Projektname
ESPACOMP Medication adherence reporting guideline

Projektleitung
Sabina De Geest

INS-Projektteam
Sabina De Geest collaboration with ESPACOMP

Externe Projektpartner
Members of the association ESPACOMP (European Society for Patient Adherence, COMpliance, and Persistence) 

Laufzeit
2015 bis fortlaufend

Projektbeschreibung
Hintergrund
Medication adherence research reporting is commonly substandard. A solid conceptual underpinning and adequate measurement and analysis of medication adherence data are often lacking in published articles. Existing medication adherence guidelines and recommendations overlap other general guidelines for health research, lack a clear conceptualization of medication adherence, or focus on study design rather than reporting.

Zielsetzung
To develop a guideline for reporting medication adherence research that is grounded in the conceptualization of medication adherence provided by a robust taxonomy. 

Design/Methode
EMERGE was developed following recommendations for health research reporting guideline developers of the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network (www.equator-network.org). A steering committee comprised of 7 members of ESPACOMP (www.espacomp.eu) led the project. That committee first convened in Prague, Czech Republic in 2015, with 4 feedback rounds via email and conference calls in 2016. Their discussion of a literature review of published adherence guidelines and a further review of existing health research reporting guidelines yielded an initial pool of 26 items for reporting, organized according to the sections of the most used health research reporting guidelines (i.e., CONSORT, STROBE), avoiding overlapping with existing guidelines.

The initial 26-item pool was the basis for two rounds of reactive e-Delphi surveys (30, 31). Respondents included a purposive sample of international experts (15 countries, 6 continents) representing diverse disciplines and fields engaged in medication adherence research (e.g., clinical research, public health, statistics, health policy, the pharmaceutical industry, journal editors). Forty-five experts were invited, of whom 29 participated in the first round (64% response rate). They evaluated each item for relevance and clarity, and could comment, suggest further items and/or modify the initial items. Guided by pre-defined rules on decisions and stopping, as well as by qualitative comments received from the survey experts, the steering committee reviewed and discussed the first-round e-Delphi results during a meeting in Húsafell (Iceland) in July 2016.

Based on the agreed criteria, all 26 items initially evaluated in the first Delphi round were judged relevant (mean 91%, SD 5%, range: 79%-97%) and clear (mean 84%, SD 10% range: 59%-97%). Nevertheless, the experts’ qualitative comments and subsequent discussion in the steering committee revealed possibilities to optimize the wording of several items. Due to redundancy or inconsistency with other EMERGE items, or with items from main reporting guidelines, the committee chose to exclude 5 items.

The remaining 21 items entered the second e-Delphi round, during which 26 of the 29 experts who participated in the first round re-rated the items for relevance and clarity. All items again cleared the threshold for relevance (mean 93%, range: 85%-100%) and clarity (mean 90%, range: 73%-100%). The qualitative comments allowed fine-tuning of several items’ wording, resulting in the 21-item list presented at the annual ESPACOMP conference in Lisbon, Portugal in November 2016 and approved by a formal vote of all members.

Once finalized, EMERGE will be published in peer-reviewed journals to be available for use by researchers.

Erwarteter Nutzen / Relevanz
The ESPACOMP Medication Adherence Reporting Guideline (EMERGE) offers a standard method for researchers to report their medication adherence findings. Implementation of the ESPACOMP Medication Adherence Reporting Guideline (EMERGE) is expected to enhance the quality of medication adherence research reporting via standardization, reducing research waste, accelerating progress in this and related fields, and ultimately, improving patient outcomes.