Bmc Med Res Methodol
-
Bmc Med Res Methodol · Jan 2012
Patient, caregiver, health professional and researcher views and experiences of participating in research at the end of life: a critical interpretive synthesis of the literature.
The development of the evidence-base informing end of life (EoL) care is hampered by the assumption that patients at the EoL are too vulnerable to participate in research. This study aims to systematically and critically review the evidence regarding the experiences and views of patients, caregivers, professionals and researchers about participation in EoL care research, and to identify best practices in research participation. ⋯ The evidence explored within this study demonstrates that the ethical concerns regarding patient participation in EoL care research are often unjustified. However, research studies in EoL care require careful design and execution that incorporates sensitivity to participants' needs and concerns to enable their participation. An innovative conceptual model for research participation relevant for potentially vulnerable people was developed.
-
Bmc Med Res Methodol · Jan 2012
Quality assessment of systematic reviews or meta-analyses of nursing interventions conducted by Korean reviewers.
A systematic review is used to investigate the best available evidence of clinical safety and effectiveness of healthcare intervention. This requires methodological rigor in order to minimize bias and random error. The purpose of this study is to assess the quality of systematic reviews or meta-analyses for nursing interventions conducted by Korean researchers. ⋯ The methodological quality of published reviews on nursing interventions conducted by Korean reviewers was assessed as low to moderate. In order to use the best available evidence in clinical decision making, reviewers should conduct systematic reviews or meta- analyses using rigorous research methods.
-
Bmc Med Res Methodol · Jan 2012
Randomized Controlled Trial Comparative StudyTelephone follow-up to a mail survey: when to offer an interview compared to a reminder call.
Using a different mode of contact on the final follow-up to survey non-respondents is an identified strategy to increase response rates. This study was designed to determine if a reminder phone call or a phone interview as a final mode of contact to a mailed survey works better to increase response rates and which strategy is more cost effective. ⋯ The additional cost of completing an interview is worth it when an additional signed form is not required of the respondent. However, when such a signed form is required, offering an interview instead of a reminder phone call as a follow up to non-respondents does not increase response rates enough to outweigh the additional costs.
-
Bmc Med Res Methodol · Jan 2012
Randomized Controlled TrialAlternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE).
Clinical trial participants may be temporarily absent or withdraw from trials, leading to missing data. In intention-to-treat (ITT) analyses, several approaches are used for handling the missing information - complete case (CC) analysis, mixed-effects model (MM) analysis, last observation carried forward (LOCF) and multiple imputation (MI). This report discusses the consequences of applying the CC, LOCF and MI for the ITT analysis of published data (analysed using the MM method) from the Fracture Reduction Evaluation (FREE) trial. ⋯ The FREE trial results are robust as the alternative methods used for substituting missing data produced similar results. The MM method showed the highest statistical precision suggesting it is the most appropriate method to use for analysing the FREE trial data.
-
Bmc Med Res Methodol · Jan 2012
Bayesian model selection techniques as decision support for shaping a statistical analysis plan of a clinical trial: an example from a vertigo phase III study with longitudinal count data as primary endpoint.
A statistical analysis plan (SAP) is a critical link between how a clinical trial is conducted and the clinical study report. To secure objective study results, regulatory bodies expect that the SAP will meet requirements in pre-specifying inferential analyses and other important statistical techniques. To write a good SAP for model-based sensitivity and ancillary analyses involves non-trivial decisions on and justification of many aspects of the chosen setting. In particular, trials with longitudinal count data as primary endpoints pose challenges for model choice and model validation. In the random effects setting, frequentist strategies for model assessment and model diagnosis are complex and not easily implemented and have several limitations. Therefore, it is of interest to explore Bayesian alternatives which provide the needed decision support to finalize a SAP. ⋯ The proposed Bayesian methods are not only appealing for inference but notably provide a sophisticated insight into different aspects of model performance, such as forecast verification or calibration checks, and can be applied within the model selection process. The mean of the logarithmic score is a robust tool for model ranking and is not sensitive to sample size. Therefore, these Bayesian model selection techniques offer helpful decision support for shaping sensitivity and ancillary analyses in a statistical analysis plan of a clinical trial with longitudinal count data as the primary endpoint.