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2.
Gesundheitswesen ; 86(3): 216-219, 2024 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-38471514

RESUMO

The World Health Organization (WHO) published the "Guidelines on mental health at work" in September 2022. WHO developed the guidelines in accordance with WHO standards. The summary of this guideline was translated into German by the team of the WHO Collaborating Center for Evidence-based Medicine at the University for Continuing Education Krems (Austria) for use in German-speaking countries. An estimated 15+% of working-age adults have had some mental disorder at some point of time in their lives. This can lead to impaired capacity to work, resulting in reduction in productivity and performance, and ability to work safely, or in difficulties in retaining their jobs or obtaining gainful employment. The guidelines contain 12 recommendations. These provide evidence-based global public health guidance on organizational interventions, manager and worker training, and individual interventions for the promotion of positive mental health and prevention of mental health conditions, as well as recommendations on returning to work following absence associated with mental health conditions and gaining employment for people living with mental health conditions. Through the provision of these WHO recommendations, it is anticipated that the guidelines will facilitate national and workplace-level actions in the areas of policy development, service planning and delivery in the domains of mental and occupational health.


Assuntos
Transtornos Mentais , Saúde Mental , Adulto , Humanos , Alemanha , Local de Trabalho , Emprego , Organização Mundial da Saúde
3.
Gesundheitswesen ; 86(4): 289-293, 2024 Apr.
Artigo em Alemão | MEDLINE | ID: mdl-38467152

RESUMO

BACKGROUND: Premature infants (gestation age<37 weeks) and low-birth-weight infants (< 2.5 kg) require complex care to ensure their survival, growth and neurological development. Increased risk for developmental disorders, infections, and challenges with nutrition and body temperature regulation require comprehensive measures in care. AIM: The aim of this guideline was to improve the care of premature and low-birth-weight infants through updated recommendations. METHODS: The recommendations of the World Health Organization (WHO) have been implemented in this guideline in accordance with the WHO handbook for guideline development. This publication has been translated into German by staff members of the WHO Collaborating Centre at the Danube University Krems (Austria). RESULTS/CONCLUSIONS: This guideline includes 11 strong and 14 conditional recommendations, of which 16 describe preventive and promotive care, 6 recommendations about care for complications and 3 for family involvement and support, as well as one statement of good practice.


Assuntos
Recém-Nascido de Baixo Peso , Nascimento Prematuro , Recém-Nascido , Lactente , Feminino , Humanos , Alemanha , Recém-Nascido Prematuro , Nascimento Prematuro/prevenção & controle , Organização Mundial da Saúde
4.
Gesundheitswesen ; 85(4): 266-269, 2023 Apr.
Artigo em Alemão | MEDLINE | ID: mdl-36216327

RESUMO

BACKGROUND: Most HBV-associated deaths among adults are secondary to infections acquired at birth or in the first five years of life. AIM: To extend the guideline for the prevention of mother-to-child transmission of the hepatitis B virus to include antiviral prophylaxis. METHODS: The guideline was developed by the World Health Organization (WHO) in accordance with WHO standards. The summary was translated into German by employees of the WHO Collaborating Centre at Danube University Krems (Austria). RESULTS: In addition to the recommendation to test pregnant women for heptatitis B virus (HBV) and vaccinate newborns against hepatitis B as soon as possible after birth, two new recommendations have been formulated: pregnant women testing positive for HBV infection should receive tenofovir prophylaxis to prevent mother-to-child transmission of HBV. WHO recommends that in settings in which antenatal HBV DNA testing is not available, HBeAg testing can be used as an alternative to determine eligibility for tenofovir prophylaxis.


Assuntos
Hepatite B , Complicações Infecciosas na Gravidez , Adulto , Feminino , Humanos , Recém-Nascido , Gravidez , Vírus da Hepatite B/genética , Antígenos de Superfície da Hepatite B/uso terapêutico , Transmissão Vertical de Doenças Infecciosas/prevenção & controle , Complicações Infecciosas na Gravidez/tratamento farmacológico , Complicações Infecciosas na Gravidez/prevenção & controle , Alemanha , Hepatite B/tratamento farmacológico , Hepatite B/prevenção & controle , Tenofovir/uso terapêutico , Parto , Antivirais/uso terapêutico
5.
Sci Total Environ ; 806(Pt 1): 150480, 2022 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-34844314

RESUMO

OBJECTIVE: To summarize the evidence on the effectiveness of soil remediation to prevent or reduce lead exposure. METHODS: We systematically searched MEDLINE, the Agricultural & Environmental Science Database, Web of Science, and Scopus from 1980 to February 15, 2021. We also performed reference list checking, hand-searched websites, and contacted experts. Eligible studies evaluated the effect of soil remediation to prevent or reduce lead exposure in humans of any age. We screened all records dually; one investigator performed the data extraction; a second checked for completeness and accuracy. Two investigators independently rated the risk of bias of included studies and graded the certainty of evidence. We synthesized findings narratively. RESULTS: We identified 6614 potentially relevant publications, all focused on children, of which five studies (six records) fulfilled our prespecified inclusion criteria. The number of evaluated participants ranged from 31 to 1425, with follow-up periods of 11 months to one year. The primary soil remediation method was the replacement of the upper layer with clean soil. Outcomes were limited to blood lead levels (BLL), dust lead levels, and soil lead levels. The largest study, a controlled before- after study (n = 1425) reported favorable effects of soil remediation compared to no intervention. This finding was consistent with results from two cross-sectional studies and one uncontrolled before-after study. One year post-remediation, the mean reduction in BLL was 2.1 µg/dL (p < 0.0001) greater in the intervention group than in the control group. Two randomized controlled trials with a total of 511 participants showed no statistically significant incremental effect of soil remediation when combined with paint and/or dust abatement. The certainty of evidence for all outcomes was low. CONCLUSION: Soil remediation appears to reduce BLL in children when used as a single intervention. The incremental benefit of soil remediation when part of other interventions is limited.


Assuntos
Intoxicação por Chumbo , Chumbo , Criança , Estudos Transversais , Exposição Ambiental , Humanos , Solo
6.
Gesundheitswesen ; 83(7): 509-511, 2021 Jul.
Artigo em Alemão | MEDLINE | ID: mdl-34049417

RESUMO

BACKGROUND: Early childhood is a time during which a child's habits are formed and family lifestyle habits are open to changes and adaptations. OBJECTIVE: This guideline provides recommendations on the amount of time during the 24 hours of a day that young children, under 5 years of age, should spend being physically active or sleeping for their health and wellbeing. METHOD: The guideline was developed by the World Health Organization (WHO) in accordance with WHO standards. The summary was translated into German by employees of the WHO Collaborating Center at Danube University Krems (Austria). RESULTS AND CONCLUSION: A day consists of sleep time, sedentary time and physical activity of light, moderate or vigorous intensity. Young children should have opportunities to participate in a range of developmentally appropriate, safe, enjoyable play-based physical activities.


Assuntos
Exercício Físico , Comportamento Sedentário , Áustria , Criança , Pré-Escolar , Alemanha , Humanos , Sono , Organização Mundial da Saúde
7.
Gesundheitswesen ; 83(3): 173-179, 2021 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-33634462

RESUMO

AIMS: During the COVID-19 pandemic, many health-related questions require rapid answers. In the Competence Network Public Health COVID-19, founded by representatives of several scientific societies in March 2020, rapid reviews are often conducted to generate evidence-based answers that are useful for policy makers. The aim of this paper is to reflect on the practical experience with rapid reviews in the context of the Competence Network Public Health. Methods for high-quality and practicable implementation of rapid reviews were developed, which are particularly helpful for rapid evidence generation based on observational studies. METHODS: Using the 8-step approach proposed by Tricco et al. [1], we describe the acute challenges that have arisen in the Public Health Competence Network COVID-19 while conducting rapid reviews on public health-related issues related to the COVID-19-pandemic. The 8 steps are: 1. conceptualization of the research question, 2. literature search, 3. title/abstract and full text screening, 4. data extraction, 5. risk of bias assessment, 6. evidence synthesis, 7. dissemination, 8. update. We develop a methodological approach for conducting rapid reviews by expert consensus of the members (n=42 as of 01/28/2021) of the Rapid Reviews Working Group in the Competence Network Public Health COVID-19. RESULTS: A standardized approach is presented that closely follows the approach of the Cochrane Rapid Reviews Methods Group and takes into account the special requirements of etiological - but often also ecological - observational studies on COVID-19. CONCLUSIONS: The proposed approach for conducting rapid reviews can form an important basis for evidence-based policy advice - certainly beyond questions related to COVID-19. Flexible and rapid funding concepts should be made available for the short-term realization of methodologically high-quality rapid reviews on emerging questions. Scientific cooperation in conducting rapid reviews needs to be expanded, and more methodologically high-quality approaches such as prospective meta-analyses should be used.


Assuntos
COVID-19 , Saúde Pública , Literatura de Revisão como Assunto , Alemanha , Humanos , Pandemias , Estudos Prospectivos , SARS-CoV-2
8.
Z Evid Fortbild Qual Gesundhwes ; 156-157: 105-112, 2020 Nov.
Artigo em Alemão | MEDLINE | ID: mdl-32863163

RESUMO

OBJECTIVES: The aim of this paper is to provide detailed guidance on how to incorporate health equity within the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) evidence to decision process. STUDY DESIGN AND SETTING: We developed this guidance based on the GRADE evidence to decision frame-work, iteratively reviewing and modifying draft documents, in person discussion of project group members and input from other GRADE members. This is a German translation of the original paper published in English. RESULTS: Considering the impact on health equity may be required, both in general guidelines and guide-lines that focus on disadvantaged populations. We suggest two approaches to incorporate equity considerations: (1) assessing the potential impact of interventions on equity and (2) incorporating equity considerations when judging or weighing each of the evidence to decision criteria. We provide guidance and include illustrative examples. CONCLUSION: Guideline panels should consider the impact of recommendations on health equity with attention to remote and underserviced settings and disadvantaged populations. Guideline panels may wish to incorporate equity judgments across the evidence to decision framework. This is the fourth and final paper in a series about considering equity in the GRADE guideline development process. This series is coming from the GRADE equity subgroup.


Assuntos
Equidade em Saúde , Alemanha , Humanos , Populações Vulneráveis
9.
Gesundheitswesen ; 82(11): 885-889, 2020 Nov.
Artigo em Alemão | MEDLINE | ID: mdl-32977345

RESUMO

BACKGROUND: Despite considerable progress in the fight against tuberculosis, it is still the most deadly bacterial infectious disease worldwide. Every year, up to 10 million people worldwide still die of tuberculosis. The World Health Assembly has set itself the goal of reducing the number of tuberculosis deaths by 90% and the number of new infections by 80% by 2030. Prevention and infection control measures in public health facilities and wherever the risk of transmission of the tuberculosis bacterium "Mycobacterium tuberculosis" is high are especially important. OBJECTIVE: The aim of the guideline is to provide updated and evidence-based recommendations for public health measures to prevent the spread of the tuberculosis bacterium in clinical settings and in tuberculosis management. METHODOLOGY: The World Health Organization (WHO) developed these recommendations according to the methods outlined in the WHO handbook for guideline development. This publication is a summary of the most important aspects of this guideline translated into German by members of the WHO Collaborating Centre at the Danube University Krems (Austria). RESULTS: This guideline takes into account the current evidence base and provides recommendations and comments on the implementation of tuberculosis prevention and control measures at the level of health care institutions and at the national level.


Assuntos
Tuberculose , Áustria/epidemiologia , Alemanha/epidemiologia , Humanos , Controle de Infecções , Tuberculose/epidemiologia , Tuberculose/prevenção & controle , Organização Mundial da Saúde
10.
Gesundheitswesen ; 82(6): 501-506, 2020 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-32413914

RESUMO

BACKGROUND: COVID-19 (coronavirus disease 2019) is a new, rapidly emerging zoonotic infectious disease, that was reported to the World Health Organization for the first time on 31 December 2019. Currently, no effective pharmacological interventions or vaccines are available to treat or prevent COVID-19, therefore nonpharmacological public health measures are more in focus. OBJECTIVES: The aim was to assess the effects of quarantine - alone or in combination with other measures - during coronavirus outbreaks. METHODS: Because of the current COVID-19 pandemic, WHO commissioned a rapid review. To save time, the method of systematic reviews was slightly and with caution modified. This publication is a summary of the most important aspects of the rapid review, translated into German by members of the WHO Collaborating Centre at the Danube University Krems (Austria). RESULTS: Overall, 29 studies were included. Ten modeling studies focused on COVID-19, 4 observational studies and 15 modeling studies focused on SARS and MERS. The modeling studies consistently reported a benefit of the simulated quarantine measures. For example, the models estimated that quarantine of people exposed to confirmed or suspected cases of COVID-19 prevented between 44 and 81% of the cases that would otherwise have happened and 31 to 63% of the deaths, when compared to no such measures. In regard to costs, the earlier the quarantine measures are implemented, the greater the cost savings will be. CONCLUSION: Our confidence in the evidence is very limited. This is mainly because the COVID-19 studies based their models on the limited data that have been available in the early weeks of the pandemic and made different assumptions about the virus. The studies of SARS and MERS are not completely generalizable to COVID-19. Despite only having limited evidence, all the studies found quarantine to be important for controlling the spread of severe coronavirus diseases. Looking to the coming months, in order to maintain the best possible balance of measures, decision makers must continue to constantly monitor the outbreak situation and the impact of the measures they implement.


Assuntos
Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Saúde Pública , Quarentena , Áustria , Betacoronavirus , COVID-19 , Humanos , Estudos Observacionais como Assunto , SARS-CoV-2
11.
Z Evid Fortbild Qual Gesundhwes ; 150-152: 124-133, 2020 Apr.
Artigo em Alemão | MEDLINE | ID: mdl-31980320

RESUMO

OBJECTIVE: To provide guidance on how systematic review authors, guideline developers, and health technology assessment practitioners should approach the use of the risk of bias in nonrandomized studies of interventions (ROBINS-I) tool as a part of GRADE's certainty rating process. STUDY DESIGN AND SETTING: The study design and setting comprised iterative discussions, testing in systematic reviews, and presentation at GRADE working group meetings with feedback from the GRADE working group. RESULTS: We describe where to start the initial assessment of a body of evidence with the use of ROBINS-I and where one would anticipate the final rating would end up. The GRADE accounted for issues that mitigate concerns about confounding and selection bias by introducing the upgrading domains: large effects, dose-effect relations, and when plausible residual confounders or other biases increase certainty. They will need to be considered in an assessment of a body of evidence when using ROBINS-I. CONCLUSION: The use of ROBINS-I in GRADE assessments may allow for a better comparison of evidence from randomized controlled trials (RCTs) and nonrandomized studies (NRSs) because they are placed on a common metric for risk of bias. Challenges remain, including appropriate presentation of evidence from RCTs and NRSs for decision-making and how to optimally integrate RCTs and NRSs in an evidence assessment.


Assuntos
Projetos de Pesquisa , Aves Canoras , Animais , Viés , Alemanha , Avaliação da Tecnologia Biomédica
12.
Gesundheitswesen ; 82(3): 274-279, 2020 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-31863448

RESUMO

BACKGROUND: Breastfeeding is one of the foundations of child health, development, and survival. Despite extensive evidence that lack of breastfeeding is associated with higher mortality rates and other long-term negative health outcomes, less than half of all babies under the age of 6 months are breastfed worldwide. Breastfeeding counselling is one of the key interventions, to improve breastfeeding rates. AIM: The objective of this guideline is to give recommendations on how to implement breastfeeding counselling to improve breastfeeding practices. METHODS: This guideline was developed by the World Health Organization (WHO) according to the methods outlined in the WHO handbook for guideline development. This publication is a summary of the most important aspects of this guideline translated into German by members of the WHO Collaborating Centre at the Danube University Krems (Austria). RESULTS/CONCLUSIONS: This guideline is based on current evidence and gives recommendations and makes comments on the implementation of breastfeeding counselling, such as frequency, timing, or mode and provider of breastfeeding counselling to improve breastfeeding practices. The scope of the guideline is limited to this intervention.


Assuntos
Aleitamento Materno , Aconselhamento , Organização Mundial da Saúde , Áustria , Aleitamento Materno/tendências , Criança , Aconselhamento/normas , Feminino , Alemanha , Humanos , Lactente
13.
Z Evid Fortbild Qual Gesundhwes ; 147-148: 120-126, 2019 Nov.
Artigo em Alemão | MEDLINE | ID: mdl-31757658

RESUMO

OBJECTIVE: To provide guidance for guideline developers on how to consider health equity at key stages of the guideline development process. STUDY DESIGN AND SETTING: Literature review followed by group discussions and consensus building. RESULTS: The key stages at which guideline developers could consider equity include setting priorities, guideline group membership, identifying the target audience(s), generating the guideline questions, considering the importance of outcomes and interventions, deciding what evidence to include and searching for evidence, summarizing the evidence and considering additional information, wording of recommendations, and evaluation and use. We provide examples of how guidelines have actually considered equity at each of these stages. CONCLUSION: Guideline projects should consider the aforementioned suggestions for recommendations that are equity sensitive.


Assuntos
Lista de Checagem , Equidade em Saúde , Guias de Prática Clínica como Assunto , Consenso , Alemanha , Humanos
14.
Z Evid Fortbild Qual Gesundhwes ; 146: 53-59, 2019 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-31537503

RESUMO

OBJECTIVES: This article introduces the rationale and methods for explicitly considering health equity in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology for developing clinical, public health, and health system guidelines. This article is a German translation of the original version published in English. STUDY DESIGN AND SETTING: We searched for guideline methodology articles, conceptual articles about health equity, and examples of guidelines that considered health equity explicitly. We held three meetings with GRADE Working Group members and invited comments from the GRADE Working Group listserve. RESULTS: We developed three articles on incorporating equity considerations into the overall approach to guideline development, rating certainty, and assembling the evidence base and evidence to decision and/or recommendation. CONCLUSION: Clinical and public health guidelines have a role to play in promoting health equity by explicitly considering equity in the process of guideline development.


Assuntos
Guias como Assunto , Equidade em Saúde , Tomada de Decisões , Alemanha , Humanos
15.
Wien Med Wochenschr ; 169(13-14): 339-349, 2019 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-31187373

RESUMO

The Austrian periodic health examination (PHE) was introduced in 1974 as a health insurance benefit and was redesigned for the last time in 2005. Therefore, the aim of this work was to revise the scientific basis of the PHE using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. We updated the scientific evidence of examinations and consultations that are currently part of the PHE and searched and integrated new examinations. We assessed the expectations of the population towards the PHE in three focus groups. A panel of experts developed evidence-based recommendations for the revised PHE. They formulated 26 recommendations on 20 target diseases or risk factors. In comparison to the previous PHE, the panel added screening for abdominal aortic aneurysm, osteoporotic fracture risk, and chronic kidney disease to the recommendations, while screening for asymptomatic bacteriuria, screening for iron deficiency/pernicious anaemia, and risk identification of glaucoma should no longer be included.


Assuntos
Programas de Rastreamento , Exame Físico , Áustria , Humanos , Fatores de Risco
16.
Gesundheitswesen ; 81(10): 846-849, 2019 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-31108560

RESUMO

BACKGROUND: Risk communication in public health emergencies is an essential part of any emergency response. AIM: The World Health Organization (WHO) aims to provide WHO Member States, partners and stakeholders involved in emergency preparedness and response structures evidence-based, up-to-date, system-focused guidance. METHODS: Guideline development followed WHO standards. RESULTS: These guidelines give recommendations in the following areas: (1) approaches for building trust and engaging with communities and affected populations, (2) approaches for integrating risk communication into existing national and local emergency preparedness and response-structures, and (3) planning, conducting, and evaluating emergency risk communication in practice. CONCLUSION: Specific step-by-step instructions are beyond the remit of these recommendations. These will be provided by WHO in other formats in the future.


Assuntos
Defesa Civil , Comunicação , Emergências , Saúde Pública , Defesa Civil/métodos , Alemanha , Humanos , Prática de Saúde Pública , Organização Mundial da Saúde
17.
Dtsch Arztebl Int ; 114(5): 71, 2017 02 03.
Artigo em Inglês | MEDLINE | ID: mdl-28241919
18.
Dtsch Arztebl Int ; 113(26): 445-53, 2016 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-27412989

RESUMO

BACKGROUND: To date, most clinical comparisons of ezetimibe-statin combination therapy versus statin monotherapy have relied entirely on surrogate variables. In this systematic review, we study the efficacy and safety of ezetimibe-statin combination therapy in comparison to statin monotherapy in terms of the prevention of cardiovascular events in hyperlipidemic patients with atherosclerosis and/or diabetes mellitus. METHODS: This review is based on a systematic literature search (1995 to July 2015) in PubMed, the Excerpta Medica Database (EMBASE), the Cochrane Library, and the ClinicalTrials.gov registry. RESULTS: Nine randomized, controlled trials with data from a total of 19 461 patients were included. Ezetimibe-statin combination therapy was associated with a lower risk of cardiovascular events than statin monotherapy: 33% of the patients treated with ezetimibe and a statin, and 35% of those treated with a statin alone, had a cardiovascular event within seven years (number needed to treat [NNT]: 50 over 7 years). Combination therapy was also significantly more effective in preventing a composite endpoint consisting of death due to cardiovascular disease, nonfatal myocardial infarction, unstable angina pectoris, coronary revascularization, and nonfatal stroke (hazard ratio [HR] 0.94, 95% confidence interval [0,89; 0,99]; p = 0.016). Diabetic patients benefited from combination therapy rather than monotherapy with respect to cardiovascular morbidity (HR 0.87 [0.78; 0.94]). On the other hand, the addition of ezetimibe to statin therapy did not lessen either cardiovascular or overall mortality. Serious undesired events occurred in 38% of the patients taking ezetimibe and a statin nd in 39% of the patients taking a statin alone (relative risk 1.09 [0.77; 1.55]). CONCLUSION: In high-risk patients with an acute coronary syndrome, combination therapy with ezetimibe and a statin lowered the risk of cardiovascular events in comparison to statin monotherapy. The risk of dying or suffering an adverse drug effect was similar in the two treatment groups.


Assuntos
Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/prevenção & controle , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/mortalidade , Ezetimiba/administração & dosagem , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Hiperlipidemias/tratamento farmacológico , Hiperlipidemias/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticolesterolemiantes/administração & dosagem , Causalidade , Comorbidade , Morte Súbita Cardíaca/epidemiologia , Diabetes Mellitus/mortalidade , Diabetes Mellitus/prevenção & controle , Combinação de Medicamentos , Medicina Baseada em Evidências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Taxa de Sobrevida , Resultado do Tratamento
19.
J Clin Epidemiol ; 69: 16-22, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25840752

RESUMO

OBJECTIVES: The objective of our study was to use a diverse sample of medical interventions to assess empirically whether first trials rendered substantially different treatment effect estimates than reliable, high-quality bodies of evidence. STUDY DESIGN AND SETTING: We used a meta-epidemiologic study design using 100 randomly selected bodies of evidence from Cochrane reports that had been graded as high quality of evidence. To determine the concordance of effect estimates between first and subsequent trials, we applied both quantitative and qualitative approaches. For quantitative assessment, we used Lin's concordance correlation and calculated z-scores; to determine the magnitude of differences of treatment effects, we calculated standardized mean differences (SMDs) and ratios of relative risks. We determined qualitative concordance based on a two-tiered approach incorporating changes in statistical significance and magnitude of effect. RESULTS: First trials both overestimated and underestimated the true treatment effects in no discernible pattern. Nevertheless, depending on the definition of concordance, effect estimates of first trials were concordant with pooled subsequent studies in at least 33% but up to 50% of comparisons. The pooled magnitude of change as bodies of evidence advanced from single trials to high-quality bodies of evidence was 0.16 SMD [95% confidence interval (CI): 0.12, 0.21]. In 80% of comparisons, the difference in effect estimates was smaller than 0.5 SMDs. In first trials with large treatment effects (>0.5 SMD), however, estimates of effect substantially changed as new evidence accrued (mean change 0.68 SMD; 95% CI: 0.50, 0.86). CONCLUSION: Results of first trials often change, but the magnitude of change, on average, is small. Exceptions are first trials that present large treatment effects, which often dissipate as new evidence accrues.


Assuntos
Estudos Epidemiológicos , Medicina Baseada em Evidências , Estatística como Assunto/normas , Ensaios Clínicos como Assunto , Humanos
20.
Cochrane Database Syst Rev ; (11): CD011268, 2015 Nov 08.
Artigo em Inglês | MEDLINE | ID: mdl-26558418

RESUMO

BACKGROUND: Seasonal affective disorder (SAD) is a seasonal pattern of recurrent major depressive episodes that most commonly occurs during autumn or winter and remits in spring. The prevalence of SAD ranges from 1.5% to 9%, depending on latitude. The predictable seasonal aspect of SAD provides a promising opportunity for prevention. This review - one of four reviews on efficacy and safety of interventions to prevent SAD - focuses on second-generation antidepressants (SGAs). OBJECTIVES: To assess the efficacy and safety of second-generation antidepressants (in comparison with other SGAs, placebo, light therapy, melatonin or agomelatine, psychological therapies or lifestyle interventions) in preventing SAD and improving patient-centred outcomes among adults with a history of SAD. SEARCH METHODS: A search of the Specialised Register of the Cochrane Depression, Anxiety and Neuorosis Review Group (CCDANCTR) included all years to 11 August 2015. The CCDANCTR contains reports of randomised controlled trials derived from EMBASE (1974 to date), MEDLINE (1950 to date), PsycINFO (1967 to date) and the Cochrane Central Register of Controlled Trials (CENTRAL). Furthermore, we searched the Cumulative Index to Nursing and Allied Health Literature, Web of Knowledge, The Cochrane Library and the Allied and Complementary Medicine Database (to 26 May 2014). We also conducted a grey literature search and handsearched the reference lists of included studies and pertinent review articles. SELECTION CRITERIA: For efficacy, we included randomised controlled trials on adults with a history of winter-type SAD who were free of symptoms at the beginning of the study. For adverse events, we planned to include non-randomised studies. Eligible studies compared an SGA versus another SGA, placebo, light therapy, psychological therapy, melatonin, agomelatine or lifestyle changes. We also intended to compare SGAs in combination with any of the comparator interventions versus the same comparator intervention as monotherapy. DATA COLLECTION AND ANALYSIS: Two review authors screened abstracts and full-text publications and assigned risk of bias ratings based on the Cochrane 'Risk of bias' tool. We resolved disagreements by consensus or by consultation with a third party. Two review authors independently extracted data and assessed risk of bias of included studies. When data were sufficient, we conducted random-effects (Mantel-Haenszel) meta-analyses. We assessed statistical heterogeneity by calculating the Chi(2) statistic and the Cochran Q. We used the I(2) statistic to estimate the magnitude of heterogeneity and examined potential sources of heterogeneity using sensitivity analysis or analysis of subgroups. We assessed publication bias by using funnel plots. However, given the small number of component studies in our meta-analyses, these tests have low sensitivity to detect publication bias. We rated the strength of the evidence using the system developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. MAIN RESULTS: We identified 2986 citations after de-duplication of search results and excluded 2895 records during title and abstract reviews. We assessed 91 full-text papers for inclusion in the review, of which four publications (on three RCTs) providing data from 1100 people met eligibility criteria for this review. All three RCTs had methodological limitations due to high attrition rates.Overall moderate-quality evidence indicates that bupropion XL is an efficacious intervention for prevention of recurrence of depressive episodes in patients with a history of SAD (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.44 to 0.72; three RCTs, 1100 participants). However, bupropion XL leads to greater risk of headaches (moderate-quality evidence), insomnia and nausea (both low-quality evidence) when compared with placebo. Numbers needed to treat for additional beneficial outcomes (NNTBs) vary by baseline risks. For a population with a yearly recurrence rate of 30%, the NNTB is 8 (95% CI 6 to 12). For populations with yearly recurrence rates of 40% and 50%, NNTBs are 6 (95% CI 5 to 9) and 5 (95% CI 4 to 7), respectively.We could find no studies on other SGAs and no studies comparing SGAs with other interventions of interest such as light therapy, psychological therapies, melatonin or agomelatine. AUTHORS' CONCLUSIONS: Available evidence indicates that bupropion XL is an effective intervention for prevention of recurrence of SAD. Nevertheless, even in a high-risk population, four of five patients will not benefit from preventive treatment with bupropion XL and will be at risk for harm. Clinicians need to discuss with patients advantages and disadvantages of preventive SGA treatment and might want to consider offering other potentially efficacious interventions, which might confer lower risk of adverse events. Given the lack of comparative evidence, the decision for or against initiating preventive treatment of SAD and the treatment selected should be strongly based on patient preferences.Future researchers need to assess the effectiveness and risk of harms of SGAs other than bupropion for prevention of SAD. Investigators also need to compare benefits and harms of pharmacological and non-pharmacological interventions.


Assuntos
Antidepressivos de Segunda Geração/uso terapêutico , Bupropiona/uso terapêutico , Transtorno Afetivo Sazonal/prevenção & controle , Adulto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Transtorno Afetivo Sazonal/epidemiologia
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