When Will Real-World Data Fulfill Its Promise to Provide Timely Insights in Oncology?

Randomized trials provide high-quality, internally consistent data on selected clinical questions, but lack generalizability for the aging population who are most often diagnosed with cancer and have comorbid conditions that may affect the interpretation of treatment benefit. The need for high-quality, relevant, and timely data is greater than ever. Promising solutions lie in the collection and analysis of real-world data (RWD), which can potentially provide timely insights about the patient's course during and after initial treatment and the outcomes of important subgroups such as the elderly, rural populations, children, and patients with greater social health needs.

Association between body mass index and localized prostate cancer management and disease-specific quality of life.

Purpose: The purpose of this work is to describe the association between body mass index (BMI) and (1) management option for localized prostate cancer (PCa) and (2) disease-specific quality of life (ds-QoL) after treatment or active surveillance.

Subjects/patients And Methods: We analysed data from men with localized PCa managed with radical prostatectomy (RP), radiation therapy (RT), or active surveillance (AS) in a prospective, population-based cohort study. We evaluated the association between BMI and management option with multivariable multinomial logistic regression analysis.

Postdischarge Noninvasive Telemonitoring and Nurse Telephone Coaching Improve Outcomes in Heart Failure Patients With High Burden of Comorbidity.

Background: Noninvasive telemonitoring and nurse telephone coaching (NTM-NTC) is a promising postdischarge strategy in heart failure (HF). Comorbid conditions and disease burden influence health outcomes in HF, but how comorbidity burden modulates the effectiveness of NTM-NTC is unknown. This study aims to identify patients with HF who may benefit from postdischarge NTM-NTC based on their burden of comorbidity.

Prostate volume, baseline urinary function, and their association with treatment choice and post-treatment urinary function in men treated for localized prostate cancer.

Background: Benign prostatic hyperplasia, lower urinary tract symptoms, and prostate cancer often co-occur. Their effect on urinary function is an important consideration regarding prostate cancer treatment choices. While prostate volume (PV) and urinary symptoms are commonly used in treatment choice decision making, their association with post-treatment urinary function is unknown.

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.

Patient-reported Outcomes After External Beam Radiotherapy With Low Dose Rate Brachytherapy Boost vs Radical Prostatectomy for Localized Prostate Cancer: Five-year Results From a Prospective Comparative Effectiveness Study.

Purpose: Data comparing radical prostatectomy and external beam radiation therapy with low dose rate brachytherapy boost are lacking. To better guide shared decision making regarding treatment, we compared patient reported outcomes through 5 years following radical prostatectomy or external beam radiation therapy with low dose rate brachytherapy boost for localized prostate cancer.

Materials And Methods: From 2011-2012, men aged <80 years with localized prostate adenocarcinoma were enrolled and followed longitudinally.

Association between adherence to radiation therapy quality metrics and patient reported outcomes in prostate cancer.

Background: Prior studies have shown significant variability in the quality of prostate cancer care in the US with questionable associations between quality measures and patient reported outcomes. We evaluated the impact of compliance with nationally recognized radiation therapy (RT) quality measures on patient-reported health-related quality of life (HRQOL) outcomes in the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) cohort.

Methods: CEASAR is a population-based, prospective cohort study of men with localized prostate cancer from which we identified 649 who received primary RT and completed HRQOL surveys for inclusion.

Association between Treatment for Localized Prostate Cancer and Mental Health Outcomes.

Purpose: We aimed to compare patient-reported mental health outcomes for men undergoing treatment for localized prostate cancer longitudinally over 5 years.

Materials And Methods: We conducted a prospective population-based analysis using the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study. Patient-reported depressive symptoms (Centers for Epidemiologic Studies Depression [CES-D]) and domains of the Medical Outcomes Study 36-item Short Form survey evaluating emotional well-being and energy/fatigue were assessed through 5 years after treatment with surgery, radiotherapy (with or without androgen deprivation therapy) and active surveillance.

Online seminars as an information source for direct-to-consumer stem cell therapy.

To attend stem cell (SC) seminars hosted by US-based direct-to-consumer SC businesses either in person or via online 'webinars' to determine accuracy and regulatory oversight of the advertised SC therapies. The therapeutic claims, costs, risks, scientific evidence in support of a therapy and any regulatory oversight were collated using pre-established checklists. Participation consisted of one live attendance of a seminar, and following COVID-19 restrictions, review of seven recorded presentations available on the internet from SC businesses.

Association of Treatment Modality, Functional Outcomes, and Baseline Characteristics With Treatment-Related Regret Among Men With Localized Prostate Cancer.

Importance: Treatment-related regret is an integrative, patient-centered measure that accounts for morbidity, oncologic outcomes, and anxiety associated with prostate cancer diagnosis and treatment.

Objective: To assess the association between treatment approach, functional outcomes, and patient expectations and treatment-related regret among patients with localized prostate cancer.

Design, Setting, And Participants: This population-based, prospective cohort study used 5 Surveillance, Epidemiology, and End Results (SEER)-based registries in the Comparative Effectiveness Analysis of Surgery and Radiation cohort.

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.

Sexual function outcomes of radiation and androgen deprivation therapy for localized prostate cancer in men with good baseline function.

Background: Sexual dysfunction, including erectile dysfunction and loss of libido, are common among men undergoing treatment for localized prostate cancer. Both local treatments and systemic androgen deprivation therapy may contribute to these outcomes and are differentially indicated based on disease characteristics. We sought to compare sexual function through 5 years after radiation treatment with and without androgen deprivation therapy in men with good baseline sexual function to better understand long-term effects in this understudied subset of patients.

Five-year outcomes from a prospective comparative effectiveness study evaluating external-beam radiotherapy with or without low-dose-rate brachytherapy boost for localized prostate cancer.

Background: To inform patients who are in the process of selecting prostate cancer treatment, the authors compared disease-specific function after external-beam radiotherapy (EBRT) alone versus EBRT plus a low-dose-rate (LDR) brachytherapy boost (EBRT-LDR).

Methods: For this prospective study, men who had localized prostate cancer in 2011 and 2012 were enrolled. Assessments at baseline, 0.

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.

Radiotherapy after radical prostatectomy: Effect of timing of postprostatectomy radiation on functional outcomes.

Introduction And Objective: The timing of radiotherapy (RT) after prostatectomy is controversial, and its effect on sexual, urinary, and bowel function is unknown. This study seeks to compare patient-reported functional outcomes after radical prostatectomy (RP) and postprostatectomy radiation as well as elucidate the timing of radiation to allow optimal recovery of function.

Methods: The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, observational study of men with localized prostate cancer.

Assessing the Quality of Surgical Care for Clinically Localized Prostate Cancer: Results from the CEASAR Study.

Purpose: Prior studies suggest that nationally endorsed quality measures for prostate cancer care are not linked closely with outcomes. Using a prospective, population based cohort we measured clinically relevant variation in structure, process and outcome measures in men undergoing radical prostatectomy.

Materials And Methods: The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) Study enrolled men with clinically localized prostate cancer diagnosed from 2011 to 2012 with 1,069 meeting the final inclusion criteria.

Development and Internal Validation of a Web-based Tool to Predict Sexual, Urinary, and Bowel Function Longitudinally After Radiation Therapy, Surgery, or Observation.

Background: Shared decision making to guide treatment of localized prostate cancer requires delivery of the anticipated quality of life (QOL) outcomes of contemporary treatment options (including radical prostatectomy [RP], intensity-modulated radiation therapy [RT], and active surveillance [AS]). Predicting these QOL outcomes based on personalized features is necessary.

Objective: To create an easy-to-use tool to predict personalized sexual, urinary, bowel, and hormonal function outcomes after RP, RT, and AS.

Patient-Reported Outcomes Through 5 Years for Active Surveillance, Surgery, Brachytherapy, or External Beam Radiation With or Without Androgen Deprivation Therapy for Localized Prostate Cancer.

Importance: Understanding adverse effects of contemporary treatment approaches for men with favorable-risk and unfavorable-risk localized prostate cancer could inform treatment selection.

Objective: To compare functional outcomes associated with prostate cancer treatments over 5 years after treatment.

Design, Setting, And Participants: Prospective, population-based cohort study of 1386 men with favorable-risk (clinical stage cT1 to cT2bN0M0, prostate-specific antigen [PSA] ≤20 ng/mL, and Grade Group 1-2) prostate cancer and 619 men with unfavorable-risk (clinical stage cT2cN0M0, PSA of 20-50 ng/mL, or Grade Group 3-5) prostate cancer diagnosed in 2011 through 2012, accrued from 5 Surveillance, Epidemiology and End Results Program sites and a US prostate cancer registry, with surveys through September 2017.

The Comorbidities Coma Scale (CoCoS): Psychometric Properties and Clinical Usefulness in Patients With Disorders of Consciousness.

Although comorbidities have a well-known impact on the functional recovery of patients with disorders of consciousness, including coma, vegetative state (VS), and minimally conscious state (MCS), a specific tool for their assessment in this challenging group of patients is lacking. For this aim, a multistep process was used to develop and validate the Comorbidities Coma Scale (CoCoS) in a sample of 162 patients with a diagnosis of coma, VS or MCS admitted to four Acute Inpatient Rehabilitation Units. To establish the psychometric properties of the scale, content validity, and internal consistency were investigated through Exploratory Factor Analysis in the whole sample ( = 162).

Interpretation of Domain Scores on the EPIC-How Does the Domain Score Translate into Functional Outcomes?

Purpose: The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring health related quality of life. However, the relationship between domain scores and functional outcomes remains unclear, leading to potential confusion about expectations after treatment. For instance, does a sexual function domain score of 80 mean that a patient can achieve erection sufficient for intercourse? Consequently we sought to determine the relationship between the domain score and the response to obtaining the best possible outcome for each question.