Journal articles on the topic 'Outcome analyses'
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Viechtbauer, Wolfgang. "Accounting for Heterogeneity via Random-Effects Models and Moderator Analyses in Meta-Analysis." Zeitschrift für Psychologie / Journal of Psychology 215, no. 2 (January 2007): 104–21. http://dx.doi.org/10.1027/0044-3409.215.2.104.
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Abstract. To conduct a meta-analysis, one needs to express the results from a set of related studies in terms of an outcome measure, such as a standardized mean difference, correlation coefficient, or odds ratio. The observed outcome from a single study will differ from the true value of the outcome measure because of sampling variability. The observed outcomes from a set of related studies measuring the same outcome will, therefore, not coincide. However, one often finds that the observed outcomes differ more from each other than would be expected based on sampling variability alone. A likely explanation for this phenomenon is that the true values of the outcome measure are heterogeneous. One way to account for the heterogeneity is to assume that the heterogeneity is entirely random. Another approach is to examine whether the heterogeneity in the outcomes can be accounted for, at least in part, by a set of study-level variables describing the methods, procedures, and samples used in the different studies. The purpose of the present paper is to discuss these different approaches with particular emphasis on the interpretation of the results and practical issues.
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Steyerberg, Ewout W., Sander P. G. Frankema, and Frank E. Harrell. "Statistical Analyses of Trauma Outcome." Journal of Trauma: Injury, Infection, and Critical Care 54, no. 6 (June 2003): 1256–57. http://dx.doi.org/10.1097/00005373-200306000-00048.
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Miller, Harold L. "Quantitative analyses of student outcome measures." International Journal of Educational Research 27, no. 2 (January 1997): 119–36. http://dx.doi.org/10.1016/s0883-0355(97)90028-8.
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Evans, Scott R., Mikael Knutsson, Pierre Amarenco, Gregory W. Albers, Philip M. Bath, Hans Denison, Per Ladenvall, et al. "Methodologies for pragmatic and efficient assessment of benefits and harms: Application to the SOCRATES trial." Clinical Trials 17, no. 6 (July 15, 2020): 617–26. http://dx.doi.org/10.1177/1740774520941441.
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Background/Aims: Standard approaches to trial design and analyses can be inefficient and non-pragmatic. Failure to consider a range of outcomes impedes evidence-based interpretation and reduces power. Traditional approaches synthesizing information obtained from separate analysis of each outcome fail to incorporate associations between outcomes and recognize the cumulative nature of outcomes in individual patients, suffer from competing risk complexities during interpretation, and since efficacy and safety analyses are often conducted on different populations, generalizability is unclear. Pragmatic and efficient approaches to trial design and analyses are needed. Methods: Approaches providing a pragmatic assessment of benefits and harms of interventions, summarizing outcomes experienced by patients, and providing sample size efficiencies are described. Ordinal outcomes recognize finer gradations of patient responses. Desirability of outcome ranking is an ordinal outcome combining benefits and harms within patients. Analysis of desirability of outcome ranking can be based on rank-based methodologies including the desirability of outcome ranking probability, the win ratio, and the proportion in favor of treatment. Partial credit analyses, involving grading the levels of the desirability of outcome ranking outcome similar to an academic test, provides an alternative approach. The methodologies are demonstrated using the acute stroke or transient ischemic attack treated with aspirin or ticagrelor and patient outcomes study (SOCRATES; NCT01994720), a randomized clinical trial. Results: Two 5-level ordinal outcomes were developed for SOCRATES. The first was based on a modified Rankin scale. The odds ratio is 0.86 (95% confidence interval = 0.75, 0.99; p = 0.04) indicating that the odds of worse stroke categorization for a trial participant assigned to ticagrelor is 0.86 times that of a trial participant assigned to aspirin. The 5-level desirability of outcome ranking outcome incorporated and prioritized survival; the number of strokes, myocardial infarction, and major bleeding events; and whether a stroke event was disabling. The desirability of outcome ranking probability and win ratio are 0.504 (95% confidence interval = 0.499, 0.508; p = 0.10) and 1.11 (95% confidence interval = 0.98, 1.26; p = 0.10), respectively, implying that the probability of a more desirable result with ticagrelor is 50.4% and that a more desirable result occurs 1.11 times more frequently on ticagrelor versus aspirin. Conclusion: Ordinal outcomes can improve efficiency through required pre-specification, careful construction, and analyses. Greater pragmatism can be obtained by composing outcomes within patients. Desirability of outcome ranking provides a global assessment of the benefits and harms that more closely reflect the experience of patients. The desirability of outcome ranking probability, the proportion in favor of treatment, the win ratio, and partial credit can more optimally inform patient treatment, enhance the understanding of the totality of intervention effects on patients, and potentially provide efficiencies over standard analyses. The methods provide the infrastructure for incorporating patient values and estimating personalized effects.
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Esposito, Eleonora, Andrea Cipriani, and Corrado Barbui. "Outcome reporting bias in clinical trials." Epidemiologia e Psichiatria Sociale 18, no. 1 (March 2009): 17–18. http://dx.doi.org/10.1017/s1121189x00001408.
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Randomised controlled trials (RCTs) are designed and powered to measure one single outcome, calledprimary outcome(Sibbald & Roland, 1998; Barbuiet al., 2007). The primary outcome is the pre-specified outcome of greatest clinical importance and is usually the one used in the sample size calculation (Accordini, 2007). In addition to the primary outcome, RCTs may have several other outcomes, calledsecondary outcomes. In contrast with the analysis of the primary outcome, the analysis of secondary outcomes and its interpretation may be complicated by at least two factors:1)the trial may not have enough statistical power to detect differences (so it is possible to incur in a type II error, that is failing to see a difference that is present);2)increasing the number of secondary outcomes generates the problem of multiplicity of analyses, that is the proliferation of possible comparisons in a trial (and increasing the number of comparisons increases the possibility to incur in a type I error, that is detecting significant differences by chance). For all these reasons, the results of the analysis of primary outcomes is considered less susceptible to bias than the analysis of secondary outcomes.
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Carifi, Gianluca, Nikolaos Kopsachilis, Christos Pitsas, and Vasiliki Zygoura. "Comment on: Refractive outcome analyses in myopes." Indian Journal of Ophthalmology 63, no. 2 (2015): 175. http://dx.doi.org/10.4103/0301-4738.154419.
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Liu, Lan, Hongwei Gao, Weihua Yu, Shanyan Zhang, Jianqiang Guo, and Kongxi Zhu. "Outcome Analyses of 15,189 Screenings Via Colonoscopy." Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 27, no. 5 (October 2017): 400–403. http://dx.doi.org/10.1097/sle.0000000000000457.
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WACHTER, KERRI. "QoL, Cancer Outcome Linked in Meta-Analyses." Clinical Psychiatry News 36, no. 7 (July 2008): 53. http://dx.doi.org/10.1016/s0270-6644(08)70504-6.
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Alper, Brian Scott, Gary Foster, Lehana Thabane, Alex Rae-Grant, Meghan Malone-Moses, and Eric Manheimer. "Thrombolysis with alteplase 3–4.5 hours after acute ischaemic stroke: trial reanalysis adjusted for baseline imbalances." BMJ Evidence-Based Medicine 25, no. 5 (May 19, 2020): 168–71. http://dx.doi.org/10.1136/bmjebm-2020-111386.
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ObjectivesAlteplase is commonly recommended for acute ischaemic stroke within 4.5 hours after stroke onset. The Third European Cooperative Acute Stroke Study (ECASS III) is the only trial reporting statistically significant efficacy for clinical outcomes for alteplase use 3–4.5 hours after stroke onset. However, baseline imbalances in history of prior stroke and stroke severity score may confound this apparent finding of efficacy. We reanalysed the ECASS III trial data adjusting for baseline imbalances to determine the robustness or sensitivity of the efficacy estimates.DesignReanalysis of randomised placebo-controlled trial. We obtained access to the ECASS III trial data and replicated the previously reported analyses to confirm our understanding of the data. We adjusted for baseline imbalances using multivariable analyses and stratified analyses and performed sensitivity analysis for missing data.SettingEmergency care.Participants821 adults with acute ischaemic stroke who could be treated 3–4.5 hours after symptom onset.InterventionsIntravenous alteplase (0.9 mg/kg of body weight) or placebo.Main outcome measuresThe original primary efficacy outcome was modified Rankin Scale (mRS) score 0 or 1 (ie, being alive without any disability) and the original secondary efficacy outcome was a global outcome based on a composite of functional end points, both at 90 days. Adjusted analyses were only reported for the primary efficacy outcome and the original study protocol did not specify methods for adjusted analyses. Our adjusted reanalysis included these outcomes, symptom-free status (mRS 0), dependence-free status (mRS 0–2), mortality (mRS 6) and change across the mRS 0–6 spectrum at 90 days; and mortality and symptomatic intracranial haemorrhage at 7 days.ResultsWe replicated previously reported unadjusted analyses but discovered they were based on a modified interpretation of the National Institutes of Health Stroke Scale (NIHSS) score. The secondary efficacy outcome was no longer significant using the original NIHSS score. Previously reported adjusted analyses could only be replicated with significant effects for the primary efficacy outcome by using statistical approaches not reported in the trial protocol or statistical analysis plan. In analyses adjusting for baseline imbalances, all efficacy outcomes were not significant, but increases in symptomatic intracranial haemorrhage remained significant.ConclusionsReanalysis of the ECASS III trial data with multiple approaches adjusting for baseline imbalances does not support any significant benefits and continues to support harms for the use of alteplase 3–4.5 hours after stroke onset. Clinicians, patients and policymakers should reconsider interpretations and decisions regarding management of acute ischaemic stroke that were based on ECASS III results.Trial registration numberNCT00153036.
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Bronner, Shaw, and Igor Urbano. "Dance Functional Outcome Survey: Development and Preliminary Analyses." Sports Medicine International Open 02, no. 06 (November 2018): E191—E199. http://dx.doi.org/10.1055/a-0729-3000.
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AbstractThe Dance Functional Outcome Survey (DFOS) was developed as a self-report questionnaire for healthy and injured ballet and modern dancers, focusing on the low back and lower extremities. Our aim was to determine factor analysis and internal consistency of the 16 items and to investigate test-retest and equivalence reliability and validity of the DFOS compared to three orthopedic outcomes instruments. Data were collected from 80 healthy and injured adult ballet and modern pre-professional and professional dancers. DFOS Likert-type and visual analog scales were completed twice within 4–9 days to study test-retest reliability. The Cincinnati Knee Rating System, Olerud and Molander Foot-Ankle Questionnaire, and Oswestry Disability Index were used to assess concurrent validity using intraclass correlation coefficients in SPSS, p<0.05. To determine instrument dimensions and internal consistency of the items, we conducted exploratory factor analysis and calculated Cronbach’s α in JASP. DFOS demonstrated single factor loading and high Cronbach’s α; high test-retest repeatability and equivalence reliability (r=0.74–0.99) and acceptable criterion validity compared to the orthopedic outcomes instruments (r≥0.67). These results support further study of a revised 14 item Likert-version DFOS for repeatability, validity and responsiveness.
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Rahman, Mahboob, Nishigandha Pradhan, Zhengyi Chen, Radhika Kanthety, Raymond R. Townsend, Curtis Tatsuoka, and Jackson T. Wright. "Orthostatic Hypertension and Intensive Blood Pressure Control; Post-Hoc Analyses of SPRINT." Hypertension 77, no. 1 (January 2021): 49–58. http://dx.doi.org/10.1161/hypertensionaha.120.15887.
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We evaluated the association between orthostatic hypertension and cardiovascular outcomes and the effect of intensive blood pressure (BP) control on cardiovascular outcomes in patients with orthostatic hypertension. Post hoc analyses of the SPRINT (Systolic Blood Pressure Intervention Trial) data were conducted; orthostatic hypertension was defined as increase in systolic BP≥20 mm Hg or increase in diastolic BP≥10 mm Hg with standing. Of 9329 participants, 1986 (21.2%) had orthostatic hypertension at baseline. Within the intensive treatment group, participants with orthostatic hypertension were at higher risk of developing the composite cardiovascular outcome (hazard ratio, 1.44 [95% CI, 1.1–1.87], P =0.007) compared with participants without orthostatic hypertension. Within the standard treatment group, there were no significant differences in cardiovascular outcome between participants with and without orthostatic hypertension. In participants with orthostatic hypertension, there was no statistically significant difference in risk of the composite cardiovascular outcome between the intensive and the standard BP treatment group (hazard ratio, 1.07 [95% CI, 0.78–1.47], P =0.68). In participants without orthostatic hypertension at baseline, the intensive treatment group was associated with a lower risk of the composite cardiovascular outcome (hazard ratio, 0.67 [95% CI, 0.56–0.79], P <0.0001). Orthostatic hypertension was associated with a higher risk of cardiovascular outcomes in the intensive and not in the standard treatment group; intensive treatment of BP did not reduce the risk of cardiovascular outcomes compared with standard treatment in patients with orthostatic hypertension. These post hoc analyses are hypothesis generating and will need to be confirmed in future studies.
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Soto, Christopher J. "Do Links Between Personality and Life Outcomes Generalize? Testing the Robustness of Trait–Outcome Associations Across Gender, Age, Ethnicity, and Analytic Approaches." Social Psychological and Personality Science 12, no. 1 (April 4, 2020): 118–30. http://dx.doi.org/10.1177/1948550619900572.
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The Big Five personality traits have been linked with a broad range of consequential life outcomes. The present research systematically tested whether such trait–outcome associations generalize across gender, age, ethnicity, and analytic approaches that control for demographic and personality covariates. Analyses of nationally representative samples from the Life Outcomes of Personality Replication project ( N = 6,126) indicated that (a) most trait–outcome associations do generalize across gender, age, and ethnicity; (b) controlling for overlap between personality traits substantially reduces the strength of many associations; and (c) several dozen trait–outcome associations proved highly generalizable across all analyses. These findings have important implications for evaluating the robustness of the personality–outcome literature, updating the canon of established trait–outcome associations, and conducting future research.
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Yousefi, Omid, Pouria Azami, Mohammadmahdi Sabahi, Rocco Dabecco, Badih Adada, and Hamid Borghei-Razavi. "Management of Optic Pathway Glioma: A Systematic Review and Meta-Analysis." Cancers 14, no. 19 (September 30, 2022): 4781. http://dx.doi.org/10.3390/cancers14194781.
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Background: OPG accounts for 3–5% of childhood central nervous system (CNS) tumors and about 2% of pediatric glial lesions. Methods: Article selection was performed by searching PubMed, Web of Science, and Cochrane databases. Results: The pooled mortality rate was 0.12 (95%CI 0.09–0.14). Due to the unrepresentative data, improved and not changed outcomes were classified as favorable outcomes and worsened as unfavorable. Meta-analyses were performed to determine the rate of clinical and radiological favorable outcomes. In terms of visual assessment, the pooled rate of a favorable outcome in chemotherapy, radiotherapy, and surgery was 0.74, 0.81, and 0.65, respectively, and the overall pooled rate of the favorable outcome was 0.75 (95%CI 0.70–0.80). In terms of radiological assessment, the rate of a favorable outcome following chemotherapy, radiotherapy, and surgery was 0.71, 0.74, and 0.67, respectively, and the overall pooled rate of the favorable outcome is 0.71 (95%CI 0.65–0.77). The subgroup analysis revealed no significant difference in the rate of clinical and radiological favorable outcomes between the different treatment modalities (p > 0.05). Conclusion: Our analyses showed that each therapeutic modality represents viable treatment options to achieve remission for these patients.
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Penttilä, Matti, Erika Jääskeläinen, Noora Hirvonen, Matti Isohanni, and Jouko Miettunen. "Duration of untreated psychosis as predictor of long-term outcome in schizophrenia: systematic review and meta-analysis." British Journal of Psychiatry 205, no. 2 (August 2014): 88–94. http://dx.doi.org/10.1192/bjp.bp.113.127753.
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BackgroundDuration of untreated psychosis (DUP) is one of the few potentially modifiable predictors of outcomes of schizophrenia. Long DUP as a predictor of poor short-term outcome has been addressed in previous meta-analyses, but the long-term effects of DUP remain unclear.AimsTo analyse the associations between DUP and long-term outcomes of schizophrenia.MethodA systematic literature search was performed using seven electronic databases and manual searches. Random effects weighted meta-analysis with correlation coefficients was used to pool the results.ResultsWe identified 3493 unique publications, from which 33 samples met our predefined selection criteria. Long DUP correlated statistically significantly with poor general symptomatic outcome, more severe positive and negative symptoms, lesser likelihood of remission and poor social functioning and global outcome (correlations 0.13–0.18). Long DUP was not associated with employment, quality of life or hospital treatment.ConclusionsThe small but mostly consistent correlation between long DUP and poor outcome indicates that early intervention in psychosis may have at least subtle positive effects on the long-term course of illness.
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Cuijpers, Pim, Marketa Ciharova, Soledad Quero, Clara Miguel, Ellen Driessen, Mathias Harrer, Marianna Purgato, David Ebert, and Eirini Karyotaki. "The Contribution of “Individual Participant Data” Meta-Analyses of Psychotherapies for Depression to the Development of Personalized Treatments: A Systematic Review." Journal of Personalized Medicine 12, no. 1 (January 11, 2022): 93. http://dx.doi.org/10.3390/jpm12010093.
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While randomized trials typically lack sufficient statistical power to identify predictors and moderators of outcome, ”individual participant data” (IPD) meta-analyses, which combine primary data of multiple randomized trials, can increase the statistical power to identify predictors and moderators of outcome. We conducted a systematic review of IPD meta-analyses on psychological treatments of depression to provide an overview of predictors and moderators identified. We included 10 (eight pairwise and two network) IPD meta-analyses. Six meta-analyses showed that higher baseline depression severity was associated with better outcomes, and two found that older age was associated with better outcomes. Because power was high in most IPD meta-analyses, non-significant findings are also of interest because they indicate that these variables are probably not relevant as predictors and moderators. We did not find in any IPD meta-analysis that gender, education level, or relationship status were significant predictors or moderators. This review shows that IPD meta-analyses on psychological treatments can identify predictors and moderators of treatment effects and thereby contribute considerably to the development of personalized treatments of depression.
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Presneill, Jeffrey J., Rinaldo Bellomo, Kathy Brickell, Heidi Buhr, Belinda J. Gabbe, Doug W. Gould, Meg Harrold, et al. "Protocol and statistical analysis plan for the phase 3 randomised controlled Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial." Critical Care and Resuscitation 23, no. 3 (September 6, 2021): 262–72. http://dx.doi.org/10.51893/2021.3.oa3.
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OBJECTIVE: To describe the protocol and statistical analysis plan for the Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial. DESIGN: An international, multicentre, parallel-group, randomised controlled phase 3 trial. SETTING: Intensive care units (ICUs) in Australia, New Zealand, Germany, Ireland, the United Kingdom and Brazil. PATIENTS: 750 adult patients expected to receive mechanical ventilation for more than 48 hours. INTERVENTIONS: Early activity and mobilisation delivered to critically ill patients in an ICU for up to 28 days compared with standard care. MAIN OUTCOME MEASURES: The primary outcome is the number of days alive and out of hospital at 180 days after randomisation. Secondary outcomes include ICU-free days, ventilator-free days, delirium-free days, all-cause mortality at 28 and 180 days after randomisation, and functional outcome at 180 days after randomisation. RESULTS: Recruitment at 46 research sites passed 576 patients in March 2021. Final collection of all 180-day outcome data for the target of 750 patients is anticipated by May 2022. CONCLUSIONS: Consistent with international guidelines, a detailed protocol and prospective analysis plan has been developed for the TEAM III trial. This plan specifies the statistical models for evaluating primary and secondary outcomes, defines covariates for adjusted analyses, and defines methods for exploratory analyses. Application of this protocol and statistical analysis plan to the forthcoming TEAM III trial will facilitate unbiased analyses of the clinical data collected. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03133377.
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Garcia-Alamino, Josep M., Clare Bankhead, Carl Heneghan, Nicola Pidduck, and Rafael Perera. "Impact of heterogeneity and effect size on the estimation of the optimal information size: analysis of recently published meta-analyses." BMJ Open 7, no. 11 (November 2017): e015888. http://dx.doi.org/10.1136/bmjopen-2017-015888.
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ObjectiveTo estimate the proportion of systematic reviews that meet the optimal information size (OIS) and assess the impact heterogeneity and effect size have on the OIS estimate by type of outcome (eg, mortality, semiobjective or subjective).MethodsWe carried out searches of Medline and Cochrane to retrieve meta-analyses published in systematic reviews from 2010 to 2012. We estimated the OIS usingTrial Sequential Analysissoftware (TSA V.0.9) and based on several heterogeneity and effect size scenarios, stratifying by type of outcome (mortality/semiobjective/subjective) and by Cochrane/non-Cochrane reviews.ResultsWe included 137 meta-analyses out of 218 (63%) potential systematic reviews (one meta-analysis from each systematic review). Of these reviews, 83 (61%) were Cochrane and 54 (39%) non-Cochrane. The Cochrane reviews included a mean of 6.5 (SD 6.1) studies and the non-Cochrane included a mean of 13.2 (SD 10.2) studies. The mean number of patients was 2619.1 (SD 6245.8 or median 586.0) for the Cochrane and 19 888.5 (SD 32 925.7 or median 6566.5) patients for the non-Cochrane reviews. The percentage of systematic reviews that achieved the OIS for all-cause mortality outcome were 0% Cochrane and 25% for non-Cochrane reviews; for semiobjective outcome 17% for Cochrane and 46% for non-Cochrane reviews and for subjective outcome 45% for Cochrane and 72% for non-Cochrane reviews.ConclusionsThe number of systematic reviews that meet an optimal information size is low and varies depending on the type of outcome and the type of publication. Less than half of primary outcomes synthesised in systematic reviews achieve the OIS, and therefore the conclusions are subject to substantial uncertainty.
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Abouyannis, Michael, Dinesh Aggarwal, David G. Lalloo, Nicholas R. Casewell, Mainga Hamaluba, and Hanif Esmail. "Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review." PLOS Neglected Tropical Diseases 15, no. 8 (August 2, 2021): e0009589. http://dx.doi.org/10.1371/journal.pntd.0009589.
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Background Snakebite is a priority neglected tropical disease and causes a range of complications that vary depending on the snake species. Randomised clinical trials have used varied outcome measures that do not allow results to be compared or combined. In accordance with the Core Outcomes Measurements in Effectiveness Trials (COMET) initiative, this systematic review aims to support the development of a globally relevant core outcome set for snakebite. Methods All randomised controlled trials, secondary analyses of randomised controlled trials and study protocols investigating the efficacy of therapeutics for human snakebite envenoming were eligible for inclusion. Study screening and data extraction were conducted in duplicate by two independent reviewers. All primary and secondary outcome measures were extracted and compiled, as were adverse event outcome measures. Similar outcome measures were grouped into domains. The study was prospectively registered with PROSPERO: CRD42020196160. Results This systematic review included 43 randomised controlled trials, two secondary analyses and 13 study protocols. A total of 382 outcome measures were extracted and, after duplicates were merged, there were 153 unique outcomes. The most frequently used outcome domain (‘venom antigenaemia’) was included in less than one third of the studies. The unique outcomes were classified into 60 outcome domains. Patient-centred outcomes were used in only three of the studies. Discussion Significant heterogeneity in outcome measures exists in snakebite clinical trials. Consensus is needed to select outcome measures that are valid, reliable, patient-centred and feasible. The results of this systematic review strongly support the development of a core outcome set for use in snakebite clinical trials.
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Heesen, M., M. Klimek, and S. E. Hoeks. "Restrictive or responsive? Outcome classification and unplanned sub-group analyses in meta-analyses." Anaesthesia 73, no. 3 (October 4, 2017): 279–83. http://dx.doi.org/10.1111/anae.14078.
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Wang, Rui, Zechun Xie, Bo Li, and Peng Zhang. "Renal impairment and the prognosis of endovascular thrombectomy: a meta-analysis and systematic review." Therapeutic Advances in Neurological Disorders 15 (January 2022): 175628642210836. http://dx.doi.org/10.1177/17562864221083620.
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Background: The association between renal impairment (RI) and stroke outcome after endovascular thrombectomy (EVT) remains unclear, which limits the estimation of patient prognosis by clinicians involved in EVT decision-making. Purpose: This study aimed to investigate the association between RI and acute ischemic stroke (AIS) outcomes in patients treated with EVT. Methods: Studies involving the association between RI at admission and AIS outcomes after EVT were retrieved from the PubMed and Embase databases from their inception to 17 January 2022. A fixed-effects model was used to synthesize the data of the included studies. Sensitivity analysis was performed to identify the source of heterogeneity. Results: Overall, 11 studies, including 5053 patients with stroke receiving EVT, were included in the full analysis. In unadjusted analyses, RI was associated with 3-month poor functional outcome and mortality; the odds ratios (ORs) were 2.13 [10 studies; 95% confidence interval (CI), 1.77–2.56; I2 = 45%] and 2.42 (8 studies; 95% CI, 2.02–2.90; I2 = 58%), respectively. In adjusted analyses, the above associations remained significant; the OR of the 3-month poor functional outcome was 1.49 (5 studies; 95% CI, 1.17–1.90; I2 = 58%), and the OR of the 3-month mortality was 1.84 (6 studies; 95% CI, 1.45–2.33; I2 = 74%). Similar results were obtained in sensitivity analyses. Conclusion: Our results suggest that in patients with AIS who underwent EVT, RI at admission was associated with 3-month poor functional outcome and mortality.
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Papa, Vincenzo, Paolo Rama, Cherry Radford, Darwin C. Minassian, and John K. G. Dart. "Acanthamoeba keratitis therapy: time to cure and visual outcome analysis for different antiamoebic therapies in 227 cases." British Journal of Ophthalmology 104, no. 4 (August 10, 2019): 575–81. http://dx.doi.org/10.1136/bjophthalmol-2019-314485.
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AimsTo test the hypothesis that Acanthamoeba keratitis (AK) outcomes differ for different topical antiamoebic therapies (AAT) and to provide the detailed patient outcome data.MethodsA retrospective cohort study of 227 patients developing AK between 25 July 1991 and 10 August 2012. Inclusion criteria required a complete record of AAT treatment for both the primary outcome of a medical cure rate at 12 months and the secondary outcome of Snellen visual acuity ≤6/24 and/or surgical intervention. Analysis used multivariable regression to control for differences in baseline disease characteristics for both primary and secondary outcomes with unadjusted analyses for other outcomes. Subjects were categorised for analysis both by the AAT used at baseline and also by mutually exclusive AAT (patients exposed to all the drugs in each group, and no others, for some period). AAT categories were PHMB monotherapy, PHMB+diamidine, PHMB+chlorhexidine+diamidine, diamidine monotherapy and other AAT.ResultsAnalysis by baseline AAT showed no notable difference between treatments for both a medical cure at 12 months in 60.79% (138/227) or for a poor outcome in 49.34% (112/227). When AATs were analysed by mutually exclusive groups, PHMB monotherapy provided the best outcomes. These findings are subject to bias requiring careful interpretation. Overall cure rates for the 214 subjects with resolved outcomes were 94.27% (214/227), median time to cure 5 months (IQR 3.25–9.00 months) and range 1–26.24 months.ConclusionPHMB 0.02% monotherapy for the initial treatment of AK is as effective as biguanide+diamidine combination therapy. Chlorhexidine monotherapy was too infrequent for comparison. The outcome data are the most detailed available.
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Sparks, Teresa, Kristen Gosnell, Cinthia Blat, Mary Norton, Hanmin Lee, Juan Gonzalez-Velez, Ruth Goldstein, and Rachel Shulman. "Fetal Congenital Pulmonary Airway Malformation: The Role of an Objective Measurement of Cardiomediastinal Shift." American Journal of Perinatology 36, no. 03 (September 10, 2018): 225–32. http://dx.doi.org/10.1055/s-0038-1669909.
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Objective To examine the relationship between cardiomediastinal shift angle (CMSA) and adverse perinatal outcomes and hydrops in cases of congenital pulmonary airway malformation (CPAM). Study Design This retrospective study evaluated CPAM cases referred to our institution from 2008 to 2015. The primary outcome was a composite score for adverse perinatal outcome. CMSA was measured for each case and evaluated for its association with the primary outcome. The prediction accuracy of CMSA for adverse perinatal outcome was assessed using receiver operator characteristic (ROC) curves. Results Eighteen (21.2%) of the 85 cases experienced an adverse perinatal outcome. Increases in CMSA were associated with adverse perinatal outcomes and hydrops in bivariate analyses. Adjusted analyses found each 10-degree increase in CMSA to be associated with increased odds of an adverse perinatal outcome (adjusted odds ratio [aOR] 2.2, 95% confidence interval [CI]: 1.4–3.3) and hydrops (aOR 3.0, 95% CI: 1.5–6.1). CMSA performed well and was comparable to CPAM volume ratio in predicting adverse perinatal outcomes (area under the curve 0.81 and 0.84, respectively). Conclusion We describe a novel measurement of mediastinal shift in cases of CPAM and its relationship with adverse perinatal outcomes and hydrops. These findings may shape the evaluation and management of CPAMs, improve our understanding of their prognosis, and influence patient counseling.
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Propert, K. J., and J. R. Anderson. "Assessing the effect of toxicity on prognosis: methods of analysis and interpretation." Journal of Clinical Oncology 6, no. 5 (May 1988): 868–70. http://dx.doi.org/10.1200/jco.1988.6.5.868.
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There has recently been an increased interest in and reporting of the association between toxicity and treatment outcome in cancer clinical trials. Such comparisons may be used to suggest mechanisms by which cytotoxic agents function in the cancer patient, especially regarding the importance of the effect of dose on the individual patient. However, analyses of "time-to-failure" outcomes such as survival by toxicity are subject to bias due to the time-dependence of both the predictor and outcome variables. In addition, interpretation of even appropriately conducted statistical analyses is problematic, as with analyses of survival by outcome variables such as response. The use of statistical methodology designed to avoid such biases in these comparisons is shown and the problems in the interpretation of results are discussed.
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Dharia, Atit, Abid Khan, Vikas S. Sridhar, and David Z. I. Cherney. "SGLT2 Inhibitors: The Sweet Success for Kidneys." Annual Review of Medicine 74, no. 1 (January 27, 2023): 369–84. http://dx.doi.org/10.1146/annurev-med-042921-102135.
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Sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors) were originally developed as antidiabetic agents, with cardiovascular (CV) outcome trials demonstrating improved CV outcomes in patients with type 2 diabetes mellitus (T2D). Secondary analyses of CV outcome trials and later dedicated kidney outcome trials consistently reported improved kidney-related outcomes independent of T2D status and across a range of kidney function and albuminuria. Importantly, SGLT2 inhibitors are generally safe and well tolerated, with clinical trials and real-world analyses demonstrating a decrease in the risk of acute kidney injury. The kidney protective effects of SGLT2 inhibitors generally extend across different members of the class, possibly on the basis of hemodynamic, metabolic, anti-inflammatory, and antifibrotic mechanisms. In this review, we summarize the effects of SGLT2 inhibitors on kidney outcomes in diverse patient populations.
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Bandeen-Roche, Karen, Jiafeng Zhu, Deidra Crews, Mara McAdams-DeMarco, Brian Buta, Ravi Varadhan, and Jeremy Walston. "Resilience in Incident Hemodialysis: Characterization and Outcome Prediction." Innovation in Aging 4, Supplement_1 (December 1, 2020): 753. http://dx.doi.org/10.1093/geroni/igaa057.2713.
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Abstract The Resiliency in Dialysis Initiation (ReDI) Study aims to develop physical resilience signatures in older adults initiating hemodialysis. Study design—comprising a pilot, confirmatory study, and secondary data analyses—will be presented. So also will a method for characterizing resilience phenotypes—using mixed-model analysis of SF-36 subscale trajectories—among participants of age 55 and older who had undergone hemodialysis in the Choices for Healthy Outcomes in Caring for ESRD study (n=485). Analyses revealed stable, improving, and declining phenotypes. In Cox models, both baseline phenotypic status and trajectory type predicted mortality after adjusting for age, CVD status, and CHF (global Wald test for trajectory type P-value=0.020 for vitality; 0.030 for general health). These analyses evidence usefulness of resilience phenotypes as markers of adverse outcome risk and foreshadow application to novel ReDI data.
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Kishimori, Takefumi, Tasuku Matsuyama, Kosuke Kiyohara, Tetsuhisa Kitamura, Haruka Shida, Takeyuki Kiguchi, Chika Nishiyama, et al. "Prehospital cardiopulmonary resuscitation duration and neurological outcome after adult out-of-hospital cardiac arrest by location of arrest." European Heart Journal: Acute Cardiovascular Care 9, no. 4_suppl (April 29, 2020): S90—S99. http://dx.doi.org/10.1177/2048872620921598.
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Background Little is known about the association between prehospital cardiopulmonary resuscitation duration for adults with out-of-hospital cardiac arrest and outcome by the location of arrests. This study aimed to investigate the association between prehospital cardiopulmonary resuscitation duration and one-month survival with favourable neurological outcome. Methods We analysed 276,391 adults aged 18 years and older with out-of-hospital cardiac arrest of medical origin before emergency medical service arrival. Prehospital cardiopulmonary resuscitation duration was defined as the time from emergency medical service-initiated cardiopulmonary resuscitation to prehospital return of spontaneous circulation or to hospital arrival. The primary outcome was one-month survival with favourable neurological outcome (cerebral performance category 1 or 2). The association between prehospital cardiopulmonary resuscitation duration and favourable neurological outcome was assessed using univariable and multivariable logistic regression analyses. Results The proportion of favourable neurological outcomes was 2.3% in total, 7.6% in public locations, 1.5% in residential locations and 0.7% in nursing homes ( P < 0.001). In univariable and multivariable logistic regression analyses, longer prehospital cardiopulmonary resuscitation duration was associated with poor neurological outcome, regardless of arrest location ( P for trend < 0.001). Patients with shockable rhythm in both public and residential locations had better neurological outcome than those in nursing homes at any time point, and residential and public locations had a similar neurological outcome tendency among patients with shockable rhythm. Conclusions Longer prehospital cardiopulmonary resuscitation duration was independently associated with a lower proportion of patients with favourable neurological outcomes. Moreover, the association between prehospital cardiopulmonary resuscitation duration and neurological outcome differed according to the location of arrest and the first documented rhythm.
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Meek, M. E. (Bette). "Evolution of mode of action/adverse outcome pathway analyses." Toxicology Letters 229 (September 2014): S10. http://dx.doi.org/10.1016/j.toxlet.2014.06.063.
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Erle, Joan B., and Daniel A. Goldberg. "The Course of 253 Analyses from Selection to Outcome." Journal of the American Psychoanalytic Association 51, no. 1 (March 2003): 257–93. http://dx.doi.org/10.1177/00030651030510011101.
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Thomopoulos, Costas, and Helena Michalopoulou. "Outcome standardization to blood pressure reduction in meta-analyses." Journal of Hypertension 36, no. 1 (January 2018): 31–33. http://dx.doi.org/10.1097/hjh.0000000000001610.
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Cramer, JA, and J. Urquhart. "WW12: USE OF MEDICATION COMPLIANCE DATA IN OUTCOME ANALYSES." Value in Health 4, no. 2 (September 2001): 193. http://dx.doi.org/10.1046/j.1524-4733.2001.40203-11.x.
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Zaloshnja, Eduard, Ted R. Miller, Maury S. Galbraith, Bruce A. Lawrence, Lemyra M. DeBruyn, Nancy Bill, Kenny R. Hicks, Michael Keiffer, and Ronald Perkins. "Reducing injuries among Native Americans: five cost-outcome analyses." Accident Analysis & Prevention 35, no. 5 (September 2003): 631–39. http://dx.doi.org/10.1016/s0001-4575(02)00041-6.
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Daneyemez, M., A. Sali, S. Kahraman, A. Beduk, and N. Seber. "Outcome Analyses in 1072 Surgically Treated Lumbar Disc Herniations." min - Minimally Invasive Neurosurgery 42, no. 02 (June 1999): 63–68. http://dx.doi.org/10.1055/s-2008-1053372.
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Matsuzaka, Tetsuo, Kenji Ono, Hiroshi Baba, Mitsuhiro Matsuo, Shigeki Tanaka, Naohisa Kamimura, and Yoshiro Tsuji. "Quantitative EEG Analyses and Surgical Outcome After Corpus Callosotomy." Epilepsia 40, no. 9 (September 1999): 1269–78. http://dx.doi.org/10.1111/j.1528-1157.1999.tb00857.x.
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Nathoo, Narendra, Syed Sameer Nadvi, Eleanor Gouws, and James R. van Dellen. "Craniotomy Improves Outcomes for Cranial Subdural Empyemas: Computed Tomography-Era Experience with 699 Patients." Neurosurgery 49, no. 4 (October 1, 2001): 872–78. http://dx.doi.org/10.1097/00006123-200110000-00017.
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Abstract OBJECTIVE Uncertainty regarding the best surgical management for subdural empyemas (SDEs) continues. Our unit has considered craniotomy the preferred method of surgical drainage for all cranial SDEs since 1988. We performed an analysis of our previously published, computed tomography-era, experience with 699 patients. METHODS Two analyses of the database (1983–1997) were performed. First, analysis of the periods from 1983 to 1987 and from 1988 to 1997 was performed. Second, analysis of the composite database was performed. Outcomes were compared for possible outcome predictors by univariate analysis. Multivariate analysis was used to identify variables that contributed independently to outcomes, using stepwise discriminant analysis. RESULTS Significant correlations between the analyzed periods with respect to outcome and type of surgery (P = 0.001) were noted. Analysis of the entire database (1983–1997) revealed a significant relationship between outcome and surgery type (P = 0.05). Pairwise comparison of limited procedures such as burr holes or craniectomies with wide-exposure surgical procedures such as primary craniotomies or procedures proceeding to full craniotomies indicated significant correlation with outcomes (P = 0.027). Reoperation and morbidity rates were increased with limited procedures. Stepwise discriminant analyses revealed that the type of surgery was correlated with outcomes (P = 0.0008, partial r2 = 0.034). CONCLUSION Craniotomy was determined to be the surgical procedure of choice for treatment of cranial SDEs, allowing complete evacuation of the pus and, more importantly, decompressing the underlying cerebral hemisphere. Limited procedures such as burr holes or craniectomies may be performed for patients in septic shock, for patients with parafalcine empyemas, or for children with SDEs secondary to meningitis.
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Austin, Peter C., Neal Thomas, and Donald B. Rubin. "Covariate-adjusted survival analyses in propensity-score matched samples: Imputing potential time-to-event outcomes." Statistical Methods in Medical Research 29, no. 3 (December 20, 2018): 728–51. http://dx.doi.org/10.1177/0962280218817926.
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Matching on an estimated propensity score is frequently used to estimate the effects of treatments from observational data. Since the 1970s, different authors have proposed methods to combine matching at the design stage with regression adjustment at the analysis stage when estimating treatment effects for continuous outcomes. Previous work has consistently shown that the combination has generally superior statistical properties than either method by itself. In biomedical and epidemiological research, survival or time-to-event outcomes are common. We propose a method to combine regression adjustment and propensity score matching to estimate survival curves and hazard ratios based on estimating an imputed potential outcome under control for each successfully matched treated subject, which is accomplished using either an accelerated failure time parametric survival model or a Cox proportional hazard model that is fit to the matched control subjects. That is, a fitted model is then applied to the matched treated subjects to allow simulation of the missing potential outcome under control for each treated subject. Conventional survival analyses (e.g., estimation of survival curves and hazard ratios) can then be conducted using the observed outcome under treatment and the imputed outcome under control. We evaluated the repeated-sampling bias of the proposed methods using simulations. When using nearest neighbor matching, the proposed method resulted in decreased bias compared to crude analyses in the matched sample. We illustrate the method in an example prescribing beta-blockers at hospital discharge to patients hospitalized with heart failure.
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Ji, Lingyun, Lisa M. McShane, Mark Krailo, and Richard Sposto. "Bias in retrospective analyses of biomarker effect using data from an outcome-adaptive randomized trial." Clinical Trials 16, no. 6 (October 3, 2019): 599–609. http://dx.doi.org/10.1177/1740774519875969.
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Background/Aims Biomarker-stratified outcome-adaptive randomization trials, in which randomization probabilities depend on both biomarker value and outcomes of previously treated patients, are receiving increased attention in oncology research. Data from these trials can also form the basis of investigation of additional biomarkers that may not have been incorporated into the original trial design. In this article, we investigate the validity of a standard analytical method that utilizes data from a biomarker-stratified outcome-adaptive randomization trial to assess the effect of a newly identified biomarker on patient outcomes. Methods In the context of an ancillary biomarker study for a two-arm phase II trial with a response endpoint, we conduct analytic and simulation studies to investigate bias in estimated biomarker effects under outcome-adaptive randomization. Conditions under which bias arises and magnitude of the bias are examined in several settings. We then propose unbiased estimators of biomarker effects with appropriate variance estimators. Results We demonstrate that use of biomarker-stratified outcome-adaptive randomization perturbs the patient population and treatment assignments. Consequently, application of standard analysis methods to data from an outcome-adaptive randomization trial either to estimate prognostic effect of a new biomarker in uniformly treated patients or to estimate effect of treatment in relation to the new biomarker can lead to substantially biased estimates. The proposed adjusted estimators are asymptotically unbiased, and the proposed variance estimators correctly reflect the sample variability in the estimators. Conclusion This article demonstrates existence of bias when standard, naïve statistical methods are utilized to assess biomarker effects using data from a biomarker-stratified outcome-adaptive randomization trial, and hence that results from naïve analyses must be interpreted with great caution. These findings highlight that, in an era where data and specimens are increasingly being shared for biomarker studies, care must be taken to document and understand implications of the study design under which specimens or data have been obtained.
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Tellum, T., J. Naftalin, M. Hirsch, E. Saridogan, and D. Jurkovic. "A protocol for developing, disseminating, and implementing a core outcome set for adenomyosis research." Facts, Views and Vision in ObGyn 13, no. 3 (June 2021): 203–9. http://dx.doi.org/10.52054/fvvo.13.3.034.
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Background: Adenomyosis is a common benign gynaecological condition that has been associated with heavy and/or painful periods, subfertility and poor obstetric outcomes including miscarriage and preterm delivery. Studies evaluating treatments for adenomyosis have reported a wide range of outcomes and outcome measures. This variation in outcomes and outcome measures prevents effective data synthesis, thereby hampering the ability of meta-analyses to draw useful conclusions and inform clinical practice. Objectives: Our aim is to develop a minimum set of outcomes to be reported in all future studies that investigate any uterus-sparing intervention for treating uterine adenomyosis. Wide adoption of ‘core outcomes’ into research on adenomyosis would reduce the heterogeneity of studies and make data synthesis easier. This will ultimately lead to comparable, prioritised, and patient-centred conclusions from meta-analyses and guidelines. Materials and Methods: Outcomes identified from a systematic review of the literature will form a long list, agreed by an international steering group representing key stakeholders, including healthcare professionals, researchers, and public research partners. Through a modified Delphi process, key stakeholders will score outcomes from the agreed long list on a nine-point Likert scale that ranges from 1 (not important) to 9 (critical). Following the Delphi process, the refined outcome set will be finalised by the steering group. Finally, the steering group will develop recommendations for high-quality measures for each outcome. The study was prospectively registered with Core Outcome Measures in Effectiveness Trials Initiative; number 1649. Conclusion: The implementation of the core outcome set for adenomyosis in future trials will enhance the availability of comparable data to facilitate more patient-centred evidence-based care. What is new? The core outcome set will facilitate the generation of clinically important and patient centred outcomes for studies evaluating treatments for adenomyosis.
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Prentice, Ross L., Aaron K. Aragaki, Rowan T. Chlebowski, Shanshan Zhao, Garnet L. Anderson, Jacques E. Rossouw, Robert Wallace, et al. "Dual-Outcome Intention-to-Treat Analyses in the Women’s Health Initiative Randomized Controlled Hormone Therapy Trials." American Journal of Epidemiology 189, no. 9 (April 21, 2020): 972–81. http://dx.doi.org/10.1093/aje/kwaa033.
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Abstract Dual-outcome intention-to-treat hazard rate analyses have potential to complement single-outcome analyses for the evaluation of treatments or exposures in relation to multivariate time-to-response outcomes. Here we consider pairs formed from important clinical outcomes to obtain further insight into influences of menopausal hormone therapy on chronic disease. As part of the Women’s Health Initiative, randomized, placebo-controlled hormone therapy trials of conjugated equine estrogens (CEE) among posthysterectomy participants and of these same estrogens plus medroxyprogesterone acetate (MPA) among participants with an intact uterus were carried out at 40 US clinical centers (1993–2016). These data provide the context for analyses covering the trial intervention periods and a nearly 20-year (median) cumulative duration of follow-up. The rates of multiple outcome pairs were significantly influenced by hormone therapy, especially over cumulative follow-up, providing potential clinical and mechanistic insights. For example, among women randomized to either regimen, hazard ratios for pairs defined by fracture during intervention followed by death from any cause were reduced and hazard ratios for pairs defined by gallbladder disease followed by death were increased, though these findings may primarily reflect single-outcome associations. In comparison, hazard ratios for diabetes followed by death were reduced with CEE but not with CEE + MPA, and those for hypertension followed by death were increased with CEE + MPA but not with CEE.
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Linden, Ariel, Maya B. Mathur, and Tyler J. VanderWeele. "Conducting sensitivity analysis for unmeasured confounding in observational studies using E-values: The evalue package." Stata Journal: Promoting communications on statistics and Stata 20, no. 1 (March 2020): 162–75. http://dx.doi.org/10.1177/1536867x20909696.
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In this article, we introduce the evalue package, which performs sensitivity analyses for unmeasured confounding in observational studies using the methodology proposed by VanderWeele and Ding (2017, Annals of Internal Medicine 167: 268–274). evalue reports E-values, defined as the minimum strength of association on the risk-ratio scale that an unmeasured confounder would need to have with both the treatment assignment and the outcome to fully explain away a specific treatment-outcome association, conditional on the measured covariates. evalue computes E-values for point estimates (and optionally, confidence limits) for several common outcome types, including risk and rate ratios, odds ratios with common or rare outcomes, hazard ratios with common or rare outcomes, standardized mean differences in outcomes, and risk differences.
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Pong, Sandra, Martin Urner, Robert A. Fowler, Nicholas Mitsakakis, Winnie Seto, James S. Hutchison, Michelle Science, and Nick Daneman. "Testing for non-inferior mortality: a systematic review of non-inferiority margin sizes and trial characteristics." BMJ Open 11, no. 4 (April 2021): e044480. http://dx.doi.org/10.1136/bmjopen-2020-044480.
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ObjectiveTo describe the size and variability of non-inferiority margins used in non-inferiority trials of medications with primary outcomes involving mortality, and to examine the association between trial characteristics and non-inferiority margin size.DesignSystematic review.Data sourcesMedline, Medline In Process, Medline Epub Ahead of Print and Embase Classic+Embase databases from January 1989 to December 2019.Eligibility criteriaProspective non-inferiority randomised controlled trials comparing pharmacological therapies, with primary analyses for non-inferiority and primary outcomes involving mortality alone or as part of a composite outcome. Trials had to prespecify non-inferiority margins as absolute risk differences or relative to risks of outcome and provide a baseline risk of primary outcome in the control intervention.Results3992 records were screened, 195 articles were selected for full text review and 111 articles were included for analyses. 82% of trials were conducted in thrombosis, infectious diseases or oncology. Mortality was the sole primary outcome in 23 (21%) trials, and part of a composite primary outcome in 88 (79%) trials. The overall median non-inferiority margin was an absolute risk difference of 9% (IQR 4.2%–10%). When non-inferiority margins were expressed relative to the baseline risk of primary outcome in control groups, the median relative non-inferiority margin was 1.5 (IQR 1.3–1.7). In multivariable regression analyses examining the association between trial characteristics (medical specialty, inclusion of paediatric patients, mortality as a sole or part of a composite primary outcome, presence of industry funding) and non-inferiority margin size, only medical specialty was significantly associated with non-inferiority margin size.ConclusionAbsolute and relative non-inferiority margins used in published trials comparing medications are large, allowing conclusions of non-inferiority in the context of large differences in mortality. Accepting the potential for large increases in outcomes involving mortality while declaring non-inferiority is a challenging methodological issue in the conduct of non-inferiority trials.
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Yamaguchi, Kazuo. "Multigroup Segregation Analyses with Covariates." Sociological Methodology 51, no. 2 (January 6, 2021): 224–52. http://dx.doi.org/10.1177/0081175020981120.
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The author introduces methods for the decomposition analysis of multigroup segregation measured by the index of dissimilarity, the squared coefficient of variation, and Theil’s entropy measure. Using a new causal framework, the author takes a unified approach to the decomposition analysis by specifying conditions that must be satisfied to decompose segregation into unexplained and explained components. Here, the unexplained component represents the direct effects of the group variable on the conditional probability of acquiring a social position—such as a residential district in an analysis of residential segregation or an occupation in an analysis of occupational segregation—and the explained component represents indirect effects of the group variable on the outcome through covariates. The major merit of this approach is its ability to control individual-level covariates for the decomposition analysis of segregation. Two methods, one for semiparametric outcome models with the identity link function and the other for semiparametric outcome models with the multinomial logit link function, are introduced in this unified framework. The application of these methods focuses on occupational segregation among racial/ethnic groups. Father’s occupation, subject’s educational attainment, and the region of interview are included as covariates, using data from the General Social Surveys.
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McAuley, Edward, and Terry E. Duncan. "Causal Attributions and Affective Reactions to Discontinuing Outcomes in Motor Performance." Journal of Sport and Exercise Psychology 11, no. 2 (June 1989): 187–200. http://dx.doi.org/10.1123/jsep.11.2.187.
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Research suggests that attributional search is a consequence of disconfirming outcomes and that causal dimensions influence affective reactions to achievement outcomes. The present study manipulated future expectancies for performance and actual outcome in a competitive motor task. Following competitive outcome, causal attributions for and affective reactions to the outcome were assessed. Discriminant analysis indicated that winners experienced significantly more positive affect than did losers, who reported more intense negative affects. Regression analyses examined the relationship between causal dimensions and affective reactions. The locus of causality and stability dimensions significantly influenced a number of negative affects in losers, whereas all three dimensions in combination significantly influenced confidence in winners. The findings are discussed in relation to previous attribution-affect research in achievement settings and the role of disconfirm-ing experiences in the attribution process.
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Robey, Randall R., and Susan D. Dalebout. "A Tutorial on Conducting Meta-Analyses of Clinical Outcome Research." Journal of Speech, Language, and Hearing Research 41, no. 6 (December 1998): 1227–41. http://dx.doi.org/10.1044/jslhr.4106.1227.
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Throughout the educational, medical, psychological, and social sciences, meta-analysis is the present-day, broadly accepted means for combining many quasiexperiments in a synthesis for the purpose of establishing the weight of scientific evidence bearing on a certain research question. Meta-analysis thereby is the preferred method for determining the preponderance of evidence in clinical-outcome research relating to questions of treatment efficacy and treatment effectiveness. Relatively few meta-analyses appear in the literature of the communication disorder sciences. The purpose of this tutorial is to enhance the familiarity and accessibility of this technology in the domains of audiology and speech-language pathology. The results of the accompanying example constitute a preliminary meta-analysis of patient-perceived treatment effectiveness. The substance of the tutorial, however, transcends disciplinary interests regarding types of communication disorder.
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Gelfer, Yael, Katie Patterson Hughes, Andreas Fontalis, Shlomo Wientroub, and Deborah M. Eastwood. "A systematic review of reported outcomes following Ponseti correction of idiopathic club foot." Bone & Joint Open 1, no. 8 (August 1, 2020): 457–64. http://dx.doi.org/10.1302/2633-1462.18.bjo-2020-0109.r1.
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Aims To analyze outcomes reported in studies of Ponseti correction of idiopathic clubfoot. Methods A systematic review of the literature was performed to identify a list of outcomes and outcome tools reported in the literature. A total of 865 studies were screened following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and 124 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Each outcome tool was assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). Bias assessment was not deemed necessary for the purpose of this paper. Results In total, 20 isolated outcomes and 16 outcome tools were identified representing five OMERACT domains. Most outcome tools were appropriately designed for children of walking age but have not been embraced in the literature. The most commonly reported isolated outcomes are subjective and qualitative. The quantitative outcomes most commonly used are ankle range of motion (ROM), foot position in standing, and muscle function. Conclusions There is a diverse range of outcomes reported in studies of Ponseti correction of clubfoot. Until outcomes can be reported unequivocally and consistently, research in this area will be limited. Completing the process of establishing and validating COS is the much-needed next step. Cite this article: Bone Joint Open 2020;1-8:457–464.
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VanderWeele, Tyler J., Linda Valeri, and Cande V. Ananth. "Counterpoint: Mediation Formulas With Binary Mediators and Outcomes and the “Rare Outcome Assumption”." American Journal of Epidemiology 188, no. 7 (December 24, 2018): 1204–5. http://dx.doi.org/10.1093/aje/kwy281.
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Abstract In their accompanying article, Samoilenko and Lefebvre (Am J Epidemiol. 2019;188(7):1203–1205) correctly note 2 typographical errors in the formulas presented in a 2011 paper on placental abruption by Ananth and VanderWeele (Am J Epidemiol. 2011;174(1):99–108). Fortunately, to the best of our knowledge, researchers are using our methods papers and Dr. VanderWeele’s 2015 book on mediation analysis (Explanation in Causal Inference; Oxford University Press, New York, New York), rather than the paper on placental abruption, to carry out their direct and indirect effect analyses; and in our methods papers and the book, the formulas are correct. The formulas discussed by Samoilenko and Lefebvre and in our work make reference to a “rare outcome assumption.” In evaluating this assumption, it is important to note that the outcome is to be relatively rare across all strata defined by the exposure and the mediator—a point that is often neglected.
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Jiang, Bin, Nancy K. Hills, Rob Forsyth, Lori C. Jordan, Mahmoud Slim, Steven G. Pavlakis, Neil Freidman, et al. "Imaging Predictors of Neurologic Outcome After Pediatric Arterial Ischemic Stroke." Stroke 52, no. 1 (January 2021): 152–61. http://dx.doi.org/10.1161/strokeaha.120.030965.
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Background and Purpose: To assess whether initial imaging characteristics independently predict 1-year neurological outcomes in childhood arterial ischemic stroke patients. Methods: We used prospectively collected demographic and clinical data, imaging data, and 1-year outcomes from the VIPS study (Vascular Effects of Infection in Pediatric Stroke). In 288 patients with first-time stroke, we measured infarct volume and location on the acute magnetic resonance imaging studies and hemorrhagic transformation on brain imaging studies during the acute presentation. Neurological outcome was assessed with the Pediatric Stroke Outcome Measure. We used univariate and multivariable ordinal logistic regression models to test the association between imaging characteristics and outcome. Results: Univariate analysis demonstrated that infarcts involving uncinate fasciculus, angular gyrus, insular cortex, or that extended from cortex to the subcortical nuclei were significantly associated with poorer outcomes with odds ratios ranging from 1.95 to 3.95. All locations except the insular cortex remained significant predictors of poor outcome on multivariable analysis. When infarct volume was added to the model, the locations did not remain significant. Larger infarct volumes and younger age at stroke onset were significantly associated with poorer outcome, but the strength of the relationships was weak. Hemorrhagic transformation did not predict outcome. Conclusions: In the largest pediatric arterial ischemic stroke cohort collected to date, we showed that larger infarct volume and younger age at stroke were associated with poorer outcomes. We made the novel observation that the strength of these associations was modest and limits the ability to use these characteristics to predict outcome in children. Infarcts affecting specific locations were significantly associated with poorer outcomes in univariate and multivariable analyses but lost significance when adjusted for infarct volume. Our findings suggest that infarcts that disrupt critical networks have a disproportionate impact upon outcome after childhood arterial ischemic stroke.
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Takahashi, Satoshi, Takenori Akiyama, Takashi Horiguchi, Tomoru Miwa, Ryo Takemura, and Kazunari Yoshida. "Loss of consciousness at ictus and/or poor World Federation of Neurosurgical Societies grade on admission reflects the impact of EBI and predicts poor outcome in patients with SAH." Surgical Neurology International 11 (March 6, 2020): 40. http://dx.doi.org/10.25259/sni_551_2019.
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Background: There are many scores and markers that predict poor outcome in patients with subarachnoid hemorrhage (SAH). However, parameters that can predict outcomes in patients with SAH with high specificity and sensitivity, which can be identified in the early postictal state and utilized as a clinical marker of early brain injury (EBI) have not been identified so far. Methods: Thirty-nine patients with SAH due to a saccular intracranial aneurysm rupture were reviewed. We retrospectively analyzed the relationships between patients’ baseline characteristics and patients’ outcomes to identify parameters that could predict patient outcomes in the early postictal state. Results: In the univariate analysis, older age (>65), loss of consciousness (LOC) at ictus, poor initial World Federation of Neurosurgical Societies (WFNS) grade (3–5), and delayed cerebral ischemia (DCI) were associated with poor outcome (GOS 1–3). Statistical analyses revealed that combined LOC at ictus and/or poor initial WFNS grade (3–5) was a more powerful surrogate marker of outcome (OR 15.2 [95% CI 3.1–75.5]) than either LOC at ictus or the poor initial WFNS grade (3–5) alone. Multivariate logistic regression analyses revealed that older age, combined LOC at ictus and/or poor initial WFNS grade, and DCI were independently associated with poor outcome. Conclusion: Combined LOC at ictus and/or poor initial WFNS grade (3–5) reflects the impact of EBI and was a useful surrogate marker of poor prognosis in SAH patients, independent of patients’ age and state of DCI.
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Niedermeier, Christina, Andrea Barrera, Eva Esteban, Ivana Ivandic, and Carla Sabariego. "The Impact of the Change in Payment System for German Psychiatric Clinics on Treatment Success: An Interrupted Time Series Analysis." Das Gesundheitswesen 82, no. 06 (February 25, 2019): 559–67. http://dx.doi.org/10.1055/a-0828-7504.
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Abstract Background In Germany a new reimbursement system for psychiatric clinics was proposed in 2009 based on the § 17d KHG Psych-Entgeltsystem. The system can be voluntary implemented by clinics since 2013 but therapists are frequently afraid it might affect treatment negatively. Objectives To evaluate whether the new system has a negative impact on treatment success by analysing routinely collected data in a Bavarian clinic. Material and methods Aggregated data of 1760 patients treated in the years 2007–2016 was analysed with segmented regression analysis of interrupted time series to assess the effects of the system on treatment success, operationalized with three outcome variables. A negative change in level after a lag period was hypothesized. The robustness of results was tested by sensitivity analyses. Results The percentage of patients with treatment success tends to increase after the new system but no significant change in level was observed. The sensitivity analyses corroborate results for 2 outcomes but when the intervention point was shifted, the positive change in level for the third outcome became significant. Conclusions Our initial hypothesis is not supported. However, the sensitivity analyses disclosed uncertainties and our study has limitations, such as a short observation time post intervention. Results are not generalizable as data of a single clinic was analysed. Nevertheless, we show the importance of collecting and analysing routine data to assess the impact of policy changes on patient outcomes.
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Bero, Lisa, Rosa Lawrence, Louis Leslie, Kellia Chiu, Sally McDonald, Matthew J. Page, Quinn Grundy, et al. "Cross-sectional study of preprints and final journal publications from COVID-19 studies: discrepancies in results reporting and spin in interpretation." BMJ Open 11, no. 7 (July 2021): e051821. http://dx.doi.org/10.1136/bmjopen-2021-051821.
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ObjectiveTo compare results reporting and the presence of spin in COVID-19 study preprints with their finalised journal publications.DesignCross-sectional study.SettingInternational medical literature.ParticipantsPreprints and final journal publications of 67 interventional and observational studies of COVID-19 treatment or prevention from the Cochrane COVID-19 Study Register published between 1 March 2020 and 30 October 2020.Main outcome measuresStudy characteristics and discrepancies in (1) results reporting (number of outcomes, outcome descriptor, measure, metric, assessment time point, data reported, reported statistical significance of result, type of statistical analysis, subgroup analyses (if any), whether outcome was identified as primary or secondary) and (2) spin (reporting practices that distort the interpretation of results so they are viewed more favourably).ResultsOf 67 included studies, 23 (34%) had no discrepancies in results reporting between preprints and journal publications. Fifteen (22%) studies had at least one outcome that was included in the journal publication, but not the preprint; eight (12%) had at least one outcome that was reported in the preprint only. For outcomes that were reported in both preprints and journals, common discrepancies were differences in numerical values and statistical significance, additional statistical tests and subgroup analyses and longer follow-up times for outcome assessment in journal publications.At least one instance of spin occurred in both preprints and journals in 23/67 (34%) studies, the preprint only in 5 (7%), and the journal publications only in 2 (3%). Spin was removed between the preprint and journal publication in 5/67 (7%) studies; but added in 1/67 (1%) study.ConclusionsThe COVID-19 preprints and their subsequent journal publications were largely similar in reporting of study characteristics, outcomes and spin. All COVID-19 studies published as preprints and journal publications should be critically evaluated for discrepancies and spin.
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Mahmood, Abda, Ian Roberts, and Haleema Shakur-Still. "A nested randomised trial of the effect of tranexamic acid on intracranial haemorrhage and infarction in traumatic brain injury (CRASH-3 trial intracranial bleeding mechanistic study): Statistical analysis plan." Wellcome Open Research 3 (January 8, 2019): 99. http://dx.doi.org/10.12688/wellcomeopenres.14731.2.
Full textAbstract:
Background: The CRASH-3 trial is a randomised trial on the effect of tranexamic acid (TXA) on death and disability in traumatic brain injury (TBI). The CRASH-3 intracranial bleeding mechanistic study (IBMS) is a randomised trial nested within the CRASH-3 trial to examine the effect of TXA on intracranial bleeding and infarction. Methods: Patients eligible for the CRASH-3 trial, with a GCS of 12 or less or intracranial bleeding on a pre-randomisation CT scan are eligible for the IBMS. The occurrence of intracranial bleeding, infarction, haemorrhagic oedematous lesions, mass effect and haemorrhage evacuation is examined within 28 days of randomisation using routinely collected brain scans. The primary outcome is the volume of intra-parenchymal bleeding in patients randomised within three hours of injury (adjusted for prognostic covariates). Secondary outcomes include a composite “poor” outcome, progressive and new intracranial bleeding, intracranial bleeding after neurosurgery and cerebral infarcts seen up to 28 days post-randomisation. All outcomes will be compared between treatment groups. Statistical analyses: The primary outcome will be analysed using a covariate adjusted linear mixed model. The same analysis will be done separately for patients who undergo haemorrhage evacuation post-randomisation. We will express the effect of TXA on the composite outcome, new and progressive bleeding using relative risks and 95% CIs, and on cerebral infarcts using hazard ratios and 95% CIs. We will conduct sensitivity analyses assuming missing data are MCAR or MNAR. Conclusion: The IBMS will provide information on the mechanism of action of TXA in TBI. This pre-specified statistical analysis plan is a technical extension of the published protocol. Trial registration: The CRASH-3 trial was prospectively registered at the International Standard Randomised Controlled Trials registry (19 July 2011) and ClinicalTrials.gov (25 July 2011). The registries were updated with details for the IBMS on 20 December 2016.