Randomised trial investigating the relationship of response rate for blood sample donation to site of biospecimen collection, fasting status and reminder letter: the 45 and Up Study.

BACKGROUND

Various options exist for collecting biospecimens and biomarkers from cohort study participants, and these have important logistic, resource and scientific implications. Evidence on how different collection methods affect participation and data quality is lacking. This parallel-design randomised trial, the Link-Up Study, involved blood sample donation and other data collection among participants in an existing cohort study, The 45 and Up Study. It aimed to investigate the relation of fasting status, reminder letters and data collection site to response rates, data quality and biospecimen yield.

METHODS

Individuals aged 45 and over participating in The 45 and Up Study and living ≤ 20 km from central Wagga Wagga, NSW (regional area) or ≤ 10 km from central Parramatta, NSW (urban area) (n=2340) were randomised, stratified by area of residence, to be invited to give a blood sample and additional data by attending either a clinic established specifically for the trial, with an appointment time ("dedicated clinic", n=1336) or an existing local commercial pathology centre (n=1004). Within dedicated clinic groups, participants were randomised into fasting (n=668) or non-fasting (n=668) and, at the Parramatta pathology centre site, reminder letter after two weeks (n=336) or no reminder (n=334).

RESULTS

Overall, 33% (762/2340) of invitees took part in the Link-Up Study; 41% (410/1002) among regional and 26% (352/1338) among urban-area residents (p<0.0001). At the dedicated clinics, response rates were 38% (257/668) not fasting and 38% fasting (257/668) (participation rate ratio (RR) =1.00, 95%CI 0.91-1.08, p=0.98). The response rate was 22% among individuals randomised to attend the Parramatta pathology centre without a reminder and 23% among those sent a reminder letter (RR=1.01, 0.93-1.09, p=0.74). In total, the response rate was 38% (514/1336) at the dedicated clinics and 25% (248/1004) at the pathology centres (RR=0.67, 0.56-0.78, p<0.01); measures of height, weight and systolic and diastolic blood pressure did not vary materially between these groups, nor did the median number of aliquots of plasma, buffy coat and red cells collected.

CONCLUSIONS

Among cohort study participants, response rates for an additional study involving biospecimen collection, but not data quality or average biospecimen yield, were considerably higher at dedicated clinics than at existing commercial pathology sites.