Design and methods of the StepByStep randomized trial of a mobile health and social media physical activity intervention among adolescent and young adult survivors of childhood cancer: A report from the Children's Oncology Group.

BACKGROUND: Interventions to increase physical activity are needed in adolescent and young adult survivors of childhood cancer who are largely inactive but at lifelong elevated risk of multiple chronic conditions improved by physical activity. The goals of the StepByStep study are to evaluate the effects of a 48-week distance-based, multi-component mobile health and social media behavioral intervention on physical activity, biomarkers of cardiometabolic health, and health-related quality of life. METHODS: This ongoing study is a two-arm, prospective, multi-site randomized controlled trial. 384 childhood cancer survivors age ≥ 15 years and < 21 years who were 3-36 months off therapy and not meeting physical activity guidelines were enrolled. The trial will test the efficacy of a 24-week intensive multi-component physical activity intervention combining a wearable physical activity tracker, social media peer support group, and individualized goal setting followed by a 24-week maintenance phase of the intervention to improve outcomes. The control group receives the wearable physical activity tracker only. CONCLUSION: There is a growing need for novel, developmentally appropriate interventions to increase physical activity and improve the health trajectory of adolescent and young adult survivors of childhood cancer. If efficacious, this portable and scalable intervention would be a much-needed tool to reduce the morbidity from cancer treatment and improve quality of life among survivors after treatment ends. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04089358; COG Identifier: ALTE2031.

Effect of Rabbit ATG PK on Outcomes after TCR-αß/CD19-depleted Pediatric Haploidentical HCT for Hematologic Malignancy.

We hypothesized that inferior disease-free survival (DFS) seen in older patients undergoing αß/CD19-T-cell depleted (AB-TCD) haploidentical hematopoietic cell transplantation (HCT) for patients with hematologic malignancies was due to excessive exposure to rabbit antithymocyte globulin (rATG; Thymoglobulin®). Between 2015-2023, 163 patients with a median age of 13 years (range, 0.4-27.4) underwent AB-TCD haploidentical HCT for treatment of ALL (n=98), AML/MDS (n=49), or other malignancies (n=16) at nine centers on two prospective trials. Exposures of rATG pre- and post-HCT were predicted with a validated pharmacokinetic (PK) model. ROC curves were used to identify optimal target windows of rATG exposure related to outcomes. We identified four quadrants of rATG exposure - quadrant 1 (n=52): high pre-HCT AUC (≥50 AU*day/mL) and low post-HCT (<12 AU*day/L); quadrant 2 (n=47): both low pre-HCT and post-HCT AUCs, quadrant 3 (n=13): low pre-HCT AUC and high post-HCT, and quadrant 4 (n=51): both high pre- and post-HCT AUCs. Quadrant 1 had a 3-year DFS of 86.5% (95% CI, 76.3-96.7%), compared to quadrant 2 (64.6%; 95% CI, 49.1-80.1%), quadrant 3 (32.9%; 95% CI, 0.1-80.5%) or quadrant 4 (48.2%; 95% CI, 22.1-63.3%) (p<0.001). Adjusted regression analysis demonstrated additional factors associated with increased hazard for worse DFS: MRD-positivity (HR=2.45; 1.36-4.41; p=0.003) and CMV R+/D- serostatus (HR=3.33; 1.8-6.16; p<0.001). Non-optimal rATG exposure exhibited the strongest effect in unadjusted (HR=4.24; 1.79-10.03; p=0.001) and adjusted (MRD status or CMV serostatus) analyses (HR=3.84, 1.63-9.05; p=0.002). High exposure to rATG post-HCT is associated with inferior DFS following AB-TCD haploidentical HCT for pediatric patients with hematologic malignancies. Model-based dosing of rATG to achieve optimal exposure may improve DFS. Clinical trials: NCT02646839 & NCT04337515.

Comparing Bayesian hierarchical meta-regression methods and evaluating the influence of priors for evaluations of surrogate endpoints on heterogeneous collections of clinical trials.

BACKGROUND: Surrogate endpoints, such as those of interest in chronic kidney disease (CKD), are often evaluated using Bayesian meta-regression. Trials used for the analysis can evaluate a variety of interventions for different sub-classifications of disease, which can introduce two additional goals in the analysis. The first is to infer the quality of the surrogate within specific trial subgroups defined by disease or intervention classes. The second is to generate more targeted subgroup-specific predictions of treatment effects on the clinical endpoint. METHODS: Using real data from a collection of CKD trials and a simulation study, we contrasted surrogate endpoint evaluations under different hierarchical Bayesian approaches. Each approach we considered induces different assumptions regarding the relatedness (exchangeability) of trials within and between subgroups. These include partial-pooling approaches, which allow subgroup-specific meta-regressions and, yet, facilitate data adaptive information sharing across subgroups to potentially improve inferential precision. Because partial-pooling models come with additional parameters relative to a standard approach assuming one meta-regression for the entire set of studies, we performed analyses to understand the impact of the parameterization and priors with the overall goals of comparing precision in estimates of subgroup-specific meta-regression parameters and predictive performance. RESULTS: In the analyses considered, partial-pooling approaches to surrogate endpoint evaluation improved accuracy of estimation of subgroup-specific meta-regression parameters relative to fitting separate models within subgroups. A random rather than fixed effects approach led to reduced bias in estimation of meta-regression parameters and in prediction in subgroups where the surrogate was strong. Finally, we found that subgroup-specific meta-regression posteriors were robust to use of constrained priors under the partial-pooling approach, and that use of constrained priors could facilitate more precise prediction for clinical effects in trials of a subgroup not available for the initial surrogacy evaluation. CONCLUSION: Partial-pooling modeling strategies should be considered for surrogate endpoint evaluation on collections of heterogeneous studies. Fitting these models comes with additional complexity related to choosing priors. Constrained priors should be considered when using partial-pooling models when the goal is to predict the treatment effect on the clinical endpoint.

Effect of carvedilol versus placebo on cardiac function in anthracycline-exposed survivors of childhood cancer (PREVENT-HF): a randomised, controlled, phase 2b trial.

BACKGROUND: Carvedilol improves cardiac function in patients with heart failure but remains untested as cardioprotective therapy in long-term childhood cancer survivors (ie, those who have completed treatment for childhood cancer and are in remission) at risk for heart failure due to high-dose anthracycline exposure. We aimed to evaluate the activity and safety of low-dose carvedilol for heart failure risk reduction in childhood cancer survivors at highest risk for heart failure. METHODS: PREVENT-HF was a randomised, double-blind, phase 2b trial done at 30 hospitals in the USA and Canada. Patients were eligible if they had any cancer diagnosis that resulted in at least 250 mg/m2 cumulative exposure to anthracycline by age 21 years; completed their cancer treatment at least 2 years previously; an ejection fraction of at least 50% or fractional shortening of at least 25%, or both; and bodyweight of at least 40 kg. Patients were randomly assigned (1:1) with automated computer-generated permuted block randomisation (block size of 4), stratified by age at diagnosis, time since diagnosis, and history of chest-directed radiotherapy, to carvedilol (up-titrated from 3·125 g per day to 12·5 mg per day) or placebo orally for 2 years. Participants, staff, and investigators were masked to study group allocation. The primary endpoint was to establish the effect of carvedilol on standardised left ventricular wall thickness-dimension ratio Z score (LVWT/Dz). Treatment effects were analysed with a linear mixed-effects model for normally distributed data with a linear time effect and testing the significance of treatment*time interaction in the modified intention-to-treat (mITT) cohort (ie, all randomly assigned participants who had a baseline and at least one subsequent echocardiogram measurement). Safety was assessed in the ITT population (ie, all randomly assigned participants). This trial was registered with ClinicalTrials.gov, NCT027175073, and enrolment and follow-up are complete. FINDINGS: Between July 3, 2012, and June 22, 2020, 196 participants were enrolled, of whom 182 (93%) were eligible and randomly assigned to either carvedilol (n=89) or placebo (n=93; ITT population). Median age was 24·7 years (IQR 19·6-36·6), 91 (50%) participants were female, 91 (50%) were male, and 119 (65%) were non-Hispanic White. As of data cutoff (June 10, 2022), median follow-up was 725 days (IQR 378-730). 151 (n=75 in the carvedilol group and n=76 in the placebo group) of 182 participants were included in the mITT population, among whom LVWT/Dz was similar between the two groups (-0·14 [95% CI -0·43 to 0·16] in the carvedilol group vs -0·45 [-0·77 to -0·13] in the placebo group; difference 0·31 [95% CI -0·10 to 0·73]; p=0·14). Two (2%) of 89 patients in the carvedilol group two adverse events of grade 2 or higher (n=1 shortness of breath and n=1 arthralgia) and none in the placebo group. There were no adverse events of grade 3 or higher and no deaths. INTERPRETATION: Low-dose carvedilol appears to be safe in long-term childhood cancer survivors at risk for heart failure, but did not result in significant improvement of LVWT/Dz compared with placebo. These results do not support the use of carvedilol for secondary heart failure prevention in anthracycline-exposed childhood cancer survivors. FUNDING: National Cancer Institute, Leukemia & Lymphoma Society, St Baldrick's Foundation, Altschul Foundation, Rally Foundation, American Lebanese Syrian Associated Charities.

Handling missing within-study correlations in the evaluation of surrogate endpoints.

Rigorous evaluation of surrogate endpoints is performed in a trial-level analysis in which the strength of the association between treatment effects on the clinical and surrogate endpoints is quantified across a collection of previously conducted trials. To reduce bias in measures of the performance of the surrogate, the statistical model must account for the sampling error in each trial's estimated treatment effects and their potential correlation. Unfortunately, these within-study correlations can be difficult to obtain, especially for meta-analysis of published trial results where individual patient data is not available. As such, these terms are frequently partially or completely missing in the analysis. We show that improper handling of these missing terms can meaningfully alter the perceived quality of the surrogate and we introduce novel strategies to handle the missingness.

A meta-analysis of GFR slope as a surrogate endpoint for kidney failure.

Glomerular filtration rate (GFR) decline is causally associated with kidney failure and is a candidate surrogate endpoint for clinical trials of chronic kidney disease (CKD) progression. Analyses across a diverse spectrum of interventions and populations is required for acceptance of GFR decline as an endpoint. In an analysis of individual participant data, for each of 66 studies (total of 186,312 participants), we estimated treatment effects on the total GFR slope, computed from baseline to 3 years, and chronic slope, starting at 3 months after randomization, and on the clinical endpoint (doubling of serum creatinine, GFR < 15 ml min-1 per 1.73 m2 or kidney failure with replacement therapy). We used a Bayesian mixed-effects meta-regression model to relate treatment effects on GFR slope with those on the clinical endpoint across all studies and by disease groups (diabetes, glomerular diseases, CKD or cardiovascular diseases). Treatment effects on the clinical endpoint were strongly associated with treatment effects on total slope (median coefficient of determination (R2) = 0.97 (95% Bayesian credible interval (BCI) 0.82-1.00)) and moderately associated with those on chronic slope (R2 = 0.55 (95% BCI 0.25-0.77)). There was no evidence of heterogeneity across disease. Our results support the use of total slope as a primary endpoint for clinical trials of CKD progression.

Change in Albuminuria and GFR Slope as Joint Surrogate End Points for Kidney Failure: Implications for Phase 2 Clinical Trials in CKD.

SIGNIFICANCE STATEMENT: Changes in albuminuria and GFR slope are individually used as surrogate end points in clinical trials of CKD progression, and studies have demonstrated that each is associated with treatment effects on clinical end points. In this study, the authors sought to develop a conceptual framework that combines both surrogate end points to better predict treatment effects on clinical end points in Phase 2 trials. The results demonstrate that information from the combined treatment effects on albuminuria and GFR slope improves the prediction of treatment effects on the clinical end point for Phase 2 trials with sample sizes between 100 and 200 patients and duration of follow-up ranging from 1 to 2 years. These findings may help inform design of clinical trials for interventions aimed at slowing CKD progression. BACKGROUND: Changes in log urinary albumin-to-creatinine ratio (UACR) and GFR slope are individually used as surrogate end points in clinical trials of CKD progression. Whether combining these surrogate end points might strengthen inferences about clinical benefit is unknown. METHODS: Using Bayesian meta-regressions across 41 randomized trials of CKD progression, we characterized the combined relationship between the treatment effects on the clinical end point (sustained doubling of serum creatinine, GFR <15 ml/min per 1.73 m 2 , or kidney failure) and treatment effects on UACR change and chronic GFR slope after 3 months. We applied the results to the design of Phase 2 trials on the basis of UACR change and chronic GFR slope in combination. RESULTS: Treatment effects on the clinical end point were strongly associated with the combination of treatment effects on UACR change and chronic slope. The posterior median meta-regression coefficients for treatment effects were -0.41 (95% Bayesian Credible Interval, -0.64 to -0.17) per 1 ml/min per 1.73 m 2 per year for the treatment effect on GFR slope and -0.06 (95% Bayesian Credible Interval, -0.90 to 0.77) for the treatment effect on UACR change. The predicted probability of clinical benefit when considering both surrogates was determined primarily by estimated treatment effects on UACR when sample size was small (approximately 60 patients per treatment arm) and follow-up brief (approximately 1 year), with the importance of GFR slope increasing for larger sample sizes and longer follow-up. CONCLUSIONS: In Phase 2 trials of CKD with sample sizes of 100-200 patients per arm and follow-up between 1 and 2 years, combining information from treatment effects on UACR change and GFR slope improved the prediction of treatment effects on clinical end points.

Evaluation of Variation in the Performance of GFR Slope as a Surrogate End Point for Kidney Failure in Clinical Trials that Differ by Severity of CKD.

BACKGROUND: The GFR slope has been evaluated as a surrogate end point for kidney failure in meta-analyses on a broad collection of randomized controlled trials (RCTs) in CKD. These analyses evaluate how accurately a treatment effect on GFR slope predicts a treatment effect on kidney failure. We sought to determine whether severity of CKD in the patient population modifies the performance of GFR slope. METHODS: We performed Bayesian meta-regression analyses on 66 CKD RCTs to evaluate associations between effects on GFR slope (the chronic slope and the total slope over 3 years, expressed as mean differences in ml/min per 1.73 m2/yr) and those of the clinical end point (doubling of serum creatinine, GFR <15 ml/min per 1.73 m2, or kidney failure, expressed as a log-hazard ratio), where models allow interaction with variables defining disease severity. We evaluated three measures (baseline GFR in 10 ml/min per 1.73 m2, baseline urine albumin-to-creatinine ratio [UACR] per doubling in mg/g, and CKD progression rate defined as the control arm chronic slope, in ml/min per 1.73 m2/yr) and defined strong evidence for modification when 95% posterior credible intervals for interaction terms excluded zero. RESULTS: There was no evidence for modification by disease severity when evaluating 3-year total slope (95% credible intervals for the interaction slope: baseline GFR [-0.05 to 0.03]; baseline UACR [-0.02 to 0.04]; CKD progression rate [-0.07 to 0.02]). There was strong evidence for modification in evaluations of chronic slope (95% credible intervals: baseline GFR [0.02 to 0.11]; baseline UACR [-0.11 to -0.02]; CKD progression rate [0.01 to 0.15]). CONCLUSIONS: These analyses indicate consistency of the performance of total slope over 3 years, which provides further evidence for its validity as a surrogate end point in RCTs representing varied CKD populations.

Characteristics of Nonelderly Adult Health Care Persistent Super Utilizers in Utah.

In the United States, the top 1% and top 5% of health care spenders account for 23% and 50% of total health care spending, respectively. These high spenders have been coined the term super utilizers (SU). The aim of this study was to identify the characteristics associated with these patients to aid in developing public health interventions aimed at transitioning patients out of the SU category and thus ultimately helping to control health care costs. The authors utilized the Utah All-Payer Claims Database and Utah Population Database from 2013 to 2015 to identify demographics, comorbid conditions, health care utilization, and cost characteristics of persistent super utilizers (PSU) (≥3 hospitalizations per year for 3 years) of health care compared with persistent nonsuper utilizers (PNSU) (<3 hospitalizations per year for 3 years). Multivariable logistic regression was utilized to identify the characteristics associated with PSU versus PNSU. Higher outpatient/Emergency Department/noninpatient (eg, visits with imaging and Centers for Medicare & Medicaid Services preventive visits) health care utilization and spending, and prevalence of comorbid disease and psychosocial conditions were associated with PSU. In multivariable analysis, factors such as heart disease, chronic kidney disease (CKD), diabetes, alcohol abuse, and depression were statistically significantly associated with higher odds of PSU, with the most noteworthy being CKD (odds ratio [OR] 6.85, 95% confidence interval [95% CI] 5.84-8.02; P < 0.001), alcohol abuse (OR 5.90, 95% CI 4.49-7.69; P < 0.001), and heart diseases (OR 4.41, 95% CI 3.74-5.18; P < 0.001). The annual health care cost of a PSU is about 11.5 times greater than a PNSU ($54,776 vs. $4801; P < 0.001).

Patient-reported opioid use for tissue expander-based breast reconstruction.

INTRODUCTION: There is limited evidence for appropriate post-operative opioid prescribing in breast reconstruction patients. We sought to describe postoperative outpatient prescription opioid use patterns (quantity and duration) following discharge after immediate breast reconstruction with tissue expanders (TE) and to identify demographic and/or clinical risk factors associated with postoperative outpatient opioid use. METHODS: Patients 18 years and older undergoing immediate TE-based breast reconstruction were given a 28-day postoperative pain medication log book. Descriptive statistics were performed to describe the quantity and duration of opioid use. Preoperative, intraoperative, and postoperative characteristics were examined and tested for their associations with postoperative opioid use. RESULTS: A total of 45 logbooks were completed. On average, patients used opioids for 7.42 days (SD = 6.45) after discharge home and used 15.9 (SD = 18.71) oxycodone 5 mg tablet equivalents (119.3 morphine milligram equivalents, SD = 140.31). The total number of oxycodone 5 mg equivalents consumed prior to discharge was associated with the amount of post-discharge opioid consumption (IRR=1.08, p<0.01). Each additional year of age was associated with a reduction in the days-to-opioid cessation by a factor of 0.97 (p=0.01). Each additional oxycodone 5mg equivalent consumed prior to hospital discharge was associated with an increase in the days-to-cessation after discharge by a factor of 1.04 (p=0.026). CONCLUSIONS: These patient-reported data will provide a benchmark which plastic surgeons can use to minimize narcotic use in patients and will help prevent issues of dependence, misuse, and diversion, while being mindful of adequate pain control. For patients discharging home after a one-night stay for immediate TE breast reconstruction, we recommend a prescription for 10 oxycodone 5 mg tablets, or 15 tablets if they are less than age 49 or have had high inpatient opioid use. Patients should also be counseled that the expected duration of outpatient opioid use is 7-11 days, and that 20 % of patients did not use any opioids following hospital discharge, making nonnarcotic pain regimens a real possibility.

A Comparison of Common Plastic Surgery Operations Using the NSQIP and TOPS Databases.

Both the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) and the American Society of Plastic Surgeons Tracking Operations and Outcomes for Plastic Surgeons (TOPS) databases track 30-day outcomes. METHODS: Using the 2008-2016 TOPS and NSQIP databases, we compared patient characteristics and postoperative outcomes for 5 common plastic surgery procedures. A weighted TOPS population was used to mirror the NSQIP population in clinical and demographic characteristics to compare postoperative outcomes. RESULTS: We identified 154,181 cases. Compared with NSQIP patients, TOPS patients were more likely to be younger (47.9 versus 50.0 years), have American Society of Anesthesiologists class I-II (92.1% versus 74.6%), be outpatient (66.0% versus 49.3%), and be smokers (18.7% versus 11.7%). TOPS had extensive missing data: body mass index (40.6%), American Society of Anesthesiologists class (34.9%), diabetes (39.3%), and smoking status (37.2%). NSQIP was missing <1% of all shared categories except race (15.6%). The entire TOPS cohort versus only TOPS patients without missing data had higher rates of dehiscence (5.1% versus 3.5%) and infection (2.1% versus 1.7%). TOPS versus NSQIP patients had higher dehiscence rates (5.1% versus 1.0%) but lower rates of return to the operating room (3.1% versus 6.6%), infection (2.1% versus 3.0%), and medical complications (0.3% versus 2.2%). Nonweighted and weighted TOPS cohorts had similar 30-day outcomes. CONCLUSIONS: NSQIP and TOPS populations are different in characteristics and outcomes, likely due to differences in collection methodology and the types physicians using the databases. The strengths of each dataset can be used together for research and quality improvement.

A Nationwide Analysis of Early and Late Readmissions following Free Tissue Transfer for Breast Reconstruction.

BACKGROUND: Traditionally, surgical quality outcomes are assessed using a 30-day postoperative window. For breast cancer patients undergoing free tissue transfer for breast reconstruction, we sought to describe the distribution of and specific risk factors for early and late readmissions within a 0- to 90-day postoperative period. PATIENTS AND METHODS: The Nationwide Readmissions Database was used to conduct a retrospective cohort study. Breast cancer patients undergoing free tissue transfer for breast reconstruction were identified using International Classification of Diseases -9 diagnosis and procedure codes. Ninety-day readmissions related to infection or wound complications were identified. Univariable and multivariable logistic regression models were used to identify patient risk factors for readmissions that occurred early (0-30 days) and late (31-90 days) after their index procedure. RESULTS: In the weighted sample, we identified approximately 7,305 free flap breast reconstructions and a surgical wound-related readmission rate of 4.3% (n = 312): 65.4% of the readmissions occurred early while 34.6% occurred late after surgery. The mean days to readmission was 26, and 75% of all readmissions occurred within the first 36 days after surgery. Variables independently associated with readmissions during the 0- to 90-day postoperative period included: history of chronic obstructive pulmonary disease (p = 0.036), hypertension (p = 0.03), obesity (p ≤ 0.001), and history of smoking (p = 0.004). The variables independently associated with the early readmission period were the same as those identified for the 0- to 90-day postoperative period. The variables independently associated with late readmissions were different: history of depression (p = 0.001) and history of smoking (p = 0.001). CONCLUSION: The conventional 30-day hospital readmission rate classically used as a quality metric is overlooking a significant portion of admissions after free flap-based breast reconstruction. Different variables were found to be associated with readmission in the early versus late cohorts. Interventions targeting these variables could decrease readmissions and their associated costs.

The Rate of Infectious Complications After Intrathecal Drug Delivery System Implant for Cancer-Related Pain Is Low Despite Frequent Concurrent Anticancer Treatment or Leukopenia.

BACKGROUND: The efficacy of intrathecal drug delivery (IDD) for cancer-related pain is well established. Cancer therapies are often associated with immunosuppression and increased risk of infection, and the rate of infection after intrathecal drug delivery system (IDDS) implant in cancer patients has been reported as 2.4%-6.3%. Our objective is to report on the rate of surgical site infections (SSI) in patients implanted with IDDS for cancer-related pain and to provide a data-driven discussion on the relationship between antineoplastic treatment, leukopenia, and other clinical or demographic characteristics and SSI. METHODS: Following local institutional review board approval, we conducted a retrospective chart review of IDDS implants from May 2014 through December 2018. Data collected included demographic data, health status, prophylactic antibiotic administration, surgery duration, presence of leukopenia (white blood cell [WBC] count of <4.0 K/µL) or moderate neutropenia (absolute neutrophil count [ANC] of <1000/µL) within the 30 days before IDDS implant, and details of antineoplastic treatment or systemic corticosteroid use in the perioperative period. This information was assessed in relation to SSI incidence up to 6 months following implant. RESULTS: Two hundred seventeen IDDS implants were identified. A majority of patients (79.3%) received ≥1 form of antineoplastic therapy within 30 days before or after implant, and 42.4% received multiple forms of antineoplastic therapy. Therapies included chemotherapy in 46.5%, immunotherapy in 28.6%, systemic steroids in 32.3%, and radiation therapy in 28.1%. One-quarter of patients (25.8%) were leukopenic within 30 days before implant, with 3.2% having moderate neutropenia. There were 2 infectious complications representing an infection rate of 0.9% (95% CI, 0.1%-3.3%), with limited shared characteristics between those experiencing SSI. CONCLUSIONS: SSI risk after IDDS placement for cancer pain is low, despite frequent concurrent antineoplastic therapy and leukopenia in the perioperative period. Concomitant cancer therapies should not be a barrier to the implementation of IDD for cancer pain.

Examining the relationship between epidural steroid injections and patient satisfaction.

BACKGROUND CONTEXT: Hospitals and policy makers have placed increasing importance on patient satisfaction with medical care. Minimal research exists on patient satisfaction in the context of epidural steroid injections (ESIs) for radicular pain. PURPOSE: Describe patient satisfaction with ESIs for the treatment of radicular pain and identify patient demographic and clinical characteristics associated with patient satisfaction. STUDY DESIGN/SETTING: This was a retrospective study conducted at a large, academic medical center. METHODS: This was a single-center retrospective study of prospectively collected registry data including patients treated with ESIs from August 2006 to May 2018. The primary outcomes were: overall Press Ganey (PG) score, patient satisfaction with the physician, and likelihood to recommend both the physician and the practice. Age, body mass index, Charlson Comorbidity Index, immediate change in pain, sex, spinal segmental level of injection, prior opioid use, insurance status, and ethnicity were compared with the four PG measures of satisfaction using both univariable and multivariable regression analysis. No sources of funding were used for this project. The authors report no conflict of interest in relation to this manuscript. RESULTS: Two-hundred ninety patients underwent 377 injections. Overall, patients were highly satisfied; 86% recommend their physician and 85% recommend the practice, each with the highest possible PG score. The median overall PG score was 97.2 (interquartile range [IQR]: 89.3, 100), and the median physician satisfaction score was 100 (IQR: 95, 100). The median immediate reduction in pain was 3 points (IQR: -5,-2) on the numerical rating scale scale postinjection. Increased age was associated with increased satisfaction with the physician (reported rate ratios [Relative Risk (RR)] for dissatisfaction: 0.73, 95% confidence interval [CI]: 0.58, 0.93, p=.011) and increased likelihood to recommend the physician (odds ratio: 1.46, 95% CI: 1.06, 2.01, p=.022) in multivariable analysis. Medicare as opposed to private insurance was associated with higher dissatisfaction with the physician (RR: 2.04, 95% CI: 1.15, 3.61, p=.014) and decreased likelihood to recommend the practice (RR: 0.38, 95% CI: 0.15, 0.94, p=.037). CONCLUSIONS: The present data, based on PG scores, demonstrated that ESIs are associated with greater patient satisfaction with increasing age, but lower satisfaction in patients with Medicare compared with private insurance when controlling for other demographic factors. Satisfaction was not associated with the degree of pain relief.

2011 ACGME Duty Hour Limits had No Association With Breast Reconstruction Complications.

BACKGROUND: In 2011, the Accreditation Council for Graduate Medical Education (ACGME) instituted further duty hour restrictions in response to concerns over long work hours and sleep deprivation in trainees and their effects on patient outcomes. The effect of duty hour restrictions on complications after breast reconstruction procedures has not been clarified. MATERIALS AND METHODS: A retrospective cross-sectional analysis was designed. The National Inpatient Sample database was queried in the 2 y before and 2 y after the 2011 duty hour changes. Patients undergoing breast reconstruction, the most common elective admission diagnosis for plastic surgery patients, were selected for analysis. Patient groups were separated by teaching hospitals (THs) and nonteaching hospitals and by pre- and post-ACGME change periods. Surgical complication rates, length of stay, and procedures were analyzed using complex survey-weighted univariate and multivariate logistic regression analysis, with additional sensitivity analysis applied. RESULTS: The number of procedures did not vary significantly in the period after duty hour restrictions in THs (n = 46,188, pre-ACGME versus n = 48,980, post-ACGME). Overall complication rates in teaching (9.54%, pre-ACGME versus 9.04%, post-ACGME; P = 0.561) and nonteaching hospitals (8.54%, pre-ACGME versus 7.70%, post-ACGME; P = 0.319) did not significantly change after the implementation of duty hour changes. On multivariate analysis, surgery performed in resident THs after duty hour changes was not associated with a significant change in overall (odds ratio [OR], 1.03; 95% confidence interval [95% CI], 0.77-1.37; P = 0.857) breast-specific complications (OR, 1.06; 95% CI, 0.77-1.46; P = 0.731) or general complications (OR, 1.11; 95% CI, 0.80-1.54; P = 0.541). CONCLUSIONS: Duty hour restrictions enacted in 2011 were not associated with postoperative complications after breast reconstruction.

Direct Comparison of Patient-completed and Physician-completed Caprini Scores for Plastic Surgery Patients.

We examined the ability of plastic surgery patients to perform their own venous thromboembolism (VTE) risk stratification using a previously validated patient-completed Caprini risk scoring sheet. METHODS: Patients' Caprini scores were obtained by an attending physician at an office visit through interview and chart review. Subsequently, patients independently completed a previously validated patient reported scoring sheet. We compared patient and physician reported Caprini scores by each Caprini subquestion and by the overall score. We described discordance of scores using frequencies and proportions, quantified the level of agreement using Cohen's Kappa coefficient, Spearman's correlation coefficient, and the Wilcoxon rank-sum test, and visualize scoring differences using Bland-Altman plots, where appropriate. RESULTS: We prospectively enrolled 50 patients. Only 24% (n = 12) of patients had exact matches in physician-completed and patient-completed Caprini scores. Among the 76% (n = 38) with discrepancies, 26 received a higher patient-reported score (median = 2 points, range 1-8 points) and 12 received a lower patient-reported score (median = -1.5 points, range -1 to -6 points). Existing venous thromboembolism prophylaxis guidelines support chemical prophylaxis for inpatients with Caprini scores ≥7. Among 38 patients with score discrepancies, 8 (21.1%) would have been incorrectly prescribed chemical prophylaxis and 4 (10.5%) would have been incorrectly denied chemical prophylaxis. CONCLUSIONS: Plastic surgery patients cannot reliably calculate their own 2005 Caprini scores. Reliance on patient completed scores alone would promote ~25% of patients receiving inappropriate prophylaxis strategies.

Are 30-Day Outcomes Enough? Late Infectious Readmissions following Prosthetic-Based Breast Reconstruction.

BACKGROUND: Surgical-site infection is a major concern in prosthetic-based breast reconstruction. Thirty-day postoperative readmission rates are a common quality metric, but little is known about readmission rates for later infections. METHODS: Using the 2013 to 2014 Nationwide Readmissions Database, the authors identified breast cancer patients undergoing breast reconstruction with implants and tissue expanders who had an infectious readmission. The authors used univariate and multivariate logistic regression models to identify predictors of infectious readmission and explantation within the early (0 to 30 days) and late (31 to 90 days) postoperative periods. RESULTS: In the weighted sample, the authors identified 18,338 patients undergoing prosthetic-based breast reconstruction. The overall infectious readmission rate was 4.1 percent (n = 759): 49.3 percent occurred early and 50.7 percent occurred late. Of the infectious readmissions, 39.5 percent required explantation, 55.1 percent of which occurred during a late infectious readmission. Seventy-five percent of these infectious readmissions and explantations occurred within 49 days of initial surgery. Median annual household income less than $40,000 (p = 0.035), diabetes (p = 0.038), and obesity (p = 0.004) were independent predictors of infectious readmission. Diabetes (p = 0.049) and hypertension (p = 0.011) were independent predictors of early readmission. Median annual household income less than $40,000 (p = 0.049), obesity (p = 0.006), and increasing length of stay during the index procedure (p = 0.028) were independent predictors of late readmission. No statistically significant independent predictors for explantation were identified. CONCLUSIONS: Traditional 30-day readmission rates are not an adequate quality metric for breast reconstruction given the number of late postoperative readmissions, many of which lead to explantation. Early and late infectious readmissions have different predictors. Interventions targeting these predictors may decrease the number of readmissions, thus reducing cost and improving quality. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

A national analysis of readmissions for wound healing complications following the repair of lower back, hip, and buttock pressure ulcers using the Nationwide Readmissions Database.

BACKGROUND: Traditionally, a 30-day postoperative period is used to assess outcomes in surgery. However, it is not clear if this is sufficient. Our study assessed readmissions and their risk factors following the surgical repair of pressure ulcers in a 90-day postoperative period. METHODS: Patients with a pressure ulcer to the lower back, hip, and/or buttocks who underwent a pedicled or flap based wound operation were identified in the National Readmissions Database. We then analyzed risk factors for overall 0-90-day readmissions, early readmissions (0-30 days), and late-readmissions (31-90 days). RESULTS: 3329 patients were identified, of which 154 (4.66%) had surgical wound-related readmissions. A majority of these occurred after 30 days (53.89%). 90% of patients with a surgical-wound related readmission were readmitted within 63 days of index procedure. CONCLUSIONS: The traditional 30-day outcome period is not enough to properly assess outcomes in pressure ulcer surgery such as readmission. We demonstrate that a period of at least 10 weeks and perhaps the entire global 90-day postoperative period would be more appropriate to evaluate readmissions after ulcer repair.