Patient-Reported Outcome Measures in High-Risk Medical Device Registries: A Scoping Review.

Little is known about the methods and outcomes of patient-reported outcome measure (PROM) use among high-risk medical device registries. The objective of this scoping review was to assess the utility and predictive ability of PROMs in high-risk medical device registries. We searched Ovid Medline, Embase, APA PsychINFO, Cochrane Library, and Scopus databases for published literature. After searching, 4323 titles and abstracts were screened, and 262 full texts were assessed for their eligibility. Seventy-six papers from across orthopedic (n = 64), cardiac (n = 10), penile (n = 1), and hernia mesh (n = 1) device registries were identified. Studies predominantly used PROMs as an outcome measure when comparing cohorts or surgical approaches (n = 45) or to compare time points (n = 13) including pre- and postintervention. Fifteen papers considered the predictive ability of PROMs. Of these, 8 treated PROMs as an outcome, 5 treated PROMs as a risk factor through regression analysis, and 2 papers treated PROMs as both a risk factor and as an outcome. One paper described PROMs to study implant survival. To advance methods of PROM integration into clinical decision-making for medical devices, an understanding of their use in high-risk device registries is needed. This scoping review found that there is a paucity of studies using PROMs to predict long-term patient and clinical outcomes in high-risk medical device registries. Determination as to why PROMs are rarely used for predictive purposes in long-term data collection is needed if PROM data are to be considered suitable as real-world evidence for high-risk device regulatory purposes, as well as to support clinical decision-making.

Follow-up assessment of sleep-related symptoms in patients after treatment for cancer: responses to continuous positive airway pressure treatment for co-morbid obstructive sleep apnoea.

PURPOSE: To assess changes in sleep-related symptoms in patients with breast cancer, endometrial cancer and melanoma previously examined for sleep-related symptoms and the presence of PSG (polysomnography)-determined OSA, ≥ 3 years post-treatment; and to evaluate how CPAP treatment affects sleep-related symptoms in patients previously diagnosed with OSA. METHODS: Patients initially recruited from breast cancer, endometrial cancer, and melanoma follow-up clinics at Westmead Hospital (Sydney, Australia) participated in this questionnaire-based study. Demographic and change in cancer status data were collected at follow-up. Patients completed the Pittsburgh Sleep Quality Index [poor sleep quality, PSQITOTAL ≥ 5au], Insomnia Severity Index, Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire; with ΔPSQITOTAL ≥ 3au indicating a clinically meaningful change in sleep quality over follow-up. PSG-determined OSA was confirmed using the apnoea-hypopnoea index. CPAP compliance was determined via self-report (CPAP compliant, CPAP; not compliant, non-CPAP). Logistic regression models determined if changes in cancer status, AHI, cancer subgroup or CPAP treatment was predictive of ΔPSQITOTAL ≥ 3 au and p < 0.05 indicated statistical significance. RESULTS: The 60 patients recruited had breast cancer (n = 22), endometrial cancer (n = 15), and melanoma (n = 23). Cancer subgroups were similarly aged, and all had median follow-up PSQITOTAL scores ≥ 5au; breast cancer patients scoring the highest (p < 0.05). The CPAP group had significantly reduced PSQITOTAL scores (p = 0.02) at follow-up, unlike the non-CPAP group. Cancer subgroups had similar median ISITOTAL, ESSTOTAL and FOSQ-10TOTAL scores at follow-up, regardless of CPAP treatment. There were no significant predictors of ΔPSQITOTAL ≥ 3 au at follow-up. CONCLUSION: Sleep-related symptoms persist in patients with cancer ≥ 3 years after treatment, although these symptoms improve with CPAP. Future studies should evaluate how CPAP affects survival outcomes in cancer patients with comorbid OSA.

How to convert a submuscular/dual plane reconstruction to a pre-pectoral pocket implant reconstruction.

A conversion from subpectoral breast reconstruction to pre-pectoral breast reconstruction can help with animation resolution and improved patient satisfaction. We describe the conversion technique involving removal of the existing implant, creating a neo-pre-pectoral pocket and restoring the pectoral muscle to its natural position.

A National Health and Wellness SMS Text Message Program for Breast Cancer Survivors During COVID-19 (EMPOWER-SMS COVID-19): Mixed Methods Evaluation Using the RE-AIM Framework.

BACKGROUND: COVID-19 lockdowns caused widespread closures of supportive care services for breast cancer survivors in Australia. In a randomized controlled trial, our team's lifestyle-focused, evidence-based SMS text message support program (EMPOWER-SMS COVID-19) was found to be acceptable and useful for breast cancer survivors, and it was ready for rapid widespread delivery. OBJECTIVE: This study aims to evaluate the reach (uptake) of an adapted 3-month lifestyle-focused SMS text message program (EMPOWER-SMS COVID-19) and barriers and enablers to implementation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. METHODS: A mixed methods pre-post study was conducted to evaluate the EMPOWER-SMS COVID-19 program. The study evaluated the following aspects: (1) reach/representativeness, which refers to the proportion of participant enrollment (ie, number enrolled/number that visited the study website) and demographics (eg, age, sex, ethnicity, time since completing treatment, Index of Relative Socio-economic Advantage and Disadvantage [IRSAD; quintile 1, which refers to most disadvantaged areas, to quintile 5, which refers to least disadvantaged areas, and remoteness); (2) effectiveness, in which participant engagement and acceptability were evaluated using SMS text message reply data and a feedback survey (5-point Likert scale and free-text responses); (3) adoption, which corresponds to the proportion of organizations or health professionals who agreed to promote the program; (4) implementation fidelity and maintenance, which evaluated SMS text message delivery data, opt-outs, costs, and adaptations. Quantitative data were summarized using means and SDs or frequencies and percentages, while qualitative data were analyzed thematically. RESULTS: With regard to the reach/representativeness of the program, 841/1340 (62.8%) participants enrolled and provided electronic consent. Participants had a mean age of 58.8 (SD 9.8; range 30-87) years. According to the data collected, most participants identified as female (837/840, 99.6%) and White (736/840, 87.6%) and nearly half (418/841, 49.7%) finished treatment ≤18 months ago. Most resided in major cities (574/838, 68.5%) and 30% (251/838) in IRSAD quintile 1 or 2. In terms of effectiveness, 852 replies were received from 511 unique participants (median 1; range 1-26). The most common replies were participants stating how they heard about the program (467/852, 54.8%) or "thank you" (131/852, 15.4%). None of the replies contained urgent safety concerns. Among participants who provided feedback (449/841, 53.4%), most "(strongly) agreed" the SMS text messages were easy to understand (445/448, 99.3%), useful (373/440, 84.8%), helped participants feel supported (388/448, 86.6%), and motivated participants to be physically active (312/445, 70.1%) and eat healthier (313/457, 68.5%). Free-text responses revealed 5 factors influencing engagement: (1) feeling supported and less alone, (2) motivation and reassurance for health self-management, (3) the variety of information, (4) weblinks to information and resources, and (5) the option to save the SMS text messages. Concerning adoption, 50% (18/36) of organizations/health professionals agreed to promote the program. With regard to implementation/maintenance, SMS text messages were delivered as planned (97.43% [41,257/42,344] of SMS text messages were successfully delivered) with minimal opt-outs (62/838, 7.4%) and low cost (Aus $15.40/participant; Aus $1=US $0.67). No adaptations were made during the intervention period. Postintervention adaptations included adding weblinks and participant-selected customizations. CONCLUSIONS: EMPOWER-SMS COVID-19 was implemented quickly, had a broad reach, and had high engagement and acceptability among socioeconomically diverse participants. The program had high fidelity, low cost, and required minimal staff oversight, which may facilitate future implementation. However, further research is needed to evaluate barriers and enablers to adoption and implementation for health professionals and strategies for long-term maintenance.

Current Challenges and Perspectives in Breast Cancer in Elderly Women: The Senologic International Society (SIS) Survey.

Objective: Mammographic screening and management of breast cancer (BC) in elderly women are controversial and continue to be an important health problem. To investigate, through members of the Senologic International Society (SIS), the current global practices in BC in elderly women, highlighting topics of debate and suggesting perspectives. Materials and Methods: The questionnaire was sent to the SIS network and included 55 questions on definitions of an elderly woman, BC epidemiology, screening, clinical and pathological characteristics, therapeutic management in elderly women, onco-geriatric assessment and perspectives. Results: Twenty-eight respondents from 21 countries and six continents, representing a population of 2.86 billion, completed and submitted the survey. Most respondents considered women 70 years and older to be elderly. In most countries, BC was often diagnosed at an advanced stage compared to younger women, and age-related mortality was high. For this reason, participants recommended that personalized screening be continued in elderly women with a long life expectancy.In addition, this survey highlighted that geriatric frailty assessment tools and comprehensive geriatric evaluations needed to be used more and should be developed to avoid undertreatment. Similarly, multidisciplinary meetings dedicated to elderly women with BC should be encouraged to avoid under- and over-treatment and to increase their participation in clinical trials. Conclusion: Due to increased life expectancy, BC in elderly women will become a more important field in public health. Therefore, screening, personalized treatment, and comprehensive geriatric assessment should be the cornerstones of future practice to avoid the current excess of age-related mortality. This survey described, through members of the SIS, a global picture of current international practices in BC in elderly women.

Supporting women's health outcomes after breast cancer treatment comparing a text message intervention to usual care: the EMPOWER-SMS randomised clinical trial.

PURPOSE: The aim of this study is to evaluate the efficacy, feasibility and acceptability of a co-designed lifestyle-focused text message intervention (EMPOWER-SMS) for breast cancer survivors' self-efficacy, quality of life (QOL), mental (anxiety, depression, stress) and physical (endocrine therapy medication adherence, physical activity, BMI) health. METHODS: Single-blind randomised controlled trial (1:1) comparing EMPOWER-SMS to usual care at 6-months (intention-to-treat). SETTING: public Breast Cancer Institute (Sydney, Australia). ELIGIBILITY CRITERIA: adult (> 18 years) females, < 18-months post-active breast cancer treatment (stage I-III), owned a mobile phone, written informed consent. PRIMARY OUTCOME: Self-Efficacy for Managing Chronic Disease Scale at 6 months. Process data: message delivery analytics, cost, and post-intervention survey. RESULTS: Participants (N = 160; mean age ± SD 55.1 ± 11.1 years) were recruited 29th-March-2019 to 7th-May-2020 and randomised (n = 80 EMPOWER-SMS: n = 80 control). Baseline mean self-efficacy was high (I: 7.1 [95%CI 6.6, 7.5], C: 7.4 [7, 7.8]). Six-month follow-up: no significant differences between groups for self-efficacy (I: 7.6 [7.3, 7.9], C: 7.6 [7.3, 7.9], adjusted mean difference 0 (95%CI 0.4, 0.4), QOL, mental health, physical activity, or BMI. Significantly less EMPOWER-SMS participants missed ≥ 1 endocrine therapy medication doses compared to control (I: 3/42[7.1%], C: 8/47[17.0%], Adjusted RR 0.13 [95%CI 0.02, 0.91]). Text messages were delivered successfully (7925/8061, 98.3%), costing $13.62USD/participant. Participants strongly/agreed EMPOWER-SMS was easy-to-understand (64/64; 100%), useful (58/64; 90.6%), motivating for lifestyle change (43/64; 67.2%) and medication adherence (22/46; 47.8%). CONCLUSION: EMPOWER-SMS was feasible, inexpensive, acceptable for delivering health information to breast cancer survivors between medical appointments, with minor improvements in medication adherence. IMPLICATIONS FOR CANCER SURVIVORS: Text messages offer a feasible strategy for continuity-of-care between medical appointments.

Evaluation of Vectra® XT 3D Surface Imaging Technology in Measuring Breast Symmetry and Breast Volume.

BACKGROUND: Breast symmetry is an essential component of breast cosmesis. The Harvard Cosmesis scale is the most widely adopted method of breast symmetry assessment. However, this scale lacks reproducibility and reliability, limiting its application in clinical practice. The VECTRA® XT 3D (VECTRA®) is a novel breast surface imaging system that, when combined with breast contour measuring software (Mirror®), aims to produce a more accurate and reproducible measurement of breast contour to aid operative planning in breast surgery. OBJECTIVES: This study aims to compare the reliability and reproducibility of subjective (Harvard Cosmesis scale) with objective (VECTRA®) symmetry assessment on the same cohort of patients. METHODS: Patients at a tertiary institution had 2D and 3D photographs of their breasts. Seven assessors scored the 2D photographs using the Harvard Cosmesis scale. Two independent assessors used Mirror® software to objectively calculate breast symmetry by analysing 3D images of the breasts. RESULTS: Intra-observer agreement ranged from none to moderate (kappa - 0.005-0.7) amongst the assessors using the Harvard Cosmesis scale. Inter-observer agreement was weak (kappa 0.078-0.454) amongst Harvard scores compared to VECTRA® measurements. Kappa values ranged 0.537-0.674 for intra-observer agreement (p < 0.001) with Root Mean Square (RMS) scores. RMS had a moderate correlation with the Harvard Cosmesis scale (rs = 0.613). Furthermore, absolute volume difference between breasts had poor correlation with RMS (R2 = 0.133). CONCLUSION: VECTRA® and Mirror® software have potential in clinical practice as objectifying breast symmetry, but in the current form, it is not an ideal test. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Prospective Surveillance with Compression for Subclinical Lymphedema: Symptoms, Skin, and Quality-of-Life Outcomes.

Background: Patients underwent a compression (sleeve and gauntlet) intervention for subclinical breast cancer-related lymphedema (S-BCRL). Physical, emotional, and quality-of-life (QoL) outcomes were examined. Associations of change in extracellular fluid alone through bioimpedance spectroscopy (BIS) or change in whole-arm volume through tape measure with the outcomes at time of S-BCRL were explored. Methods and Results: We enrolled newly diagnosed nonmetastatic breast cancer patients for surveillance up to 36 months postoperatively. Upon detection of S-BCRL, a 28-day compression intervention was initiated. Data were obtained through physical examination/measurement and self-report instruments: skin examination, Lymphedema Symptom Intensity and Distress Survey-Arm, and Functional Assessment of Cancer Therapy General (FACT-G), Breast (FACT-B), and FACT-B+4. Improvements with intervention were observed in the proportion of patients reporting symptom scores ≥3 in function (Cohen's d = -0.46, p < 0.01), in biobehavioral (Cohen's d = -0.30, p < 0.05), maximum number of skin conditions (Cohen's d = -0.34, p < 0.05. 3), FACT-B (Cohen's d = 0.52, p < 0.01), and FACT-B + four (Cohen's d = -0.42, p < 0.01). At the study endpoint, compared with those who did not progress, chronic breast cancer-related lymphedema (C-BCRL) progressing patients had higher overall symptom scores (p = 0.037), more skin conditions (p = 0.009), and lower total FACT-G and FACT-B scores (p < 0.05). At the time of S-BCRL, detection of greater BIS unit change correlated with higher symptom, skin condition, and QoL values. Greater whole-arm volume change correlated with higher FACT-B+4 scores (all p < 0.05). Conclusions: Prospective surveillance, symptom assessment, and compression intervention promote low progression rates from S-BCRL to C-BCRL and as such reduce symptom burden. This closed study is registered with ClinicalTrials.gov NCT02167659.

Screening for obstructive sleep apnoea in post-treatment cancer patients.

BACKGROUND AND AIMS: For cancer patients, comorbid obstructive sleep apnea (OSA) poses additional risk to their surgical/anaesthetic outcomes, quality of life, and survival. However, OSA screening is not well-established in oncology settings. We tested two screening tools (STOP-Bang questionnaire [SBQ] and the at-home monitoring device, ApneaLink™Air), for predicting polysomnography (PSG) confirmed OSA in post-treatment cancer patients. METHODS: Breast (n = 56), endometrial (n = 37) and melanoma patients (n = 50) were recruited from follow-up clinics at Westmead Hospital (Sydney, Australia). All underwent overnight PSG, 137 completed SBQ, and 99 completed ApneaLink™Air. Positive (PPV) and negative (NPV) predictive values for PSG-determined moderate-to-severe OSA and severe OSA, were calculated using an SBQ threshold ≥3 au and ApneaLink™Air apnoea-hypopnea index thresholds of ≥10, ≥15 and ≥30 events/h. RESULTS: Both SBQ and ApneaLink™Air had high NPVs (92.7% and 85.2%-95.6% respectively) for severe OSA, but NPVs were lower for moderate-to-severe OSA (69.1% and 59.1%-75.5%, respectively). PPV for both tools were relatively low (all <73%). Combining both tools did not improve screening performance. CONCLUSIONS: These screening tools may help identify cancer patients without severe OSA, but both are limited in identifying those with moderate-to-severe or severe OSA. PSG remains optimal for adequately identifying and managing comorbid OSA in cancer patients.

Assessing variability in breast cancer management across the world: results of a questionnaire survey amongst global international experts in breast cancer management.

Background: Breast cancer is the most common cancer in women worldwide with an estimated 2.3 million breast cancer cases diagnosed annually. The outcome of breast cancer management varies widely across the globe which could be due to a multitude of factors. Hence, a blanket approach in standardisation of care across the world is neither practical nor feasible. Aim: To assess the extent and type of variability in breast cancer management across the globe and to do a gap analysis of patient care pathway. Method: An online questionnaire survey and virtual consensus meeting was carried out amongst 31 experts from 25 countries in the field of breast cancer surgical management. The questionnaire was designed to understand the variability in diagnosis and treatment of breast cancer, and potential factors contributing to this heterogeneity. Result: The questionnaire survey shows a wide variation in breast surgical training, diagnosis and treatment pathways for breast cancer patients. There are several factors such as socioeconomic status, patient culture and preferences, lack of national screening programmes and training, and paucity of resources, which are barriers to the consistent delivery of high-quality care in different parts of the world. Conclusion: On-line survey platforms distributed to global experts in breast cancer care can assess gaps in the diagnosis and treatment of breast cancer patients. This survey confirms the need for an in-depth gap analysis of patient care pathways and treatments to enable the development of personalised plans and policies to standardise high quality care.

Risk factors for breast cancer-related lymphedema in patients undergoing 3 years of prospective surveillance with intervention.

BACKGROUND: To evaluate risk factors (treatment-related, comorbidities, and lifestyle) for breast cancer-related lymphedema (BCRL) within the context of a Prospective Surveillance and Early Intervention (PSEI) model of care for subclinical BCRL. METHODS: The parent randomized clinical trial assigned patients newly diagnosed with breast cancer to PSEI with either bioimpedance spectroscopy (BIS) or tape measurement (TM). Surgical, systemic and radiation treatments, comorbidities, and lifestyle factors were recorded. Detection of subclinical BCRL (change from baseline of either BIS L-Dex ≥6.5 or tape volume ≥ 5% and < 10%) triggered an intervention with compression therapy. Volume change from baseline ≥10% indicated progression to chronic lymphedema and need for complex decongestive physiotherapy. In this secondary analysis, multinomial logistic regressions including main and interaction effects of the study group and risk factors were used to test for factor associations with outcomes (no lymphedema, subclinical lymphedema, progression to chronic lymphedema after intervention, progression to chronic lymphedema without intervention). Post hoc tests of significant interaction effects were conducted using Bonferroni-corrected alphas of .008; otherwise, an alpha of .05 was used for statistical significance. RESULTS: The sample (n = 918; TM = 457; BIS = 461) was female with a median age of 58.4 years. Factors associated with BCRL risk included axillary lymph node dissection (ALND) (p < .001), taxane-based chemotherapy (p < .001), regional nodal irradiation (RNI) (p ≤ .001), body mass index >30 (p = .002), and rurality (p = .037). Mastectomy, age, hypertension, diabetes, seroma, smoking, and air travel were not associated with BCRL risk. CONCLUSIONS: Within the context of 3 years of PSEI for subclinical lymphedema, variables of ALND, taxane-based chemotherapy, RNI, body mass index >30, and rurality increased risk.

The Senologic International Society Survey on Ductal Carcinoma In Situ: Present and Future.

Objective: Therapeutic management of ductal carcinoma in situ (DCIS) is heterogeneous among countries worldwide, and some treatment indications are still controversial. To investigate DCIS management in different countries; identify both consensual practices and controversial topics; and survey opinions about the future management of DCIS. Materials and Methods: The Senologic International Society network members participated to an online survey using a questionnaire, between November 2021 and February 2022. Results: Twenty-two responses from 20 different countries showed that organized breast cancer screening programs were present for 87% participants, and DCIS cases represented 13.7% of all breast cancers. Most participants used the grade classification (100%), the morphological classification (78%) and performed immunohistochemistry assays (73%). In case of conservative treatment, the mean re-excision rate was 10.3% and clear margins of mean 2.5 mm were considered healthy. Radical mastectomy rate was 35.5% with a breast reconstruction rate of 53%. Tumor bed boost indications were heterogeneous, and 73% of participants indicated hormone therapy for hormone-positive DCIS. Surgery and radiotherapy omission for some low-risk DCIS were considered by 73% of participants. Multigene assays were used by 43% of participants. Concerning future changes in DCIS management, participants mostly answered surgical de-escalation (48%), radiotherapy de-escalation (35) and/or active surveillance for some cases (22%). Conclusion: This survey provided an overview of the current practices of DCIS management worldwide. It showed that some areas are rather consensual: incidence increases over time, treatment in young women, pathological classifications, definition of healthy margins, the skin-sparing mastectomy and immediate breast reconstruction. However, some topics are still debated and result in heterogeneous practices, such as evolution in the age of diagnosis, the benefit of de-escalation in low-risk DCIS among elderly women, indications for hormone therapy, radiotherapy omission, or multigene assays. Further evidence is needed to reach consensus on these points, and innovative approaches are still under evaluation in clinical trials. The International Senologic Society, by its members, encourages precision medicine and personalized treatments for DCIS, to avoid overtreatment and overdiagnosis, and provide better healthcare to women with DCIS.

A Qualitative Study Exploring Feasibility and Acceptability of Acupuncture, Yoga, and Mindfulness Meditation for Managing Weight After Breast Cancer.

INTRODUCTION: Weight gain is common after breast cancer. Yoga, mindfulness meditation, and acupuncture may assist with managing weight. However, evidence on effectiveness is limited. This study assessed the feasibility and acceptability of recruiting for and implementing a randomized controlled trial (RCT) evaluating these interventions as adjuncts to lifestyle interventions (diet and exercise) for weight management in women with breast cancer. METHODS: Qualitative study involving virtual focus groups or semi-structured interviews. Participants were recruited via email invitation from a breast cancer consumer organization and breast cancer center in Australia. Eligible participants had received treatment for breast cancer, and were fluent in English. A purposive sample of culturally and linguistically diverse (CALD) participants was also recruited. Focus groups and interviews were audio-recorded, transcribed verbatim and analyzed using thematic analysis with the constant comparison method. RESULTS: Emails were sent to 1415 women of which 37 provided data in 5 focus groups and 1 semi-structured interview, including 1 focus group (n = 6) with only women from CALD backgrounds. Yoga and mindfulness meditation were perceived as feasible and acceptable for weight management, but acupuncture was seen to be too invasive to be acceptable. A focus on wellness rather than weight reduction, flexible program delivery, trusted advice, consideration of participant burden and benefit, and peer-support were key factors perceived to increase feasibility and acceptability. CONCLUSIONS: Yoga and mindfulness meditation are acceptable and useful adjuncts to lifestyle interventions for weight management after breast cancer. This research places end-users at the forefront of trial design, and will inform future trials using these interventions for weight management and improving health and wellbeing after breast cancer.

Improving Bone Mineral Density Screening by Using Digital X-Radiogrammetry Combined With Mammography.

Fracture risk evaluation of postmenopausal women is suboptimal, but most women undergo screening mammography. Digital X-radiogrammetry (DXR) determines bone mineral density (BMD) at the metacarpal shaft and can be performed on mammography equipment. This study examined correlations between DXR and dual-energy X-ray absorptiometry (DXA) in women undergoing mammography, to identify optimal DXR thresholds for triage to osteoporosis screening by central DXA. Postmenopausal women over age 50 years, recruited from Westmead Hospital's Breast Cancer Institute, underwent mammography, DXR and DXA. Agreements were determined using the area under the receiver operator characteristic (AUC ROC) curve and Lin's concordance correlation coefficient. Optimal DXR T-scores to exclude osteoporosis by DXA were determined using the Youden's method. Of 200 women aged 64 ± 7 years (mean ± standard deviation [SD]), 82% had been diagnosed with breast cancer and 37% reported prior fracture. DXA T-scores were ≤ -1 at the spine, hip or forearm in 77.5% and accorded with DXR T-scores in 77%. For DXR and DXA T-scores ≤ -2.5, the AUC ROC was 0.87 (95% confidence interval [CI], 0.81-0.94) at the 1/3 radius, and 0.74 (95% CI, 0.64-0.84) for hip or spine. DXR T-scores > -1.98 provided a negative predictive value of 94% (range, 88%, 98%) for osteoporosis by central DXA. In response to a questionnaire, radiography staff responded that DXR added 5 minutes to patient throughput with minimal workflow impact. In the mammography setting, triaging women with a screening DXR T-score < -1.98 for DXA evaluation would capture a significant proportion of at-risk women who may not otherwise be identified and improve current low rates of osteoporosis screening. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Electronic Health Interventions for Patients With Breast Cancer: Systematic Review and Meta-Analyses.

PURPOSE: Ongoing supportive care using electronic health (eHealth) interventions has the potential to provide remote support and improve health outcomes for patients with breast cancer. This study aimed to evaluate the effectiveness of eHealth interventions on patient-reported outcomes (quality of life [QOL], self-efficacy, and mental or physical health) for patients during and after breast cancer treatment and patient-reported experience measures (acceptability and engagement). METHODS: Systematic review with meta-analyses (random-effects model) of randomized controlled trials was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Nine databases were searched using a prespecified search strategy. Patient-directed eHealth interventions for adult patients during or after active breast cancer treatment measuring QOL, self-efficacy, and mental (depressive, anxiety, and distress symptoms) or physical (physical activity, nutrition, and fatigue) health outcomes were included. Data from eligible full-text articles were independently extracted by six observers. RESULTS: Thirty-two unique studies (4,790 patients) were included. All were health self-management interventions, and most were multicomponent (videos, forums, and electronic reminder systems) websites. Meta-analyses revealed a significant effect of eHealth interventions on QOL (standardized mean difference [SMD], 0.20 [95% CI, 0.03 to 0.36]), self-efficacy (SMD, 0.45 [95% CI, 0.24 to 0.65]), distress (SMD, -0.41 [95% CI,-0.63 to -0.20]), and fatigue (SMD, -0.37 [95% CI, -0.61 to -0.13]). Twenty-five studies (78.1%) measured patient-reported experience measures. Acceptability (n = 9) was high, with high ratings for satisfaction (range, 71%-100%), usefulness (range, 71%-95%), and ease-of-use (range, 73%-92%). Engagement (n = 25) decreased over time, but disease-focused information and interactive support were most engaging. CONCLUSION: eHealth interventions may provide an acceptable and effective strategy for improving QOL, distress, self-efficacy, and fatigue among patients with breast cancer.

Cancer sleep symptom-related phenotypic clustering differs across three cancer specific patient cohorts.

Specific sleep disorders have been linked to disease progression in different cancers. We hypothesised sleep symptom clusters would differ between cancer types. The aim of this study was to compare sleep symptom clusters in post-treatment melanoma, breast and endometrial cancer patients. Data were collected from 124 breast cancer patients (1 male, 60 ± 15 years, 28.1 ± 6.6 kg/m2 ), 82 endometrial cancer patients (64.0 ± 12.5 years, 33.5 ± 10.4 kg/m2 ) and 112 melanoma patients (59 male, 65.0 ± 18.0 years, 29.1 ± 6.6 kg/m2 ). All patients completed validated questionnaires to assess sleep symptoms, including the Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10). Snoring, tiredness, observed apneas, age, BMI, and gender data were also collected. Binary values (PSQI, ISI, FOSQ), or continuous variables for sleepiness (ESS) and perceived sleep quality (PSQI), were created and sleep symptom clusters were identified and compared across cancer cohorts. Four distinct sleep symptom clusters were identified: minimally symptomatic (n = 152, 47.7%); insomnia-predominant (n = 87, 24.9%); very sleepy with upper airway symptoms (n = 51, 16.3%), and severely symptomatic with severe dysfunction (n = 34, 11.1%). Breast cancer patients were significantly more likely to be in the insomnia predominant or severely symptomatic with severe dysfunction clusters, whereas melanoma patients were more likely to be minimally symptomatic or sleepy with upper airway symptoms (p <0.0001). Endometrial cancer patients were equally distributed across symptom clusters. Sleep symptom clusters vary across cancer patients. A more personalised approach to the management of sleep-related symptoms in these patients may improve the long term quality of life and survival.

Oncoplastic breast consortium recommendations for mastectomy and whole breast reconstruction in the setting of post-mastectomy radiation therapy.

AIM: Demand for nipple- and skin- sparing mastectomy (NSM/SSM) with immediate breast reconstruction (BR) has increased at the same time as indications for post-mastectomy radiation therapy (PMRT) have broadened. The aim of the Oncoplastic Breast Consortium initiative was to address relevant questions arising with this clinically challenging scenario. METHODS: A large global panel of oncologic, oncoplastic and reconstructive breast surgeons, patient advocates and radiation oncologists developed recommendations for clinical practice in an iterative process based on the principles of Delphi methodology. RESULTS: The panel agreed that surgical technique for NSM/SSM should not be formally modified when PMRT is planned with preference for autologous over implant-based BR due to lower risk of long-term complications and support for immediate and delayed-immediate reconstructive approaches. Nevertheless, it was strongly believed that PMRT is not an absolute contraindication for implant-based or other types of BR, but no specific recommendations regarding implant positioning, use of mesh or timing were made due to absence of high-quality evidence. The panel endorsed use of patient-reported outcomes in clinical practice. It was acknowledged that the shape and size of reconstructed breasts can hinder radiotherapy planning and attention to details of PMRT techniques is important in determining aesthetic outcomes after immediate BR. CONCLUSIONS: The panel endorsed the need for prospective, ideally randomised phase III studies and for surgical and radiation oncology teams to work together for determination of optimal sequencing and techniques for PMRT for each patient in the context of BR.

Incidental findings on single-photon emission computed tomography/computed tomography (SPECT/CT) lymphoscintigraphy in breast cancer: the proposed Westmead SPECT/CT incidental findings classification.

BACKGROUND: The aim of this study is to determine the prevalence of incidental radiological findings detected on SPECT/CT performed as part of pre-operative lymphoscintigraphy for sentinel lymph node biopsy (SLNB) in patients undergoing breast cancer surgery and development of a modified classification to workup these lesions. METHODS: A retrospective audit was performed of all SPECT/CT performed in combination with lymphoscintigrams in breast cancer patients presenting with clinically node negative axillae and operated on by breast surgeons at the Westmead Breast Cancer Institute over a 12-month period. RESULTS: Four hundred and nineteen patients were included in the study. In 149 patients (35.6%), there was a total of 205 incidental findings. The most common findings were, pulmonary abnormalities (38.5%), abdominal findings (27.8%), thyroid nodules (14.6%), cardiac abnormalities (10.7%) and others (8.3%). Using our proposed Westmead SPECT/CT incidental findings (WSIF) classification, 7.8% were known, 17.6% were major findings, 48.3% were minor findings, 15.1% were minimal findings and 11.2% were equivocal findings. 17.6% (n = 36) underwent further workup and investigation and 3.4% of patients (n = 5) required therapeutic intervention, including chemotherapy for primary lung cancer(n = 1) and surgeries (thoracotomy, n = 1; thyroidectomy, n = 2; colonoscopy, n = 1). 93.8% (n = 393) had at least one SLN mapped, most commonly located in Level 1 of the axilla. CONCLUSION: The incidental findings on SPECT/CT in combination with lymphoscintigraphy is within the range of previous studies (27.3-59.5%). A small proportion of patients required significant major interventions (3.4%). We propose that all incidental findings should be assessed according to our WSIF classification to aid in triaging need for further investigation and management.

The Modified M-plasty Approach to Mastectomy: Avoiding the Lateral Dog-ear.

Postmastectomy "dog-ears" are cosmetically displeasing, can contribute to a poorly fitting bra, and may cause discomfort for patients. They occur most commonly in patients with high body mass index and/or large breasts and can be challenging to manage. To avoid the lateral dog-ear following simple mastectomy, we describe the M-plasty with the addition of a lipodermal flap. We demonstrate that the addition of a lipodermal flap not only flattens the lateral contour of the chest wall but also facilitates a tension-free closure. This helps reduce wound-healing issues in high-risk patients with multiple comorbidities, high body mass index, and large breast size.