Improve Study Compliance by Replacing / Complimenting Paper Diaries

Paper diaries are commonly used in healthcare and clinical research to assess medication adherence and patient experiences. Unfortunately, many patients do not comply with diary protocols, possibly invalidating the benefit of diary data. The validity of diary studies rests on the assumption that participants will accurately recall and record their experiences. However, the concern is that recall is unreliable and rife with inaccuracies and biases.1 Moreover, one study found that although patients reported high compliance (90%) with paper diaries, actual compliance was low (11%) and there was hoarding where previously-missed entries are ‘backfilled’ or completed all at once. This contrasted another cohort using electronic diaries where actual compliance was 94%.2

Noncompliance Increases Costs

Nonadherence by patients can lead to underestimated harms, misinterpretation of results, type II error and low statistical power – all leading to increased costs. Based on an extended analysis of Alsumdaie’s3 findings, Synegys reported that for a typical Phase 2 study, a 1% improvement in adherence would deliver nearly $400,000 in cost savings.4

Improve Study Outcomes and Assess Patient Experiences with mComply

Synegys offers health technology services based on a cloud-based solution called mComply. The solution allows Study Sponsors, CROs, Research Sites and Health Centers to engage in realtime with patients through two-way communications, timely notifications and data collection methods accessible on ALL mobile platforms and phones.

Armed with a compliance tool such as Synegys’ mComply, study teams can manage behaviours that impact costs. In fact, adherence rates as high as 97.5% can be achieved with mComply. The solution offers compliance-enhancing features, is easy to use, and is ubiquitious (i.e. no need of an additional device).

For more information, contact us.

1 Gorin AA, Stone AA. Recall biases and cognitive errors in retrospective self-reports: A call for momentary assessments. In: Baum A, Revenson T, Singer J, eds. Handbook of health psychology. Mahwah, NJ: Erlbaum,2001: 405-13.

2 Stone, Arthur & Shiffman, Saul & Schwartz, Joseph & Broderick, Joan & Hufford, Michael. (2003). Patient compliance with paper and electronic diaries. Controlled clinical trials. 24. 182-99. 10.1016/S0197-2456(02)00320-3.

3 Alsumidaie Moe, Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost, Applied Clinical Trials, Apr 2017.

4 Synegys, mComply: Running Successful Clinical Trials – Adherence Delivered., 2021.