Association of Vitamin C, Thiamine, and Hydrocortisone Infusion With Long-term Cognitive, Psychological, and Functional Outcomes in Sepsis Survivors: A Secondary Analysis of the Vitamin C, Thiamine, and Steroids in Sepsis Randomized Clinical Trial.

Importance: Sepsis is associated with long-term cognitive impairment and worse psychological and functional outcomes. Potential mechanisms include intracerebral oxidative stress and inflammation, yet little is known about the effects of early antioxidant and anti-inflammatory therapy on cognitive, psychological, and functional outcomes in sepsis survivors. Objective: To describe observed differences in long-term cognitive, psychological, and functional outcomes of vitamin C, thiamine, and hydrocortisone between the intervention and control groups in the Vitamin C, Thiamine, and Steroids in Sepsis (VICTAS) randomized clinical trial. Design, Setting, and Participants: This prespecified secondary analysis reports the 6-month outcomes of the multicenter, double-blind, placebo-controlled VICTAS randomized clinical trial, which was conducted between August 2018 and July 2019. Adult patients with sepsis-induced respiratory and/or cardiovascular dysfunction who survived to discharge or day 30 were recruited from 43 intensive care units in the US. Participants were randomized 1:1 to either the intervention or control group. Cognitive, psychological, and functional outcomes at 6 months after randomization were assessed via telephone through January 2020. Data analyses were conducted between February 2021 and December 2022. Interventions: The intervention group received intravenous vitamin C (1.5 g), thiamine hydrochloride (100 mg), and hydrocortisone sodium succinate (50 mg) every 6 hours for 96 hours or until death or intensive care unit discharge. The control group received matching placebo. Main Outcomes and Measures: Cognitive performance, risk of posttraumatic stress disorder and depression, and functional status were assessed using a battery of standardized instruments that were administered during a 1-hour telephone call 6 months after randomization. Results: After exclusions, withdrawals, and deaths, the final sample included 213 participants (median [IQR] age, 57 [47-67] years; 112 males [52.6%]) who underwent long-term outcomes assessment and had been randomized to either the intervention group (n = 108) or control group (n = 105). The intervention group had lower immediate memory scores (adjusted OR [aOR], 0.49; 95% CI, 0.26-0.89), higher odds of posttraumatic stress disorder (aOR, 3.51; 95% CI, 1.18-10.40), and lower odds of receiving mental health care (aOR, 0.38; 95% CI, 0.16-0.89). No other statistically significant differences in cognitive, psychological, and functional outcomes were found between the 2 groups. Conclusions and Relevance: In survivors of sepsis, treatment with vitamin C, thiamine, and hydrocortisone did not improve or had worse cognitive, psychological, and functional outcomes at 6 months compared with patients who received placebo. These findings challenge the hypothesis that antioxidant and anti-inflammatory therapy during critical illness mitigates the development of long-term cognitive, psychological, and functional impairment in sepsis survivors. Trial Registration: ClinicalTrials.gov Identifier: NCT03509350.

Securely sharing DSMB reports to speed decision making from multiple, concurrent, independent studies of similar treatments in COVID-19.

Introduction: As clinical trials were rapidly initiated in response to the COVID-19 pandemic, Data and Safety Monitoring Boards (DSMBs) faced unique challenges overseeing trials of therapies never tested in a disease not yet characterized. Traditionally, individual DSMBs do not interact or have the benefit of seeing data from other accruing trials for an aggregated analysis to meaningfully interpret safety signals of similar therapeutics. In response, we developed a compliant DSMB Coordination (DSMBc) framework to allow the DSMB from one study investigating the use of SARS-CoV-2 convalescent plasma to treat COVID-19 to review data from similar ongoing studies for the purpose of safety monitoring. Methods: The DSMBc process included engagement of DSMB chairs and board members, execution of contractual agreements, secure data acquisition, generation of harmonized reports utilizing statistical graphics, and secure report sharing with DSMB members. Detailed process maps, a secure portal for managing DSMB reports, and templates for data sharing and confidentiality agreements were developed. Results: Four trials participated. Data from one trial were successfully harmonized with that of an ongoing trial. Harmonized reports allowing for visualization and drill down into the data were presented to the ongoing trial's DSMB. While DSMB deliberations are confidential, the Chair confirmed successful review of the harmonized report. Conclusion: It is feasible to coordinate DSMB reviews of multiple independent studies of a similar therapeutic in similar patient cohorts. The materials presented mitigate challenges to DSMBc and will help expand these initiatives so DSMBs may make more informed decisions with all available information.

Promoting patient and nurse safety: testing a behavioural health intervention in a learning healthcare system: results of the DEMEANOR pragmatic, cluster, cross-over trial.

BACKGROUND: Based on clinical staff safety within a learning healthcare system, the purpose of this study was to test an innovative model of care for addressing disruptive behaviour in hospitalised patients to determine whether it should be scaled up at the system level. METHODS: The Disruptive bEhaviour manageMEnt ANd prevention in hospitalised patients using a behaviOuRal (DEMEANOR) intervention team was a pragmatic, cluster, cross-over trial. A behavioural intervention team (BIT) with a psychiatric mental health advanced practice nurse and a social worker, with psychiatrist consultation, switched between units each month and occurrences of disruptive behaviours (eg, documented violence control measures, violence risk) compared. Nursing surveys assessed self-perceived efficacy and comfort managing disruptive patient behaviour. RESULTS: A total of 3800 patients hospitalised on the two units met the criteria for inclusion. Of those, 1841 (48.4%) were exposed to the BIT intervention and 1959 (51.6%) were in the control group. A total of 11 132 individual behavioural issues associated with 203 patient encounters were documented. There were no differences in the use of behavioural interventions, violence risk or injurious behaviour or sitter use between patients exposed to BIT and those in the control group. Tracking these data did rely on nursing documentation of such events. Nurses (82 pre and 48 post) rated BIT as the most beneficial support they received to manage patients exhibiting disruptive, threatening or acting out behaviour. CONCLUSIONS: The BIT intervention was perceived as beneficial by nurses in preparing them to provide care for patients exhibiting disruptive, threatening or acting out behaviour, but documented patient behaviour was not observed to change. TRIAL REGISTRATION NUMBER: NCT03777241.

Influenza Vaccine Effectiveness for Prevention of Severe Influenza-Associated Illness Among Adults in the United States, 2019-2020: A Test-Negative Study.

BACKGROUND: Influenza vaccine effectiveness (VE) against a spectrum of severe disease, including critical illness and death, remains poorly characterized. METHODS: We conducted a test-negative study in an intensive care unit (ICU) network at 10 US hospitals to evaluate VE for preventing influenza-associated severe acute respiratory infection (SARI) during the 2019-2020 season, which was characterized by circulation of drifted A/H1N1 and B-lineage viruses. Cases were adults hospitalized in the ICU and a targeted number outside the ICU (to capture a spectrum of severity) with laboratory-confirmed, influenza-associated SARI. Test-negative controls were frequency-matched based on hospital, timing of admission, and care location (ICU vs non-ICU). Estimates were adjusted for age, comorbidities, and other confounders. RESULTS: Among 638 patients, the median (interquartile) age was 57 (44-68) years; 286 (44.8%) patients were treated in the ICU and 42 (6.6%) died during hospitalization. Forty-five percent of cases and 61% of controls were vaccinated, which resulted in an overall VE of 32% (95% CI: 2-53%), including 28% (-9% to 52%) against influenza A and 52% (13-74%) against influenza B. VE was higher in adults 18-49 years old (62%; 95% CI: 27-81%) than those aged 50-64 years (20%; -48% to 57%) and ≥65 years old (-3%; 95% CI: -97% to 46%) (P = .0789 for interaction). VE was significantly higher against influenza-associated death (80%; 95% CI: 4-96%) than nonfatal influenza illness. CONCLUSIONS: During a season with drifted viruses, vaccination reduced severe influenza-associated illness among adults by 32%. VE was high among young adults.

Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial.

Importance: Sepsis is a common syndrome with substantial morbidity and mortality. A combination of vitamin C, thiamine, and corticosteroids has been proposed as a potential treatment for patients with sepsis. Objective: To determine whether a combination of vitamin C, thiamine, and hydrocortisone every 6 hours increases ventilator- and vasopressor-free days compared with placebo in patients with sepsis. Design, Setting, and Participants: Multicenter, randomized, double-blind, adaptive-sample-size, placebo-controlled trial conducted in adult patients with sepsis-induced respiratory and/or cardiovascular dysfunction. Participants were enrolled in the emergency departments or intensive care units at 43 hospitals in the United States between August 2018 and July 2019. After enrollment of 501 participants, funding was withheld, leading to an administrative termination of the trial. All study-related follow-up was completed by January 2020. Interventions: Participants were randomized to receive intravenous vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) every 6 hours (n = 252) or matching placebo (n = 249) for 96 hours or until discharge from the intensive care unit or death. Participants could be treated with open-label corticosteroids by the clinical team, with study hydrocortisone or matching placebo withheld if the total daily dose was greater or equal to the equivalent of 200 mg of hydrocortisone. Main Outcomes and Measures: The primary outcome was the number of consecutive ventilator- and vasopressor-free days in the first 30 days following the day of randomization. The key secondary outcome was 30-day mortality. Results: Among 501 participants randomized (median age, 62 [interquartile range {IQR}, 50-70] years; 46% female; 30% Black; median Acute Physiology and Chronic Health Evaluation II score, 27 [IQR, 20.8-33.0]; median Sequential Organ Failure Assessment score, 9 [IQR, 7-12]), all completed the trial. Open-label corticosteroids were prescribed to 33% and 32% of the intervention and control groups, respectively. Ventilator- and vasopressor-free days were a median of 25 days (IQR, 0-29 days) in the intervention group and 26 days (IQR, 0-28 days) in the placebo group, with a median difference of -1 day (95% CI, -4 to 2 days; P = .85). Thirty-day mortality was 22% in the intervention group and 24% in the placebo group. Conclusions and Relevance: Among critically ill patients with sepsis, treatment with vitamin C, thiamine, and hydrocortisone, compared with placebo, did not significantly increase ventilator- and vasopressor-free days within 30 days. However, the trial was terminated early for administrative reasons and may have been underpowered to detect a clinically important difference. Trial Registration: ClinicalTrials.gov Identifier: NCT03509350.

Meniscal Repair in the Setting of Revision Anterior Cruciate Ligament Reconstruction: Results From the MARS Cohort.

BACKGROUND: Meniscal preservation has been demonstrated to contribute to long-term knee health. This has been a successful intervention in patients with isolated tears and tears associated with anterior cruciate ligament (ACL) reconstruction. However, the results of meniscal repair in the setting of revision ACL reconstruction have not been documented. PURPOSE: To examine the prevalence and 2-year operative success rate of meniscal repairs in the revision ACL setting. STUDY DESIGN: Case-control study; Level of evidence, 3. METHODS: All cases of revision ACL reconstruction with concomitant meniscal repair from a multicenter group between 2006 and 2011 were selected. Two-year follow-up was obtained by phone and email to determine whether any subsequent surgery had occurred to either knee since the initial revision ACL reconstruction. If so, operative reports were obtained, whenever possible, to verify the pathologic condition and subsequent treatment. RESULTS: In total, 218 patients (18%) from 1205 revision ACL reconstructions underwent concurrent meniscal repairs. There were 235 repairs performed: 153 medial, 48 lateral, and 17 medial and lateral. The majority of these repairs (n = 178; 76%) were performed with all-inside techniques. Two-year surgical follow-up was obtained on 90% (197/218) of the cohort. Overall, the meniscal repair failure rate was 8.6% (17/197) at 2 years. Of the 17 failures, 15 were medial (13 all-inside, 2 inside-out) and 2 were lateral (both all-inside). Four medial failures were treated in conjunction with a subsequent repeat revision ACL reconstruction. CONCLUSION: Meniscal repair in the revision ACL reconstruction setting does not have a high failure rate at 2-year follow-up. Failure rates for medial and lateral repairs were both <10% and consistent with success rates of primary ACL reconstruction meniscal repair. Medial tears underwent reoperation for failure at a significantly higher rate than lateral tears.

In response: Letter on update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT03509350. Registered on 26 April 2018.

Update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol: statistical analysis plan for a prospective, multicenter, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial.

BACKGROUND: Observational research suggests that combined therapy with Vitamin C, thiamine and hydrocortisone may reduce mortality in patients with septic shock. METHODS AND DESIGN: The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) trial is a multicenter, double-blind, adaptive sample size, randomized, placebo-controlled trial designed to test the efficacy of combination therapy with vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) given every 6 h for up to 16 doses in patients with respiratory or circulatory dysfunction (or both) resulting from sepsis. The primary outcome is ventilator- and vasopressor-free days with mortality as the key secondary outcome. Recruitment began in August 2018 and is ongoing; 501 participants have been enrolled to date, with a planned maximum sample size of 2000. The Data and Safety Monitoring Board reviewed interim results at N = 200, 300, 400 and 500, and has recommended continuing recruitment. The next interim analysis will occur when N = 1000. This update presents the statistical analysis plan. Specifically, we provide definitions for key treatment and outcome variables, and for intent-to-treat, per-protocol, and safety analysis datasets. We describe the planned descriptive analyses, the main analysis of the primary end point, our approach to secondary and exploratory analyses, and handling of missing data. Our goal is to provide enough detail that our approach could be replicated by an independent study group, thereby enhancing the transparency of the study. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03509350. Registered on 26 April 2018.

Predictors of Patient-Reported Outcomes at 2 Years After Revision Anterior Cruciate Ligament Reconstruction.

BACKGROUND: Patient-reported outcomes (PROs) are a valid measure of results after revision anterior cruciate ligament (ACL) reconstruction. Revision ACL reconstruction has been documented to have worse outcomes when compared with primary ACL reconstruction. Understanding positive and negative predictors of PROs will allow surgeons to modify and potentially improve outcome for patients. PURPOSE/HYPOTHESIS: The purpose was to describe PROs after revision ACL reconstruction and test the hypothesis that patient- and technique-specific variables are associated with these outcomes. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Patients undergoing revision ACL reconstruction were identified and prospectively enrolled by 83 surgeons over 52 sites. Data included baseline demographics, surgical technique and pathology, and a series of validated PRO instruments: International Knee Documentation Committee (IKDC), Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index, and Marx Activity Rating Scale. Patients were followed up at 2 years and asked to complete the identical set of outcome instruments. Multivariate regression models were used to control for a variety of demographic and surgical factors to determine the positive and negative predictors of PRO scores at 2 years after revision surgery. RESULTS: A total of 1205 patients met the inclusion criteria and were successfully enrolled: 697 (58%) were male, with a median cohort age of 26 years. The median time since their most recent previous ACL reconstruction was 3.4 years. Two-year questionnaire follow-up was obtained from 989 patients (82%). The most significant positive predictors of 2-year IKDC scores were a high baseline IKDC score, high baseline Marx activity level, male sex, and having a longer time since the most recent previous ACL reconstruction, while negative predictors included having a lateral meniscectomy before the revision ACL reconstruction or having grade 3/4 chondrosis in either the trochlear groove or the medial tibial plateau at the time of the revision surgery. For KOOS, having a high baseline score and having a longer time between the most recent previous ACL reconstruction and revision surgery were significant positive predictors for having a better (ie, higher) 2-year KOOS, while having a lateral meniscectomy before the revision ACL reconstruction was a consistent predictor for having a significantly worse (ie, lower) 2-year KOOS. Statistically significant positive predictors for 2-year Marx activity levels included higher baseline Marx activity levels, younger age, male sex, and being a nonsmoker. Negative 2-year activity level predictors included having an allograft or a biologic enhancement at the time of revision surgery. CONCLUSION: PROs after revision ACL reconstruction are associated with a variety of patient- and surgeon-related variables. Understanding positive and negative predictors of PROs will allow surgeons to guide patient expectations as well as potentially improve outcomes.

Variants in BMI-Associated Genes and Adrenergic Genes are not Associated with Gestational Weight Trajectory.

OBJECTIVE: The aim of this study is to define the association between a genetic risk score (GRS) that combined the effect of multiple BMI-associated variants and gestational weight trajectory. Because pregnancy is a state of sympathetic activation, the association between gestational weight trajectory and variants in adrenergic pathways previously associated with weight was examined. METHODS: In a previously defined cohort of pregnant women with (n = 1,504) and without gestational diabetes (GDM) (n = 435), weight trajectory was calculated using all weights during pregnancy. A GRS for BMI (GRSBMI ) was calculated using 31 common variants associated with BMI, and 10 variants in the adrenergic pathways were genotyped. Clinical and genetic factors were studied using generalized linear models. RESULTS: Prepregnancy BMI was associated with the GRSBMI (P = 9.3 × 10-11 ) and parity (P = 4.54 × 10-17 ). The GRSBMI was associated with gestational weight trajectory in women with and without GDM (P = 0.041 and P < 0.0001, respectively); however, when prepregnancy BMI was included in the models, the associations disappeared (P > 0.05). Variants in adrenergic genes were not associated with gestational weight trajectory. CONCLUSIONS: A GRS for BMI was associated with prepregnancy BMI but was not independently associated with gestational weight trajectory in women with and without GDM. Selected variants in adrenergic genes were not associated with gestational weight trajectory.

Randomized Trial of a Positive Psychology Intervention for Adolescents With Type 1 Diabetes.

OBJECTIVE: To evaluate the effects of a positive psychology intervention for adolescents with type 1 diabetes (T1D) on adherence, glycemic control, and quality of life. METHODS: Adolescents with T1D (n = 120) and their caregivers were randomized to either an Education (EDU) (n = 60) or Positive Affect (PA) intervention (n = 60). Adolescents in the PA group received the intervention reminders (gratitude, self-affirmation, parental affirmation, and small gifts) via text messages or phone calls over 8 weeks. Questionnaires were completed by adolescents and caregivers and clinical data (glucometer and HbA1c) were collected at baseline 3 and 6 months. Data were analyzed using generalized linear modeling. RESULTS: After adjusting for covariates, adolescents in the PA group demonstrated significant improvement in quality of life at 3 months, compared to the EDU group, but this was not sustained at 6 months. Similarly, the PA group showed a significant decrease in disengagement coping at 3 months but not at 6 months. There was no significant intervention effect on blood glucose monitoring, but the odds of clinically significantly improvement (checking at least one more time/day) were about twice as high in the PA group as the EDU group. No significant effects were found for glycemic control. CONCLUSIONS: A positive psychology intervention had initial significant, positive effects on coping and quality of life in adolescents with T1D. A more intensive or longer-lasting intervention may be needed to sustain these effects and to improve adherence and glycemic control.

Integrated specialty pharmacy yields high PCSK9 inhibitor access and initiation rates.

BACKGROUND: Access to proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors that lower low-density lipoprotein cholesterol in patients at high risk of atherosclerotic cardiovascular disease events has proven challenging. Methods to overcome access barriers are needed to fully realize the benefits of these novel agents. OBJECTIVE: This study evaluated medication access rates in patients prescribed a PCSK9 inhibitor at a health care system with integrated specialty pharmacy services. METHODS: We performed a single-center, ambispective cohort study of patients prescribed a PCSK9 inhibitor between September 2015 and December 2016 at Vanderbilt University Medical Center outpatient clinics. The primary end point was the percentage of PCSK9 inhibitor prescriptions resulting in access of the total prescriptions triaged to Vanderbilt Specialty Pharmacy. Secondary end points assessed among patients approved for therapy included time between benefits investigation and insurance approval, financial assistance use, and treatment initiation rates. RESULTS: Two hundred ninety-nine patients met inclusion criteria (average age = 63 years). Forty-six percent were female, 57% held commercial insurance, and 70% had an atherosclerotic cardiovascular disease indication. Overall, 96% of prescriptions resulted in access to a PCSK9 inhibitor. Most patients were approved with an initial prior authorization (58%) or after one appeal (29%). The median time to approval was 8 days. Among patients approved for therapy, 53% received financial assistance and 94% initiated therapy. CONCLUSION: An integrated specialty pharmacy service model in outpatient clinics produced high rates of PCSK9 inhibitor therapy access and initiation. This high level of access supports this model as a best practice for prescribing PCSK9 inhibitor therapy.

Perceived health competence predicts health behavior and health-related quality of life in patients with cardiovascular disease.

OBJECTIVE: Evaluate the effect of perceived health competence, a patient's belief in his or her ability to achieve health-related goals, on health behavior and health-related quality of life. METHODS: We analyzed 2063 patients hospitalized with acute coronary syndrome and/or congestive heart failure at a large academic hospital in the United States. Multivariable linear regression models investigated associations between the two-item perceived health competence scale (PHCS-2) and positive health behaviors such as medication adherence and exercise (Health Behavior Index) as well as health-related quality of life (5-item Patient Reported Outcome Information Measurement System Global Health Scale). RESULTS: After multivariable adjustment, perceived health competence was highly associated with health behaviors (p<0.001) and health-related quality of life (p<0.001). Low perceived health competence was associated with a decrease in health-related quality of life between hospitalization and 90days after discharge (p<0.001). CONCLUSIONS: Perceived health competence predicts health behavior and health-related quality of life in patients hospitalized with cardiovascular disease as well as change in health-related quality of life after discharge. PRACTICE IMPLICATIONS: Patients with low perceived health competence may be at risk for a decline in health-related quality of life after hospitalization and thus a potential target for counseling and other behavioral interventions.

Preparedness for hospital discharge and prediction of readmission.

BACKGROUND, OBJECTIVE: Patients' self-reported preparedness for discharge has been shown to predict readmission. It is unclear what differences exist in the predictive abilities of 2 available discharge preparedness measures. To address this gap, we conducted a comparison of these measures. DESIGN, SETTING, PATIENTS: Adults hospitalized for cardiovascular diagnoses were enrolled in a prospective cohort. MEASUREMENTS: Two patient-reported preparedness measures assessed during postdischarge calls: the 11-item Brief Prescriptions, Ready to re-enter community, Education, Placement, Assurance of safety, Realistic expectations, Empowerment, Directed to appropriate services (B-PREPARED) and the 3-item Care Transitions Measure (CTM-3). Cox proportional hazard models analyzed the relationship between preparedness and time to first readmission or death at 30 and 90 days, adjusted for readmission risk using the administrative database-derived Length of stay, Acuity, Comorbidity, and Emergency department use (LACE) index and other covariates. RESULTS: Median preparedness scores were: B-PREPARED 21 (interquartile range [IQR] 18-22) and CTM-3 77.8 (IQR 66.7-100). In individual Cox models, a 4-point increase in B-PREPARED score was associated with a 16% decrease in time to readmission or death at 30 and 90 days. A 10-point increase in CTM-3 score was not associated with readmission or death at 30 days, but was associated with a 6% decrease in readmission or death at 90 days. In models with both preparedness scores, B-PREPARED retained an association with readmission or death at both 30 and 90 days. However, neither preparedness score was as strong a predictor as the LACE index when all were included in the model predicting 30- and 90-day readmission or death. CONCLUSION: The B-PREPARED score was more strongly associated with readmission or death than the more widely adopted CTM-3, but neither predicted readmission as well as the LACE index. Journal of Hospital Medicine 2016;11:603-609. © 2016 Society of Hospital Medicine.

Outcomes of ACL Reconstruction in Patients with Diabetes.

PURPOSE: Diabetes has been associated with adverse outcomes after various types of surgery. There are no previously published data regarding the effect of diabetes on outcomes from anterior cruciate ligament reconstruction (ACLR). The purpose of this study was to test the hypotheses that diabetes is associated with worse clinical outcomes and a higher prevalence of subsequent surgeries after ACLR. METHODS: Anterior cruciate ligament-deficient patients (n = 2198) undergoing unilateral ACLR from a multicenter prospective study were included. Patients who self-reported diabetes on the basis of comorbidity questions before surgery were identified from the database. They were compared with the remainder of the cohort who did not self-report diabetes. All patients were followed up for a minimum of 2 yr after their index surgery. A minimum 2-yr follow-up was attained on 1905/2198 (87%) via completed outcome questionnaires and 2096/2198 (95%) regarding subsequent surgery. The primary outcome measures were three validated outcome instruments. The secondary outcome measure was the incidence of additional surgery on the ipsilateral and contralateral knees. RESULTS: Patients with diabetes had a significantly higher activity level at 2 yr (OR = 2.96; 95% CI, 1.30-6.77; P = 0.01), but otherwise slightly worse clinical outcomes, compared with patients without diabetes (OR range = 0.42-0.59). The prevalence of subsequent surgeries in patients with diabetes was not significantly different from the prevalence in patients without diabetes. CONCLUSIONS: Patients with diabetes maintain a higher activity level after ACLR despite slightly lower patient-reported outcome scores compared with patients without diabetes and do not have a higher rate of subsequent surgery.

Prevalence of Hypertension in Pediatric Tibia Vara and Slipped Capital Femoral Epiphysis.

BACKGROUND: Slipped capital femoral epiphysis (SCFE) and tibia vara (Blount disease) are associated with childhood obesity. However, the majority of obese children do not develop SCFE or tibia vara. Therefore, it is hypothesized that other obesity-related biological changes to the physis, in addition to increased biomechanical stress, potentiate the occurrence of SCFE and tibia vara. Considering that hypertension can impose pathologic changes in the physis similar to those observed in these obesity-related diseases we set out to determine the prevalence of hypertension in patients with SCFE and tibia vara. METHODS: Blood pressure measurements were obtained in 44 patients with tibia vara and 127 patients with SCFE. Body mass index and blood pressure were adjusted for age, sex, and height percentiles utilizing normative distribution data from the CDC. These cohorts were compared with age-matched and sex-matched cohorts derived from an obesity clinic who did not have either bone disease. A multivariable proportional odds model was used to determine association. RESULTS: The prevalence of prehypertension/hypertension was significantly higher in the tibia vara (64%) and SCFE cohort (64%) compared with respective controls (43%). Patients diagnosed with either SCFE or tibia vara had 2.5-fold higher odds of having high blood pressure compared with age-matched and sex-matched obese patients without bone disease. Sex, age, and race did not have a significant effect on a patient's blood pressure. CONCLUSIONS: This is the first study to establish that the obesity-related bone diseases, SCFE and tibia vara, are significantly associated with high blood pressure. These data have immediate clinical impact as they demonstrate that children with obesity-related developmental bone disease have increased prevalence of undiagnosed and untreated hypertension. Furthermore, this prevalence study supports the hypothesis that hypertension in conjunction with increased biomechanical forces together potentiate the occurrence of SCFE and tibia vara. If proven true, it is plausible that hypertension may represent a modifiable risk factor for obesity-related bone disease. LEVEL OF EVIDENCE: Level III-case-control study.

Surgical site infection in orthopedic trauma: A case-control study evaluating risk factors and cost.

BACKGROUND: With the shift of our healthcare system toward a value-based system of reimbursement, complications such as surgical site infections (SSI) may not be reimbursed. The purpose of our study was to investigate the costs and risk factors of SSI for orthopedic trauma patients. METHODS: Through retrospective analysis, 1819 patients with isolated fractures were identified. Of those, 78 patients who developed SSIs were compared to 78 uninfected control patients. Patients were matched by fracture location, type of fracture, duration of surgery, and as close as possible to age, year of surgery, and type of procedure. Costs for treatment during primary hospitalization and initial readmission were determined and potential risk factors were collected from patient charts. A Wilcoxon test was used to compare the overall costs of treatment for case and control patients. Costs were further broken down into professional fees and technical charges for analysis. Risk factors for SSIs were analyzed through a chi-squared analysis. RESULTS: Median cost for treatment for patients with SSIs was $108,782 compared to $57,418 for uninfected patients (p < 0.001). Professional fees and technical charges were found to be significantly higher for infected patients. No significant risk factors for SSIs were determined. CONCLUSIONS: Our findings indicate the potential for financial losses in our new healthcare system due to uncompensated care. SSIs nearly double the cost of treatment for orthopedic trauma patients. There is no single driver of these costs. Reducing postoperative stay may be one method for reducing the cost of treating SSIs, whereas quality management programs may decrease risk of infection.

Predictors for Surgery in Shoulder Instability: A Retrospective Cohort Study Using the FEDS System.

BACKGROUND: Shoulder instability is a common cause of pain and dysfunction in young, active patients. While studies have analyzed risk factors for recurrent instability and failure after instability surgery, few have examined which variables are associated with initial surgery in this patient population. PURPOSE: To identify variables that may be associated with surgical intervention in patients with shoulder instability in the context of the FEDS (frequency, etiology, direction, severity) classification, a system that may be useful in the surgical treatment of shoulder instability patients. STUDY DESIGN: Cohort study (prognosis); Level of evidence, 2. METHODS: A database of patients treated for shoulder instability from 3 separate institutions from 2005 to 2010 was generated using International Classification of Diseases-9th Revision data. Data were collected via retrospective review. Injury data were categorized according to the FEDS system. Data were analyzed for significance, with the primary outcome of surgical intervention. Summary statistics were used to assess which variables were associated with eventual surgery. To test the unadjusted bivariate associations between shoulder surgery and each data point, Pearson chi-square tests were used for categorical variables and Wilcoxon tests were used for continuous variables. RESULTS: Over the study time period, 377 patients were treated for shoulder instability. Patients who had surgery were more likely younger, had recurrent instability, and had their initial injury while playing a sport. Most patients had anterior instability; however, there was a greater proportion of posterior instability patients in the operative group. Severity of dislocation, measured by whether the patient required help to relocate the shoulder, was not significantly associated with eventual surgery. While imaging was not available for all patients, surgical patients were more likely to have magnetic resonance imaging findings of anterior labral injury and less likely to have a supraspinatus or subscapularis tear. CONCLUSION: Patients who underwent surgery for shoulder instability were younger, more likely to have experienced recurrent instability, and more likely to have sustained their original injury while playing sports. The FEDS classification, particularly the frequency and etiology of the patient's shoulder instability, may be helpful in identifying patients with a higher likelihood of undergoing surgical treatment.

Development of a multivariable model to predict vulnerability in older American patients hospitalised with cardiovascular disease.

OBJECTIVES: To identify vulnerable cardiovascular patients in the hospital using a self-reported function-based screening tool. PARTICIPANTS: Prospective observational cohort study of 445 individuals aged ≥ 65 years admitted to a university medical centre hospital within the USA with acute coronary syndrome and/or decompensated heart failure. METHODS: Participants completed an inperson interview during hospitalisation, which included vulnerable functional status using the Vulnerable Elders Survey (VES-13), sociodemographic, healthcare utilisation practices and clinical patient-specific measures. A multivariable proportional odds logistic regression model examined associations between VES-13 and prior healthcare utilisation, as well as other coincident medical and psychosocial risk factors for poor outcomes in cardiovascular disease. RESULTS: Vulnerability was highly prevalent (54%) and associated with a higher number of clinic visits, emergency room visits and hospitalisations (all p<0.001). A multivariable analysis demonstrating a 1-point increase in VES-13 (vulnerability) was independently associated with being female (OR 1.55, p=0.030), diagnosis of heart failure (OR 3.11, p<0.001), prior hospitalisations (OR 1.30, p<0.001), low social support (OR 1.42, p=0.007) and depression (p<0.001). A lower VES-13 score (lower vulnerability) was associated with increased health literacy (OR 0.70, p=0.002). CONCLUSIONS: Vulnerability to functional decline is highly prevalent in hospitalised older cardiovascular patients and was associated with patient risk factors for adverse outcomes and an increased use of healthcare services.

Association of Meniscal Status, Lower Extremity Alignment, and Body Mass Index With Chondrosis at Revision Anterior Cruciate Ligament Reconstruction.

BACKGROUND: Knees undergoing revision anterior cruciate ligament reconstruction (rACLR) have a high prevalence of articular cartilage lesions. HYPOTHESIS: The prevalence of chondrosis at the time of rACLR is associated with meniscal status and lower extremity alignment. STUDY DESIGN: Cross-sectional study; Level of evidence, 3. METHODS: Data from the prospective Multicenter ACL Revision Study (MARS) cohort were reviewed to identify patients with preoperative lower extremity alignment films. Lower extremity alignment was defined by the weightbearing line (WBL) as a percentage of the tibial plateau width, while the chondral and meniscal status of each weightbearing compartment was recorded at the time of surgery. Multivariable proportional odds models were constructed and adjusted for relevant factors to examine which risk factors were independently associated with the degree of medial and lateral compartment chondrosis. RESULTS: The cohort included 246 patients with lower extremity alignment films at the time of rACLR. Mean (±SD) patient age was 26.9 ± 9.5 years and body mass index (BMI) was 26.4 ± 4.6. The medial compartment had more chondrosis (grade 2/3, 42%; grade 4, 6.5%) than did the lateral compartment (grade 2/3, 26%; grade 4, 6.5%). Disruption of the meniscus was noted in 35% of patients on the medial side and 16% in the lateral side. The mean WBL was 0.43 ± 0.13. Medial compartment chondrosis was associated with BMI (P = .025), alignment (P = .002), and medial meniscal status (P = .001). None of the knees with the WBL lateral to 0.625 had grade 4 chondrosis in the medial compartment. Lateral compartment chondrosis was significantly associated with age (P = .013) and lateral meniscal status (P < .001). Subjects with "intact" menisci were found to decrease their odds of having chondrosis by 64% to 84%. CONCLUSION: The status of articular cartilage in the tibiofemoral compartments at the time of rACLR is related to meniscal status. Lower extremity alignment and BMI are associated with medial compartment chondrosis.