Bmc Med Res Methodol
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Bmc Med Res Methodol · Jul 2016
LetterProtecting patient privacy when sharing patient-level data from clinical trials.
Greater transparency and, in particular, sharing of patient-level data for further scientific research is an increasingly important topic for the pharmaceutical industry and other organisations who sponsor and conduct clinical trials as well as generally in the interests of patients participating in studies. A concern remains, however, over how to appropriately prepare and share clinical trial data with third party researchers, whilst maintaining patient confidentiality. Clinical trial datasets contain very detailed information on each participant. Risk to patient privacy can be mitigated by data reduction techniques. However, retention of data utility is important in order to allow meaningful scientific research. In addition, for clinical trial data, an excessive application of such techniques may pose a public health risk if misleading results are produced. After considering existing guidance, this article makes recommendations with the aim of promoting an approach that balances data utility and privacy risk and is applicable across clinical trial data holders. ⋯ Our key recommendations are as follows: 1. Data anonymisation/de-identification: Data holders are responsible for generating de-identified datasets which are intended to offer increased protection for patient privacy through masking or generalisation of direct and some indirect identifiers. 2. Controlled access to data, including use of a data sharing agreement: A legally binding data sharing agreement should be in place, including agreements not to download or further share data and not to attempt to seek to identify patients. Appropriate levels of security should be used for transferring data or providing access; one solution is use of a secure 'locked box' system which provides additional safeguards. This article provides recommendations on best practices to de-identify/anonymise clinical trial data for sharing with third-party researchers, as well as controlled access to data and data sharing agreements. The recommendations are applicable to all clinical trial data holders. Further work will be needed to identify and evaluate competing possibilities as regulations, attitudes to risk and technologies evolve.
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Bmc Med Res Methodol · Jul 2016
LetterEFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets - a primer for academic researchers.
Access to patient level datasets from clinical trial sponsors continues to be an important topic for the Pharmaceutical Industry as well as academic institutions and researchers. How to make access to patient level data actually happen raises many questions from the perspective of the researcher. ⋯ Whilst the benefits and value of patient level data sharing have yet to be fully realised, we hope that the information outlined in this article will encourage researchers to consider accessing and re-using clinical trial data to support their research questions.
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Bmc Med Res Methodol · Jun 2016
ReviewStepped wedge cluster randomised trials: a review of the statistical methodology used and available.
Previous reviews have focussed on the rationale for employing the stepped wedge design (SWD), the areas of research to which the design has been applied and the general characteristics of the design. However these did not focus on the statistical methods nor addressed the appropriateness of sample size methods used.This was a review of the literature of the statistical methodology used in stepped wedge cluster randomised trials. ⋯ Many studies which employ the stepped wedge design have few clusters but use methods of analysis which may require more clusters for unbiased and efficient intervention effect estimates. There is the need for research on the minimum number of clusters required for both types of stepped wedge design. Researchers should distinguish in the sample size calculation between cohort and cross sectional stepped wedge designs. Further research is needed on the effect of adjusting for the potential confounding of time on the study power.
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Bmc Med Res Methodol · Jun 2016
Modeling the oxygen uptake kinetics during exercise testing of patients with chronic obstructive pulmonary diseases using nonlinear mixed models.
The six-minute walk test (6MWT) is commonly used to quantify exercise capacity in patients with several cardio-pulmonary diseases. Oxygen uptake ([Formula: see text]O2) kinetics during 6MWT typically follow 3 distinct phases (rest, exercise, recovery) that can be modeled by nonlinear regression. Simultaneous modeling of multiple kinetics requires nonlinear mixed models methodology. To the best of our knowledge, no such curve-fitting approach has been used to analyze multiple [Formula: see text]O2 kinetics in both research and clinical practice so far. ⋯ Hereby we demonstrate the novelty and usefulness of this methodology in the context of physiological exercise testing.
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Bmc Med Res Methodol · May 2016
Using the modified Delphi method to establish clinical consensus for the diagnosis and treatment of patients with rotator cuff pathology.
Patients presenting to the healthcare system with rotator cuff pathology do not always receive high quality care. High quality care occurs when a patient receives care that is accessible, appropriate, acceptable, effective, efficient, and safe. The aim of this study was twofold: 1) to develop a clinical pathway algorithm that sets forth a stepwise process for making decisions about the diagnosis and treatment of rotator cuff pathology presenting to primary, secondary, and tertiary healthcare settings; and 2) to establish clinical practice guidelines for the diagnosis and treatment of rotator cuff pathology to inform decision-making processes within the algorithm. ⋯ This consensus guideline will help to standardize care, provide guidance on the diagnosis and treatment of rotator cuff pathology, and assist in clinical decision-making for all healthcare professionals.