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Princeton, NJ, United States

Formoso G.,Guideline
Cochrane database of systematic reviews (Online) | Year: 2012

Tibolone is an option available for the treatment of menopausal symptoms, based on short-term data on its efficacy. However, there is a need to consider the balance between the benefits and risks of tibolone as there are concerns about breast and endometrial cancer as well as stroke. To evaluate the effectiveness and safety of tibolone in treating postmenopausal women. We searched the Cochrane Menstrual Disorders and Subfertility Group (MDSG) Specialised Register (19 April 2011), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, 2nd Quarter), MEDLINE (from inception to 19 April 2011), EMBASE (1980 to week 3 April 2011), PsycINFO (1806 to week 3 April 2011), Clinical Trials.gov (30 April 2011). Individual researchers and the current manufacturer of tibolone were contacted to identify unpublished and ongoing trials. Randomised controlled trials (RCTs) that compared tibolone versus placebo, estrogens or combined hormone replacement therapy (HT) by assessing the percentage of women with menopausal symptoms, the severity of those symptoms and the occurrence of safety outcomes in postmenopausal women. Four review authors independently extracted information from the articles, resolving discrepancies by consensus. All outcomes studied were dichotomous. Odds ratios (OR) and 95% confidence intervals (CI) were calculated using the random-effects model. Heterogeneity of studies was taken into account before deciding to combine the data. When compared to placebo, tibolone was more effective in relieving the frequency of vasomotor symptoms (two RCTs, n = 847; OR 0.42, 95% CI 0.25 to 0.69), although only the 2.5 mg/day dose of tibolone was significantly better than placebo; but with increased vaginal bleeding (seven RCTs, n = 7462; OR 2.75, 95% CI 1.99 to 3.80). When compared to equipotent doses of combined HT, tibolone reduced vaginal bleeding (15 RCTs, n = 6342; OR 0.32, 95% CI 0.24 to 0.42) but was less effective in relieving the frequency of vasomotor symptoms (two RCTs, n = 545; OR 4.16, 95% CI 1.50 to 11.58).As for long term safety, two major RCTs of tibolone versus placebo provided the most relevant data. An RCT of 3098 women with breast cancer and menopausal symptoms was halted after 3.1 years because of increased tumour recurrence (OR 1.50; 95% CI 1.21 to 1.85). However, in another RCT that selected osteoporotic women with negative mammograms (n = 4506) tibolone was associated with a reduction in breast cancer compared to placebo after 2.8 years (OR 0.32, 95% CI 0.13 to 0.79) although the trial was not specifically designed to assess that outcome and the number of overall events was low. In the same RCT, an excess risk of stroke was observed (OR 2.18, 95% CI 1.12 to 4.21). There was no clear evidence of a tibolone effect on endometrial cancer compared with placebo given the low number of events (seven RCTs, n = 8152; OR 1.98, 95% CI 0.73 to 5.32).There was no evidence of a difference in long term safety between tibolone and combined HT. Tibolone, used at the daily dose of 2.5 mg, may be less effective than combined HT in alleviating menopausal symptoms although it reduced the incidence of vaginal bleeding. There was evidence that treatment with combined HT was more effective in managing menopausal symptoms than was tibolone. Available data on the long term safety of tibolone is concerning given the increase in the risk of breast cancer in women who had already suffered from breast cancer in the past and in a separate trial the increase in the risk of stroke in women whose mean age was over 60 years. Similar concerns may exist for estroprogestins but their overall benefit-risk profile is better known and is more directly related to women with menopausal symptoms. Source


O'Mahony R.,Guideline | Murthy L.,Uk Cochrane Center | Akunne A.,KSG Trans | Young J.,Royal Infirmary
Annals of Internal Medicine | Year: 2011

Description: Delirium is common, is often underrecognized, and is associated with poor outcomes and high costs. In July 2010, the National Institute for Health and Clinical Excellence released a guideline that addressed diagnosis, prevention, and management of delirium. This synopsis focuses on the main recommendations about prevention of delirium. Methods: The National Clinical Guideline Centre developed these guidelines by using standard methodology of the National Institute for Health and Clinical Excellence. A multidisciplinary guideline development group posed review questions, discussed evidence, and formulated the recommendations. To underpin the guideline, a technical team from the National Clinical Guideline Centre systematically reviewed and graded pertinent evidence identified from literature searches of studies published in English to August 2009 and performed health economic modeling. Stakeholder and public comment informed guideline development and modifications. Recommendations: Considering prevention a feasible and costeffective health strategy, the guideline development group made 13 specific recommendations that addressed the stability of the care environment (both the care team and location) and the provision of a multicomponent intervention package tailored for persons at risk for delirium. The multicomponent intervention package included assessment and modification of key clinical factors that may precipitate delirium, including cognitive impairment or disorientation, dehydration or constipation, hypoxia, infection, immobility or limited mobility, several medications, pain, poor nutrition, sensory impairment, and sleep disturbance. © 2011 American College of Physicians. Source


O'Flynn N.,Guideline | Potter J.,Clinical Effectiveness and Evaluation Unit
Annals of Internal Medicine | Year: 2011

The general election in the United Kingdom in May 2010 resulted in the election of a new government, a coalition between Conservative and Liberal Democrat parties. Six weeks after the election, a white paper, "Equity and Excellence: Liberating the NHS," that proposed profound changes to the structure and organization of the health service was published. The change that generated the most discussion was the proposal that general practitioners be placed at the center of the system and given control of about 80% of the National Health Service's £100 billion budget. The proposals were greeted with considerable concern by many health care professionals, patient representatives, and the media. In response, the government organized an independent review, and proposals have been altered in response. This article outlines the current organization of the National Health Service, the rationale for change, and government proposals. © 2011 American College of Physicians. Source


Dworzynski K.,Guideline | Ronald A.,Birkbeck, University of London | Bolton P.,Kings College London | Happe F.,Kings College London
Journal of the American Academy of Child and Adolescent Psychiatry | Year: 2012

Objective: This study aimed to explore sex differences in autistic traits in relation to diagnosis, to elucidate factors that might differentially impact whether girls versus boys meet diagnostic criteria for autism or a related autism spectrum disorder (ASD). Method: Data from a large population-based sample of children were examined. Girls and boys (aged 10-12 years) meeting diagnostic criteria for an ASD were compared with those failing to meet diagnostic criteria despite very high scores on a trait measure of ASD, the Childhood Autism Spectrum Test (CAST). Information about behavioral difficulties as reported by teachers, and early estimates of intellectual functioning, were compared. Results: Girls, but not boys, meeting diagnostic criteria for ASD showed significantly more additional problems (low intellectual level, behavioral difficulties) than peers with similarly high CAST scores who did not meet diagnostic criteria. Conclusions: These data suggest that, in the absence of additional intellectual or behavioral problems, girls are less likely than boys to meet diagnostic criteria for ASD at equivalently high levels of autistic-like traits. This might reflect gender bias in diagnosis or genuinely better adaptation/compensation in girls. © 2012 American Academy of Child and Adolescent Psychiatry. Source


Wonderling D.,Guideline | Sawyer L.,Guideline | Fenu E.,Guideline | Lovibond K.,Guideline
Annals of Internal Medicine | Year: 2011

The National Clinical Guideline Centre (NCGC) develops evidencebased clinical guidelines on behalf of the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom. The U.K. Department of Health has commissioned NICE to make recommendations on the basis of both clinical effectiveness and costeffectiveness. This article describes how cost-effectiveness is evaluated and accounted for in NCGC guidelines. Six recent case studies are presented, in which consideration of cost-effectiveness has informed recommendations in various ways for clinical guidelines on alcohol use disorders, chronic obstructive pulmonary disease, glaucoma, lower urinary tract symptoms, non-ST-segment elevation myocardial infarction and unstable angina, and venous thromboembolism prophylaxis. Some of the challenges faced in trying to account for cost-effectiveness in clinical guidelines are outlined, as well as some of the difficulties in adapting cost-effectiveness guidelines for other settings. © 2011 American College of Physicians. Source

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