Comparing the efficacy of electronic cognitive behavioral therapy to medication and combination therapy for generalized anxiety disorder: a quasi-experimental clinical trial.

Background: Generalized anxiety disorder (GAD) is a debilitating mental health disorder with first-line treatments include cognitive behavioral therapy (CBT) and pharmacotherapy. CBT is costly, time-consuming, and inaccessible. Electronic delivery (e-CBT) is a promising solution to address these barriers. However, due to the novelty of this intervention, more research testing the e-CBT efficacy independently and in conjunction with other treatments is needed. Objective: This study investigated the efficacy of e-CBT compared to and in conjunction with pharmacotherapy for GAD. Methods: This study employed a quasi-experimental design where patients selected their preferred treatment modality. Patients with GAD were enrolled in either e-CBT, medication, or combination arms. The 12-week e-CBT program was delivered through a digital platform. The medications followed clinical guidelines. The efficacy of each arm was evaluated using questionnaires measuring depression, anxiety, and stress severity, as well as quality of life. Results: There were no significant differences between arms (N e-CBT = 41; N Medication = 41; N Combination = 33) in the number of weeks completed or baseline scores. All arms showed improvements in anxiety scores after treatment. The medication and combination arms improved depression scores. The e-CBT and Combination arms improved quality of life, and the combination arm improved stress scores. There were no differences between the groups in depression, anxiety, or stress scores post-treatment. However, the combination arm had a significantly larger improvement in quality of life. Gender and treatment arm were not predictors of dropout, whereas younger age was. Conclusion: Incorporating e-CBT on its own or in combination with pharmaceutical interventions is a viable option for treating GAD. Treating GAD with e-CBT or medication appears to offer significant improvements in symptoms, with no meaningful difference between the two. Combining the treatments also offer significant improvements, while not necessarily superior to either independently. The findings suggest that all options are viable. Taking the patient's preferred treatment route based on their lifestyle, personality, and beliefs into account when deciding on treatment should be a priority for care providers.

Comparison of online and in-person cognitive behavioral therapy in individuals diagnosed with major depressive disorder: a non-randomized controlled trial.

Objective: The increased prevalence of major depressive disorder (MDD) amid the COVID-19 pandemic has resulted in substantial growth in online mental health care delivery. Compared to its in-person counterpart, online cognitive behavioral therapy (e-CBT) is a time-flexible and cost-effective method of improving MDD symptoms. However, how its efficacy compares to in-person CBT is yet to be explored. Therefore, the current study compared the efficacy of a therapist-supported, electronically delivered e-CBT program to in-person therapy in individuals diagnosed with MDD. Methods: Participants (n = 108) diagnosed with MDD selected either a 12 week in-person CBT or an asynchronous therapist-supported e-CBT program. E-CBT participants (n = 55) completed weekly interactive online modules delivered through a secure cloud-based online platform (Online Psychotherapy Tool; OPTT). These modules were followed by homework in which participants received personalized feedback from a trained therapist. Participants in the in-person CBT group (n = 53) discussed sessions and homework with their therapists during one-hour weekly meetings. Program efficacy was evaluated using clinically validated symptomatology and quality of life questionnaires. Results: Both treatments yielded significant improvements in depressive symptoms and quality of life from baseline to post-treatment. Participants who opted for in-person therapy presented significantly higher baseline symptomatology scores than the e-CBT group. However, both treatments demonstrated comparable significant improvements in depressive symptoms and quality of life from baseline to post-treatment. e-CBT seems to afford higher participant compliance as dropouts in the e-CBT group completed more sessions on average than those in the in-person CBT group. Conclusion: The findings support e-CBT with therapist guidance as a suitable option to treat MDD. Future studies should investigate how treatment accessibility is related to program completion rates in the e-CBT vs. in-person group. Clinical Trial Registration: ClinicalTrials.Gov Protocol Registration and Results System (NCT04478058); clinicaltrials.gov/ct2/show/NCT04478058.

Economic studies in medical research: 'Importance, targets, outcome evaluation'.

Economic studies in healthcare are used to measure the cost and effectiveness of an intervention and are valuable in determining how healthcare resources can be distributed to achieve the greatest overall gain. Most economic studies in healthcare are cost-benefit analyses, cost-effectiveness analyses (CEAs), or cost-utility analyses (CUAs). CEAs and CUAs compare alternative interventions based on cost and effectiveness but are influenced by different methodologies and assumptions employed by researchers. The perspective from which an economic study is evaluated (the patient, the provider, the payor, or the society) should be carefully considered. The incremental cost effectiveness ratio (ICER) describes the difference between two interventions in cost and health outcomes and can be expressed in dollars per quality-adjusted life year (QALY). A threshold ICER <$50,000/QALY is often used to determine whether an intervention is cost-effective, in conjunction with patient factors, healthcare system factors, and opportunity cost associated with the intervention. The Consolidated Health Economic Evaluating Reporting Standards (CHEERS) statement provides guidelines for reporting healthcare economic studies. Key elements to be reported include the study design, target population and subgroups, time horizon, health outcomes, perspectives, comparison group, and sensitivity analyses performed. Economic studies are particularly important in orthopedics given the prevalence of musculoskeletal disease, high upfront costs, and potential quality of life improvements associated with orthopedic surgical procedures. An understanding of economic evaluations in healthcare is important to critically review the available literature.

Labral Tears and Chondral Lesions Are Common Comorbidities Identified During Endoscopic Repair of Gluteal Tendon Tears for Greater Trochanteric Pain Syndrome: A Systematic Review.

PURPOSE: The primary purpose of this study was to systematically review the literature on intraoperative findings during endoscopic treatment for greater trochanteric pain syndrome (GTPS). Secondary outcomes were preoperative imaging findings and postoperative functional outcome measures. METHODS: Medline, PubMED, and Embase databases were searched from inception (1946, 1966, and 1974, respectively), to July 15, 2021, for records reporting intraoperative findings during endoscopic surgery for GTPS. Studies of Level I-IV evidence were eligible. All studies were assessed for quality using the Methodological Index for Non-Randomized Studies (MINORS) score. RESULTS: Sixteen studies met the inclusion criteria. Most patients underwent endoscopic greater trochanteric bursectomy with repair of the gluteal tendons. Intraoperative conditions reported were gluteal tendon tears usually involving the gluteus medius tendon, labral tears, and chondral lesions. Three studies reported an average of 9% of patients who subsequently underwent conversion to total hip arthroplasty. Pain was assessed using the visual analog scale, and functional outcome measures were measured using the modified Harris Hip Score, Non-Arthritic Hip Score, Hip Outcome Score Sport-Specific subscale, Hip Outcome Score Activities of Daily Living subscale, and iHOT-12. Pain and functional outcomes demonstrated significant improvement in nearly all the studies where they were reported. CONCLUSIONS: Patients who underwent endoscopic management of GTPS commonly underwent repair of gluteal tendon tears, and in many cases had concomitant labral tears and chondral lesions identified intraoperatively. There were low rates of adverse events, repair failure, and revision surgery. Patient-reported functional outcomes were improved at follow-up at least 1 year postoperatively. LEVEL OF EVIDENCE: IV, systematic review of level IV or better investigations.

Comparative Efficacy and Tolerability of Antipsychotics for Juvenile Psychotic Disorders: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Psychotic disorders produce important morbidity and disability in children and adolescents. There have been few relevant treatment trials, encouraging assessment of research aimed at testing efficacy and safety of antipsychotics for juveniles. We aimed to compare the short- and long-term efficacy and safety of antipsychotics to treat psychotic disorders among children and adolescents. METHODS: Four major bibliographic databases (PubMed, MEDLINE, PsycINFO, and EMBASE) were searched for clinical trials of antipsychotics in children or adolescents, from database inception to May 2021. We searched for clinical trials comparing antipsychotics with control conditions for juvenile psychosis based on blinded review by 2 independent investigators (C.S.Y. and M.L.). We adhered to the Preferred Reporting Items for Systematic Reviews and Meta-analyses and applied the Cochrane risk-of-bias tool to appraise study quality. One reviewer (A.B.) performed data abstraction which was confirmed by 2 independent, blinded reviewers (C.S.Y. and M.L.). Primary outcomes were scores rating psychosis symptoms and dichotomized retention in treatment protocols versus dropouts because of adverse events. Effect sizes were pooled using frequentist random-effects network meta-analysis modeling to generate summary rate ratios (RRs) and Cohen d standardized mean differences. RESULTS: Systematic searching generated 1330 unique records. Of these, short-term (n = 15, for 6 [3-12] weeks) and long-term (n = 10, for 12 [6-60] months) treatment trials involved 2208 (39.2% females; median age, 15.3 years), and 1366 subjects (35.0% females; median age, 15.6 years), respectively. Short-term reduction of psychosis scores ranked clozapine (d = -1.35; 95% confidence interval [CI], -1.97 to -0.73]), molindone (-1.22; 95% CI, -1.68 to -0.75), olanzapine (-1.12; 95% CI, -1.44 to -0.81), and risperidone (-0.93; 95% CI, -1.22 to -0.63) as the most effective agents. In longer-term treatment, only lurasidone was effective. Clozapine (RR, 12.8) and haloperidol (RR, 5.15) led to more all-cause and adverse event-related dropouts. There were few trials/drug (1 each for aripiprazole, asenapine, lurasidone, molindone, paliperidone, and ziprasidone, short term; aripiprazole, clozapine, haloperidol, lurasidone, and molindone, long-term). Heterogeneity and inconsistency were high, especially in long-term trials, without evidence of publication bias. CONCLUSIONS: Some antipsychotics were effective and tolerated short term, but longer-term evidence was very limited. The overall paucity of trials and of adequate controls indicates that more well-designed randomized controlled trials are required for adequate assessment of antipsychotic drug treatment for juveniles. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021232937.

Dosimetry and outcomes in patients receiving radiotherapy for synchronous bilateral breast cancers.

BACKGROUND: Synchronous bilateral breast cancer (SBBC) is rare and there is little evidence describing organs at risk (OAR) and limits to the heart and lungs caused by radiotherapy (RT). Quantifying mean heart dose (MHD) and mean lung dose (MLD) from RT in this patient cohort may lead to better understanding of doses to OAR and resultant effects on clinical outcomes. The primary objective was to assess median MHD and MLD in SBBC, while secondary aims included analyses of 1) factors associated with MHD and MLD, 2) V5 and V20 values and 3) factors associated with clinical outcomes. METHODS: Patients planned for adjuvant bilateral whole breast/chest wall (WB) RT from a single institution treated in 2011-2018 were included. Median MHD and MLD (Gy) were stratified by hypofractionated (42.56 Gy/16 fractions, HFRT) and conventional fractionation (50 Gy/ 25 fractions, CFRT) and summarized separately based on the following treatments: 1) locoregional RT, WB tangential RT either 2) no boost 3) sequential boost or 4) simultaneous integrated boost. MHD, MLD, lung V5 and V20 values, and demographics were collected. Linear regression analyses identified factors associated with MHD and MLD and factors associated with clinical outcomes. RESULTS: A total of 88 patients were included. The median MHD for HFRT and CFRT was 1.99 Gy and 2.94 Gy, respectively. The median MLD for HFRT and CFRT was 6.00 Gy and 10.08 Gy, respectively. MHD and MLD were significantly associated with the occurrence of a cardiac or pulmonary event post-radiation. Patients who had a mastectomy or tumoral muscle involvement were more likely to develop a local recurrence, metastasis or new primary while patients who had a lumpectomy or tumor with a positive estrogen receptor status were less likely to experience these events. CONCLUSIONS: Further investigation should be conducted to identify SBBC RT techniques that mitigate dose to OARs to improve clinical outcomes in bilateral breast patients.

Feasibility and Efficacy of Delivering Cognitive Behavioral Therapy Through an Online Psychotherapy Tool for Depression: Protocol for a Randomized Controlled Trial.

BACKGROUND: Major depressive disorder (MDD) is a prevalent and debilitating mental health disorder. Among different therapeutic approaches (eg, medication and psychotherapy), psychotherapy in the form of cognitive behavioral therapy (CBT) is considered the gold standard treatment for MDD. However, although efficacious, CBT is not readily accessible to many patients in need because of hurdles such as stigma, long wait times, high cost, the large time commitment for health care providers, and cultural or geographic barriers. Electronically delivered cognitive behavioral therapy (e-CBT) can effectively address many of these accessibility barriers. OBJECTIVE: This study aims to investigate the efficacy and feasibility of implementing an e-CBT program compared with in-person treatment for MDD. It is hypothesized that the e-CBT program will offer results comparable with those of the in-person treatment program, regarding symptom reduction and quality of life improvement. METHODS: This nonrandomized controlled trial intervention will provide e-CBT for MDD through the Online Psychotherapy Tool, a secure, cloud-based, digital mental health platform. Participants (aged 18-65 years) will be offered 12 weekly sessions of an e-CBT program tailored to MDD to address their depressive symptoms. Participants (n=55) will complete predesigned modules and homework assignments while receiving personalized feedback and interacting with a therapist through the platform. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be compared with that of a group (n=55) receiving in-person CBT. Questionnaires will be completed at baseline, at week 6 and week 12, and at a 6-month follow-up. Focus groups will be conducted to investigate personal, cultural, and social factors impacting the accessibility and feasibility of implementing a web-based psychotherapy tool from a patient and care provider perspective. Inclusion criteria include diagnosis of MDD, competence to consent to participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include active psychosis, acute mania, severe alcohol or substance use disorder, and active suicidal or homicidal ideation. RESULTS: Ethics approval was obtained in January 2019, and recruitment of participants began in June 2019. Recruitment has been conducted via social media, web-based communities, and physician referrals. To date, 52 participants have been recruited to the e-CBT group, and 48 patients have been recruited to the in-person CBT group. Data collection is expected to be completed by March 2021, and analyses are expected to be completed by June 2021, as linear regression (for continuous outcomes) and binomial regression analysis (for categorical outcomes) are still being conducted. CONCLUSIONS: The results of this study can provide valuable information for the development of more accessible and scalable mental health interventions with increased care capacity for MDD, without sacrificing the quality of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04478058; http://clinicaltrials.gov/ct2/show/NCT04478058. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27489.

Long-Term Treatment of Bipolar Disorder with Valproate: Updated Systematic Review and Meta-analyses.

LEARNING OBJECTIVE: After participating in this activity, learners should be better able to:• Evaluate the evidence regarding the effectiveness of long-term treatment of bipolar disorder with valproate. BACKGROUND: Prophylactic treatment is critical for bipolar disorder (BD) patients. Valproate is commonly used for this purpose but lacks regulatory approval and carries appreciable risks. METHODS: Systematic literature searching through June 2020 sought prospective trials lasting ≥12 months with adults diagnosed with BD to support comparisons of risk of new illness episodes with valproate versus placebo or other agents. RESULTS: Included were 13 reports involving 9240 subjects treated for an average of 29.1 months (range, 12-124) in 21 trials: 9 were blinded, randomized trials (RCTs) of valproate versus placebo (n = 3), lithium (5), or olanzapine (1); 2 were unblinded RCTs versus lithium (1) or quetiapine (1); and 10 were open-label trials versus lithium (5), quetiapine (2), carbamazepine (1), lamotrigine (1), or olanzapine (1). Random-effects meta-analysis found valproate superior to placebo in 3 trials (odds ratio [OR] = 0.42 [95% confidence level (CI), 0.30-0.60]; p < .0001). In 11 trials, protective effects with valproate and lithium were similar (OR = 1.20 [CI, 0.81-1.79]; p = .36), as well in 5 comparisons versus antipsychotics quetiapine and olanzapine (OR = 0.96 [CI, 0.66-1.40]; p = .84), and 2 versus other mood-stabilizing anticonvulsants (carbamazepine and lamotrigine) (OR = 1.30 [CI, 0.75-2.26]; p = .34). Valproate was nonsignificantly more effective versus new mania than depression (χ2 = 3.03; p = .08). CONCLUSIONS: Valproate was more effective than placebo in preventing new BD episodes of mania or depression, and not significantly different from lithium, second-generation antipsychotics, or other anticonvulsants. Overall benefits were nonsignificantly greater versus mania than bipolar depression.

Determining the Efficacy of Electronic Cognitive Behavioral Therapy for Generalized Anxiety Disorder Compared to Pharmaceutical Interventions: Protocol for a Quasi-Experimental Study.

BACKGROUND: Generalized anxiety disorder (GAD) is an extremely prevalent and debilitating mental health disorder. Currently, the gold standard treatment for GAD is cognitive behavioral therapy (CBT) and/or pharmacotherapy. The most common medications used to treat GAD are selective serotonin reuptake inhibitors and selective norepinephrine reuptake inhibitors. While CBT is the gold standard treatment for GAD, it is costly, time-consuming, and often inaccessible. Fortunately, the electronic delivery of CBT (e-CBT) has emerged as a promising solution to address these barriers. e-CBT has shown to offer comparable results to in-person CBT while improving accessibility for patients and time efficiency for clinicians. OBJECTIVE: This study aims to investigate the treatment efficacy of e-CBT compared to and in conjunction with pharmacotherapy for GAD. METHODS: This study will use a quasi-experimental design to allow patients the freedom to choose which treatment modality they would like to receive. Participants with a diagnosis of GAD will be enrolled in 1 of 3 possible treatment arms: (1) e-CBT, (2) medication, or (3) a combination of e-CBT and medication. The e-CBT program will include a 12-week psychotherapy program delivered through the Online Psychotherapy Tool-a secure, cloud-based, digital mental health platform. The treatment efficacy of e-CBT will be compared with that of medication alone and medication in combination with e-CBT. RESULTS: The study received ethics approval in April 2019 and participant recruitment began in June 2019. Participant recruitment has been conducted through social media advertisements, physical advertisements, and physician referrals. To date, 146 participants (e-CBT: n=53; medication: n=49; combination: n=44) have been recruited. Data collection is expected to conclude by June 2021, and data analysis is expected to be completed by October 2021. Linear regression (for continuous outcomes) and binomial regression (for categorical outcomes) analysis will be conducted using interpretive qualitative methods. CONCLUSIONS: If either the efficacy of e-CBT is shown to be comparable to that of medication or the effects of both treatments are augmented when used in tandem, these findings could have major implications on the mental health care system. e-CBT is a more accessible and affordable treatment that could increase mental health care capacity 4-fold if proven viable. TRIAL REGISTRATION: ClinicalTrials.gov NCT04478526; https://clinicaltrials.gov/ct2/show/NCT04478526. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27772.

Patient-Reported Pain in Patients with Breast Cancer Who Receive Radiotherapy.

BACKGROUND: Patients who receive radiation treatment (RT) for breast cancer often report pain, which contributes negatively to quality of life (QoL). AIMS: To identify demographic, treatment, and disease characteristics associated with pain and changes in pain before and after RT using the Edmonton Symptom Assessment Scale (ESAS). DESIGN: Retrospective study. SETTINGS: Odette Cancer Centre. PARTICIPANTS: Patients diagnosed with nonmetastatic breast cancer from January 2011-June 2017 with at least one ESAS completed pre-RT and one completed post-RT. METHODS: Data on systemic treatment, radiation, patient demographics, and disease stage were extracted. To identify factors associated with pain before and after RT and changes in pain, univariate and multivariate general linear regression analysis were conducted. p < .05 was considered statistically significant. RESULTS: This study included 1,222 female patients with a mean age of 59 years. ESAS was completed an average of 28 days before RT (baseline) and 142 days after RT, respectively. In multivariable analysis, higher baseline pain scores were associated with having recently completed adjuvant chemotherapy (p = .002) and eventual receipt of locoregional (p = .026) or chest wall (p = .003) radiation. Adjuvant chemotherapy (p = .002) and chest wall radiation (p = .03), were associated with a significant reduction in pain score after radiotherapy, while locoregional RT was associated with a higher pain score after RT (p < .001). CONCLUSIONS: Patients with locoregional RT had higher baseline pain that remained elevated after RT completion and should be screened for pain and provided with pain management and support when necessary.

A Feasibility Study of Mepitel Film for the Prevention of Breast Radiation Dermatitis in a Canadian Center.

PURPOSE: Severe radiation dermatitis (RD) is distressing and may have adverse long-term effects including fibrosis and telangiectasia. Treatment interruptions due to severe RD may increase the risk of recurrence. Two randomized trials of Mepitel film demonstrated efficacy in preventing severe RD in breast cancer, but this product has not been widely adopted in North America. We aimed to assess the feasibility and efficacy of Mepitel film for prevention of breast RD at a Canadian center. METHODS AND MATERIALS: Patients were stratified based on breast size and receipt of postmastectomy radiation therapy. The primary outcome was RD grade using the Common Terminology Criteria for Adverse Events. Secondary outcomes included moist desquamation, patient- and clinician-reported symptoms of skin toxicity, and cosmetic outcomes. RESULTS: Thirty patients receiving external beam radiation therapy to the breast or chest wall were enrolled. Two patients (6.7%) discontinued use of the Mepitel film before completing radiation therapy. No patients developed grade 3 RD or higher. Five patients (17.9%) developed grade 2 RD: 3 (10.7%) had moist desquamation, and 2 (7.1%) had brisk erythema without moist desquamation. CONCLUSIONS: Mepitel film completely prevented grade 3 RD. Rates of moist desquamation and grade 2 RD were lower with Mepitel film than in studies using aqueous cream, but unlike previous trials of Mepitel film we did not achieve complete prevention of moist desquamation. Further research is needed to confirm the efficacy of Mepitel film versus standard prophylaxis for RD and identify the patients who will benefit the most from the film.

Self-reported pain in breast cancer patients receiving adjuvant radiotherapy.

PURPOSE: Breast cancer patients receiving radiotherapy (RT) commonly report pain, contributing to physical and emotional distress, and potentially resulting in poor quality of life. This study prospectively identified trends and risk factors in patient-reported pain associated with breast irradiation using the Edmonton Symptom Assessment Scale (ESAS) and a study-specific Skin Symptom Assessment (SSA). METHODS: Before RT and once per week during RT, patients completed the ESAS and SSA. Upon RT completion, patients were contacted via telephone to complete both assessments weekly for 6 weeks, and a final assessment was conducted 1-3 months post-RT. Only data from patients who had completed both assessments before, at least once during, and at least once after RT were included in our analysis. RESULTS: A total of 426 patients provided data for the analysis. Overall acute pain increased significantly at week 1-2 (p < 0.0001), week 5 (p = 0.0011), and at 1-3 months (p < 0.0001) post-RT compared with baseline, and acute breast pain increased significantly at week 1 (p < 0.001) and week 2 (p = 0.0002) post-RT compared with baseline. Previous chemotherapy (adjuvant or neoadjuvant) in mastectomy patients was associated with increased overall pain compared with mastectomy patients without previous chemotherapy (p = 0.017). Younger patients (40-49 or 50-59 years of age) reported more overall pain (p = 0.0001, p = 0.038) and breast pain (p = 0.0003, p = 0.0038) compared with patients ≥ 60 years of age. CONCLUSIONS: Patient-reported pain associated with breast irradiation peaked 1 week after RT completion. Our findings provide support for closer monitoring of acute pain associated with breast RT in younger patients.

Quantitative Effect of Bolus on Skin Dose in Postmastectomy Radiation Therapy.

BACKGROUND: In postmastectomy radiation therapy (PMRT), some centres prescribe the use of a tissue-equivalent bolus to the skin to reduce the risk of chest wall recurrence. The addition of bolus causes an increase in the skin dose, which may lead to increased risk of radiodermatitis. Radiodermatitis can decrease patients' overall quality of life, bringing into question the benefit of using the bolus. The purpose of this retrospective chart review was to quantify the increase in skin dose associated with the use of bolus in the PMRT setting. MATERIALS AND METHODS: We evaluated 70 patients who underwent PMRT at our institution during 2012-2018. Two similar treatment plans were generated for each patient: one with bolus and one without. Skin dose-volume histogram values were evaluated, and statistical analysis was performed using MATLAB R2015b. RESULTS: There was no significant difference in the maximum skin dose within a depth of 5 mm for bolus versus nonbolus plans (P = 0.4). However, within a depth of 3 mm, bolus plans had a maximum skin dose 7% ± 2.5% higher than the nonbolus plans (P < .00001). Mean skin dose within depths of 3 and 5 mm were both significantly higher (P < .00001) for bolus plans. The photon beam energy and chest wall separation showed minimal or no effect on skin dose. CONCLUSION: Given the differing opinions in the literature regarding the role for bolus in PMRT, there is still uncertainty of the optimal treatment method. This retrospective study demonstrates a 20%-30% reduction in mean skin dose when bolus is not used.

The impact of smoking on adjuvant breast cancer radiation treatment: A systematic review.

BACKGROUND: The influence of cigarette smoking on cancer risk has been well-studied. Similarly, exposure to ionizing radiation from radiotherapy (RT) can produce detrimental effects on an individual's health. In patients administered RT, there has been an observed relationship in other primary carcinomas. The purpose of this systematic review was to summarize the influence of cigarette smoking on outcomes post adjuvant RT in breast cancer patients. METHODS: OVID Medline, Cochrane and Embase were searched and 1893 articles were identified. A total of 71 articles were included in the review. Study type, published year and sample size, age, systemic therapies, RT techniques and treatment side effects were collected if available. RESULTS: The review found 198 different outcomes which fell into 7 categories and similar outcomes were recorded. 40% of skin reaction outcomes, 50% of cardiovascular outcomes, 71% of reconstruction outcomes, 29% of pulmonary function outcomes, 33% of mortality outcomes and 42% of secondary recurrence outcomes reported significant differences between smokers and non-smokers. None of the articles reported non-smokers to have a higher risk than smokers. CONCLUSION: Cigarette smoking can pose a higher risk of post-treatment complications that can influence an individual's quality of life, survival rate and/or recurrence risk. This review further assessed the impact of smoking on various patient outcomes and side-effects in the adjuvant breast RT setting. The information provided in this review suggest that smoking cessation programs would help educate patients to understand their risks of being a current or former smoker when undergoing RT.

Factors Affecting Mean Heart Dose in Patients Receiving Breast Radiotherapy from 2011 to 2018 in a Single Institution.

INTRODUCTION: Breast cancer radiotherapy (RT) can increase the risk of cardiac disease with increasing dose; as such, reducing excessive dosage to the heart is a concern for clinicians. The purpose of the present study was to assess mean heart dose (MHD) in patients with breast cancer receiving RT, where it was hypothesized that MHD decreased over time. METHODS: Patients planned for adjuvant unilateral whole breast/chest wall RT from 2011 to 2018 were included for a retrospective chart-review at a single-institution, academic center. MHD (Gy) was summarized by laterality, fractionation, and heart-sparing techniques. RESULTS: A total of 4,687 patients were included. The median MHD for left-sided conventional RT (50 Gy in 25 fractions) was 2.16 Gy across all years, decreasing until 2015 and increasing after. Median MHD for left-sided hypofractionated RT (42.6 Gy in 16 fractions) was 1.47 Gy, also decreasing until 2015 and increasing after. The increase in MHD after 2015 was attributed to a significant increase in the use of wide tangents (including internal mammary chain) after 2015 (P < .0001). Several treatment factors were associated with higher MHD in both right- and left-sided cancers, including locoregional RT, high tangents, wide tangents, bolus, heart shielding, treatment to the chest wall, higher volume of tissue irradiated by tangential fields, higher baseline breast separation values, and smaller heart volume. After adjusting for laterality and fractionation in the multivariate analysis, locoregional RT, wide tangents, heart shielding, boost, treatment to the chest wall, higher volume of tissue irradiated by tangential fields, higher baseline breast separation, and lower heart volume were significantly associated with higher MHD (P < .0001). DISCUSSION/CONCLUSIONS: MHD should be considered when determining the most appropriate RT techniques for both right- and left-sided cancers as higher MHD was significantly associated with various treatment techniques and patient factors.

Ultrasound-Guided Focused Ultrasound Treatment for Painful Bone Metastases: A Pilot Study.

Focused ultrasound (FUS) for palliation of bone metastases has typically been performed under magnetic resonance guidance. To address limitations of this approach, this pilot study evaluated a stand-alone, portable FUS device guided by diagnostic ultrasound alone (ultrasound [US]-guided FUS). Nine patients were treated; safety and efficacy were assessed for 10 d after the procedure, and medical charts were evaluated to assess durability of pain response. The procedure was safe and tolerable, with four patients reporting minor skin-related irritations. Average pain score decreased from 6.9 at baseline to 3.2 at day 10; analgesic use on average also decreased from baseline to day 10. Six patients had durable pain relief as assessed after the follow-up period. Our study provides evidence that US-guided FUS is a safe, tolerable and versatile procedure. It appears to be effective in achieving durable pain response in patients with painful bone metastases. Further research is required to refine the technology and optimize its efficacy.

A systematic review and meta-analysis of clinician-reported versus patient-reported outcomes of radiation dermatitis.

Radiation dermatitis is a common adverse effect of radiotherapy (RT) in breast cancer patients. Although radiation dermatitis is reported by either the clinician or the patient, previous studies have shown disagreement between clinician-reported outcomes (CROs) and patient-reported outcomes (PROs). This review evaluated the extent of discordance between CROs and PROs for radiation dermatitis. Studies reporting both clinician and patient-reported outcomes for external beam RT were eligible. Nine studies met the inclusion criteria for the systematic review, while 8 of these studies were eligible for inclusion in a meta-analysis of acute and late skin toxicities. We found an overall agreement between CROs and PROs of acute skin colour change, fibrosis and/or retraction, and moist desquamation (p > 0.005). Reporting of late breast pain, breast edema, skin colour change, telangiectasia, fibrosis and/or retraction and induration/fibrosis alone (p > 0.005) were also in agreement between clinicians and patients. Our meta-analysis revealed a greater reporting of acute breast pain by patients (RR = 0.89, 95% CI 0.87-0.92, p < 0.001), greater reporting of acute breast edema by physicians (RR = 1.80, 95% CI 1.65-1.97, p < 0.001) and a greater reporting of late breast shrinkage by patients (RR = 0.61, 95% CI 0.44-0.86, p = 0.005). However, our review was limited by the discrepancies between PRO and CRO measurement tools as well as the absence of standard time points for evaluation of radiation dermatitis. Given potential discrepancies between CROs and PROs, both measures should be reported in future studies. Ultimately, we advocate for the development of a single tool to assess symptoms from both perspectives.

Symptom correlates of dyspnea in advanced cancer patients using the Edmonton Symptom Assessment System.

PURPOSE: Dyspnea is frequently experienced in advanced cancer patients and is associated with poor prognosis and functional decline. This study used the Edmonton Symptom Assessment System (ESAS) to characterize the relationship between dyspnea and concurrent symptoms experienced by advanced cancer patients. METHODS: A prospective database was collected and analyzed to extract patient demographics and ESAS scores. Logistic regression analysis and generalized estimating equations (GEE) identified correlations of other ESAS symptoms in three categories: severity of dyspnea (none, mild, moderate, severe), moderate/severe dyspnea (ESAS ≥ 4), and presence of dyspnea (ESAS ≥ 1), at patients' first visit and over time, respectively. RESULTS: Multivariable analysis revealed drowsiness (p = 0.001), and anxiety (p = 0.01) and appetite loss (p = 0.02) were associated with increased severity of dyspnea at first visit. Over time, tiredness (p = 0.02), drowsiness (p = 0.04), nausea (p = 0.02), and anxiety (p = 0.0006) were more likely to experience increased dyspnea severity. Tiredness (p = 0.0003), depression (p = 0.03), and appetite loss (p = 0.003) were significant for moderate/severe dyspnea at first visit. Over multiple visits, tiredness (p < 0.0001), anxiety (p = 0.0008), and appetite loss (p = 0.0008) had higher probabilities of moderate/severe dyspnea. For the presence of dyspnea at the first visit, anxiety (p = 0.03) and drowsiness (p = 0.002) were significantly correlated with an increased frequency of dyspnea. Over time, anxiety (p < 0.0001) and drowsiness (p < 0.0001) remained significant with the addition of nausea (p = 0.0007). CONCLUSIONS: The highly interactive relationship between dyspnea and other common cancer symptoms necessitates the development of comprehensive symptom assessments and utilization of multimodal management approaches that consider concurrent symptoms for improved identification and treatment of dyspnea.

Psychological morbidity in women diagnosed with ductal carcinoma in situ compared with women with early breast cancer receiving radiotherapy.

PURPOSE: Despite having an excellent prognosis, patients with ductal carcinoma in situ (DCIS) report significant anxiety and depression following diagnosis. This study evaluated psychological morbidity using the Edmonton Symptom Assessment Scale (ESAS) in patients with DCIS compared with women with early-stage invasive breast cancer (EIBC) receiving radiotherapy (RT). METHODS: We identified patients diagnosed with DCIS or EIBC (stage I or II breast cancer) from 2011 to 2017 who had at least one ESAS completed pre- and post-RT. Data on systemic treatment, radiation, patient demographics, and disease stage were extracted from existing databases. Psychological morbidity was evaluated through measurement of depression, anxiety, and overall wellbeing within the ESAS. The Wilcoxon rank-sum test or chi-square test was performed for continuous or categorical variables. RESULTS: This study included 137 women with DCIS and 963 women with EIBC. ESAS was completed on average 28 days before RT (baseline) and 142 days after RT. Baseline ESAS scores showed significantly higher rates of depression among women with EIBC compared with those with DCIS (p = 0.006). Patients with EIBC also reported higher levels of anxiety and lower overall wellbeing than patients with DCIS, but this difference was not statistically significant. Post-RT ESAS scores showed significantly higher anxiety in patients with EIBC compared with DCIS (p = 0.049). Post-RT measures of anxiety and overall wellbeing were higher in patients with EIBC but differences were not statistically significant. CONCLUSION: Women with DCIS experience relatively less psychological morbidity than women with EIBC, pre- and post-RT.

Thermal Therapy With a Fully Electronically Steerable HIFU Phased Array Using Ultrasound Guidance and Local Harmonic Motion Monitoring.

The method of localized harmonic motion (LHM) monitoring has been proposed as an ultrasound-based monitoring technique for in vivo real-time ultrasound-guidance during thermal surgery. OBJECTIVE: The focus of this paper is to study the performance of LHM monitoring in vivo in order to assess the tissue coagulation during ultrasound surgery of bone metastases. This is done through a pre-clinical study on large scale animals (pigs) as well as a first-in-human pilot study, using a hand held ultrasound-guided HIFU phased array. METHODS: A flat, fully steerable HIFU phased array system (1024 elements, 100 mm diameter, 516 kHz), in combination with a co-aligned 64 element imaging system, is used to perform thermal surgery and monitor tissue coagulation using the LHM technique. The in vivo experiments are conducted using thirteen animals, followed by a first-in-human pilot study in which nine patients are enrolled. RESULTS: The pre-clinical results show that the LHM monitoring method is able to detect about 80% of the observed coagulated tissue volumes visible in dissection. In the pilot study, six out of nine patients have durable pain reduction with good correlation observed from LHM detections. CONCLUSION: In general, the results suggest that the LHM monitoring performance is promising in detecting thermal tissue coagulation during focused ultrasound surgery in tissues close to the bone. SIGNIFICANCE: The LHM technique can offer a very accessible and cost-efficient monitoring solution during ultrasound surgery within a clinical setting.