Exploratory analyses of clinical trial data used for health technology assessments: a retrospective evaluation.

Objectives: To examine the validity and statistical limitations of exploratory analyses of clinical trial data commonly requested by agencies responsible for determining which medical products may be financed or reimbursed by a healthcare system.

Design: This was a retrospective review of efficacy and safety analyses conducted for German Health Technology Assessment (HTA) evaluations with a decision date between 2015 and 2020, and an illustrative safety-related exploratory analysis of data from two phase III clinical trials of verubecestat (an anti-amyloid drug whose development was stopped for lack of efficacy) as would be mandated by the German HTA agency.

Results: We identified 422 HTA evaluations of 404 randomised controlled clinical trials.

Influence of structured counseling on women's selection of hormonal contraception in Israel: results of the CHOICE study.

Background: The multinational CHOICE (Contraceptive Health Research Of Informed Choice Experience) study evaluated the effects of structured counseling on women's contraceptive decisions, their reasons for making those decisions, and their perceptions of combined hormonal contraceptive (CHC) methods in eleven countries. The aim of this paper to present data from the 1,802 women participating in Israel's CHOICE program.

Methods: Women (aged 17-40 years) who consulted their health care providers about contraception and who would consider a CHC method qualified to participate.

Factors influencing women's selection of combined hormonal contraceptive methods after counselling in 11 countries: results from a subanalysis of the CHOICE study.

Objectives: To investigate which characteristics of women and healthcare professionals (HCPs) were associated with changing to another combined hormonal contraceptive (CHC) method after contraceptive counselling.

Methods: CHOICE was a cross-sectional survey in which 18,787 women were counselled about combined hormonal contraceptives, during which their contraceptive methods preferred both prior to and after counselling were recorded. In this subanalysis, characteristics associated with changing the method after counselling were determined using logistic regression models.

Women's perceptions and reasons for choosing the pill, patch, or ring in the CHOICE study: a cross-sectional survey of contraceptive method selection after counseling.

Background: The European CHOICE study was a cross-sectional survey that evaluated women's combined hormonal contraceptive choices before and after contraceptive counseling in Austria, Belgium, Czech Republic and Slovakia, the Netherlands, Poland, Sweden, Switzerland, Israel, Russia, and Ukraine. The changes in method selection before and after counseling were reported previously. In this paper we present the reasons given by the 18,787 participating women for selecting their contraceptive method of choice, as well as their perceptions about the contraceptive pill, patch, and ring after counseling.

C-reactive protein, an indicator for maintained response or remission to infliximab in patients with Crohn's disease: a post-hoc analysis from ACCENT I.

Background: Secondary loss of response to anti-TNF-α therapy is observed in Crohn's disease patients.

Aim: Serum C-reactive protein (CRP) levels at baseline and after infliximab induction therapy at week 14 were assessed as predictors for maintained response or remission through 54 weeks of treatment in patients with Crohn's disease who responded to induction therapy.

Methods: ACCENT I was a multicenter, randomised, placebo-controlled study.