Comparative Study of Prepectoral and Subpectoral Expander-Based Breast Reconstruction and Clavien IIIb Score Outcomes

Background: Prepectoral breast reconstruction is increasingly popular. This study compares complications between 2 subpectoral and 1 prepectoral breast reconstruction technique. Methods: Between 2008 and 2015, 294 two-staged expander breast reconstructions in 213 patients were performed with 1 of 3 surgical techniques: (1) Prepectoral, (2) subpectoral with acellular dermal matrix (ADM) sling (“Classic”), or (3) subpectoral/subserratus expander placement without ADM (“No ADM”). Demographics, comorbidities, radiation therapy, and chemotherapy were assessed for correlation with Clavien IIIb score outcomes. Follow-up was a minimum of 6 months. Results: Surgical cohorts (n = 165 Prepectoral; n = 77 Classic; n = 52 No ADM) had comparable demographics except Classic had more cardiac disease (P = 0.03), No ADM had higher body mass index (BMI) (P = 0.01), and the Prepectoral group had more nipple-sparing mastectomies (P 40, stage 4 cancer, and contralateral prophylactic mastectomy were associated with adverse expander outcomes and a prior history of radiation therapy adversely impacted implant outcomes. Ninety-day follow-up for expander and implant complications may be a better National Surgical Quality Improvement Program measure

Massage Therapy for Osteoarthritis of the Knee: A Randomized Dose-Finding Trial

In a previous trial of massage for osteoarthritis (OA) of the knee, we demonstrated feasibility, safety and possible efficacy, with benefits that persisted at least 8 weeks beyond treatment termination.We performed a RCT to identify the optimal dose of massage within an 8-week treatment regimen and to further examine durability of response. Participants were 125 adults with OA of the knee, randomized to one of four 8-week regimens of a standardized Swedish massage regimen (30 or 60 min weekly or biweekly) or to a Usual Care control. Outcomes included the Western Ontario and McMaster Universities Arthritis Index (WOMAC), visual analog pain scale, range of motion, and time to walk 50 feet, assessed at baseline, 8-, 16-, and 24-weeks.WOMAC Global scores improved significantly (24.0 points, 95% CI ranged from 15.3-32.7) in the 60-minute massage groups compared to Usual Care (6.3 points, 95% CI 0.1-12.8) at the primary endpoint of 8-weeks. WOMAC subscales of pain and functionality, as well as the visual analog pain scale also demonstrated significant improvements in the 60-minute doses compared to usual care. No significant differences were seen in range of motion at 8-weeks, and no significant effects were seen in any outcome measure at 24-weeks compared to usual care. A dose-response curve based on WOMAC Global scores shows increasing effect with greater total time of massage, but with a plateau at the 60-minute/week dose.Given the superior convenience of a once-weekly protocol, cost savings, and consistency with a typical real-world massage protocol, the 60-minute once weekly dose was determined to be optimal, establishing a standard for future trials.ClinicalTrials.gov NCT00970008

The Risks And Rewards Of Investing In The Stocks Of Bankrupt Companies

This paper tracks the effect of reorganization on the equity issues of firms in Chapter 11 both before and after the filing date. It computes risk and return characteristics before and after filing. The calculations indicate that after filing the systematic risk of shares of Chapter 11 firms declines and the total variance rises. This result is important for investors interested in speculating in shares of companies in reorganization

Comparative Study of Prepectoral and Subpectoral Expander-Based Breast Reconstruction and Clavien IIIb Score Outcomes

Background:. Prepectoral breast reconstruction is increasingly popular. This study compares complications between 2 subpectoral and 1 prepectoral breast reconstruction technique. Methods:. Between 2008 and 2015, 294 two-staged expander breast reconstructions in 213 patients were performed with 1 of 3 surgical techniques: (1) Prepectoral, (2) subpectoral with acellular dermal matrix (ADM) sling (“Classic”), or (3) subpectoral/subserratus expander placement without ADM (“No ADM”). Demographics, comorbidities, radiation therapy, and chemotherapy were assessed for correlation with Clavien IIIb score outcomes. Follow-up was a minimum of 6 months. Results:. Surgical cohorts (n = 165 Prepectoral; n = 77 Classic; n = 52 No ADM) had comparable demographics except Classic had more cardiac disease (P = 0.03), No ADM had higher body mass index (BMI) (P = 0.01), and the Prepectoral group had more nipple-sparing mastectomies (P < 0.001). Univariate analysis showed higher expander complications with BMI ≥ 40 (P = 0.05), stage 4 breast cancer (P = 0.01), and contralateral prophylactic mastectomy (P = 0.1), whereas implant complications were associated with prior history of radiation (P < 0.01). There was more skin necrosis (P = 0.05) and overall expander complications (P = 0.01) in the Classic cohort, whereas the No ADM group trended toward the lowest expander complications among the 3. Multivariate analysis showed no difference in overall expander complication rates between the 3 groups matching demographics, mastectomy surgery, risks, and surgical technique. Conclusions:. Prepectoral and subpectoral Classic and No ADM breast reconstructions demonstrated comparable grade IIIb Clavien score complications. BMI > 40, stage 4 cancer, and contralateral prophylactic mastectomy were associated with adverse expander outcomes and a prior history of radiation therapy adversely impacted implant outcomes. Ninety-day follow-up for expander and implant complications may be a better National Surgical Quality Improvement Program measure

Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial.

BACKGROUND AND OBJECTIVES: Many investigators of Alzheimer\u27s disease and related dementias (AD/ADRD) are unfamiliar with the embedded pragmatic clinical trials (ePCTs) and the indispensable pilot phase preceding ePCTs. This paper provides a much-needed example for such a pilot phase and discusses implementation barriers and additional infrastructure and implementation strategies developed in preparation for a nationwide AD/ADRD ePCT. RESEARCH DESIGN AND METHODS: Two pilot trials were conducted in two hospices sequentially to refine and test Aliviado Dementia Care-Hospice Edition, a complex quality improvement intervention for advanced dementia symptom management. Readiness for the subsequent full-scale ePCT was assessed by three milestones: ≥80% training completion rate ( feasibility ), ≥80% post-training survey respondents indicating intention for practice changes ( applicability ), and at least one Aliviado care plan/assessment instrument administered in ≥75% of dementia patients admitted to home hospice within one-month post training ( fidelity ). RESULTS: Participants included 72 interdisciplinary team (IDT) members and 11 patients with AD/ADRD across the pilots. Feasibility, applicability, and fidelity outcomes (92%, 93%, and 100%, respectively) all surpassed the pre-established milestones (80%, 80%, and 75%). Main implementation challenges were related to hospice staff turnover, integration of the Aliviado toolbox materials within the electronic health records, and hospices\u27 limited research experience and infrastructure. DISCUSSION AND IMPLICATIONS: This pilot phase demonstrated feasibility, applicability, and fidelity required to proceed to the full-scale ePCT. Our study findings and discussions of additional infrastructure and implementation strategies developed following the pilot phase can inform researchers and clinicians interested in conducting AD/ADRD-related pilot studies for ePTCs or quality improvement initiatives. CLINICAL TRIAL NUMBER: NCT03681119