Additional file 1: of Knowledge transfer: what drug information would specialist doctors need to support their clinical practice? Results of a survey and of three focus groups in Italy

Questionnaire. Description of data: 24-item questionnaire used for the quantitative survey. (RTF 371 kb

Inhaled Corticosteroid Use in Chronic Obstructive Pulmonary Disease and Risk of Pneumonia: A Nested Case-Control Population-based Study in Lazio (Italy)—The OUTPUL Study

<p>Inhaled corticosteroid (ICS) use in chronic obstructive pulmonary disease (COPD) patients is associated with a reduction of exacerbations and a potential risk of pneumonia. The objective was to determine if ICS use, with or without long-acting β₂-agonist, increases pneumonia risk in COPD patients. A cohort study was performed using linked hospital and drug prescription databases in the Lazio region. Patients (45+) discharged with COPD in 2006–2009 were enrolled and followed from cohort entry until first admission for pneumonia, death or study end, 31 December, 2012. A nested case-control approach was used to estimate the rate ratio (RR) associated with current or past use of ICS adjusted for age, gender, number of exacerbations in the previous year and co-morbidities. Current users were defined as patients with their last ICS prescribed in the 60 days prior to the event. Past users were those with the last prescription between 61 and 365 days before the event. Current use was classified into three levels (high, medium, low) according to the medication possession ratio. Among the cohort of 19288 patients, 3141 had an event of pneumonia (incidence rate for current use 87/1000py, past use 32/1000py). After adjustment, patients with current use were 2.29 (95% confidence interval [CI]: 1.99–2.63) times more likely to be hospitalised for pneumonia with respect to no use; for past use RR was 1.23 (95% CI: 1.07–1.42). For older patients (80+), the rate was higher than that for younger patients. ICS use was associated with an excess risk of pneumonia. The effect was greatest for higher doses and in the very elderly.</p

Long Term Effectiveness on Prescribing of Two Multifaceted Educational Interventions: Results of Two Large Scale Randomized Cluster Trials

<div><p>Introduction</p><p>Information on benefits and risks of drugs is a key element affecting doctors’ prescribing decisions. Outreach visits promoting independent information have proved moderately effective in changing prescribing behaviours.</p><p>Objectives</p><p>Testing the short and long-term effectiveness on general practitioners’ prescribing of small groups meetings led by pharmacists.</p><p>Methods</p><p>Two cluster open randomised controlled trials (RCTs) were carried out in a large scale NHS setting. Ad hoc prepared evidence based material were used considering a therapeutic area approach - TEA, with information materials on osteoporosis or prostatic hyperplasia - and a single drug oriented approach - SIDRO, with information materials on me-too drugs of 2 different classes: barnidipine or prulifloxacin. In each study, all 115 Primary Care Groups in a Northern Italy area (2.2 million inhabitants, 1737 general practitioners) were randomised to educational small groups meetings, in which available evidence was provided together with drug utilization data and clinical scenarios. Main outcomes were changes in the six-months prescription of targeted drugs. Longer term results (24 and 48 months) were also evaluated.</p><p>Results</p><p>In the TEA trial, one of the four primary outcomes showed a reduction (prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia: prescribing ratio −8.5%, p = 0.03). Another primary outcome (prescription of risedronate) showed a reduction at 24 and 48 months (−7.6%, p = 0.02; and −9,8%, p = 0.03), but not at six months (−5.1%, p = 0.36). In the SIDRO trial both primary outcomes showed a statistically significant reduction (prescription of barnidipine −9.8%, p = 0.02; prescription of prulifloxacin −11.1%, p = 0.04), which persisted or increased over time.</p><p>Interpretation</p><p>These two cluster RCTs showed the large scale feasibility of a complex educational program in a NHS setting, and its potentially relevant long-term impact on prescribing habits, in particular when focusing on a single drug. National Health systems should invest in independent drug information programs.</p><p>Trial Registration</p><p>Controlled-Trials.com <a href="http://www.controlled-trials.com/ISRCTN05866587" target="_blank">ISRCTN05866587</a></p></div

SIDRO trial: GPs’ mean baseline prescription (in the 3 months preceding the outreach visit) of considered drugs, expressed as DDD per 1000 patients.

<p>SIDRO trial: GPs’ mean baseline prescription (in the 3 months preceding the outreach visit) of considered drugs, expressed as DDD per 1000 patients.</p

TEA trial: GPs’ mean baseline prescription (in the 3 months preceding the outreach visit) of drugs considered in the primary outcomes, expressed as DDD per 1000 patients.

<p>TEA trial: GPs’ mean baseline prescription (in the 3 months preceding the outreach visit) of drugs considered in the primary outcomes, expressed as DDD per 1000 patients.</p

SIDRO trial: differences in DDD per 1000 patients of prescribed drugs (intervention vs control).

<p>*a lower increase was observed in the intervention group.</p><p>SIDRO trial: differences in DDD per 1000 patients of prescribed drugs (intervention vs control).</p

% differences in primary outcomes at 6 months (main analysis), 12, 24 and 48 months.

<p>% differences in primary outcomes at 6 months (main analysis), 12, 24 and 48 months.</p

TEA trial: differences in DDD per 1000 patients of prescribed drugs (intervention vs control: 1605 included GPs).

†<p>56 physicians who had not prescribed tamsulosin or terazosin could not be included in the calculation since this is a ratio.</p>§<p>300 physicians who had not prescribed risedronate or ibandronate could not be included in the calculation since this is a ratio.</p><p>TEA trial: differences in DDD per 1000 patients of prescribed drugs (intervention vs control: 1605 included GPs).</p

The main components of the multifaceted educational intervention.

<p>The main components of the multifaceted educational intervention.</p

Flow-charts of the two cluster RCTs.

<p>Flow-charts of the two cluster RCTs.</p