IMproving PArticipation of patients in Clinical Trials--rationale and design of IMPACT.
BACKGROUND
One of the most commonly reported problems of randomised trials is that recruitment is usually slower than expected. Trials will cost more and take longer, thus delaying the use of the results in clinical practice, and incomplete samples imply decreased statistical power and usefulness of its results. We aim to identify barriers and facilitators for successful patient recruitment at the level of the patient, the doctor and the hospital organization as well as the organization and design of trials over a broad range of studies.


METHODS
We will perform two cohort studies and a case-control study in The Netherlands. The first cohort study will report on a series of multicenter trials performed in a nationwide network of clinical trials in obstetrics and gynaecology. A questionnaire will be sent to all clinicians recruiting for these trials to identify determinants--aggregated at centre level--for the recruitment rate. In a case control-study nested in this cohort we will interview patients who refused or consented participation to identify factors associated with patients' consent or refusal. In a second cohort study, we will study trials that were prospectively registered in the Netherlands Trial Register. Using a questionnaire survey we will assess whether issues on hospital organization, trial organization, planning and trial design were associated with successful recruitment, i.e. 80% of the predefined number of patients recruited within the planned time.


CONCLUSIONS
This study will provide insight in barriers and facilitators for successful patient recruitment in trials. The results will be used to provide recommendations and a checklist for individual trialists to identify potential pitfalls for recruitment and judge the feasibility prior to the start of the study. Identified barriers and motivators coupled to evidence-based interventions can improve recruitment of patients in clinical trials.
Oude Rengerink
Katrien
K
Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands. K.OudeRengerink@amc.uva.nl
Opmeer
Brent C
BC
Logtenberg
Sabine L M
SL
Hooft
Lotty
L
Bloemenkamp
Kitty W M
KW
Haak
Monique C
MC
Oudijk
Martijn A
MA
Spaanderman
Marc E
ME
Duvekot
Johannes J
JJ
Willekes
Christine
C
van Pampus
Maria G
MG
Porath
Martina M
MM
van Eyck
Jim
J
Sikkema
Marko J
MJ
Mol
Ben Willem J
BW
D000328:Adult; D001530:Belgium; D016022:Case-Control Studies; D015331:Cohort Studies; D006302:Health Services Research; D006801:Humans; D007407:Interviews as Topic; D008875:Middle Aged; D018579:Patient Selection; D010821:Physicians, Family / Q000523:psychology*; D019338:Polypharmacy; D012424:Rural Population; D014505:Urban Population