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2.
J Clin Epidemiol ; 122: 12-19, 2020 Feb 24.
Artigo em Inglês | MEDLINE | ID: mdl-32105799

RESUMO

OBJECTIVE: The objective of this study was to identify potential trial characteristics associated with reported treatment effect estimates in randomized trials of testosterone therapy in adult men. STUDY DESIGN AND SETTING: This is a meta-epidemiological study. MEDLINE was searched for meta-analyses of randomized trials of testosterone therapy in men published between 2008 and 2018. Data on trial characteristics were extracted independently by two reviewers. The impact of trial characteristics on reported treatment effects was investigated using a two-step meta-analytic approach. RESULTS: We identified 132 randomized trials, included in 19 meta-analyses, comprising data from 10,725 participants. None of the investigated design characteristics, including year of publication, sample size, trial registration status, center status, regionality, funding source, and conflict of interest were statistically significantly associated with reported treatment effects of testosterone therapy in men. Although trials rated at high risk of bias overall reported treatment effects that were 21% larger compared with trials rated at low risk of bias overall, the 95% confidence interval included the null (ratio of odds ratio: 0.79, 95% confidence interval: 0.60 to 1.03). CONCLUSION: The present study found no clear evidence that trial characteristics are associated with treatment effects in randomized trials of testosterone therapy in men. To establish stronger evidence about the treatment effects of testosterone therapy in men, future randomized trials should not only be adequately designed but also transparently reported. STUDY REGISTRATION: osf.io/x9g6m.

3.
Syst Rev ; 9(1): 33, 2020 Feb 13.
Artigo em Inglês | MEDLINE | ID: mdl-32054517

RESUMO

BACKGROUND: Understanding the long-term health effects of low to moderate alcohol consumption is important for establishing thresholds for minimising the lifetime risk of harm. Recent research has elucidated the dose-response relationship between alcohol and cardiovascular outcomes, showing an increased risk of harm at levels of intake previously thought to be protective. The primary objective of this review was to examine (1) whether there is a dose-response relationship between levels of alcohol consumption and long-term cognitive effects, and (2) what the effects are of different levels of consumption. METHODS: The review was conducted according to a pre-specified protocol. Eligible studies were those published 2007 onwards that compared cognitive function among people with different levels of alcohol consumption (measured ≥ 6 months prior to first follow-up of cognition). Major cognitive impairment was excluded. Searches were limited to MEDLINE, Embase and PsycINFO (January 2007 to April 2018). Screening, data extraction, and risk of bias assessment (ROBINS-I) were piloted by three authors, then completed by a single author and checked by a second. Analyses were undertaken to identify and characterise dose-response relationships between levels of alcohol consumption and cognition. Certainty of evidence was assessed using GRADE. RESULTS: We included 27 cohort studies (from 4786 citations). Eighteen studies examined the effects of alcohol consumption at different levels (risk of bias 16 serious, 2 critical). Ten studies provided data for dose-response analysis. The pooled dose-response relationship showed a maximum standardised mean difference (SMD) indicating slightly better cognition among women with moderate alcohol consumption compared to current non-drinkers (SMD 0.18, 95%CI 0.02 to 0.34, at 14.4 grams/day; 5 studies, very low certainty evidence), and a trivial difference for men (SMD 0.05, 95% CI 0.00 to 0.10, at 19.4 grams/day; 6 studies, very low certainty evidence). CONCLUSIONS: Major limitations in the design and reporting of included studies made it impossible to discern if the effects of 'lower' levels of alcohol intake are due to bias. Further review of the evidence is unlikely to resolve this issue without meta-analysis of individual patient data from cohort studies that address biases in the selection of participants and classification of alcohol consumption.

4.
J Clin Epidemiol ; 118: 60-68, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31740319

RESUMO

OBJECTIVES: The aim of the study was to generate a comprehensive bank of systematic review (SR) reporting items to inform an update of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2009 statement. METHODS: We searched the Enhancing the QUAlity and Transparency Of health Research Network library in May 2019 to identify all reporting guidelines for SRs that were published after 2009, regardless of the scope of the guideline. We also conducted a selective review of four guidance manuals for SRs, three tools for assessing the risk of bias in SRs, six meta-research studies evaluating the reporting quality of SRs using a tailored checklist, and five reporting guidelines for other study designs. One author screened and selected sources for inclusion, extracted reporting guidance from sources, and mapped guidance against the PRISMA 2009 checklist items. RESULTS: We included 60 sources providing guidance on reporting of SRs and meta-analyses. From these, we collated a list of 221 unique reporting items. Items were categorized into title (four items), abstract (10 items), introduction (12 items), methods (111 items), results (61 items), discussion (12 items), funding and conflicts of interest (four items), administrative information (three items), and data availability (four items). This exercise generated 175 reporting items that could be added to the guidance in the PRISMA 2009 statement. CONCLUSION: Generation of a comprehensive item bank through review and mapping of the literature facilitates identification of missing items and those needing modification, which may not otherwise be identified by the guideline development team or from other activities commonly used to develop reporting guidelines.

5.
BMJ Open ; 9(11): e031840, 2019 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-31699738

RESUMO

INTRODUCTION: Current recommendations for vitamin D and calcium in dietary guidelines and bone health guidelines vary significantly among countries and professional organisations. It is unknown whether the methods used to develop these recommendations followed a rigourous process and how the differences in methods used may affect the recommended intakes of vitamin D and calcium. The objectives of this study are (1) collate and compare recommendations for vitamin D and calcium across guidelines, (2) appraise methodological quality of the guideline recommendations and (3) identify methodological factors that may affect the recommended intakes for vitamin D and calcium. This study will make a significant contribution to enhancing the methodological rigour in public health guidelines for vitamin D and calcium recommendations. METHODS AND ANALYSES: We will conduct a systematic review to evaluate vitamin D and calcium recommendations for osteoporosis prevention in generally healthy middle-aged and older adults. Methodological assessment will be performed for each guideline against those outlined in the 2014 WHO handbook for guideline development. A systematic search strategy will be applied to locate food-based dietary guidelines and bone health guidelines indexed in various electronic databases, guideline repositories and grey literature from 1 January 2009 to 28 February 2019. Descriptive statistics will be used to summarise the data on intake recommendation and on proportion of guidelines consistent with the WHO criteria. Logistic regression, if feasible, will be used to assess the relationships between the methodological factors and the recommendation intakes. ETHICS AND DISSEMINATION: Ethics approval is not required as we will only extract published data or information from the published guidelines. Results of this review will be disseminated through conference presentations and peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42019126452.

7.
JAMA Oncol ; 2019 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-31486837

RESUMO

Importance: Reproducible research practices are essential to biomedical research because these practices promote trustworthy evidence. In systematic reviews and meta-analyses, reproducible research practices ensure that summary effects used to guide patient care are stable and trustworthy. Objective: To evaluate the reproducibility in theory of meta-analyses in oncology systematic reviews cited by the 49 National Comprehensive Cancer Network (NCCN) guidelines for the treatment of cancer by site and evaluate whether Cochrane reviews or systematic reviews that report adherence to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines use more reproducible research practices. Design, Setting, and Participants: A cross-sectional investigation of all systematic reviews with at least 1 meta-analysis and at least 1 included randomized clinical trial (RCT) that are cited by NCCN guidelines for treatment of cancer by site. We scanned the reference list of all NCCN guidelines (n = 49) for potential systematic reviews and meta-analyses. All retrieved studies were screened, and data were extracted, independently and in duplicate. The analysis was carried out between May 6, 2018, and January 28, 2019. Main Outcomes and Measures: The frequency of reproducible research practices, defined as (1) effect estimate and measure of precision (eg, hazard ratio with 95% confidence interval); (2) clear list of studies included for each analysis; and (3) for subgroup and sensitivity analyses, it must be clear which studies were included in each group or level. Results: We identified 1124 potential systematic reviews, and 154 meta-analyses comprising 3696 meta-analytic effect size estimates were included. Only 2375 of the 3696 meta-analytic estimates (64.3%), including subgroup and sensitivity analyses, were reproducible in theory. Forest plots appear to improve the reproducibility of meta-analyses. All meta-analytic estimates were reproducible in theory in 100 systematic reviews (64.9%), and in 15 systematic reviews (9.7%), no meta-analytic estimates could potentially be reproduced. Data were said to be imputed in 29 meta-analyses, but none specified which data. Only 1 meta-analysis included a link to an online data set. Conclusions and Relevance: More reproducible research practices are needed in oncology meta-analyses, as suggested by those that are cited by the NCCN. Reporting meta-analyses in forest plots and requirements for full data sharing are recommended.

8.
BMJ Open ; 9(9): e031138, 2019 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-31492792

RESUMO

OBJECTIVE: To determine (i) the difference in the frequency of serious adverse events (SAEs) reported in trial registrations and their respective primary publications and (ii) the effect of adding SAE data from registries to a network meta-analysis (NMA) in changing the surface under the cumulative ranking (SUCRA) curve values of interventions. DESIGN: Secondary analysis of primary publications from two NMAs. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included randomised trials published in English after 2005 that were included in two NMAs of pharmacological interventions for Alzheimer's disease and chronic obstructive pulmonary disease. DATA EXTRACTION: Two reviewers independently searched multiple international trial registries for registration status and abstracted data from the included study publications and ClinicalTrials.gov. RESULTS: Of the 203 randomised trials included, 140 (69.0%) were registered with a trial registry and 72 (35.5%) posted results in the registry. The proportion of registered trials increased over time (38.5% in 2005 vs 78.6% in 2014). Of the publications with results posted in a trial registry, 14 (19.4%) had inconsistent reporting of overall SAEs; 7 (10.4%) studies did not report SAEs in the publication but did in the registry. In the 134 randomised trials with a prespecified primary outcome in the registry, 19 studies (9.4%) had a change in the primary outcome in the publication. Adding SAEs reported in registries to the NMAs did not affect the ranking of interventions. CONCLUSION: We identified inconsistent reporting of SAEs in randomised trials that were included in two NMAs. Findings highlight the importance of including trial registries in the grey literature search and verifying safety data before incorporating it into NMAs. STUDY REGISTRATION: osf.io/mk6dr.

10.
Lancet Diabetes Endocrinol ; 7(10): 754-766, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31353194

RESUMO

BACKGROUND: The benefits and risks of testosterone treatment for women with diminished sexual wellbeing remain controversial. We did a systematic review and meta-analysis to assess potential benefits and risks of testosterone for women. METHODS: We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and Web of Science for blinded, randomised controlled trials of testosterone treatment of at least 12 weeks' duration completed between Jan 1, 1990, and Dec 10, 2018. We also searched drug registration applications to the European Medicine Agency and the US Food and Drug Administration to identify any unpublished data. Primary outcomes were the effects of testosterone on sexual function, cardiometabolic variables, cognitive measures, and musculoskeletal health. This study is registered with the International Prospective Register of Systematic Reviews (PROSPERO), number CRD42018104073. FINDINGS: Our search strategy retrieved 46 reports of 36 randomised controlled trials comprising 8480 participants. Our meta-analysis showed that, compared with placebo or a comparator (eg, oestrogen, with or without progestogen), testosterone significantly increased sexual function, including satisfactory sexual event frequency (mean difference 0·85, 95% CI 0·52 to 1·18), sexual desire (standardised mean difference 0·36, 95% CI 0·22 to 0·50), pleasure (mean difference 6·86, 95% CI 5·19 to 8·52), arousal (standardised mean difference 0·28, 95% CI 0·21 to 0·35), orgasm (standardised mean difference 0·25, 95% CI 0·18 to 0·32), responsiveness (standardised mean difference 0·28, 95% CI 0·21 to 0·35), and self-image (mean difference 5·64, 95% CI 4·03 to 7·26), and reduced sexual concerns (mean difference 8·99, 95% CI 6·90 to 11·08) and distress (standardised mean difference -0·27, 95% CI -0·36 to -0·17) in postmenopausal women. A significant rise in the amount of LDL-cholesterol, and reductions in the amounts of total cholesterol, HDL-cholesterol, and triglycerides, were seen with testosterone administered orally, but not when administered non-orally (eg, by transdermal patch or cream). An overall increase in weight was recorded with testosterone treatment. No effects of testosterone were reported for body composition, musculoskeletal variables, or cognitive measures, although the number of women who contributed data for these outcomes was small. Testosterone was associated with a significantly greater likelihood of reporting acne and hair growth, but no serious adverse events were recorded. INTERPRETATION: Testosterone is effective for postmenopausal women with low sexual desire causing distress, with administration via non-oral routes (eg, transdermal application) preferred because of a neutral lipid profile. The effects of testosterone on individual wellbeing and musculoskeletal and cognitive health, as well as long-term safety, warrant further investigation. FUNDING: Australian National Health and Medical Research Council.

12.
JAMA Netw Open ; 2(6): e195313, 2019 06 05.
Artigo em Inglês | MEDLINE | ID: mdl-31173122

RESUMO

Importance: Anorexia nervosa is recognized as an important cause of morbidity in young people. However, the risk of cancer in people with anorexia nervosa remains uncertain. Objective: To evaluate the association of anorexia nervosa with the risk of developing or dying of cancer. Data Sources: MEDLINE, Scopus, Embase, and Web of Science from database inception to January 9, 2019. Study Selection: Published observational studies in humans examining the risk of cancer in people with anorexia nervosa compared with the general population or those without anorexia nervosa. Studies needed to report incidence or mortality rate ratios (RRs). Data Extraction and Synthesis: Screening, data extraction, and methodological quality assessment were performed by at least 2 researchers independently. A random-effects model was used to synthesize individual studies. Heterogeneity (I2) was assessed and 95% prediction intervals (PIs) were calculated. Main Outcomes and Measures: All cancer incidence and cancer mortality associated with anorexia nervosa. Secondary outcomes were site-specific cancer incidence and mortality. Results: Seven cohort studies published in 10 articles (42 602 participants with anorexia nervosa) were included. Anorexia nervosa was not associated with risk of developing any cancer (4 studies in women; RR, 0.97; 95% CI, 0.89-1.06; P = .53; I2, 0%; 95% PI, 0.80-1.18; moderate confidence). Anorexia nervosa was associated with decreased breast cancer incidence (5 studies in women; RR, 0.60; 95% CI, 0.50-0.80; P < .001; I2, 0%; 95% PI, 0.44-0.83; high confidence). Conversely, anorexia nervosa was associated with increased risk of developing lung cancer (3 studies in women; RR, 1.50; 95% CI, 1.06-2.12; P = .001; I2, 0%; 95% PI, 0.19-16.46; low confidence) and esophageal cancer (2 studies in women; RR, 6.10; 95% CI, 2.30-16.18; P < .001; I2, 0%; low confidence). Conclusions and Relevance: Among people with anorexia nervosa, risk of developing cancer did not differ compared with the general population, but a significantly reduced risk of breast cancer was observed. Understanding the mechanisms underlying these associations could have important preventive potential.


Assuntos
Anorexia Nervosa/complicações , Neoplasias/mortalidade , Adulto , Idoso , Métodos Epidemiológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/etiologia , Distribuição por Sexo , Adulto Jovem
13.
J Rheumatol ; 46(8): 1047-1052, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30824659

RESUMO

OBJECTIVE: To describe the experience of the first OMERACT Emerging Leaders Program (ELP). METHODS: A Delphi process identified positive aspects, areas for improvement, and future directions. Core items were defined as essential if they received ≥ 70% ratings. RESULTS: Participants valued relatable/accessible mentors (100%), including an OMERACT Executive mentor (100%), and a support network of peers (90%). Key items for future development were funding support (100%) and developing knowledge about OMERACT processes (90%) and politics (80%). CONCLUSION: The ELP has the potential to provide targeted training for early career researchers to develop relevant skills for future leadership roles within OMERACT.

14.
BMJ Open ; 9(3): e022769, 2019 03 04.
Artigo em Inglês | MEDLINE | ID: mdl-30837245

RESUMO

INTRODUCTION: Transparency and completeness of health research is highly variable, with important deficiencies in the reporting of methods and results of studies. Reporting guidelines aim to improve transparency and quality of research reports, and are often developed by consortia of journal editors, peer reviewers, authors, consumers and other key stakeholders. The objective of this study will be to investigate the characteristics of scientific collaboration among developers and the citation metrics of reporting guidelines of health research. METHODS AND ANALYSIS: This is the study protocol for a cross-sectional analysis of completed reporting guidelines indexed in the Enhancing the QUAlity and Transparency Of health Research Network Library. We will search PubMed/MEDLINE and the Web of Science. Screening, selection and data abstraction will be conducted by one researcher and verified by a second researcher. Potential discrepancies will be resolved via discussion. We will include published papers of reporting guidelines written in English. Published papers will have to meet the definition of a reporting guideline related to health research (eg, a checklist, flow diagram or explicit text), with no restrictions by study design, medical specialty, disease or condition. Raw data from each included paper (including title, publication year, journal, subject category, keywords, citations, and the authors' names, author's affiliated institution and country) will be exported from the Web of Science. Descriptive analyses will be conducted (including the number of papers, citations, authors, countries, journals, keywords and main collaboration metrics). We will identify the most prolific authors, institutions, countries, journals and the most cited papers. Network analyses will be carried out to study the structure of collaborations. ETHICS AND DISSEMINATION: No ethical approval will be required. Findings from this study will be published in peer-reviewed journals. All data will be deposited in a cross-disciplinary public repository. It is anticipated the study findings could be relevant to a variety of audiences.

15.
Artigo em Inglês | MEDLINE | ID: mdl-30843587

RESUMO

OBJECTIVES: To describe the experiences (including symptoms and perceived impacts on daily living) of people with a shoulder disorder. METHODS: Systematic review of qualitative studies. We searched for eligible qualitative studies indexed in Ovid MEDLINE, Ovid Embase, CINAHL (EBSCO), SportDiscus (EBSCO) and Ovid PsycINFO up until November 2017. Two authors independently screened studies for inclusion, appraised their methodological quality using the Critical Appraisal Skills Programme checklist, used thematic synthesis methods to generate themes describing the experiences reported by participants and assessed the confidence in the findings using the Grading of Recommendations Assessment, Development and Evaluation Confidence in Evidence from Reviews of Qualitative research (GRADE-CERQual) approach. RESULTS: The inclusion criteria were met by eight studies, which included 133 participants (49 females and 84 males) with either rotator cuff disease, adhesive capsulitis, proximal humeral fracture, shoulder instability or unspecified shoulder pain. We generated seven themes to describe what people in the included studies reported experiencing: pain; physical function/activity limitations; participation restriction; sleep disruption; cognitive dysfunction; emotional distress; and other pathophysiological manifestations (other than pain). There were interactions between the themes, with particular experiences impacting on others (e.g. pain leading to reduced activities and sleep disruption). Following grading of the evidence, we considered it likely that most of the review findings were a reasonable representation of the experiences of people with shoulder disorders. CONCLUSION: Patients with shoulder disorders contend with considerable disruption to their life. The experiences described should be considered by researchers seeking to select the most appropriate outcomes to measure in clinical trials and other research studies in people with shoulder disorders.

16.
J Dent ; 82: 71-84, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30716451

RESUMO

OBJECTIVE: This study aimed to evaluate the epidemiological and reporting characteristics of systematic reviews (SRs) in dentistry indexed within PubMed during the year 2017. METHODS: We searched for SRs in dentistry indexed within PubMed in 2017. Study selection was undertaken by two reviewers independently. Data related to epidemiological and reporting characteristics were extracted by one of three reviewers. A descriptive analysis of the data was performed. Characteristics of SRs were analyzed considering all SRs included and subgrouped by dental specialties. In addition, we explored if the reporting of 24 characteristics of treatment/therapeutic SRs was associated with the self-reported use of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement calculating the risk ratio (RR) with a 95% confidence interval for each characteristic. RESULTS: 495 articles fulfilled the eligibility criteria. The main specialty considered was Oral Surgery numbering 75 articles. Brazil presented the highest contribution with 117 SRs (23.6%). The reporting quality was variable. Items such as, use of the term "systematic review", or "meta-analysis" in the title or abstract was well reported. In contrast, the study risk of bias/quality assessment method was not reported in 40.5% of SRs. In addition, only four reporting characteristics were described more often in those SR that reported using the PRISMA Statement. CONCLUSION: A large number of SRs were published in dentistry in 2017 and the reporting and epidemiological characteristics varied among dental specialties. There is a mandatory need to improve the quality of reporting and conduct of SRs in dentistry. CLINICAL SIGNIFICANCE: Poor reporting and conduction of SRs could generate SRs with imprecise and biased results.


Assuntos
Odontologia , Revisão Sistemática como Assunto , /estatística & dados numéricos , Viés , Brasil , Odontologia/estatística & dados numéricos , Razão de Chances
17.
BMJ ; 364: l42, 2019 01 30.
Artigo em Inglês | MEDLINE | ID: mdl-30700403

RESUMO

OBJECTIVE: To examine the effect of regular breakfast consumption on weight change and energy intake in people living in high income countries. DESIGN: Systematic review and meta-analysis. DATA SOURCES: PubMed, Ovid Medline, and CINAHL were searched for randomised controlled trials published between January 1990 and January 2018 investigating the effect of breakfast on weight or energy intake. ClinicalTrials.gov and the World Health Organization's International Clinical Trials Registry Platform search portal were also searched in October 2018 to identify any registered yet unpublished or ongoing trials. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials from high income countries in adults comparing breakfast consumption with no breakfast consumption that included a measure of body weight or energy intake. Two independent reviewers extracted the data and assessed the risk of bias of included studies. Random effects meta-analyses of the effect of breakfast consumption on weight and daily energy intake were performed. RESULTS: Of 13 included trials, seven examined the effect of eating breakfast on weight change, and 10 examined the effect on energy intake. Meta-analysis of the results found a small difference in weight favouring participants who skipped breakfast (mean difference 0.44 kg, 95% confidence interval 0.07 to 0.82), but there was some inconsistency across trial results (I2=43%). Participants assigned to breakfast had a higher total daily energy intake than those assigned to skip breakfast (mean difference 259.79 kcal/day, 78.87 to 440.71; 1 kcal=4.18 kJ), despite substantial inconsistency across trial results (I2=80%). All of the included trials were at high or unclear risk of bias in at least one domain and had only short term follow-ups (mean period seven weeks for weight, two weeks for energy intake). As the quality of the included studies was mostly low, the findings should be interpreted with caution. CONCLUSION: This study suggests that the addition of breakfast might not be a good strategy for weight loss, regardless of established breakfast habit. Caution is needed when recommending breakfast for weight loss in adults, as it could have the opposite effect. Further randomised controlled trials of high quality are needed to examine the role of breakfast eating in the approach to weight management. STUDY REGISTRATION: PROSPERO registration number CRD42017057687.


Assuntos
Peso Corporal , Desjejum/fisiologia , Ingestão de Energia , Comportamento Alimentar , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas
18.
J Rheumatol ; 46(8): 969-975, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30709947

RESUMO

OBJECTIVE: To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Core Domain Set process. METHODS: At OMERACT 2018, the OMERACT Shoulder Working Group conducted a workshop that presented the OMERACT 2016 preliminary core domain set and its rationale based upon a systematic review of domains measured in shoulder trials and international Delphi sessions involving patients, clinicians, and researchers, as well as a new systematic review of qualitative studies on the experiences of people with shoulder disorders. After discussions in breakout groups, the OMERACT core domain set for clinical trials of shoulder disorders was presented for endorsement by OMERACT 2018 participants. RESULTS: The qualitative review (n = 8) identified all domains included in the preliminary core set. An additional domain, cognitive dysfunction, was also identified, but confidence that this represents a core domain was very low. The core domain set that was endorsed by the OMERACT participants, with 71% agreement, includes 4 "mandatory" trial domains: pain, function, patient global - shoulder, and adverse events including death; and 4 "important but optional" domains: participation (recreation/work), sleep, emotional well-being, and condition-specific pathophysiological manifestations. Cognitive dysfunction was voted out of the core domain set. CONCLUSION: OMERACT 2018 delegates endorsed a core domain set for clinical trials of shoulder disorders. The next step includes identification of a core outcome measurement set that passes the OMERACT 2.1 Filter for measuring each domain.

19.
Br J Nutr ; 121(5): 481-495, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30630543

RESUMO

The relationship between alcohol consumption and body weight is complex and inconclusive being potentially mediated by alcohol type, habitual consumption levels and sex differences. Heavy and regular alcohol consumption has been positively correlated with increasing body weight, although it is unclear whether this is due to alcohol consumption per se or to additional energy intake from food. This review explores the effects of alcohol consumption on food energy intake in healthy adults. CINAHL Plus, EMBASE, Medline and PsycINFO were searched through February 2018 for crossover and randomised controlled trials where an alcohol dose was compared with a non-alcohol condition. Study quality was assessed using the Effective Public Health Practice Project tool. A total of twenty-two studies involving 701 participants were included from the 18 427 papers retrieved. Studies consistently demonstrated no compensation for alcoholic beverage energy intake, with dietary energy intake not decreasing due to alcoholic beverage ingestion. Meta-analyses using the random-effects model were conducted on twelve studies and demonstrated that alcoholic beverage consumption significantly increased food energy intake and total energy intake compared with a non-alcoholic comparator by weighted mean differences of 343 (95 % CI 161, 525) and 1072 (95 % CI 820, 1323) kJ, respectively. Generalisability is limited to younger adults (18-37 years), and meta-analyses for some outcomes had substantial statistical heterogeneity or evidence of small-study effects. This review suggests that adults do not compensate appropriately for alcohol energy by eating less, and a relatively modest alcohol dose may lead to an increase in food consumption.


Assuntos
Consumo de Bebidas Alcoólicas/efeitos adversos , Ingestão de Alimentos/efeitos dos fármacos , Ingestão de Energia/efeitos dos fármacos , Comportamento Alimentar/efeitos dos fármacos , Adolescente , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
20.
J Clin Epidemiol ; 106: 121-135, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30312656

RESUMO

OBJECTIVES: The aim of the article was to identify and summarize studies assessing methodologies for study selection, data abstraction, or quality appraisal in systematic reviews. STUDY DESIGN AND SETTING: A systematic review was conducted, searching MEDLINE, EMBASE, and the Cochrane Library from inception to September 1, 2016. Quality appraisal of included studies was undertaken using a modified Quality Assessment of Diagnostic Accuracy Studies 2, and key results on accuracy, reliability, efficiency of a methodology, or impact on results and conclusions were extracted. RESULTS: After screening 5,600 titles and abstracts and 245 full-text articles, 37 studies were included. For screening, studies supported the involvement of two independent experienced reviewers and the use of Google Translate when screening non-English articles. For data abstraction, studies supported involvement of experienced reviewers (especially for continuous outcomes) and two independent reviewers, use of dual monitors, graphical data extraction software, and contacting authors. For quality appraisal, studies supported intensive training, piloting quality assessment tools, providing decision rules for poorly reported studies, contacting authors, and using structured tools if different study designs are included. CONCLUSION: Few studies exist documenting common systematic review practices. Included studies support several systematic review practices. These results provide an updated evidence-base for current knowledge synthesis guidelines and methods requiring further research.


Assuntos
/normas , Revisão Sistemática como Assunto , Estudos Transversais , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
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