Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome

Abstract

Background:The reliability of symptom data collected during efficacy studies in irritable bowel syndrome (IBS) is paramount to the proper assessment of potential therapeutic agents. Historically, data have been collected on paper diary cards, which patients were requested to fill out at a specified interval. However, with paper diary cards it is not possible to determine whether the cards are filled out as required, or at random times. To circumvent this problem, a novel electronic data collection system that ensures the reliability and security of data entry was used.Methods:Data were collected from 640 patients during the 2‐week screening and 12‐week treatment phases of two multicentre trials of IBS. The electronic data collection system used was based upon a touchtone telephone system.Results:The electronic data collection system had a potential 8135 up‐time hours during the study. An up‐time of 8040 h and down‐time of 95 h was observed. This corresponds to an up‐time of approximately 99%. Patient compliance for data entry in the two studies was 81% and 83%, respectively. On a single random day during their daily telephone call, patients were asked questions to assess satisfaction with the system. On aggregate, 79% of patients were satisfied or very satisfied with the system, only 10% were dissatisfied or very dissatisfied.Conclusion:A unique electronic data collection system was tested for use in clinical studies in IBS. This system provided 100% reliability as to the date of data entry, and data were not subject to modification once entered. This methodology represents a marked advancement in clinical studies of IBS.

Interactive voice response: Review of studies 1989–2000

“…In only 18 studies (Alemi et al, 1994;Baer et al, 1993;Baer et al, 1995;Burke, 1993;Ershoff et al, 1999;Greist et al, 1998;Harding et al, 1997;Kadison et al, 1998;Kempe et al, 1999;Kobak et al, 1999;Kobak, Taylor, Dottl, Greist, Jefferson, Burroughs, Katzelnick, & Mandell, 1997;Lieu et al, 1998;OsgoodHynes et al, 1998;Phipps & Tupek, 1991;Piette & Mah, 1997;Tanke & Leirer, 1994;Tanke et al, 1997;Temple et al, 1998) have researchers attempted to measure acceptability, and there was little agreement on the methods used.…”

“…In four studies (Albisser, Harris, Sakkal, Parson, & En Chao, 1996;Alemi et al, 1994;Harding et al, 1997;Meneghini, Albisser, Goldberg, & Mintz, 1998), patients called into an IVR system in order to report symptoms or progress.…”

“…Study Study Area Havice (1989) media surveys Havice (1990a) survey refusal rates Havice (1990b) survey of student accommodation living conditions Troutman et al (1990) poisoning incidence survey Havice & Banks (1991) media surveys Leirer et al (1991) medication nonadherence in the elderly Phipps & Tupek (1991) establishment survey Patel & Babbs (1992) symptom monitoring for cardiac patients Baer et al (1993) assessment of obsessive compulsive disorder Burke (1993) tobacco cessation support line Stehr-Green et al (1993) telephone immunization reminders Alemi et al (1994) monitoring drug client treatment after-care Linkins et al (1994) reminders for childhood immunization Tanke & Leirer (1994) automatic reminders for tuberculosis clinic attendance Baer et al (1995) assessment of depression risk Dini et al (1995) telephone clinic appointment reminders longitudinal monitoring of tobacco and alcohol consumption longitudinal monitoring of alcohol consumption Perrine et al (1995) monitoring of alcohol consumption Schneider et al (1995) automatic smoking self-treatment cessation program Searles et al (1995) longitudinal monitoring of alcohol consumption Albisser et al (1996) diabetes monitoring and feedback Alemagno et al (1996) substance abuse survey among the homeless Hyman et al (1996) cholesterol reduction Frank et al (1997) anonymous HIV testing Harding et al (1997) symptoms monitoring for irritable bowel syndrome Havel & Wright (1997) hepatitis B risk assessment and referral Kobak, Taylor, Dottl, Greist, Jefferson, Burroughs, Mantle, et al (1997) assessment of psychological conditions Kobak, Taylor, Dottl, Greist, Jefferson, Burroughs, Katzelnick, & Mandell (1997) assessment of psychological conditions Mundt et al (1997) psychological performance assessment Piette & Mah (1997) symptom monitoring for diabetes …”

“…An irritable bowel syndrome study (Harding et al, 1997) monitored the symptoms of 640 patients and showed a compliance rate of between 74% and 83%. However, in another study (Alemi et al, 1994) of 42 recovering drug users and alcoholics, compliance was reduced from 100% to 20% after 19 weeks.…”

Evaluation of Crofelemer in the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome Patients

“…Randomization was also stratified to ensure equal gender distributions between treatment groups. Efficacy data were collected using an interactive voice response system (IVRS) [11]. Safety data were collected through spontaneous reports and at scheduled visits throughout the study.…”