The ENGAGE study: a 3-arm randomized hybrid type 1 effectiveness and implementation study of an in-home, collaborative PCP model of remote telegenetic services to increase uptake of cancer genetic services in childhood cancer survivors.

BACKGROUND: Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and screening guidelines for genetic carriers. Access to genetic services is limited in many places, which leaves many genetic carriers unidentified and at risk for late diagnosis of cancers and poor outcomes. This poses a problem for childhood cancer survivors, as this is a population with an increased risk for subsequent malignant neoplasms (SMN) due to cancer therapy or inherited cancer predisposition. The ENGaging and Activating cancer survivors in Genetic services (ENGAGE) study evaluates the effectiveness of an in-home, collaborative PCP model of remote telegenetic services to increase uptake of cancer genetic testing in childhood cancer survivors compared to usual care options for genetic testing. METHODS: The ENGAGE study is a 3-arm randomized hybrid type 1 effectiveness and implementation study within the Childhood Cancer Survivor Study population which tests a clinical intervention while gathering information on its delivery during the effectiveness trial and its potential for future implementation among 360 participants. Participants are randomized into three arms. Those randomized to Arm A receive genetic services via videoconferencing, those in Arm B receive these services by phone, and those randomized to Arm C will receive usual care services. DISCUSSION: With many barriers to accessing genetic services, innovative delivery models are needed to address this gap and increase uptake of genetic services. The ENGAGE study evaluates the effectiveness of an adapted model of remote delivery of genetic services to increase the uptake of recommended genetic testing in childhood cancer survivors. This study assesses the uptake in remote genetic services and identify barriers to uptake to inform future recommendations and a theoretically-informed process evaluation which can inform modifications to enhance dissemination beyond this study population and to realize the benefits of precision medicine. TRIAL REGISTRATION: This protocol was registered at clinicaltrials.gov (NCT04455698) on July 2, 2020.

Eliminating children's tobacco smoke exposure: a pathway to bioverified abstinence among low-income maternal smokers in the Babies Living Safe and Smokefree (BLiSS) trial.

BACKGROUND: Identifying behavioral pathways to smoking cessation in high-risk populations, such as low-income maternal smokers, could reduce tobacco disparities. The previous "BLiSS" multilevel intervention trial demonstrated efficacy of the BLiSS intervention in facilitating low-income maternal smokers' bioverified abstinence. This present study examined four putative pathways measured at 3-month end of treatment (Time 2) that could account for the observed intervention effect on smoking abstinence through 12 months (Time 2 - Time 3). METHODS: Nutritionists in community clinics delivering safety net nutrition promotion programs across Philadelphia, Pennsylvania, USA, were trained by trial principal investigators to deliver a brief tobacco intervention informed by the American Academy of Pediatrics best practice guidelines ("Ask, Advise, Refer [AAR]"). After referral, 396 eligible participants were randomized to either a multimodal behavioral intervention (AAR + MBI) or a parallel attention control (AAR + control). Random effects regression analysis tested mediation. RESULTS: Elimination of children's tobacco smoke exposure (TSE) at Time 2 was the only significant mediator of longitudinal smoking abstinence through Time 3. AAR + MBI mothers were more likely to eliminate their children's TSE by Time 2 (OR = 2.11, 95%CI 1.30, 3.42), which was significantly associated with Time 3 abstinence (OR = 6.72, CI 2.28, 19.80). Modeling showed a significant total effect of AAR + MBI on abstinence (OR = 6.21, CI 1.86, 20.71), a direct effect of AAR + MBI on abstinence (OR = 4.80, CI 1.45, 15.94) and an indirect effect through TSE elimination (OR = 1.29, CI 1.06, 1.57). CONCLUSIONS: Integrating smoking cessation interventions with counseling prior to the quit attempt that is designed to facilitate adoption of smokefree home policies and efforts to eliminate children's TSE could enhance the likelihood of long-term abstinence in populations of smokers with elevated challenges quitting smoking.

Timing of Unplanned Reoperation After Lower Extremity Free Flap Reconstruction: What Are the Roles of Procedure Indication and Defect Etiology?

BACKGROUND: Advancements in lower extremity (LE) microsurgery have allowed for the expansion of indications for LE reconstructions. This project aims to better understand the temporal pattern and risk factors associated with LE free flap failure based on the clinical indication. MATERIALS AND METHODS: We analyzed all patients undergoing LE free flap reconstruction from the American College of Surgeons National Surgical Quality Improvement Program 2012-2019 prospectively collected data to determine rates and timing of reoperation. Free flaps were stratified by indication, type, and timing of reoperation. Weibull survival models were used to compare rates of takebacks among time intervals. Multivariable logistic regression was used to identify independent predictors for unplanned reoperation. RESULTS: Four hundred seven of LE free flaps were analyzed. There was a 14.5% rate (59/407) of unplanned reoperation within the first 30 postoperative days (PODs) after surgery. When stratified by the indication necessitating reoperation, patients with an underlying vascular indication had the highest rate of reoperation (40.9%). The reoperation rates were significantly different between indications (P < 0.05) The mean daily proportion of patients experiencing reoperation was highest during POD 0 to 2 (1.47% reoperations per day), which dropped significantly during POD 3 to 10 (0.55% per day) and again during POD 11 to 30 (0.28% per day, P < 0.05). African American race as well as malignant, prosthetic/implant, and wound/infectious indications were significant independent predictors for unplanned reoperation. CONCLUSIONS: Lower extremity reconstruction is an important reconstructive option for the coverage of a myriad of defects. Understanding the differences between postoperative reoperation timelines among indication subtypes is important for updated flap monitoring protocols, optimizing ERAS pathways, and beginning dangle protocols.

Significant Reduction in Length of Stay in Deep Inferior Epigastric Perforator Flap Breast Reconstruction With Implementation of Multimodal ERAS Protocol.

BACKGROUND: Enhanced Recovery After Surgery (ERAS) implementation achieves earlier recovery, reduced hospital length of stay (LOS) and improved outcomes in patients undergoing deep inferior epigastric perforator (DIEP) free flaps. We sought to review our ERAS protocols and their impact on our patients' LOS compared with the literature. METHODS: This was a retrospective review of a single surgeon's experience from 2017 to 2021 of patients undergoing DIEP free-flap breast reconstruction with LOS as the primary outcome. Complication rates and patient demographics are described as secondary outcomes. RESULTS: One hundred twenty-one patients underwent DIEP free-flap breast reconstruction. After adapting ERAS protocols, there has been a 0.98 [SD, 0.17; confidence interval [CI], -1.3 to -0.64; P < 0.001) day decrease in length of stay comparing pre-ERAS to post-ERAS implementation. Length of stay has routinely decreased from an average discharge on day 4.17 (SD, 1.1; range, 3-8 days) in 2017 to discharge on day 2.91 (SD, 1.1; range, 1-5 days) in 2021. Seventy-five percent of patients in 2021 were hospitalized for 3 or fewer days compared with 75% of patients in 2017 hospitalized for 4 or more days. One patient experienced a flap failure. Our study supports successful discharge on postoperative days 2-3 compared with postoperative days 3-4 in the current literature. CONCLUSIONS: The implementation of our ERAS protocol for DIEP free-flap breast reconstruction has resulted in a shorter LOS compared with contemporary literature. The ERAS protocols can be efficiently adopted in microsurgical DIEP breast reconstruction to achieve a shorter LOS without jeopardizing patient outcomes.

The critical need to implement and utilize patient-reported measures of function in cancer care delivery.

The study by Smith et al. on the Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3D Profile shows that it can be used to measure how an individual functions and how his or her function changes during cancer treatments. This is important because most patients will experience a decline in function during cancer treatment and will struggle to fully participate in their life roles. Strong evidence demonstrates that rehabilitation improves function for individuals with cancer; rehabilitation is relatively underutilized. We suggest that using the PROMIS tool as a repeated measure throughout cancer treatment will help to identify those with functional decline who will benefit most from rehabilitation.

Multilevel Intervention for Low-Income Maternal Smokers in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

Objectives. To test the efficacy of Babies Living Safe and Smokefree (BLiSS), a multilevel intervention initiated in a citywide safety net health system to improve low-income maternal smokers' abstinence and reduce child tobacco smoke exposure. Methods. This randomized controlled trial in Philadelphia, Pennsylvania (2015-2020), recruited low-income maternal smokers who received a brief smoking intervention (Ask, Advise, Refer [AAR]) from nutrition professionals in the Special Supplemental Nutrition Program for Women, Infants, and Children before randomization to (1) a multilevel intervention (AAR + multimodal behavioral intervention [MBI]; n = 199) or (2) an attention control intervention (AAR + control; n = 197). Results. AAR + MBI mothers had significantly higher 12-month bioverified abstinence rates than did AAR + control mothers (odds ratio [OR] = 9.55; 95% confidence interval [CI] = 1.54, 59.30; P = .015). There were significant effects of time (b = -0.15; SE = 0.04; P < .001) and condition by time (b = -0.19; SE = 0.06; P < .001) on reported child exposure favoring AAR + MBI, but no group difference in child cotinine. Presence of other residential smokers was related to higher exposure. Higher baseline nicotine dependence was related to higher child exposure and lower abstinence likelihood at follow-up. Conclusions. The multilevel BLiSS intervention was acceptable and efficacious in a population that experiences elevated challenges with cessation. Public Health Implications. BLiSS is a translatable intervention model that can successfully improve efforts to address the persistent tobacco-related burdens in low-income communities. Trial Registration. Clinical Trials.gov identifier: NCT02602288. (Am J Public Health. 2022;112(3):472-481. https://doi.org/10.2105/AJPH.2021.306601).

Critical Importance of the First Postoperative Days After Head and Neck Free Flap Reconstruction: An Analysis of Timing of Reoperation Using the National Surgical Quality Improvement Program Database.

BACKGROUND: Head and neck free flaps remain associated with considerable rates of take-back and prolonged hospital length of stay. However, there have been no studies on a national level benchmarking the timeline and predictors of head and neck free flap take-back. METHODS: Patients undergoing head and neck free flap reconstruction from the American College of Surgeons National Surgical Quality Improvement Program 2012-2019 database were analyzed to determine the rates of take-back. Timing and rates of unplanned head and neck free flap take-backs were stratified by tissue type and postoperative day (POD) over the first month. Weibull survival models were used to compare rates of take-backs among time intervals. Multivariable logistic regression was used to identify the independent predictors of take-back. RESULTS: Three thousand nine hundred six head and neck free flaps were analyzed. The mean daily proportion of patients experiencing take-back during PODs 0 to 1 was 0.95%; this dropped significantly to a mean daily proportion of 0.54% during POD 2 (P < 0.01). In addition, there were significant drops in take-back when comparing POD 2 (0.54%) to POD 3 (0.26%) and also when comparing POD 4 (0.20%) with PODs 5 to 30 (0.032% per day) (P < 0.05). The soft tissue and osseous flap populations demonstrated a similar trend in unplanned take-back. CONCLUSION: This is the first national study to specifically analyze the timing of take-back in the head and neck reconstruction population. These data highlight the importance of flap monitoring during the first 5 PODs, with ERAS pathway optimization aiming for discharge by the end of the first postoperative week.

Data Quality of Automated Comorbidity Lists in Patients With Mental Health and Substance Use Disorders.

EHRs provide an opportunity to conduct research on underrepresented oncology populations with mental health and substance use disorders. However, a lack of data quality may introduce unintended bias into EHR data. The objective of this article is describe our analysis of data quality within automated comorbidity lists commonly found in EHRs. Investigators conducted a retrospective chart review of 395 oncology patients from a safety-net integrated healthcare system. Statistical analysis included κ coefficients and a condition logistic regression. Subjects were racially and ethnically diverse and predominantly used Medicaid insurance. Weak κ coefficients ( κ = 0.2-0.39, P < .01) were noted for drug and alcohol use disorders indicating deficiencies in comorbidity documentation within the automated comorbidity list. Further, conditional logistic regression analyses revealed deficiencies in comorbidity documentation in patients with drug use disorders (odds ratio, 11.03; 95% confidence interval, 2.71-44.9; P = .01) and psychoses (odds ratio, 0.04; confidence interval, 0.02-0.10; P < .01). Findings suggest deficiencies in automatic comorbidity lists as compared with a review of provider narrative notes when identifying comorbidities. As healthcare systems increasingly use EHR data in clinical studies and decision making, the quality of healthcare delivery and clinical research may be affected by discrepancies in the documentation of comorbidities.

Postoperative Complications Associated with the Choice of Reconstruction in Head and Neck Cancer: An Outcome Analysis of 4,712 Patients from the ACS-NSQIP Database.

BACKGROUND: Microsurgical free flaps have largely supplanted pedicled flaps as the gold standard for head and neck cancer reconstruction. However, incidence of postoperative complications after accounting for patient comorbidities based on choice of reconstruction has not been well-defined in the literature in recent years. METHODS: Patients undergoing head and neck reconstruction were identified in the 2011-2016 ACS-NSQIP (American College of Surgeons National Surgical Quality Improvement Program) database and stratified into groups by free flap, myocutaneous pedicled flap, and other reconstruction. Demographics were analyzed and covariates balanced using overlap propensity score-based weighting. Logistic regression was used for binary outcomes and Gamma generalized linear model was used for length of stay. RESULTS: A total of 4,712 patients met inclusion criteria out of which 1,297 patients (28%) underwent free flap, 208 patients (4%) pedicled flap, and 3,207 patients (68%) had other, or no reconstruction performed. After adjusting for patient and disease-specific factors, pedicled flap reconstruction was associated with a higher risk of deep vein thrombosis (odds ratio [OR] = 2.64, confidence interval [CI] 1.02-6.85, p = 0.045), sepsis (OR = 2.95, CI 1.52-5.71, p = 0.001), and infection (OR = 2.03, CI 1.39-2.96, p <0.001) compared with free flap reconstruction. Free flaps had the longest mean operative time compared with the other two groups (unadjusted 578 vs. 440 vs. 326, p <0.001). Pedicled flaps had a lower incidence of bleeding requiring transfusion (adjusted OR = 0.65, CI 0.50-0.85, p = 0.002), and lower incidence of prolonged mechanical ventilation (adjusted OR = 0.33, CI 0.12-0.92, p = 0.034) compared with free flaps. There was no difference in rates of reoperation, hospital readmission, or hospital length-of-stay between pedicled and free flaps. CONCLUSION: Myocutaneous pedicled flaps are associated with higher overall short-term postoperative complications compared with free flaps in head and neck reconstruction, which demonstrate a more favorable morbidity profile without significantly impacting hospital readmission, reoperation, or length-of-stay.

Early postoperative outcomes in implant, pedicled, and free flap reconstruction for breast cancer: an analysis of 23,834 patients from the ACS-NSQIP datasets.

INTRODUCTION: Many patients seek breast reconstruction following mastectomy. Debate exists regarding the best reconstructive option. The authors evaluate outcomes comparing implant, free flap, and pedicled flap reconstruction. METHODS: Patients undergoing implant, pedicled flap, and free flap reconstruction were identified in the 2011-2016 NSQIP database. Demographics were analyzed and covariates were balanced using overlap propensity score. Logistic regression was used for binary outcomes and Gamma GLM for length of stay (LOS). RESULTS: Of 23,834 patients, 87.7% underwent implant, 8.1% free flap, and 4.2% pedicled flap reconstruction. The implant group had the lowest mean operative time (206 min, SD 85.6). Implant patients had less pneumonia (OR 0.09, CI 0.02-0.36, p < 0.01), return to operating room (OR 0.62, CI 0.50-0.75, p < 0.01), venous thromboembolism (VTE) (OR 0.33, CI 0.14-0.79, p = 0.01), postoperative bleeding (OR 0.10, CI 0.06-0.15, p < 0.01), and urinary tract infections (UTI) (OR 0.21, CI 0.07-0.58, p < 0.01) than free flap patients. Pedicled flap patients had less postoperative bleeding (OR 0.69, CI 0.49-0.96, p = 0.03) than free flap patients. Pedicled flap patients had more superficial surgical site infections (p = 0.03), pneumonia (p = 0.02), postoperative bleeding (p < 0.01), VTE (p = 0.04), sepsis (p = 0.05), and unplanned reintubation (p = 0.01) than implant patients. Implant patients had the lowest LOS (1.6 days, p < 0.01). CONCLUSION: Implant reconstruction has less short-term postoperative complications than free flaps and pedicled flap reconstructions. The overall complication rate among all reconstructive modalities remains acceptably low and patients should be informed of all surgical options.