excluded patients with concomitant chronic condition(s).

conclusionsDespite widespread multimorbidity, more than three-quarters of ongoing trials assessing interventions for patients with chronic conditions excluded patients with concomitant chronic conditions.

Indexed as

chronic conditionexternal validitymultimorbidityPRIMARY CARErandomized controlled trials

Identifiers

PMID27678540
PMCPMC5051474
OpenAlexW2525999137

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.