A cluster randomised control trial to evaluate the effectiveness and cost-effectiveness of the Italian medicines use review (I-MUR) for asthma patients

Abstract

BackgroundThe economic burden of asthma, which relates to the degree of control, is €5 billion annually in Italy. Pharmacists could help improve asthma control, reducing this burden. This study aimed to evaluate the effectiveness and cost-effectiveness of Medicines Use Reviews provided by community pharmacists in asthma.MethodsThis cluster randomised, multi-centre, controlled trial in adult patients with asthma was conducted in 15 of the 20 regions of Italy between September 2014 and July 2015. After stratification by region, community pharmacists were randomly allocated to group A (trained in and delivered the intervention at baseline) or B (training and delivery 3 months later), using computerised random number generation in blocks of 10. Each recruited up to five patients, with both groups followed for 9 months.The intervention consisted of a systematic, structured face-to-face consultation with a pharmacist, covering asthma symptoms, medicines used, attitude towards medicines and adherence, recording pharmacist-identified pharmaceutical care issues (PCIs). The primary outcome was asthma control, assessed using the Asthma-Control-Test (ACT) score (ACT ≥ 20 represents good control). Secondary outcomes were: number of active ingredients, adherence, cost-effectiveness compared with usual care. Although blinding was not possible for either pharmacists or patients, assessment of outcomes was conducted by researchers blind to group allocation.ResultsNumbers of pharmacists and patients enrolled were 283 (A = 136; B = 147) and 1263 (A = 600; B = 663), numbers completing were 201 (A = 97; B = 104) and 816 (A = 400; B = 416), respectively. Patients were similar in age and gender and 56.13% (458/816) had poor/partial asthma control. Pharmacists identified 1256 PCIs (mean 1.54/patient), mostly need for education, monitoring and potentially ineffective therapy. Median ACT score at baseline differed between groups (A = 19, B = 18; p < 0.01). Odds ratio for improved asthma control was 1.76 (95% CI 1.33–2.33) and number needed to treat 10 (95% CI 6–28). Number of active ingredients reduced by 7.9% post-intervention (p < 0.01). Adherence improved by 35.4% 3 months post-intervention and 40.0% at 6 months (p < 0.01). The probability of the intervention being more cost-effective than usual care was 100% at 9 months.ConclusionsThis community pharmacist-based intervention demonstrated both effectiveness and cost-effectiveness. It has since been implemented as the first community pharmacy cognitive service in Italy.Trial registrationTRN: ISRCTN72438848 (registered 5th January 2015, retrospectively).

Do randomised controlled trials relevant to pharmacy meet best practice standards for quality conduct and reporting? A systematic review

“…Only one paper met all criteria of the Cochrane tool and two papers did not meet any. The median CONSORT score was 59.5% (IQR 52.0–70.3%) with three papers meeting 83.8% of the criteria and one meeting only 29.7% . The median adjusted CONSORT score was 72.4% (IQR 61.8–83.9%), with the highest score of 96.9% achieved by one paper, and the lowest (35.5%) by one paper (see Appendices and ).…”

Pharmacists and medication adherence in asthma: a systematic review and meta-analysis

“…Primary reasons for exclusion were: same participant sample, not asthma patients, not RCT, author non-response to request for information, no adherence measure, not pharmacist-led, no usual care control group and unpublished studies (figure 2). We included 11 studies in the narrative synthesis [23][24][25][26][27][28][29][30][31][32][33] and nine studies in the meta-analysis [23-26, 28, 30-33]. Authors of eight included studies provided further information upon request [23-25, 28, 29, 31-33].…”

“…Two authors did not respond [26,30]. One author was unable to provide further details due to intellectual property restrictions [27].…”

Relationship between the Asthma Control Test (ACT) and other outcomes: a targeted literature review

“…Despite its clinical utility, a need remains to assess the link between ACT score and asthma treatment benefits and outcomes, and its suitability as an endpoint in clinical trials. Previous studies have used the ACT as a measure of response to treatment [5,6], including a recent Phase III study that was not published in time to be included in this review [7]. The aim of the current study was to assess the extent to which ACT score is correlated, or associated, with other important clinical, patient-reported, and economic asthma outcomes.…”