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Background and Objectives: Administrative data are invaluable for assessing outcomes at the population level. However, there are few validated patient-centered outcome measures that capture morbidity following traumatic brain injury (TBI) using these data. We sought to characterize and validate days at home (DAH) as a measure to quantify population-level outcomes after moderate to severe TBI. We additionally assessed the earliest feasible outcome assessment period for patients with TBI using this outcome measure., Methods: This multicenter retrospective cohort study used linked health administrative data sources to identify adults with moderate to severe TBI presenting to trauma centers in Ontario, Canada, between 2009 and 2021. DAH at 180 days (DAH 180 days ) reflects the total number of days spent alive and at home excluding the days spent institutionalized across care settings. Construct validity was determined using hierarchical quantile regression to assess the associations between clinical and injury covariates with DAH 180 days . Predictive validity was assessed using Spearman rank correlation. We estimated minimally important difference (MID) in DAH 180 days to aid with outcome measure interpretability., Results: There were 6,340 patients who met inclusion criteria. Median DAH 180 days was 70 days (interquartile range 0-144). Mortality occurred in 2,162 (34.1%) patients within 90 days following injury. Patients in the lower DAH 180 days group were more commonly older (absolute standardized difference [ASD] = 0.68) with higher preinjury health resource utilization (ASD = 0.36) and greater injury severity (ASD = 0.81). Increased baseline health resource utilization (-10.1 days, 95% CI -17.4 to -2.8, p = 0.0041), older age (-4.6 days, 95% CI -5.7 to -3.4, p < 0.001), higher cranial injury severity (-84.6 days, 95% CI -98.3 to -71.0, p < 0.001), and major extracranial injuries (-14.2 days, 95% CI -19.5 to -8.93, p < 0.001) were significantly associated with fewer DAH 180 days . DAH 180 days was positively correlated with DAH at up to 3 years ( r = 0.91, 95% CI 0.90-0.92) and negatively correlated with direct health care expenditure ( r s = -0.89, 95% CI -0.88 to -0.90). The average MID estimated from anchor-based and distribution-based methods was 18 days., Discussion: We validate DAH 180 days as a potentially useful outcome measure with construct, predictive, and face validity in a population with moderate to severe TBI. Given the intensity of acute care requirements for patients with TBI, our work highlights DAH 180 days as a feasible and sufficiently responsive outcome measure.

Background: We aimed to investigate the association between a diagnosis of untreated unruptured intracranial aneurysms (UIAs) and the development of mental illness., Methods: This retrospective, propensity-score-matched cohort study was based on the nationwide South Korean database. The UIA diagnosis group included participants newly diagnosed with UIA between 2011 and 2019. For a well-matched control group, patients diagnosed with an acute upper respiratory infection but without UIA during the same period were selected through 1:4 matching based on propensity scores, which were calculated using age, sex, economic status, and comorbidities. The study's outcome measure encompassed the incidence of mental illnesses over a 10-year period, using International Classification of Diseases-Tenth Revision codes for anxiety, stress, depressive, bipolar, and eating disorders, insomnia, and alcohol or drug misuse., Results: After propensity score matching, 85 438 participants with untreated UIAs (50.75% male; average age, 56.41 [±13.82] years; follow-up, 4.21 [±2.56] years) and 331 123 controls (49.44% males; average age, 56.69 [±12.92] years; follow-up, 7.48 [±2.12] years) were compared. Incidence rate of mental illness was higher in the UIA group (113.07 versus 90.41 per 1000 person-years; hazard ratio, 1.104 [95% CI, 1.089-1.119]). The risk of mental illness varied slightly by sex (males: hazard ratio, 1.131 [95% CI, 1.108-1.155]; females: hazard ratio, 1.082 [95% CI, 1.063-1.103]). Hazard ratios showed a U-shaped relationship with age, peaking in younger age groups, decreasing in middle-aged groups, and slightly increasing in older age groups, especially in patients with severe mental illness receiving psychotherapy., Conclusions: Our findings indicate a higher risk of mental illness in patients with UIA diagnosis in specific demographic groups, suggesting a possible psychological burden associated with UIAs. Clinicians treating cerebral aneurysms should be aware that the psychological burden caused by the diagnosis of UIA itself could contribute to mental illness and strive to provide comprehensive care for these patients., Competing Interests: None.

Objectives: Critically ill adults requiring artificial airways experience profound communication deficits. Studies of interventions supporting communication report disparate outcomes, creating subsequent challenges in the interpretation of their effectiveness. Therefore, we aimed to develop international consensus for a communication core outcome set (Comm-COS) for future trials of communication interventions in this population., Design: 1) Systematic review, 2) patient/family interviews, 3) two-round modified Delphi, and 4) virtual consensus meetings with a final voting round. A multidisciplinary expert steering committee oversaw all stages., Setting: Interviews and consensus meetings were conducted via videoconferencing. Digital methods were used for Delphi and final Comm-COS voting., Subjects: Three stakeholder groups: 1) patient and family members with lived experience within 3 years, 2) clinicians with experience working in critical care, and 3) researchers publishing in the field., Intervention: None., Measurements and Main Results: We identified 59 outcomes via our systematic review, 3 unique outcomes from qualitative interviews, and 2 outcomes from our steering committee. Following item reduction, 32 outcomes were presented in Delphi round 1; 134 participants voted; 15 patient/family (11%), 91 clinicians (68%), and 28 researchers (21%). Nine additional outcomes were generated and added to round 2; 106 (81%) participants voted. Following completion of the consensus processes, the Comm-COS includes seven outcomes: 1) changes in emotions and wellbeing associated with ability to communicate, 2) physical impact of communication aid use, 3) time to functional communication, 4) ability to communicate healthcare needs (comfort/care/safety/decisions), 5) conversation agency, 6) ability to establish a communication connection to develop and maintain relationships, and 7) acceptability of the communication intervention., Conclusions: This is the first COS to specifically focus on communication for critically ill adults. Limitations for operationalization include selection of measures to use with these outcomes. Identification of suitable measures and adoption of the Comm-COS in future trials will help establish effective interventions to ameliorate the highly prevalent and negative experience of communicative incapacity., Competing Interests: Dr. Freeman-Sanderson received support for article research from an internal university seed grant from Faculty of Health, University of Technology Sydney (UTS). Dr. Brodsky’s institution received funding from the National Institutes of Health and the Food and Drug Administration; he received funding from MedBridge and Phagenesis. Dr. Happ received funding from internal research funds, the Healthy State Alliance Momentum grant; she disclosed that she holds the copyright to the Study of Patient-Nurse Effectiveness with Assisted Communication Strategies (SPEACS-2) online communication training program. Sullivan’s institution received funding from UTS. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and Wolters Kluwer Health, Inc.)

Background: Low plasma levels of eicosapentaenoic acid (EPA) are associated with cardiovascular events. This trial aimed to assess the clinical benefits of icosapent ethyl in patients with coronary artery disease, a low EPA/arachidonic acid (AA) ratio, and statin treatment., Methods: In this prospective, multicenter, randomized, open-label, blinded end-point study, patients with stable coronary artery disease and a low EPA/AA ratio (<0.4) were randomized to EPA (1800 of icosapent ethyl administered daily) or control group. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, unstable angina pectoris, and coronary revascularization. The secondary composite end points of coronary events included sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina requiring emergency hospitalization and coronary revascularization, or coronary revascularization., Results: Overall, 3884 patients were enrolled at 95 sites in Japan. Among them, 2506 patients had a low EPA/AA ratio, and 1249 and 1257 patients were randomized to the EPA and control group, respectively. The median EPA/AA ratio was 0.243 (interquartile range, 0.180-0.314) and 0.235 (interquartile range, 0.163-0.310) in the EPA and control group, respectively. Over a median period of 5 years, the primary end point occurred in 112 of 1225 patients (9.1%) and 155 of 1235 patients (12.6%) in the EPA and control group, respectively (hazard ratio, 0.79 [95% CI, 0.62-1.00]; P =0.055). Meanwhile, the secondary composite end point of coronary events in the EPA group was significantly lower (81/1225 [6.6%] versus 120/1235 [9.7%] patients; hazard ratio, 0.73 [95% CI, 0.55-0.97]). Adverse events did not differ between the groups, but the rate of new-onset atrial fibrillation was significantly higher in the EPA group (3.1% versus 1.6%; P =0.017)., Conclusions: Icosapent ethyl treatment resulted in a numerically lower risk of cardiovascular events that did not reach statistical significance in patients with chronic coronary artery disease, a low EPA/AA ratio, and statin treatment., Registration: URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000012069., Competing Interests: Dr Miyauchi has received lecture fees from Amgen Astellas BioPharma, Astellas Pharma, MSD, Bayer Yakuhin, Sanofi, Takeda Pharmaceutical, Daiichi-Sankyo, Nippon Boehringer Ingelheim, and Bristol-Myers Squibb. Dr Iwata has received lecture fees from Kowa, Daiichi-Sankyo, Sumitomo Pharma, MSD, Novo Nordisk, Mochida Pharmaceutical, and Bayer Yakuhin. Dr Hirayama has received lecture fees from Bayer Yakuhin and Daiichi-Sankyo. Dr Kimura has received grants from Bayer Yakuhin, consulting fees from Idorsia Pharmaceuticals Japan, and lecture fees from Bayer Yakuhin and Daiichi-Sankyo. Dr Ozaki has received grants from Takeda Pharmaceutical, Daiichi-Sankyo, and Otsuka Pharmaceutical. Dr Murohara has received from Daiichi-Sankyo, Jansen Pharmaceutical, Bayer Yakuhin, Ono Pharmaceutical, Mochida Pharmaceutical, Pfizer, AstraZeneca, and Boehringer Ingelheim Japan. Dr Daida has received grants from Philips Japan, FUJIFILM Holdings Corp, Asahi Kasei Corp, Inter Reha, TOHO HOLDINGS, GLORY, Bristol-Myers Squibb, Abbott Japan, Boehringer Ingelheim Japan, Eisai, Bayer Yakuhin, and Daiichi-Sankyo, as well as lecture fees from Novartis Pharma, Bayer Yakuhin, Sanofi, Kowa, Taisho Pharmaceutical, Abbott Medical Japan, Otsuka Pharmaceutical, Amgen, MSD, Daiichi-Sankyo, Pfizer Japan, FUKUDA DENSHI, Tsumura, and TOA EIYO. The other authors report no conflicts.

Objectives: To assess the current quality of surgical outcome reporting in the medical literature and to provide recommendations for improvement., Background: In 1996, The Lancet labeled surgery as a "comic opera" mostly referring to the poor quality of outcome reporting in the literature impeding improvement in surgical quality and patient care., Methods: We screened 3 first-tier and 2 second-tier surgical journals, as well as 3 leading medical journals for original articles reporting on results of surgical procedures published over a recent 18-month period. The quality of outcome reporting was assessed using a prespecified 12-item checklist., Results: Six hundred twenty-seven articles reporting surgical outcomes were analyzed, including 125 randomized controlled trials. Only 1 (0.2%) article met all 12 criteria of the checklist, whereas 356 articles (57%) fulfilled less than half of the criteria. The poorest reporting was on cumulative morbidity burden, which was missing in 94% of articles (n=591) as well as patient-reported outcomes missing in 83% of publications (n=518). Comparing journal groups for the individual criterion, we found moderate to very strong statistical evidence for better quality of reporting in high versus lower impact journals for 7 of 12 criteria and strong statistical evidence for better reporting of patient-reported outcomes in medical versus surgical journals ( P <0·001)., Conclusions: The quality of outcomes reporting in the medical literature remains poor, lacking improvement over the past 20 years on most key end points. The implementation of standardized outcome reporting is urgently needed to minimize biased interpretation of data thereby enabling improved patient care and the elaboration of meaningful guidelines., Competing Interests: P.A.C. developed the Clavien-Dindo classification. P.A.C. and M.A.P. developed the Comprehensive Complication Index (CCI). The remaining authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Multimorbidity or the co-occurrence of multiple health conditions is increasing globally and is associated with significant psychological complications. It is unclear whether digital mental health (DMH) interventions for patients experiencing multimorbidity are effective, particularly given that this patient population faces more treatment resistance. The goal of the current study was to examine the impact of smartphone-delivered DMH interventions for patients presenting with elevated internalizing symptoms that have reported multiple lifetime medical conditions., Methods: This preregistered (see https://osf.io/vh2et/ ) retrospective cohort intent-to-treat study with 2819 patients enrolled in a therapist-supported DMH intervention examined the associations between medical multimorbidity (MMB) and mental health outcomes., Results: Results indicated that more MMB was significantly associated with greater presenting mental health symptom severity. MMB did not have a deleterious influence on depressive symptom trajectories across treatment, although having one medical condition was associated with a steeper decrease in anxiety symptoms compared to patients with no medical conditions. Finally, MMB was not associated with time to dropout, but was associated with higher dropout and was differentially associated with fewer beneficial treatment outcomes, although this is likely attributable to higher presenting symptom severity, rather than lesser symptom reductions during treatment., Conclusions: Overall, the Meru Health Program was associated with large effect size decreases in depressive and anxiety symptoms regardless of the number of MMB. Future DMH treatments and research might investigate tailored barrier reduction and extended treatment lengths for patients experiencing MMB to allow for greater treatment dose to reduce symptoms below clinical outcome thresholds., (Copyright © 2024 by the American Psychosomatic Society.)

Objectives: Studies on the consequences of juvenile vulvar lichen sclerosus (JVLS) in adulthood are limited. A number of measuring tools are available for analyzing adult vulvar lichen sclerosus (VLS), but these have not been applied in studies on JVLS. The aim is to study physical findings, quality of life, sexual well-being, and self-image in adult women with a history of juvenile VLS., Materials and Methods: Adult women with a biopsy proven history of JVLS were recruited to be examined and surveyed using available standardized measurement tools. This took place in an outpatient setting by physicians who were not involved in the treatment of participants., Results: Twenty-seven women (median age 29 years) with a history of JVLS and median time since biopsy of 19.5 years were recruited. Of these women, 59% currently had symptoms, 63% had signs of active disease, and 85% had moderate to severe architectural changes. Despite these residual signs, vulvar specific-quality of life and vulvar self-image scored favorably while generic health-related quality of life was somewhat effected., Conclusions: JVLS has consequences in adulthood involving physical findings and vulvar quality of life. The use of standardized outcome measures for clinical practice and research purposes facilitates a better understanding of the sequelae to JVLS., Competing Interests: Conflicts of interest: None to declare., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASCCP.)

Federally Qualified Health Centers (FQHCs) are ideally positioned to identify and address health-related social needs, but little is understood about the relationship between social risk factor (SRF) screening and health outcomes. We studied 1352 FQHCs from the 2019 Uniform Data System. Ordinary least squares regression was used to estimate the relationship between SRF screening and the percentage of patients with adequately controlled diabetes and hypertension. Results show 71% of the FQHCs in the sample collected SRFs. FQHCs' screened for SRFs had higher percentages of patients with adequately controlled diabetes (69.5% vs 67.0%, P < .001) and hypertension (63.8% vs 59.4%, P < .001) relative to FQHCs not collecting SRFs., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: Healthcare is a complex adaptive system, requiring agile, innovative leaders to transform care. Clinical nurse specialists (CNSs) are uniquely positioned to influence change and achieve high-quality outcomes. Nurse leaders need strategies to onboard and retain CNSs considering high demand across the nation. The purpose of this program evaluation was to describe the core components and outcomes of CNS fellowship programs., Design: This program evaluation used the Kirkpatrick Model as a framework to assess learning and knowledge translation., Methods: The study was conducted within 3 Indiana healthcare organizations. Clinical nurse specialist leaders from each organization identified fellowship core components and analyzed team composition (ie, percentage of CNS team that was current/past fellows). Current and past CNS fellows were invited to participate in a survey evaluating program effectiveness, impact on role transition, project leadership, and outcomes achieved., Results: Overlap was identified among 85% (17/20) of the core components, team composition was 71% (25/35) past/current fellows, and retention was 100% (12/12). Of the 23 invited, 18 (78%) participated in the program evaluation. Program effectiveness was evaluated as very/extremely effective by 94% (17/18) of participants. Themes salient to independent practice transition were applying learning, achieving influence, and developing relationally, contributing to incremental gain of the CNS perspective (ie, CNS values and guiding principles influencing critical thinking and behavior)., Conclusion: Nurse leaders should consider fellowship implementation to recruit and retain CNS talent within organizations., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: The authors have disclosed that they do not have any potential conflicts of interest.

Competing Interests: Disclosures None.

Background and Objectives: Clinical trials in Duchenne muscular dystrophy (DMD) require 3-6 months of stable glucocorticoids, and the primary outcome is explored at 48-52 weeks. The factors that influence the clinical outcome assessment (COA) trajectories soon after glucocorticoid initiation are relevant for the design and analysis of clinical trials of novel drugs. We describe early COA trajectories, associated factors, and the time from glucocorticoid initiation to COA peak., Methods: This was a prospective 18-month analysis of the Finding the Optimum Corticosteroid Regimen for Duchenne Muscular Dystrophy study. Four COAs were investigated: rise from supine velocity (RFV), 10-meter walk/run velocity (10MWRV), North Star Ambulatory Assessment (NSAA) total score, and 6-minute walk test distance (6MWT). The relationships of baseline age (4-5 vs 6-7 years), COA baseline performance, genotype, and glucocorticoid regimen (daily vs intermittent) with the COA trajectories were evaluated using linear mixed-effects models., Results: One hundred ninety-six glucocorticoid-naïve boys with DMD aged 4-7 years were enrolled. The mean age at baseline was 5.9 ± 1.0 years, 66% (n = 130) were on daily regimens, 55% (n = 107) showed a 6MWT distance >330 metres; 41% (n = 78) showed RFV >0.2 rise/s; 76% (n = 149) showed 10MWRV >0.142 10m/s, and 41.0% (n = 79) showed NSAA total score >22 points. Mean COA trajectories differed by age at glucocorticoid initiation ( p < 0.01 for RFV, 10MWRV, and NSAA; p < 0.05 for 6MWT) and regimen ( p < 0.01 for RFV, 10MWRV, and NSAA). Boys younger than 6 years reached their peak performance 12-18 months after glucocorticoid initiation. Boys aged 6 years or older on a daily regimen peaked between months 9 and 12 and those on an intermittent regimen by 9 months. The baseline COA performance was associated with the NSAA ( p < 0.01) and the 6MWT trajectory in boys younger than 6 years on a daily regimen ( p < 0.01). Differences in the mean trajectories by genotype were not significant., Discussion: Glucocorticoid regimen, age, duration of glucocorticoid exposure, and baseline COA performance need to be considered in the design and analysis of clinical trials in young boys with DMD.

Objectives: To determine the postoperative trajectory and recovery of patients who undergo Lisfranc open reduction and internal fixation using Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and pain interference (PI)., Design: Retrospective cohort study., Setting: Level 1 trauma center., Patient Selection Criteria: Patients who underwent Lisfranc open reduction and internal fixation between January 2002 and December 2022 with documented PROMIS PF and/or PI scores after surgery., Outcome Measures and Comparisons: PROMIS PF and PI were mapped over time up to 1 year after surgery. A subanalysis was performed to compare recovery trajectories between high-energy and low-energy injuries., Results: A total of 182 patients were included with average age of 38.7 (SD 15.9) years (59 high-energy and 122 low-energy injuries). PROMIS PF scores at 0, 6, 12, 24, and 48 weeks were 30.2, 31.4, 39.2, 43.9, and 46.7, respectively. There was significant improvement in PROMIS PF between 6 and 12 weeks ( P < 0.001), 12-24 weeks ( P < 0.001), and 24-48 weeks ( P = 0.022). A significant difference in PROMIS PF between high and low-energy injuries was seen at 0 week (28.4 vs. 31.4, P = 0.010). PROMIS PI scores at 0, 6, 12, 24, and 48 weeks were 62.2, 58.5, 56.6, 55.7, and 55.6, respectively. There was significant improvement in PROMIS PI 0-6 weeks ( P = 0.016). A significant difference in PROMIS PI between high-energy and low-energy injuries was seen at 48 weeks with scores of (58.6 vs. 54.2, P = 0.044)., Conclusions: After Lisfranc open reduction and internal fixation, patients can expect improvement in PF up to 1 year after surgery, with the biggest improvement in PROMIS PF scores between 6 and 12 weeks and PROMIS PI scores between 0 and 6 weeks after surgery. Regardless the energy type, Lisfranc injuries seem to regain comparable PF by 6-12 months after surgery. However, patients with higher energy Lisfranc injuries should be counseled that these injuries may lead to worse PI at 1 year after surgery as compared with lower energy injuries., Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence., Competing Interests: The authors report no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

The CheckMate-141 trial led to the approval of nivolumab in platinum-resistant metastatic/advanced squamous cell carcinomas of the head and neck (SCCHN). We evaluated the outcomes of SCCHN patients in Ontario, Canada, treated with nivolumab through retrospective review of the provincial treatment registry. Kaplan-Meier method was used to estimate overall survival (OS) and Cox regression to evaluate the prognostic effect of selected factors. Nivolumab was used as second-line therapy after disease relapse for curative-intent platinum chemotherapy (PC) (indication 1-I1), as second-line therapy post-PC in noncurative intent (indication 2-I2), and as first-line therapy in noncurative intent due to contraindication for PC (indication 3-I3). The median OS for patients treated with nivolumab was 5.8 months (95% CI: 4.5-7.3), and the 1-year OS was 28.4% (CI: 2.10-36.1). When patients with I3 were excluded to match inclusion criteria for CheckMate-141, median OS was 4.8 months (CI: 3.6-6.7) with 1-year OS of 21.8% (14.4-30.1). Patients with lower body surface area (BSA) (<1.81) had a median OS of 3.9 months (CI: 3.1-6.7) versus 9.0 months (CI: 6.5-14.8) in those with higher BSA, hazard ratio (HR)=0.12 (CI: 0.04-0.39, P <0.001). Patients receiving nivolumab for I1 had a median OS of 7.2 months (CI 3.8-9.8) versus 11.9 months (CI: 6.2-not reached) for I3, HR=1.73 (CI: 0.94-3.16). Patients receiving nivolumab for I2 had a median OS of 3.9 months (CI: 2.9-5.4) as compared with I3, HR=3.27 (CI: 1.80-5.94). Real-world analysis of patients with advanced/metastatic SCCHN in Ontario, Canada, treated with nivolumab demonstrates poorer median OS compared with CheckMate-141 trial. Lower BSA was a predictor of poorer median OS., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Abstract: Many gaps remain in finding effective, safe, and equitable treatments for children and adolescents with chronic pain and in accessing treatments in different settings. A major goal of the field is to improve assessment of pain and related experience. Valid and reliable patient-reported outcome measures are critical for advancing knowledge of clinical interventions for pediatric chronic pain. Building on the work of the Ped-IMMPACT group, we previously updated a core outcome set (COS) for pediatric chronic pain clinical trials using stakeholder feedback from providers, youth, and parents. The new COS includes 3 mandatory domains: pain severity, pain-related interference with daily living, and adverse events and 4 optional domains: overall well-being, emotional functioning, physical functioning, and sleep quality. The aim of this study was to use a multiphased approach to recommend specific measures for each of the 7 domains identified in our new COS for pediatric chronic pain. We synthesized evidence through conducting the following: (1) a Delphi study of experts to identify candidate measures for the new COS domains, (2) a review phase to gather evidence for measurement properties for candidate measures, and (3) an expert consensus conference to reach agreement on measurement recommendations. Final recommendations included 9 patient-reported measures. Important contextual considerations are discussed, and guidance is provided regarding strengths and limitations of the recommendations. Implementation of these recommendations may be enhanced by widespread dissemination and ease of access to measurement tools., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)

In 2021, the American Heart Association celebrates its 40th anniversary in advocacy. This policy statement details the arc of the organization's nonpartisan, evidence-based, equity-focused approach to advocating for public policy change, highlighting key milestones and describing the core components of the association's capacity and activity at all levels of government. This policy statement presents a vision and strategic imperative for future American Heart Association advocacy efforts to inform and influence policy changes that advance equitable, impactful societal solutions that transform and improve cardiovascular health for everyone. The American Heart Association maintains accountability by measuring and evaluating the totality of this work and its impact on equitable health outcomes. The American Heart Association will apply these lessons to constantly refine its own strategic policy focus and advocacy efforts. The association will also serve as a resource and catalyst to other organizations working to engage and educate policy makers, partners, the media, and funders about the important role and contribution of public policy change to achieve shared goals. [ABSTRACT FROM AUTHOR]

Background and Objectives: Outcome reporting bias occurs when publication of trial results is dependent on clinical significance, thereby threatening the validity of trial results. Research on immunomodulatory drugs in multiple sclerosis has thrived in recent years. We aim to comprehensively examine to what extent outcome reporting bias is present in these trials and the possible underlying factors., Methods: We identified clinical trials evaluating the efficacy and safety of immunomodulatory drugs in patients with multiple sclerosis (MS) registered in ClinicalTrials.gov after September 2007 and completed before the end of 2018. Information about study design, type of funding, and primary and secondary outcome measures was extracted from the registry. Timing of registration in relation to study initiation and subsequent amendments to the planned outcomes were reviewed. Publications related to these trials were identified in several bibliographic databases using the trial registration number. Registered primary and secondary outcomes were recorded for each trial and compared with outcomes in the publication describing the main outcomes of the trial., Results: A search of ClinicalTrials.gov identified 535 eligible registered clinical trials; of these, 101 had a matching publication. Discrepancies between registered and published primary and secondary outcomes were found in 95% of the trials, including discrepancies between the registered and published primary outcomes in 26 publications. Forty-four percent of the published secondary outcomes were not included in the registry. A similar proportion of registered and nonregistered reported primary efficacy outcomes were positive (favoring the intervention). Nonindustry-funded and open-label trials in MS were more prone to selective primary outcome reporting, although these findings did not reach statistical significance. Only two-thirds of the trials were registered in ClinicalTrials.gov before the trial start date, and 62% of trials made amendments in registered outcomes during or after the trial period., Discussion: Selective outcome reporting is prevalent in trials of disease-modifying drugs in people with MS. We propose methods to diminish the occurrence of this bias in future research.

Competing Interests: S.C. is supported by the Australian National Health and Medical Research Council Emerging Leadership Scholarship and the Royal Australasian College of Physicians Research Establishment Fellowship. C.H. is the recipient of research grants paid to her institution from Baxter Health and Fresenius Medical Care and from Otsuka, Janssen, and GlaxoSmithKline for trial steering committee activities, paid to her institution. D.J. has received consultancy fees, research grants, speaker’s honoraria, and travel sponsorships from Baxter Health and Fresenius Medical Care. He has received consultancy fees from AstraZeneca, Bayer, and AWAK; speaker’s honoraria from Ono and BI and Lilly; and travel sponsorships from Amgen. He is a current recipient of an Australian National Health and Medical Research Council (NHMRC) Leadership Investigator Grant. A.J. is supported by the NHMRC Research Fellowship. A.V. receives grant support from the Royal Australasian College of Physicians (Jacquot Research Establishment Award) and the Princess Alexandra Research Foundation. D.C.B. receives institutional research grant funding from CareDx and is a consultant for CareDx, Medeor, Sanofi, and Vera Therapeutics and is supported by National Institute of Diabetes and Digestive and Kidney Diseases U01 DK116042, U01AI063594, and R44DK123978. E.B. receives research support from Merck, Takeda and Hologix, and DSMB for Amplyx and is an unpaid consultant for Merck and Takeda. Y.C. has received research grants and speaker’s honoraria from Baxter Health and Fresenius Medical Care and is a current recipient of an Australian NHMRC Emerging Leadership Investigator Grant and Queensland Health Advancing Care Fellowship (mid-career). The other authors declare no conflicts of interest.

Healthcare clinicians strive to make meaningful changes in patient function and participation. A minimal clinically important difference (MCID) is an estimate of the magnitude of change needed to be meaningful to a patient. Clinicians and investigators may assume that a cited MCID is a valid and generalizable estimate of effect. There are, however, at least two concerns about this assumption. First, multiple methods exist for calculating an MCID that can yield divergent values and raise doubt as to which one to apply. Second, MCID values may be erroneously generalized to patients with dissimilar health conditions. With this in mind, we reviewed the methods used to calculate MCID and citations of reported MCID values for outcome measures commonly used in neurologic, orthopedic, and geriatric populations. Our goal was to assess whether the calculation methods were acknowledged in the cited work and whether the enrolled patients were similar to the sample from which the MCID estimate was derived. We found a concerning variation in the methods employed to estimate MCID. We also found a lack of transparency in identifying calculation methods and applicable health conditions in the cited work. Thus, clinicians and researchers must pay close attention and exercise caution in assuming changes in patient status that exceed a specific MCID reflect meaningful improvements in health status. A common standard for the calculation and reporting of an MCID is needed to address threats to the validity of conclusions drawn from the interpretation of an MCID., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background and Objectives: Charcot-Marie-Tooth disease type 1A (CMT1A), caused by a duplication of PMP22 , is the most common hereditary peripheral neuropathy. For participants with CMT1A, few clinical trials have been performed; however, multiple therapies have reached an advanced stage of preclinical development. In preparation for imminent clinical trials in participants with CMT1A, we have produced a Clinical Outcome Assessment (COA), known as the CMT-Functional Outcome Measure (CMT-FOM), in accordance with the FDA Roadmap to Patient-Focused Outcome Measurement to capture the key clinical end point of function., Methods: Participants were recruited through CMT clinics in the United States (n = 130), the United Kingdom (n = 52), and Italy (n = 32). To derive the most accurate signal with the fewest items to identify a therapeutic response, a series of validation studies were conducted including item and factor analysis, Rasch model analysis and testing of interrater reliability, discriminative ability, and convergent validity., Results: A total of 214 participants aged 18-75 years with CMT1A (58% female) were included in this study. Item, factor, and Rasch analysis supported the viability of the 12-item CMT-FOM as a unidimensional interval scale of function in adults with CMT1A. The CMT-FOM covers strength, upper and lower limb function, balance, and mobility. The 0-100 point scoring system showed good overall model fit, no evidence of misfitting items, and no person misfit, and it was well targeted for adults with CMT1A exhibiting high inter-rater reliability across a range of clinical settings and evaluators. The CMT-FOM was significantly correlated with the CMT Examination Score ( r = 0.643; p < 0.001) and the Overall Neuropathy Limitation Scale ( r = 0.516; p < 0.001). Significantly higher CMT-FOM total scores were observed in participants self-reporting daily trips and falls, unsteady ankles, hand tremor, and hand weakness ( p < 0.05)., Discussion: The CMT-FOM is a psychometrically robust multi-item, unidimensional, disease-specific COA covering strength, upper and lower limb function, balance, and mobility to capture how participants with CMT1A function to identify therapeutic efficacy.

Competing Interests: Disclosures At the time of the study, A. Morales, and Drs Moretz, Callis, Esplin, Hatchell, Nussbaum, Regalado, Rojahn, and Vatta were employees and stockholders of Invitae Corporation and Drs Ren, Smith, Hall, and Murillo were employees and stockholders of UnitedHealth Group.

Objectives: The purpose of this study was to determine whether a significant difference existed in the rate of infection after ballistic traumatic arthrotomy managed operatively compared with those managed without surgery., Design: Retrospective cohort study., Setting: Academic Level I Trauma Center., Patient Selection Criteria: Patients with ballistic traumatic arthrotomies of the shoulder, elbow, wrist, hip, knee, or ankle who received operative or nonoperative management., Outcome Measures and Comparisons: The rates of infection and septic arthritis in those who received operative or nonoperative management., Results: One hundred ninety-five patients were studied. Eighty patients were treated nonoperatively (Non-Op group), 16 patients were treated with formal irrigation and debridement in the operating room (I&D group), and 99 patients were treated with formal I&D and open reduction and internal fixation (ORIF) (I&D + ORIF group). Patients in all 3 groups received local wound care and systemic antibiotics. No patients in the Non-Op or I&D group developed an infection. Six patients in the I&D + ORIF group developed extra-articular postoperative infections requiring additional interventions., Conclusions: The infection rate in the I&D + ORIF group was consistent with the infection rates reported in orthopaedic literature after fixation alone. In addition, none of the infections were cases of septic arthritis. This suggests that traumatic arthrotomy does not increase the risk for infection beyond what is expected after fixation alone. Importantly, the Non-Op group represented a series of 80 patients who were treated nonoperatively without developing an infection, indicating that I&D may not be necessary to prevent infection after ballistic arthrotomy. The results suggest that septic arthritis after civilian ballistic arthrotomy is a rare complication regardless of the choice of treatment., Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence., Competing Interests: The authors report no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: To characterize the Orthopaedic Trauma Association Open Fracture Classification (OTA-OFC) and Gustilo-Anderson classification of open extremity fractures and determine if there is meaningful alignment between these grading systems., Design: Retrospective case series., Setting: Level I academic trauma center., Patient Selection Criteria: Adult patients with at least 1 operatively treated open extremity fracture and surgeon-assigned OTA-OFC and Gustilo-Anderson classification., Outcome Measures and Comparisons: Frequency, distribution, and association measures of OTA-OFC category scores and Gustilo-Anderson classification types., Results: Two thousand twenty-seven patients (mean age, 43.1 ± 17.5 years) with 2215 fractures were included. Gustilo-Anderson type I or II fractures (n = 961; 43%) most frequently had the least severe scores for all OTA-OFC categories. Type IIIA fractures (n = 978; 44%) were most often assigned intermediate scores for OTA-OFC Bone Loss (n = 564; 58%). Type IIIB fractures (n = 204, 9%) were most often assigned intermediate OTA-OFC Skin scores (n = 120; 59%). Type IIIC fractures (n = 72; 3%) were most often assigned the most severe OTA-OFC Arterial score (n = 60; 83%). In the multivariable model, OTA-OFC Contamination scores showed little association (β = 0.05; 95% confidence interval [CI], 0.01-0.09) with Gustilo-Anderson classification severity. Conversely, higher OTA-OFC Arterial (β = 0.50; 95% CI 0.44-0.56) and Skin (β = 0.46; 95% CI, 0.40-0.51) scores were strongly associated with more severe Gustilo-Anderson classifications., Conclusions: OTA-OFC Contamination scores were weakly associated with Gustilo-Anderson classification severity for open fractures. The study findings suggest that the current Gustilo-Anderson classification does not adequately account for injury contamination, a known predictor of infection., Level of Evidence: Diagnostic Level IV. See Instructions for Authors for a complete description of levels of evidence., Competing Interests: N.N.O'Hara receives stock options from Arbutus Medical, Inc, unrelated to this research. R.V. O'Toole is a paid consultant for Stryker, receives stock options from Imagen, and receives royalties from Lincotek, all unrelated to this research. G.P. Slobogean receives research funding from the Patient-Centered Outcomes Research Institute, the US Department of Defense, and the National Institutes of Health unrelated to this research; and serves as a paid consultant for Smith & Nephew and Zimmer unrelated to this research. The remaining authors report no conflict of interest. No funding was received for this work., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Optimal strategies to improve national congenital heart surgery outcomes and reduce variability across hospitals remain unclear. Many policy and quality improvement efforts have focused primarily on higher-risk patients and mortality alone. Improving our understanding of both morbidity and mortality and current variation across the spectrum of complexity would better inform future efforts.Methods: Hospitals participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database (2014-2017) were included. Case mix-adjusted operative mortality, major complications, and postoperative length of stay were evaluated using Bayesian models. Hospital variation was quantified by the interdecile ratio (IDR, upper versus lower 10%) and 95% credible intervals (CrIs). Stratified analyses were performed by risk group (Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery [STAT] category) and simulations evaluated the potential impact of reductions in variation.Results: A total of 102 hospitals (n=84 407) were included, representing ≈85% of US congenital heart programs. STAT category 1 to 3 (lower risk) operations comprised 74% of cases. All outcomes varied significantly across hospitals: adjusted mortality by 3-fold (upper versus lower decile 5.0% versus 1.6%, IDR 3.1 [95% CrI 2.5-3.7]), mean length of stay by 1.8-fold (19.2 versus 10.5 days, IDR 1.8 [95% CrI 1.8-1.9]), and major complications by >3-fold (23.5% versus 7.0%, IDR 3.4 [95% CrI 3.0-3.8]). The degree of variation was similar or greater for low- versus high-risk cases across outcomes, eg, ≈3-fold mortality variation across hospitals for STAT 1 to 3 (IDR 3.0 [95% CrI 2.1-4.2]) and STAT 4 or 5 (IDR 3.1 [95% CrI 2.4-3.9]) cases. High-volume hospitals had less variability across outcomes and risk categories. Simulations suggested potential reductions in deaths (n=282), major complications (n=1539), and length of stay (101 183 days) over the 4-year study period if all hospitals were to perform at the current median or better, with 37% to 60% of the improvement related to the STAT 1 to 3 (lower risk) group across outcomes.Conclusions: We demonstrate significant hospital variation in morbidity and mortality after congenital heart surgery. Contrary to traditional thinking, a substantial portion of potential improvements that could be realized on a national scale were related to variability among lower-risk cases. These findings suggest modifications to our current approaches to optimize care and outcomes in this population are needed. [ABSTRACT FROM AUTHOR]

Background: The utility of 30-day risk-standardized readmission rate (RSRR) as a hospital performance metric has been a matter of debate. Home time is a patient-centered outcome measure that accounts for rehospitalization, mortality, and postdischarge care. We aim to characterize risk-adjusted 30-day home time in patients with acute myocardial infarction (AMI) as a hospital-level performance metric and to evaluate associations with 30-day RSRR, 30-day risk-standardized mortality rate (RSMR), and 1-year RSMR.Methods: The study included 984 612 patients with AMI hospitalization across 2379 hospitals between 2009 and 2015 derived from 100% Medicare claims data. Home time was defined as the number of days alive and spent outside of a hospital, skilled nursing facility, or intermediate-/long-term acute care facility 30 days after discharge. Correlations between hospital-level risk-adjusted 30-day home time and 30-day RSRR, 30-day RSMR, and 1-year RSMR were estimated with the Pearson correlation. Reclassification in hospital performance using 30-day home time versus 30-day RSRR and 30-day RSMR was also evaluated.Results: Median hospital-level risk-adjusted 30-day home time was 24.0 days (range, 15.3-29.0 days). Hospitals with higher home time were more commonly academic centers, had available cardiac surgery and rehabilitation services, and had higher AMI volume and percutaneous coronary intervention use during the AMI hospitalization. Of the mean 30-day home time days lost, 58% were to intermediate-/long-term care or skilled nursing facility stays (4.7 days), 30% to death (2.5 days), and 12% to readmission (1.0 days). Hospital-level risk-adjusted 30-day home time was inversely correlated with 30-day RSMR (r=-0.22, P<0.0001) and 30-day RSRR (r=-0.25, P<0.0001). Patients admitted to hospitals with higher risk-adjusted 30-day home time had lower 30-day readmission (quartile 1 versus 4, 21% versus 17%), 30-day mortality rate (5% versus 3%), and 1-year mortality rate (18% versus 12%). Furthermore, 30-day home time reclassified hospital performance status in ≈30% of hospitals versus 30-day RSRR and 30-day RSMR.Conclusions: Thirty-day home time for patients with AMI can be assessed as a hospital-level performance metric with the use of Medicare claims data. It varies across hospitals, is associated with postdischarge readmission and mortality outcomes, and meaningfully reclassifies hospital performance compared with the 30-day RSRR and 30-day RSMR metrics. [ABSTRACT FROM AUTHOR]

Background: Patients with bicuspid aortic valve (AV) stenosis were excluded from the pivotal evaluations of transcatheter AV replacement (TAVR) devices. We sought to evaluate the outcomes of TAVR in patients with bicuspid AV stenosis in comparison with those with tricuspid AV stenosis.Methods: We used data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 through November 2018) to determine device success, procedural outcomes, post-TAVR valve performance, and in-hospital clinical outcomes (mortality, stroke, and major bleeding) according to valve morphology (bicuspid versus tricuspid). Results were stratified by older and current (Sapien 3 and Evolut R) generation valve prostheses. Medicare administrative claims were used to evaluate mortality and stroke to 1 year among eligible individuals (≥65 years).Results: After exclusions, there were 170 959 eligible procedures at 593 sites during the specified interval. Of these, 5412 TAVR procedures (3.2%) were performed in patients with bicuspid AV, including 3705 with current-generation devices. In comparison with patients with tricuspid valves, patients with bicuspid AV were younger and had a lower Society of Thoracic Surgeons Predicted Risk of Operative Mortality score. When current-generation devices were used to treat patients with bicuspid AV, device success increased (93.5 versus 96.3; P=0.001) and the incidence of 2+ aortic insufficiency declined (14.0% versus 2.7%; P<0.001) in comparison with older-generation devices. With current-generation devices, device success was slightly lower in the bicuspid (versus tricuspid) AV group (96.3% in bicuspid versus 97.4% in tricuspid, P=0.07), with a slightly higher incidence of residual moderate or severe aortic insufficiency among patients with bicuspid AV (2.7% versus 2.1%; P<0.001). A lower 1-year adjusted risk of mortality (hazard ratio, 0.88 [95% CI, 0.78-0.99]) was observed for patients with bicuspid AV versus patients with tricuspid AV in the Medicare-linked cohort, whereas no difference was observed in the 1-year adjusted risk of stroke (hazard ratio, 1.14 [95% CI, 0.94-1.39]).Conclusions: Using current-generation devices, procedural, postprocedural, and 1-year outcomes were comparable following TAVR for bicuspid AV versus tricuspid AV disease. With newer-generation devices, TAVR is a viable treatment option for patients with bicuspid AV disease. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this systematic review was to synthesize research completed between 2011 and 2021 to report the current state of the science on the use of standardized patients (SPs) to teach communication skills. The research question that guided this study was, "Among health care professionals, does the use of SP methodology as a means of teaching communication skills result in improved learner knowledge, skills, attitudes, and/or patient outcomes when compared with other simulation methodologies?", Design: This review was reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).Data SourcesFour databases (CINAHL, Ovid Embase, Ovid Medline, and Scopus) were searched using a combination of medical subject headings, or Mesh terms, as well as keywords to retrieve nonindexed citations.Review MethodsThe inclusion criteria were broad to complete a comprehensive search of the literature. To be eligible for inclusion, a study had to be original research that compared simulation using an SP to another simulation methodology. The study had to evaluate communication knowledge, skill, attitude, and/or patient outcome with an academic or practicing health care professional., Results: The initial database search strategy yielded 8058 citations. These results were narrowed down to 18 studies through an in-depth analysis of each article using identified inclusion criteria. The SPs were superior to role play in 1 (33%, n = 3) study where knowledge was evaluated, 6 (75%, n = 8) studies where skills were evaluated, and 1 (20%, n = 5) study where attitude was evaluated. The SPs were compared with a manikin in 5 studies. The SPs were superior to a manikin in 3 (60%, n = 5) studies where knowledge was measured and in 1 (100%, n = 1) study where attitude was measured. No study measured the outcome knowledge of an SP to a manikin. Finally, SPs were compared with a virtual SP in 3 studies. When knowledge was evaluated, SPs were superior to a virtual SP in 1 study (100%, n = 1). When skills were evaluated, SPs were superior to a virtual SP in 1 study (50%, n = 2), and when attitude was evaluated, SPs were superior to a virtual SP in no study (0%, n = 2). No study evaluated patient outcomes in the comparison of an SP to another simulation methodology., Conclusions: Studies show a weak indication that SP-based education is superior to other simulation methodologies in most contexts. However more rigorous studies with larger sample sizes, validated instruments, and effects on patient outcomes are needed to definitively determine the optimal method/modality for teaching communication to health care professionals., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 Society for Simulation in Healthcare.)

Background: With the natural cessation of estrogen, after menopause, women, especially those who are overweight, are at a high risk for cardiovascular disease. Diet control and adequate physical activity (PA) are recommended as the essence of promoting cardiovascular health for women after menopause., Objective: The aim of this study was to examine the effects of a theory-based educational program on health behaviors and cardiovascular health outcomes among overweight postmenopausal Chinese women compared with conventional didactic education., Methods: In this randomized controlled trial, 288 participants were randomly allocated to intervention (n = 144) or control (n = 144) groups. The control group received conventional didactic education. The intervention group received a 3-month theory-based educational program. Primary outcomes were PA and dietary behavior. Secondary outcomes included cardiovascular health knowledge, self-efficacy in PA and diet, and cardiovascular health outcomes. Data were collected at baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)., Results: The intervention group demonstrated significantly greater improvements in PA, dietary behavior, self-efficacy in PA and diet, and several cardiovascular health outcomes (body weight, body mass index, waist circumference, blood pressure, and Framingham risk score [body mass index]) at postintervention compared with the control group (all P s < .05). These significant effects maintained at T2, and the effects on self-efficacy in PA and diet also were maintained at T3., Conclusions: A theory-based educational program may be an effective strategy for improving PA, dietary behavior, self-efficacy in PA and diet, and several cardiovascular health outcomes for overweight postmenopausal Chinese women. However, further strategies are needed to enhance the sustainability of the positive changes., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: Disclosures In the past 3 years, Dr Krumholz received expenses and personal fees from UnitedHealth, Eyedentify, and F-Prime. He is a co-founder of Hugo Health, Refactor Health, and Ensight-AI. He is the editor of Journal Watch: Cardiology of the Massachusetts Medical Society and is a section editor of UpToDate. He is associated with contracts, through Yale New Haven Hospital, from the Centers for Medicare & Medicaid Services and through Yale University from Janssen, Johnson & Johnson Consumer, and Pfizer.

This study aimed to develop a Mobile Application to Prevent Recurrent Stroke to prevent recurrent stroke by enhancing self-management and to evaluate its effects on stroke survivors' health outcomes. The Mobile Application to Prevent Recurrent Stroke was developed based on social cognitive theory and the model in order of analysis, design, development, implementation, and evaluation process. The Mobile Application to Prevent Recurrent Stroke consisted of health management contents such as information about stroke, its associated risk factors, and required skills to conduct self-management with tailored support and counseling. A quasi-experimental preintervention and postintervention design was used involving a total of 54 stroke survivors. The experimental group (n = 27) was provided the Mobile Application to Prevent Recurrent Stroke for 8 weeks, whereas the control group (n = 27) received an education booklet. The result revealed that medication adherence ( P = .002), healthy eating habit ( P < .001), physical activity ( P < .001), and affected-side grip strength ( P = .002) in the experimental group were significantly better than those in the control group. The systolic blood pressure ( P = .020), diastolic blood pressure ( P < .001), body mass index ( P < .001), and waist circumference ( P < .001) in the experimental group were significantly lower than those in the control group. Stroke survivors can easily use this Mobile Application to Prevent Recurrent Stroke to improve self-management. Nurses can provide tailored care based on the lifelogging data of stroke survivors to prevent recurrent stroke., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

According to this study., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Pain catastrophizing has been shown to be a prognostic indicator for pain severity and the co-occurrence of mental health conditions such as depression and post-traumatic stress disorder after whiplash injury. However, the pattern of available findings is limited in its implications for the possible "antecedent" or "causal" role of pain catastrophizing. The purpose of the present study was to examine the temporal relations between pain catastrophizing, pain severity, depressive symptoms, and post-traumatic stress symptoms (PTSS) in individuals receiving treatment for whiplash injury., Materials and Methods: The sample consisted of 388 individuals enrolled in a multidisciplinary program for whiplash injury. Participants completed self-report measures of pain catastrophizing, pain severity, depressive symptoms, and PTSS at the time of admission, mid-treatment (4 week), and treatment completion (7 week). A cross-lagged panel analysis was used to examine the temporal relations between pain catastrophizing, pain severity, depressive symptoms, and PTSS across all 3 timepoints., Results: Model fit was acceptable after the inclusion of modification indices. Pain catastrophizing at the time of admission predicted all other variables at 4 weeks. Pain catastrophizing at 4 weeks also predicted all other variables at 7 weeks. In addition, some bidirectional relations were present, particularly for variables assessed at week 4 and week 7., Discussion: Findings support the view that pain catastrophizing might play a transdiagnostic role in the onset and maintenance of health and mental health conditions. The findings call for greater emphasis on the development of treatment techniques that target pain catastrophizing in intervention programs for whiplash injury., Competing Interests: This research was supported by funds from the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) and the Canada Research Chairs (CRC) Program (Montreal, QC, Canada). M.J.L.S. receives royalties from Mapi Research Trust for licensing fees associated with the use of the Pain Catastrophizing Scale for commercial or funded research applications. C.P. and K.Y. report no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Social distancing has reemerged as a public health measure for containing the spread of COVID-19. This integrative review aims to analyze the historical use of social distancing, the current application during COVID-19, individual factors that affect social distancing practices, and consequential health outcomes. We analyzed relevant literature from searches conducted on Scopus, PubMed, and PsycINFO. We found that resources, culture, age, gender, and personality are associated with the degree to which people practice social distancing. Furthermore, social distancing changes our lifestyles and behavior and results in multifaceted health outcomes, including decreased physical activity and sunlight exposure, increased weight gain, and impaired sleep quality. On the positive side, social distancing has been linked to reduced crime rates and environmental damage, as well as better social and family ties. Future interventions may be utilized to increase adherence to social distancing practices and to mitigate the negative health effects of social distancing., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The CLEFT-Q, a questionnaire developed and validated specifically for cleft patients, contains seven appearance scales. The International Consortium of Health Outcomes Measurement (ICHOM) has incorporated only some CLEFT-Q appearance scales in the Standard Set to minimize burden. This study evaluates which appearance scales provide the most meaningful information in the different cleft types at specific ages, for the most efficient cleft appearance outcome assessment., Methods: Within this international multicenter study, outcomes of the seven appearance scales were collected, either as part of the ICHOM Standard Set, or as part of the field test study performed to validate the CLEFT-Q. Analyses were performed in separate age groups and cleft types, and involved univariate regression analyses, trend analyses, t tests, correlations, and floor and ceiling effects., Results: A total of 3116 patients were included. Scores for most appearance scales showed a downward trend by age group, with the exception of the Teeth and Jaw scales. In all cleft types, several scales correlated strongly with each other. No floor effects were observed, but ceiling effects were found in several scales in different age groups, most often in the CLEFT-Q Jaw scale., Conclusions: A proposition for the most meaningful and efficient appearance outcome assessment in cleft patients is made. It was composed so that recommendations are of value for different cleft protocols and initiatives. Suggestions for the use of scales in the ICHOM Standard Set at different ages are given, and also from a clinical perspective. Use of the CLEFT-Q Scar, Lips, and Nose scales will provide additional relevant information., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Objective: To examine the relationship between coronavirus disease 2019 (COVID-19) diagnosis at delivery and adverse maternal health and pregnancy outcomes during pre-Delta, Delta, and Omicron variant predominance, with a focus on the time period of Omicron variant predominance., Methods: We conducted a cross-sectional observational study with data from delivery hospitalizations in the Premier Healthcare Database from February 2020 to August 2023. The pre-Delta (February 2020-June 2021), Delta (July 2021-December 2021), and Omicron (January 2022-August 2023) periods of variant predominance were examined. Exposure to COVID-19 was identified by having a diagnostic code for COVID-19 during the delivery hospitalization. Adjusted prevalence ratios (aPRs) were calculated to compare the risks of adverse maternal and pregnancy outcomes for women with and without COVID-19 diagnoses at the time of delivery for each variant period., Results: Among 2,990,973 women with delivery hospitalizations, 1.9% (n=56,618) had COVID-19 diagnoses noted at delivery admission discharge, including 26,053 during the Omicron period. Across all variant time periods, the prevalence of many adverse maternal and pregnancy outcomes during the delivery hospitalization was significantly higher for pregnant women with COVID-19 compared with pregnant women without COVID-19. In adjusted models, COVID-19 during the Omicron period was associated with significant increased risks for maternal sepsis (COVID-19: 0.4% vs no COVID-19: 0.1%; aPR 3.32, 95% CI, 2.70-4.08), acute respiratory distress syndrome (0.6% vs 0.1%; aPR 6.19, 95% CI, 5.26-7.29), shock (0.2% vs 0.1%; aPR 2.14, 95% CI, 1.62-2.84), renal failure (0.5% vs 0.2%; aPR 2.08, 95% CI, 1.73-2.49), intensive care unit admission (2.7% vs 1.7%; aPR 1.64, 95% CI, 1.52-1.77), mechanical ventilation (0.3% vs 0.1%; aPR 3.15, 95% CI, 2.52-3.93), in-hospital death (0.03% vs 0.01%; aPR 5.00, 95% CI, 2.30-10.90), stillbirth (0.7% vs 0.6%; aPR 1.17, 95% CI, 1.01-1.36), and preterm delivery (12.3% vs 9.6%; aPR 1.28, 95% CI, 1.24-1.33)., Conclusion: Despite the possibility of some level of immunity due to previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, vaccination, or testing differences, risks of adverse outcomes associated with COVID-19 diagnosis at delivery remained elevated during the Omicron variant time period., Competing Interests: Financial Disclosure Regina M. Simeone disclosed previously owning Pfizer stock. Jeffrey Carlson disclosed previously owning Moderna stock. Laura Riley disclosed being an author for Up to Date (HSV, Rubella, Parvovirus), consultant to GSK and Pfizer, and consulted on Medscape education module. The other authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Pregnancy stress, anxiety, and depression increase the risk of short-term and long-term health problems for the mother and fetus. Mindfulness-based intervention (MBI) is one of the most popular, nonpharmacological interventions used to treat mental health problems. The results of prior research indicate MBI has a less consistent effect on mental health problems in pregnant women., Purpose: The purpose of this systematic review and meta-analysis was to clarify and determine the effect of MBI on mental health outcomes in pregnant women., Methods: Six databases, including Embase, Ovid MEDLINE, CINAHL, EBSCOhost, Cochrane Library, and ScienceDirect, were searched from their dates of inception to November 2021. Google Scholar was also used for the literature inquiry. The inclusion criteria followed the PICO (Patient/Problem, Intervention, Comparison, and Outcome) model in terms of only including studies that used mindfulness therapy, reported mental health outcomes, and applied randomized controlled trial and quasi-experimental approaches. The Cochrane risk of bias tool was applied to evaluate the quality of the studies. Review Manager 5 software with random effect with a standardized mean difference (SMD) was used to analyze level of effect., Results: Thirteen studies (10 randomized controlled trials and three quasi-experimental studies) were included. MBI was found to have a small effect on mental health outcomes in pregnant women (p < .0001, SMDs = -0.48, 95% CI [-0.74, -0.22], I2 = 87%). Specifically, MBI had moderate effects on stress and anxiety (SMDs = -0.59, 95% CI [-1.09, -0.09], and SMDs = -0.55, 95% CI [-1.00, -0.10], respectively) and no significant effect on depression (SMDs = -0.33, 95% CI [-0.74, 0.08])., Conclusions: MBIs have a small but notable effect on mental health in pregnant women. The high heterogeneity found in this review may reflect the different types and durations of interventions used. Notably, none of the studies in the review examined intervention effects by trimester. Future research should use larger sample sizes and assess the effects of therapy for each trimester of pregnancy., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc.)

Objectives: To develop, evaluate, and explore the use of a pediatric ordinal score as a potential clinical trial outcome metric in children hospitalized with acute hypoxic respiratory failure caused by viral respiratory infections., Design: We modified the World Health Organization Clinical Progression Scale for pediatric patients (CPS-Ped) and assigned CPS-Ped at admission, days 2-4, 7, and 14. We identified predictors of clinical improvement (day 14 CPS-Ped ≤ 2 or a three-point decrease) using competing risks regression and compared clinical improvement to hospital length of stay (LOS) and ventilator-free days. We estimated sample sizes (80% power) to detect a 15% clinical improvement., Setting: North American pediatric hospitals., Patients: Three cohorts of pediatric patients with acute hypoxic respiratory failure receiving intensive care: two influenza (pediatric intensive care influenza [PICFLU], n = 263, 31 sites; PICFLU vaccine effectiveness [PICFLU-VE], n = 143, 17 sites) and one COVID-19 ( n = 237, 47 sites)., Interventions: None., Measurements and Main Results: Invasive mechanical ventilation rates were 71.4%, 32.9%, and 37.1% for PICFLU, PICFLU-VE, and COVID-19 with less than 5% mortality for all three cohorts. Maximum CPS-Ped (0 = home at respiratory baseline to 8 = death) was positively associated with hospital LOS ( p < 0.001, all cohorts). Across the three cohorts, many patients' CPS-Ped worsened after admission (39%, 18%, and 49%), with some patients progressing to invasive mechanical ventilation or death (19%, 11%, and 17%). Despite this, greater than 76% of patients across cohorts clinically improved by day 14. Estimated sample sizes per group using CPS-Ped to detect a percentage increase in clinical improvement were feasible (influenza 15%, n = 142; 10%, n = 225; COVID-19, 15% n = 208) compared with mortality ( n > 21,000, all), and ventilator-free days (influenza 15%, n = 167)., Conclusions: The CPS-Ped can be used to describe the time course of illness and threshold for clinical improvement in hospitalized children and adolescents with acute respiratory failure from viral infections. This outcome measure could feasibly be used in clinical trials to evaluate in-hospital recovery., Competing Interests: Drs. Newhams, Young, Maddux, Hall, Coates, Kong, Nofziger, Cullinmore, Halasa, Schuster, Gertz, Hume, and Randolph’s (contracts 75D30119C05584 and 75D30120C07725) institutions received funding from the U.S. Centers for Disease Control and Prevention (CDC). Drs. Newhams and Randolph’s institutions received funding from the National Institute of Allergy and Infectious Diseases. Drs. Newhams, Nofziger, Cvijanovich, Flori, and Randolph (AI084011 and AI154470) received support for article research from the National Institutes of Health (NIH). Dr. Khemani received funding from Orange Med/Nihon Kohden and Bayer Pharmaceutical. Dr. Marshall’s institution received funding from the Canadian Institutes of Health Research; he received funding from AM-Pharma and Adrenomed. Drs. Maddux, Kong, Nofziger, Cullimore, Cvijanovich, Schuster, Flori, and Hume’s institutions received funding from the NIH. Dr. Hall received funding from Abbvie, Kiadis, and the American Board of Pediatrics. Dr. Coates’ institution received funding from the National Heart, Lung, and Blood Institute (NHLBI), the American Lung Association, the American Thoracic Society, and the Doris Duke Foundation/Walder Foundation; she received funding from Sobi and Triplett Woolf Garretson LLC. Drs. Kong, Nofziger, Cullimore, Gertz, and Hume received support for article research from the CDC. Drs. Thomas and Cvijanovich’s institution received funding from Boston Children’s Hospital. Dr. Thomas received funding from Bayer AG. Dr. Halasa’s institution received funding from Sanofi and Quidel. Dr. Cvijanovich’s institution received funding from the Cincinnati Children’s Hospital Medical Center. Dr. Shuster’s institution received funding from the AAMC; she received funding from the AAP Department of Health and Human Services. Dr. Flori received funding from Nota Laboratories and Lucira Health; she disclosed that they are a commissioner for a Lancet Child Health report and that they worked as an expert for the NIH-funded pediatric acute respiratory distress syndrome Master Protocol development. Drs. Olson and Patel disclosed government work. Dr. Randolph received funding from UpToDate, Inc. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)

Objective: This study aimed to estimate the age-specific probability of 4 health outcomes in a large registry of individuals with spina bifida (SB)., Methods: The association between age and 4 health outcomes was examined in individuals with myelomeningocele (MMC, n = 5627) and non-myelomeningocele (NMMC, n = 1442) from the National Spina Bifida Patient Registry. Sixteen age categories were created, 1 for each year between the ages of 5 and 19 years and 1 for those aged 20 years or older. Generalized linear models were used to calculate the adjusted probability and 95% prediction intervals of each outcome for each age category, adjusting for sex and race/ethnicity., Results: For the MMC and NMMC groups, the adjusted coefficients for the correlation between age and the probability of each outcome were -0.933 and -0.657 for bladder incontinence, -0.922 and -0.773 for bowel incontinence, 0.942 and 0.382 for skin breakdown, and 0.809 and 0.619 for lack of ambulation, respectively., Conclusion: In individuals with SB, age is inversely associated with the probability of bladder and bowel incontinence and directly associated with the probability of skin breakdown and lack of ambulation. The estimated age-specific probabilities of each outcome can help SB clinicians estimate the expected proportion of patients with the outcome at specific ages and explain the probability of the occurrence of these outcomes to patients and their families., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Mental health can be negatively affected if work and private life demands are not balanced. This study proposes exploring work-life balance (WLB) as a predictor of Generation Z's mental health outcomes., Methods: A cross-sectional online study was conducted to collect data on mental health outcomes and WLB from a sample of Generation Z (N = 134). Three regression models were calculated to examine the predictive effect of WLB on stress, anxiety, and depressive symptoms., Results: The results show a strong statistically significant association between all three mental health outcomes. The regression model suggests work-life balance as a predictor of stress (β =.-0.404 P = 0.001, R2 = 0.16) and anxiety (β = .-256 P = 0.001, R2 = 0.06)., Conclusion: WLB must be considered a significant factor in mental health problems among Generation Z., Competing Interests: Hanft-Robert, Adedeji, Langel, Feick, Greibaum, and Rahimi have no relationships/conditions/circumstances that present potential conflict of interest., (Copyright © 2023 American College of Occupational and Environmental Medicine.)

Purpose of Review: High-cervical spinal cord stimulation can alter cortical activity and cerebral metabolism. These effects are potentially beneficial for disorders of consciousness. A better understanding of the effects of clinical application of stimulation is needed. We aimed to evaluate the existing literature to determine the state of available knowledge. We performed a literature review of clinical studies assessing cervical spinal cord epidural stimulation for disorders of consciousness. Only peer-reviewed articles reporting preoperative and postoperative clinical status were included., Recent Findings: Nineteen studies were included. A total of 532 cases were reported, and 255 patients were considered responsive (47.9%). Considering only studies published after the definition of minimally conscious state (MCS) as an entity, 402 individuals in unresponsive wakefulness syndrome (UWS) and 113 in MCS were reported. Responsiveness to SCS was reported in 170 UWS patients (42.3%) and in 78 MCS cases (69.0%), although the criteria for responsiveness and outcome measures varied among publications., Summary: Cervical SCS yielded encouraging results in patients with disorders of consciousness and seems to be more effective in MCS. More extensive investigation is needed to understand its potential role in clinical practice., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

PCORnet, the National Patient-Centered Clinical Research Network, provides the ability to conduct prospective and observational pragmatic research by leveraging standardized, curated electronic health records data together with patient and stakeholder engagement. PCORnet is funded by the Patient-Centered Outcomes Research Institute (PCORI) and is composed of 8 Clinical Research Networks that incorporate at total of 79 health system "sites." As the network developed, linkage to commercial health plans, federal insurance claims, disease registries, and other data resources demonstrated the value in extending the networks infrastructure to provide a more complete representation of patient's health and lived experiences. Initially, PCORnet studies avoided direct economic comparative effectiveness as a topic. However, PCORI's authorizing law was amended in 2019 to allow studies to incorporate patient-centered economic outcomes in primary research aims. With PCORI's expanded scope and PCORnet's phase 3 beginning in January 2022, there are opportunities to strengthen the network's ability to support economic patient-centered outcomes research. This commentary will discuss approaches that have been incorporated to date by the network and point to opportunities for the network to incorporate economic variables for analysis, informed by patient and stakeholder perspectives. Topics addressed include: (1) data linkage infrastructure; (2) commercial health plan partnerships; (3) Medicare and Medicaid linkage; (4) health system billing-based benchmarking; (5) area-level measures; (6) individual-level measures; (7) pharmacy benefits and retail pharmacy data; and (8) the importance of transparency and engagement while addressing the biases inherent in linking real-world data sources., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

The aims of this study were to determine the prevalence of frailty and its relationship with health outcomes in elderly outpatients attending a Diabetes Specialist Clinic. This study was a cross-sectional study. A total of 168 elderly patients (aged 65 years and above) attending the Diabetes Specialist Clinic of a Three-A hospital of Sichuan province were recruited from January 2021 to February 2021, and follow-up was conducted 1 year after day of screening. Baseline characteristics of patients were collected and frail status were assessed at recruitment. The longitudinal outcomes included hospitalization, fall, mortality, emergency visit, and clinic visit. The presence of frailty was determined by the 5-item FRAIL scale, which ranges from 0 to 5 and are categorized as frail (3-5), prefrail (1-2), and robust (0). A phone questionnaire was carried out to obtain health outcomes. Logistic regression analyses was used to evaluate adverse health outcomes at 1 year follow-up. Of the 168 outpatients, 28.0% was robust, 49.4% was prefrail, and 22.6% was frail. Frailty (both prefrail and frail status) was more prevalent in those patients, which were 75 years old and above (57.0%; P < .001), insulin dependent (45.6%; P = .008), and those had diabetic complications (43.8%; P = .005), previous admission (68.6%; P = .016), and co-morbidities (36.4%; P = .001). In the following year after recruitment, 19.1% of robust patients were hospitalized, while the proportion was 45.8% for prefrail patients and 65.8% for frail patients. Prefrail (OR [odds ratio] = 2.35, 95% confidence interval (CI) 1.63-2.88; P = .028) and frail (OR = 4.63, 95% CI 2.52-5.81; P = .005) patients were more likely to be hospitalized. Frail (OR = 3.37, 95% CI 2.68-4.04; P < .001) patients were more inclined to fall while prefrail patients (OR = 1.03, 95% CI 0.82-1.56; P = .371) were not. Moreover, prefrail (OR = 3.37, 95% CI 2.31-5.72; P = .017) and frail (OR = 4.29, 95% CI 3.16-5.54; P = .006) patients were more likely to return to the clinic. There is a high incidence of frailty among elderly patients attending a Diabetes Specialist Clinic. Frailty is a predictor of hospitalization, fall, and clinic visits within 1 year., Competing Interests: The authors have no funding and conflicts of interest to disclose., (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Dorsal hump deformity is prevalent in Caucasians because of their nasal structure. The dorsal preservation techniques became more popular in recent years. However, there is still not a clear solution for patients who have nasal hump deformity and a wide nasal roof. The present study aims defining a new technique that combines push-down or let-down procedures with ostectomy in patients who have nasal hump deformity and a wide nasal roof. In the present research, the records of patients were assessed retrospectively. The patients who had nasal hump deformity and who have undergone either push-down or let-down approaches were included. The push-down or let-down techniques used in this study involved ostectomy to reduce the nasal hump and narrow the nasal roof. The initial median Rhinoplasty Outcome Evaluation score before surgery was 57.5, which significantly improved to 93.00 points at 12 months after surgery ( P <0.001). The study suggests that experienced surgeons using push-down and let-down techniques can achieve better esthetic results in patients with a wide nasal roof., Competing Interests: The author reports no conflicts of interest., (Copyright © 2023 by Mutaz B. Habal, MD.)

Background: Research examining the effects of historical redlining on present-day health outcomes is often complicated by the misalignment of contemporary census boundaries with the neighborhood boundaries drawn by the US Home Owners' Loan Corporation (HOLC) in the 1930s. Previous studies have used different approaches to assign historical HOLC grades to contemporary geographies, but how well they capture redlining exposure is unknown., Methods: Our analysis included 7711 residences identified in the Multiple Listing Service database in Atlanta, Georgia (2017-2022). We evaluated the classification of HOLC grade assignment (A, B, C, D, or ungraded) when assigning exposure under four area-level approaches (centroid, majority land area, weighted score, and highest HOLC) compared with using complete address data (gold standard). We additionally compared approaches across three 2020 census geographies (tract, block group, and block)., Results: When comparing the use of census tracts to complete address data, sensitivity was highest for the weighted score approach, which correctly identified 77% of residences in truly A-D graded neighborhoods as compared with the majority land area (44%), centroid (54%), and highest HOLC (59%) approaches. Regarding specificity, the majority land area approach best-classified residences in truly ungraded neighborhoods (93%) as compared with the weighted score (65%), centroid (81%), and highest HOLC (54%) approaches. Classification improved regardless of approach when using census block compared with the census tract., Conclusions: Misclassification of historical redlining exposure is inevitable when using contemporary census geographies rather than complete address data. This study provides a framework for assessing spatial misalignment and selecting an approach for classification., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The aim of this study is to define and assess Ideal Outcome in the national or multicenter registries of North America, Germany, the Netherlands, and Sweden., Background: Assessing outcomes after pancreatoduodenectomy among centers and countries requires a broad evaluation that cannot be captured by a single parameter. Previously, 2 composite outcome measures (textbook outcome and optimal pancreatic surgery) for pancreatoduodenectomy have been described from Europe and the United States. These composites were harmonized into ideal outcome (IO)., Methods: This analysis is a transatlantic retrospective study (2018-2020) of patients after pancreatoduodenectomy within the registries from North America, Germany, The Netherlands, and Sweden. After 3 consensus meetings, IO for pancreatoduodenectomy was defined as the absence of all 6 parameters: (1) in-hospital mortality, (2) severe complications-Clavien-Dindo ≥3, (3) postoperative pancreatic fistula-International Study Group of Pancreatic Surgery (ISGPS) grade B/C, (4) reoperation, (5) hospital stay >75th percentile, and (6) readmission. Outcomes were evaluated using relative largest difference (RLD) and absolute largest difference (ALD), and multivariate regression models., Results: Overall, 21,036 patients after pancreatoduodenectomy were included, of whom 11,194 (54%) reached IO. The rate of IO varied between 55% in North America, 53% in Germany, 52% in The Netherlands, and 54% in Sweden (RLD: 1.1, ALD: 3%, P <0.001). Individual components varied with an ALD of 2% length of stay, 4% for in-hospital mortality, 12% severe complications, 10% postoperative pancreatic fistula, 11% reoperation, and 9% readmission. Age, sex, absence of chronic obstructive pulmonary disease, body mass index, performance status, American Society of Anesthesiologists (ASA) score, biliary drainage, absence of vascular resection, and histologic diagnosis were associated with IO. In the subgroup of patients with pancreatic adenocarcinoma, country, and neoadjuvant chemotherapy also was associated with improved IO., Conclusions: The newly developed composite outcome measure "Ideal Outcome" can be used for auditing and comparing outcomes after pancreatoduodenectomy. The observed differences can be used to guide collaborative initiatives to further improve the outcomes of pancreatic surgery., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)