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Background: The left atrial (LA) volume has been demonstrated to be an important predictor of adverse outcome in patients with various cardiac conditions, including acute myocardial infarction (AMI). However, new treatment strategies in patients with AMI have led to better patient outcomes. We hypothesised that increased LA size could still predict mortality in patients with AMI despite improved treatment strategies. Methods: We included patients with AMI in a prospective multicenter cohort study and the study patients were enrolled from 2014 to 2022. We recorded echocardiographic and clinical data during their index hospitalisation. Indexed LA volume (LAVi) was assessed in all patients and was used as a continuous variable in the univariate and multivariate Cox regression analysis. The study took place over a period of five years and median follow-up time was 3.8 years (range 3.1 to 5.0 years). The primary study outcomes were all-cause mortality and major adverse cardiac events (MACE). MACE was defined as hospital readmission due to myocardial infarction, cardiac arrest, stroke, heart failure, or onset of new atrial fibrillation. Results: We included 487 patients (69 ± 12 years old, 26% female) with AMI. During the follow-up period all-cause mortality was 50 (10.3%) and patients who reached the primary outcomes were 153 (31.4%). The deceased patients had higher LAVi compared to survivors (40.0 ± 12.9 mL/m2 vs. 29.7 ± 11.2 mL/m2, p < 0.001). Factors associated with all-cause mortality and MACE were age, year of enrollment, left ventricular (LV) ejection fraction, LV global longitudinal strain (GLS), LV filling pressure, moderate or severe mitral regurgitation and LAVi. GLS and EF were segregated into two distinct models due to their moderately high correlation (r = 0.57, p < 0.001). LAVi remained as an independent echocardiographic predictor of primary outcomes after adjusting for the covariates above in two separates multivariable Cox regression models (hazard ratio 1.02/1.02 mL/m2 [95% CI 1.01–1.03/1.01–1.03], p = 0.006/0.003). Conclusions: Our study demonstrated that LA dilatation is an independent echocardiographic predictor of mortality and MACE in patients with AMI despite improved treatment strategies. This finding highlights the potential of using LAVi as a marker for prognostication in these patients. [ABSTRACT FROM AUTHOR]

Abstract Background The left atrial (LA) volume has been demonstrated to be an important predictor of adverse outcome in patients with various cardiac conditions, including acute myocardial infarction (AMI). However, new treatment strategies in patients with AMI have led to better patient outcomes. We hypothesised that increased LA size could still predict mortality in patients with AMI despite improved treatment strategies. Methods We included patients with AMI in a prospective multicenter cohort study and the study patients were enrolled from 2014 to 2022. We recorded echocardiographic and clinical data during their index hospitalisation. Indexed LA volume (LAVi) was assessed in all patients and was used as a continuous variable in the univariate and multivariate Cox regression analysis. The study took place over a period of five years and median follow-up time was 3.8 years (range 3.1 to 5.0 years). The primary study outcomes were all-cause mortality and major adverse cardiac events (MACE). MACE was defined as hospital readmission due to myocardial infarction, cardiac arrest, stroke, heart failure, or onset of new atrial fibrillation. Results We included 487 patients (69 ± 12 years old, 26% female) with AMI. During the follow-up period all-cause mortality was 50 (10.3%) and patients who reached the primary outcomes were 153 (31.4%). The deceased patients had higher LAVi compared to survivors (40.0 ± 12.9 mL/m2 vs. 29.7 ± 11.2 mL/m2, p

In research, outcomes are often categorized as primary and secondary. The primary outcome is the most important one; it determines whether the study is considered ‘successful’ or not. Secondary outcomes are chosen because they provide supporting evidence for the results of the primary outcome or additional information about the subject being studied. For reasons that are explained in this paper, secondary outcomes should be cautiously interpreted. There are varying practices regarding publishing secondary outcomes. Some authors publish these separately, while others include them in the main publication. In some contexts, the former can lead to concerns about the quality and relevance of the data being published. In this article, we discuss primary and secondary outcomes, the importance and interpretation of secondary outcomes, and considerations for publishing multiple outcomes in separate papers. We also discuss the special case of secondary analyses and post hoc analyses and provide guidance on good publishing practices. Throughout the article, we use relevant examples to make these concepts easier to understand. While the article is primarily aimed at early career researchers, it offers insights that may be helpful to researchers, reviewers, and editors across all levels of expertise.

In research, outcomes are often categorized as primary and secondary. The primary outcome is the most important one; it determines whether the study is considered 'successful' or not. Secondary outcomes are chosen because they provide supporting evidence for the results of the primary outcome or additional information about the subject being studied. For reasons that are explained in this paper, secondary outcomes should be cautiously interpreted. There are varying practices regarding publishing secondary outcomes. Some authors publish these separately, while others include them in the main publication. In some contexts, the former can lead to concerns about the quality and relevance of the data being published. In this article, we discuss primary and secondary outcomes, the importance and interpretation of secondary outcomes, and considerations for publishing multiple outcomes in separate papers. We also discuss the special case of secondary analyses and post hoc analyses and provide guidance on good publishing practices. Throughout the article, we use relevant examples to make these concepts easier to understand. While the article is primarily aimed at early career researchers, it offers insights that may be helpful to researchers, reviewers, and editors across all levels of expertise. [ABSTRACT FROM AUTHOR]

As primary outcomes differ among clinical lumbar disc herniation (LDH) studies, this study aimed to explore outcomes reflecting real-world patient experiences through an exploratory questionnaire survey. Those diagnosed with LDH having radiating leg pain in South Korea in November of 2022 (N = 500) were administered a questionnaire including basic characteristics, disease onset, symptoms and severity, priority symptoms for improvement, and important treatment factors. Outcome measures included the identification of priority symptoms and disabilities. Most common symptoms were numbness in the leg (N = 435, 87.0%) and back pain (N = 406, 81.2%); most common disabilities were discomfort in sitting (N = 323, 64.6%) and lifting (N = 318, 63.6%). The highest priority symptom was back pain (N = 242, 48.4%). A satisfactory degree of symptom improvement was a decrease of at least 3 points on the numeric rating scale. The majority of respondents preferred improvement in disability over pain (N = 270, 55.8%), a stable effect over a rapid effect (N = 391, 78.2%), and safety over treatment efficacy (N = 282, 56.4%). Safety (N = 129, 25.8%) and cost (N = 111, 22.2%) were the most important treatment factors. Improvements in back pain, leg pain, sitting, and sleeping were prioritized, and safety, stable treatment effect, and functional recovery were desired. Clinical trials for LDH should be designed to reflect this real-world patient need. Further study to examine the patients' symptoms and needs in details is needed. [ABSTRACT FROM AUTHOR]

Background: Robot-assisted radical prostatectomy (RARP) has been a treatment for men who suffer from intermediated to high-risk prostate cancer in Australia since 2003. The primary outcomes in relation to learning curves in robotic surgery have been extensively researched in overseas populations, but there is no study from a cohort of Australian surgeons performing RARP. This study aims to highlight the effect of RARP learning curves on primary surgical outcomes in a high-volume Australian centre. Methods: A retrospective audit of all RARP performed at Epworth Healthcare from 2016 to 2021 was performed. The primary outcome data collected included operating time (OT), estimated blood loss (EBL), and positive surgical margins (PSM). Exclusion criteria were applied. Positive outcomes were set at OT 240 min, blood loss 310 mL, and negative surgical margins. Results: A total of 3969 cases were analysed for a cohort of 53 surgeons. Of these surgeons, 24 surgeons have performed >50 operations to be able to undergo learning curve analysis. The median OT was 229 min, the median blood loss was 353 mL, and most cases had negative surgical margins (>1 mm, n = 3681, 92.7%). The mean learning curve transition point was 65 cases. There was a significant difference in the EBL and rate of PSM for the higher volume cohort (p = 0.002 and

Objectives: Patient-reported outcomes (PROs) provide a global perspective of patient health status which plays an enormous role in evaluating clinical efficacy. However, the application of PROs in traditional Chinese medicine (TCM) was still insufficiently studied in mainland China. Methods: This cross-sectional study was performed based on interventional clinical trials of TCM that were conducted in mainland China from 1 January 2010, to 15 July 2022. Data was retrieved from the ClinicalTrials.gov and Chinese Clinical Trial Registry. We included interventional clinical trials of TCM for which the country of the primary sponsors or recruitment settings in mainland China. For each included trial, data including clinical trial phases, study settings, participant's age, sex, diseases, and the patient-reported outcome measures (PROMs) were extracted. Trials were categorized into four categories according to 1) listed PROs as primary endpoints, 2) listed PROs as secondary endpoints, 3) listed PROs as coprimary outcomes (both primary and secondary endpoints), and 4) did not mention any PROMs. Results: Among a total of 3,797 trials, 680 (17.9%) trials listed PROs as primary endpoints, 692 (18.2%) trials listed PROs as secondary endpoints, and 760 (20.0%) trials listed PROs as coprimary endpoints. Among 675,787 participants included in the registered trials, 448,359 (66.3%) patients' data were scientifically collected by PRO instruments. Neurological diseases (11.8%), musculoskeletal symptoms (11.5%), mental health conditions (9.1%) were the most common conditions evaluated by PROMs. Disease-specific symptoms related concepts were used most frequently (51.3%), followed by health-related quality of life concepts. Visual analog scale, 36-item Short-Form Health Questionnaire, and TCM symptom score were the most common PROMs in these trials. Conclusion: In this cross-sectional study, the use of PROs increased in the past decades according to clinical trials of TCM conducted in mainland China. Considering that the application of PROs in clinical trials of TCM has some existing issues including uneven distribution and lack of normalized PROs of TCM, further study should be focused on the standardization and normalization of TCM-specific scales. [ABSTRACT FROM AUTHOR]

As primary outcomes differ among clinical lumbar disc herniation (LDH) studies, this study aimed to explore outcomes reflecting real-world patient experiences through an exploratory questionnaire survey. Those diagnosed with LDH having radiating leg pain in South Korea in November of 2022 (N = 500) were administered a questionnaire including basic characteristics, disease onset, symptoms and severity, priority symptoms for improvement, and important treatment factors. Outcome measures included the identification of priority symptoms and disabilities. Most common symptoms were numbness in the leg (N = 435, 87.0%) and back pain (N = 406, 81.2%); most common disabilities were discomfort in sitting (N = 323, 64.6%) and lifting (N = 318, 63.6%). The highest priority symptom was back pain (N = 242, 48.4%). A satisfactory degree of symptom improvement was a decrease of at least 3 points on the numeric rating scale. The majority of respondents preferred improvement in disability over pain (N = 270, 55.8%), a stable effect over a rapid effect (N = 391, 78.2%), and safety over treatment efficacy (N = 282, 56.4%). Safety (N = 129, 25.8%) and cost (N = 111, 22.2%) were the most important treatment factors. Improvements in back pain, leg pain, sitting, and sleeping were prioritized, and safety, stable treatment effect, and functional recovery were desired. Clinical trials for LDH should be designed to reflect this real-world patient need. Further study to examine the patients’ symptoms and needs in details is needed.

Abstract Background Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. Methods RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as “fully reported”, “partially reported”, or “not reported” for each checklist item, as applicable. Results Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6 to 17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time. Conclusions Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed.

Consensus as to best practices for the selection, reporting, and interpretation of primary and secondary outcomes of randomized controlled trials is lacking. We reviewed the strategies adopted in publications of randomized controlled trials (RCTs) for the analysis, presentation, and interpretation of efficacy outcomes from a survey of all cardiovascular RCTs published in the New England Journal of Medicine, Lancet, and the Journal of the American Medical Association during 2019. We focus on the choice of primary outcomes, the variety of approaches to selecting secondary outcomes, the options sometimes used to control type I error, and the common practice to not correct for multiple testing in reporting secondary outcomes. We comment on current practice across journals in the reporting of P values and also how conclusions in trial reports frequently adhere to an undue reliance on P < 0.05 as a basis for positive claims of treatment efficacy. We conclude with recommendations for how future RCT reports could best select, report, and interpret their findings on primary and secondary outcomes. [ABSTRACT FROM AUTHOR]

Background: Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD.Methods: RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as "fully reported", "partially reported", or "not reported" for each checklist item, as applicable.Results: Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6 to 17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time.Conclusions: Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed. [ABSTRACT FROM AUTHOR]

Objectives: Patient-reported outcomes (PROs) provide a global perspective of patient health status which plays an enormous role in evaluating clinical efficacy. However, the application of PROs in traditional Chinese medicine (TCM) was still insufficiently studied in mainland China. Methods: This cross-sectional study was performed based on interventional clinical trials of TCM that were conducted in mainland China from 1 January 2010, to 15 July 2022. Data was retrieved from the ClinicalTrials.gov and Chinese Clinical Trial Registry. We included interventional clinical trials of TCM for which the country of the primary sponsors or recruitment settings in mainland China. For each included trial, data including clinical trial phases, study settings, participant's age, sex, diseases, and the patient-reported outcome measures (PROMs) were extracted. Trials were categorized into four categories according to 1) listed PROs as primary endpoints, 2) listed PROs as secondary endpoints, 3) listed PROs as coprimary outcomes (both primary and secondary endpoints), and 4) did not mention any PROMs. Results: Among a total of 3,797 trials, 680 (17.9%) trials listed PROs as primary endpoints, 692 (18.2%) trials listed PROs as secondary endpoints, and 760 (20.0%) trials listed PROs as coprimary endpoints. Among 675,787 participants included in the registered trials, 448,359 (66.3%) patients' data were scientifically collected by PRO instruments. Neurological diseases (11.8%), musculoskeletal symptoms (11.5%), mental health conditions (9.1%) were the most common conditions evaluated by PROMs. Disease-specific symptoms related concepts were used most frequently (51.3%), followed by health-related quality of life concepts. Visual analog scale, 36-item Short-Form Health Questionnaire, and TCM symptom score were the most common PROMs in these trials. Conclusion: In this cross-sectional study, the use of PROs increased in the past decades according to clinical trials of TCM conducted in mainland China. Considering that the application of PROs in clinical trials of TCM has some existing issues including uneven distribution and lack of normalized PROs of TCM, further study should be focused on the standardization and normalization of TCM-specific scales., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Dong, Liu, Zhang, Gong, Yan, Li, Li, Rong and Liu.)

Background: Robot-assisted radical prostatectomy (RARP) has been a treatment for men who suffer from intermediated to high-risk prostate cancer in Australia since 2003. The primary outcomes in relation to learning curves in robotic surgery have been extensively researched in overseas populations, but there is no study from a cohort of Australian surgeons performing RARP. This study aims to highlight the effect of RARP learning curves on primary surgical outcomes in a high-volume Australian centre., Methods: A retrospective audit of all RARP performed at Epworth Healthcare from 2016 to 2021 was performed. The primary outcome data collected included operating time (OT), estimated blood loss (EBL), and positive surgical margins (PSM). Exclusion criteria were applied. Positive outcomes were set at OT 240 min, blood loss 310 mL, and negative surgical margins., Results: A total of 3969 cases were analysed for a cohort of 53 surgeons. Of these surgeons, 24 surgeons have performed >50 operations to be able to undergo learning curve analysis. The median OT was 229 min, the median blood loss was 353 mL, and most cases had negative surgical margins (>1 mm, n  = 3681, 92.7%). The mean learning curve transition point was 65 cases. There was a significant difference in the EBL and rate of PSM for the higher volume cohort (p = 0.002 and <0.0001, respectively)., Conclusion: We perform a retrospective study of all RARP performed at a high-volume Australian centre. Higher volume surgeons demonstrate that primary outcomes improve with a higher caseload (EBL, PSM). Learning curve transition points for RARP are comparable to international high-volume surgeons. Learning curve data could form the benchmark for RARP training and skills development., Competing Interests: None to declare., (© 2022 Asian Pacific Prostate Society. Publishing services by Elsevier B.V.)