A top 5 list for French general practice.

BACKGROUND: Medical overuse is an issue that has recently gained attention. The "Choosing Wisely" campaign invited each specialty in each country to create its own top five lists of care procedures with a negative benefit-risk balance to promote dialogue between patients and physicians. This study aims to create such a list for French general practice. METHODS: A panel of general practitioners (GPs) suggested care procedures that they felt ought to be prescribed less. Using the Delphi method, a short list of those suggestions was selected. Systematic literature reviews were performed for each item on the short list. The results were presented to the panel to assist with the final selection of the top five list. RESULTS: The panel included 40 GPs. The list includes: i/ antibiotics prescription for acute bronchitis, nasopharyngitis, otitis media with effusion, or uncomplicated influenza, ii/ systematic prostate specific antigen testing in men older than 50, iii/ prescription of cholinesterase inhibitors for mild cognitive impairment and for Alzheimer's disease and memantine for Alzheimer's disease, iv/ statins prescription in primary prevention of cardio-vascular risk in older patients, and v/ benzodiazepine or benzodiazepine-like agents prescription for generalised anxiety, insomnia, and for all indications in older patients. CONCLUSIONS: This study resulted in a French top five list in general practice using a panel of GPs. All the items selected have a negative risk-benefit balance and are frequently prescribed by French general practitioners. This list differs from other top five lists for general practice, reflecting the local medical culture.

Outcomes in registered, ongoing randomized controlled trials of patient education.

BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs) evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life). METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1) patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2) surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333) of all primary outcomes and 46% (286 of 623) of all secondary outcomes. Overall, 69% of trials (104 of 150) used at least one patient-important outcome as a primary outcome and 66% (99 of 150) as a secondary outcome. Finally, for 31% of trials (46 of 150), primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61) of primary outcomes, as compared with 54% (32 of 59) in malignant neoplasm and 18% (4 of 22) in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months). CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

Inadequate description of educational interventions in ongoing randomized controlled trials.

BACKGROUND: The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs) of patient education. METHODS: On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health) and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. RESULTS: We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%). The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47%) or active treatment (47%). A minority of records (17%, 95% CI 11 to 23%) reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention). Further, for most reports (59%), important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63%. Information about the caregivers was missing for 70% of trials. Most trials (73%) took place in the United States or United Kingdom, 64% involved only one centre, and participating centers were mainly tertiary-care, academic or university hospitals (51%). CONCLUSIONS: Educational interventions assessed in ongoing RCTs of educational interventions are poorly described in trial registries. The lack of adequate description raises doubts about the ability of trial registration to help patients and researchers know about the treatment evaluated in trials of education.