Bmc Med Res Methodol
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Bmc Med Res Methodol · Jan 2010
A life-course and time perspective on the construct validity of psychological distress in women and men. Measurement invariance of the K6 across gender.
Psychological distress is a widespread indicator of mental health and mental illness in research and clinical settings. A recurrent finding from epidemiological studies and population surveys is that women report a higher mean level and a higher prevalence of psychological distress than men. These differences may reflect, to some extent, cultural norms associated with the expression of distress in women and men. Assuming that these norms differ across age groups and that they evolve over time, one would expect gender differences in psychological distress to vary over the life-course and over time. The objective of this study was to investigate the construct validity of a psychological distress scale, the K6, across gender in different age groups and over a twelve-year period. ⋯ This study confirms the cross-gender construct validity of psychological distress as assessed with the K6 despite differences in the expression of some symptoms in women and in men over the life-course and over time. Findings suggest that the higher mean level of psychological distress observed in women reflects a true difference in distress and is unlikely to be gender-biased. Gender differences in psychological distress are an important public health and clinical issue and further researches are needed to decipher the factors underlying these differences.
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Bmc Med Res Methodol · Jan 2010
What differences are detected by superiority trials or ruled out by noninferiority trials? A cross-sectional study on a random sample of two-hundred two-arms parallel group randomized clinical trials.
The smallest difference to be detected in superiority trials or the largest difference to be ruled out in noninferiority trials is a key determinant of sample size, but little guidance exists to help researchers in their choice. The objectives were to examine the distribution of differences that researchers aim to detect in clinical trials and to verify that those differences are smaller in noninferiority compared to superiority trials. ⋯ Superiority trials are designed to detect larger differences than noninferiority trials are designed to rule out. The variability between studies is considerable and is partly explained by the type of outcome and the medical context. A more explicit and rational approach to choosing the difference to be detected or to be ruled out in clinical trials may be desirable.
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There is considerable clinician and researcher interest in whether the outcomes for patients with low back pain, and the efficiency of the health systems that treat them, can be improved by 'subgrouping research'. Subgrouping research seeks to identify subgroups of people who have clinically important distinctions in their treatment needs or prognoses. Due to a proliferation of research methods and variability in how subgrouping results are interpreted, it is timely to open discussion regarding a conceptual framework for the research designs and statistical methods available for subgrouping studies (a method framework). The aims of this debate article are: (1) to present a method framework to inform the design and evaluation of subgrouping research in low back pain, (2) to describe method options when investigating prognostic effects or subgroup treatment effects, and (3) to discuss the strengths and limitations of research methods suitable for the hypothesis-setting phase of subgroup studies. ⋯ This article proposes a research method framework for studies of subgroups in low back pain. Research designs and statistical methods appropriate for sequential phases in this research are discussed, with an emphasis on those suitable for hypothesis-setting studies of subgroups of people seeking care.
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Bmc Med Res Methodol · Jun 2009
Randomized Controlled Trial Comparative StudyAre we drawing the right conclusions from randomised placebo-controlled trials? A post-hoc analysis of data from a randomised controlled trial.
Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally, and that treatment effects are additional to the placebo effect. However, these assumptions have recently been challenged, and different mechanisms may potentially be operating in the placebo and treatment arms. The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a randomised, placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms. A substantial placebo response was observed but no significant difference in efficacy between the two arms. ⋯ This study was a post hoc analysis of predictors of the placebo versus treatment response. Whilst this study does not explore neurobiological mechanisms, these observations are consistent with the hypotheses that 'drug' effects and placebo effects are not necessarily additive, and that mutually exclusive mechanisms may be operating in the two arms. The need for more research in the area of mechanisms and mediators of placebo versus active responses is supported.
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Bmc Med Res Methodol · Jun 2009
Comparative StudyComparison of Bayesian and classical methods in the analysis of cluster randomized controlled trials with a binary outcome: the Community Hypertension Assessment Trial (CHAT).
Cluster randomized trials (CRTs) are increasingly used to assess the effectiveness of interventions to improve health outcomes or prevent diseases. However, the efficiency and consistency of using different analytical methods in the analysis of binary outcome have received little attention. We described and compared various statistical approaches in the analysis of CRTs using the Community Hypertension Assessment Trial (CHAT) as an example. The CHAT study was a cluster randomized controlled trial aimed at investigating the effectiveness of pharmacy-based blood pressure clinics led by peer health educators, with feedback to family physicians (CHAT intervention) against Usual Practice model (Control), on the monitoring and management of BP among older adults. ⋯ We used data from the CHAT trial to compare different methods for analysing data from CRTs. Using different methods to analyse CRTs provides a good approach to assess the sensitivity of the results to enhance interpretation.