Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial.

BACKGROUND: Moderately severe or major trauma (injury severity score (ISS) > 8) is common, often resulting in physical and psychological problems and leading to difficulties in returning to work. Vocational rehabilitation (VR) can improve return to work/education in some injuries (e.g. traumatic brain and spinal cord injury), but evidence is lacking for other moderately severe or major trauma. METHODS: ROWTATE is an individually randomised controlled multicentre pragmatic trial of early VR and psychological support in trauma patients. It includes an internal pilot, economic evaluation, a process evaluation and an implementation study. Participants will be screened for eligibility and recruited within 12 weeks of admission to eight major trauma centres in England. A total of 722 participants with ISS > 8 will be randomised 1:1 to VR and psychological support (where needed, following psychological screening) plus usual care or to usual care alone. The ROWTATE VR intervention will be provided within 2 weeks of study recruitment by occupational therapists and where needed, by clinical psychologists. It will be individually tailored and provided for ≤ 12 months, dependent on participant need. Baseline assessment will collect data on demographics, injury details, work/education status, cognitive impairment, anxiety, depression, post-traumatic distress, disability, recovery expectations, financial stress and health-related quality of life. Participants will be followed up by postal/telephone/online questionnaires at 3, 6 and 12 months post-randomisation. The primary objective is to establish whether the ROWTATE VR intervention plus usual care is more effective than usual care alone for improving participants' self-reported return to work/education for at least 80% of pre-injury hours at 12 months post-randomisation. Secondary outcomes include other work outcomes (e.g. hours of work/education, time to return to work/education, sickness absence), depression, anxiety, post-traumatic distress, work self-efficacy, financial stress, purpose in life, health-related quality of life and healthcare/personal resource use. The process evaluation and implementation study will be described elsewhere. DISCUSSION: This trial will provide robust evidence regarding a VR intervention for a major trauma population. Evidence of a clinically and cost-effective VR intervention will be important for commissioners and providers to enable adoption of VR services for this large and important group of patients within the NHS. TRIAL REGISTRATION: ISRCTN: 43115471. Registered 27/07/2021.

Prospective, early longitudinal assessment of lymphedema-related quality of life among patients with locally advanced breast cancer: The foundation for building a patient-centered screening program.

BACKGROUND: We examined how breast cancer-related lymphedema (BCRL) affects health-related quality of life (HRQOL), productivity, and compliance with therapeutic interventions to guide structuring BCRL screening programs. METHODS: We prospectively followed consecutive breast cancer patients who underwent axillary lymph node dissection (ALND) with arm volume screening and measures assessing patient-reported health-related quality of life (HRQOL) and perceptions of BCRL care. Comparisons by BCRL status were made with Mann-Whitney U, Chi-square, Fisher's exact, or t tests. Trends over time from ALND were assessed with linear mixed-effects models. RESULTS: With a median follow-up of 8 months in 247 patients, 46% self-reported ever having BCRL, a proportion that increased over time. About 73% reported fear of BCRL, which was stable over time. Further in time from ALND, patients were more likely to report that BCRL screening reduced fear. Patient-reported BCRL was associated with higher soft tissue sensation intensity, biobehavioral, and resource concerns, absenteeism, and work/activity impairment. Objectively measured BCRL had fewer associations with outcomes. Most patients reported performing prevention exercises, but compliance decreased over time; patient-reported BCRL was not associated with exercise frequency. Fear of BCRL was positively associated with performing prevention exercises and using compressive garments. CONCLUSIONS: Both incidence and fear of BCRL were high after ALND for breast cancer. Fear was associated with improved therapeutic compliance, but compliance decreased over time. Patient-reported BCRL was more strongly associated with worse HRQOL and productivity than was objective BCRL. Screening programs must support patients' psychological needs and aim to sustain long-term compliance with recommended interventions.

The Association Between Financial Toxicity and Treatment Regret in Men With Localized Prostate Cancer.

BACKGROUND: Financial toxicity is emerging as an important patient-centered outcome and is understudied in prostate cancer patients. We sought to understand the association between financial burden and treatment regret in men with localized prostate cancer to better evaluate the role of financial discussions in patient counseling. METHODS: Utilizing the Comparative Effectiveness Analysis of Surgery and Radiation dataset, we identified all men accrued between 2011 and 2012 who underwent surgery, radiation, or active surveillance for localized prostate cancer. Financial burden and treatment regret were assessed at 3- and 5-year follow-up. The association between financial burden and regret was assessed using multivariable longitudinal logistic regression controlling for demographic and disease characteristics, treatment, functional outcomes, and patient expectations. RESULTS: Of the 2924 eligible patients, regret and financial burden assessments for 3- and/or 5-year follow-up were available for 81% (n = 2359). After adjustment for relevant covariates, financial burden from "finances in general" was associated with treatment regret at 3 years (odds ratio [OR] = 2.47, 95% confidence interval [CI] = 1.33 to 4.57; P = .004); however, this association was no longer statistically significant at 5-year follow-up (OR = 1.19, 95% CI = 0.56 to 2.54; P = .7). CONCLUSIONS: In this population-based sample of men with localized prostate cancer, we observed associations between financial burden and treatment regret. Our findings suggest indirect treatment costs, especially during the first 3 years after diagnosis, may impact patients more profoundly than direct costs and are important for inclusion in shared decision making.

Association between pelvic nodal radiotherapy and patient-reported functional outcomes through 5 years among men undergoing external-beam radiotherapy for prostate cancer: An assessment of the comparative effectiveness analysis of surgery and radiation (CEASAR) cohort.

BACKGROUND: The role of pelvic irradiation in men receiving external beam radiotherapy (EBRT) for prostate cancer is unclear, in part due to a lack of data on patient-reported outcomes. We sought to compare functional outcomes for men receiving prostate and pelvic versus prostate-only radiotherapy, longitudinally over 5 years. MATERIALS AND METHODS: We performed a population-based, prospective cohort study of men with clinically-localized prostate cancer undergoing EBRT. We examined the effect of prostate and pelvic (n = 102) versus prostate-only (n = 485) radiotherapy on patient-reported disease-specific (using the Expanded Prostate Cancer Index Composite[EPIC]-26) and general health-related (using the SF-36) function, over 5 years. Regression models were adjusted for outcome-specific baseline function, clinicopathologic characteristics, and androgen deprivation therapy (ADT). RESULTS: 587 men (median [quartiles] age 69 [64-73] years) met inclusion criteria and completed ≥1 post-treatment survey. More men treated with prostate and pelvic radiotherapy had high-risk disease (58% vs. 18%, P < 0.01) and received ADT (75% vs. 41%, P < 0.01). These men reported worse sexual (6 months-5 years), hormonal (at 6 months), and physical (6 months-5 years) function. Accounting for baseline function, patient and tumor characteristics, and use of ADT, pelvic irradiation was not associated with statistically or clinically significant differences in bowel function, urinary incontinence, irritative voiding symptoms or sexual function through 5-years (all P > 0.05). Marginally clinically important differences were noted in hormonal function at 3-years (adjusted mean difference 4.7, 95% confidence interval [1.2-8.3]; minimally clinically important difference (MCID) 4 to 6) and 5-years (4.2, [0.4-8.0]) following treatment. After adjustment, there was a transient statistically significant, but not clinically important, difference in emotional well-being at 6 months (3.0, [0.19-5.8]; MCID 6) that resolved by 1 year and no differences in physical functioning or energy and fatigue. CONCLUSION: This prospective, population-based cohort study of men with localized prostate cancer treated with EBRT, showed no clinically important differences in disease-specific or general health-related quality of life with the addition of pelvic irradiation to prostate radiotherapy, supporting the use of pelvic radiotherapy when it may be of clinical benefit, such as men with increased risk of nodal involvement.

Five-Year Longitudinal Analysis of Patient-Reported Outcomes and Cosmesis in a Randomized Trial of Conventionally Fractionated Versus Hypofractionated Whole-Breast Irradiation.

PURPOSE: There are limited prospective data on predictors of patient-reported outcomes (PROs) after whole-breast irradiation (WBI) plus a boost. We sought to characterize longitudinal PROs and cosmesis in a randomized trial comparing conventionally fractionated (CF) versus hypofractionated (HF) WBI. METHODS AND MATERIALS: From 2011 to 2014, women aged ≥40 years with Tis-T2 N0-N1a M0 breast cancer who underwent a lumpectomy with negative margins were randomized to CF-WBI (50 Gray [Gy]/25 fractions plus boost) versus HF-WBI (42.56 Gy/16 fractions plus boost). At baseline (pre-radiation), at 6 months, and yearly thereafter through 5 years, PROs included the Breast Cancer Treatment Outcome Scale (BCTOS), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Body Image Scale; cosmesis was reported by the treating physician using Radiation Therapy Oncology Group cosmesis values. Multivariable mixed-effects growth curve models evaluated associations of the treatment arm and patient factors with outcomes and tested for relevant interactions with the treatment arm. RESULTS: A total of 287 patients were randomized, completing a total of 14,801 PRO assessments. The median age was 60 years, 37% of patients had a bra cup size ≥D, 44% were obese, and 30% received chemotherapy. Through 5 years, there were no significant differences in PROs or cosmesis by treatment arm. A bra cup size ≥D was associated with worse BCTOS cosmesis (P < .001), BCTOS pain (P = .001), FACT-B Trial Outcome Index (P = .03), FACT-B Emotional Well-being (P = .03), and Body Image Scale (P = .003) scores. Physician-rated cosmesis was worse in patients who were overweight (P = .02) or obese (P < .001). No patient subsets experienced better PROs or cosmesis with CF-WBI. CONCLUSIONS: Both CF-WBI and HF-WBI confer similar longitudinal PROs and physician-rated cosmesis through 5 years of follow-up, with no relevant subsets that fared better with CF-WBI. This evidence supports broad adoption of hypofractionation with boost, including in patients receiving chemotherapy and in a population with a high prevalence of obesity. The associations of large breast size and obesity with adverse outcomes across multiple domains highlight the opportunity to engage at-risk patients in lifestyle intervention strategies, as well as to consider alternative radiation treatment regimens.

Patient-Reported Financial Toxicity Associated with Contemporary Treatment for Localized Prostate Cancer.

PURPOSE: Contemporary treatment modalities for localized prostate cancer provide comparable overall and cancer-specific survival. However, the degree of financial burden imposed by treatment, the factors contributing to that burden, and how different treatments compare with regard to financial toxicity remain poorly understood. MATERIALS AND METHODS: The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study enrolled men with localized prostate cancer from 2011 to 2012. Questionnaires were collected at 6, 12, 36, and 60 months after enrollment. Differences in patient-reported financial burden were compared between active surveillance, radical prostatectomy, and external beam radiotherapy using multivariable logistic regression. RESULTS: Among 2,121 patients meeting inclusion criteria, 15% reported large or very large burden of treatment costs within 6 months, declining to 3% by year 5. When controlling for age, education, income and other covariates, external beam radiotherapy was associated with greater financial burden than active surveillance and radical prostatectomy at 1 year (OR 2.2, 95% CI 1.2-4.1 and OR 1.5, 95% CI 1.0-2.3, respectively) and 3 years (OR 3.1 95% CI 1.1-8.8 and OR 2.1, 95% CI 1.2-3.7, respectively). Radical prostatectomy and active surveillance had similar rates of financial burden at all time points. Age, race, education, and D'Amico risk group were associated with financial burden. CONCLUSIONS: External beam radiotherapy was associated with the highest financial burden, even when controlling for age, education and income. Prospective studies that directly measure out-of-pocket and indirect costs and account more thoroughly for baseline socioeconomic differences are warranted in order to identify those most at risk.

Costs and Complications After a Diagnosis of Prostate Cancer Treated With Time-Efficient Modalities: An Analysis of National Medicare Data.

PURPOSE: Recent trends in payer and patient preferences increasingly incentivize time-efficient (≤2-week treatment time) prostate cancer treatments. METHODS AND MATERIALS: National Medicare claims from January 1, 2011, through December 31, 2014, were analyzed to identify newly diagnosed prostate cancers. Three "radical treatment" cohorts were identified (prostatectomy, brachytherapy, and stereotactic body radiation therapy [SBRT]) and matched to an active surveillance (AS) cohort by using inverse probability treatment weighting via propensity score. Total costs at 1 year after biopsy were calculated for each cohort, and treatment-specific costs were estimated by subtracting total 1-year costs in each radical treatment group from those in the AS group. RESULTS: Mean 1-year adjusted costs were highest among patients receiving SBRT ($26,895), lower for prostatectomy ($23,632), and lowest for brachytherapy ($19,980), whereas those for AS were $9687. Costs of radical modalities varied significantly by region, with the Mid-Atlantic and New England regions having the highest cost ranges (>$10,000) and the West South Central and Mountain regions the lowest range in costs (<$2000). Quantification of toxic effects showed that prostatectomy was associated with higher genitourinary incontinence (hazard ratio [HR] = 10.8 compared with AS) and sexual dysfunction (HR = 3.5), whereas the radiation modalities were associated with higher genitourinary irritation/bleeding (brachytherapy HR = 1.7; SBRT HR = 1.5) and gastrointestinal ulcer/stricture/fistula (brachytherapy HR = 2.7; SBRT HR = 3.0). Overall mean toxicity costs were highest among patients treated with prostatectomy ($3500) followed by brachytherapy ($1847), SBRT ($1327), and AS ($1303). CONCLUSIONS: Time-efficient treatment techniques exhibit substantial variability in toxicity and costs. Furthermore, geographic location substantially influenced treatment costs.

Association of Sociodemographic and Health-Related Factors With Receipt of Nondefinitive Therapy Among Younger Men With High-Risk Prostate Cancer.

Importance: Multiple randomized clinical trials have shown that definitive therapy improves overall survival among patients with high-risk prostate cancer. However, many patients do not receive definitive therapy because of sociodemographic and health-related factors. Objective: To identify factors associated with receipt of nondefinitive therapy (NDT) among patients aged 70 years and younger with high-risk prostate cancer. Design, Setting, and Participants: This cohort study identified 72 036 patients aged 70 years and younger with high-risk prostate cancer and Charlson Comorbidity Index scores of 2 or less who were entered in the National Cancer Database between January 2004 and December 2014. Data analysis was conducted from November 2018 to December 2019. Exposure: Receipt of NDT as an initial treatment approach. Main Outcomes and Measures: Survival rates were compared based on receipt of definitive therapy or NDT, and sociodemographic and health-related factors were associated with the type of therapy received. Residual life expectancy was estimated from the National Center for Health Statistics to calculate person-years of life lost. Results: A total of 72 036 men with a median (range) age of 63 (30-70) years, Charlson Comorbidity Index scores of 2 or less, and high-risk prostate cancer without regional lymph node or distant metastatic disease were analyzed. Among eligible patients, 5252 (7.3%) received NDT as an initial therapeutic strategy. On univariate and multivariate analyses, NDT was associated with worse overall survival (univariate analysis hazard ratio, 2.54; 95% CI, 2.40-2.69; P < .001; multivariate analysis hazard ratio, 2.40; 95% CI, 2.26-2.56; P < .001). Compared with patients with private insurance or managed care, those with no insurance, Medicaid, or Medicare were more likely to receive systemic therapy only (no insurance: odds ratio [OR], 3.34; 95% CI, 2.81-3.98; P < .001; Medicaid: OR, 2.92; 95% CI, 2.48-3.43; P < .001; Medicare: OR, 1.36; 95% CI, 1.20-1.53; P < .001) or no treatment (no insurance: OR, 2.63; 95% CI, 2.24-3.08; P < .001; Medicaid: OR, 1.71; 95% CI, 1.45-2.01; P < .001; Medicare: OR, 1.14; 95% CI, 1.04-1.24; P = .004). Compared with white patients, black patients were more likely to receive systemic therapy only (OR, 1.93; 95% CI, 1.74-2.14; P < .001) or no treatment (OR, 1.46; 95% CI, 1.32-1.61; P < .001), and Hispanic patients were more likely to receive systemic therapy only (OR, 1.36; 95% CI, 1.13-1.64; P = .001) or no treatment (OR, 1.36; 95% CI, 1.14-1.60; P < .001). Between 2004 and 2014, patients without insurance or enrolled in Medicaid had 1.83-fold greater person-years of life lost compared with patients with private insurance (area under the curve, 77 600 vs 42 300 person-years of life lost). Conclusions and Relevance: In this study, receipt of NDT was associated with insurance status and race/ethnicity. While treatment decisions should be individualized for every patient, younger men with high-risk prostate cancer and minimal comorbidities should be encouraged to receive definitive local therapy regardless of other factors. These data suggest that significant barriers to life-extending treatment options for patients with prostate cancer remain.

Mean treatment cost of incident cases of penile cancer for privately insured patients in the United States.

PURPOSE: The aims of this study were to estimate the short-term cost of treating newly diagnosed penile cancer and determine the correlates of penile cancer treatment cost in the United States. METHODS: The Truven MarketScan database was used to identify commercially insured patients with penile cancer newly diagnosed during 2011 to 2014. A control group without HPV-related cancer diagnosis was selected by matching to the case group by the propensity score method. Total healthcare costs in the 2 years after the cancer diagnosis index date were measured for each patient. The mean difference between case and control groups was considered the cancer-related cost. For patients without complete 2-year data, a generalized linear regression was performed to predict cost for censored months and identify predictors associated with monthly cost. RESULTS: A total of 250 patients with newly diagnosed penile cancer and 250 matched controls were included in the study. The adjusted mean differential healthcare cost for penile cancer was $76,404 in the first 2 years. For the penile cancer group, cost peaked in month 1 at $10,202 and dropped substantially each month thereafter until month 7, when the cost was $4,295. After month 7, the monthly cost remained steady at $2,700 to $4,200. CONCLUSIONS: The estimated average cost of penile cancer for insured patients in the United States was about $76,000 in the first 2 years after diagnosis. Monthly cost was directly related to age, length of follow-up, comorbidity score, and prediagnosis cost.

Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT.

BACKGROUND: Up to 160,000 people incur traumatic brain injury (TBI) each year in the UK. TBI can have profound effects on many areas of human functioning, including participation in work. There is limited evidence of the clinical effectiveness and cost-effectiveness of vocational rehabilitation (VR) after injury to promote early return to work (RTW) following TBI. OBJECTIVE: To assess the feasibility of a definitive, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early, specialist VR plus usual care (UC) compared with UC alone on work retention 12 months post TBI. DESIGN: A multicentre, feasibility, parallel-group RCT with a feasibility economic evaluation and an embedded mixed-methods process evaluation. Randomisation was by remote computer-generated allocation. SETTING: Three NHS major trauma centres (MTCs) in England. PARTICIPANTS: Adults with TBI admitted for > 48 hours and working or studying prior to injury. INTERVENTIONS: Early specialist TBI VR delivered by occupational therapists (OTs) in the community using a case co-ordination model. MAIN OUTCOME MEASURES: Self-reported RTW 12 months post randomisation, mood, functional ability, participation, work self-efficacy, quality of life and work ability. Feasibility outcomes included recruitment and retention rates. Follow-up was by postal questionnaires in two centres and face to face in one centre. Those collecting data were blind to treatment allocation. RESULTS: Out of 102 target participants, 78 were recruited (39 randomised to each arm), representing 39% of those eligible and 5% of those screened. Approximately 2.2 patients were recruited per site per month. Of those, 56% had mild injuries, 18% had moderate injuries and 26% had severe injuries. A total of 32 out of 45 nominated carers were recruited. A total of 52 out of 78 (67%) TBI participants responded at 12 months (UC, n = 23; intervention, n = 29), completing 90% of the work questions; 21 out of 23 (91%) UC respondents and 20 out of 29 (69%) intervention participants returned to work at 12 months. Two participants disengaged from the intervention. Face-to-face follow-up was no more effective than postal follow-up. RTW was most strongly related to social participation and work self-efficacy. It is feasible to assess the cost-effectiveness of VR. Intervention was delivered as intended and valued by participants. Factors likely to affect a definitive trial include deploying experienced OTs, no clear TBI definition or TBI registers, and repatriation of more severe TBI from MTCs, affecting recruitment of those most likely to benefit/least likely to drop out. LIMITATIONS: Target recruitment was not reached, but mechanisms to achieve this in future studies were identified. Retention was lower than expected, particularly in UC, potentially biasing estimates of the 12-month RTW rate. CONCLUSIONS: This study met most feasibility objectives. The intervention was delivered with high fidelity. When objectives were not met, strategies to ensure feasibility of a full trial were identified. Future work should test two-stage recruitment and include resources to recruit from 'spokes'. A broader measure covering work ability, self-efficacy and participation may be a more sensitive outcome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38581822. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 33. See the NIHR Journals Library website for further project information.

Comparative Toxicities and Cost of Intensity-Modulated Radiotherapy, Proton Radiation, and Stereotactic Body Radiotherapy Among Younger Men With Prostate Cancer.

Purpose To compare the toxicities and cost of proton radiation and stereotactic body radiotherapy (SBRT) with intensity-modulated radiotherapy (IMRT) for prostate cancer among men younger than 65 years of age with private insurance. Methods Using the MarketScan Commercial Claims and Encounters database, we identified men who received radiation for prostate cancer between 2008 and 2015. Patients undergoing proton therapy and SBRT were propensity score-matched to IMRT patients on the basis of clinical and sociodemographic factors. Proportional hazards models compared the cumulative incidence of urinary, bowel, and erectile dysfunction toxicities by treatment. Cost from a payer's perspective was calculated from claims and adjusted to 2015 dollars. Results A total of 693 proton therapy patients were matched to 3,465 IMRT patients. Proton therapy patients had a lower risk of composite urinary toxicity (33% v 42% at 2 years; P < .001) and erectile dysfunction (21% v 28% at 2 years; P < .001), but a higher risk of bowel toxicity (20% v 15% at 2 years; P = .02). Mean radiation cost was $115,501 for proton therapy patients and $59,012 for IMRT patients ( P < .001). A total of 310 SBRT patients were matched to 3,100 IMRT patients. There were no significant differences in composite urinary, bowel, or erectile dysfunction toxicities between SBRT and IMRT patients ( P > .05), although a higher risk of urinary fistula was noted with SBRT (1% v 0.1% at 2 years; P = .009). Mean radiation cost for SBRT was $49,504 and $57,244 for IMRT ( P < .001). Conclusion Among younger men with prostate cancer, proton radiation was associated with significant reductions in urinary toxicity but increased bowel toxicity at nearly twice the cost of IMRT. SBRT and IMRT were associated with similar toxicity profiles; SBRT was modestly less expensive than IMRT.

Long-term economic value of hypofractionated prostate radiation: Secondary analysis of a randomized trial.

PURPOSE: Moderately hypofractionated intensity modulated radiation therapy (HIMRT) for prostate cancer shortens the treatment course while providing outcomes comparable with those of conventional intensity modulated radiation therapy (CIMRT). To determine the long-term economic value of HIMRT, including the costs of managing long-term radiation toxicities, a cost minimization analysis compared CIMRT with dose-escalated HIMRT using patient-level data from a randomized trial. METHODS AND MATERIALS: Men with localized prostate cancer were randomized to CIMRT (75.6 Gy in 42 fractions over 8.4 weeks) or HIMRT (72 Gy in 30 fractions over 6 weeks). A decision tree modeled trial probabilities of maximum late bowel and urinary toxicities using patient-level data with a median follow-up of 6 years. Costs were estimated from the healthcare perspective using the 2014 national reimbursement rates for services received. Patient-level institutional costs, adjusted to 2014 dollars, verified reimbursements. A sensitivity analysis assessed model uncertainty. RESULTS: The cost for HIMRT and toxicity management was $22,957, saving $7,000 compared with CIMRT ($30,241). CIMRT was the common factor among the 5 most influential scenarios that contributed to total costs. Toxicity represented a small part (<10%) of the average total cost for patients with either grade 2-3 bowel toxicity or grade 2-3 urinary toxicity. However, toxicity management reached up to 26% of the total cost for patients with both high-grade bowel and urinary toxicities. There was no threshold at which CIMRT became the less costly regimen. Institutional costs confirmed the economic value of HIMRT ($6,000 in savings). CONCLUSIONS: HIMRT is more cost-efficient than CIMRT for treating prostate cancer, even when taking into account the costs related to late radiation toxicities. HIMRT enhances the value of prostate radiation when compared with CIMRT.

Influence of Age on Guideline-Concordant Cancer Care for Elderly Patients in the United States.

PURPOSE: To examine the frequency of guideline-concordant cancer care in elderly patients, including "older" elderly (age ≥80 years). METHODS AND MATERIALS: Using the Surveillance, Epidemiology and End Results-Medicare dataset in patients aged ≥66 years diagnosed with nonmetastatic breast cancer (n=55,094), non-small cell lung (NSCLC) (n=36,203), or prostate cancer (n=86,544) from 2006 to 2011, chemotherapy, surgery, and radiation (RT) treatments were identified using claims. Pearson χ2 tested associations between age and guideline concordance. RESULTS: Older patients were less likely to receive guideline-concordant curative treatment: in stage III breast cancer, receipt of postmastectomy RT (70%, 46%, and 21% in patients aged 66-79, 80-89, and ≥90 years, respectively; P<.0001); in stage I NSCLC, RT or surgery (89%, 80%, and 64% in age 66-79, 80-89, and ≥90 years; P<.0001); in stage III NSCLC, RT or surgery plus chemotherapy (79%, 58%, and 27% in age 66-79, 80-89, and ≥90 years; P<.0001); and in intermediate/high-risk prostate cancer, RT or prostatectomy (projected life expectancy >10 years: 85% and 82% in age 66-69 and 70-75 years; and ≤10 years: 70%, 42%, and 9% in age 76-79, 80-89, and ≥90 years; P<.0001). However, older patients were more likely to receive guideline-concordant de-intensified treatment: in stage I to II node-negative breast cancer, hypofractionated postlumpectomy RT (9%, 16%, and 23% in age 66-79, 80-89, and ≥90 years; P<.0001); in stage I estrogen receptor-positive breast cancer, observation after lumpectomy (12%, 42%, and 84% in age 66-79, 80-89, and ≥90 years; P<.0001); in stage I NSCLC, stereotactic body RT instead of surgery (7%, 16%, and 25% in age 66-79, 80-89, and ≥90 years; P<.0001); and in lower-risk prostate cancer, no active treatment (25%, 54%, and 68% in age 66-79, 80-89, and ≥90 years; P<.0001). CONCLUSION: Actual treatment of older elderly cancer patients frequently diverged from guidelines, especially in curative treatment of advanced disease. Results suggest a need for better metrics than existing guidelines alone to evaluate quality and appropriateness of care in this population.

Discerning the survival advantage among patients with prostate cancer who undergo radical prostatectomy or radiotherapy: The limitations of cancer registry data.

BACKGROUND: The objective of this study was to compare the overall survival of patients who undergo radical prostatectomy or radiotherapy versus noncancer controls to discern whether there is a survival advantage according to prostate cancer treatment and the impact of selection bias on these results. METHODS: A matched cohort study was performed using the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked database. In total, 34,473 patients ages 66 to 75 years were identified who were without significant comorbidity, were diagnosed with localized prostate cancer, and received treatment treated with surgery or radiotherapy between 2004 and 2011. These patients were matched to a noncancer control cohort. The rates of all-cause mortality that occurred within the study period were compared. Cox proportional hazards regression analysis was used to identify determinants associated with overall survival. RESULTS: Of 34,473 patients who were included in the analysis, 21,740 (63%) received radiation therapy, and 12,733 (37%) underwent surgery. There was improved survival in patients who underwent surgery (hazard ratio, 0.35; 95% confidence interval, 0.32-0.38) and in those who received radiotherapy (hazard ratio, 0.72; 95% confidence interval, 0.68-0.75) compared with noncancer controls. Overall survival improved significantly in both treatment groups, with the greatest benefit observed among patients who underwent surgery (log rank P < .001). CONCLUSIONS: Population-based data indicated that patients with prostate cancer who received treatment with either surgery or radiotherapy had improved overall survival compared with a cohort of matched noncancer controls. Surgery produce longer survival compared with radiation therapy. These results suggest an inherent selection-bias because of unmeasured confounding variables. Cancer 2017;123:1617-1624. © 2017 American Cancer Society.

Risk of hospitalisation after primary treatment for prostate cancer.

OBJECTIVE: To compare the risk of hospitalisation and associated costs in patients after treatment for prostate cancer. PATIENTS AND METHODS: We identified 29 571 patients aged 66-75 years without significant comorbidity from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database who were diagnosed with localised prostate cancer between 2004 and 2009. We compared the rates of all-cause and treatment-related hospitalisation that occurred within 365 days of the initiation of definitive therapy. We used multivariable logistic regression analysis to identify determinants associated with hospitalisation. RESULTS: Men who underwent radical prostatectomy (RP) rather than radiotherapy (RT) had lower odds of being hospitalised for any cause after therapy [odds ratio (OR) 0.80, 95% confidence interval (CI): 0.74-0.87]. Patients who underwent RP rather than RT had higher odds of being hospitalised for treatment-related complications (OR 1.15, 95% CI: 1.03-1.29). However, men who underwent external beam RT (EBRT)/intensity modulated RT (IMRT) (OR 0.84, 95% CI: 0.72-0.99) had a 16% lower odds of hospitalisation from treatment-related complications than patients undergoing RP. Using propensity score-weighted analyses there was no significant difference in the odds of hospitalisation from treatment-related complications for men who underwent RP vs RT (OR 1.06, 95% CI: 0.92-1.21). Patients hospitalised for treatment-related complications after RT were costlier than patients who underwent RP (Mean $18 381 vs $13 203, P < 0.001). CONCLUSIONS: With the exception of men who underwent EBRT/IMRT, there was no statistically significant difference in the odds of hospitalisation from treatment-related complications. Costs from hospitalisation after treatment were significantly higher for men undergoing RT than RP. Our findings are relevant in the context of penalties linked to hospital readmissions and bundled payment models.

Regional differences in recommended cancer treatment for the elderly.

BACKGROUND: Little is known about regional variation in cancer treatment and its determinants. We compare rates of adherence to treatment guidelines for elderly patients across Texas and whether local specialist supply is an important determinant of treatment variation. METHODS: Previous literature reviewed indicated 7 recommended courses of treatment for colorectal, pancreatic, and prostate cancer. We analyzed Texas Cancer Registry data linked with Medicare claims for the years 2004 to 2007 to study patients with these cancers. We tested for unadjusted and adjusted differences in treatment rates across 22 hospital referral regions (HRR). We tested whether variation in the local supply of specialists treating each cancer was an important determinant of treatment. RESULTS: We found significant differences in adjusted treatment rates across regions. For removal and examination of 12+ lymph nodes with colon cancer resection, 13 of 22 HRRs had rates significantly different from the median region. For adjuvant chemotherapy for regional colon cancer, five HRRs significantly differed from the median. For prostate cancer treatment with a favorable diagnosis, nine HRRs differed from the median HRR. Of the 7 treatments, only the local availability of surgeons was an important determinant for excision of lymph nodes for colon cancer patients. CONCLUSIONS: There are significant variations across Texas for seven recommended cancer treatments. No one region has consistently higher or lower treatments than other regions, and local specialist supply is not an important predictor of treatment. Different factors may be determining regional variation in treatment rates across cancer types and treatment options.

Impact of Adherence to Quality Measures for Localized Prostate Cancer on Patient-reported Health-related Quality of Life Outcomes, Patient Satisfaction, and Treatment-related Complications.

BACKGROUND AND OBJECTIVE: Quality measures used in pay-for-performance systems are intended to address specific quality goals, such as safety, efficiency, effectiveness, timeliness, equity, and patient-centeredness. Given the small number of narrowly focused measures in prostate cancer care, we sought to determine whether adherence to any of the available payer-driven quality measures influences patient-centered outcomes, including health-related quality of life (HRQOL), patient satisfaction, and treatment-related complications. METHODS: The Comparative Effectiveness Analysis of Surgery and Radiation study is a population-based, prospective cohort study that enrolled 3708 men with clinically localized prostate cancer during 2011 and 2012, of whom 2601 completed the 1-year survey and underwent complete chart abstraction. Compliance with 6 quality indicators endorsed by national consortia was assessed. Multivariable regression was used to determine the relationship between indicator compliance and Expanded Prostate Cancer Index Composite (EPIC-26) instrument summary scores, satisfaction scale scores (service satisfaction scale for cancer care), and treatment-related complications. RESULTS: Overall rates of compliance with these quality measures ranged between 64% and 88%. Three of the 6 measures were weakly associated with 1-year sexual function and bowel function scores (ß=-4.6, 1.69, and 2.93, respectively; P≤0.05), whereas the remaining measures had no significant relationship with patient-reported HRQOL outcomes. Satisfaction scores and treatment-related complications were not associated with quality measure compliance. CONCLUSIONS: Compliance with available nationally endorsed quality indicators, which were designed to incentivize effective and efficient care, was not associated with clinically important changes in patient-centered outcomes (HRQOL, satisfaction, or complications) within 1-year.

Trends in Local Therapy Utilization and Cost for Early-Stage Breast Cancer in Older Women: Implications for Payment and Policy Reform.

PURPOSE: Older women with early-stage disease constitute the most rapidly growing breast cancer demographic, yet it is not known which local therapy strategies are most favored by this population in the current era. Understanding utilization trends and cost of local therapy is important for informing the design of bundled payment models as payers migrate away from fee-for-service models. We therefore used the Surveillance, Epidemiology, and End Results Medicare database to determine patterns of care and costs for local therapy among older women with breast cancer. METHODS AND MATERIALS: Treatment strategy and covariables were determined in 55,327 women age ≥66 with Tis-T2N0-1M0 breast cancer who underwent local therapy between 2000 and 2008. Trends in local therapy were characterized using Joinpoint. Polychotomous logistic regression determined predictors of local therapy. The median aggregate cost over the first 24 months after diagnosis was determined from Medicare claims through 2010 and reported in 2014 dollars. RESULTS: The median age was 75. Local therapy distribution was as follows: 27,896 (50.3%) lumpectomy with external beam radiation, 18,356 (33.1%) mastectomy alone, 6159 (11.1%) lumpectomy alone, 1488 (2.7%) mastectomy with reconstruction, and 1455 (2.6%) lumpectomy with brachytherapy. Mastectomy alone declined from 39.0% in 2000 to 28.2% in 2008, and the use of breast conserving local therapies rose from 58.7% to 68.2%. Mastectomy with reconstruction was more common among the youngest, healthiest patients, whereas mastectomy alone was more common among patients living in rural low-income regions. By 2008, the costs were $36,749 for lumpectomy with brachytherapy, $35,030 for mastectomy with reconstruction, $31,388 for lumpectomy with external beam radiation, $21,993 for mastectomy alone, and $19,287 for lumpectomy alone. CONCLUSIONS: The use of mastectomy alone in older women declined in favor of breast conserving strategies between 2000 and 2008. Using these cost estimates, price points for local therapy bundles can be constructed to incentivize the treatment strategies that confer the highest value.

Minimum data set to measure rehabilitation needs and health outcome after major trauma: application of an international framework.

BACKGROUND: Measurement of long term health outcome after trauma remains non-standardized and ambiguous which limits national and international comparison of burden of injuries. The World Health Organization (WHO) has recommended the application of the International Classification of Function, Disability and Health (ICF) to measure rehabilitation and health outcome worldwide. No previous poly-trauma studies have applied the ICF comprehensively to evaluate outcome after injury. AIM: To apply the ICF categorization in patients with traumatic injuries to identify a minimum data set of important rehabilitation and health outcomes to enable national and international comparison of outcome data. DESIGN: A mixed methods design of patient interviews and an on-line survey. SETTING: An ethnically diverse urban major trauma center in London. POPULATION: Adult patients with major traumatic injuries (poly-trauma) and international health care professionals (HCPs) working in acute and post-acute major trauma settings. METHODS: Mixed methods investigated patients and health care professionals (HCPs) perspectives of important rehabilitation and health outcomes. Qualitative patient data and quantitative HCP data were linked to ICF categories. Combined data were refined to identify a minimum data set of important rehabilitation and health outcome categories. RESULTS: Transcribed patient interview data (N.=32) were linked to 234 (64%) second level ICF categories. Two hundred and fourteen HCPs identified 121 from a possible 140 second level ICF categories (86%) as relevant and important. Patients and HCPs strongly agreed on ICF body structures and body functions categories which include temperament, energy and drive, memory, emotions, pain and repair function of the skin. Conversely, patients prioritised domestic tasks, recreation and work compared to HCP priorities of self-care and mobility. Twenty six environmental factors were identified. Patient and HCP data were refined to recommend a 109 possible ICF categories for a minimum data set. CONCLUSIONS: The comprehensive measurement of health outcomes after trauma is important for patients, health professionals and trauma systems. An internationally applied ICF minimum data set will standardize the language used and concepts measured after major trauma to enable national and international comparison of outcome data. CLINICAL REHABILITATION IMPACT: A minimum ICF data set for trauma will standardize rehabilitation language and provide a minimum dataset to capture outcome in trauma systems to enable comparison and service improvement.