Bmc Med Res Methodol
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Bmc Med Res Methodol · Dec 2011
Stopping rules employing response rates, time to progression, and early progressive disease for phase II oncology trials.
Response rate (RR), the most common early means of assessing oncology drugs, is not suitable as the sole endpoint for phase II trials of drugs which induce disease stability but not regression. Time to progression (TTP) may be more sensitive to such agents, but induces recruitment delays in multistage studies. Early progressive disease (EPD) is the earliest signal of time to progression, but is less intuitive to investigators, To study drugs with unknown anti-tumour effect, we designed the Combination Stopping Rule (CSR), which allows investigators to establish a hypothesis using RR and TTP, while the program also employs early progressive disease (EPD) to assess for drug inactivity during the first stage of study accrual. ⋯ Stopping rules are provided for phase II trials for drugs which have either a desirable RR or TTP. In addition, early stopping can be achieved using RR and EPD.
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Bmc Med Res Methodol · Sep 2011
Randomized Controlled TrialA randomised trial and economic evaluation of the effect of response mode on response rate, response bias, and item non-response in a survey of doctors.
Surveys of doctors are an important data collection method in health services research. Ways to improve response rates, minimise survey response bias and item non-response, within a given budget, have not previously been addressed in the same study. The aim of this paper is to compare the effects and costs of three different modes of survey administration in a national survey of doctors. ⋯ Decisions on which survey mode to use depend on response rates, response bias, item non-response and costs. The sequential mixed mode appears to be the most cost-effective mode of survey administration for surveys of the population of doctors, if one is prepared to accept a degree of response bias. Online surveys are not yet suitable to be used exclusively for surveys of the doctor population.
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Bmc Med Res Methodol · Aug 2011
Protocol--realist and meta-narrative evidence synthesis: evolving standards (RAMESES).
There is growing interest in theory-driven, qualitative and mixed-method approaches to systematic review as an alternative to (or to extend and supplement) conventional Cochrane-style reviews. These approaches offer the potential to expand the knowledge base in policy-relevant areas - for example by explaining the success, failure or mixed fortunes of complex interventions. However, the quality of such reviews can be difficult to assess. This study aims to produce methodological guidance, publication standards and training resources for those seeking to use the realist and/or meta-narrative approach to systematic review. ⋯ Realist and meta-narrative review are relatively new approaches to systematic review whose overall place in the secondary research toolkit is not yet fully established. As with all secondary research methods, guidance on quality assurance and uniform reporting is an important step towards improving quality and consistency of studies.
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Bmc Med Res Methodol · Feb 2011
FORM: an Australian method for formulating and grading recommendations in evidence-based clinical guidelines.
Clinical practice guidelines are an important element of evidence-based practice. Considering an often complicated body of evidence can be problematic for guideline developers, who in the past may have resorted to using levels of evidence of individual studies as a quasi-indicator for the strength of a recommendation. This paper reports on the production and trial of a methodology and associated processes to assist Australian guideline developers in considering a body of evidence and grading the resulting guideline recommendations. ⋯ The framework has now been widely adopted by Australian guideline developers who find it to be a logical and intuitive way to formulate and grade recommendations in clinical practice guidelines.
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Bmc Med Res Methodol · Jan 2011
"Do I really want to do this?" Longitudinal cohort study participants' perspectives on postal survey design: a qualitative study.
Randomised controlled trials have investigated aspects of postal survey design yet cannot elaborate on reasons behind participants' decision making and survey behaviour. This paper reports participants' perspectives of the design of, and participation in, a longitudinal postal cohort survey. It describes strengths and weaknesses in study design from the perspectives of study participants and aims to contribute to the: 1) design of future cohort surveys and questionnaires generally and, 2) design of cohort surveys for people with musculoskeletal disorders (MSDs) specifically. ⋯ Ideas generated in this study provide an insight into participants' decision making and survey behaviour and may enhance the acceptability of future surveys to potential participants. As well as clear communication, participants valued incentives and survey questions that were relevant to them. However, opinions varied as to the preferred format for responses with some advising more opportunity for open-ended feedback. We also found that some standard format questions can raise quandaries for individual participants.