Comparative effectiveness of biological medicines in rheumatoid arthritis: systematic review and network meta-analysis including aggregate results from reanalysed individual patient data.

Objective: To assess the comparative effectiveness of biological medicines in rheumatoid arthritis in sufficiently similar patient populations, based on the current definitions of key outcomes.

Design: Systematic review and network meta-analysis including aggregate results from reanalysed individual patient data.

Data Sources: Clinical study reports and aggregate results from reanalyses of individual patient data on key outcomes for rheumatoid arthritis provided by study sponsors for studies conducted up to 2017, and several databases and registries from inception up to February 2017.

Impact of inclusion of industry trial results registries as an information source for systematic reviews.

Background: Clinical trial results registries may contain relevant unpublished information. Our main aim was to investigate the potential impact of the inclusion of reports from industry results registries on systematic reviews (SRs).

Methods: We identified a sample of 150 eligible SRs in PubMed via backward selection.

Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data.

Background: Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs.

Access to regulatory data from the European Medicines Agency: the times they are a-changing.

Systematic reviewers are increasingly trying to obtain regulatory clinical study reports (CSRs) to correct for publication bias. For instance, our organization, the Institute for Quality and Efficiency in Health Care, routinely asks drug manufacturers to provide full CSRs of studies considered in health technology assessments. However, since cooperation is voluntary, CSRs are available only for a subset of studies analysed.

Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications.

Objective: To investigate to what extent three types of documents for reporting clinical trials provide sufficient information for trial evaluation.

Design: Retrospective analysis

Data Sources: Primary studies and corresponding documents (registry reports, clinical study reports, journal publications) from 16 health technology assessments of drugs conducted by the German Institute for Quality and Efficiency in Health Care between 2006 and February 2011. Data analysis We assessed reporting quality for each study and each available document for six items on methods and six on outcomes, and dichotomised them as "completely reported" or "incompletely reported.

[Prevalence of male breast cancer in our department during a 5-year period].

Male breast cancer is a rare entity. Statistics suggest the female:male ratio is100:1. Male breast cancer is most frequent in elderly patients, but it can occur at any age.

Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials.

Objectives: To assess the benefits and harms of reboxetine versus placebo or selective serotonin reuptake inhibitors (SSRIs) in the acute treatment of depression, and to measure the impact of potential publication bias in trials of reboxetine.

Design: Systematic review and meta-analysis including unpublished data.

Data Sources: Bibliographic databases (Medline, Embase, PsycINFO, BIOSIS, and Cochrane Library), clinical trial registries, trial results databases, and regulatory authority websites up until February 2009, as well as unpublished data from the manufacturer of reboxetine (Pfizer, Berlin).

A systematic review of duloxetine and venlafaxine in major depression, including unpublished data.

Objective: To determine the short-term antidepressant efficacy and tolerability of duloxetine and venlafaxine vs. each other, placebo, selective serotonin reuptake inhibitors (SSRIs), and tri- and tetracyclic antidepressants (TCAs) in adults with major depression.

Method: Meta-analysis of randomised controlled trials identified through bibliographical databases and other sources, including unpublished manufacturer reports.

[Changing trends in breast surgery over a five year period (1998-2002)--a retrospective analysis].

Today's development in breast cancer surgery are characterized by the principle of the smallest necessary intervention in contrast with the radicality of the past. To achieve this goal the primary and crucial task is the recognition of early (stage I or II) breast cancer. The National Screening Program started 2002 provides ideal conditions.