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We examined the importance of understanding and incorporating cultural context within Aotearoa/New Zealand when engaging in clinical research and practice. This paper reports on the qualitative findings of a mixed methods study aimed at determining what effect a cardiac risk reduction exercise and lifestyle management programme, embedded within a kaupapa Māori methodological approach, had on Māori participants. This methodology saw participants able to redevelop a western model cardiac risk reduction programme by introducing a Māori worldview. Our study revealed how the kaupapa Māori approach empowered participants to examine and evaluate not only their own health and lifestyle choices, but those of family and the wider community. Combining biomedical and kaupapa Māori components into the programme was found to benefit participants' mental, physical, spiritual and family well-being. [ABSTRACT FROM AUTHOR]

Distributed networks of health-care data sources are increasingly being utilized to conduct pharmacoepidemio-logic database studies. Such networks may contain data that are not physically pooled but instead are distributed horizontally (separate patients within each data source) or vertically (separate measures within each data source) in order to preserve patient privacy. While multivariable methods for the analysis of horizontally distributed data are frequently employed, few practical approaches have been put forth to deal with vertically distributed healthcare databases. In this paper, we propose 2 propensity score-based approaches to vertically distributed data analysis and test their performance using 5 example studies. We found that these approaches produced point estimates close to what could be achieved without partitioning. We further found a performance benefit (i.e., lower mean squared error) for sequentially passing a propensity score through each data domain (called the "sequential approach") as compared with fitting separate domain-specific propensity scores (called the "parallel approach"). These results were validated in a small simulation study. This proof-of-concept study suggests a new multivariable analysis approach to vertically distributed health-care databases that is practical, preserves patient privacy, and warrants further investigation for use in clinical research applications that rely on health-care databases. [ABSTRACT FROM AUTHOR]

We propose a Bayesian phase I/II dose-finding trial design that simultaneously accounts for toxicity and efficacy. We model the toxicity and efficacy of investigational doses using a flexible Bayesian dynamic model, which borrows information across doses without imposing stringent parametric assumptions on the shape of the dose-toxicity and dose-efficacy curves. An intuitive utility function that reflects the desirability trade-offs between efficacy and toxicity is used to guide the dose assignment and selection. We also discuss the extension of this design to handle delayed toxicity and efficacy. We conduct extensive simulation studies to examine the operating characteristics of the proposed method under various practical scenarios. The results show that the proposed design possesses good operating characteristics and is robust to the shape of the dose-toxicity and dose-efficacy curves. [ABSTRACT FROM AUTHOR]

Background Consensus indicates that a comprehensive, multimodal, holistic approach is foundational to the practice of acute pain medicine (APM), but lack of uniform, evidence-based clinical pathways leads to undesirable variability throughout U. S. healthcare systems. Acute pain studies are inconsistently synthesized to guide educational programs. Advanced practice techniques involving regional anesthesia assume the presence of a physician-led, multidisciplinary acute pain service, which is often unavailable or inconsistently applied. This heterogeneity of educational and organizational standards may result in unnecessary patient pain and escalation of healthcare costs. Methods A multidisciplinary panel was nominated through the APM Shared Interest Group of the American Academy of Pain Medicine. The panel met in Chicago, IL, in July 2014, to identify gaps and set priorities in APM research and education. Results The panel identified three areas of critical need: 1) an open-source acute pain data registry and clinical support tool to inform clinical decision making and resource allocation and to enhance research efforts; 2) a strong professional APM identity as an accredited subspecialty; and 3) educational goals targeted toward third-party payers, hospital administrators, and other key stakeholders to convey the importance of APM. Conclusion This report is the first step in a 3-year initiative aimed at creating conditions and incentives for the optimal provision of APM services to facilitate and enhance the quality of patient recovery after surgery, illness, or trauma. The ultimate goal is to reduce the conversion of acute pain to the debilitating disease of chronic pain. [ABSTRACT FROM AUTHOR]

The definitive classification or diagnosis of gout normally relies upon the identification of MSU crystals in SF or from tophi. Where microscopic examination of SF is not available or is impractical, the best approach may differ depending upon the context. For many types of research, clinical classification criteria are necessary. The increasing prevalence of gout, advances in therapeutics and the development of international research collaborations to understand the impact, mechanisms and optimal treatment of this condition emphasize the need for accurate and uniform classification criteria for gout. Five clinical classification criteria for gout currently exist. However, none of the currently available criteria has been adequately validated. An international project is currently under way to develop new validated gout classification criteria. These criteria will be an essential step forward to advance the research agenda in the modern era of gout management. [ABSTRACT FROM AUTHOR]

Background. It is unknown whether changes in study sponsorship have affected the proportion of prospective research on surgery, radiotherapy, and pharmacotherapy for head and neck squamous cell carcinoma (HNSCC) being published over time. Patients and Methods. We examined prospective studies from PubMed, Ovid MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from 1980, 1985, 1990, 1995, 2000, 2005, and 2010. Chi-squared tests were used to identify significant associations between sponsorship and authorship, treatments within study protocols, and presentation of results, whereas time-based trends were analyzed using the Cochran-Armitage test. Results. Among 309 articles, industry (70, 22.7%) and the U.S. government (65, 21%) were the most common sponsors. There was a significant increase in the proportion of industry- sponsored research (p for trend =.013) and a decline in U.S. government-sponsored research (p for trend = .001) over time. The inclusion of surgery in treatment protocols declined over the past four decades (p for trend = .003). Protocols incorporating pharmacotherapy were more likely to have industry support than those without pharmacotherapy (p =.001), whereas protocols with radiotherapy (p = .003) or surgery (p = .002) were less likely to have industry support. Conclusion. Industry is the predominant sponsor of prospective HNSCC research, with an emphasis on pharmacotherapy. [ABSTRACT FROM AUTHOR]

The current state of the palliative oncology literature is unclear. We examined and compared the quantity, research design, and research topics of palliative oncology publications in the first 6months of 2004 with the first 6months of 2009. We systematically searched MEDLINE, PsychInfo, EMBASE, ISI Web of Science, and CINAHL for original studies, review articles, and systematic reviews related to "palliative care" and "cancer" during the first 6months of 2004 and 2009. Two physicians reviewed the literature independently and coded the study characteristics with high inter-rater reliability. We found a consistent decrease in the proportion of oncology studies related to palliative care between 2004 and 2009, despite an absolute increase in the total number of palliative oncology studies. Combining the two time periods, the most common original study designs were case report/series, cross-sectional studies, and qualitative studies. Randomized controlled trials comprised 6% of all original studies. The most common topics were physical symptoms, health services research, and psychosocial issues. Communication, decision making, spirituality, education, and research methodologies all represented <5% of the literature. Comparing 2004 with 2009, we found an increase in the proportion of original studies among all palliative oncology publications but no significant difference in study design or research topic. We identified significant deficiencies in the quantity, design, and scope of the palliative oncology literature. Further effort and resources are necessary to improve the evidence base for this important field. [ABSTRACT FROM AUTHOR]

Musculoskeletal (MS) ultrasonography (US) offers an overall assessment of the joints in OA. MSUS of the peripheral joints can be carried out at the time of consultation with high patient acceptability. This allows an immediate correlation between imaging findings and clinical data that improves diagnosis and management of patients with OA. The principal indications for MSUS in OA include detection of articular cartilage damage, bone changes, joint inflammation and adjacent soft tissue lesions. The main added value of US over clinical examination and plain radiography is its higher sensitivity for detecting synovitis and bone surface abnormalities, respectively. In addition, MSUS can be routinely used to guide accurate and safe diagnostic or therapeutic injections in the OA joints. The objective of the article is to describe the current applications of MSUS in both clinical practice and research in OA. [ABSTRACT FROM AUTHOR]