Can Patient-centered Education and Pain Management Delivered by Coaches Improve Pain Outcomes After Orthopaedic Trauma? A Randomized Trial.

BACKGROUND: Pain after orthopaedic trauma is complex, and many patients who have experienced orthopaedic trauma are at increased risk for prolonged opioid utilization after the injury. Patient-centered interventions capable of delivering enhanced education and opioid-sparing pain management approaches must be implemented and evaluated in trauma care settings to improve pain outcomes and minimize opioid-related risks. QUESTIONS/PURPOSES: Does personalized pain education and management delivered by coaches (1) improve pain-related outcomes, (2) reduce opioid consumption, and (3) improve patient-reported outcome measures (Patient-Reported Outcomes Measurement Information System [PROMIS] scores) compared to written discharge instructions on pain management and opioid safety? METHODS: This clinical trial aimed to examine the effect of a personalized pain education and management intervention, delivered by paraprofessional coaches, on pain-related outcomes and opioid consumption compared with usual care (written discharge instructions on pain management and opioid safety). Between February 2021 and September 2022, 212 patients were randomized to the intervention (49% [104]) or control group (51% [108]). A total of 31% (32 of 104) and 47% (51 of 108) in those groups, respectively, were lost before the minimum study follow-up of 12 weeks or had incomplete datasets, leaving 69% (72 of 104) and 53% (57 of 108) for analysis in the intervention and control group, respectively. Patients randomized to the intervention worked with the paraprofessional coaches throughout hospitalization after their orthopaedic injury and at their 2-, 6-, and 12-week visits with the surgical team after discharge to implement mindfulness-based practices and nonpharmacological interventions. Most participants in the final sample of 129 identified as Black (73% [94 of 129]) and women (56% [72 of 129]), the mean Injury Severity score was 8 ± 4, and one-third of participants were at medium to high risk for an opioid-use disorder based on the Opioid Risk Tool. Participants completed surveys during hospitalization and at the 2-, 6-, and 12-week follow-up visits. Surveys included average pain intensity scores over the past 24 hours measured on the pain numeric rating scale from 0 to 10 and PROMIS measures (physical functioning, pain interference, sleep disturbance). Opioid utilization, measured as daily morphine milligram equivalents, was collected from the electronic health record, and demographic and clinical characteristics were collected from self-report surveys. Groups were compared in terms of mean pain scores at at the 12-week follow-up, daily morphine milligram equivalents both during inpatient and at discharge, and mean PROMIS scores at 12 weeks of follow-up. Additionally, differences in the proportion of participants in each group achieving minimum clinically important differences (MCID) on pain and PROMIS scores were examined. For pain scores, an MCID of 2 points on the pain numeric rating scale assessing past 24-hour pain intensity was utilized. RESULTS: We found no difference between the intervention and control in terms of mean pain score at 12 weeks nor in the proportions of patients who achieved the MCID of 2 points for 24-hour average pain scores (85% [61 of 72] versus 72% [41 of 57], respectively, OR 2.2 [95% confidence interval (CI) 0.9 to 5.3]; p = 0.08). No differences were noted in daily morphine milligram equivalents utilized between the intervention and control groups during hospitalization, at discharge, or in prescription refills. Similarly, we observed no differences in the proportions of patients in the intervention and control groups who achieved the MCID on PROMIS Physical Function (81% [58 of 72] versus 63% [36 of 57], respectively, OR 2.2 [95% CI 0.9 to 5.2]; p = 0.06). We saw no differences in the proportions of patients who achieved the MCID on PROMIS Sleep Disturbance between the intervention and control groups (58% [42 of 72] versus 47% [27 of 57], respectively, OR 1.4 [95% CI 0.7 to 3.0]; p = 0.31). The proportion of patients who achieved the MCID on PROMIS Pain Interference scores did not differ between the intervention and the control groups (39% [28 of 72] versus 37% [21 of 57], respectively, OR 1.1 [95% CI 0.5 to 2.1]; p = 0.95). CONCLUSION: In this trial, we observed no differences between the intervention and control groups in terms of pain outcomes, opioid medication utilization, or patient-reported outcomes after orthopaedic trauma. However, future targeted research with diverse samples of patients at increased risk for poor postoperative outcomes is warranted to ascertain a potentially meaningful patient perceived effect on pain outcomes after working with coaches. Other investigators interested in this interventional approach may consider the coach program as a framework at their institutions to increase access to evidence-based nonpharmacological interventions among patients who are at increased risk for poor postoperative pain outcomes. Smaller, more focused programs connecting patients to coaches to learn about nonpharmacological pain management interventions may deliver a larger impact on patient's recovery and outcomes. LEVEL OF EVIDENCE: Level I, therapeutic study.

Integration of Life Care Specialists Into Orthopaedic Trauma Care to Improve Postoperative Outcomes: A Pilot Study.

BACKGROUND: AIM: This pilot study assessed the feasibility and impact of integrating a Life Care Specialist (LCS) into orthopaedic trauma care. DESIGN: This was a prospective feasibility single group pilot study at a level 1 trauma center. METHOD: The LCS is a paraprofessional behavior-based "pain coach" and delivered patient-centered opioid safety education, trained participants on nonpharmacologic pain management approaches, conducted opioid risk assessments, and coordinated care. Numeric Rating Scale pain scores were assessed on admission, at discharge, and at 2-week follow-up. Daily morphine milligram equivalents (MME) during hospitalization, opioid medication use at 2-weeks, and patient satisfaction were recorded. T test compared mean morphine milligram equivalents (MME) to historical orthopaedic trauma patient population's mean dosage at discharge from the study site. Generalized linear models assessed pain scores over time. RESULTS: Twenty-two percent of 121 total participants met criteria for moderate to severe risk of opioid misuse at initial hospitalization. On average, 2.8 LCS pain management interventions were utilized, most frequently progressive muscle relaxation (80%) and sound therapy (48%). Mean inpatient MME/day was 40.5, which was significantly lower than mean historical MME/day of 49.7 (p < .001). Pain scores improved over time from admission to 2-weeks postoperatively (p < .001). Nearly all participants agreed that the LCS was helpful in managing pain (99%). CONCLUSIONS: The findings indicate feasibility to integrate LCS into orthopaedic trauma care, evident by participant engagement and satisfaction, and that LCS serve as valuable resources to assist with pain management and opioid education.

Implementation of Pressure Injury Prevention Best Practices Across 6 Canadian Rehabilitation Sites: Results From the Spinal Cord Injury Knowledge Mobilization Network.

OBJECTIVE: To use the theoretical frameworks of implementation science to implement pressure injury (PI) prevention best practices in spinal cord injury (SCI) rehabilitation. DESIGN: Quality improvement. SETTING: Six Canadian SCI rehabilitation centers. PARTICIPANTS: Inpatients (N=2371) admitted from 2011 to 2015. INTERVENTIONS: The SCI Knowledge Mobilization Network (SCI KMN) selected and implemented 2 PI prevention best practices at 6 Canadian SCI rehabilitation centers: (1) completing a comprehensive PI risk assessment comprised of a structured risk assessment instrument followed by an individualized, interprofessional risk factor determination and prevention plan; and (2) providing structured and individualized PI prevention patient education. Active Implementation Frameworks provided a systematic approach to best practice implementation. MAIN OUTCOME MEASURES: Implementation indicators (completion rates) and patient outcomes (PI incidence, patient education survey). RESULTS: After implementation, risk assessment completion rates improved from 46% to 94% (P<.05). Between initial (2012-2013) and full (2014-2015) implementation stages, completion rates improved for both interprofessional risk factor determination (67% to 96%) and prevention plans (67% to 94%). Documentation of patient education also increased to 86% (vs. 71% preimplementation). At rehabilitation admission 22% of patients had PIs, with 14% of individuals developing new PIs during rehabilitation. The overall PI prevalence was 30%. Considering only PIs of stage 2 or greater, prevalence was 21% and incidence 7%. There were no statistically significant differences in PI incidence between pre- and postimplementation. Patient education surveys indicated that PI education improved patients' knowledge of prevention strategies. CONCLUSIONS: Active Implementation Frameworks supported successful implementation of PI prevention best practices across the 6 participating SCI KMN sites. Achieving a reduction in PI incidence will require additional measures, and there is an ongoing need to strengthen the evidence base underpinning PI prevention guidelines.

Methemoglobinemia in a 14-year-old girl with new-onset dyspnea.

Methemoglobinemia is a rare and potentially life-threatening medical emergency that can be overlooked when evaluating a patient in respiratory distress. Without early recognition, patients may develop respiratory failure and die. This article describes a teenager who presented to the ED for dyspnea and lightheadedness and failed to respond to supplemental oxygen. She was eventually diagnosed with methemoglobinemia.

Improving patient flow through collaboration.

For over two decades, capacity issues within Edmonton hospitals have existed. Crowded emergency departments with numerous patients waiting for admission into inpatient beds has made patient flow a topic at all administrative levels for all services. From a systems perspective, most strategies have simply displaced the problem from one part of the system to another. If we are going to make a true difference, a "big picture" systems approach is required and traditional ways of doing business need to be challenged. Like any discussion around flow, inputs and outputs must have a level of equilibrium and equality, or bottlenecks will occur. Although patient flow has been a huge focus across the continuum of care, discharge planning traditionally has remained with the provider where the patient currently is, as opposed to where the team feels the patient's end destination will be.

Health Equity and Policy Considerations for Pediatric and Adult Congenital Heart Disease Care among Minoritized Populations in the United States.

Achieving health equity in populations with congenital heart disease (CHD) requires recognizing existing disparities throughout the lifespan that negatively and disproportionately impact specific groups of individuals. These disparities occur at individual, institutional, or system levels and often result in increased morbidity and mortality for marginalized or racially minoritized populations (population subgroups (e.g., ethnic, racial, social, religious) with differential power compared to those deemed to hold the majority power in the population). Creating actionable strategies and solutions to address these health disparities in patients with CHD requires critically examining multilevel factors and health policies that continue to drive health inequities, including varying social determinants of health (SDOH), systemic inequities, and structural racism. In this comprehensive review article, we focus on health equity solutions and health policy considerations for minoritized and marginalized populations with CHD throughout their lifespan in the United States. We review unique challenges that these populations may face and strategies for mitigating disparities in lifelong CHD care. We assess ways to deliver culturally competent CHD care and to help lower-health-literacy populations navigate CHD care. Finally, we review system-level health policies that impact reimbursement and research funding, as well as institutional policies that impact leadership diversity and representation in the workforce.

The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial.

BACKGROUND: Orthopedic trauma patients face complex pain management needs and are frequently prescribed opioids, leaving them at-risk for prolonged opioid use. To date, post-trauma pain management research has placed little emphasis on individualized risk assessments for misuse and systematically implementing non-pharmacologic pain management strategies. Therefore, a community-academic partnership was formed to design a novel position in the healthcare field (Life Care Specialist (LCS)), who will educate patients on the risks of opioids, tapering usage, safe disposal practices, and harm reduction strategies. In addition, the LCS teaches patients behavior-based strategies for pain management, utilizing well-described techniques for coping and resilience. This study aims to determine the effects of LCS intervention on opioid utilization, pain control, and patient satisfaction in the aftermath of orthopedic trauma. METHODS: In total, 200 orthopedic trauma patients will be randomized to receive an intervention (LCS) or a standard-of-care control at an urban level 1 trauma center. All patients will be assessed with comprehensive social determinants of health and substance use surveys immediately after surgery (baseline). Follow-up assessments will be performed at 2, 6, and 12 weeks postoperatively, and will include pain medication utilization (morphine milligram equivalents), pain scores, and other substance use. In addition, overall patient wellness will be evaluated with objective actigraphy measures and patient-reported outcomes. Finally, a survey of patient understanding of risks of opioid use and misuse will be collected, to assess the influence of LCS opioid education. DISCUSSION: There is limited data on the role of individualized, multimodal, non-pharmacologic, behavioral-based pain management intervention in opioid-related risk-mitigation in high-risk populations, including the orthopedic trauma patients. The findings from this randomized controlled trial will provide scientific and clinical evidence on the efficacy and feasibility of the LCS intervention. Moreover, the final aim will provide early evidence into which patients benefit most from LCS intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04154384 . Registered on 11/6/2019 (last updated on 6/10/2021).

Development of an implementation-focused network to improve healthcare delivery as informed by the experiences of the SCI knowledge mobilization network.

Context: Implementing research findings into clinical practice is challenging. This manuscript outlines the experiences and key learnings from a network that operated as a community of practice across seven Canadian Spinal Cord Injury (SCI) rehabilitation centers. These learnings are being used to inform a new implementation-focused network involving SCI rehabilitation programs based in Ontario, Canada. Methods: The SCI KMN adapted and applied implementation science principles based on the National Implementation Research Network's (NIRN) Active Implementation Frameworks in the implementation of best practices in pressure injury and pain prevention and management. Results: The SCI KMN was successful in implementing best practices in both pressure ulcer and pain prevention and management across the various participating sites. Other key objectives met were building capacity in implementation methods in site personnel so that project scaling could occur with these skills and expertise applied to numerous other initiatives. Additionally, various papers, abstracts and conference presentation as well as an implementation guide were disseminated to inform the field of implementation science. Conclusion: The key lessons learned from this experience are being used to develop a new implementation-focused network. Features felt to be especially important for the SCI KMN includes a highly representative governance structure, the use of indicators within an overall evaluation framework and the systematic application of implementation processes with shared learnings supporting each site.

The dose-volume relationship of small bowel irradiation and acute grade 3 diarrhea during chemoradiotherapy for rectal cancer.

PURPOSE: Previous work has found a highly significant relationship between the irradiated small-bowel volume and development of Grade 3 small-bowel toxicity in patients with rectal cancer. This study tested the previously defined parameters in a much larger group of patients. METHODS AND MATERIALS: A total of 96 consecutive patients receiving pelvic radiation therapy for rectal cancer had treatment planning computed tomographic scans with small-bowel contrast that allowed the small bowel to be outlined with calculation of a small-bowel dose-volume histogram for the initial intended pelvic treatment to 45 Gy. Patients with at least one parameter above the previously determined dose-volume parameters were considered high risk, whereas those with all parameters below these levels were low risk. The grade of diarrhea and presence of liquid stool was determined prospectively. RESULTS: There was a highly significant association with small-bowel dose-volume and Grade 3 diarrhea (p < or = 0.008). The high-risk and low-risk parameters were predictive with Grade 3 diarrhea in 16 of 51 high-risk patients and in 4 of 45 low-risk patients (p = 0.01). Patients who had undergone irradiation preoperatively had a lower incidence of Grade 3 diarrhea than those treated postoperatively (18% vs. 28%; p = 0.31); however, the predictive ability of the high-risk/low-risk parameters was better for preoperatively (p = 0.03) than for postoperatively treated patients (p = 0.15). Revised risk parameters were derived that improved the overall predictive ability (p = 0.004). CONCLUSIONS: The highly significant dose-volume relationship and validity of the high-risk and low-risk parameters were confirmed in a large group of patients. The risk parameters provided better modeling for the preoperative patients than for the postoperative patients.

Molecular evidence demonstrating local treatment failure is the source of distant metastases in some patients treated for breast cancer.

PURPOSE: To examine the clonality relationships among initial invasive breast carcinoma (IBC), ipsilateral breast failure (IBF), and distant metastasis (DM) to determine the effect of local tumor recurrence on the development of DMs. METHODS AND MATERIALS: A total of 18 patients treated with breast-conserving therapy who developed an IBF followed by DMs were studied using a 20 informative-marker, polymerase chain reaction-based allelic imbalance clonality assay. RESULTS: Four relationships were identified. First, in 7 cases, the IBF and DMs were clonally related to the initial IBC as one progressively genetic unstable process. Second, in 3 cases, the IBF and DMs were each clonally related to the IBC but clonally distinct from each other. Third, in 3 cases, the IBC and the IBF were clonally related and the DMs were clonally related to the IBFs, with a weak relationship to the initial IBC. Finally, in 5 cases, the IBF was clonally distinct from the initial IBC (new second primary) and the DMs were clonally related to the IBF and clonally distinct from the initial IBC. CONCLUSION: These findings provide molecular evidence demonstrating that some DMs can directly develop from IBFs and support the importance of local tumor control in the overall treatment of breast cancer patients.

Six-Year Results From a Phase I/II Trial for Hypofractionated Accelerated Partial Breast Irradiation Using a 2-Day Dose Schedule.

BACKGROUND: To report 6-year outcomes from a phase I/II trial using balloon-based brachytherapy to deliver APBI in 2 days. METHODS: A total of 45 patients with early-stage breast cancer received adjuvant APBI in 2 days with high-dose rate (HDR) brachytherapy totaling 2800 cGy in 4 fractions (700 cGy BID) using a balloon-based applicator as part of a prospective phase I/II clinical trial. All patients had negative margins and skin spacing ≥8 mm. We evaluated toxicities (CTCAE v3) as well as ipsilateral breast tumor recurrence (IBTR), regional nodal failure (RNF), distant metastasis, disease-free survival, cause-specific survival, and overall survival. RESULTS: Median age and tumor size were 66 years old (48 to 83) and 0.8 cm (0.2 to 2.3 cm), respectively. Four percent of patients were N1 (n=2) and 73% were estrogen receptor (ER) positive (n=32). Median follow-up was 6.2 years (2.4 to 8.0 y). Nearly all toxicities at 6 years were grade 1 to 2 except 1 instance of grade 3 telangiectasia (2%). Eleven percent (n=5) of patients had chronic asymptomatic fat necrosis whereas asymptomatic seromas were noted on mammogram in 13% of cases (n=6). Cosmesis at last follow-up was good or excellent in 91% of cases (n=40) and fair in 9% (n=4). Two of the previously reported rib fractures healed with conservative measures. There were no IBTR or RNF (6 y IBTR/RNF rate 0%); however, 2 patients experienced distant metastasis (4% at 6 y). The 6-year actuarial disease-free survival, cause-specific survival, and overall survival were 96%, 100%, and 93%, respectively. CONCLUSIONS: Hypofractionated 2-day APBI using brachytherapy resulted in excellent clinical outcomes with acceptable chronic toxicities.

A Guide to Single-Cell Transcriptomics in Adult Rodent Brain: The Medium Spiny Neuron Transcriptome Revisited.

Recent advances in single-cell technologies are paving the way to a comprehensive understanding of the cellular complexity in the brain. Protocols for single-cell transcriptomics combine a variety of sophisticated methods for the purpose of isolating the heavily interconnected and heterogeneous neuronal cell types in a relatively intact and healthy state. The emphasis of single-cell transcriptome studies has thus far been on comparing library generation and sequencing techniques that enable measurement of the minute amounts of starting material from a single cell. However, in order for data to be comparable, standardized cell isolation techniques are essential. Here, we analyzed and simplified methods for the different steps critically involved in single-cell isolation from brain. These include enzymatic digestion, tissue trituration, improved methods for efficient fluorescence-activated cell sorting in samples containing high degree of debris from the neuropil, and finally, highly region-specific cellular labeling compatible with use of stereotaxic coordinates. The methods are exemplified using medium spiny neurons (MSN) from dorsomedial striatum, a cell type that is clinically relevant for disorders of the basal ganglia, including psychiatric and neurodegenerative diseases. We present single-cell RNA sequencing (scRNA-Seq) data from D1 and D2 dopamine receptor expressing MSN subtypes. We illustrate the need for single-cell resolution by comparing to available population-based gene expression data of striatal MSN subtypes. Our findings contribute toward standardizing important steps of single-cell isolation from adult brain tissue to increase comparability of data. Furthermore, our data redefine the transcriptome of MSNs at unprecedented resolution by confirming established marker genes, resolving inconsistencies from previous gene expression studies, and identifying novel subtype-specific marker genes in this important cell type.

Intensity-modulated radiotherapy results in significant decrease in clinical toxicities compared with conventional wedge-based breast radiotherapy.

PURPOSE: We have previously demonstrated that intensity-modulated radiotherapy (IMRT) with a static multileaf collimator process results in a more homogenous dose distribution compared with conventional wedge-based whole breast irradiation (WBI). In the present analysis, we reviewed the acute and chronic toxicity of this IMRT approach compared with conventional wedge-based treatment. METHODS AND MATERIALS: A total of 172 patients with Stage 0-IIB breast cancer were treated with lumpectomy followed by WBI. All patients underwent treatment planning computed tomography and received WBI (median dose, 45 Gy) followed by a boost to 61 Gy. Of the 172 patients, 93 (54%) were treated with IMRT, and the 79 patients (46%) treated with wedge-based RT in a consecutive fashion immediately before this cohort served as the control group. The median follow-up was 4.7 years. RESULTS: A significant reduction in acute Grade 2 or worse dermatitis, edema, and hyperpigmentation was seen with IMRT compared with wedges. A trend was found toward reduced acute Grade 3 or greater dermatitis (6% vs. 1%, p = 0.09) in favor of IMRT. Chronic Grade 2 or worse breast edema was significantly reduced with IMRT compared with conventional wedges. No difference was found in cosmesis scores between the two groups. In patients with larger breasts (> or =1,600 cm(3), n = 64), IMRT resulted in reduced acute (Grade 2 or greater) breast edema (0% vs. 36%, p <0.001) and hyperpigmentation (3% vs. 41%, p = 0.001) and chronic (Grade 2 or greater) long-term edema (3% vs. 30%, p = 0.007). CONCLUSION: The use of IMRT in the treatment of the whole breast results in a significant decrease in acute dermatitis, edema, and hyperpigmentation and a reduction in the development of chronic breast edema compared with conventional wedge-based RT.

Long-term efficacy and patterns of failure after accelerated partial breast irradiation: a molecular assay-based clonality evaluation.

PURPOSE: To determine the long-term efficacy and cosmetic results of accelerated partial breast irradiation (APBI) by reviewing our institution's experience. METHODS AND MATERIALS: A total of 199 patients with early-stage breast cancer were treated prospectively with adjuvant APBI after lumpectomy using interstitial brachytherapy. All patients had negative margins, 82% had Stage I disease, median tumor size was 1.1 cm, and 12% had positive lymph nodes. The median follow-up for surviving patients was 8.6 years. Fifty-three patients (27%) have been followed for >or=10 years. RESULTS: Six ipsilateral breast tumor recurrences (IBTRs) were observed, for a 5-year and 10-year actuarial rate of 1.6% and 3.8%, respectively. A total of three regional nodal failures were observed, for a 10-year actuarial rate of 1.6%. Five contralateral breast cancers developed, for a 5- and 10-year actuarial rate of 2.2% and 5.2%, respectively. The type of IBTR (clonally related vs. clonally distinct) was analyzed using a polymerase chain reaction-based loss of heterozygosity assay. Eighty-three percent of IBTRs (n = 5) were classified as clonally related. Multiple clinical, pathologic, and treatment-related factors were analyzed for an association with the development of an IBTR, regional nodal failure, or contralateral breast cancer. On multivariate analysis, no variable was associated with any of these events. Cosmetic results were rated as excellent/good in 99% of patients. CONCLUSIONS: Long-term results with APBI using interstitial brachytherapy continue to demonstrate excellent long-term local and regional control rates and cosmetic results. According to a polymerase chain reaction-based loss of heterozygosity assay, 83% of recurrences were classified as clonally related.

Analysis of treatment efficacy, cosmesis, and toxicity using the MammoSite breast brachytherapy catheter to deliver accelerated partial-breast irradiation: the william beaumont hospital experience.

PURPOSE: To review our institution's experience of treating patients with the MammoSite (Cytyc Corp., Marlborough, MA) breast brachytherapy catheter to deliver accelerated partial-breast irradiation (APBI), for determining short-term treatment efficacy, cosmesis, and toxicity. METHODS AND MATERIALS: From January 2000 to April 2006, 80 patients treated with breast-conserving therapy (BCT) received adjuvant radiation using the MammoSite (34 Gy in 3.4-Gy fractions prescribed to 1.0 cm from the balloon surface). Twenty-three patients (29%) had Stage 0 breast cancer, 46 (57%) had Stage I breast cancer, and 11 (14%) had Stage II breast cancer. The median follow-up was 22.1 months. RESULTS: Two ipsilateral breast-tumor recurrences (IBTRs) (2.5%) developed for a 3-year actuarial rate of 2.9% (no regional failures were observed). On molecular-based clonality assay evaluation, both recurrences were clonally related. Younger age at diagnosis was the only variable associated with IBTR (continuous variable, p = 0.044; categorical variable [<55 years vs. >/=55 years], p = 0.012). The percentages of patients with good/excellent cosmetic results at 12 and 36 months were 96.9% and 88.2%, respectively (p = NS). Patients with applicator-to-skin spacing <7 mm and those who received adjuvant systemic chemotherapy exhibited lower rates of good/excellent cosmetic results, though the association was not statistically significant. The overall incidence of symptomatic seromas and any seromas was 10% and 45%, respectively. The overall incidence of fat necrosis and infections was 8.8% and 11.3%, respectively. CONCLUSIONS: Early-stage breast-cancer patients treated with adjuvant APBI using the MammoSite catheter exhibited a 3-year treatment efficacy, cosmesis, and toxicity similar to those observed with other forms of interstitial APBI at this length of follow-up.

Interim cosmetic results and toxicity using 3D conformal external beam radiotherapy to deliver accelerated partial breast irradiation in patients with early-stage breast cancer treated with breast-conserving therapy.

PURPOSE: We present our ongoing clinical experience utilizing three-dimensional (3D)-conformal radiation therapy (3D-CRT) to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer treated with breast-conserving therapy. METHODS AND MATERIALS: Ninety-one consecutive patients were treated with APBI using our previously reported 3D-CRT technique. The clinical target volume consisted of the lumpectomy cavity plus a 10- to 15 -mm margin. The prescribed dose was 34 or 38.5 Gy in 10 fractions given over 5 consecutive days. The median follow-up was 24 months. Twelve patients have been followed for > or =4 years, 20 for > or =3.5 years, 29 for >3.0 years, 33 for > or =2.5 years, and 46 for > or =2.0 years. RESULTS: No local recurrences developed. Cosmetic results were rated as good/excellent in 100% of evaluable patients at > or = 6 months (n = 47), 93% at 1 year (n = 43), 91% at 2 years (n = 21), and in 90% at > or =3 years (n = 10). Erythema, hyperpigmentation, breast edema, breast pain, telangiectasias, fibrosis, and fat necrosis were evaluated at 6, 24, and 36 months after treatment. All factors stabilized by 3 years posttreatment with grade I or II rates of 0%, 0%, 0%, 0%, 9%, 18%, and 9%, respectively. Only 2 patients (3%) developed grade III toxicity (breast pain), which resolved with time. CONCLUSIONS: Delivery of APBI with 3D-CRT resulted in minimal chronic (> or =6 months) toxicity to date with good/excellent cosmetic results. Additional follow-up is needed to assess the long-term efficacy of this form of APBI.

Matched-Pair Analysis of High Dose Versus Standard Dose Definitive Chemoradiation for Locally Advanced Non-Small-Cell Lung Cancer.

BACKGROUND: Recent data have called into question the use of dose-escalated radiotherapy for locally advanced non-small-cell lung cancer and the effect of cardiac radiotherapy doses. We compared the outcomes after chemoradiation using standard-dose (SD; ≤ 64 Gy) or high-dose (HD; > 64 Gy) radiotherapy. PATIENTS AND METHODS: A matched-pair analysis was performed of 178 patients with stage IIB-IIIB non-small-cell lung cancer for SD versus HD groups using age ± 5 years, gender, stage, tumor size ± 2 cm, yielding 86 patients. The clinical endpoints were estimated using the Kaplan-Meier method. Univariate and multivariate analyses were performed using the Cox regression method. RESULTS: The median follow-up was 16.8 months for the entire cohort (HD, 21.6 months; SD, 12.1 months; P = .06). No significant differences were found in disease stage, histologic type, age, performance status, gender, or tumor size between the 2 groups. The median overall survival was 23.1 months for the HD group (95% confidence interval, 20.6-25.5) versus 13.6 months for the SD group (95% confidence interval, 9.6-17.5; P = .03). The 2-year freedom from locoregional recurrence was 48.7% for the SD and 65.3% for the HD groups (P = .07). The 2-year freedom from distant metastasis was 46.7% for the SD and 70.3% for the HD groups (P = .05). A higher cardiac V30 dose (P = .03) was the strongest predictor of survival besides clinical stage (P = .02). CONCLUSION: Dose-escalated radiotherapy resulted in improved survival and recurrence rates. A higher cardiac dose was a significant predictor of decreased survival.