Dyspepsia in the community: value of a community-based mailed survey to identify potential participants for a randomized clinical trial

Abstract

Objective: To assess the usefulness of a community-based mailed survey to identify participants with functional dyspepsia (FD) for a clinical trial.

Material and methods: In 2008, a valid self-report questionnaire of gastrointestinal symptoms required for diagnosis of FD was mailed to randomly selected cohorts of Olmsted County, Minnesota, residents. From survey responses (54%), FD cases and controls were identified. Phone calls were completed in 2010 and 2011 to 54% of respondents offering participation to those meeting criteria.

Results: Of 937 people identified from the survey, 189 cases and 265 controls were contacted by phone using four questions similar to the written survey resulting in a moderate level of agreement (Kappa 0.43, 95% CI: 0.35- 0.51; p = 0.11). The proportion reporting FD symptoms by survey was 42%, while the proportion by phone was 38%. Comparing classification of cases and controls, 118 (62%) survey cases had dyspepsia symptoms on phone screening while 53 (20%) of the survey controls reported FD symptoms. Of 171 who had symptoms, 60 (35%) declined, 33 (19%) were over study age limit, 24 (14%) had inadequate symptom levels and 36 (21%) had comorbidities. Of survey respondents contacted, six (3%) people were enrolled with two screen fails resulting in four (1%) randomized.

Conclusion: Agreement between survey and phone questions was modest. Classifications between case and control changed. People eligible and willing to participate were a fraction of people reporting symptoms. People participating in clinical trials do not broadly represent those in the population.

Trial registration: ClinicalTrials.gov NCT00248651.

Keywords: clinical trial; dyspepsia; epidemiology; prevalence; response rate.

Figures

Figure 1

Consort diagram of individuals surveyed and called.

Figure 2

Breakdown and transition of cases and controls