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.
OBJECTIVE
To 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.


METHODS
Systematic review of trial registration records.


METHODS
ClinicalTrials.gov register.


METHODS
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.


METHODS
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.


RESULTS
Among 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).


CONCLUSIONS
Despite widespread multimorbidity, more than three-quarters of ongoing trials assessing interventions for patients with chronic conditions excluded patients with concomitant chronic conditions.
Faculté 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.
Céline
C
Buffel du Vaure
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 Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Epidémiologie Clinique, Paris, France French Cochrane Center, Paris, France.
Agnès
A
Dechartres
METHODS Team, Epidemiology and Statistics Sorbonne Paris Cité Research Center UMR 1153, INSERM, Paris, France.
Constance
C
Battin
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 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.
Philippe
P
Ravaud
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 Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Epidémiologie Clinique, Paris, France French Cochrane Center, Paris, France.
Isabelle
I
Boutron
PRIMARY CARE; chronic condition; external validity; multimorbidity; randomized controlled trials
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