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1.
Ophthalmol Retina ; 2020 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-32362554

RESUMO

PURPOSE: To conduct a systematic review and meta-analysis of the natural history of atrophy secondary to choroideremia (CHM). CLINICAL RELEVANCE: A sensitive and reliable anatomic measure to monitor disease progression is needed in treatment trials for CHM. However, the long-term natural history of the residual retinal pigment epithelium (RPE) is unclear, with reported RPE area decline rates varying widely among patients. METHODS: We searched in 7 literature databases up through July 17, 2019, to identify studies that assessed the residual RPE area in untreated eyes with CHM using fundus autofluorescence (FAF). We sought individual-eye data and investigated the RPE decline pattern using 3 models: the area linear model (ALM), radius linear model (RLM), and area exponential model (AEM), in which the area, radius, and log-transformed area of RPE change linearly with time, respectively. To account for different eyes' entry times into the studies, we added a horizontal translation factor to each dataset. The RPE decline rate was estimated using a 2-stage random-effects meta-analysis. We assessed the risk of bias using the Quality In Prognosis Studies tool. RESULTS: Of 807 articles screened, we included 9 articles containing cross-sectional data (257 eyes) from 6 studies and longitudinal data (229 visits from 68 eyes) from 5 studies. The residual RPE area followed a trend of exponential decay as a function of patient age. After the introduction of horizontal translation factors to longitudinal datasets of individual eyes, the datasets fit along a straight line in the AEM over nearly 60 years (r2 = 0.997). The decline rate of log-transformed RPE area was 0.050 (95% confidence interval, 0.046-0.055) log(mm2)/year and was independent of the baseline RPE area (r = -0.18; P = 0.15) and age (r = 0.06; P = 0.63). In contrast, the decline rates of the area and effective radius of residual RPE strongly correlated with the baseline RPE area (r = 0.90 and 0.61, respectively; P < 0.001). CONCLUSIONS: The loss of residual RPE area in untreated eyes with CHM follows the AEM over approximately 60 years. Log-transformed residual RPE area measured by FAF can serve as an anatomic endpoint to monitor CHM.

2.
Ophthalmol Retina ; 2020 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-32423772

RESUMO

TOPIC: Determining the natural history of unifocal versus multifocal geographic atrophy (GA) secondary to nonexudative age-related macular degeneration. CLINICAL RELEVANCE: The association between GA focality (i.e., unifocal vs. multifocal lesions) and enlargement rate is inconsistent in the literature. Some studies report a comparable growth rate between unifocal and multifocal GA, whereas others suggest the growth rate varies widely between the 2 groups. METHODS: We searched 5 literature databases up to May 3, 2019, for studies that classified treatment-naïve GA patients based on lesion focality. We performed a random effects meta-analysis to determine the growth rates of GA. To account for different entry times among cohorts, we introduced a horizontal translation factor to the dataset of each cohort. Heterogeneity and study quality were assessed using the I2 statistic and Quality in Prognosis Studies tool, respectively. Publication bias was evaluated by funnel plots and the Egger test. RESULTS: We included 12 studies with 3489 eyes from 3001 patients. After the introduction of translation factors, the effective radius of unifocal and multifocal GA enlarged linearly over approximately 7 years. The effective radius growth rate of multifocal GA (0.199±0.012 mm/year) was 46.3% higher than the growth rate of unifocal GA (0.136±0.008 mm/year; P < 0.001). Interestingly, unifocal and multifocal GA lesions with the same total baseline area grew at vastly different rates, with an estimated ratio of the growth rate as 1.46 (between 2 and 3). This difference disappeared after we accounted for different baseline total perimeters between unifocal and multifocal groups. The measured GA growth rate was consistent across studies using color fundus photography, fundus autofluorescence, or OCT (P = 0.35-0.99). CONCLUSIONS: The effective radius of GA enlarges linearly and steadily over time in both unifocal and multifocal GA. The lesion focality is a significant prognostic factor for the GA effective radius growth rate. We propose that the growth rate of GA area is directly proportional to the total lesion perimeter (a measure of the number of retinal pigment epithelium cells exposed at the lesion border). Additional studies are needed to understand the cellular mechanisms underlying this relationship.

3.
BMJ ; 368: l7078, 2020 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-32024657

RESUMO

OBJECTIVES: To conduct a systematic review and meta-analysis of the effects of rosiglitazone treatment on cardiovascular risk and mortality using multiple data sources and varying analytical approaches with three aims in mind: to clarify uncertainties about the cardiovascular risk of rosiglitazone; to determine whether different analytical approaches are likely to alter the conclusions of adverse event meta-analyses; and to inform efforts to promote clinical trial transparency and data sharing. DESIGN: Systematic review and meta-analysis of randomized controlled trials. DATA SOURCES: GlaxoSmithKline's (GSK's) ClinicalStudyDataRequest.com for individual patient level data (IPD) and GSK's Study Register platforms, MEDLINE, PubMed, Embase, Web of Science, Cochrane Central Registry of Controlled Trials, Scopus, and ClinicalTrials.gov from inception to January 2019 for summary level data. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomized, controlled, phase II-IV clinical trials that compared rosiglitazone with any control for at least 24 weeks in adults. DATA EXTRACTION AND SYNTHESIS: For analyses of trials for which IPD were available, a composite outcome of acute myocardial infarction, heart failure, cardiovascular related death, and non-cardiovascular related death was examined. These four events were examined independently as secondary analyses. For analyses including trials for which IPD were not available, myocardial infarction and cardiovascular related death were examined, which were determined from summary level data. Multiple meta-analyses were conducted that accounted for trials with zero events in one or both arms with two different continuity corrections (0.5 constant and treatment arm) to calculate odds ratios and risk ratios with 95% confidence intervals. RESULTS: 33 eligible trials were identified from ClinicalStudyDataRequest.com for which IPD were available (21 156 patients). Additionally, 103 trials for which IPD were not available were included in the meta-analyses for myocardial infarction (23 683 patients), and 103 trials for which IPD were not available contributed to the meta-analyses for cardiovascular related death (22 772 patients). Among 29 trials for which IPD were available and that were included in previous meta-analyses using GSK's summary level data, more myocardial infarction events were identified by using IPD instead of summary level data for 26 trials, and fewer cardiovascular related deaths for five trials. When analyses were limited to trials for which IPD were available, and a constant continuity correction of 0.5 and a random effects model were used to account for trials with zero events in only one arm, patients treated with rosiglitazone had a 33% increased risk of a composite event compared with controls (odds ratio 1.33, 95% confidence interval 1.09 to 1.61; rosiglitazone population: 274 events among 11 837 patients; control population: 219 events among 9319 patients). The odds ratios for myocardial infarction, heart failure, cardiovascular related death, and non-cardiovascular related death were 1.17 (0.92 to 1.51), 1.54 (1.14 to 2.09), 1.15 (0.55 to 2.41), and 1.18 (0.60 to 2.30), respectively. For analyses including trials for which IPD were not available, odds ratios for myocardial infarction and cardiovascular related death were attenuated (1.09, 0.88 to 1.35, and 1.12, 0.72 to 1.74, respectively). Results were broadly consistent when analyses were repeated using trials with zero events across both arms and either of the two continuity corrections was used. CONCLUSIONS: The results suggest that rosiglitazone is associated with an increased cardiovascular risk, especially for heart failure events. Although increased risk of myocardial infarction was observed across analyses, the strength of the evidence varied and effect estimates were attenuated when summary level data were used in addition to IPD. Because more myocardial infarctions and fewer cardiovascular related deaths were reported in the IPD than in the summary level data, sharing IPD might be necessary when performing meta-analyses focused on safety. SYSTEMATIC REVIEW REGISTRATION: OSF Home https://osf.io/4yvp2/.


Assuntos
Doenças Cardiovasculares/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Rosiglitazona/efeitos adversos , Doenças Cardiovasculares/mortalidade , Humanos , Hipoglicemiantes/farmacologia , Disseminação de Informação , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Rosiglitazona/farmacologia
4.
Invest Ophthalmol Vis Sci ; 61(1): 2, 2020 Jan 23.
Artigo em Inglês | MEDLINE | ID: mdl-31995152

RESUMO

Purpose: To determine the impact of topographic locations on the progression rate of geographic atrophy (GA). Methods: We searched in five literature databases up to May 3, 2019, for studies that evaluated the growth rates of GA lesions at different retinal regions. We performed random-effects meta-analyses to determine and compare the GA effective radius growth rates in four location groups defined by two separate classification schemes: (1) macular center point involved (CPI) or spared (CPS) in classification 1, and (2) foveal zone involved (FZI) or spared (FZS) in classification 2. We then estimated the GA growth rate in eight topographic zones and used the data to model the GA expansion. Results: We included 11 studies with 3254 unique eyes. In studies that used classification 1, the effective radius growth rate was 30.1% higher in the CPS group (0.203 ± 0.013 mm/year) than in the CPI group (0.156 ± 0.011 mm/year) (P < 0.001). This trend became significantly more prominent in classification 2, where the growth rate was 61.7% higher in the FZS group (0.215 ± 0.012 mm/year) than in the FZI group (0.133 ± 0.009 mm/year) (P < 0.001). The estimated GA effective radius growth rates in eight retinal zones fit a Gaussian function, and the modeling of GA expansion gave rise to various GA configurations comparable to clinical observations. Conclusions: This study indicates that the GA progression rate varies significantly across different retinal locations. Our analysis may shed light on the natural history and underlying mechanism of GA progression.


Assuntos
Atrofia Geográfica/diagnóstico , Retina/patologia , Bases de Dados Factuais , Progressão da Doença , Exsudatos e Transudatos , Atrofia Geográfica/fisiopatologia , Humanos , Degeneração Macular/diagnóstico
5.
Res Integr Peer Rev ; 4: 23, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31798974

RESUMO

Background: Developing a comprehensive, reproducible literature search is the basis for a high-quality systematic review (SR). Librarians and information professionals, as expert searchers, can improve the quality of systematic review searches, methodology, and reporting. Likewise, journal editors and authors often seek to improve the quality of published SRs and other evidence syntheses through peer review. Health sciences librarians contribute to systematic review production but little is known about their involvement in peer reviewing SR manuscripts. Methods: This survey aimed to assess how frequently librarians are asked to peer review systematic review manuscripts and to determine characteristics associated with those invited to review. The survey was distributed to a purposive sample through three health sciences information professional listservs. Results: There were 291 complete survey responses. Results indicated that 22% (n = 63) of respondents had been asked by journal editors to peer review systematic review or meta-analysis manuscripts. Of the 78% (n = 228) of respondents who had not already been asked, 54% (n = 122) would peer review, and 41% (n = 93) might peer review. Only 4% (n = 9) would not review a manuscript. Respondents had peer reviewed manuscripts for 38 unique journals and believed they were asked because of their professional expertise. Of respondents who had declined to peer review (32%, n = 20), the most common explanation was "not enough time" (60%, n = 12) followed by "lack of expertise" (50%, n = 10).The vast majority of respondents (95%, n = 40) had "rejected or recommended a revision of a manuscript| after peer review. They based their decision on the "search methodology" (57%, n = 36), "search write-up" (46%, n = 29), or "entire article" (54%, n = 34). Those who selected "other" (37%, n = 23) listed a variety of reasons for rejection, including problems or errors in the PRISMA flow diagram; tables of included, excluded, and ongoing studies; data extraction; reporting; and pooling methods. Conclusions: Despite being experts in conducting literature searches and supporting SR teams through the review process, few librarians have been asked to review SR manuscripts, or even just search strategies; yet many are willing to provide this service. Editors should involve experienced librarians with peer review and we suggest some strategies to consider.

6.
Ophthalmology ; 126(9): 1288-1296, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31227323

RESUMO

TOPIC: Systematic review and meta-analysis of the natural history of autosomal recessive Stargardt disease (STGD1). CLINICAL RELEVANCE: Controversy exists regarding the progression pattern of atrophic lesions secondary to STGD1, and the reported growth rates vary widely among studies. METHODS: We searched in 6 literature databases up through March 15, 2019, to identify studies that monitored atrophy progression by fundus autofluorescence in untreated eyes with STGD1 for 6 months or more. We analyzed both study- and individual-level data from the included studies using 3 models: the area linear model (ALM), radius linear model (RLM), and area exponential model (AEM), in which the area, radius, and natural log-transformed area changes linearly with time, respectively. A horizontal translation factor was added to each dataset to correct for different participants' entry times into the studies. The best model was determined by the predicted age of lesion onset and dependence of growth rates on baseline lesion sizes. The risk of bias was assessed using the Newcastle-Ottawa scale. RESULTS: Of 3158 articles screened, 7 studies (564 eyes) met our inclusion criteria. Cumulative study- and individual-level datasets fit along a straight line in the RLM after introducing horizontal translation factors to correct for different entry times (r2 = 0.99 and r2 = 0.93, respectively). The growth rate of effective lesion radius was 0.104 mm/year (95% confidence interval, 0.086-0.123 mm/year). The age of atrophy onset predicted by the RLM (22.7±5.0 years) was comparable to the reported age at onset of symptoms (22.1±3.1 years); in contrast, the predictions by the ALM and AEM deviated from this number by more than 5 years. Based on the individual-level data, the effective radius growth rate was independent of the baseline lesion size (r = 0.06); in comparison, the growth rates of area and natural log-transformed area were significantly dependent on the baseline lesion size (r = 0.47 and r = -0.33, respectively). CONCLUSIONS: The progression of STGD1 lesions followed the RLM in both study- and individual-level data. The effective radius growth rate of atrophic lesions could serve as a reliable outcome measure to monitor STGD1 progression.

7.
Ophthalmol Retina ; 3(4): 305-315, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-31014681

RESUMO

TOPIC: Systematic review and meta-analysis of how fellow eye status predicts the progression rate of geographic atrophy (GA). CLINICAL RELEVANCE: The status of age-related macular degeneration (AMD) in the fellow eye has been used as an indicator of the GA progression rates in primary eyes, but the reported growth rates vary widely in prior clinical studies. METHODS: We searched MEDLINE, EMBASE, Cochrane Library, Clinicaltrials.gov, and PubMed up to September 12, 2018, for studies that classified treatment-naive GA patients based on different AMD manifestations in the fellow eyes and that monitored GA progression in the primary eyes. Three fellow eye statuses were analyzed: (1) no GA or choroidal neovascularization (CNV) in the fellow eye, (2) GA in the fellow eye, and (3) CNV in the fellow eye. To account for the patients' different entry times, we introduced a horizontal translation factor to shift each dataset within each group. We determined the translation factor by adjusting it 1 month at a time until the r2 in weighted least squares regression (r2WLS) was maximized for the cumulative linear trend line of all datasets. Heterogeneity and study quality were assessed using the I2 statistic and Newcastle-Ottawa scale, respectively. Publication bias was evaluated by funnel plots, the Egger test, and the Begg test. RESULTS: We included 9 studies with 2134 eyes from 1835 patients. After the introduction of translation factors, the datasets in each fellow eye group fit along a straight line with a high r2WLS. The GA radius growth rate in fellow eyes with GA (0.179±0.003 mm/year) and fellow eyes with CNV (0.159±0.015 mm/year) was significantly higher than that in fellow eyes without GA or CNV (0.110±0.009 mm/year; P < 0.001 and P = 0.02, respectively). We found no significant difference in the GA radius growth rates between fellow eyes with GA and fellow eyes with CNV (P = 0.42). CONCLUSIONS: We confirmed that the presence of advanced AMD in the fellow eye, defined as GA or CNV, can serve as a biomarker of the GA enlargement rate in the primary eye. This may assist the design of clinical trials and may shed light on the natural history of GA expansion.


Assuntos
Corioide/patologia , Atrofia Geográfica/diagnóstico , Retina/patologia , Acuidade Visual , Progressão da Doença , Angiofluoresceinografia/métodos , Fundo de Olho , Atrofia Geográfica/fisiopatologia , Humanos
9.
Obstet Gynecol ; 131(2): 214-223, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29324608

RESUMO

OBJECTIVE: To assess hospital practices in obstetric quality management activities and identify institutional characteristics associated with utilization of evidence-supported practices. METHODS: Data for this study came from a statewide survey of obstetric hospitals in California regarding their organization and delivery of perinatal care. We analyzed responses from 185 hospitals that completed quality assurance sections of the survey to assess their practices in a broad spectrum of quality enhancement activities. The association between institutional characteristics and adoption of evidence-supported practices (ie, those supported by prior literature or recommended by professional organizations as beneficial for improving birth outcome or patient safety) was examined using bivariate analysis and appropriate statistical tests. RESULTS: Most hospitals regularly audited adherence to written protocols regarding critical areas of care; however, 77.7% and 16.8% reported not having written guidelines on diagnosis of labor arrest and management of abnormal fetal heart rate, respectively. Private nonprofit hospitals were more likely to have a written protocol for management of abnormal fetal heart rate (P=.002). One in 10 hospitals (9.7%) did not regularly review cases with significant morbidity or mortality, and only 69.0% regularly tracked indications for cesarean delivery. Moreover, 26.3%, 14.3%, and 8.7% of the hospitals reported never performing interprofessional simulations for eclampsia, shoulder dystocia, or postpartum hemorrhage, respectively. Teaching status was associated with more frequent simulations in these three areas (P≤.04 for all), while larger volume was associated with more frequent simulations for eclampsia (P=.04). CONCLUSION: Hospitals in California engage in a wide range of practices to assure or improve quality of obstetric care, but substantial variation in practice exists among hospitals. There is opportunity for improvement in adoption of evidence-supported practices.


Assuntos
Hospitais , Obstetrícia , Padrões de Prática Médica , Garantia da Qualidade dos Cuidados de Saúde/organização & administração , California , Pesquisas sobre Serviços de Saúde , Humanos
10.
Ann Intern Med ; 167(1): 26-33, 2017 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-28586893

RESUMO

Background: Small unruptured intracranial aneurysms (UIAs) are increasingly diagnosed. Management depends on growth and rupture risks, which may vary by aneurysm size. Purpose: To summarize evidence about the growth and rupture risk of UIAs 7 mm and smaller and to explore differences in growth and rupture risks of very small (≤3 mm) and small (≤5 mm) aneurysms. Data Sources: MEDLINE, EMBASE, Scopus, and the Cochrane Library from inception to 2017 (with no language restrictions). Study Selection: Published case series and observational studies that reported natural history data on UIAs 7 mm and smaller. Data Extraction: 2 reviewers abstracted study information, evaluated study quality, and graded strength of evidence. Data Synthesis: Of 26 studies, 5, 10, and 8 described the growth rate of aneurysms 3 mm and smaller, 5 mm and smaller, and 7 mm and smaller, respectively, whereas rupture rates were reported in 7, 11, and 13 studies for aneurysms 3 mm and smaller, 5 mm and smaller, and 7 mm and smaller, respectively. The annualized growth rate was less than 3% in all but 1 study for all 3 size categories. The annualized rupture rate was 0%, less than 0.5%, and less than 1% for the 3 size categories, respectively. Strength of evidence was very low quality for growth rates and low quality for rupture rates. Limitation: Heterogeneous definitions of growth; heterogeneous and selective treatment and follow-up methods, particularly in high-risk patients. Conclusion: Poor-quality evidence suggests that small UIAs have low growth and rupture rates and very small UIAs have little or no risk for rupture. Primary Funding Source: None.


Assuntos
Aneurisma Intracraniano/patologia , Feminino , Humanos , Masculino , Fatores de Risco , Ruptura Espontânea
11.
Expert Rev Ophthalmol ; 12(3): 233-241, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29333193

RESUMO

Introduction: Community-engaged research (CEnR) allows researchers and community organizations to partner together to improve health outcomes and to decrease health disparities. While prevalent in other fields of medicine, it is rarely used in ophthalmology. Areas covered: A comprehensive search of Ovid MEDLINE, NLM Pubmed, Ovid Embase, Scopus and the Cochrane Library for the Medical Subject Headings (MeSH) "Community-based participatory research" and text word variations including participatory research, community engagement, community research, partnered research, community-institutional relations, CENR, CBPR in addition to variations on ophthalmology, eye diseases, vision disorders and eye injuries yielded 451 unique references. Two ophthalmologists (KN, PANC) reviewed the titles and abstracts and identified 37 relevant studies. Expert consultation yielded an additional reference. After reviewing the full texts and excluding non-English texts, 18 articles met the necessary criteria. The eighteen articles all utilized at least one of the nine principles of CEnR. Expert commentary: Ophthalmology is perfectly positioned to benefit from CEnR. Increased community engagement in ophthalmic research would expand the reach of our work and address some of the most difficult problems in vision disparities and outcomes.

12.
Syst Rev ; 3: 47, 2014 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-24887208

RESUMO

BACKGROUND: Micro-costing is a cost estimation method that allows for precise assessment of the economic costs of health interventions. It has been demonstrated to be particularly useful for estimating the costs of new interventions, for interventions with large variability across providers, and for estimating the true costs to the health system and to society. However, existing guidelines for economic evaluations do not provide sufficient detail of the methods and techniques to use when conducting micro-costing analyses. Therefore, the purpose of this study is to review the current literature on micro-costing studies of health and medical interventions, strategies, and programs to assess the variation in micro-costing methodology and the quality of existing studies. This will inform current practice in conducting and reporting micro-costing studies and lead to greater standardization in methodology in the future. METHODS/DESIGN: We will perform a systematic review of the current literature on micro-costing studies of health and medical interventions, strategies, and programs. Using rigorously designed search strategies, we will search Ovid MEDLINE, EconLit, BIOSIS Previews, Embase, Scopus, and the National Health Service Economic Evaluation Database (NHS EED) to identify relevant English-language articles. These searches will be supplemented by a review of the references of relevant articles identified. Two members of the review team will independently extract detailed information on the design and characteristics of each included article using a standardized data collection form. A third reviewer will be consulted to resolve discrepancies. We will use checklists that have been developed for critical appraisal of health economics studies to evaluate the quality and potential risk of bias of included studies. DISCUSSION: This systematic review will provide useful information to help standardize the methods and techniques for conducting and reporting micro-costing studies in research, which can improve the quality and transparency of future studies and enhance comparability and interpretation of findings. In the long run, these efforts will facilitate clinical and health policy decision-making about resource allocation. TRIAL REGISTRATION: Systematic review registration: PROSPERO CRD42014007453.


Assuntos
Custos de Cuidados de Saúde , Análise Custo-Benefício , Custos de Cuidados de Saúde/normas , Custos de Cuidados de Saúde/estatística & dados numéricos , Pesquisa sobre Serviços de Saúde/métodos , Pesquisa sobre Serviços de Saúde/normas , Humanos , Revisões Sistemáticas como Assunto
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