Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift.

Bayesian adaptive designs with response adaptive randomization (RAR) have the potential to benefit more participants in a clinical trial. While there are many papers that describe RAR designs and results, there is a scarcity of works reporting the details of RAR implementation from a statistical point exclusively. In this paper, we introduce the statistical methodology and implementation of the trial Changing the Default (CTD). CTD is a single-center prospective RAR comparative effectiveness trial to compare opt-in to opt-out tobacco treatment approaches for hospitalized patients. The design assumed an uninformative prior, conservative initial allocation ratio, and a higher threshold for stopping for success to protect results from statistical bias. A particular emerging concern of RAR designs is the possibility that time trends will occur during the implementation of a trial. If there is a time trend and the analytic plan does not prespecify an appropriate model, this could lead to a biased trial. Adjustment for time trend was not pre-specified in CTD, but post hoc time-adjusted analysis showed no presence of influential drift. This trial was an example of a successful two-armed confirmatory trial with a Bayesian adaptive design using response adaptive randomization.

Healthcare Utilization (HCU) Reduction with High-Frequency (10 kHz) Spinal Cord Stimulation (SCS) Therapy.

Spinal cord stimulation (SCS) is a well-established treatment for patients with chronic pain. With increasing healthcare costs, it is important to determine the benefits of SCS in healthcare utilization (HCU). This retrospective, single-center observational study involved 160 subjects who underwent implantation of a high-frequency (10 kHz) SCS device. We focused on assessing trends in HCU by measuring opioid consumption in morphine milligram equivalents (MME), as well as monitoring emergency department (ED) and office visits for interventional pain procedures during the 12-month period preceding and following the SCS implant. Our results revealed a statistically significant reduction in HCU in all domains assessed. The mean MME was 51.05 and 26.52 pre- and post-implant, respectively. There was a 24.53 MME overall decrease and a mean of 78.2% statistically significant dose reduction (p < 0.0001). Of these, 91.5% reached a minimally clinically important difference (MCID) in opioid reduction. Similarly, we found a statistically significant (p < 0.01) decrease in ED visits, with a mean of 0.12 pre- and 0.03 post-implant, and a decrease in office visits for interventional pain procedures from a 1.39 pre- to 0.28 post-10 kHz SCS implant, representing a 1.11 statistically significant (p < 0.0001) mean reduction. Our study reports the largest cohort of real-world data published to date analyzing HCU trends with 10 kHz SCS for multiple pain etiologies. Furthermore, this is the first and only study evaluating HCU trends with 10 kHz SCS by assessing opioid use, ED visits, and outpatient visits for interventional pain procedures collectively. Preceding studies have individually investigated these outcomes, consistently yielding positive results comparable to our findings.

Oncoplastic Breast Reconstruction in Morbidly Obese Patients: An Acceptable Practice.

Background: Breast cancer is the most common noncutaneous malignancy amongst women. Lumpectomy with adjuvant radiation is a mainstay of surgical treatment. Oncoplastic breast reconstruction reduces the resultant breast deformity. Obesity is a risk factor for the development of complications after breast reconstruction. This study's purpose was to determine if oncoplastic breast reconstruction is a safe procedure in obese patients. Methods: A single institution retrospective chart review was performed on women undergoing oncoplastic breast reduction from 2009 to 2021. Patients were then divided into groups based on body mass index (BMI). A statistical analysis was performed comparing rates of complications and time to adjuvant therapy. Results: An estimated 340 patients were identified with an average age of 56.2 years (140 with BMI <30 kg/m2, 87 with BMI 30-34.9 kg/m2, 62 with BMI 35-39.9 kg/m2, and 51 with BMI >40 kg/m2). There was a significant difference between the BMI greater than 40 kg per m2 and BMI less than 30 kg per m2 group in the number of returns to the operating room (P = 0.0096), major complications (P = 0.0002), and minor complications (P = 0.0051). Average time to adjuvant treatment was 47 days and there was no statistically significant difference between the groups (P = 0.1691). Conclusions: There was a significant difference in major and minor complications between the BMI groups; however, there was no delay in the time to adjuvant therapy. Therefore, we conclude that with appropriate counseling on surgical risks, oncoplastic breast reduction is an acceptable option for breast cancer patients after lumpectomy, regardless of BMI.

Autologous Breast Reconstruction Success Rates in Hypercoagulable Patients.

BACKGROUND: Hypercoagulable disorders may adversely affect microsurgical outcomes, including increased flap failure and complication rates. Outcomes specific to autologous breast reconstruction are not well described. METHODS: A retrospective review was performed of autologous breast reconstructions between 2009 and 2020. Patients with either a thrombophilic disorder (TD) diagnosis or a previous thrombotic event (TE) were identified. The analysis compared perioperative complications and flap success rates. RESULTS: In this series, 23 patients with a TD underwent 39 flaps, and 78 patients who had experienced a TE underwent 126 flaps, compared with 815 control patients, who underwent 1300 flaps. In logistic regression models, a TD diagnosis was an independent predictor of early total flap loss [OR, 8.42 (95% CI, 1.59 to 44.47); P = 0.01], late partial flap loss [OR, 3.9 (95% CI, 1.0 to 15.22); P = 0.05], and delayed healing [OR, 2.26 (95% CI, 1.02 to 5.04); P = 0.04]. TE history trended toward an association only with late partial flap loss ( P = 0.057). Flap salvage rates (25%) and flap success rates (92.3%) were statistically lower in patients with a TD but normal in patients who had experienced a TE. CONCLUSIONS: Microsurgical breast reconstruction is a reasonable option for patients with hypercoagulation disorders. No increased risk of flap complications was associated with a previous TE; however, TDs carried increased risk. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Variables associated with nonresponders to high-frequency (10 kHz) spinal cord stimulation.

INTRODUCTION: The use of spinal cord stimulation (SCS) therapy to treat chronic pain continues to rise. Optimal patient selection remains one of the most important factors for SCS success. However, despite increased utilization and the existence of general indications, predicting which patients will benefit from neuromodulation remains one of the main challenges for this therapy. Therefore, this study aims to identify the variables that may correlate with nonresponders to high-frequency (10 kHz) SCS to distinguish the subset of patients less likely to benefit from this intervention. MATERIALS AND METHODS: This was a retrospective single-center observational study of patients who underwent 10 kHz SCS implant. Patients were divided into nonresponders and responders groups. Demographic data and clinical outcomes were collected at baseline and statistical analysis was performed for all continuous and categorical variables between the two groups to calculate statistically significant differences. RESULTS: The study population comprised of 237 patients, of which 67.51% were responders and 32.49% were nonresponders. There was a statistically significant difference of high levels of kinesiophobia, high self-perceived disability, greater pain intensity, and clinically relevant pain catastrophizing at baseline in the nonresponders compared to the responders. A few variables deemed potentially relevant, such as age, gender, history of spinal surgery, diabetes, alcohol use, tobacco use, psychiatric illness, and opioid utilization at baseline were not statistically significant. CONCLUSION: Our study is the first in the neuromodulation literature to raise awareness to the association of high levels of kinesiophobia preoperatively in nonresponders to 10 kHz SCS therapy. We also found statistically significant differences with greater pain intensity, higher self-perceived disability, and clinically relevant pain catastrophizing at baseline in the nonresponders relative to responders. It may be appropriate to screen for these factors preoperatively to identify patients who are less likely to respond to SCS. If these modifiable risk factors are present, it might be prudent to consider a pre-rehabilitation program with pain neuroscience education to address these factors prior to SCS therapy, to enhance successful outcomes in neuromodulation.

The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial.

Importance: Tobacco use causes 7 million deaths per year; most national guidelines require people who use tobacco to opt in to care by affirming they are willing to quit. Use of medications and counseling is low even in advanced economy countries. Objective: To evaluate the efficacy of opt-out care vs opt-in care for people who use tobacco. Design, Setting, and Participants: In Changing the Default (CTD), a Bayesian adaptive population-based randomization trial, eligible patients were randomized into study groups, treated according to group assignment, and debriefed and consented for participation at 1-month follow-up. A total of 1000 adult patients were treated at a tertiary care hospital in Kansas City. Patients were randomized from September 2016 to September 2020; final follow-up was in March 2021. Interventions: At bedside, counselors screened for eligibility, conducted baseline assessment, randomized patients to study group, and provided opt-out care or opt-in care. Counselors and medical staff provided opt-out patients with inpatient nicotine replacement therapy, prescriptions for postdischarge medications, a 2-week medication starter kit, treatment planning, and 4 outpatient counseling calls. Patients could opt out of any or all elements of care. Opt-in patients willing to quit were offered each element of treatment described previously. Opt-in patients who were unwilling to quit received motivational counseling. Main Outcomes and Measures: The main outcomes were biochemically verified abstinence and treatment uptake at 1 month after randomization. Results: Of a total of 1000 eligible adult patients who were randomized, most consented and enrolled (270 [78%] of opt-in patients; 469 [73%] of opt-out patients). Adaptive randomization assigned 345 (64%) to the opt-out group and 645 (36%) to the opt-in group. The mean (SD) age at enrollment was 51.70 (14.56) for opt-out patients and 51.21 (14.80) for opt-out patients. Of 270 opt-in patients, 123 (45.56%) were female, and of 469 opt-out patients, 226 (48.19%) were female. Verified quit rates for the opt-out group vs the opt-in group were 22% vs 16% at month 1 and 19% vs 18% at 6 months. The Bayesian posterior probability that opt-out care was better than opt-in care was 0.97 at 1 month and 0.59 at 6 months. Treatment use for the opt-out group vs the opt-in group was 60% vs 34% for postdischarge cessation medication (bayesian posterior probability of 1.0), and 89% vs 37% for completing at least 1 postdischarge counseling call (bayesian posterior probability of 1.0). The incremental cost-effectiveness ratio was $678.60, representing the cost of each additional quit in the opt-out group. Conclusions and Relevance: In this randomized clinical trial, opt-out care doubled treatment engagement and increased quit attempts, while enhancing patients' sense of agency and alliance with practitioners. Stronger and longer treatment could increase cessation. Trial Registration: ClinicalTrials.gov Identifier: NCT02721082.

Autologous Breast Reconstruction after Massive Weight Loss: Understanding Risks in a Growing Population.

BACKGROUND: Massive weight loss (MWL) may have suboptimal effects on tissues used for autologous reconstruction. With the rising rates of obesity and bariatric surgery, more patients who have experienced MWL will be presenting for breast reconstruction. The authors hypothesize that autologous breast reconstruction in patients with a history of MWL will have more complications and require more revisions compared with reconstruction in patients without a history of MWL. METHODS: A retrospective review was performed on patients who underwent autologous breast reconstruction by five microsurgeons at an academic institution from 2009 through 2020. Patients with a history of bariatric surgery or greater than 50-pound weight loss were identified and compared with patients who had not experienced MWL. Analysis compared demographics, operative details, complications, revision rates, and BREAST-Q scores. RESULTS: Of 916 patients who underwent 1465 flaps, 39 patients with MWL (4.3%) underwent 68 flaps (4.6%), and 877 patients without MWL underwent 1397 flaps. MWL patients were more likely to require blood transfusions postoperatively ( P = 0.005); experienced more surgical-site infections ( P = 0.02), wound-healing complications of flap ( P = 0.007) and donor sites ( P = 0.03), and late partial flap losses ( P = 0.03); and required more revisional surgery for flap ( P = 0.009) and donor sites ( P = 0.01). BREAST-Q scores were not statistically different for satisfaction with breasts or surgeon but were lower in MWL patients for psychosocial ( P = 0.01) and sexual well-being ( P = 0.04). CONCLUSIONS: Reconstructive surgeons should expect increased postoperative complications when performing autologous breast reconstruction in patients who have experienced MWL. These patients should be counseled on the possibility of an increased risk of postoperative complications and need for revisional surgery. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Preoperative Examination Is Not Associated with Postoperative Function following Radial Forearm Free Flap Harvest.

BACKGROUND: There is debate on the utility of a preoperative Allen test or ultrasound before radial forearm free flap (RFFF) harvest. This study sought to evaluate correlations between preoperative testing and donor-site morbidity. METHODS: A survey of plastic surgery and otolaryngology RFFF patients was conducted at a Midwestern academic center. The modified Cold Intolerance Symptom Severity (modCISS) and Quick Disabilities of the Arm, Shoulder, and Hand (QDASH) instruments were administered. A retrospective chart review was performed to assess perioperative factors. RESULTS: Of 212 RFFFs completed over 7 years, 144 patients were contacted, and 71 patients completed the survey (33% response rate). Preoperative Allen test was negative in 92% of patients (65 of 71). There was no statistical association between Allen test and duplex ultrasound findings ( P = 0.19). Cold intolerance screening was positive on 20% of donor arms (14 of 71), with an average positive modCISS score of 39.0 ± 14.7. Disability was reported on the QDASH by 76% of patients (54 of 71), with an average score of 21.0 ± 22.3. There was no statistical correlation between preoperative Allen test or ultrasound classification and modCISS or QDASH score. There was a borderline positive correlation between modCISS and QDASH scores that did not reach statistical significance ( r = 0.22, P = 0.067). Operative characteristics also did not predict modCISS or QDASH scores. CONCLUSIONS: Following RFFF harvest, donor extremity cold intolerance is reported in 20% of patients, and extremity-related disability is reported in the majority of patients. Preoperative ultrasound and physical examination findings are not predictive of morbidity.

Minimally Invasive Mandibular Microsurgery: A Systematic Review and Meta-analysis.

Microsurgical advances have led to minimally invasive approaches for mandibular reconstruction. Currently, no resource compares all minimally invasive microvascular mandibular reconstruction (MIMMR) treatment options. Methods: All known cases of MIMMR were identified following the Preferred Reporting Items for Systematic Reviews, Meta-Analyses guidelines, and our own surgical experience. Patient demographics, MIMMR type [submandibular (SM), modified facelift/retroauricular (MFL/RA), or intraoral (IO)], methodology, and clinical outcomes were analyzed with the Fisher exact and Kruskal-Wallis tests. Results: Forty-seven patients underwent MIMMR. Ameloblastoma was the most common pathology treated using all approaches, and MFL/RA was the only approach used to treat squamous cell carcinoma (P = 0.0103). Reconstruction was reported for large, bilateral defects only via the SM or IO approach (P = 0.0216). The iliac crest or fibula was used as a donor site. The facial artery was the most common recipient vessel using the IO and SM approaches, whereas the superior thyroid and external carotid vessels were the most common in the MFL/RA approach (P < 0.0001). Virtual planning was used in all cases performed via an IO approach, 80.0% of cases using an SM approach, and no MFL/RA cases (P < 0.0001). Good aesthetic and functional outcomes were reported for every patient, and there was no difference in complication rates (P = 0.2880). Conclusions: Minimally invasive approaches are safe and effective treatment options for patients requiring mandibular microsurgery, usually in the setting of benign pathology. The IO and SM approaches usually rely on the facial vessels, whereas the MFL/RA approach permits access to the superior thyroid and external carotid vessels and cervical lymphadenectomy.

Determining the impact of an interprofessional learning in practice model on learners and patients.

The Institute of Medicine recently expressed a need to measure the impact of interprofessional education (IPE) on health professions collaborative behavior in practice environments and patient outcomes, and the National Center for Interprofessional Practice and Education has focused research efforts to connect interprofessional practice and education. We describe a model intentionally designed to link interprofessional practice experience in ambulatory care setting and an IPE curriculum for students, called the Interprofessional Learning in Practice (ILIP) model. The study objective was to determine the impact of the ILIP model on student and patient outcomes during a 24-month intervention period. Student satisfaction was collected through a brief survey administered post-ILIP model. Patient outcomes were collected from before and after the intervention period through a retrospective chart review of patients who received care through the ILIP model. For the study, disease indicators for the top three chronic diagnoses of depression, hypertension, and type 2 diabetes mellitus were chosen as the patient outcomes. Student outcomes were analyzed using descriptive statistics and the Mann-Whitney U test. Patient outcomes were analyzed using McNemar's test and paired t-tests. Of the 382 students who participated in the ILIP model during the study period, 179 completed surveys, indicating that they valued the experience, valued learning from interprofessional preceptors, and gained interprofessional skills to use in their future practice. During the 24-month intervention, 401 patients were evaluated post-ILIP model, statistically significant results demonstrated HbA1c values for patients with diabetes were reduced by 0.5% and depression screening improved from 9% to 91%. Additionally, patients' hypertension control was similar to baseline and diabetes control (as defined as HbA1c ≤8%) was improved compared to baseline but did not reach statistical significance. By aligning interprofessional practice and education in the ILIP model, students had a positive experience, gained interprofessional collaboration skills, and provided value-added benefits to improve patient outcomes.

Comparing tissue oximetry to doppler monitoring in 1367 consecutive breast free flaps.

BACKGROUND: Retrospective studies evaluating tissue oximetry in a more recent cohort have shown superiority in flap outcomes. This study compares the use of tissue oximetry in a historical cohort to clinical observation and handheld doppler in a more recent cohort. We hypothesize that there is no benefit to using tissue oximetry. METHODS: A retrospective review was performed on patients who underwent abdominal-based autologous breast reconstruction by five microsurgeons at an academic institution from 2009 to 2020. Method of postoperative flap monitoring was determined then operative details and complications were analyzed. RESULTS: 1367 flaps were reviewed; 740 flaps in 460 patients were monitored with clinical observation and tissue oximetry, and 627 flaps in 391 patients were monitored with clinical observation and handheld doppler. There were no statistical differences in ischemic (p = .59) or congestive complications (p = .41), flap salvage rates when exploring for venous or arterial compromise (p = .52), or early flap loss (p = .56). Although not significant, acute flap-related return to the operating room was lower in the doppler group (4.6%) compared to the oximetry group (6.1%; p = .22). Flaps monitored with tissue oximetry had a statistical increase in length of stay (4.8 ± 1.4 days vs. 3.8 ± 1.6 days; p ≤ .001). The rates of late partial flap loss and fat necrosis were significantly higher in the oximetry group (2.6%, 19/740 vs. 0.3%, 2/740; p = .04) and (18.2%, 135/740 vs. 13.6%, 85/627; p = .02), respectively. CONCLUSIONS: There is no statistical benefit to the use of tissue oximetry compared to handheld doppler in flap monitoring with regards to flap outcomes.

Characterizing Outcomes of Medial and Lateral Perforators in Deep Inferior Epigastric Perforator Flaps.

BACKGROUND: Perforators are typically found in rows in the deep inferior epigastric perforator (DIEP) flap. As methods to assess flap perfusion continue to improve, surgeons may be more likely to select perforators traditionally avoided. The purpose of this article is to describe clinical outcomes based on row and number of perforators to reevaluate flap and abdominal donor site morbidity. METHODS: A retrospective analysis was performed on patients who underwent breast reconstruction with DIEP flaps by four microsurgeons from 2013 to 2020. The row and number of perforators were determined from operative reports. Chi-square and t-test or nonparametric Fisher's exact test and Wilcoxon two-sample test were used for discrete and continuous variable, respectively, as applicable. Logistic regression was used for multivariable analyses. RESULTS: Of 628 flaps, 305 were medial row (58.7%), 159 were lateral row (30.6%), and 55 had both rows (10.6%). Partial flap loss was higher in both rows (p = 0.003). Fat necrosis was higher with medial (p = 0.03) and both rows (p = 0.01) when compared with lateral using multivariable analysis. Hernia or bulge was higher in lateral row flaps (lateral: 8/157, 5.1%; medial, 5/299, 1.7%; both, 0/55; p = 0.05); however, mesh was more commonly used in both row flaps (p = 0.05). There was no difference in fat necrosis or abdominal morbidity between single and multiple perforators. CONCLUSION: There was no difference in fat necrosis based on the number or row of perforators. The lateral row provides adequate perfusion but may be associated with an elevated risk of hernia or bulge. Patients may benefit from mesh, especially when both rows are dissected.

Quantifying Complications: An Analysis of Operative Time and Intraoperative Factors in Microsurgical Breast Reconstruction.

BACKGROUND: Analysis of operative flow has been shown to improve efficiency in breast microsurgery. Both complex decision-making skills and technical mastery are required to overcome intraoperative challenges encountered during microsurgical reconstruction. Effects of intraoperative complications on operative time have not yet been reported. METHODS: A retrospective chart review of microsurgical breast reconstructions by three surgeons between 2013-2020 analyzed operative variables and duration. Intraoperative complications were determined from the operative report. Correlations between continuous variables were determined using Spearman correlation coefficients. Nonparametric testing was used when comparing operative duration between groups. RESULTS: Operative duration was analyzed for 547 autologous breast reconstruction cases; 210 reconstructions were unilateral and 337 were bilateral. Average operative duration was 471.2 SD 132.2 minutes overall (360.1 SD 100.5 minutes for unilateral cases and 530.5 SD 110.5 minutes for bilateral cases). Operative duration decreased with surgeon experience (r = -0.17, p< .001).Regarding intraoperative complications, difficult donor dissection was correlated with an average operative duration increase of 91.7 minutes (n = 43, 7.9%, p< .001), pedicle injury with an additional 67.7 minutes (n = 19, 3.5%, p = .02) and difficult recipient vessel dissection with an increase of 63.0 minutes (n = 35, 6.4%, p = .003). Complications with anastomosis also showed a statistically significant increase in operative duration, with arterial complications resulting in an increase of 104.3 minutes (n = 41, 7.5%, p< .001) and venous complications resulting in an increase in 78.8 minutes (n = 32, 5.8%, p< .001). Intraoperative thrombus resulted in an increase of 125.5 minutes (n = 20, 3.7%, p< .001), and requiring alternative venous outflow added an average of 193.7 minutes (n = 8, 1.5%, p< .001). CONCLUSION: Intraoperative complications in autologous breast reconstruction significantly increase operative time. The greatest increase in operative time is seen with intraoperative thrombosis or requiring alternative venous outflow. As these complications are rarely encountered in breast microsurgery, opportunities for simulation and case-based practice exist to improve efficiency.

A Paradigm Shift: Outcomes of Early Autologous Breast Reconstruction after Radiation Therapy.

BACKGROUND: Radiation creates significant challenges for breast reconstruction. There is no consensus regarding optimal timing for autologous reconstruction following radiation. This study explores clearly defined, shorter time intervals between completion of radiation and reconstruction than previously reported. METHODS: A retrospective review was performed on patients who underwent autologous reconstruction by five microsurgeons at an academic institution from 2009 to 2020. Cohorts were selected by time elapsed between radiation and autologous reconstruction including <3 months, 3 to 6 months, 6 to 9 months, 9 to 12 months, 12 to 24 months, and >24 months. Analysis compared baseline characteristics, operative details, complications, revision rates, and BREAST-Q scores. Analysis of variance was used for continuous variables and chi-square for discrete variables. RESULTS: In total, 462 radiated patients underwent 717 flaps. There were 69 patients at <3 months (14.9%), 97 at 3 to 6 months (21%), 64 at 6 to 9 months (13.9%), 36 at 9 to 12 months (7.8%), 73 at 12 to 24 months (15.8%), and 123 at >24 months (26.6%). Age, time from mastectomy, and failure of primary reconstruction were higher at >24 months (p < 0.001). There was no difference between cohorts in intraoperative complications in radiated or nonradiated breasts. There was no difference in acute and late postoperative complications between cohorts. Wound-healing complications in radiated sides were lowest at <3 months and 3 to 6 months (5/69 [7.3%] and 11/97 [11.3%], respectively) compared with other groups (18.8-22.2%) but did not reach significance (p = 0.11). More fat graft revisions occurred at <3 months (p = 0.003). CONCLUSION: Reconstruction can be safely performed within 3 months after radiation without increases in intraoperative, acute, or late reconstructive complications.

Everyday discrimination for American Indian tribal college students enrolled in the Internet All Nations Breath of Life program.

OBJECTIVE: Identify factors associated with perceived discrimination, including depression, body image satisfaction, body mass index (BMI), social support, stress, and self-reported social status. PARTICIPANTS: A total of 249 American Indian tribal college students. METHODS: Students were recruited for an Internet-based smoking cessation program. A total of 249 students answered the Everyday Discrimination Scale questions to assess perceived discrimination. We conducted bivariate analyses to determine potential significant associations between perceived discrimination and health outcomes at baseline. RESULTS: We found 63% of the sample reported racial discrimination. Among those who reported moderate/severe depression, 87% reported discrimination. Among those who were not satisfied with their body image, 70% reported racial discrimination. CONCLUSION: Reports of racial discrimination are highly prevalent among our participants. We found reports of discrimination are significantly associated with depression and dissatisfaction with body image. Our study highlights a high priority population that perceives racial discrimination, potentially increasing their risk for adverse health outcomes.

A Prospective, Randomized Single-Blind Crossover Study Comparing High-Frequency 10,000 Hz and Burst Spinal Cord Stimulation.

OBJECTIVES: Although both high-frequency and burst spinal cord stimulation (SCS) have shown improved efficacy and patient satisfaction compared with conventional tonic stimulation, there are limited data directly comparing the two. This study aimed to compare both high-frequency 10,000 Hz and burst SCS in the same patients in terms of pain relief and satisfaction in those with axial back pain with or without leg pain. MATERIALS AND METHODS: This prospective, single-blind, randomized controlled trial was conducted at an outpatient pain clinic within an academic medical center. Participants were randomly allocated to one of two groups in which they trialed either burst or high-frequency 10,000 Hz SCS over five days, followed by a 24- to 48-hour washout period with no stimulation, and the alternative therapy over the remaining four days. Visual analog scale (VAS) scores were collected immediately before and after both therapy trials. Secondary end points included percentage change in VAS score and patient preference. RESULTS: Of 25 participants, those receiving burst followed by high-frequency SCS (n = 11) had a mean VAS difference of 4.73 after the first trial period and 2.86 after the second. Of those receiving high-frequency followed by burst SCS (n = 14), mean VAS difference after the first trial period was 4.00 and 1.93 after the second trial period. Four participants were withdrawn owing to lead migration. Both therapies showed statistically significant differences in pre- minus post-VAS scores and percent relief. There were no significant differences in carryover or treatment effects between the two groups. There was a statistically significant association between trial sequence and stimulator type implanted because the first stimulator trialed was more likely to be chosen. CONCLUSIONS: There were no observed differences in VAS pain score decrease when comparing burst and high-frequency 10,000 Hz SCS programming therapies. Patient preference followed an order effect, favoring the first programming therapy in the trial sequence.

One and Done Epinephrine in Out-of-Hospital Cardiac Arrest? Outcomes in a Multiagency United States Study.

BACKGROUND: Cardiac arrest guidelines recommend epinephrine every 3-5 minutes during cardiac arrest resuscitation. However, it is unclear if multiple epinephrine doses are associated with improved outcomes. The objective of this study was to determine if a single-dose epinephrine protocol was associated with improved survival compared to traditional multidose protocols. METHODS: We conducted a pre-post study across five North Carolina EMS agencies from 11/1/2016 to 10/29/2019. Patients ≥18 years old with attempted resuscitation for non-traumatic prehospital cardiac arrest were included. Data were collected 1 year before and after implementation of the single-dose epinephrine protocol. Prior to implementation, all agencies used a multidose epinephrine protocol. The Cardiac Arrest Registry to Enhance Survival (CARES) was used to obtain patient outcomes. Study outcomes were survival to hospital discharge (primary) and return of spontaneous circulation (ROSC). Analysis was by intention to treat. Outcomes were compared pre- vs. post-implementation using generalized estimating equations to account for clustering within EMS agencies. Adjusted analyses included age, sex, race, shockable vs. non-shockable rhythm, witnessed arrest, automatic external defibrillator availability, EMS response interval, and bystander cardiopulmonary resuscitation. RESULTS: During the study period there were 1,690 encounters (899 pre- and 791 post-implementation). The population was 74.7% white, 61.1% male, and had a median age of 65 (IQR 53-76) years. Survival to hospital discharge was similar pre- vs. post-implementation [13.6% (122/899) vs. 15.4% (122/791); OR 1.19, 95%CI 0.89-1.59]. However, ROSC was more common post-implementation [42.3% (380/899) vs. 32.5% (257/791); OR 0.66, 95%CI 0.54-0.81]. After adjusting for covariates, the single-dose protocol was associated with similar survival to discharge rates (aOR 0.88, 95%CI 0.77-1.29), but with decreased ROSC rates (aOR 0.58, 95%CI 0.47-0.72). CONCLUSION: A prehospital single-dose epinephrine protocol was associated with similar survival to hospital discharge, but decreased ROSC rates compared to the traditional multidose epinephrine protocol.

Closed-Incision Negative Pressure Therapy Prevents Major Abdominal Donor-Site Complications in Autologous Breast Reconstruction.

BACKGROUND: Outcomes in autologous breast reconstruction continue to improve with refinements in microsurgical techniques; however, donor-site morbidity remains a concern. Closed-incision negative pressure therapy (ciNPT) has been shown to reduce wound complications. Limited evaluation in abdominal donor sites has shown promising results. We hypothesize that ciNPT will reduce abdominal donor-site complications. METHODS: A retrospective chart review was performed of patients who underwent abdominally based autologous free tissue transfer for breast reconstruction by 4 microsurgeons at an academic institution from 2015 to 2020. The application of a commercial ciNPT for donor-site management was at the discretion of the operating surgeon. Demographics, operative details, and management of donor-site complications were analyzed. RESULTS: Four hundred thirty-three patients underwent autologous breast reconstruction; 212 abdominal donor sites were managed with ciNPT and 219 with standard dressings. Demographics were statistically similar between groups. Abdominal wound healing complications were noted in 30.2% of ciNPT patients (64/212) and 22.8% of control patients (50/219, P = 0.08); however, overall wound complications were attributed to obesity on multivariable analysis. Closed-incision negative pressure therapy significantly decreased complications requiring reoperation (ciNPT 6.2%, 4/64; control 26.5%, 13/51; P = 0.004). There were no significant differences in surgical site infection rates (P = 0.73) and rates of abdominal scar revisions (ciNPT 11.8%, 25/212; control 9.1%, 20/219; P = 0.37). CONCLUSIONS: Use of ciNPT in abdominal donor-site management significantly decreases the incidence of delayed wound healing requiring surgical intervention, with one major wound healing complication prevented for every 6 donor sites managed with ciNPT.