Systematic Review of Surgical Care in the Incarcerated Population: Identifying Knowledge Gaps for Future Research.

Objective: This study, examining literature up to December 2023, aims to comprehensively assess surgical care for incarcerated individuals, identifying crucial knowledge gaps for informing future health services research and interventions. Background: The US prison system detains around 2 million individuals, mainly young, indigent males from ethnic and racial minorities. The constitutional right to healthcare does not protect this population from unique health challenges and disparities. The scarcity of literature on surgical care necessitates a systematic review to stimulate research, improve care quality, and address health issues within this marginalized community. Methods: A systematic review, pre-registered with the International Prospective Register of Systematic Reviews (CRD42023454782), involved searches in PubMed, Embase, and Web of Science. Original research on surgical care for incarcerated individuals was included, excluding case reports/series (<10 patients), abstracts, and studies involving prisoners of war, plastic surgeries for recidivism reduction, transplants using organs from incarcerated individuals, and nonconsensual surgical sterilization. Results: Out of 8209 studies screened, 118 met inclusion criteria, with 17 studies from 16 distinct cohorts reporting on surgical care. Predominantly focusing on orthopedic surgeries, supplemented by studies in emergency general, burns, ophthalmology, and kidney transplantation, the review identified delayed hospital presentations, a high incidence of complex cases, and low postoperative follow-up rates. Notable complications, such as nonfusion and postarthroplasty infections, were more prevalent in incarcerated individuals compared with nonincarcerated individuals. Trauma-related mortality rates were similar, despite lower intraabdominal injuries following penetrating abdominal injuries in incarcerated patients. Conclusion: While some evidence suggests inferior surgical care in incarcerated patients, the limited quality of available studies underscores the urgency of addressing knowledge gaps through future research. This is crucial for patients, clinicians, and policymakers aiming to enhance care quality for a population at risk of surgical complications during incarceration and postrelease.

Evaluating the psychometric properties of the Hispanic Stress Inventory-2 Simplified version among a diverse sample of Latinos who smoke.

OBJECTIVE: Acculturation stress can negatively impact Latinos immigrant mental and physical health related behaviors such as smoking. It is essential to have validated and updated instruments that allow the evaluation of acculturation stress on this population. This study aims to evaluate the psychometric properties of an abbreviated version of the Hispanic Stress Inventory Version 2 (HSI2) immigration scale among Latinos who smoke. METHODS: The study consisted of a secondary data analysis from a baseline assessment of Decídetexto, a mobile health (mHealth) smoking cessation randomized clinical trial. Of 457 Latinos included in the parent study, 352 immigrants who smoke were included. Construct validity was analyzed by completing a Pearson correlation coefficient matrix. Structural validity was analyzed using an Exploratory Factor Analysis (EFA). Cronbach alpha analysis was used to estimate the internal consistency of the items constituting a factor. RESULTS: The results included an abbreviated version of the HSI2 including 52 items. From the Pearson correlation coefficient matrix with a cutoff point of 0.4, 22 of the 52 items were excluded. From the Pearson correlation coefficient matrix with a cutoff point of 0.4, 22 items were excluded. Exploratory Factor Analysis (EFA) results in six factors extracted, explaining 69.1% of the variance. According to the EFA, two items were relocated in different factors from the original scale. The HSI2 30 items scale reflected excellent reliability with a Cronbach's alpha coefficient of 0.93. The six factors reflect acceptable to excellent reliability, ranging from 0.77-0.93 across factors. The median for the HSI2 total score was 34.00 (25-45) out of a possible total score of 150. CONCLUSION: Results confirmed acceptable psychometric properties of the HSI2 simplified 30-item version and provided a reliable and shorter measure of acculturation stress for Latinos groups. Having a valid and reduced measure of acculturation stress is the first step in understanding diverse ethnic groups of Latinos that are at higher risk of presenting health risk behaviors such as smoking. The present results provided the possibility of assessing the impact of acculturation stress among adults who smoke.

Development and validation of multivariable predictive models for recurrence and mortality following nonoperative management of sigmoid volvulus.

AIM: Sigmoid volvulus is a challenging condition, and deciding between elective surgery or expectant management can be complex. The aim of this study was to develop a tool for predicting the risk of recurrent sigmoid volvulus and all-cause mortality within 1 year following initial nonoperative management. METHOD: This is a retrospective cohort study using Medicare claims data from 2016 to 2018 of beneficiaries admitted urgently/emergently for volvulus, undergoing colonic decompression and discharged alive without surgery (excluding those discharged to hospice). The primary outcomes were recurrent sigmoid volvulus and all-cause mortality within 1 year. Proportional hazards models and logistic regression were employed to identify risk factors and develop prediction equations, which were subsequently validated. RESULTS: Among the 2078 patients managed nonoperatively, 36.1% experienced recurrent sigmoid volvulus and 28.6% died within 1 year. The prediction model for recurrence integrated age, sex, race, palliative care consultations and four comorbidities, achieving area under the curve values of 0.63 in both the training and testing samples. The model for mortality incorporated age, palliative care consultations and nine comorbidities, with area under the curve values of 0.76 in the training and 0.70 in the testing sample. CONCLUSION: This study provides a straightforward predictive tool that utilizes easily accessible data to estimate individualized risks of recurrent sigmoid volvulus and all-cause mortality for older adults initially managed nonoperatively. The tool can assist clinicians and patients in making informed decisions about such risks. While the accuracy of the calculator was validated, further confirmation through external validation and prospective studies would enhance its clinical utility.

Are Black and Latino adolescents being asked if they use electronic cigarettes and advised not to use them? Results from a community-based survey.

Objective: This study aimed to explore whether African American/Black and Hispanic/Latino adolescents are being asked about electronic cigarette (e-cigarette) use (vaping) and advised not to use them. Methods: In 2021, adolescents (N = 362) with no vaping history, self-identified as African American/Black and/or Hispanic/Latino, and able to read and speak English and/or Spanish were recruited through partner schools and community-based organizations. Participants completed a survey reporting sociodemographic characteristics (e.g., race/ethnicity, gender, and language of preference) and they were asked about e-cigarette use and/or were advised not to use them by a health professional. Results: In total, 12% of African American/Black and 5% of Hispanic/Latino participants reported not seeing a health professional in the year prior to enrollment. Of the participants who reported visiting a health professional, 50.8% reported being asked and advised about vaping. Over one-quarter (28.4%) of participants were neither asked nor advised regarding vaping. Compared to English-speaking participants, Spanish-speaking participants were significantly less likely to be asked about e-cigarette use (45.2 vs. 63.9%, p = 0.009) and advised not to use them (40.3 vs. 66.9%, p < 0.001). Moreover, compared to African American/Black participants, Hispanic/Latino participants were significantly less likely to be advised not to use e-cigarettes (52.9 vs. 68.6%, p = 0.018). Furthermore, compared to male participants, female participants were significantly less likely to be advised not to use e-cigarettes (51.3 vs. 68.2%, p = 0.003). Conclusion: Compared to English-speaking participants, Spanish-speaking participants were significantly less likely to self-report being asked about e-cigarette use and advised not to use them. Moreover, Hispanic/Latino and female adolescents were significantly less likely to self-report being advised not to use e-cigarettes compared to their Black/African American and male counterparts. Future research is needed to improve health professional attention toward asking about and advising against vaping among adolescents.

Association of Medicare Mandatory Bundled Payment Reform With Joint Replacement Surgery Use for Beneficiaries With Alzheimer Disease and Related Dementias.

Importance: Medicare beneficiaries with Alzheimer disease and related dementias (ADRD) are a particularly vulnerable group in whom arthritis is a frequently occurring comorbidity. Medicare's mandatory bundled payment reform-the Comprehensive Care for Joint Replacement (CJR) model-was intended to improve quality and reduce spending in beneficiaries undergoing joint replacement surgical procedures for arthritis. In the absence of adjustment for clinical risk, hospitals may avoid performing elective joint replacements for beneficiaries with ADRD. Objective: To evaluate the association of the CJR model with utilization of joint replacements for Medicare beneficiaries with ADRD. Design Setting and Participants: This cohort study used national Medicare data from 2013 to 2017 and multivariable linear probability models and a triple differences estimation approach. Medicare beneficiaries with a diagnosis of arthritis were identified from 67 metropolitan statistical areas (MSAs) mandated to participate in CJR and 104 control MSAs. Data were analyzed from July 2020 to July 2021. Exposures: Implementation of the CJR model in 2016. Main Outcomes and Measures: Outcomes were separate binary indicators for whether or not a beneficiary underwent hip or knee replacement. Key independent variables were the MSA group, before-CJR and after-CJR phase, ADRD diagnosis, and their interactions. The linear probability models controlled for beneficiary characteristics, MSA fixed effects, and time trends. Results: The study included 24 598 729 beneficiary-year observations for 9 624 461 unique beneficiaries, of which 250 168 beneficiaries underwent hip and 474 751 underwent knee replacements. The mean (SD) age of the 2013 cohort was 77.1 (7.9) years, 3 110 922 (66.4%) were women, 3 928 432 (83.8%) were non-Hispanic White, 792 707 (16.9%) were dually eligible for Medicaid, and 885 432 (18.9%) had an ADRD diagnosis. Before CJR implementation, joint replacement rates were lower among beneficiaries with ADRD (hip replacements: 0.38% vs 1.17% for beneficiaries with and without ADRD, respectively; P < .001; knee replacements: 0.70% vs 2.25%; P < .001). After controlling for relevant covariates, CJR was associated with a 0.07-percentage-point decline in hip replacements for beneficiaries with ADRD (95% CI, -0.13 to -0.001; P = .046) and a 0.07-percentage-point decline for beneficiaries without ADRD (95% CI, -0.12 to -0.02; P = .01) residing in CJR MSAs compared with beneficiaries in control MSAs. However, this change in hip replacement rates for beneficiaries with ADRD was not statistically significantly different from the change for beneficiaries without ADRD (percentage point difference: 0.01; 95% CI, -0.08 to 0.09; P = .88). No statistically significant changes in knee replacement rates were noted for beneficiaries with ADRD compared with those without ADRD with CJR implementation (percentage point difference: -0.03, 95% CI, -0.09 to 0.02; P = .27). Conclusions and Relevance: In this cohort study of Medicare beneficiaries with arthritis, the CJR model was not associated with a decline in joint replacement utilization among beneficiaries with ADRD compared with beneficiaries without ADRD in the first 2 years of the program, thereby alleviating patient selection concerns.

Evaluating the Immediate Impact of Graphic Messages for Vaping Prevention among Black and Latino Adolescents: A Randomized Controlled Trial.

The purpose of this pilot study was to assess the immediate impact of vaping prevention graphic messages on the susceptibility to future vaping among Black and Latino adolescents (ages 12 to 17). Graphic messages (available in English and Spanish) were developed using participatory research procedures with Black and Latino adolescents. Recruitment was conducted by a team of diverse, bilingual (English and Spanish), trained recruiters. Participants (n = 362) were randomized in a 1:1:1:1 schema to receive one of four graphic messages (health rewards, financial rewards, autonomy, and social norms). Overall, all graphic messages but one showed a slight decrease in the number of participants susceptible to future vaping, though none of these differences was statistically significant. The graphic message on health rewards decreased the number of participants susceptible to future vaping the most (55.7% vs. 50%, at pre- vs. post-viewing, p = 0.125), followed by the graphic messages on social norms and autonomy (55.1% vs. 52.8%, p = 0.687; 55.4% vs. 52.2%, p = 0.435; respectively). The graphic message on financial rewards increased the number of participants susceptible to future vaping slightly (52.7% vs. 53.8%, p = 1.00). Future research is needed to evaluate susceptibility to future vaping before and after exposure to different and/or repeated vaping prevention graphic messages.

Proactive and Reactive Recruitment of Black and Latino Adolescents in a Vaping Prevention Randomized Controlled Trial.

The purpose of this study was to assesses the effectiveness of proactive and reactive methods in the recruitment of Black and Latino adolescents into a vaping-prevention randomized controlled trial (RCT). This study also assessed the characteristics of study participants by recruitment method. Proactive recruitment strategies included study presentations at community-based events (e.g., festivals, health fairs), school-based events (e.g., back-to-school events, after-school programs), and recreational centers (e.g., fitness centers, malls). Reactive recruitment strategies included study advertisements via social media (e.g., Facebook posts shared by local community-based organizations), word of mouth, and an academic-based research hub. Using proactive and reactive methods, in a 4-month period, 362 Black and Latino adolescents were successfully enrolled into the RCT. Compared to the proactive method, adolescents screened reactively were equally likely to be eligible but significantly more likely to enroll in the study. However, both proactive and reactive strategies made notable contributions to the overall recruitment effort. Moreover, proactive and reactive methods attracted adolescents with different characteristics (e.g., age, gender, sexual orientation, etc.). These findings suggest that both proactive and reactive recruitment strategies should be implemented for studies interested in recruiting a diverse sample of Black and Latino adolescents.

Height and Extremity-Length Prediction for Healthy Children Using Age-Based Versus Peak Height Velocity Timing-Based Multipliers.

BACKGROUND: The age-based multiplier method described by Paley et al. markedly simplifies height and limb length predictions but may not adequately accommodate children's maturational differences. Multipliers can be derived relative to any maturity measure. This study compares Paley age-based multipliers with those based on peak height velocity (PHV) timing. METHODS: In a longitudinal cohort of healthy children (66 male and 70 female), actual adult heights and limb lengths were compared with the measurements predicted using the Paley multipliers and multipliers developed relative to PHV timing. The age-based multipliers (adult divided by current) in our series were compared with those reported by Paley et al. to ensure that there were no systematic differences between the series. Absolute differences between the actual and predicted adult heights and limb lengths and the standard deviations of those differences were compared between the 2 methods. RESULTS: The average age-based multipliers in our series were nearly identical to those reported by Paley et al. The differences between the predicted and actual adult values showed wide ranges when either the Paley or the PHV multipliers were used during infancy. The Paley method performed better than the PHV method throughout pre-growth-spurt childhood. The PHV-timing-derived multipliers became superior as children entered their growth spurt, whereas the performance of the age-based multipliers worsened. In adolescence, the maximum standard deviation for adult-height-prediction errors with use of the Paley multipliers occurred at the age of 13.5 years for boys and 11.5 years for girls and was 7.0 cm for boys and 5.6 cm for girls. For limb lengths, the maximum standard deviations occurred 6 months earlier and were 3.9 cm for boys and 3.2 cm for girls. The maximum standard deviation for the height prediction error with the age-based method occurred at the average time of PHV for the population. The PHV method became better than the Paley method just before growth-spurt initiation, at age 8 in girls and 11 in boys. CONCLUSIONS: The age-based multipliers described by Paley et al. are superior to PHV-timing-based multipliers prior to the adolescent growth spurt for predicting height. They become less predictive, with wide standard deviations, as children enter their growth spurts, and PHV-derived multipliers become superior. The Paley height multipliers should be used before the age of 8 years in girls and 11 years in boys. After this, PHV-derived multipliers are superior for height and limb length prediction. In practice, these predictions are currently made using skeletal maturity, which is closely related to PHV during adolescence.

Association of Mandatory Bundled Payments for Joint Replacement With Postacute Care Outcomes Among Medicare and Medicaid Dual Eligible Patients.

IMPORTANCE: The Medicare comprehensive care for joint replacement (CJR) model, a mandatory bundled payment program started in April 2016 for hospitals in randomly selected metropolitan statistical areas (MSAs), may help reduce postacute care (PAC) use and episode costs, but its impact on disparities between Medicaid and non-Medicaid beneficiaries is unknown. OBJECTIVE: To determine effects of the CJR program on differences (or disparities) in PAC use and outcomes by Medicare-Medicaid dual eligibility status. DESIGN, SETTING, AND PARTICIPANTS: Observational cohort study of 2013-2017, based on difference-in-differences (DID) analyses on Medicare data for 1,239,452 Medicare-only patients, 57,452 dual eligibles with full Medicaid benefits, and 50,189 dual eligibles with partial Medicaid benefits who underwent hip or knee surgery in hospitals of 75 CJR MSAs and 121 control MSAs. MAIN OUTCOME MEASURES: Risk-adjusted differences in rates of institutional PAC [skilled nursing facility (SNF), inpatient rehabilitation, or long-term hospital care] use and readmissions; and for the subgroup of patients discharged to SNF, risk-adjusted differences in SNF length of stay, payments, and quality measured by star ratings, rate of successful discharge to community, and rate of transition to long-stay nursing home resident. RESULTS: The CJR program was associated with reduced institutional PAC use and readmissions for patients in all 3 groups. For example, it was associated with reductions in 90-day readmission rate by 1.8 percentage point [DID estimate=-1.8; 95% confidence interval (CI), -2.6 to -0.9; P<0.001] for Medicare-only patients, by 1.6 percentage points (DID estimate=-1.6; 95% CI, -3.1 to -0.1; P=0.04) for full-benefit dual eligibles, and by 2.0 percentage points (DID estimate=-2.0; 95% CI, -3.6 to -0.4; P=0.01) for partial-benefit dual eligibles. These CJR-associated effects did not differ between dual eligibles (differences in above DID estimates=0.2; 95% CI, -1.4 to 1.7; P=0.81 for full-benefit patients; and -0.3; 95% CI, -1.9 to 1.3; P=0.74 for partial-benefit patients) and Medicare-only patients. Among patients discharged to SNF, the CJR program showed no effect on successful community discharge, transition to long-term care, or their persistent disparities. CONCLUSIONS: The CJR program did not help reduce persistent disparities in readmissions or SNF-specific outcomes related to Medicare-Medicaid dual eligibility, likely due to its lack of financial incentives for reduced disparities and improved SNF outcomes.

Geographic Variation and Disparities in Total Joint Replacement Use for Medicare Beneficiaries: 2009 to 2017.

BACKGROUND: Little is known about how the geographic variation and disparities in use of elective primary total hip and knee replacements for Medicare beneficiaries have evolved in recent years. The study objectives are to determine these variations and disparities, whether Black Medicare beneficiaries have continued to undergo fewer total hip replacements and total knee replacements across regions, and whether disparities affected all Black beneficiaries or mainly affected socioeconomically disadvantaged Black beneficiaries. METHODS: We used 2009 to 2017 Medicare enrollment and claims data to examine Hospital Referral Region (HRR)-level variation and disparities by race (non-Hispanic White and Black) and socioeconomic status (Medicare-only and dual eligibility for both Medicare and Medicaid). The outcomes were HRR-level age and sex-standardized total hip replacement and total knee replacement utilization rates for White Medicare-only beneficiaries, White dual-eligible beneficiaries, Black Medicare-only beneficiaries, and Black dual-eligible beneficiaries, and the differences in rates between these groups as a representation of disparities. The key exposure variables were race-socioeconomic group and year. We constructed multilevel mixed-effects linear regression models to estimate trends in total hip replacement and total knee replacement rates and to examine whether rates were lower in HRRs with high percentages of Black beneficiaries or dual-eligible beneficiaries. RESULTS: The study included 924,844 total hip replacements and 2,075,968 total knee replacements. In 2017, the mean HRR-level total hip replacement rate was 4.64 surgical procedures per 1,000 beneficiaries, and the mean HRR-level total knee replacement rate was 9.66 surgical procedures per 1,000 beneficiaries, with a threefold variation across HRRs. In 2017, the total hip replacement rate was 32% higher for White Medicare-only beneficiaries and 48% higher for Black Medicare-only beneficiaries than in 2009 (p < 0.001). However, because the surgical rates for White and Black dual-eligible beneficiaries remained unchanged over the study period, the 2017 Medicare-only and dual-eligible disparity for White beneficiaries increased by 0.75 surgical procedures per 1,000 from 2009 (40.98% increase; p = 0.03), and the disparity for Black beneficiaries by 1.13 surgical procedures per 1,000 beneficiaries (297.37% increase; p < 0.001). The total knee replacement disparities remained unchanged. Notably, the rates for White dual-eligible beneficiaries were significantly lower than those for Black Medicare-only beneficiaries (p < 0.001 for both total hip replacements and total knee replacements), and fewer surgical procedures were conducted in HRRs with a higher density of Black or dual-eligible beneficiaries. CONCLUSIONS: Although the total hip replacement use for Medicare-only beneficiaries of both races increased, disparities for White and Black dual-eligible beneficiaries (compared with their Medicare-only counterparts) are increasing. Efforts to improve equity must identify and address both racial and socioeconomic barriers and focus on regions with high concentrations of disadvantaged beneficiaries. CLINICAL RELEVANCE: Although total hip replacements and total knee replacements are highly successful surgical procedures for end-stage osteoarthritis, our findings show that, as recently as 2017, Black beneficiaries and those dual eligible for Medicaid (a proxy for socioeconomic status) are less likely to undergo these surgical procedures and that there is profound geographic variation in the use of these surgical procedures. This evidence is essential for the design and implementation of disparity-reduction strategies focused on patients, providers, and geographic areas that can potentially improve the equity in joint replacement care.

Trends in Postacute Care Use and Outcomes After Hip and Knee Replacements in Dual-Eligible Medicare and Medicaid Beneficiaries, 2013-2016.

Importance: Several Medicare alternative payment models were implemented in recent years, but their implications for socioeconomic gaps in postacute care (PAC) are unknown. Objectives: To determine the longitudinal trends in PAC use and outcomes after hip and knee replacements and in gaps among 3 groups: Medicare-only patients, dual-eligible patients with full Medicaid benefits, and dual-eligible patients with partial Medicaid benefits. Design, Setting, and Participants: A cohort study was conducted of PAC use and outcomes among Medicare fee-for-service patients undergoing hip or knee replacement surgery from January 1, 2013, to December 31, 2016, in approximately 3000 hospitals, using Medicare claims, assessment, hospital, and skilled nursing facility (SNF) files. Statistical analysis was performed from October 1, 2018, to December 17, 2019. Main Outcomes and Measures: Risk-adjusted differences among dual-eligible groups in institutional PAC use (SNF, inpatient rehabilitation, or long-term hospital care), readmission rate, and payment for readmissions; for patients discharged to a SNF, risk-adjusted differences in SNF quality measured by star ratings, proportion successfully discharged to the community, proportion transitioned to long-stay residence, and SNF length of stay and payments. Results: The sample included 1 302 256 patients (837 256 women [64.3%]; mean [SD] age, 75.4 [7.2] years) who underwent joint replacement. The proportion of patients discharged to institutional PAC and the 30-day and 90-day readmission rates decreased for all 3 groups during the period from 2013 to 2016. In 2013, institutional PAC use was 43.7% (95% CI, 43.5%-43.9%) for Medicare-only patients (n = 1 182 555), 70.1% (95% CI, 69.4%-70.8%; n = 60 461) for dual-eligible patients with full benefits, and 70.3% (95% CI, 69.6%-71.0%; n = 59 240) for dual-eligible patients with partial benefits; in 2016, the rates decreased to 32.5% (95% CI, 32.4%-32.7%) for Medicare-only patients, 62.3% (95% CI, 61.5%-63.0%) for dual-eligible patients with full benefits, and 61.5% (95% CI, 60.7%-62.3%) for dual-eligible patients with partial benefits. Among patients discharged to SNFs, outcomes remained flat over time. For example, the proportion of patients successfully discharged to the community remained at 80.5% (95% CI, 80.4%-80.7%) for Medicare-only patients, 59.8% (95% CI, 59.3%-60.3%) for dual-eligible patients with full benefits, and 50.0% (95% CI, 49.4%-50.5%) for dual-eligible patients with partial benefits. Multivariable analyses with adjustment for patient, hospital (or SNF), and geographical covariates suggested maintained or enlarged gaps in all outcomes. Conclusions and Relevance: This study suggests that, during the period from 2013 to 2016, Medicare patients undergoing hip or knee replacement showed reduced institutional PAC use, reduced readmissions, and, among those discharged to SNFs, roughly unchanged outcomes. However, dual-eligible patients, especially those with partial Medicaid benefits, had persistently worse outcomes than Medicare-only patients.

Impact of Hospital Readmissions Reduction Program Penalties on Hip and Knee Replacement Readmissions: Comparison of Hospitals at Risk of Varying Penalty Amounts.

BACKGROUND: Little is known about the impact of the U.S. Centers for Medicare & Medicaid Services' Hospital Readmissions Reduction Program (HRRP) expansion to include readmissions following elective primary total hip and knee replacements; the expansion was finalized in 2013 and was implemented in 2014. We examined whether hospitals at risk of relatively large penalties from this expansion experienced greater declines in joint replacement readmissions compared with hospitals at risk of smaller penalties. METHODS: We used Medicare's 2009 to 2016 Hospital Compare data sets to examine the impact of the HRRP's expansion in the July 2013 to June 2016 period (post-expansion) compared with the July 2009 to June 2012 period (pre-expansion). The primary outcome was the hospital-level, 30-day, risk-standardized readmission rate (hereafter called the readmission rate) following joint replacement surgical procedures. We used the percentage of a hospital's total inpatient revenue attributed to Medicare (categorized into quartiles) to represent the risk of penalties. We used hierarchical linear regression models to examine the adjusted impact of the HRRP's expansion. RESULTS: Our study cohort included 2,326 acute care hospitals. In the pre-HRRP expansion phase, the mean readmission rate was 5.36% among hospitals with the highest proportion of Medicare revenues (quartile 4) and 5.46% among hospitals with the lowest proportion of Medicare revenues (quartile 1). With the HRRP expansion, the readmission rate declined by 18.92% (1.01 percentage points) among quartile-4 hospitals and by 17.97% (0.98 percentage point) among quartile-1 hospitals (p = 0.45). This nonsignificant difference in readmission rate declines between quartiles persisted in multivariable analysis (a decline of 18.41% [0.98 percentage point] in quartile 4 and a decline of 17.35% [0.94 percentage point] in quartile 1; p = 0.35). CONCLUSIONS: The HRRP's expansion to include joint replacements did not lead to greater reductions in postoperative readmissions among hospitals at risk of larger penalties in comparison with hospitals at risk of smaller penalties. Readmission rates were declining at similar rates among all hospitals, before and after the HRRP's expansion. CLINICAL RELEVANCE: Readmissions and complications following joint replacements are measures of the quality of surgical care. These events have important clinical and economic implications for patients and providers. This study is clinically relevant because it examines whether policy interventions, such as the HRRP, have the potential to reduce these unintended consequences of surgical care.

Frequency, Clinicopathologic Characteristics, and Follow-up of HER2-Positive Nonpleomorphic Invasive Lobular Carcinoma of the Breast.

OBJECTIVES: To investigate human epidermal growth factor receptor 2 (HER2)-positive nonpleomorphic invasive lobular carcinoma (ILC), which has rarely been addressed. METHODS: Clinicopathologic characteristics and follow-up of HER2-positive nonpleomorphic ILCs were collected and compared to those of HER2-negative counterparts. RESULTS: Twenty-one cases of HER2-positive nonpleomorphic ILCs were identified, 6.3% of the study population. Compared to HER2-negative nonpleomorphic ILC, patients with HER2 positivity were older (P < .05), likely to be hormonal receptor negative (P < .01), and had higher histologic grade and angiolymphatic invasion (P < .01). HER2 positivity in nonpleomorphic ILCs was associated with higher recurrence/metastasis with hazard ratio of 2.03 (P < .05). No patient who received neoadjuvant therapy achieved pathologic complete response, and HER2-targeted therapy tended to reduce recurrence/metastasis in patients with HER2-positive nonpleomorphic ILC. CONCLUSIONS: Our results highlight the existence of HER2 positivity in nonpleomorphic ILCs and reinforce that HER2 is associated with worse prognosis in nonpleomorphic ILC.

Demonstrating Heterogeneity of Treatment Effects Among Patients: An Overlooked but Important Step Toward Precision Medicine.

Although heterogeneity in the observed outcomes in clinical trials is often assumed to reflect a true heterogeneous response, it could actually be due to random variability. This retrospective analysis of four randomized, double-blind, placebo-controlled multiperiod (i.e., episode) crossover trials of fentanyl for breakthrough cancer pain illustrates the use of multiperiod crossover trials to examine heterogeneity of treatment response. A mixed-effects model, including fixed effects for treatment and episode and random effects for patient and treatment-by-patient interaction, was used to assess the heterogeneity in patients' responses to treatment during each episode. A significant treatment-by-patient interaction was found for three of four trials (P < 0.05), suggesting heterogeneity of the effect of fentanyl among different patients in each trial. Similar analyses in other therapeutic areas could identify conditions and therapies that should be investigated further for predictors of treatment response in efforts to maximize the efficiency of developing precision medicine strategies.

Extended-release gabapentin for failed back surgery syndrome: results from a randomized double-blind cross-over study.

Persistent pain after lumbar surgery (failed back surgery syndrome [FBSS]) remains a leading indication for chronic analgesia. However, no analgesics have proven efficacious for this condition. Although trials have evaluated gabapentinoids for chronic low back pain, none of these trials focused solely on FBSS. This randomized, double-blind cross-over trial evaluated the efficacy of gabapentin (1800 mg/day) for FBSS. Eligible patients had a diagnosis of FBBS, an average daily pain score of at least 4 of 10, a neuropathic pain component (indicated by the PainDetect), and reported at least half of their pain radiating in their lower extremity. Participants were randomized to 2, 7-week study periods separated by a 10-day washout. The primary outcome measure was a 0 to 10 numeric rating scale (NRS) of average pain. Secondary measures included the McGill Pain Questionnaire and Patient Global Impression of Change. The treatment effect was analyzed using a mixed effect analysis of covariance with fixed effects for treatment, period, and baseline 7-day mean NRS pain score and a random effect for the participant. The outcome of the model was the mean 7-day NRS score for the last 7 days of each treatment period. Thirty-two participants were randomized and included in the primary analysis; 25 completed both study periods. No difference was detected between treatments on any outcome measure, including the primary (least square mean difference in NRS: -0.01 confidence interval: [-0.22 to 0.20]). Given the escalating rate of complex lumbar surgery, future research to develop novel therapies for this prevalent syndrome is needed.

Impact of Nursing Home Palliative Care Teams on End-of-Life Outcomes: A Randomized Controlled Trial.

BACKGROUND: Deficits in end-of-life care in nursing homes (NHs) are reported, but the impact of palliative care teams (PCTeams) on resident outcomes remains largely untested. OBJECTIVE: Test the impact of PCTeams on end-of-life outcomes. RESEARCH DESIGN: Multicomponent strategy employing a randomized, 2-arm controlled trial with a difference-in-difference analysis, and a nonrandomized second control group to assess the intervention's placebo effect. SUBJECTS: In all, 25 New York State NHs completed the trial (5830 decedent residents) and 609 NHs were in the nonrandomized group (119,486 decedents). MEASURES: Four risk-adjusted outcome measures: place of death, number of hospitalizations, self-reported moderate-to-severe pain, and depressive symptoms. The Minimum Data Set, vital status files, staff surveys, and in-depth interviews were employed. For each outcome, a difference-in-difference model compared the pre-post intervention periods using logistic and Poisson regressions. RESULTS: Overall, we found no statistically significant effect of the intervention. However, independent analysis of the interview data found that only 6 of the 14 treatment facilities had continuously working PCTeams throughout the study period. Decedents in homes with working teams had significant reductions in the odds of in-hospital death compared to the other treatment [odds ratio (OR), 0.400; P<0.001), control (OR, 0.482; P<0.05), and nonrandomized control NHs (0.581; P<0.01). Decedents in these NHs had reduced rates of depressive symptoms (OR, 0.191; P≤0.01), but not pain or hospitalizations. CONCLUSIONS: The intervention was not equally effective for all outcomes and facilities. As homes vary in their ability to adopt new care practices, and in their capacity to sustain them, reforms to create the environment in which effective palliative care can become broadly implemented are needed.

Multiple Risk Factor Counseling to Promote Heart-healthy Lifestyles in the Chest Pain Observation Unit: Pilot Randomized Controlled Trial.

OBJECTIVE: Admission to the chest pain observation unit (CPOU) may be an advantageous time for patients to consider heart-healthy lifestyle changes while undergoing diagnostic evaluation to rule out myocardial ischemia. The aim of this pragmatic trial was to assess the effectiveness of a multiple risk factor intervention in changing CPOU patients' health beliefs and readiness to change health behaviors. A secondary aim was to obtain preliminary estimates of the intervention's effect on diet, physical activity, and smoking. METHODS: We conducted a pilot randomized controlled trial of a moderate-intensity counseling intervention that aimed to build motivation to change and problem-solving skills in 140 adult patients with at least one modifiable cardiovascular risk factor (CRF) who were admitted to the CPOU of an academic emergency department (ED) with symptoms of possible acute coronary syndrome. Study patients were randomly assigned to full counseling (face-to-face cardiovascular risk assessment and personalized counseling on nutrition, physical activity, and smoking cessation in the ED, plus two telephone follow-up sessions) or minimal counseling (brief instruction [<5 minutes] on benefits of modifying cardiovascular risk factors) by a cardiac rehabilitation specialist. We measured Health Belief Model constructs for ischemic heart disease, stage of change, and self-reported CRF-related behaviors (diet, exercise, and smoking) during 6-month follow-up using previously validated measures. We used linear mixed models and logistic regression (with generalized estimating equations) to compare continuous and dichotomous behavioral outcomes across treatment arms, respectively. RESULTS: Approximately 20% more patients in the full counseling arm reported having received counseling on diet and physical activity during CPOU admission, compared to the minimal counseling arm; a similar proportion of patients in both counseling arms reported having received advice or assistance in quitting smoking. There were no significant differences between treatment arms for any cardiovascular health beliefs, readiness to change, or CRF-related behaviors during longitudinal follow-up. In secondary analyses in both treatment arms combined, however, patients showed significant differences between follow-up and baseline measurements: increases in the perceived benefits of improving CRF-related behaviors (27.7 vs. 26.6 on a scale from 7 to 35, p = 0.0001) and increased readiness to change dietary behavior and physical activity during follow-up-intake of saturated fat (83% vs. 49%), readiness to change fruit and vegetable consumption (83% vs 56%), and readiness to perform regular exercise (34% vs. 14%) at 6 months and baseline, respectively (p < 0.0001 for all comparisons in both treatment arms combined). CONCLUSIONS: A multiple risk factor intervention that focused on increasing motivation to change and problem-solving skills did not significantly improve behavioral outcomes, compared to minimal counseling. Patients admitted to the CPOU demonstrated sustained changes in several cardiovascular health beliefs and risk-related behaviors during follow-up; this provides further evidence that the CPOU visit is a "teachable moment" for cardiovascular risk reduction. Future studies should evaluate the effectiveness of ED-initiated counseling interventions to engage patients in changing cardiovascular risk behaviors, in coordination with primary care.

Trends and Hospital Variations in Surgical Outcomes for Cholangiocarcinoma in New York State.

BACKGROUND: This population-based study examined surgical outcomes and hospital and post-acute care resource use after operations of cholangiocarcinoma during 2005-2012. STUDY DESIGN: Using New York State hospital claims, we identified subjects with intrahepatic tumor who underwent hepatectomy only (n = 2089), subjects with perihilar tumor who underwent hepatectomy and biliary-enteric anastomosis (BEA; n = 389) or BEA only (n = 3721), and subjects with distal cholangiocarcinoma undergoing pancreatectomy or pancreaticoduodenectomy (n = 228). We performed trend analyses for each group and calculated overall risk-adjusted mortality, complication, and 30-day readmission rates for hospitals using multivariable logistic regressions. RESULTS: Mortality rate was roughly 12 % over years for perihilar cases undergoing hepatectomy and BEA, significantly higher than the rates of other 3 groups (p = 0.000). The overall complication rate was 40 % for subjects undergoing both hepatectomy and BEA, more than doubling the rate for subjects undergoing hepatectomy or BEA alone (p = 0.000). Average LOS declined markedly for perihilar cases undergoing hepatectomy and BEA (from 21 days in 2005 to 16 days in 2012) and subjects with distal cholangiocarcinoma (from 22 days in 2005 to 16 days in 2012), but other outcomes did not change dramatically. Risk-adjusted hospital outcome rates varied substantially. CONCLUSIONS: Surgical patients with cholangiocarcinoma incur considerable mortality, postoperative complications, and resource uses, especially among those undergoing hepatectomy and BEA for perihilar tumors.

Lifetime Exposure to Intimate Partner Violence and Proinflammatory Cytokine Levels Across the Perinatal Period.

BACKGROUND: Intimate partner violence (IPV) is a public health concern, affecting one-third of US women. Prior research suggests an association between exposure to IPV and poor maternal perinatal health, but the underlying biological correlates are not well understood. This study examined the relationship between exposure to IPV and proinflammatory cytokine levels, a candidate mechanism accounting for poor psychiatric and obstetric outcomes, across the perinatal period. MATERIALS AND METHODS: Data were obtained from a prospective, longitudinal cohort study of 171 women receiving obstetrical care from a hospital-based practice serving a predominantly low-income minority population. Participants completed questionnaires on IPV exposure, psychiatric symptoms, and psychosocial and obstetric factors and provided blood samples at 18 and 32 weeks of gestation and 6 weeks and 6 months postpartum. Serum levels of interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-α) were assayed via enzyme-linked immunosorbent assay. RESULTS: Thirty-five (20.5%) women reported lifetime exposure to IPV and 7 (4.1%) reported being physically hurt in the preceding 12 months (4 while pregnant). Lifetime exposure to IPV was associated with increased likelihood of experiencing perinatal depression and smoking during pregnancy. Women with a history of IPV had significantly higher levels of TNF-α at 18 weeks (z = -2.29, p < 0.05), but significantly smaller changes in levels of IL-6 (ß = -0.36, p = 0.04) across time. CONCLUSION: Lifetime exposure to IPV was associated with a range of adverse mental health outcomes and may affect proinflammatory cytokine levels in pregnancy.

Developing palliative care practice guidelines and standards for nursing home-based palliative care teams: a Delphi study.

CONTEXT: Lack of nursing home (NH)-specific palliative care practice guidelines has been identified as a barrier to improving palliative and end-of-life (EOL) quality of care. OBJECTIVES: The objectives of this study were to (1) assess which of the guidelines developed by the National Consensus Project, and the corresponding preferred care practices endorsed by the National Quality Forum, are important and feasible to implement in NHs; and (2) identify the operational standards for palliative care teams in NHs. METHODS: Two-round mail Delphi study. Based on the existing literature, a set of 7 domains with associated 22 palliative practice guidelines was drafted. We invited 48 NH leaders, including clinicians, to review the importance (10-point Likert scale) and the feasibility (5-point Likert scale) of these guidelines. Participants were also asked about palliative care team composition rounding frequency. RESULTS: The response rate to both rounds was 85%. With regard to importance, the mean rating for all guidelines was 8 or higher (ie, highly important), but there was variability in agreement with regard to 5 of the guidelines. The same 5 guidelines were also considered more difficult to implement (eg, costly, unrealistic). Overall, 17 palliative care guidelines were identified for use by NH palliative care teams. Five disciplines (social work, certified nurse assistant, nurse, physician, and nurse practitioner or physician assistant) were identified as comprising a core team and 3 were proposed as extended or ad hoc members. CONCLUSION: The palliative care guidelines and team standards identified in this study may be helpful in providing practical direction to NH administrators and staff looking to improve palliative care practice for their residents.