ObjectiveTo develop and validate an instrument to assess adherence to each individual drug taken by patients undergoing long-term treatment.DesignMulticentre prospective observational validation study.SettingSix general practitioners' clinics and 6 university hospitals in Paris, France.ParticipantsPatients 18 years and older receiving at least one long-term treatment.MethodsThe instrument was developed from a literature search and interviews with experts. Clarity and wording were assessed during pilot testing with 51 patients. The tool was validated in a sample of consecutive patients. We assessed agreement between adherence measured with our tool and drug diaries and compared measurements from our instrument with (1) the Lu instrument; (2) the Adherence Estimator (AE); (3) patient's adherence assessed by physicians; (4) the Morisky Medication Adherence Scale-4 items (MMAS-4); and (5) the Treatment Burden Questionnaire (TBQ). Reliability was assessed by a test–retest method.ResultsA total of 243 patients taking 961 drugs were recruited in 2014. We found good agreement between adherence measured by our tool and drug diaries (intraclass correlation coefficient (ICC) 0.69, 95% CI 0.34 to 0.91) and a linear relationship between measurement with our tool and (1) the Lu instrument (p<0.01); (2) 2 items of the AE (perceived need for medication (p<0.01) and concerns about medication (p<0.01)); (3) patients' adherence assessed by their physicians (p<0.01); (4) the MMAS-4 (p<0.01) and (5) the TBQ (p<0.01). Reliability of the retest was good (ICC 0.67, 95% CI 0.42 to 0.85).ConclusionsWe developed an instrument with acceptable validity and reliability to assess adherence for each drug taken by patients, usable in hospital and primary care settings.

Background and Aims Baclofen is a promising drug for treating patients with alcohol‐related disorders. Nevertheless, the first randomized clinical trials (mainly with target doses) reported inconsistent efficacy, possibly because of the effective dose widely varying between patients. The Bacloville study aimed to test the efficacy of titrated baclofen for achieving low‐risk alcohol consumption. Design Twelve‐month multicenter pragmatic double‐blind randomized clinical trial from June 2012 to June 2014. Setting Sixty‐two French primary care centers. Participants Out‐patients with high‐risk alcohol consumption (> 40 g/day for women and > 60 g/day for men). Intervention and comparator Patients were randomly assigned (1 : 1 ratio) to receive titrated baclofen up to 300 mg/day or placebo for 12 months. Switching to open‐label baclofen was allowed in cases of perceived inefficacy. Measurements The primary outcome defined success as no or low‐risk alcohol consumption (≤ 20 g/day for women and ≤ 40 g/day for men) during the last month of the 1‐year follow up, with patients who switched to open‐label baclofen classified as failures. Findings A total of 320 patients were randomized, 162 to baclofen and 158 to placebo (consumption 129 g/day in both arms). Discontinuation rates were 30 and 34% in the baclofen and placebo arms, respectively, and return rates of the last‐month diaries were 42 and 34%, respectively. Primary success rates were 57 and 36% in the baclofen and placebo arms, respectively [difference: 21 percentage points, 95% confidence interval (CI) = 8–34, P = 0.003]. When switchers were not classified as failures unless they failed, the success rates were 62 versus 55% (difference: 6 percentage points, 95% CI = –7 to 20). Over 12 months, daily consumption differed between both arms (11 g less in the baclofen arm), as did the number of abstinence days (3.3 days more in the baclofen arm). Adverse events were more frequent with baclofen than placebo and were mostly drowsiness, fatigue and insomnia. Serious adverse events occurred in 85 (seven deaths) and 36 (three deaths) patients with baclofen and placebo, respectively. Conclusions Baclofen was more effective than placebo in reducing alcohol consumption to low‐risk levels. The number of adverse events and more serious adverse events was greater with baclofen than placebo.