Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Nov 12, 2019
Date Accepted: Feb 1, 2020
Who participates in a web-based self-management intervention study for patients with lymphoma?: The reach of an RCT embedded in the population-based PROFILES registry
ABSTRACT
Background:
Randomized controlled trials (RCTs) often provide accurate estimates of the internal validity but lack information on the external validity (generalizability). We conducted an RCT on the effectiveness of a self-management intervention among patients with lymphoma within a population-based setting.
Objective:
The objectives of the current study were to describe the proportion of RCT participants compared to all patients invited to participate, and compare sociodemographic and clinical characteristics of RCT participants with all respondents, all patients invited to participate, and all patients selected from the Netherlands Cancer Registry (NCR) in order to determine the reach of the intervention. In addition, another objective was to assess differences on RCT outcome variables between RCT and paper respondents.
Methods:
Patients with lymphoma or chronic lymphocytic leukemia ≥ 18 years at diagnosis from 13 hospitals were selected from the population-based NCR, which routinely collects data on sociodemographic and clinical characteristics. Eligible patients were invited to participate in an RCT and complete a questionnaire. Web-based completion resulted in RCT enrolment, whereas paper respondents were observationally followed.
Results:
A total of 1193 patients were selected from the NCR, of which 892 (75%) were invited by their hematologist after verifying eligibility. A quarter participated by completing the web-based questionnaire and were enrolled in the RCT (227/892). RCT participants were younger and more often male than non-participants. Another quarter (229/892) opted to participate in the paper-based observational follow-up study. Compared with paper respondents, RCT participants were younger, more often male, and higher educated. RCT participants more often wanted to receive all available information. Paper respondents reported higher levels of emotional distress.
Conclusions:
From a population-based sample of eligible patients, the participation rate in the RCT was 25%. RCT participants may be not representative of the target population because of different sociodemographic and clinical characteristics. As RCT participants represent a minority of the target population, RCT results should be considered with caution as patients in the RCT were those who may need the self-management intervention the least. Clinical Trial: Netherlands Trial Register NTR5953
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