A randomized prospective trial of an ostomy telehealth intervention for cancer survivors.

BACKGROUND: Cancer survivors with ostomies face complex challenges. This study compared the Ostomy Self-Management Telehealth program (OSMT) versus attention control usual care (UC). METHODS: Three academic centers randomized participants. OSMT group sessions were led by ostomy nurses and peer ostomates (three for ostomates-only, one for support persons, and one review session for both). Surveys at baseline, OSMT completion, and 6 months were primary outcome patient activation (PAM), self-efficacy (SE), City of Hope quality of life-Ostomy (COH-O), and Hospital Anxiety and Depression Scale (HADS). Surveys were scored per guidelines for those completing at least two surveys. Linear mixed effects models were used to select potential covariates for the final model and to test the impact of OSMT within each timeframe. RESULTS: A total of 90 OSMT and 101 UC fulfilled analysis criteria. Arms were well-matched but types of tumors were unevenly distributed (p = .023). The OSMT arm had a nonsignificant improvement in PAM (confidence interval [CI], -3.65 to 5.3]; 4.0 vs. 2.9) at 6 months. There were no significant differences in other surveys. There was a significant OSMT benefit for urinary tumors (four SE domains). Higher OSMT session attendance was associated with post-session improvements in five SE domains (p < .05), two COH-O domains (p < .05), and HADS anxiety (p = .01). At 6 months, there remained improvements in one SE domain (p < .05), one COH-O domain (p < .05), and HADS anxiety (p < .01). CONCLUSIONS: No clear benefit was seen for the OSMT intervention, although there may be an advantage based on type of tumor. Benefit with greater session attendance was also encouraging. PLAIN LANGUAGE SUMMARY: Cancer patients with ostomies have many challenges. We tested a telehealth curriculum compared to usual care. There are indications of benefit for the program for those that attend more sessions and those with urostomies.

A targeted strategic peer support intervention to increase adherence to video teletherapy exposure and response prevention treatment for obsessive-compulsive disorder: a retrospective observational analysis.

Exposure and response prevention (ERP) therapy, a form of cognitive-behavioral therapy, is a first-line, evidence-based treatment for obsessive-compulsive disorder (OCD) for adults and children. It is effective for the majority of those who engage in it, but treatment adherence can be challenging for some due to the stress involved in the treatment as well as different life circumstances that arise. To help improve treatment adherence, NOCD, a provider of video teletherapy ERP, identifies those at risk of non-adherence using a prediction algorithm trained on a data set of N = 13,809 and provides targeted peer support interventions by individuals ("Member Advocates") who successfully completed ERP treatment for OCD. Member Advocates, using lived OCD experience as well as experience with ERP, engage at-risk patients through digital messaging to engage, educate, and encourage patients in the early stages of treatment. From June 2022 to August 2022, N = 815 patients deemed at risk were reached out to and n = 251 responded and engaged with the Member Advocates. In the at-risk patients who engaged, the intervention resulted in a significant mean 30.4% more therapy hours completed compared to those who did not engage. Additionally, engaged patients had greater reductions in OCD severity. These results have implications for how data science, digital interventions, and strategic peer-to-peer communication and support can be combined to enhance the effectiveness of treatment.

Intimacy and survivors of cancer with ostomies: findings from the Ostomy Self-management Training trial.

BACKGROUND: Many people with abdominal or pelvic cancers require an ostomy during surgical treatment, which can cause significant issues with physical and emotional intimacy in relationships. AIM: To evaluate the effect of a telehealth-based education program on intimacy over time for survivors of cancer with ostomies. METHODS: We performed a secondary analysis of our multicenter randomized controlled trial to determine intimacy outcomes and to compare the effects of the Ostomy Self-management Training (OSMT) program vs usual care. Partnered patients were included who provided answers to the City of Hope Quality of Life-Ostomy survey for at least 2 time points during the study. We evaluated the effect of baseline information, such as gender on intimacy. OUTCOMES: The primary outcome was intimacy, estimated by a composite score created from questions within the City of Hope Quality of Life-Ostomy survey. RESULTS: Of 216 enrolled volunteers, 131 had a partner: 68 in the OSMT arm and 63 in the usual care arm. Of these, 48 were women and 83 were men. The tumor types represented in this study were colorectal (n = 69), urinary (n = 45), gynecologic (n = 10), and other (n = 7; eg, melanoma, liposarcoma). From the cohort, 87 answered the 5 composite intimacy score questions at 2 time points, including baseline. There was significant improvement over time in composite intimacy scores for participants in the OSMT arm vs the usual care arm. CLINICAL IMPLICATIONS: Our OSMT intervention had a positive effect on factors that contribute to intimacy for survivors of cancer with ostomies, suggesting that a survivorship curriculum can improve their experiences after ostomy surgery. STRENGTHS AND LIMITATIONS: OSMT allowed for discussion of intimacy and other sensitive topics, which can be challenging. These discussions demonstrate benefit to participants and can serve as frameworks for cancer treatment providers. The focus of this work on partnered participants provides insight into the interpersonal challenges of a life with an ostomy, but it may overlook the important perspectives of nonpartnered participants and the partners themselves. Furthermore, limited power prevented us from conducting subgroup analyses exploring the effects of factors such as gender and tumor type on intimacy. CONCLUSION: At 6-month follow-up, the novel intimacy composite score indicated improvement for participants completing the OSMT intervention. Future research studies with higher power will validate this intimacy measurement and identify intimacy differences in similar populations based on tumor type.

Central and peripheral α-synuclein in Parkinson disease detected by seed amplification assay.

OBJECTIVES: Detection of α-synuclein aggregates by seed amplification is a promising Parkinson disease biomarker assay. Understanding intraindividual relationships of α-synuclein measures could inform optimal biomarker development. The objectives were to test accuracy of α-synuclein seed amplification assay in central (cerebrospinal fluid) and peripheral (submandibular gland) sources, compare to total α-synuclein measures, and investigate within-subject relationships. METHODS: The Systemic Synuclein Sampling Study aimed to characterize α-synuclein in multiple tissues and biofluids within Parkinson disease subjects (n = 59) and compared to healthy controls (n = 21). Motor and non-motor measures and dopamine transporter scans were obtained. Four measures of α-synuclein were compared: seed amplification assay in cerebrospinal fluid and formalin-fixed paraffin-embedded submandibular gland, total α-synuclein quantified in biofluids using enzyme-linked immunoassay, and aggregated α-synuclein in submandibular gland detected by immunohistochemistry. Accuracy of seed amplification assay for Parkinson disease diagnosis was examined and within-subject α-synuclein measures were compared. RESULTS: Sensitivity and specificity of α-synuclein seed amplification assay for Parkinson disease diagnosis was 92.6% and 90.5% in cerebrospinal fluid, and 73.2% and 78.6% in submandibular gland, respectively. 25/38 (65.8%) Parkinson disease participants were positive for both cerebrospinal fluid and submandibular gland seed amplification assay. Comparing accuracy for Parkinson disease diagnosis of different α-synuclein measures, cerebrospinal fluid seed amplification assay was the highest (Youden Index = 83.1%). 98.3% of all Parkinson disease cases had ≥1 measure of α-synuclein positive. INTERPRETATION: α-synuclein seed amplification assay (cerebrospinal fluid>submandibular gland) had higher sensitivity and specificity compared to total α-synuclein measures, and within-subject relationships of central and peripheral α-synuclein measures emerged.

CT findings and outcomes of acute cholecystitis: is additional ultrasound necessary?

BACKGROUND: While ultrasound is often the preferred imaging modality for suspected acute cholecystitis (AC), CT is often the first line study when patients are being evaluated for abdominal pain. The diagnostic value of CT in the setting of AC is controversial, given the prevalent use of additional imaging. PURPOSE: To evaluate the positive predictive value (PPV) of CT for diagnosing acute cholecystitis (AC) when used as a first line imaging study for evaluating abdominal pain and assess if additional imaging with ultrasound studies provides additional clinically useful information. MATERIALS AND METHODS: Abnormal gallbladder findings in CT imaging studies were queried in a retrospective study over a 25-month period within a large urban health system. Sonographic (US) studies performed within 72 h of the initial CT were also included. Outcomes were determined by surgical pathology, fluid analysis, and clinical outcomes. Cases were stratified by the interpreting radiologist's subjective confidence level of diagnosing AC, and the PPVs were compared between cases using CT without US and cases with both CT and US. RESULTS: Of the 468 CT studies meeting criteria, 192 were read as concerning for AC. PPV of CT was 44.7% without US and 50.5% when US was positive, which amounted to an insignificant gain (p = 0.41). When subdividing by confidence level, high-confidence positive CTs demonstrated no significant difference without ultrasound (80%) compared to with ultrasound (75%). Less confident reads in CT demonstrated potential gain from ultrasound; in the case of a "probable" CT impression, PPV increased from 45% without US to 90% with a high-confidence ultrasound impression. CONCLUSION: Based on current practice within a large health system, CT examinations with high suspicion for AC demonstrated little gain from follow-up ultrasound. However, ultrasound may be of benefit when CT interpretations are less confident but still suspicious for AC.

Risk factors for an advanced breast cancer diagnosis within 2 years of a negative mammogram.

BACKGROUND: Identifying women at risk for advanced interval cancers would allow better targeting of mammography and supplemental screening. The authors assessed risk factors for advanced breast cancer within 2 years of a negative mammogram. METHODS: The authors included 293,520 negative mammograms performed from 2006 to 2015 among 74,736 women. Breast cancers were defined as advanced if they were >2 cm, were >1 cm and triple-negative or human epidermal growth factor receptor 2-positive, had positive lymph nodes, or were metastatic. Cox proportional hazards modeling was used to evaluate associations of age, breast density, menopause, mammogram type, prior breast biopsy, body mass index (BMI), and a family history of breast cancer with a cancer diagnosis within 2 years of a negative mammogram. Models were stratified by year since a negative mammogram. RESULTS: Among 1345 breast cancers, 357 were advanced (26.5%), and 988 (73.5%) were at an early stage. Breast density, prior biopsy, and family history were associated with an increased risk of both advanced and early-stage cancers. Overweight and obese women had a 40% higher risk of early-stage cancer only in year 2 (overweight hazard ratio [HR], 1.41; 95% confidence interval [CI], 1.19-1.67; P < .001; obese HR, 1.41; 95% CI, 1.17-1.70; P < .001). Obese women had a 90% increased risk of advanced cancer in year 1 (HR, 1.90; 95% CI, 1.14-3.18; P = .014), and both overweight and obese women had a 40% or greater increased risk in year 2 (overweight HR, 1.55; 95% CI, 1.14-2.07; P = .005; obese HR, 1.42; 95% CI, 1.00-2.01; P = .051). CONCLUSIONS: A higher BMI was associated with an advanced breast cancer diagnosis within 2 years of a negative mammogram. These results have important implications for risk assessment, screening intervals, and use of supplemental screening.

Correction: Propensity score matching in otolaryngologic literature: A systematic review and critical appraisal.

[This corrects the article DOI: 10.1371/journal.pone.0244423.].

Time to Clinical Response in the Treatment of Early Onset Schizophrenia Spectrum Disorders Study.

Objectives: We investigated the time course of clinical response in the Treatment of Early Onset Schizophrenia Spectrum Disorders Study (TEOSS). Methods: TEOSS randomized 119 predominantly outpatient youth ages 8-19 years with schizophrenia or schizoaffective disorder to 8 weeks of treatment with molindone, risperidone, or olanzapine. We used proportional hazards regression to determine whether these three antipsychotics differed in the time until clinical response, defined as the time from treatment initiation to the point of achieving a Clinical Global Impressions-Improvement (CGI-I) scale score of 1 ("very much improved") or 2 ("much improved") that was maintained until week 8. Results: Of the 116 youth who initiated treatment, 56 (48%) achieved clinical response. Among clinical responders, the median (±interquartile range) time until clinical response was 4.0 (±4.0) weeks for olanzapine, 4.5 (±4.0) weeks for risperidone, and 6.0 (±4.0) weeks for molindone. There were no significant differences in time course for clinical response between medications (p = 0.84). Youth without symptom improvement (CGI-I ≥ 4) after 3 weeks were more likely to be clinical nonresponders at week 8 (relative risk ratio = 1.98, 95% confidence interval 1.29-3.05), compared with youth with at-least-minimal symptom improvement after 3 weeks when looking at all antipsychotics combined. Conclusion: To our knowledge, our study is the first to investigate medication differences in treatment response timing in early onset schizophrenia spectrum disorders. Clinical response times for molindone, risperidone, and olanzapine were not significantly different. Furthermore, while lack of early improvement predicted clinical nonresponse, whether or not to continue antipsychotic treatment after 3 or more weeks without symptom improvement should be based on clinical judgment after weighing potential risks, benefits, and alternatives. ClinicalTrials.gov Identifier: NCT00053703.

Propensity score matching in otolaryngologic literature: A systematic review and critical appraisal.

BACKGROUND: Propensity score techniques can reduce confounding and bias in observational studies. Such analyses are able to measure and balance pre-determined covariates between treated and untreated groups, leading to results that can approximate those generated by randomized prospective studies when such trials are not feasible. The most commonly used propensity score -based analytic technique is propensity score matching (PSM). Although PSM popularity has continued to increase in medical literature, improper methodology or methodological reporting may lead to biased interpretation of treatment effects or limited scientific reproducibility and generalizability. In this study, we aim to characterize and assess the quality of PSM methodology reporting in high-impact otolaryngologic literature. METHODS: PubMed and Embase based systematic review of the top 20 journals in otolaryngology, as measured by impact factor from the Journal Citations Reports from 2012 to 2018, for articles using PSM analysis throughout their publication history. Eligible articles were reviewed and assessed for quality and reporting of PSM methodology. RESULTS: Our search yielded 101 studies, of which 92 were eligible for final analysis and review. The proportion of studies utilizing PSM increased significantly over time (p < 0.001). Nearly all studies (96.7%, n = 89) specified the covariates used to calculate propensity scores. Covariate balance was illustrated in 67.4% (n = 62) of studies, most frequently through p-values. A minority (17.4%, n = 16) of studies were found to be fully reproducible according to previously established criteria. CONCLUSIONS: While PSM analysis is becoming increasingly prevalent in otolaryngologic literature, the quality of PSM methodology reporting can be improved. We provide potential recommendations for authors regarding optimal reporting for analyses using PSM.

Three-Dimensional Augmented Reality Visualization Informs Locoregional Therapy in a Translational Model of Hepatocellular Carcinoma.

PURPOSE: To evaluate the utility of visualizing preprocedural MR images in 3-dimensional (3D) space using augmented reality (AR) before transarterial embolization of hepatocellular carcinoma (HCC) in a preclinical model. MATERIALS AND METHODS: A total of 28 rats with diethylnitrosamine-induced HCCs > 5 mm treated with embolization were included in a prospective study. In 12 rats, 3D AR visualization of preprocedural MR images was performed before embolization. Procedural metrics including catheterization time and radiation exposure were compared vs a prospective cohort of 16 rats in which embolization was performed without AR. An additional cohort of 15 retrospective cases was identified and combined with the prospective control cohort (n = 31) to improve statistical power. RESULTS: A 37% reduction in fluoroscopy time, from 11.7 min to 7.4 minutes, was observed with AR when compared prospectively, which did not reach statistical significance (P = .12); however, when compared with combined prospective and retrospective controls, the reduction in fluoroscopy time from 14.1 min to 7.4 minutes (48%) was significant (P = .01). A 27% reduction in total catheterization time, from 42.7 minutes to 31.0 minutes, was also observed with AR when compared prospectively, which did not reach statistical significance (P = .11). No significant differences were seen in dose-area product or air kerma prospectively. CONCLUSIONS: Three-dimensional AR visualization of preprocedural imaging may aid in the reduction of procedural metrics in a preclinical model of transarterial embolization. These data support the need for further studies to evaluate the potential of AR in endovascular oncologic interventions.

Goals-of-Care Consultation Associated With Increased Hospice Enrollment Among Propensity-Matched Cohorts of Seriously Ill African American and White Patients.

CONTEXT: African Americans are less likely to receive hospice care and more likely to receive aggressive end-of-life care than whites. Little is known about how palliative care consultation (PCC) to discuss goals of care is associated with hospice enrollment by race. OBJECTIVES: To compare enrollment in hospice at discharge between propensity-matched cohorts of African Americans with and without PCC and whites with and without PCC. METHODS: Secondary analysis of a retrospective cohort study at a high-acuity hospital; using stratified propensity-score matching for 35,154 African Americans and whites aged 18+ admitted for conditions other than childbirth or rehabilitation, who were not hospitalized at end of study, and did not die during index hospitalization (hospitalization during which first PCC occurred). RESULTS: Compared with African Americans without PCC, African Americans with PCC were 15 times more likely to be discharged to hospice from index hospitalization (2.4% vs. 36.5%; P < 0.0001). Compared with white patients without PCC, white patients with PCC were 14 times more likely to be discharged to hospice from index hospitalization (3.0% vs. 42.7%; P < 0.0001). CONCLUSION: In propensity-matched cohorts of seriously ill patients, PCC to discuss goals of care was associated with significant increases in hospice enrollment at discharge among both African Americans and whites. Research is needed to understand how PCC influences decision making by race, how PCC is associated with postdischarge hospice outcomes such as disenrollment and hospice lengths of stay, and if PCC is associated with improving racial disparities in end-of-life care.

Goals-of-Care Consultations Are Associated with Lower Costs and Less Acute Care Use among Propensity-Matched Cohorts of African Americans and Whites with Serious Illness.

Background: African Americans receive more aggressive end-of-life care than Whites. Little is known about how palliative care consultation to discuss goals-of-care ("PCC") is associated with acute care utilization and costs by race. Objective: To compare future acute care costs and utilization between propensity-matched cohorts of African Americans with and without PCC, and Whites with and without PCC. Design: Secondary analysis of a retrospective cohort study. Setting/Subjects: Thirty-five thousand one hundred and fifty-four African Americans and Whites age 18+ admitted for conditions other than childbirth or rehabilitation, who were not hospitalized at the end of the study, and did not die during index hospitalization (hospitalization during which the first PCC occurred). Measurements: Accumulated mean acute care costs and utilization (30-day readmissions, future hospital days, future intensive care unit [ICU] admission, future number of ICU days) after discharge from index hospitalization. Results: No significant difference between African Americans with or without PCC in mean future acute care costs ($11,651 vs. $15,050, p = 0.09), 30-day readmissions (p = 0.58), future hospital days (p = 0.34), future ICU admission (p = 0.25), or future ICU days (p = 0.30). There were significant differences between Whites with PCC and those without PCC in mean future acute care costs ($8,095 vs. $16,799, p < 0.001), 30-day readmissions (10.2% vs. 16.7%, p < 0.0001), and future days hospitalized (3.7 vs. 6.3 days, p < 0.0001). Conclusions: PCC decreases future acute care costs and utilization in Whites and, directionally but not significantly, in African Americans. Research is needed to explain why utilization and cost disparities persist among African Americans despite PCC.

Energy expenditure and body composition changes after an isocaloric ketogenic diet in overweight and obese men: A secondary analysis of energy expenditure and physical activity.

BACKGROUND: A previously published pilot study assessed energy expenditure (EE) of participants with overweight and obesity after they were switched from a baseline high-carbohydrate diet (BD) to an isocaloric low-carbohydrate ketogenic diet (KD). EE measured using metabolic chambers increased transiently by what was considered a relatively small extent after the switch to the KD, whereas EE measured using doubly labeled water (EEDLW) increased to a greater degree after the response in the chambers had waned. Using a publicly available dataset, we examined the effect of housing conditions on the magnitude of the increase in EEDLW after the switch to the KD and the role of physical activity in that response. METHODS: The 14-day EEDLW measurement period included 4 days when subjects were confined to chambers instead of living in wards. To determine the effect on EEDLW only for the days subjects were living in the wards, we calculated non-chamber EE (EEnonchamber). To assess the role of physical activity in the response to the KD, we analyzed chamber and non-chamber accelerometer data for the BD and KD EEDLW measurement periods. RESULTS: In comparison with the increase in average 14-day EEDLW of 151 kcal/d ± 63 (P = 0.03) after the switch to the KD, EEnonchamber increased by 203 ± 89 kcal/d (P = 0.04) or 283 ± 116 kcal/d (P = 0.03) depending on the analytical approach. Hip accelerometer counts decreased significantly (P = 0.01) after the switch to the KD, whereas wrist and ankle accelerometer counts did not change. CONCLUSIONS: Switching from the BD to the KD substantially increased EEDLW, but apparently only on days subjects were living in the ward outside the metabolic chamber. Increased physical activity as measured by accelerometry did not appear to account for this effect.

Relationship between pulmonary artery acceleration time and pulmonary artery pressures in infants.

BACKGROUND: Pulmonary artery acceleration time measured by echocardiography inversely correlates with pulmonary artery pressures in adults and children older than 1 year of age. There is a paucity of data investigating this relationship in young children, particularly among preterm infants. OBJECTIVE: To characterize the relationship between pulmonary artery acceleration time (PAAT) and pulmonary artery pressures in infants. DESIGN/METHODS: Patients ≤ 1 year of age at Children's Hospital of Philadelphia between 2011 and 2017 were reviewed. Infants with congenital heart disease were excluded, except those with a patent ductus arteriosus (PDA), atrial septal defect (ASD), or ventricular septal defect (VSD). Linear regression analysis was used to assess the correlation between PAAT measured by echocardiography and systolic pulmonary artery pressure, mean pulmonary artery pressure, and indexed pulmonary vascular resistance from cardiac catheterization. RESULTS: Fifty-seven infants were included, of which 61% were preterm and 49% had a diagnosis of bronchopulmonary dysplasia. The median postmenstrual age and weight at catheterization were 51.1 weeks (IQR 35.8-67.9 weeks) and 4400 g (IQR 3100-6500 g), respectively. Forty-four infants (77%) had a patent ductus arteriosus (PDA). There was a weak inverse correlation between PAAT with mPAP (r = -0.35, P = 0.01), sPAP (r = -0.29, P = 0.03), and PVRi (r = -0.29, P = 0.03). CONCLUSION: There is a weak inverse relationship between PAAT and pulmonary artery pressures. This relationship is less robust in our population of infants with a high incidence of PDAs compared to previous studies in older children. Thus, PAAT may be less clinically meaningful for diagnosing pulmonary arterial hypertension in infants, particularly those with PDAs.

Palliative Care Consultation for Goals of Care and Future Acute Care Costs: A Propensity-Matched Study.

BACKGROUND: Hospitals are under increasing pressure to manage costs across multiple episodes of care. Most studies of the financial impact of palliative care have focused on costs during a single hospitalization. OBJECTIVE: To compare future acute health-care costs and utilization between patients who received inpatient palliative care consultation for goals of care (Palliative Care Service [PCS]) and a propensity-matched cohort of patients who did not receive palliative care consultation (non-PCS) in a single academic medical center. METHODS: Data were extracted from the hospital's electronic records for admissions and discharges between July 2014 and October 2016. A stratified propensity score matching was used to account for nonrandom assignment and potential inherent differences between PCS and non-PCS groups using variables of theoretical interest: age, gender, race, diagnosis, risk of mortality, and prior acute care costs. RESULTS: The analytical sample for this study included 41 363 patients (PCS = 1853; non-PCS = 39 510). Future acute care costs were significantly higher in the non-PCS group after propensity score matching (highest tier = US$15 654 vs US$8831; second highest tier = US$12 200 vs US$5496; P = .0001). The non-PCS group also had significantly higher future acute care utilization across all propensity tiers and outcomes including 30-day readmission ( P = .0001), number of future hospital days ( P = .0001), and number of future intensive care unit days ( P = .0001). CONCLUSION: Palliative care consultations for goals of care may decrease future health-care utilization with cost savings that persist into future hospitalizations.