Impact of a Community Pharmacist-Delivered Information Program on the Follow-up of Type-2 Diabetic Patients: A Cluster Randomized Controlled Study.

INTRODUCTION: Low-quality communication between patients and care providers and limited patient knowledge of the disease and the therapy are important factors associated with poor glycemic control in patients with type 2 diabetes. We conducted a multicenter study to determine whether structured and tailored information delivered by pharmacists to type 2 diabetic patients could improve patient treatment adherence, hemoglobin A1c (HbA1c) levels and knowledge about diabetes. METHODS: One hundred seventy-four pharmacies were randomized to deliver an educational program on diet, drug treatment, disease and complications during three 30-min interviews over a 6-month period, or to provide no intervention, to type 2 diabetic patients treated with oral antidiabetic agents. Medication adherence was assessed by measuring the medication possession ratio and diabetes control by collecting HbA1c values. Levels of patient treatment self-management and disease knowledge were assessed using self-questionnaires. RESULTS: Three hundred seventy-seven patients were analyzed. The medication possession ratio, already very high at baseline in the intervention (94.8%) and control (92.3%) groups, did not vary significantly after 6 months with no difference between the two groups. Significant decreases in HbA1c were observed in both groups at 6 months (p < 0.001) and 12 months (p < 0.01), with significantly greater changes from baseline in the intervention group than in the control group at 6 months (- 0.5% vs. - 0.2%, p = 0.0047) and 12 months (- 0.6% vs. - 0.2%, p = 0.0057). Patients in the intervention group showed greater improvement in their ability to self-manage treatment (+ 4.86 vs. + 1.58, p = 0.0014) and in the extent of their knowledge about diabetes (+ 0.6 vs. + 0.2, p < 0.01) at 6 months versus baseline compared with the control group. CONCLUSION: Tailored information provided by the pharmacist to patients with type 2 diabetes did not significantly improve the already high adherence rates, but was associated with a significant decrease in HbA1c and an improvement of patient knowledge about diabetes. TRIAL REGISTRATION: ISRCTN33776525. FUNDING: MSD France.

Requests for post-registration studies (PRS), patients follow-up in actual practice: Changes in the role of databases.

Early market access of health products is associated with a larger number of requests for information by the health authorities. Compared with these expectations, the growing expansion of health databases represents an opportunity for responding to questions raised by the authorities. The computerised nature of the health system provides numerous sources of data, and first and foremost medical/administrative databases such as the French National Inter-Scheme Health Insurance Information System (SNIIRAM) database. These databases, although developed for other purposes, have already been used for many years with regard to post-registration studies (PRS). The use thereof will continue to increase with the recent creation of the French National Health Data System (SNDS [2016 health system reform law]). At the same time, other databases are available in France, offering an illustration of "product use under actual practice conditions" by patients and health professionals (cohorts, specific registries, data warehouses, etc.). Based on a preliminary analysis of requests for PRS, approximately two-thirds appeared to have found at least a partial response in existing databases. Using these databases has a number of disadvantages, but also numerous advantages, which are listed. In order to facilitate access and optimise their use, it seemed important to draw up recommendations aiming to facilitate these developments and guarantee the conditions for their technical validity. The recommendations drawn up notably include the need for measures aiming to promote the visibility of research conducted on databases in the field of PRS. Moreover, it seemed worthwhile to promote the interoperability of health data warehouses, to make it possible to match information originating from field studies with information originating from databases, and to develop and share algorithms aiming to identify criteria of interest (proxies). Methodological documents, such as the French National Authority for Health (HAS) recommendations on "Les études post-inscription sur les technologies de santé (médicaments, dispositifs médicaux et actes). Principes et méthodes" [Post-registration studies on health technologies (medicinal products, medical devices and procedures). Principles and methods] should be updated to incorporate these developments.

Assessment and non-clinical impact of medical devices.

Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.

Correlates of quality of life of pre-obese and obese patients: a pharmacy-based cross-sectional survey.

BACKGROUND: The correlates of quality of life (QOL), as measured by the OSQOL questionnaire were investigated in a convenience sample of overweight patients recruited in pharmacies. METHODS: A convenience sample of patients with a Body Mass Index > or = 28 kg/m(2) were recruited in community-based pharmacies. Baseline characteristics and QOL dimensions (1-Physical state, 2-Vitality-desire to do things, 3-Relations with others, 4-Psychological state) were reported in self-completed questionnaires from which the risk of obtaining a low QOL was assessed for each dimension. RESULTS: QOL was inadequate for all dimensions in the 494 patients included in the study (median age = 61, 48% women, 21% professional persons/top executives). Older pre-obese and obese patients were more likely to report impaired physical functioning (OR = 2.02, 95%CI = [1.10-3.70]), but were less severely affected socially (OR = 0.32, 95%CI = [0.15-0.69]). Pre-obese and obese professional persons and top executives showed better physical capabilities (OR = 0.35, 95%CI = [0.15-0.81]) and increased vitality (OR = 0.47, 95%CI = [0.23-0.95]). Overall, men's psychological state was better than females' (OR = 0.46, 95%CI = [0.25-0.82]). A body-mass index > or = 35 kg/m(2) was significantly associated with poorer QOL scores on physical, relational and psychological dimensions. CONCLUSION: Our data highlighted the influence of the severity of excess weight, gender, age and socioeconomic status on QOL. These factors should be taken into account when interpreting QOL in pre-obese and obese persons.

A French national survey on infiltrating breast cancer: analysis of clinico-pathological features and treatment modalities in 1159 patients.

BACKGROUND: Despite the approximate 42,000 yearly new cases of breast cancer in France, there have been very few exhaustive studies on the clinicopathological features and treatment options of this disease. METHODS: Thus, a prospective, non-selective, nationwide survey on infiltrating breast cancer (IBC) was conducted in France from September 2001 to April 2002, in order to assess the epidemiological features of newly diagnosed disease, the prognostic and predictive variables with a special emphasis on hormone receptors, and the current approaches to therapy in everyday clinical practice. RESULTS: In total, 1159 patients were evaluable (median age 57 years); two-thirds of women were postmenopausal and 38% had undergone hormonal replacement therapy (HRT). Ductal and lobular infiltrating cancers represented 82.3% and 11.6% of cases, respectively. Most tumours expressed oestrogen (79.7%) and progesterone (69.7%) receptors. Overexpression of the human epidermal growth factor receptor-2 oncogene was found in 20.6% of the assessed cases. IBC diagnosed in women under HRT presented significantly better clinico-pathological features than in non-users. All patients underwent surgery as first treatment: 77.5% breast-conserving surgery (BCS) and 22.5% mastectomy; 1024 patients also underwent axillary surgery. The overall axillary lymph-node involvement rate was 44.4%. Radiotherapy was proposed in 98% and 83% of the women who had undergone BCS and mastectomy, respectively. Adjuvant chemotherapy was delivered in 58.7% of patients and hormonal treatment was provided in 76.5% of patients; tamoxifen was the most widely used hormonal treatment. CONCLUSIONS: This study showed a trend for global downstaging of IBC (with favourable clinico-pathological features), leading to a high rate of BCS. Postoperative treatments were widely used, in accordance with national and international guidelines. Use of aromatase inhibitors and taxanes was limited, but is likely to rise in the future.

Assessment of a therapeutic education programme for asthma patients: "un souffle nouveau".

The aim of this study was to evaluate the impact of a new patient education programme on adults with asthma. This self-management programme included an individual assessment of patient's needs and two educational group sessions. Teaching methods and session content are described as well as caregivers training programme. The training sessions included a written asthma action plan based on symptoms and personal peak expiratory flow. Patients (n = 238) aged from 18 to 60 years were allocated to the intervention (group A) or control group (group B). Patients filled during 1 year a daily diary and questionnaire and they were administered telephone interviews. 127 patients were included in the treatment program and 111 in the control group. There was a significant improvement in the educated group with regard to symptoms free days (P = 0.03), number of awakenings (P = 0.04), consumption of corticosteroids (P = 0.03), consumption of beta2-agonists (P = 0.03), and quality of life score (P = 0.01). In conclusion, this study validates a specific educational approach named "un souffle nouveau".