Factors motivating dyspepsia patients to enter clinical research

https://doi.org/10.1016/j.cct.2005.11.014Get rights and content

Abstract

One of the most influential factors in science and medicine has been the development of placebo-controlled clinical trials. However, recruitment of patients for clinical trials is sometimes a major problem in clinical research. Successful patient recruitment may be enhanced with a clear understanding of the motivating factors that determine a patient's decision to enter a study. We have developed the Patients' Expectations, Attitudes and Knowledge (PEAK) Program consisting of questionnaires designed to study the factors motivating patients to enter a clinical trial, as well as capturing the experiences of research participants. A total of 247 female patients with dyspepsia (mean age: 43.9; range: 18.0–78.0 years) who entered either of two prospective double-blind, randomized, placebo-controlled multicenter trials in the USA completed PEAK Entry questionnaires during the first study visit. Based on their responses, the top three factors motivating patients to join the clinical trial were: interest in receiving investigational treatment with average score (AS) of 4.33 ± 0.08 (M ± SEM) on a 5-point scale, possibility of getting skilled professional care (AS = 4.07 ± 0.09), and altruism expressed as an intention to help develop a new drug for the sake of other people (AS = 3.89 ± 0.09). Age, ethnicity, and educational status significantly affected motivational factors of patients. These results indicate that recruitment can be enhanced by targeting these motivations in physician/patient communications, informed consent process and advertising for study participants.

Introduction

Patient recruitment remains a major hurdle in the clinical research process, and timely recruitment has been quoted as the single most important aspect of a successful clinical trial [1], [2], [3], [4]. Prolonged and/or inefficient recruitment has negative scientific and economic consequences [3], [5], [6]. These general clinical research problems are also valid for drug development in the area of gastrointestinal (GI) diseases [7], [8].

The preferred ways of accelerating patient recruitment include:

  • (a)

    consecutive preliminary screening procedures of increasing complexity allowing gradual exclusion of subjects who do not match entry criteria, i.e., relatively simple initial examinations enabling a large throughput of patients followed by more detailed examinations of fewer subjects, by then known to fulfill some of the study-specific requirements [3]. Especially in the trials targeting large numbers of patients, consecutive screening helps create optimal workflow and, as a result, speeds up patient recruitment by eliminating initially candidates who do not fulfill some of the inclusion criteria, saving time and funds on the full set of screening tests/procedures;

  • (b)

    amending the study protocol by introducing more “relaxed” inclusion/exclusion criteria;

  • (c)

    eliminating poorly performing sites and/or adding new sites in multi-center trials;

  • (d)

    increasing advertising budget and/or adding appropriate financial incentives for the participating sites;

  • (e)

    demonstrate enthusiasm with the study participants (both study site personnel and patients) through regular investigator meetings, newsletters, etc., since enthusiastic study patients would be less prone to create non-compliance problems, decreasing potential drop-out, and enthusiastic personnel will always work more/better [6], [9].

Most of these can only be applied post factum, i.e., after the recruitment problem becomes apparent. Undoubtedly, a more successful approach would be adequate study protocol development and recruitment campaign planning based on knowledge of motivating factors for a specific patient population. Thus, good awareness of the motives behind patients' decision relative to their participation in clinical research is likely to be critical for early study success [10], [11]. However, the patients' perspectives are often not taken into account at the study development stage. This may result in a number of key problems. First, the study requirements and design might be unacceptable to patients. In addition, the questions asked might seem irrelevant, illegitimate, and of low priority to the patient. Complicating this, the language used in both advertising and in the consent form may not clearly describe the clinical problems or symptoms in terms used by the patient. Importantly, without knowing the specific psychological motives driving patient's interest and intention to participate in a study, the vitally important processes of recruitment (explanation, information, support) could be managed ineffectively. These latter elements are the most under-researched and poorly understood of trial practices [6], [12].

A literature search [13], [14] has identified a number of potential factors influencing patients' decisions to join or decline a clinical study. These range from a need for new effective, sometimes life-saving, treatment or one which improves quality of life treatment [14], [15] to social reasons (e.g., desire to visit doctor's office to socialize with medical personnel and/or other patients) and financial compensation [16], [17], [18]. In addition, patients may express altruistic intentions of helping to develop new therapy for the benefit of all mankind [15]. What motivates an individual to participate in a trial may be specific to the disease/indication or the study design. These general motives may be influenced by patient's gender, age, geographic location, ethnic origin or cultural background [19], [20], [21], [22] or possibly other variables.

Information about disease-specific motivational factors of the target research population is crucial for both designing the study protocol and developing an adequate informed consent and advertising campaign. However, this information is currently not available for the majority of indications. Trying to fill this gap, we have developed the Patients' Expectations, Attitudes, and Knowledge (PEAK) Program. It consists of a set of questionnaires designed to capture the motivating factors of patients entering a clinical trial as well as the experiences of research patients completing the trials. As a pilot program, PEAK questionnaires were introduced into several studies. Responses of patients to the PEAK Entry questionnaires are presented in the current report.

Section snippets

Patient population

Patients who completed the PEAK Entry questionnaire participated in one of two identical Phase III trials conducted in the USA. To qualify for study entry, patients had to fulfill the following major entry criteria: female aged 18 or older and have persistent or recurrent digestive problems consistent with dyspepsia for at least 12 weeks in the previous 12 months. Patients with abnormal endoscopic esophageal or gastric findings and those complaining of heartburn as a predominant symptom were

Demography

A total of 247 patients from 98 clinical sites have completed the entry questionnaires during their first office visit. The average number of patients from each site was rather small, varying from 1 to 12 per site. This will not allow us to produce meaningful inter-site comparisons. Some demographic characteristics of respondents (in descending order) are presented in Table 1.

Only female patients participated in these two clinical trials, which makes it impossible to do gender comparisons for

Conclusions

  • (1)

    The major factors motivating patients to join clinical trial for the given indication and study design were: interest in receiving investigational treatment, possibility of getting skilled professional care, and altruism — intention to help develop new drug for the sake of other people.

  • (2)

    Age, ethnicity and education of patients significantly alter individual motivating factors.

  • (3)

    PEAK Questionnaire is a useful instrument to capture and evaluate factors motivating patients to enter a clinical study.

References (38)

  • R.C. Spiller

    Problems and challenges in the design of irritable bowel syndrome clinical trials: experience from published trials

    Am J Med

    (1999)
  • Editorial. Subject recruitment: by far biggest clinical trial concern

    Appl Clin Trials

    (2004)
  • M. Hochhauser

    The self-deception syndrome

    Appl Clin Trials

    (2004 (Nov.1))
  • H. Thornton

    What can patients contribute to the design of clinical trials?

  • I. Wilets et al.

    How patients and visitors to an urban emergency department view clinical research

    Acad Emerg Med

    (2003)
  • M.L. Russell et al.

    Paying research subjects: participants' perspectives

    J Med Ethics

    (2000)
  • A. Pearl et al.

    Randomised trials in general practice—a New Zealand experience in recruitment

    N Z Med J

    (2003)
  • J.P. Bentley et al.

    The influence of risk and monetary payment on the research participation decision making process

    J Med Ethics

    (2004)
  • G.M. Swanson et al.

    Recruiting minorities into clinical trials: toward a participant-friendly system

    J Natl Cancer Inst

    (1995)
  • Cited by (11)

    View all citing articles on Scopus
    View full text