Positive Health Online

Abstract

RICHARDSON and colleagues, University of Texas-Houston School of Public Health USA review the literature (59 references) and write that, despite the widespread practice of complementary/alternative medicine (CAM), researchers face problems recruiting patients to randomised clinical trials, because of strict exclusion criteria and barriers to participation. Inadequate numbers of patients diminish the ability to researchers to detect an effect and generalise the findings. The authors describe the recruitment experience of a CAM trial, detail the reasons for non-participation and contrast participants and non-participants regarding demographic, clinical and treatment-related variables.

Background

Methodology

Eligible women were from Houston, spoke English had primary breast cancer (excluding Stage IV) and were 1 to 30 months post-treatment with no steroids, tamoxifen, substance abuse, psychiatric, heart disease or immune deficiency. The enrolment process involved an introductory letter and brochure, telephone calls and reminder post cards. Potential participants were advised that the study would require blood samples (30 cc) to assess immune function; psychosocial measures to assess emotional well-being, quality-of-life, social support and coping strategies; and possible assignment to 6 weekly support or imagery sessions. Factors influencing recruitment were assessed by stratified analysis and multivariate logistic regression.

Results

Of 158 eligible participants, 30% (n = 47) consented to participate. The primary reasons for non-participation included work/childcare (33.3%), transportation/travel (30.6%), and lack of interest (24.3%). Participants were more likely to be 40-54 years of age rather than younger or older, divorced/separated, and able to pay some/all medical expenses. Divorced or separated women appeared to be more likely to participate, regardless of financial status.

Conclusion

Researchers need to assess the impact of exclusion criteria and must recognise the special needs of their target population. Although age, marital status, and pay status were the strongest predictors of participation, these factors are not amenable to intervention. Researchers could boost recruitment to studies by providing interventions available during the day and evening to accommodate working women, child care services, transportation, or reimbursement for travel costs.

References

Richardson MA et al. Recruitment for complementary/alternative medicine trials: who participates after breast cancer. Annals of Behavioral Medicine. 20(3): 190-8. Summer 1998.