Recruitment issues in cluster randomised trials.

<p>Recruitment issues in cluster randomised trials.</p

Follow-up issues in cluster randomised trials.

<p>Follow-up issues in cluster randomised trials.</p

Example of final agreement and sequential agreement.

<p>In this example final agreement was high because the final treatment proposed at the last step of the vignette response was identical to the final treatment administered at the end of the vignette source situation in the documentation: hysterectomy. However sequential agreement was low because the management sequence was dissimilar between that proposed in the vignette response and that in the vignette source situation from the documentation: selective arterial embolization was added as a potential vignette response.</p

Outcomes in Registered, Ongoing Randomized Controlled Trials of Patient Education

<div><h3>Background</h3><p>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).</p> <h3>Methods</h3><p>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.</p> <h3>Principal Findings</h3><p>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.</p> <p>In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months).</p> <h3>Conclusions</h3><p>There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.</p> </div

Patient-important outcomes in a random sample of Cochrane reviews.

<p>Patient-important outcomes in a random sample of Cochrane reviews.</p

Probabilities of being the best among competing antidepressant agents when reporting bias affects one specific agent.

<p>The first stacked bar at the left corresponds to the network meta-analysis free of reporting biases (ie, with the data from the 74 FDA-registered trials). The other stacked bars correspond to the 12 network meta-analyses in which reporting bias hypothetically affects one specific agent in turn. For instance, for mirtazapine, we used the 6 published trials (out of 10 FDA-registered trials), with published effect sizes, and data from the 64 FDA-registered trials for the other 11 agents, which resulted in an incomplete FDA network of 70 trials; the probability of mirtazapine being the best was 80.6% with data from the incomplete FDA network and 7.3% with data from the 74 FDA-registered trials. For the sake of clarity, we presented in each analysis the 3 drugs with the 3 highest probabilities of being the best among competing antidepressant agents. Bup: Bupropion; Cit: Citalopram; Dul : Duloxetine ; Esc: Escitalopram; Flu: Fluoxetine; Mir: Mirtazapine ; Nef: Nefazodone ; Par: Paroxetine; Par CR: Paroxetine CR; Ser: Sertraline; Ven: Venlafaxine; VenXR: Venlafaxine XR.</p

Study design.

<p>This figure describes study design and flow chart of the study.</p

Classification of outcomes reported in the Summary of Findings (SoF) table in 290 recent Cochrane reviews.

<p>Classification of outcomes reported in the Summary of Findings (SoF) table in 290 recent Cochrane reviews.</p

Step 3 of sample vignette.

<p>This figure corresponds to screenshot of the website: third and last step of the same vignette with the same closed-ended question.</p

Summary effect sizes for the 12 comparisons of each antidepressant agent and placebo.

<p>Weighted mean effect-size values for each drug were derived using a random-effects model with the method of DerSimonian and Laird. N: number of trials; SMD (95%CI): summary standardized mean difference of drug vs. placebo derived from random effects meta-analysis (95% confidence interval); Τ² (SE): between-trial variance as a measure of heterogeneity in meta-analysis (standard error); NA: not assessable.</p