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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]

Patient-reported outcome measures (PROMs) quantify patient perspectives to measure outcomes that matter to patients. The aim of this study was to assess the reporting of appropriateness and quality of PROM selection in plastic surgery randomized controlled trials (RCTs). MEDLINE, Embase, and CENTRAL were searched from January 1, 2000, to June 5, 2022, to identify published RCTs within the plastic surgery literature. Included studies were categorized as follows: 1) a clearly defined patient-reported primary outcome; 2) a primary outcome could be inferred; or 3) no clear or implied primary outcome. The Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) database was consulted to assess the available literature on the PROMs. There were 130 plastic surgery RCTs identified. Of the 43 studies with a clear or inferred primary outcome, the percentage of studies that commented with supporting references on the PROM's appropriateness for the population, disease/condition, and outcome were 20.9% (n = 9/43), 18.6% (n = 8/43), and 27.9% (n = 12/43), respectively. The percentage of studies that commented on the PROM's validity, reliability, and responsiveness with supporting references were 34.9% (n = 15/43), 14.0% (n = 6/43), and 11.7% (n = 5/43), respectively. There were 21 unique PROMs identified; 28.6% (n = 6/21) were available in the COSMIN database. The majority of plastic surgery RCTs assessing patient-reported primary outcomes lack transparency surrounding PROM selection and quality. We recommend investigators conducting plastic surgery clinical research report explicitly why they used a particular PROM and support its appropriateness and psychometric properties with supporting references. Finally, they should familiarize themselves with the COSMIN initiative. [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.

Competing Interests: Conflicts of interest None disclosed.

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 and Aims: Selective outcome reporting occurs when trialists pre‐specify primary and secondary outcomes during trial planning but alter the definitions in the published report. Here, we investigate selective outcome reporting in published addiction randomized controlled trials (RCTs) and evaluate whether particular funding sources are associated with an increased likelihood of selective outcome reporting. Design We conducted a cross‐sectional study of published addiction clinical trials. A PubMed search was performed to identify RCTs in addiction journals from 2013 to 2017. Included studies used a randomized design to address one of the following topics: (1) drug, alcohol and tobacco addiction prevention, (2) stabilization following excessive use of a substance, (3) relapse prevention or (4) recovery maintenance. Setting: Single‐center, medical research institution. Participants: Our sample included 162 RCTs that were prospectively registered with a clearly defined primary outcome. Measurement We extracted the following items from addiction RCTs: journal, funding source, trial registry number (if included), sample size, dates of subject enrollment, whether primary and secondary outcomes were denoted, all published outcomes, P‐value for all outcomes and whether authors mentioned any deviations from the trial protocol as it related to RCT outcomes. Findings In total, 47 of 162 RCTs (29.0%) had at least one major discrepancy between the trial registry and published RCT. Overall, these 47 RCTs included 54 major discrepancies. The most common major discrepancy was demotion of a primary registered outcome (19/54, 35.2%). The majority of RCTs (132/162, 81.5%) were funded from public sources. Additionally, 166 RCTs were excluded from our sample because registration could not be confirmed. Conclusions: There is evidence suggestive of selective outcome reporting in addiction randomized controlled trials (RCTs). The most common major discrepancies pertained to the primary outcome. [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]

Summary: The International Committee of Medical Journal Editors recommends the prospective registration of interventional clinical trials. We aimed to assess the compliance with these guidelines for manuscripts submitted to and published by a single anaesthetic journal. We examined the rates of prospective trial registration, the incidence of discrepancies in primary outcome measure(s) and sample sizes, and the citation metrics of all randomised controlled trials published in Anaesthesia over a 3‐year period (2014–2016). Of the 422 randomised controlled trials submitted during the study period, 115 (27.3%) were accepted for publication, of which 90 (78.3%) were patient studies, with the remaining 25 comprising manikin, simulation, volunteer, bench, cadaver and other non‐patient intervention studies. Of the accepted patient studies, 64 (71.1%) were prospectively registered with a clinical trials registry, 20 (22.2%) were not registered and 6 (6.7%) were retrospectively registered after manuscript submission. There was no difference in the frequency of registration between accepted and rejected manuscripts (77.8% vs. 84.5%, respectively, p = 0.143). The median (IQR [range]) time from registration of accepted manuscripts to journal submission was 701 (331–1341 [99–2436]) days. There was no correlation between number of patients recruited to a study and time to submission. Fifty‐two (81.3%) of the prospectively registered studies reported the same primary outcomes in both registration and submission, and 34 (53.1%) studies were published with the same powered sample size as that described in the registry. Eleven (12.2%) studies recruited more patients and 19 (21.1%) recruited fewer patients than described in the registration protocol. There was no difference in the median (IQR [range]) number of citations per month since publication between prospectively (0.27 (0.15–0.46 [0.00–1.59]), and retrospectively (0.39 (0.15–0.62 [0.10–0.67]); p = 0.502) or unregistered (0.33 (0.10–0.52 [0.00–0.67]); p = 0.867) studies. Our results suggest that prospective clinical trial registration has no influence on acceptance for publication by Anaesthesia or subsequent citation metrics. The international recommendation for prospective trial registration appears to have not been universally incorporated into anaesthetic‐related research practice. [ABSTRACT FROM AUTHOR]

Selective outcome reporting is a form of bias resulting from discrepancies between outcomes presented in a trial's registration and the published report. We investigate this selective bias in obesity clinical trials. A PubMed search was conducted to identify randomized controlled trials ( RCTs) published in four obesity journals from 2013 to 2015. Primary, secondary and tertiary outcomes were recorded for each trial and compared to pre-specified outcomes in each trial's registration. Of the 392 identified articles, 142 were included in the final analysis; 22 (15%) RCTs demonstrated major outcome discrepancies between registration and publication: No primary outcomes were demoted to a secondary or tertiary outcome; 14 (36.84%) primary outcomes were omitted; 14 (36.84%) primary outcomes were added: 5 (13.16%) secondary outcomes were upgraded to primary outcomes; and timing of assessment for a primary outcome changed 5 (13.16%) times. Out of the 63 prospectively registered studies, 53 had no discrepancies. A total of 76 of the studies (29.80%) were unregistered or did not have an associated registration number. Our results suggest that selective outcome reporting may be a concern in obesity clinical trials. As selective outcome reporting may distort clinical findings and limit outcomes in systematic reviews, we encourage trialists and journal editors to work towards solutions to mitigate this issue. [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.)

To investigate publication rates in small trials and to explore which factors are associated with publication rates in small trials, including sample size, the type and number of primary and secondary outcomes. We studied a subgroup of 'small' trials from a pre-existing dataset (IntoValue), containing German trials completed between 2009 and 2017. Small trials were defined as phase II-III, III and IV trials with 150 or fewer participants. We performed an updated publication search and collected additional data from online trial records. Out of 499 trials, 325 (65%) trials published their results in a journal article or dissertation. Median time-to-publication was 3.41 years (95% CI: 3.04–4.10). Planned sample size was not associated with publication rates, but the difference between planned and achieved sample size was (per 10% unsuccessfully recruited participants, HR = 0.95, 95% CI: 0.91–1.00). Phase III vs. II-III trials, studied intervention (device vs. other) and clearly vs. unclearly defined primary outcomes predicted a higher likelihood of earlier publication. About 35% of small trials in Germany remain unpublished, even after an extensive follow-up period of over 9 years. Publication rates are low and were associated with sample size, trial phase and type of intervention. • Results from small German trials are mostly published in the first 5 years after trial completion. • About one third of small trials in Germany remain unpublished. • Trials that were unable to recruit their planned number of participants took a longer time to publish their results. [ABSTRACT FROM AUTHOR]

Objectives. The need for trial registration as well as the benefits it has brought for the transparency of medical research has been recognized for years. Trial registration has turned from an exception to a mandatory guideline in recent years. The present study aimed to examine the characteristics of registered randomized controlled trials (RCTs) in a sample of recently published gastroenterology RCTs, and to assess the consistency of registered and published primary outcome (PO) in RCTs. Methods. Articles published in the top five "general and internal journals" and top five "gastroenterology and hepatology journals" categories between 2009 and 2012 were searched in PubMed. Basic characteristics and the registration information were identified and extracted from the included RCTs. PO consistency analysis was conducted to compare between the registered and published format. Results. A total of 305 RCTs were included; among them 252 could be identified with a registration number. Nearly half of these RCTs were funded solely by industry (141/305, 46.3%). ClinicalTrials.gov was the most popular registry for these RCTs (214/252, 84.9%). A total of 155 RCTs were included in the PO consistency analysis. Among them, 22 (14.2%) RCTs had discrepancies between POs registered in the trial registry compared to the published article. Conclusions. Based on the results of the present study, selective outcome reporting of gastroenterology RCTs published in leading medical journals has been much improved over the past years. However, there might be a sampling bias to say that consistency of registered and published POs of gastroenterology RCTs has been better than before. [ABSTRACT FROM AUTHOR]

Abstract: The National Institutes of Health released the trial registry ClinicalTrials.gov in 2000 to increase public reporting and clinical trial transparency. This systematic review examined whether registered primary outcome specifications (POS; ie, definitions, timing, and analytic plans) in analgesic treatment trials correspond with published POS. Trials with accompanying publications (n =87) were selected from the Repository of Registered Analgesic Clinical Trials (RReACT) database of all postherpetic neuralgia, diabetic peripheral neuropathy, and fibromyalgia clinical trials registered at ClinicalTrials.gov as of December 1, 2011. POS never matched precisely; discrepancies occurred in 79% of the registry–publication pairs (21% failed to register or publish primary outcomes [PO]). These percentages did not differ significantly between industry and non-industry-sponsored trials. Thirty percent of the trials contained unambiguous POS discrepancies (eg, omitting a registered PO from the publication, “demoting” a registered PO to a published secondary outcome), with a statistically significantly higher percentage of non-industry-sponsored than industry-sponsored trials containing unambiguous POS discrepancies. POS discrepancies due to ambiguous reporting included vaguely worded PO registration; or failing to report the timing of PO assessment, statistical analysis used for the PO, or method to address missing PO data. At best, POS discrepancies may be attributable to insufficient registry requirements, carelessness (eg, failing to report PO assessment timing), or difficulty uploading registry information. At worst, discrepancies could indicate investigator impropriety (eg, registering imprecise PO [“pain”], then publishing whichever pain assessment produced statistically significant results). Improvements in PO registration, as well as journal policies requiring consistency between registered and published PO descriptions, are needed. [Copyright &y& Elsevier]

Background: The methodology of conducting clinical trials in lung cancer has been challenged by the particular characteristics of new targeted agents. Thus, the choice of correct outcome measures and selection of best study designs are essential. We assessed the trends in reporting of outcome measures in phase II and phase III trials conducted in advanced non-small-cell lung cancer (NSCLC) patients. Methods: Data from September 2000 to September 2012 were extracted from the ClinicalTrials.gov database, and a descriptive-comparative analysis was performed to evaluate outcome-measures reporting for the two phases. Results: We identified 459 phase II and 128 phase III trials that met our inclusion criteria. The frequently reported primary outcomes in phase II trials were progression-free survival (PFS; 32 %), response rate (RR; 21.4 %), and safety and toxicity (adverse events [AEs]; 14.6 %). In contrast, overall survival (OS; 60.9 %) and PFS (26.6 %) were frequently reported primary outcomes in phase III trials. AEs were reported as a secondary outcome measure in 50.1 and 64.8 % of phase II and phase III trials, respectively. Improvement in quality of life was identified as a secondary outcome measure significantly more frequently in phase III than in phase II trials. Conclusions: Our study identified recent trends in reports of outcome measures in advanced-stage NSCLC phase II and phase III trials. The outcomes of this study can be valuable for investigators with minimal or some experience in the field of oncology who are conducting clinical research. [ABSTRACT FROM AUTHOR]

Decision-makers in payor and provider organizations rely on the peer-reviewed literature as a source of ideas for new interventions to control costs and improve the quality of health care. However, recent evidence has emerged that spin tactics are regularly employed in the description of results from randomized controlled trials (RCTs) that actually do not show statistically significant outcomes. Observational studies, which are more commonly used to evaluate health management interventions than RCTs, offer greater opportunity for spin because evaluators control more aspects of the evaluation approach. This paper provides a detailed description of how to critically review study outcomes from health management interventions and identify spin. Our emphasis on health management is motivated by the tremendous discrepancy between the large financial savings reported by commercial vendors and the savings reported in RCTs and systematic reviews that indicate little-to-no financial benefit. We use unpublished data from a medical home pilot project to demonstrate how easily statistically non-significant findings can be portrayed in a favourable light, either through error, omission or intentional spin. We then describe additional techniques that should be utilized in order to present outcomes in an accurate and comprehensive manner. The step-by-step approach described here will hopefully assist readers in becoming more critical consumers of outcomes reported in scholarly journals or the popular media by identifying when spin tactics are used to camouflage ineffective interventions. [ABSTRACT FROM AUTHOR]

Abstract: The Displaced Femoral (neck fracture) Arthroplasty Consortium for Treatment and Outcomes study is a prospective, multicenter randomized clinical trial comparing hemiarthroplasty to total hip arthroplasty (THA) in the treatment of displaced femoral neck fractures in previously independent patients. Primary outcomes were measured at 6, 12, and 24 months with the Short Form-36 (SF-36), Western Ontario and McMaster Osteoarthritis Index (WOMAC), and the Harris Hip Score and the Timed “Up & Go” Test. Forty subjects were enrolled. At 24 months, THA patients had significantly less pain on the SF-36 subscale than hemiarthroplasty patients (54.8 ± 7.9 vs 44.7 ± 10.5, P = .04) and scored significantly better on the SF-36 mental health subscale (54.9 ± 9.4 vs 40.9 ± 10.3, P = .006). Total hip arthroplasty patients also had superior WOMAC function scores (81.8 ± 10.2 vs 65.1 ± 18.1, P = .03). Significant differences in outcomes, without a significantly greater incidence of complications, suggest THA is a valuable treatment option for the active elderly hip fracture population. [Copyright &y& Elsevier]