Shoe Allergens: A Retrospective Analysis of Cross-sectional Data From the North American Contact Dermatitis Group, 2005-2018.

BACKGROUND: Shoe contact allergy can be difficult to diagnose and manage. OBJECTIVE: The aim of the study was to characterize demographics, clinical characteristics, patch test results, and occupational data for the North American Contact Dermatitis Group patients with shoe contact allergy. METHODS: This is a retrospective study of 33,661 patients, patch tested from 2005 to 2018, with a shoe source, foot as 1 of 3 sites of dermatitis, and final primary diagnosis of allergic contact dermatitis. RESULTS: Three hundred fifty-two patients met the inclusion criteria. They were more likely to be male (odds ratio = 3.36, confidence interval = 2.71-4.17) and less likely to be older than 40 years (odds ratio = 0.49, confidence interval = 0.40-0.61) compared with others with positive patch test reactions. The most common relevant North American Contact Dermatitis Group screening allergens were potassium dichromate (29.8%), p-tert-butylphenol formaldehyde resin (20.1%), thiuram mix (13.3%), mixed dialkyl thioureas (12.6%), and carba mix (12%). A total of 29.8% (105/352) had positive patch test reactions to supplemental allergens, and 12.2% (43/352) only had reactions to supplemental allergens. CONCLUSIONS: Shoe contact allergy was more common in younger and male patients. Potassium dichromate and p-tert-butylphenol formaldehyde resin were the top shoe allergens. Testing supplemental allergens, personal care products, and shoe components should be part of a comprehensive evaluation of suspected shoe contact allergy.

Appropriate patient selection for outpatient shoulder arthroplasty: a risk prediction tool.

BACKGROUND: The transition from inpatient to outpatient shoulder arthroplasty critically depends on appropriate patient selection, both to ensure safety and to counsel patients preoperatively regarding individualized risk. Cost and patient demand for same-day discharge have encouraged this transition, and a validated predictive tool may help decrease surgeon liability for complications and help select patients appropriate for same-day discharge. We hypothesized that an accurate predictive model could be created for short inpatient length of stay (discharge at least by postoperative day 1), potentially serving as a useful proxy for identifying patients appropriate for true outpatient shoulder arthroplasty. METHODS: A multicenter cohort of 5410 shoulder arthroplasties (2805 anatomic and 2605 reverse shoulder arthroplasties) from 2 geographically diverse, high-volume health systems was reviewed. Short inpatient stay was the primary outcome, defined as discharge on either postoperative day 0 or 1, and 49 patient outcomes and factors including the Elixhauser Comorbidity Index, sociodemographic factors, and intraoperative parameters were examined as candidate predictors for a short stay. Factors surviving parameter selection were incorporated into a multivariable logistic regression model, which underwent internal validation using 10,000 bootstrapped samples. RESULTS: In total, 2238 patients (41.4%) were discharged at least by postoperative day 1, with no difference in rates of 90-day readmission (3.5% vs. 3.3%, P = .774) between cohorts with a short length of stay and an extended length of stay (discharge after postoperative day 1). A multivariable logistic regression model demonstrated high accuracy (area under the receiver operator characteristic curve, 0.762) for discharge by postoperative day 1 and was composed of 13 variables: surgery duration, age, sex, electrolyte disorder, marital status, American Society of Anesthesiologists score, paralysis, diabetes, neurologic disease, peripheral vascular disease, pulmonary circulation disease, cardiac arrhythmia, and coagulation deficiency. The percentage cutoff maximizing sensitivity and specificity was calculated to be 47%. Internal validation showed minimal loss of accuracy after bias correction for overfitting, and the predictive model was incorporated into a freely available online tool to facilitate easy clinical use. CONCLUSIONS: A risk prediction tool for short inpatient length of stay after shoulder arthroplasty reaches very good accuracy despite requiring only 13 variables and was derived from an underlying database with broad geographic diversity in the largest institutional shoulder arthroplasty cohort published to date. Short inpatient length of stay may serve as a proxy for identifying patients appropriate for same-day discharge, although perioperative care decisions should always be made on an individualized and holistic basis.

Effects of Virtual Exercise Rehabilitation In-Home Therapy Compared with Traditional Care After Total Knee Arthroplasty: VERITAS, a Randomized Controlled Trial.

BACKGROUND: Financial burden for patients, providers, and payers can reduce access to physical therapy (PT) after total knee arthroplasty (TKA). The purpose of the present study was to examine the effect of a virtual PT program on health-care costs and clinical outcomes as compared with traditional care after TKA. METHODS: At least 10 days before unilateral TKA, patients from 4 clinical sites were enrolled and randomized 1:1 to the virtual PT program (involving an avatar [digitally simulated] coach, in-home 3-dimensional biometrics, and telerehabilitation with remote clinician oversight by a physical therapist) or to traditional PT care in the home or outpatient clinic. The primary outcome was total health-care costs for the 12-week post-hospital period. Secondary (noninferiority) outcomes included 6 and 12-week Knee injury and Osteoarthritis Outcome Score (KOOS); 6-week knee extension, knee flexion, and gait speed; and 12-week safety measures (patient-reported falls, pain, and hospital readmissions). All outcomes were analyzed on a modified intent-to-treat basis. RESULTS: Of 306 patients (mean age, 65 years; 62.5% women) who were randomized from November 2016 to November 2017, 290 had TKA and 287 (including 143 in the virtual PT group and 144 in the usual care group) completed the trial. Virtual PT had lower costs at 12 weeks after discharge than usual care (median, $1,050 compared with $2,805; p < 0.001). Mean costs were $2,745 lower for virtual PT patients. Virtual PT patients had fewer rehospitalizations than the usual care group (12 compared with 30; p = 0.007). Virtual PT was noninferior to usual PT in terms of the KOOS at 6 weeks (difference, 0.77; 90% confidence interval [CI], -1.68 to 3.23) and 12 weeks (difference, -2.33; 90% CI, -4.98 to 0.31). Virtual PT was also noninferior to usual care at 6 weeks in terms of knee extension, knee flexion, and gait speed and at 12 weeks in terms of pain and hospital readmissions. Falls were reported by 19.4% of virtual PT patients and 14.6% of usual care patients (difference, 4.83%; 90% CI, -2.60 to 12.25). CONCLUSIONS: Relative to traditional home or clinic PT, virtual PT with telerehabilitation for skilled clinical oversight significantly lowered 3-month health-care costs after TKA while providing similar effectiveness. These findings have important implications for patients, health systems, and payers. Virtual PT with clinical oversight should be considered for patients managed with TKA. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Identification, diagnosis, treatment, and in-hospital outcomes of acute pulmonary embolism: Results from a single integrated health system.

BACKGROUND: Although the high-risk acute pulmonary embolism (PE) population has been described, little is known about the contemporary inpatient experience and practice patterns of the PE population as a whole. METHODS: All patients with a diagnosis of acute PE from January 1, 2016, to June 30, 2017 within our academic, multihospital health system were retrospectively identified using International Classification of Diseases, 10th Revision, codes, and data were manually abstracted by 2 clinical investigators. Descriptive analyses were performed according to clinical risk stratification categories from the European Society of Cardiology. RESULTS: Of 829 total patients, 372 (44.8%) patients had intermediate or high-risk PE. Mean age was 62.1 years old, and 42.1% of patients had a history of malignancy. One hundred fifty-three (18.5%) patients had an acute PE during a hospitalization for another indication. A total of 6.0% underwent invasive PE therapies, 26.1% required intensive care unit admission, and 9.0% experienced in-hospital death or hospice discharge. In a subgroup description, patients who developed acute PE during a hospitalization for another indication had a higher incidence of incomplete risk stratification and a higher mortality (9.8%) than the primary cohort. Mortality was attributed to PE in 48.4% of cases. CONCLUSIONS: This contemporary description of acute PE managed at a single large, multihospital academic health system highlights substantial health care utilization and high mortality despite the available of advanced therapeutics. Additional work is needed to standardize care for the heterogeneous PE population to ensure appropriate allocation of resources and improved outcomes for all PE patients.

Assessing the impact of a remote digital coaching engagement program on patient-reported outcomes in asthma.

BACKGROUND: Low adherence and poor outcomes provide opportunity for digital coaching to engage patients with uncontrolled asthma in their care to improve outcomes. OBJECTIVE(S): To examine the impact of a remote digital coaching program on asthma control and patient experience. METHODS: We recruited 51 adults with uncontrolled asthma, denoted by albuterol use of >2 times per week and/or exacerbations requiring corticosteroids, and applied a 12-week patient-centered remote digital coaching program using a combination of educational pamphlets, symptom trackers, best peak flow establishment, physical activity, and dietary counseling, as well as coaches who implemented emotional enforcement to motivate disease self-management through telephone, text, and email. Baseline and post-intervention measures were quality of life (QOL), spirometry, Asthma Control Test (ACT), Asthma Symptom Utility Index (ASUI), rescue albuterol use, and exacerbation history. RESULTS: Among 51 patients recruited, 40 completed the study. Eight subjects required assistance reading medical materials. Significant improvements from baseline were observed for Patient-Reported Outcomes Measurement Information System mental status (p = 0.010), body weight, and outpatient exacerbation frequency (p = 0.028). The changes from baseline in ACT (p = 0.005) were statistically significant but did not achieve the pre-specified minimum clinically important difference (MCID), whereas for ASUI, the MCID and statistical significance were achieved. Spirometry and rescue albuterol use were no different. CONCLUSION: A patient-oriented, remote digital coaching program that utilized trained health coaches and digital materials led to statistically significant improvement in mental status, outpatient exacerbations, body weight, and ASUI. Digital coaching programs may improve some outcomes in adults with uncontrolled asthma.

Impact of perioperative allogeneic and autologous blood transfusion on acute wound infection following total knee and total hip arthroplasty.

BACKGROUND: Patients undergoing total hip or knee arthroplasty frequently receive blood transfusions. The relationship between transfusion and the risk of infection following total joint arthroplasty is unclear. In this study, we sought to examine the impact of allogeneic and autologous transfusion on the risk of acute infection following total hip and total knee arthroplasty. METHODS: We performed a retrospective study of consecutive primary total knee arthroplasties and total hip arthroplasties. Patients who had a reoperation for suspected infection within three months after the arthroplasty were identified. Differences in risk factors were assessed across transfusion groups: no transfusion, autologous only, and allogeneic exposure (allogeneic with or without additional autologous transfusion). Backward-stepwise logistic regression analysis was used to compare reoperations (as outcomes) between cases with and those without allogeneic exposure. Prespecified covariates were body mass index, diabetes, an American Society of Anesthesiologists (ASA) score of >2, preoperative hematocrit, and total number of units transfused perioperatively. RESULTS: We identified 3352 patients treated with a total hip or knee arthroplasty (1730 total knee arthroplasties and 1622 total hip arthroplasties) for inclusion in the study. Transfusion was given in 1746 cases: 836 of them had allogeneic exposure, and 910 had autologous-only transfusion. There were thirty-two reoperations (0.95%) for suspected infection. Between-group risk-factor differences were observed. The mean age and the rates of diabetes, immunosuppression, ASA scores of >2, and bilateral surgery were highest in the allogeneic group, as were estimated blood loss, surgery duration, and total number of units transfused (p < 0.001). In the unadjusted analyses, the rate of reoperations for suspected infection was higher in the cases with allogeneic exposure (1.67%) than in those without allogeneic exposure (0.72%) (p = 0.013). Autologous-only transfusion was not associated with a higher reoperation rate. However, multivariable logistic regression demonstrated that the total number of units transfused (p = 0.011) and an ASA score of >2 (p = 0.008)-but not allogeneic exposure-were significantly predictive of a reoperation. CONCLUSIONS: Perioperative allogeneic transfusion was associated with a higher rate of reoperations for suspected acute infection. However, patients with allogeneic exposure had increased infection risk factors. After adjustment for the total number of units transfused and an ASA score of >2, allogeneic exposure was not significantly predictive of a reoperation for infection.

Detection of QT prolongation using a novel electrocardiographic analysis algorithm applying intelligent automation: prospective blinded evaluation using the Cardiac Safety Research Consortium electrocardiographic database.

BACKGROUND: The Cardiac Safety Research Consortium (CSRC) provides both "learning" and blinded "testing" digital electrocardiographic (ECG) data sets from thorough QT (TQT) studies annotated for submission to the US Food and Drug Administration (FDA) to developers of ECG analysis technologies. This article reports the first results from a blinded testing data set that examines developer reanalysis of original sponsor-reported core laboratory data. METHODS: A total of 11,925 anonymized ECGs including both moxifloxacin and placebo arms of a parallel-group TQT in 181 subjects were blindly analyzed using a novel ECG analysis algorithm applying intelligent automation. Developer-measured ECG intervals were submitted to CSRC for unblinding, temporal reconstruction of the TQT exposures, and statistical comparison to core laboratory findings previously submitted to FDA by the pharmaceutical sponsor. Primary comparisons included baseline-adjusted interval measurements, baseline- and placebo-adjusted moxifloxacin QTcF changes (ddQTcF), and associated variability measures. RESULTS: Developer and sponsor-reported baseline-adjusted data were similar with average differences <1 ms for all intervals. Both developer- and sponsor-reported data demonstrated assay sensitivity with similar ddQTcF changes. Average within-subject SD for triplicate QTcF measurements was significantly lower for developer- than sponsor-reported data (5.4 and 7.2 ms, respectively; P < .001). CONCLUSION: The virtually automated ECG algorithm used for this analysis produced similar yet less variable TQT results compared with the sponsor-reported study, without the use of a manual core laboratory. These findings indicate that CSRC ECG data sets can be useful for evaluating novel methods and algorithms for determining drug-induced QT/QTc prolongation. Although the results should not constitute endorsement of specific algorithms by either CSRC or FDA, the value of a public domain digital ECG warehouse to provide prospective, blinded comparisons of ECG technologies applied for QT/QTc measurement is illustrated.

Correlations between preprocedure mood and clinical outcome in patients undergoing coronary angioplasty.

We studied the relationship between mood and mood shift immediately before percutaneous coronary intervention (PCI) and 3 end points: total ischemic burden during PCI, adverse cardiac end points (ACE) after PCI, and death by 6-month follow up. Patients (n = 119) with unstable angina or myocardial infarction completed a visual analog scale (VAS) twice before PCI; before and after a session of stress relaxation, imagery, or touch; or approximately 30 minutes apart for patients assigned to prayer or to standard care. VAS included happiness, satisfaction, calm, hope, worry, shortness of breath, fear, and sadness. We observed a significant correlation between higher hope score before PCI and lower ischemic burden. Patients who experienced ACE had significantly lower hope and happiness scores than those who did not. Patients who survived to 6 months had significantly greater increases in worry and in hope. Our data suggest correlations between simple mood assessments before PCI and clinical outcomes during and after the procedure. More study is needed to understand whether attempts to alter patient mood can affect clinical outcomes.