Self-report |
What was the question(s) asked? (Count of doses or pills missed or taken? |
Estimation of overall adherence over the time interval?) |
Reliability and validity information for the instrument. |
What was adherence in reference to in terms of agent(s)? (i.e., All ARVs or a selected ARV?) |
How many days or months were in the recall period? |
Was one full 7 day period (or other incorporation of a weekend) included? |
Who or what posed the question(s)? (Clinician, intervener, neutral interviewer, computer with voice, computer text only?) |
Was the question(s) asked one-on-one? |
Was the question(s) part of a larger assessment or research/clinic visit? If so, when did the adherence assessment occur in relation to other procedures and total duration of the visit? (Was it at the end of a long visit? End of a long computer delivered questionnaire?) |
Were there reasons to be concerned about patient-group/item-format mismatch? (Numeracy, wording that is uncommon in local culture, asked only in a second or third language of the patient-group?) |
What threats were there in terms of reporting bias? (Were real or perceived negative consequences associated with reports of non-adherence? Were positive or negative consequences from reports of high or low adherence equal between the study arms?) |
What assurances/strategies were in place to minimize potential self-reporting bias?) |
If data were treated categorically, how were the categorical parameters established and what was the rationale for the categories? |
Electronic monitoring |
What device (version, specification) was used? |
How and when were participants instructed on device use? |
Was there a lead-in time to control for the intervention effect associated with electronic monitoring devices? |
What quality control methods were used to evaluate device use during the trial? |
What was the malfunction rate during the course of the study? |
What strategies were used to account for non-device pill administration (ie “pocket-dosing)? |
What data censoring procedures were used during analysis? |
If data were treated categorically, how were the categorical parameters established and what was the rationale for the categories? |
Pill counts |
What was the setting in which the count was conducted (home, office, community)? |
Was the count conducted face-to-face or via communications technology (telephone, internet)? |
Who counted the pills (patient, family member, professional staff)? |
Was the pill-count unannounced or scheduled? |
Which medications were included in the count? |
How was the baseline number of pills from which the remainder was subtracted established? |
If data were treated categorically, how were the categorical parameters established and what was the rationale for the categories? |
Pharmacy refill records |
Did all patients obtain all medications from a single pharmacy? |
If multiple pharmacies provided data, how was a uniform data base established? |
What information was included in the pharmacy data base? Was dosing information part of the data base or was it imputed? |
How were left-over or carry-forward medications handled? |
Was information from an EMR available and, if so, how was it used? |
If data were treated categorically, how were the categorical parameters established and what was the rationale for the categories? |