[HTML][HTML] Reporting bias in medical research-a narrative review

N McGauran, B Wieseler, J Kreis, YB Schüler, H Kölsch… - Trials, 2010 - Springer
Reporting bias represents a major problem in the assessment of health care interventions.
Several prominent cases have been described in the literature, for example, in the reporting …

[HTML][HTML] Guideline appraisal with AGREE II: online survey of the potential influence of AGREE II items on overall assessment of guideline quality and recommendation …

…, AC Brockhaus, N McGauran… - BMC health services …, 2018 - Springer
Background The AGREE II instrument is the most commonly used guideline appraisal tool. It
includes 23 appraisal criteria (items) organized within six domains. AGREE II also includes …

[HTML][HTML] Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data

B Wieseler, N Wolfram, N McGauran, MF Kerekes… - PLoS …, 2013 - journals.plos.org
Background Access to unpublished clinical study reports (CSRs) is currently being discussed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 …

New drugs: where did we go wrong and what can we do better?

B Wieseler, N McGauran, T Kaiser - Bmj, 2019 - bmj.com
More than half of new drugs entering the German healthcare system have not been shown
to add benefit. Beate Wieseler and colleagues argue that international drug development …

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

B Wieseler, MF Kerekes, V Vervoelgyi, N McGauran… - BMJ, 2012 - bmj.com
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 …

Reporting a systematic review

B Wieseler, N McGauran - Chest, 2010 - journal.chestnet.org
Objective: State objective of the review (research question with reference to PICOS). 4
Components of the question: PICOS (participants, interventions, comparisons, outcomes, and …

Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry …

…, S Haag, K Biester, AC Brockhaus, N McGauran… - Bmj, 2015 - bmj.com
Background When a new drug becomes available, patients and doctors require information
on its benefits and harms. In 2011, Germany introduced the early benefit assessment of new …

Reforming EU and national orphan drug regulations to improve outcomes for patients with rare diseases

P Kranz, N McGauran, R Banzi, C Ünal, F Lotz… - bmj, 2023 - bmj.com
Philip Kranz and colleagues argue that the alleged superior therapeutic benefit attributed to
orphan drugs is often not supported by evidence from clinical trials and propose a reform of …

[HTML][HTML] Negative pressure wound therapy: potential publication bias caused by lack of access to unpublished study results data

F Peinemann, N McGauran, S Sauerland… - BMC medical research …, 2008 - Springer
Background Negative pressure wound therapy (NPWT) is widely applied, although the
evidence base is weak. Previous reviews on medical interventions have shown that conclusions …

Early benefit assessment of new drugs in Germany–Results from 2011 to 2012

H Hörn, K Nink, N McGauran, B Wieseler - Health Policy, 2014 - Elsevier
Rising drug costs in Germany led to the Act on the Reform of the Market for Medicinal Products
(AMNOG) in January 2011. For new drugs, pharmaceutical companies have to submit …