Community-based randomised controlled trial evaluating falls and osteoporosis risk management strategies

<p>Abstract</p> <p>Background</p> <p>Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis, as well as prevention of fractures and falls, are substantially underutilized. This paper outlines the protocol for a pragmatic randomised trial of a multifaceted community-based care program aimed at optimizing the evidence-based management of falls and fractures in patients at risk.</p> <p>Design</p> <p>6-month randomised controlled study.</p> <p>Methods</p> <p>This population-based study was completed in the Algoma District of Ontario, Canada a geographically vast area with Sault Ste Marie (population 78 000) as its main city. Eligible patients were allocated to an immediate intervention protocol (IP) group, or a delayed intervention protocol (DP) group. The DP group received usual care for 6 months and then was crossed over to receive the interventions. Components of the intervention were directed at the physicians and their patients and included patient-specific recommendations for osteoporosis therapy as outlined by the clinical practice guidelines developed by Osteoporosis Canada, and falls risk assessment and treatment. Two primary outcomes were measured including implementation of appropriate osteoporosis and falls risk management. Secondary outcomes included quality of life and the number of falls, fractures, and hospital admissions over a twelve-month period. The patient is the unit of allocation and analysis. Analyses will be performed on an intention to treat basis.</p> <p>Discussion</p> <p>This paper outlines the protocol for a pragmatic randomised trial of a multi-faceted, community-based intervention to optimize the implementation of evidence based management for patients at risk for falls and osteoporosis.</p> <p>Trial Registration</p> <p>This trial has been registered with clinicaltrials.gov (ID: NCT00465387)</p

Systematic review of methods used in meta-analyses where a primary outcome is an adverse or unintended event

addresses: Peninsula College of Medicine and Dentistry, St Luke's Campus, University of Exeter, Exeter, UK. [email protected]: PMCID: PMC3528446types: Journal Article; Research Support, Non-U.S. Gov't© 2012 Warren et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Adverse consequences of medical interventions are a source of concern, but clinical trials may lack power to detect elevated rates of such events, while observational studies have inherent limitations. Meta-analysis allows the combination of individual studies, which can increase power and provide stronger evidence relating to adverse events. However, meta-analysis of adverse events has associated methodological challenges. The aim of this study was to systematically identify and review the methodology used in meta-analyses where a primary outcome is an adverse or unintended event, following a therapeutic intervention

Fendas orofaciais no recém-nascido e o uso de medicamentos e condições de saúde materna: estudo caso-controle na cidade do Rio de Janeiro, Brasil Oral clefts in the newborn and medical intakes and maternal health conditions: a case-control study in the city of Rio de Janeiro, Brazil

OBJETIVOS: avaliar a associação deste grupo de malformações e determinadas condições de saúde materna. MÉTODOS: estudo caso-controle reunindo 274 portadores de fendas lábio-palatinas e 548 controles hospitalares. As medidas de risco (odds ratio: OR), foram obtidos a partir da análise de regressão logística condicional. RESULTADOS: as principais associações foram o relato de malformações maternas (OR 8,01; IC95%: 2,23-28,81); infecções ginecológicas (OR 2,77; IC95%: 1,50-5,10); distúrbios neurológicos (OR 7,11; IC95%: 2,57-19,75); viroses (resfriados comuns, por exemplo) (OR 7,57; IC95%: 2,46-23,32). Na história reprodutiva, nenhuma condição foi estatisticamente significantes, no entanto, abortos espontâneos prévios (OR 1,42; IC95%: 0,95-2,13) e natimortos (OR 2,22; IC95%: 0,88-5,65) exibiram maior magnitude de risco. Além do uso de anticonvulsivantes (OR 20,00; IC95%: 3,36-437,97), outros grupos de medicamentos atuaram como fatores de risco, como analgésicos (OR 1,45; IC95%: 1,08-1,95); antibióticos (OR 2,43; IC95%: 1,33-4,57); antifúngicos (OR 9,00; IC95%: 2,14-61,12) e chás (OR 4,09; IC95%: 2,23-7,77). CONCLUSÕES: ao lado de exposições já descritas na literatura, como aquela relativa ao uso de anticonvulsivantes, outras tantas foram identificadas. Embora possam ter sofrido a influência de fatores de confundimento e viés de memória, que podem afetar os resultados deste estudo elas devem ser avaliadas servindo de subsídio para estudos mais específicos.<br>OBJECTIVES: to evaluate the association of this malformation group and specific conditions of maternal health. METHODS: case control study with 274 individuals with cleft lip and palate and 548 hospital controls. The odd ratio (OR) and confidence intervals were obtained based on conditional logistic interval analysis. RESULTS: the main associations were maternal malformation reports (OR 8,01; 95%IC%: 2,23-28,81); gynecological infections (OR 2,77; 95%IC: 1,50-5,10); neurological conditions (OR 7,11; IC95%: 2,57-19,75); viruses (common cold for example) (OR 7,57; 95%IC: 2,46-23,32). In reproductive history no condition was demonstrated as being statistically significant, nevertheless, previous spontaneous abortions (OR 1,42; 95%IC: 0,95-2,13) and stillborns (OR 2,22; 95%IC: 0,88-5,65) demonstrated more pronounced risks. In addition to the use of anticonvulsant drugs (OR 20,00; 95%IC: 3,36-437,97), other drug groups were indicated as risk factors such as analgesics (OR 1,45; 95%IC: 1,08-1,95); antibiotics (OR 2,43; 95%IC: 1,33-4,57); antifungical drugs (OR 9,00; 95%IC: 2,14-61,12) and teas (OR 4,09; 95%IC: 2,23-7,77). CONCLUSIONS: together with exposures already described in the literature, including the use of anticonvulsant drugs, many others were identified. Although they may have been affected by possible mental confusion and forgetfulness that could have affected the results of this study, they should be evaluated and used as subsidies to more specific studies