Improving ambulatory saliva-sampling compliance in pregnant women: a randomized controlled study

Julian Moeller; Roselind Lieb; Andrea H Meyer; Katharina Quack Loetscher; Bettina Krastel; Gunther Meinlschmidt

doi:10.1371/journal.pone.0086204

Improving ambulatory saliva-sampling compliance in pregnant women: a randomized controlled study

PLoS One. 2014 Jan 22;9(1):e86204. doi: 10.1371/journal.pone.0086204. eCollection 2014.

Authors

Julian Moeller¹, Roselind Lieb², Andrea H Meyer², Katharina Quack Loetscher³, Bettina Krastel⁴, Gunther Meinlschmidt⁵

Affiliations

¹ University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology, Basel, Switzerland ; Diagnostic and Crisis Intervention Centre, Department of Psychiatry, University of Basel, Basel, Switzerland.
² University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology, Basel, Switzerland.
³ Department of Obstetrics, University Hospital Zurich, Zurich, Switzerland.
⁴ National Centre of Competence in Research (NCCR), Swiss Etiological Study of Adjustment and Mental Health (sesam), University of Basel, Basel, Switzerland.
⁵ University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology, Basel, Switzerland ; National Centre of Competence in Research (NCCR), Swiss Etiological Study of Adjustment and Mental Health (sesam), University of Basel, Basel, Switzerland ; Faculty of Medicine, Ruhr-University Bochum, Bochum, Germany.

Abstract

Objective: Noncompliance with scheduled ambulatory saliva sampling is common and has been associated with biased cortisol estimates in nonpregnant subjects. This study is the first to investigate in pregnant women strategies to improve ambulatory saliva-sampling compliance, and the association between sampling noncompliance and saliva cortisol estimates.

Methods: We instructed 64 pregnant women to collect eight scheduled saliva samples on two consecutive days each. Objective compliance with scheduled sampling times was assessed with a Medication Event Monitoring System and self-reported compliance with a paper-and-pencil diary. In a randomized controlled study, we estimated whether a disclosure intervention (informing women about objective compliance monitoring) and a reminder intervention (use of acoustical reminders) improved compliance. A mixed model analysis was used to estimate associations between women's objective compliance and their diurnal cortisol profiles, and between deviation from scheduled sampling and the cortisol concentration measured in the related sample.

Results: Self-reported compliance with a saliva-sampling protocol was 91%, and objective compliance was 70%. The disclosure intervention was associated with improved objective compliance (informed: 81%, noninformed: 60%), F(1,60) = 17.64, p<0.001, but not the reminder intervention (reminders: 68%, without reminders: 72%), F(1,60) = 0.78, p = 0.379. Furthermore, a woman's increased objective compliance was associated with a higher diurnal cortisol profile, F(2,64) = 8.22, p<0.001. Altered cortisol levels were observed in less objective compliant samples, F(1,705) = 7.38, p = 0.007, with delayed sampling associated with lower cortisol levels.

Conclusions: The results suggest that in pregnant women, objective noncompliance with scheduled ambulatory saliva sampling is common and is associated with biased cortisol estimates. To improve sampling compliance, results suggest informing women about objective compliance monitoring but discourage use of acoustical reminders.

Publication types

Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Ambulatory Care*
Biomarkers
Female
Humans
Hydrocortisone / metabolism
Patient Acceptance of Health Care*
Pregnancy
Saliva / metabolism*
Self Report
Specimen Handling*
Stress, Psychological / epidemiology
Stress, Psychological / metabolism

Substances

Biomarkers
Hydrocortisone

Grants and funding

This work is part of the National Centre of Competence in Research (NCCR) Swiss Etiological Study of Adjustment and Mental Health (sesam). The Swiss National Science Foundation (SNSF) (project no. 51A240-104890), the University of Basel, the F. Hoffmann-La Roche Corp., and the Freie Akademische Gesellschaft provided core support for the NCCR sesam. Additionally, G.M. receives SNSF funding under project no. 100014_135328. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.