Using the web for recruitment, screen, tracking, data management, and quality control in a dietary assessment clinical validation trial

Arab, Lenore; Hahn, Harry; Henry, Judith; Chacko, Sara A.; Winter, Ashley; Cambou, Mary Catherine

doi:10.1016/j.cct.2009.11.005

Cited by 34 publications

(25 citation statements)

References 13 publications

(13 reference statements)

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“…In addition, some initial studies examining the success of recruitment via the Internet have been promising, including a study comparing a letter-only recruitment method with a letter + website method that reported a response rate significantly higher among those who received the letter + the website option [6]. Similarly, authors of a study that used a website specifically designed for initial screening of potential participants concluded that the 20% yield from screening to consent using the website reduced recruitment cost from a previously experienced yield of 10% when screening was done solely through in-person telephone calls [7]. …”

Section: Introductionmentioning

confidence: 99%

Comparison of characteristics and outcomes by initial study contact (website versus staff) for participants enrolled in a weight management study

et al. 2012

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Background Traditional recruitment methods for clinical trials, such as telephone, mail, and print-media, are often inefficient, costly and use large amounts of staff time and resources. Purpose This analysis was conducted to determine whether retention, demographics, and outcomes differed between enrolled participants who responded to recruitment outreach using an Internet-based information and registration system and enrollees whose first contact was with study staff via telephone. Methods We identified potentially eligible participants from Kaiser Permanente Northwest databases and mailed brochures inviting them to participate in the Life weight-loss maintenance study. We also used employee newsletters, a member-directed website, and messages to employee email distribution lists to publicize the study. All outreach methods contained both a website address and a telephone number through which respondents could register for an information session. The website contained the same information as was provided by staff over the telephone. Results Out of 2122 potential participants who expressed interest in the study, 70% did so through the website. There was no difference in retention rates between enrollees who initiated contact through the website (WEB = 308) and enrollees who contacted the study by telephone (Staff = 161). The WEB group was younger (p = 0.01), had higher income (p = 0.01) and education (p < 0.01) levels, and lower body mass index (p < 0.01). There was a trend toward greater weight loss in the WEB group (p = 0.06). Limitations We did not conduct a formal cost analysis of the two methods. Also, the population for this analysis was mostly Caucasian and middle income; thus, we cannot draw conclusions about the generalizability of our findings to more racially and economically diverse populations. Conclusion Enrolled participants who used a website to register for an initial study information session had similar study retention and outcome performance as enrollees who used a more traditional telephone method. For larger clinical trials, a website may help researchers more efficiently and cost-effectively achieve recruitment, eligibility, and randomization goals. More research is needed to determine whether similar recruitment and retention patterns are observed among racially and economically diverse populations when these and similar methods are compared.

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Section: Introductionmentioning

confidence: 99%

Comparison of characteristics and outcomes by initial study contact (website versus staff) for participants enrolled in a weight management study

et al. 2012

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“…An initial analysis suggests that the collection of multiple-day records of food is feasible (10,11). A recent publication by Satia et al (8) compared four 24-h dietary recalls with food-frequency questionnaires concerning the reporting of carotenoids intake in a North Carolina population.…”

Section: Introductionmentioning

confidence: 99%

Racial differences in correlations between reported dietary intakes of carotenoids and their concentration biomarkers

Arab

Cambou

Craft

et al. 2011

The American Journal of Clinical Nutrition

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Despite stronger validity in reported energy intakes for African Americans than for whites in the 24-h dietary recall in the Energetics Study, both recalls and food-frequency dietary assessment methods yielded lower correlations in African Americans than in whites. This finding might be attributable to reporting differences in both dietary sources and food preparation or to racially related genetic variants influencing circulating concentrations. The current findings support the need to account for differences in race, age, sex, and body mass index in regression calibrations of dietary reports and measurement error adjustments.

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“…We identified three nutrition-related trials that described use of patient-completed online screening for enrollment. Two nutrition trials noted an increase in recruitment success and decrease in staff time allocated to screening with use of online screening compared to telephone screening [31,32]. A third trial noted variability in use of online screening according to user age, income, and race/ethnicity, but that a diverse participant population was ultimately enrolled by this means [33].…”

Section: Discussionmentioning

confidence: 99%

Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: A structured report of real-world applicability

Yank

Stafford

Rosas

et al. 2013

Contemporary Clinical Trials

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Background Although the Diabetes Prevention Program (DPP) lifestyle intervention reduced type 2 diabetes incidence by 58% among high-risk adults at academic centers, it requires translation into typical primary care settings. Using baseline data from the Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care (E-LITE) randomized controlled trial, we evaluated the potential of its two DPP-based interventions to reach their target populations and be adopted into routine use. Methods Overweight/obese adults with increased cardiometabolic risk enrolled from one primary care clinic. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) model, we assessed reach with data on patient identification, participation, and representativeness, and adoption with data on intervention feasibility and potential for organizational diffusion. Results The target population was identified by searching electronic health records. Contact was attempted for 2391 patients who completed initial screening by phone (56% uptake) or online (44%). Most (88%) of those screened ineligible were not within the target population; 12% were excluded because of research requirements. Conservatively estimated participation rate was 44%. Participants (n=241) included 54% men and had a mean (SD) age of 52.9 years (10.6) and body mass index of 32 kg/m2 (5.4). Regarding adoption, all clinic physicians agreed to participate. The feasibility of intervention implementation and dissemination was enhanced by leveraging existing intervention, training, and primary care resources. Conclusions E-LITE's lifestyle interventions had fair-to-good potential for primary care reach and adoption. Our trial evidence and structured reporting may inform real-world implementation of translational trials by health networks, physicians, and payers.

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Using the web for recruitment, screen, tracking, data management, and quality control in a dietary assessment clinical validation trial

Cited by 34 publications

References 13 publications

Comparison of characteristics and outcomes by initial study contact (website versus staff) for participants enrolled in a weight management study

Comparison of characteristics and outcomes by initial study contact (website versus staff) for participants enrolled in a weight management study

Racial differences in correlations between reported dietary intakes of carotenoids and their concentration biomarkers

Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: A structured report of real-world applicability

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