Validity of Research Based on Publicly Obtained Data in Sports Medicine: A Quantitative Assessment of Concussions in the National Football League.

CONTEXT: Numerous researchers have leveraged publicly available internet sources to publish clinical research concerning incidence and recovery from injuries in National Football League (NFL) players. OBJECTIVE: This study aims to (1) provide a comprehensive systematic review of all publicly obtained data studies (PODS) regarding concussions in NFL athletes and (2) quantify the percentage of injuries identified by these studies in comparison with published concussion data from the NFL injury database. STUDY SELECTION: A systematic review was conducted in accordance with PRISMA guidelines to identify all published studies utilizing publicly obtained data regarding concussions in NFL athletes. STUDY DESIGN: Systematic review. LEVEL OF EVIDENCE: Level 4. DATA EXTRACTION: Manuscript details, factors related to the athletes of interest (eg, study period, positions included), and results (eg, concussion rate, number of total concussions, return-to-play data) were extracted independently by 2 authors. Results were compared with incident concussions reported from 2015 to 2019 by each medical staff member to the NFL database linked to the League's electronic health record (EHR). RESULTS: A total of 20 concussion-focused manuscripts based on PODS were identified from 2014 to 2020. PODS captured between 20% and 90% of concussions (mean, 70%) reported by medical staff to the injury database. PODS reported that 55% of concussions occurred on offensive plays, 45% on defensive plays and <1% occurred during special teams plays, compared with 44%, 37%, and 18%, respectively, as indicated by published data from the NFL injury database. When analyzed by position groups, running backs and quarterbacks comprised the most over-represented positions concussed in PODS, while offensive linemen, defensive backs, and linebackers comprised the most under-represented positions. CONCLUSION: PODS captured approximately 70% of concussions reported by NFL medical staff to the NFL injury database. There is heterogeneity in the degree to which PODS were able to identify concussions, with a bias toward concussions among players at higher profile positions.

Disparities in the prevalence and management of high-risk non-muscle invasive bladder cancer.

OBJECTIVE: To evaluate the associations of socioeconomic characteristics with the management of non-muscle invasive bladder cancer (NMIBC). METHODS: We identified adult patients aged 18 to 89 years with Ta, T1, or Tis NMIBC in the NCDB. We then examined the associations of patient and socioeconomic characteristics with the guidelines-based management of high-risk NMIBC using multivariable logistic regression. RESULTS: 163,949 patients were included in the study cohort, including 64% with Ta, 32% with T1, and 4% with Tis disease. Among those diagnosed with bladder cancer, male (OR 1.24, 95%CI 1.21-1.27), uninsured (OR 1.10, 95%CI 1.01-1.19 vs. private), and non-White (OR 1.34, 95%CI 1.28-1.41 for Black; OR 1.10; 95%CI 1.03-1.18 for Other vs. White) patients were more likely to be diagnosed with high-risk disease, as well as patients from lower education level areas. Among those with high-risk NMIBC, patients who were older, non-White, Hispanic, uninsured or insured with Medicaid were less likely to receive guideline recommended intravesical BCG, while those residing in rural and higher education level areas were more likely to receive BCG. When examining non-guidelines based use of radiotherapy for HGT1 disease, older age (OR 1.06; 95% CI 1.04-1.07) and VA/Military insurance (OR 2.73; 95%CI 1.07, 6.98 vs. private) were associated with radiotherapy use. CONCLUSION: There are strong disparities in the prevalence and management of high-risk NMIBC. These observations highlight important targets for future strategies to reduce such healthcare disparities and provide more equitable bladder cancer treatment to patients.

Artificial Intelligence Assessment of Renal Scarring (AIRS Study).

Background: The goal of the Artificial Intelligence in Renal Scarring (AIRS) study is to develop machine learning tools for noninvasive quantification of kidney fibrosis from imaging scans. Methods: We conducted a retrospective analysis of patients who had one or more abdominal computed tomography (CT) scans within 6 months of a kidney biopsy. The final cohort encompassed 152 CT scans from 92 patients, which included images of 300 native kidneys and 76 transplant kidneys. Two different convolutional neural networks (slice-level and voxel-level classifiers) were tested to differentiate severe versus mild/moderate kidney fibrosis (≥50% versus <50%). Interstitial fibrosis and tubular atrophy scores from kidney biopsy reports were used as ground-truth. Results: The two machine learning models demonstrated similar positive predictive value (0.886 versus 0.935) and accuracy (0.831 versus 0.879). Conclusions: In summary, machine learning algorithms are a promising noninvasive diagnostic tool to quantify kidney fibrosis from CT scans. The clinical utility of these prediction tools, in terms of avoiding renal biopsy and associated bleeding risks in patients with severe fibrosis, remains to be validated in prospective clinical trials.

Validity of Research Based on Public Data in Sports Medicine: A Quantitative Assessment of Anterior Cruciate Ligament Injuries in the National Football League.

BACKGROUND: Numerous researchers have leveraged publicly available Internet sources to publish publicly obtained data (POD) studies concerning various orthopaedic injuries in National Football League (NFL) players. PURPOSE: To provide a comprehensive systematic review of all POD studies regarding musculoskeletal injuries in NFL athletes and to use anterior cruciate ligament (ACL) injuries in NFL players to quantify the percentage of injuries identified by these studies. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: A systematic review was conducted to identify all published studies utilizing POD regarding ACL injury in NFL athletes from 2000 to 2019. Data regarding player demographics were extracted from each publication. These results were compared with prospectively collected data reported by the teams' medical staff to the NFL Injury Surveillance System database linked to the League's electronic health record. An ACL "capture rate" for each article was calculated by dividing the number of ACL injuries in the POD study by the total number of ACL injuries in the NFL injury database occurring in the study period of interest. RESULTS: A total of 42 studies were extracted that met the definition of a POD study: 28 evaluated a variety of injuries and 14 dealt specifically with ACL injuries, with 35 (83%) of the 42 studies published during or since 2015. POD studies captured a mean of 66% (range, 31%-90%) of ACL injuries reported by the teams' medical staff. This inability to capture all injury rates varied by position, with 86% capture of ACL injuries in skill athletes, 72% in midskill athletes, and 61% in linemen. POD studies captured 35% of injuries occurring during special teams play. CONCLUSION: The frequency of studies leveraging publicly obtained injury data in NFL players has rapidly increased since 2000. There is significant heterogeneity in the degree to which POD studies correctly identify ACL injuries from public reports. Sports medicine research relying solely on publicly obtained sources should be interpreted with an understanding of their inherent limitations and biases. These studies underreport the true incidence of injuries, with a bias toward capturing injuries in more popular players.

Using Preoperative Pelvic Floor Assessment to Predict Early Return of Continence after Robotic Radical Prostatectomy.

OBJECTIVE: To evaluate whether pre-operative pelvic floor physical therapy (PFPT) parameters may predict early return of urinary continence after RP. While long-term urinary continence is eventually achieved in most patients who undergo radical prostatectomy (RP), predicting when patients will become continent is challenging. Prior studies aiming to predict return of post-operative continence have not evaluated patient-specific pelvic floor strength parameters. METHODS: We reviewed a prospectively maintained database of patients undergoing RP who underwent pre-operative PFPT consultation and completed 3-month patient-reported quality of life evaluation. Trained therapists documented pelvic strength parameters. Urinary continence was defined as using 0 or 1 pad per day. We evaluated the association of PFPT parameters with urinary continence at 3 months, adjusting for other factors that could affect continence. RESULTS: 144 men met inclusion criteria. The majority of patients underwent nerve-sparing procedures and had intermediate- or high-risk prostate cancer. At 3 months, 90 of 144 (62.5%) were continent, while 54 of 144 (37.5%) were not. On multivariable analysis, prostate volume (OR 0.98, 95% CI 0.96-1.00) and pelvic floor endurance (OR 2.71, 95% CI 1.23-6.17) were significantly associated with being continent at 3 months. 56 of 76 (74%) men with good pelvic floor endurance were continent at 3 months, while only 34 of 68 (50%) men with poor endurance were continent (P = .006). CONCLUSION: Pre-operative assessment of pelvic floor endurance is an objective measure that may allow more accurate prediction of early continence after radical prostatectomy. Improved patient counseling could positively impact patient satisfaction and quality of life and reduce decision regret.

Outcomes of Artificial Intelligence Volumetric Assessment of Kidneys and Renal Tumors for Preoperative Assessment of Nephron-Sparing Interventions.

Background: Renal-cell carcinoma is the most common kidney cancer and the 13th most common cause of cancer death worldwide. Partial nephrectomy and percutaneous ablation, increasingly utilized to treat small renal masses and preserve renal parenchyma, require precise preoperative imaging interpretation. We sought to develop and evaluate a convolutional neural network (CNN), a type of deep learning (DL) artificial intelligence (AI), to act as a surgical planning aid by determining renal tumor and kidney volumes through segmentation on single-phase CT. Materials and Methods: After Institutional Review Board approval, the CT images of 319 patients were retrospectively analyzed. Two distinct CNNs were developed for (1) bounding cube localization of the right and left hemiabdomen and (2) segmentation of the renal parenchyma and tumor within each bounding cube. Training was performed on a randomly selected cohort of 269 patients. CNN performance was evaluated on a separate cohort of 50 patients using Sorensen-Dice coefficients (which measures the spatial overlap between the manually segmented and neural network-derived segmentations) and Pearson correlation coefficients. Experiments were run on a graphics processing unit-optimized workstation with a single NVIDIA GeForce GTX Titan X (12GB, Maxwell Architecture). Results: Median Dice coefficients for kidney and tumor segmentation were 0.970 and 0.816, respectively; Pearson correlation coefficients between CNN-generated and human-annotated estimates for kidney and tumor volume were 0.998 and 0.993 (p < 0.001), respectively. End-to-end trained CNNs were able to perform renal parenchyma and tumor segmentation on a new test case in an average of 5.6 seconds. Conclusions: Initial experience with automated DL AI demonstrates that it is capable of rapidly and accurately segmenting kidneys and renal tumors on single-phase contrast-enhanced CT scans and calculating tumor and renal volumes.

Unmet Need for Total Joint Arthroplasty in Medicaid Beneficiaries After Affordable Care Act Expansion.

BACKGROUND: The utilization of total hip arthroplasty (THA) and total knee arthroplasty (TKA) increased after Medicaid expansion under the U.S. Affordable Care Act (ACA), suggesting a potential unmet need for THA and TKA. We examined the timing of THA and TKA in patients after obtaining Medicaid expansion insurance coverage. We hypothesized that patients with Medicaid expansion insurance would undergo a surgical procedure sooner than patients in traditional Medicaid populations. METHODS: We used administrative data from a Medicaid managed care company to determine the timing of primary THA and TKA in patients who were 18 to 64 years of age in 4 states with Medicaid expansion (Illinois, Ohio, Oregon, and Washington) and 4 states without Medicaid expansion (Louisiana, Mississippi, Texas, and Wisconsin) from 2008 to 2015. The insurance types were Medicaid expansion, Medicaid plans for Supplemental Security Income (SSI), or Temporary Assistance for Needy Families (TANF). Roughly, these 3 groups correspond to relatively healthy childless adults, relatively unhealthy disabled adults, and parents of children with Medicaid insurance. The main outcome measure was time from enrollment to the surgical procedure. The primary exposure of interest was insurance type. We used a generalized linear regression model to adjust for patient age, sex, social deprivation, surgeon supply and reimbursement, and state-level Medicaid enrollment. RESULTS: In the unadjusted analysis of 4,117 patients, there was a significantly shorter time from enrollment to THA and TKA for the expansion group (median, 7.5 months) relative to the SSI group (median, 16.1 months; p < 0.0001) and the TANF group (median, 12.2 months; p < 0.0001). In the adjusted analysis, the time from enrollment to THA and TKA was significantly shorter in the expansion group (ß, -1.21 [95% confidence interval (CI), -1.35 to -1.07]; p < 0.001) compared with the TANF group (ß, -0.27 [95% CI, -0.38 to -0.17]; p < 0.001) and the SSI group (reference). Compared with the SSI group, these coefficients are equivalent to a 70% shorter time to the surgical procedure in the expansion group and a 24% shorter time to the surgical procedure in the TANF group. CONCLUSIONS: Our findings suggest an unmet need for THA and TKA among newly enrolled Medicaid expansion beneficiaries. This need should be considered by surgeons, hospitals, and policymakers in ensuring access to care. Furthermore, consideration should be given to existing insurance-based disparities in access to orthopaedic care, as these may be exacerbated by an increased demand for THA and TKA from Medicaid expansion beneficiaries.

Ultralow-input single-tube linked-read library method enables short-read second-generation sequencing systems to routinely generate highly accurate and economical long-range sequencing information.

Long-range sequencing information is required for haplotype phasing, de novo assembly, and structural variation detection. Current long-read sequencing technologies can provide valuable long-range information but at a high cost with low accuracy and high DNA input requirements. We have developed a single-tube Transposase Enzyme Linked Long-read Sequencing (TELL-seq) technology, which enables a low-cost, high-accuracy, and high-throughput short-read second-generation sequencer to generate over 100 kb of long-range sequencing information with as little as 0.1 ng input material. In a PCR tube, millions of clonally barcoded beads are used to uniquely barcode long DNA molecules in an open bulk reaction without dilution and compartmentation. The barcoded linked-reads are used to successfully assemble genomes ranging from microbes to human. These linked-reads also generate megabase-long phased blocks and provide a cost-effective tool for detecting structural variants in a genome, which are important to identify compound heterozygosity in recessive Mendelian diseases and discover genetic drivers and diagnostic biomarkers in cancers.

Fully Automated Postlumpectomy Breast Margin Assessment Utilizing Convolutional Neural Network Based Optical Coherence Tomography Image Classification Method.

BACKGROUND: The purpose of this study was to develop a deep learning classification approach to distinguish cancerous from noncancerous regions within optical coherence tomography (OCT) images of breast tissue for potential use in an intraoperative setting for margin assessment. METHODS: A custom ultrahigh-resolution OCT (UHR-OCT) system with an axial resolution of 2.7 µm and a lateral resolution of 5.5 µm was used in this study. The algorithm used an A-scan-based classification scheme and the convolutional neural network (CNN) was implemented using an 11-layer architecture consisting of serial 3 × 3 convolution kernels. Four tissue types were classified, including adipose, stroma, ductal carcinoma in situ, and invasive ductal carcinoma. RESULTS: The binary classification of cancer versus noncancer with the proposed CNN achieved 94% accuracy, 96% sensitivity, and 92% specificity. The mean five-fold validation F1 score was highest for invasive ductal carcinoma (mean standard deviation, 0.89 ± 0.09) and adipose (0.79 ± 0.17), followed by stroma (0.74 ± 0.18), and ductal carcinoma in situ (0.65 ± 0.15). CONCLUSION: It is feasible to use CNN based algorithm to accurately distinguish cancerous regions in OCT images. This fully automated method can overcome limitations of manual interpretation including interobserver variability and speed of interpretation and may enable real-time intraoperative margin assessment.

Do More Expensive Total Knee Arthroplasty Prostheses Provide Greater Improvements in Outcomes Over Less Expensive Prostheses Sold by a Physician-owned Distributorship?

BACKGROUND: It is unknown whether more expensive total knee prostheses provide better improvements in patient-determined outcomes compared with less expensive prostheses. A physician-owned distributorship (POD) was created with a goal to provide lower cost implants to hospitals as an alternative to higher cost prostheses sold by the large orthopaedic implant companies. The hypothesis was that lower cost total knee prostheses would have equivalent outcomes, while resulting in lower costs to the hospitals purchasing them compared with higher cost industry-supplied knee prostheses. METHODS: From May 2013 until January 2015, a POD existed which included five surgeons that performed total knee arthroplasties and were willing to follow the outcomes to ensure quality. The POD sold two knee arthroplasty systems at a cost that was lower than that of the large industry companies. Surgeons were allowed to use either POD knees or industry knees at their own discretion. Patients were followed up prospectively to determine The Knee Injury and Osteoarthritis Outcome Score (KOOS) outcomes at 2 years and any incidence of knee complications that required surgery. RESULTS: Two hundred-nine knees (35.2%) had a POD knee implanted, and 385 knees had an industry knee implanted. Both POD knees and industry knees showed statistically significant improvements (P < 0.0001) for all subgroups of the KOOS. No statistically significant difference was observed in improvement in any subgroup of the KOOS between the groups. Knee complications requiring surgical intervention were similar (2.9% POD knees versus 3.6% industry knees; P = 0.58). Using lower cost POD knees saved $209,875.71. CONCLUSIONS: No difference was observed in improvements in outcomes or complications in the lower cost POD-supplied knees compared with the higher cost industry-supplied knees. Hospitals and surgeons may consider using lower cost prostheses because the increased cost of the prosthesis has not been correlated to improved outcomes. LEVEL OF EVIDENCE: Level II therapeutic prospective cohort study.

Expanded Prostate Cancer Index Composite-26 (EPIC-26) Online: Validation of an Internet-Based Instrument for Assessment of Health-Related Quality of Life After Treatment for Localized Prostate Cancer.

OBJECTIVES: To test the validity of an Internet-based version of Expanded Prostate Cancer Index Composite (EPIC-26) versus the phone-based version. Most men will survive for years after treatment for localized prostate cancer (PCa) and may experience lasting treatment-related toxicities affecting health-related quality of life. The EPIC-26 is a validated instrument that measures health-related quality of life across 5 PCa-specific domains. Previously, EPIC-26 was administered via phone in a large multicenter clinical trial. METHODS: We developed an Internet-based version of EPIC-26. We recruited subjects from two prospective longitudinal study cohorts of PCa patients undergoing local therapy: PROST-QA, and PROSTQA-RP2. Subjects were randomized to either an "Internet-first" or "phone-first" group. Subjects were offered the alternate questionnaire modality 2 weeks after completing the initial modality. RESULTS: 181 subjects were offered enrollment; 133 agreed to participate. 65 subjects were randomized to the "Internet- first" group and 68 subjects to the "phone-first" group. Of these, 37 and 26 subjects respectively completed both questionnaire versions (response rate: 44.4%). Test-retest analysis showed significant intraclass correlations in all 5 domains of EPIC-26: urinary incontinence (r = 0.96), urinary irritation (r = 0.85), bowel function (r = 0.61), sexual function (r = 0.94), and hormonal function (r = 0.89). There was no effect of order of questionnaire administration. CONCLUSION: This study demonstrates excellent correlation of responses between Internet-based and phone-based EPIC-26 administration. All domains demonstrated test-retest reliability between modalities, without ordering effect. This validates the use of internet-based EPIC-26 in international registries as part of the International Consortium for Health Outcomes Measurement effort, and may facilitate its use in clinical practice and quality improvement.

Assigning value to preparation for prostate cancer decision making: a willingness to pay analysis.

BACKGROUND: The Personal Patient Profile-Prostate (P3P) is a web-based decision support system for men newly diagnosed with localized prostate cancer that has demonstrated efficacy in reducing decisional conflict. Our objective was to estimate willingness-to-pay (WTP) for men's decisional preparation activities. METHODS: In a multicenter, randomized trial of P3P, usual care group participants received typical preparation for decision making plus referral to publicly-available, educational websites. Intervention group participants received the same, plus online P3P educational media specific to the user's personal preferences and values, and a communication coaching component tailored to race\ethnicity, age and language. WTP data were collected one week after physician consultation. An iterative bidding direct contingent valuation survey format was used, randomly assigning participants to high or low starting values (SV). Tobit models were used to explore associations between SV-adjusted WTP and age, education, marital and work-status, insurance, decision-control preference and decision-making stage. RESULTS: Of 392 participants enrolled, 141 P3P and 107 usual care (UC) provided a WTP value. Men were willing to pay a median $25 (IQR $10-100) for P3P in addition to usual care preparation materials. In the final multivariable tobit regression model, SV, marital status, stage of decision making and income were significantly associated with WTP for P3P. Decision control preference was considered marginally significant (p = 0.11). Men were WTP a median $30 (IQR $10-$200) for usual care material alone. In the final multivariable model, SV, education, and stage of decision making were significantly associated with WTP in usual care. CONCLUSION: WTP was similar for UC and for the addition of P3P to UC decision preparation. The WTP values were associated with demographic and preference variables. Findings can help focus decision support on future patients who would benefit most: those without strong support systems, at earlier stages of decision making, and open to a shared-decision style. TRIAL REGISTRATION: NCT NCT01844999 . Registered May 3, 2013.

Societal costs of localized renal cancer surgery.

INTRODUCTION: Hospital-related costs of renal cancer surgery have been described, but the societal costs of surgery-related lost productivity are poorly understood. We estimated the societal cost of renal cancer surgery by assessing surgery-related time off work (TOW) taken by patients and their caretakers. MATERIALS AND METHODS: A total of 413 subjects who underwent partial or radical nephrectomy enrolled in an IRB-approved prospective study received an occupational survey assessing employment status, work physicality, income, surgery-related TOW, and caretaker assistance. We excluded subjects with incomplete occupational information or metastatic disease. We estimated potential wages lost using individual income and TOW, and used logistic regression to evaluate for factors predictive of TOW > 30 days. RESULTS: Of the 219 subjects who responded, 138 were employed at time of surgery. Ninety-seven subjects returned to work, met the inclusion criteria, and were analyzed. Mean age was 54 and 56% of subjects had sedentary jobs. TOW ranged from 7 to 92 days; mean and median TOW was 35 and 33 days, respectively and 58% of subjects took > 30 days off. Mean potential wages lost for TOW was $10,152. Eighty-three percent of subjects had at least one caretaker take TOW (mean/median caretaker TOW: 11/7 days, respectively) to assist in recovery. Subjects with sedentary jobs were less likely to take > 30 days off (OR 0.30; 95% CI 0.09-0.99). CONCLUSIONS: Most renal cancer surgery patients take over 1 month off work. Recognizing the associated societal costs may allow better adjustment of patient expectations, and more comprehensive cost-effectiveness analyses in renal cancer care.

An Analysis of the Financial Burden Associated with the Residency Match at the University of South Dakota Sanford School of Medicine.

OBJECTIVE: The application process for residency positions is a costly endeavor. This study aims to quantify the financial expenses incurred by University of South Dakota Sanford School of Medicine (USD SSOM) class of 2016. Our hope is that this study will prepare future students of USD and other smaller programs for the financial burdens associated with the match. This data should be used to guide financial decision making by medical students from USD or by regional students from medical programs that desire to apply to residency programs not offered at their home institution. METHODS: A 10-item online survey was administered in April of 2016 via the USD Sanford School of Medicine email listserv to the graduating MD class of 2016. The survey asked respondents about the number and cost of away-rotations completed, interviews attended, second-look days attended after the interview, preferences for interviewing during an away-rotation, the specialty the applicant matched into, and number on each applicant's rank list that he/she matched. RESULTS: The survey had a 68.3 percent response rate. The mean number of away-rotations completed, interviews attended, and second-look days attended were 1.3, 12.1, and 0.1 per applicant respectively. The mean costs of attendance to away-rotations, interviews, and second-look days were $1,690.63, $4,881.88, and $24 per applicant, respectively. The total mean collective cost of away-rotations, interviews, and second-look days was $6,596.51 per applicant. CONCLUSIONS: The process of applying to residencies among the graduating MD class of 2016 is a costly endeavor. Attendance of interviews for residency positions is the most costly part of the residency application process. Although the financial burden associated with applying to residency programs is high, increasing competition for graduate medical education positions may only drive the cost further.

Health-related behaviors moderate the association between age and self-reported health literacy among Taiwanese women.

The role of health-related behaviors in the association between age and health literacy has not been well-elucidated. The present cross-sectional study evaluated the interactions between age and health-related behaviors in 942 women in Taiwan between February and October 2013. Women aged 18-78 years were randomly sampled and recruited from the national administrative system. Self-reported health literacy was measured by the European Health Literacy Survey Questionnaire (HLS-EU-Q47) in Mandarin, asking about sociodemographics and essential health-related behaviors (watching health-related television, community involvement). The interviews were conducted confidentially by well-trained interviewers after having participants' consent. In multiple linear regression models adjusted for education attainment, self-perceived social status, ability to pay for medication, and health-related behaviors, health literacy was significantly negatively related to age (unstandardized regression coefficient, B = -0.04; 95% confidence interval [CI] = (-0.07; 0.00); p = .03). The lower health literacy among older women was significantly modified by watching health-related television programs (from "rarely/not-at-all", B = -0.08 (-0.12, -0.04), p < .001 to "often"; B = 0.10 (0.07, 0.12); p < .001) and community involvement (from "rarely/not-at-all", B = -0.06 (-0.10, -0.03); p = .001 to "often", B = 0.06 (0.03, 0.08); p < .001). Specific health behaviors were protective of older women's health literacy and likely their health.

Relief of Urinary Symptom Burden after Primary Prostate Cancer Treatment.

PURPOSE: Harms of prostate cancer treatment on urinary health related quality of life have been thoroughly studied. In this study we evaluated not only the harms but also the potential benefits of prostate cancer treatment in relieving the pretreatment urinary symptom burden. MATERIALS AND METHODS: In American (1,021) and Spanish (539) multicenter prospective cohorts of men with localized prostate cancer we evaluated the effects of radical prostatectomy, external radiotherapy or brachytherapy in relieving pretreatment urinary symptoms and in inducing urinary symptoms de novo, measured by changes in urinary medication use and patient reported urinary bother. RESULTS: Urinary symptom burden improved in 23% and worsened in 28% of subjects after prostate cancer treatment in the American cohort. Urinary medication use rates before treatment and 2 years after treatment were 15% and 6% with radical prostatectomy, 22% and 26% with external radiotherapy, and 19% and 46% with brachytherapy, respectively. Pretreatment urinary medication use (OR 1.4, 95% CI 1.0-2.0, p = 0.04) and pretreatment moderate lower urinary tract symptoms (OR 2.8, 95% CI 2.2-3.6) predicted prostate cancer treatment associated relief of baseline urinary symptom burden. Subjects with pretreatment lower urinary tract symptoms who underwent radical prostatectomy experienced the greatest relief of pretreatment symptoms (OR 4.3, 95% CI 3.0-6.1), despite the development of deleterious de novo urinary incontinence in some men. The magnitude of pretreatment urinary symptom burden and beneficial effect of cancer treatment on those symptoms were verified in the Spanish cohort. CONCLUSIONS: Men with pretreatment lower urinary tract symptoms may experience benefit rather than harm in overall urinary outcome from primary prostate cancer treatment. Practitioners should consider the full spectrum of urinary symptom burden evident before prostate cancer treatment in treatment decisions.

Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding.

PURPOSE: The new short Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) patient-reported health-related quality of life (HRQOL) tool has removed the rectal bleeding question from the previous much longer version, EPIC-26. Herein, we assess the impact of losing the dedicated rectal bleeding question in 2 independent prospective multicenter cohorts. METHODS AND MATERIALS: In a prospective multicenter test cohort (n=865), EPIC-26 patient-reported HRQOL data were collected for 2 years after treatment from patients treated with prostate radiation therapy from 2003 to 2011. A second prospective multicenter cohort (n=442) was used for independent validation. A repeated-effects model was used to predict the change from baseline in bowel summary scores from longer EPIC instruments using the change in EPIC-CP bowel summary scores with and without rectal bleeding scores. RESULTS: Two years after radiation therapy, 91% of patients were free of bleeding, and only 2.6% reported bothersome bleeding problems. Correlations between EPIC-26 and EPIC-CP bowel scores were very high (r2=0.90-0.96) and were statistically improved with the addition of rectal bleeding information (r2=0.94-0.98). Considering all patients, only 0.2% of patients in the test cohort and 0.7% in the validation cohort reported bothersome bleeding and had clinically relevant HRQOL changes missed with EPIC-CP. However, of the 2.6% (n=17) of men with bothersome rectal bleeding in the test cohort, EPIC-CP failed to capture 1 patient (6%) as experiencing meaningful declines in bowel HRQOL. CONCLUSIONS: Modern prostate radiation therapy results in exceptionally low rates of bothersome rectal bleeding, and <1% of patients experience bothersome bleeding and are not captured by EPIC-CP as having meaningful HRQOL declines after radiation therapy. However, in the small subset of patients with bothersome rectal bleeding, the longer EPIC-26 should strongly be considered, given its superior performance in this patient subset.

How to Quantify Recovery After Laparoscopic Adrenalectomy: An Assessment of Patient-reported Health-related Quality of Life.

INTRODUCTION AND OBJECTIVE: Minimally invasive approaches to adrenal surgery were adopted in an attempt to reduce surgical morbidity. Despite the widespread use, few studies objectively evaluate health-related quality of life (HRQOL) in patients undergoing laparoscopic adrenalectomy (LA). We assessed patients' health status and recovery after LA with the use of validated questionnaires. METHODS: Patients seen in urology clinic for evaluation of adrenal surgery were enlisted in our prospective, patient-reported, HRQOL study assessing postoperative recovery. HRQOL was measured using Convalescence And Recovery Evaluation (CARE) and Short Form-12 questionnaires administered before surgery and at 2, 4, 8, 12 weeks and annually after surgery. All operations were performed using a laparoscopic transperitoneal approach by a single fellowship-trained surgeon. RESULTS: A total of 30 patients who met study inclusion criteria from July 2009 to November 2014 were included in our evaluation. Mean patient age was 53 years. Tumor size ranged from 2.0 to 5.5 cm and consisted of benign lesions, adrenal metastasis, and 1 adrenocortical carcinoma. Mean operative time was 98 minutes and median estimated blood loss was 50 mL. Median length of hospital stay was 1 day. Quality of life reflected by the CARE survey was impacted at 2 weeks postoperative and returned to baseline after 4 weeks. Pain and activity domains of CARE showed a significant decrease from baseline status. Physical component summary of Short Form-12 questionnaire supported the finding of negative impact of surgery on activity level within first 4 weeks of recovery. CONCLUSIONS: Despite minimally invasive approach, patients undergoing LA may require about 4 weeks to return to baseline activity, gastrointestinal, and pain status.