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.

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.

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.

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.

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.

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.

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.

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.

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.

A Systematic Review of Breast Reconstruction Options After Mastectomy in Massive Weight Loss Patients.

ABSTRACT: Given global trends in obesity and bariatric surgeries, there are an increasing number of women presenting for breast reconstruction after massive weight loss. There is a paucity of literature about breast reconstruction after mastectomy in patients with a history of massive weight loss. A literature review revealed 10 articles that discussed outcomes of different reconstruction techniques in patients with massive weight loss. Autologous reconstruction techniques and implant-based reconstruction techniques were assessed to evaluate the advantages, disadvantages, and indications of each approach specific to this unique patient population. This article provides a summary of expected outcomes, including complication profiles. Ultimately, consideration should be given for breast reconstruction of mastectomy defects in patients with a history of massive weight loss, as satisfactory results are demonstrated to be possible. Both autologous reconstruction and implant-based reconstruction present feasible options, although reconstruction in this patient population may be associated with increased need for revisions and a higher complication rate compared with patients without a history of massive weight loss. For this reason, it is imperative to appropriately manage preoperative expectations in patients with a history of massive weight loss.

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.

Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment.

Background: Enrollment in smoking cessation trials remain sub-optimal. The aim of this analysis was to determine the effectiveness of a modified Zelen's design in engaging hospitalized patients who smoke in a pragmatic OPT-IN versus OPT-OUT tobacco treatment trial. Methods: At bedside, clinical staff screened smokers for eligibility, randomized eligible into study arms, and delivered the appropriate treatment approach. Study staff called randomized patients at one-month post-discharge, debriefed patients on the study design, and collected consent to participate. We used frequencies and percentages for categorical variables and means and standard deviations for quantitative variables to describe the characteristics of those who consented and were enrolled versus those who did not enroll. We also compared the characteristics of participants who consented and those who were reached and explicitly refused consent at one-month follow-up. We used the Cohen's d measure of effect size to evaluate differences. Results: Of the 1,000 randomized, 741 (74.1%) consented to continue in the study at one-month follow-up. One hundred and twenty-seven (12.7%) refused consent and 132 (13.2%) were unreachable. Cohen's d effect size differences between those who consented/enrolled (n = 741) and those who were not enrolled (n = 259) were negligible (<0.2) for age, gender, race/ethnicity, and most forms of insurance. The effect size was small for Medicaid (0.36), and other public insurance (0.48). After excluding those unreached at 1 month (12.7%), there were medium Cohen's d effect size differences between those who consented to participate (n = 741) and those who explicitly refused (n = 127) with respect to age (0.55) and self-pay or no insurance (0.51). There were small to negligible effect size differences with respect to sex, race/ethnicity, and other forms of health insurance. Conclusions: The modified Zelen's design resulted in successful enrollment of most participants who were initially randomized into the trial, including those not motivated to quit.

Does the Addition of Breast MRI Add Value to the Diagnostic Workup of Invasive Lobular Carcinoma?

BACKGROUND: Invasive lobular carcinoma (ILC) has unique histologic growth pattern. Few studies have focused on the value of breast magnetic resonance imaging (MRI) specifically for ILC. We hypothesized that MRI adds value to the diagnostic workup in ILC by better defining the extent of disease and identifying additional foci of malignancy, which can change the surgical plan. MATERIALS AND METHODS: This was a single-institution retrospective review of women diagnosed with ILC from 1/2012 to 7/2019 who underwent preoperative MRI. Patient, tumor characteristics, and initial surgical plan were reviewed. MRI had added value if ILC size correlated best to final pathologic size or if additional malignancy was identified. MRI was considered harmful if additional biopsies were benign or if the size was overestimated. RESULTS: ILC was identified in 166 breasts in 165 women. Original surgical plan was for lumpectomy in 86 (52%), mastectomy in 49 (30%), and undecided in 31 (18%). MRI changed the plan in 25 (19%) with 24 (96%) changing from lumpectomy to mastectomy. Additional biopsy was performed in 28% after MRI, the majority (n = 41, 72%) were benign or high risk and 16 (28%) identified additional malignancy. MRI was not a better size estimate than mammogram/ultrasound. Re-excision rate after lumpectomy was 6.8% (5/73). MRI added value in 48 (28.9%) and was harmful in 48 (28.9%). CONCLUSIONS: Using breast MRI in the diagnostic workup of ILC has both positive and negative implications on surgical treatment planning. A shared decision-making conversation is warranted before proceeding with MRI to maximize value and minimize harms associated with this diagnostic tool.

A Pilot Study to Evaluate the Impact of the HIV Infant Tracking System (HITSystem 2.0) on Priority Prevention of Mother-to-Child Transmission (PMTCT) Outcomes.

We assessed the preliminary impact of the adapted HIV Infant Tracking System (HITSystem v2.0) intervention on prevention of mother-to-child transmission (PMTCT) outcomes using a matched cluster randomized design in two Kenyan government hospitals. Between November 2017 and June 2019, n = 157 pregnant women with HIV were enrolled and followed from their first PMTCT appointment until 12-weeks postpartum. Data from 135 women were analyzed (HITSystem 2.0: n = 53, standard of care (SOC): n = 82), excluding eight deaths, eight pregnancy losses, and six transfers/moves. The primary outcome, complete PMTCT retention, is an aggregate measure of attendance at all scheduled antenatal appointments, hospital-based delivery, and infant HIV-testing before 7-weeks postnatal. HITSystem 2.0 participants were more likely to receive complete PMTCT services compared to SOC (56.6% vs. 17.1% p < 0.001). In multivariate modeling, HITSystem 2.0 was the strongest predictor of complete PMTCT retention (aOR 5.7, [1.2-90.8], p = 0.032). SOC participants had 1.91 increased hazard rate of PMTCT disengagement; (aHR 6.8, [2.2-21.1]; p < 0.001).

Opioid Consumption Following Breast Surgery Decreases with a Brief Educational Intervention: A Randomized, Controlled Trial.

BACKGROUND: Current rates of opioid prescribing and consumption in the United States have resulted in deleterious consequences for both patients and society. There has been a focus on opioid consumption and overprescribing, but the utility of patient education in reducing opioid consumption has only recently been explored. This randomized trial aimed to evaluate the effectiveness of a brief patient educational intervention in reducing pain and opioid consumption in patients undergoing mastectomy and breast reconstruction. METHODS: A parallel, randomized, single-center trial of women undergoing mastectomy with immediate, implant-based breast reconstruction was completed to evaluate the utility of a patient educational instrument with information on multi-modal pain control. A questionnaire was administered postoperatively to collect data on pain control and opioid consumption. RESULTS: Fifty participants were randomized to each group preoperatively; 46 control (92%) and 39 intervention (78%) participants completed the postoperative questionnaire. Active tobacco use was more common in the control group (p = 0.04). There was a trend towards lower pain scores in the intervention group (3.0/10, SD 1.8 vs 3.6/10, SD 1.6, p = 0.06). Both groups were prescribed a median of 32.0 5-mg oxycodone tablets postoperatively. Participants in the intervention group consumed 33% fewer opioids than the control group (16.2 tablets, SD 16.4 vs 24.3 tablets, SD 21.8, p = 0.05). CONCLUSIONS: The use of a brief educational intervention provided at a preoperative appointment can reduce opioid consumption. We recommend the use of an educational intervention to decrease opioid consumption among breast surgery patients.

Perception of pain and influences on opioid use in implant-based breast reconstruction patients.

Although there has been a recent focus on decreasing opioid prescribing through alternative pain medication protocols, the patient's perception of pain related to breast reconstructive surgeries has not been well described. We sought to evaluate patient perception of pain control as it influences opioid use. We hypothesize that modifiable factors may influence patterns in pain perception and postoperative opioid use. Patients undergoing consultation for mastectomy with immediate, implant-based breast reconstruction were enrolled in a prospective, cohort survey study. A survey was administered at preoperative and postoperative appointments to collect data on pain expectations and pain control. Of 100 patients enrolled, 85% completed the postoperative survey. Over half of patients (52%) reported feeling anxious about pain control after surgery. Patients with preoperative opioid use were more likely to expect complete relief of pain postoperatively (P = .038). Patients with psychiatric comorbidity were more likely to report feeling anxious about postoperative pain (P = .012; 70% vs 42%; OR 3.0 CI 1.2-7.4). Patients who reported feeling anxious about pain control preoperatively were more likely to report trying opioids (P = .047; 67% vs 44%; OR 2.5 CI 1.0-6.1) and benzodiazepines (P = .020; 80% vs 56%; OR 3.0 CI 1.2-8.0) postoperatively. Anxiety related to pain control is common and results in an increased likelihood of trying opioid and benzodiazepine medications postoperatively. This presents an opportunity to educate patients preoperatively by addressing anxiety related to pain control to decrease controlled substance use.

Predictors of Early ART Initiation Among HIV + Infants in Kenya: A Retrospective Review of HITSystem Data from 2013 to 2017.

OBJECTIVE: Early initiation of antiretroviral therapy (ART, before 12 weeks of age) among infants living with HIV reduces infant mortality and slows disease progression. However, inefficiencies in early infant diagnosis processes prevents timely ART initiation among infants living with HIV in Kenya. This study assesses predictors of early ART initiation among infants living with HIV in Kenya. DESIGN: We retrospectively reviewed data from 96 infants living with HIV born between January 2013 and June 2017 at 6 Kenyan government hospitals. METHODS: The primary outcome was infant receipt of ART by 12 weeks of age. We assessed bivariable and multivariable predictors of ART initiation by 12 weeks of age. RESULTS: Among 96 infants living with HIV, 82 (85.4%) infants initiated ART at a median infant age of 17.1 weeks. Of the 82 infants who started ART, only 17 (20.7%) initiated ART by 12 weeks of age. In multivariable logistic regression analyses, testing per national guidelines (< 7 weeks of age) (aOR 40.14 [3.96-406.97], p = 0.002), shorter turnaround time for result notification (≤ 4 weeks) (aOR 11.30 [2.02-63.34], p = 0.006), and ART initiation within 3 days of mother notification (aOR 7.32 [1.41-38.03], p = 0.006) were significantly associated with ART initiation by 12 weeks of age. CONCLUSION: Current implementation of early infant diagnosis services in Kenyan only achieves targets for early ART initiation in one-fifth of infants with HIV. Strengthening services to support earlier infant testing and streamlined processes for early infant diagnosis may increase the proportion of infants who receive timely ART.

Effects of multicomponent primary care-based intervention on immunization rates and missed opportunities to vaccinate adults.

BACKGROUND: Adult immunization rates are below Healthy People 2020 targets. Our objective was to evaluate the effectiveness of a multicomponent intervention to improve adult immunization rates. METHODS: This prospective interventional before-and-after non-randomized study was conducted through the American Academy of Family Physicians National Research Network with 43 primary care physicians from a large multi-specialty healthcare organization (multicomponent intervention group n = 23; comparator group n = 20) in the United States. The multicomponent intervention included provider reminders, quarterly provider-level performance reports, provider education, patient visual aid materials, and standing orders on adult pneumococcal, influenza, and zoster immunizations. We assessed individual and comparative provider-level vaccination rates and missed opportunities detailing concordance with targets established by Healthy People 2020 for pneumococcal, influenza, and zoster immunizations. RESULTS: Vaccination rates increased after 12 months in intervention and comparator groups respectively for: a). influenza from 44.4 ± 16.7 to 51.3% ± 12.9% (by 6.9 percentage points, p = 0.001) and from 35.1 ± 19.1 to 41.3% ± 14.2%, (by 6.2 percentage points, p = 0.01); b). pneumococcal vaccinations in older adults from 62.8 ± 17.6 to 81.4% ± 16.6% (by 18.6 percentage points, for p < 0.0001) and from 55.9 ± 20.0 to 72.7% ± 18.4% (by 16.7 percentage points, p < 0.0001); and c). zoster from 37.1 ± 13.4 to 41.9% ± 13.1% (by 4.8 percentage points, p < 0.0001) and from 35.0 ± 18.7 to 42.3% ± 20.9% (7.3 percentage points, p = 0.001). Pneumococcal vaccinations in adults at risk did not change from baseline in intervention group (35.7 ± 19.6 to 34.5% ± 19.0%, p = 0.3) and improved slightly in comparator group (24.3 ± 20.1 to 28.2% ± 20.0%, p = 0.003). Missed opportunities reduced after 12 months, most noticeably, for: a). for influenza from 57.7 to 48.6% (by 9.1 percentage points, p < 0.0001) and from 69.7 to 59.6% (by 10.1 percentage points, p < 0.0001); b). pneumococcal vaccinations in older adults from 18.1 to 11.5% (by 6.6 percentage points p < 0.0001) and from 24.6 to 20.4% (by 4.3 percentage points, p < 0.0001) in intervention and comparator groups respectively. CONCLUSIONS: Multicomponent interventions show promise in improving vaccination rates and reducing missed opportunities in older adults for pneumococcal and zoster vaccines and vaccination against influenza. Provider reminders remain the most effective strategy when delivered either as a component of these interventions or alone.

Baseline characteristics of American Indian smokeless tobacco users participating in two pilot cessation studies.

American Indians have higher rates of smokeless tobacco (SLT) use than other racial/ethnic groups in the US, yet no efficacious cessation program exists for them. Because tobacco is a sacred plant to many American Indians, it is imperative that a program respect the scared nature of tobacco while encouraging quitting recreational use. All Nations Snuff Out Smokeless (ANSOS) was designed to help American Indian SLT users quit recreational tobacco use while still using it for traditional purposes. We pilot tested the ANSOS 6-month group-based counseling program (N = 48) and a shortened version consisting of a one-time education session (N = 80). Here, we discuss the tobacco characteristics of participants at baseline in both studies. Participants across studies were more likely to be male (74.2%) and have at least a college education (65%). Participants in the one-time education sessions were younger (age 35 vs age 39) and used SLT fewer days per week (4.9 vs 5.7). Two-thirds of those in the full program reported that they often substitute SLT in locations where smoking is not allowed compared to 26%. Participants in the education sessions were more likely to report daily use of traditional tobacco (20% versus 0%). Results suggest that dual use of SLT and cigarettes needs to be addressed, as does the use of SLT to circumvent public smoking rules. The role of traditional tobacco and its relationship to lower SLT use also warrants further investigation.

One-Time Education Sessions to Help American Indian Smokeless Tobacco Users Quit.

American Indian (AI) smokeless tobacco use rates are the highest of all racial/ethnic groups within the United States. Despite this, no effective cessation program currently exists that acknowledges the cultural significance of tobacco among many American Indian tribal nations. Participants were smokeless tobacco users, over 18 years of age, and were recruited through community partners. We modified the All Nations Snuff Out Smokeless Tobacco group-based program to be delivered as a one-time education session intervention. This was delivered to 80 participants and follow-up data was collected by self-report at 6-months. The mean age of participants was 35 and most were male (70%). A majority (69%) grew up on a AI reservation; the mean age of first smokeless tobacco use was 16 years of age. Of program completers reached for 6-month post baseline, 46% reported 0 days of SLT use; 13.5% of participants reduced; while 36% reported continued daily use. In intention to treat analysis those lost to follow-up are considered current users, the quit rate was 12.5% and among those who were still using, 4.0% reduced their use. In this study, a one-time education session intervention was effective for those who prefer an individual based approach to quitting SLT use. Follow up strategies to increase participant retention at 6-months should be explored.