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Background: Critical to conducting high quality research is the ability to attract and retain participants, especially for longitudinal studies. Understanding participant experiences and motivators or barriers to participating in clinical research is crucial. There are limited data on healthy participant experiences in longitudinal research, particularly in low- and middle-income countries. This study aims to investigate quantitatively participant experiences in a South African birth cohort study. Methods: Maternal participant experience was evaluated by a self-administered survey in the Drakenstein Child Health Study, a longitudinal birth cohort study investigating the early life determinants of child health. Pregnant mothers, enrolled during the second trimester, were followed through childbirth and the early childhood years. Satisfaction scores were derived from the participant experience survey and quantitatively analyzed; associations between satisfaction scores and sociodemographic variables were then investigated using a linear regression model. Results: Data were included from 585 pregnant mothers (median age 26.6 years), who had participated in the study for a median time of 16 months. Overall participant satisfaction was high (median score 51/60) and associated with increased attendance of study visits. Reasons for participating were a belief that involvement would improve their health, their child’s health or the health of family and friends. Potential reasons for leaving the study were inconvenience, not receiving clinical or study results, and unexpected changes in study visits or procedures. Variables associated with higher overall satisfaction scores were no prior participation in research, higher socioeconomic status, less intensive follow-up schedules and having experienced stressful life events in the past year. Conclusions: Satisfaction scores were high and associated with increased visit attendance. Participants’ perceived benefits of study participation, most notably the potential for an improvement in the health of their child, were a significant motivator to enroll and remain in the study. The consistent theme of perceived health benefits as a motivator to join and remain in the study raises the question of whether participation in research results in actual improvements in health.
The Drakenstein Child Health Study (DCHS) is a multidisciplinary birth cohort study investigating the epidemiology and etiology of childhood respiratory illness and the determinants of child health in a peri-urban area in South Africa [22]. Mothers were enrolled during the second trimester of pregnancy and mother-infant pairs are followed until children reach at least 5 years of age. Mother-infant pairs attend numerous visits during this period; at enrolment mothers were able to choose to participate in usual study follow-up (main cohort) or an intensive cohort, in which 2 weekly follow-up with nasopharyngeal sampling was done in children throughout the first year of life (Fig. 1). Visits included questionnaires, clinical examination, specimen collection, lung function testing, psychosocial assessments, infant developmental measures and home visits. Study follow up visits The DCHS is located in the Drakenstein subdistrict, a peri-urban area 60 km outside Cape Town, South Africa, with a population of approximately 200,000 [22]. More than 90 % of the population access health care in the public sector including antenatal and child health services [23]. Similar to many LMICs, the area has a high burden of childhood disease, including pneumonia, [24] and a high prevalence of risk factors for childhood illness, such as tobacco smoke exposure, drug use, interpersonal violence, overcrowding, malnutrition and poverty [25]. Pregnant women were recruited from two primary health care clinics serving distinct populations – TC Newman clinic (serving a mixed race population) and Mbekweni clinic (serving a black African population). Enrolment commenced in March 2012. Exclusion criteria included women who were planning to move out of the area, women under 18 years of age, lack of informed consent or not attending study clinics for antenatal care. All mothers were asked to complete a participant experience survey at the 12 month postnatal study visit. Participants were provided with reimbursements to cover travel expenses related to study visit attendance. We evaluated participant experience using an adapted version of the Research Participant Experience Survey [26, 27]. Adaptations included adjusting questions to be relevant for healthy volunteers and local context and shortening the questionnaire for acceptability. The survey was self-administered in a private space, allowing for greater anonymity. Questionnaires were available in the first language (Afrikaans, English or Xhosa) of a participant; translations were completed by trained local translators to ensure that these were culturally appropriate. The participant experience survey assessed reasons for joining and staying in the study, reasons participants may have considered leaving the study and participant satisfaction overall. Satisfaction was assessed across several themes, including satisfaction with study information, study staff, experience versus expectations, study procedures and overall experience; themes were constructed based on focus group research used to develop the Research Participant Experience Survey [27]. A scoring system was devised, where responses indicating greater levels of satisfaction with study experiences were scored higher than those indicating dissatisfaction. Satisfaction scores for each theme in the questionnaire were calculated by summing individual item responses relating to each respective theme; theme specific content is detailed below. Satisfaction with study staff was assessed based on the quality of participant relationships with study staff, how closely study staff kept participants informed of study aspects and whether staff were accessible for questions (maximum = 6). Satisfaction with study procedures was assessed based on the amount of discomfort and duration of specimen collection and the acceptability of procedures such as lung function testing and psychosocial questionnaires and evaluations (maximum = 8). Satisfaction with study information was based on whether participants felt well informed of study procedures and well prepared for what they experienced (maximum = 6). Participants were asked about overall study experience, including whether they would participate in a similar study again, whether they would recommend participation to family or a friend and whether their overall experience was good or bad (maximum = 7). Finally, participants were asked about their experience versus expectation, specifically whether participation was better than they expected or more difficult than they expected (maximum = 2). Individual theme scores were then summed to create an overall satisfaction score (maximum = 60). Sociodemographic characteristics, including measures of socioeconomic status, were assessed at enrolment. A composite SES score was developed based on employment status and standardized scores of educational level, household income and a composite asset index made up of access to household resources, amenities and market access. Participants were categorized as low SES, low-moderate SES, moderate-high SES or high SES. A validated questionnaire, the World Mental Health Life Events Questionnaire, was used to assess stressful life events for participants based on items included in the South African Stress & Health Study [28]. For this analysis, we used a threshold of having experienced three or more stressful life events in the previous 12 months. Differences in participant motivators and study experiences across recruitment site and cohort (main versus intensive cohort) were identified using χ2 or Fisher exact tests for categorical variables and Wilcoxon rank sum tests for continuous variables. The association between participant experience scores and the number of scheduled study visits attended was explored using Spearman’s rank correlation. Variables significantly associated with higher participant experience scores (at p < 0.05) were identified using Wilcoxon rank sum tests for dichotomous variables and Kruskal-Wallis one-way analysis of variance tests for categorical variables, and were included in a multivariate model of participant experience using a forward stepwise approach. A linear regression model was built using likelihood ratio tests to assess model fit. Data were analyzed using Stata 12 (StataCorp Inc, College Station, Texas, USA).
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