TrueNTH sexual recovery study protocol: a multi-institutional collaborative approach to developing and testing a web-based intervention for couples coping with the side-effects of prostate cancer treatment in a randomized controlled trial.

BACKGROUND: Over half of men who receive treatment for prostate suffer from a range of sexual problems that affect negatively their sexual health, sexual intimacy with their partners and their quality of life. In clinical practice, however, care for the sexual side effects of treatment is often suboptimal or unavailable. The goal of the current study is to test a web-based intervention to support the recovery of sexual intimacy of prostate cancer survivors and their partners after treatment. METHODS: The study team developed an interactive, web-based intervention, tailored to type of treatment received, relationship status (partnered/non-partnered) and sexual orientation. It consists of 10 modules, six follow the trajectory of the illness and four are theme based. They address sexual side effects, rehabilitation, psychological impacts and coaching for self-efficacy. Each includes a video to engage participants, psychoeducation and activities completed by participants on the web. Tailored strategies for identified concerns are sent by email after each module. Six of these modules will be tested in a randomized controlled trial and compared to usual care. Men with localized prostate cancer with partners will be recruited from five academic medical centers. These couples (N = 140) will be assessed prior to treatment, then 3 months and 6 months after treatment. The primary outcome will be the survivors' and partners' Global Satisfaction with Sex Life, assessed by a Patient Reported Outcome Measure Information Systems (PROMIS) measure. Secondary outcomes will include interest in sex, sexual activity, use of sexual aids, dyadic coping, knowledge about sexual recovery, grief about the loss of sexual function, and quality of life. The impact of the intervention on the couple will be assessed using the Actor-Partner Interaction Model, a mixed-effects linear regression model able to estimate both the association of partner characteristics with partner and patient outcomes and the association of patient characteristics with both outcomes. DISCUSSION: The web-based tool represents a novel approach to addressing the sexual health needs of prostate cancer survivors and their partners that-if found efficacious-will improve access to much needed specialty care in prostate cancer survivorship. TRIAL REGISTRATION: Clinicaltrials.gov registration # NCT02702453 , registered on March 3, 2016.

Measuring the cost of care in benign prostatic hyperplasia using time-driven activity-based costing (TDABC).

BACKGROUND: Determining '"value'" in health care, defined as outcomes per unit cost, depends on accurately measuring cost. We used time-driven activity-based costing (TDABC) to determine the cost of care in men with benign prostatic hyperplasia (BPH) - a common urologic condition. METHODS: We implemented TDABC across the entire care pathway for BPH including primary and specialist care in both inpatient and outpatient settings. A team of expert stakeholders created detailed process maps, determined space and product costs, and calculated personnel capacity cost rates. A model pathway was derived from practice guidelines and calculated costs were applied. RESULTS: Although listed as 'optional' in practice guidelines, invasive diagnostic testing can increase costs by 150% compared with the standalone urology clinic visit. Of five different surgical options, a 400% cost discrepancy exists between the most and least expensive treatments. CONCLUSIONS: TDABC can be used to measure cost across an entire care pathway in a large academic medical center. Sizable cost variation exists between diagnostic and surgical modalities for men with BPH. IMPLICATIONS: As financial risk is shifted toward providers, understanding the cost of care will be vital. Future work is needed to determine outcome discrepancy between the diagnostic and surgical modalities in BPH.

Nationally representative trends and geographic variation in treatment of localized prostate cancer: the Urologic Diseases in America project.

BACKGROUND: Several treatment options for clinically localized prostate cancer currently exist under the established guidelines. We aim to assess nationally representative trends in treatment over time and determine potential geographic variation using two large national claims registries. METHODS: Men with prostate cancer insured by Medicare (1998-2006) or a private insurer (Ingenix database, 2002-2006) were identified using International Classification of Diseases-9 and Current Procedural Terminology-4 codes. Geographic variation and trends in the type of treatment utilized over time were assessed. Geographic data were mapped using the GeoCommons online mapping platform. Predictors of any treatment were determined using a hierarchical generalized linear mixed model using the logit link function. RESULTS: The use of radical prostatectomy increased, 33-48%, in the privately insured i3 database while remaining stable at 12% in the Medicare population. There was a rapid uptake in the use of newer technologies over time in both the Medicare and i3 cohorts. The use of laparoscopic-assisted prostatectomy increased from 1% in 2002 to 41% in 2006 in i3 patients, whereas the incidence increased from 3% in 2002 to 35% in 2006 for Medicare patients. The use of neoadjuvant/adjuvant androgen deprivation therapy was lower in the i3 cohort and has decreased over time in both i3 and Medicare. Physician density had an impact on the type of primary treatment received in the New England region; however, this trend was not seen in the western or southern regions of the United States. CONCLUSIONS: Using two large national claims registries, we have demonstrated trends over time and substantial geographic variation in the type of primary treatment used for localized prostate cancer. Specifically, there has been a large increase in the use of newer technologies (that is, laparoscopic-assisted prostatectomy and intensity-modulated radiation therapy). These results elucidate the need for improved data collection on prostate cancer treatment outcomes to reduce unwarranted variation in care.

Updated trends in imaging use in men diagnosed with prostate cancer.

BACKGROUND: Previous studies have found persistent overuse of imaging for clinical staging of men with low-risk prostate cancer. We aimed to determine imaging trends in three cohorts of men. METHODS: We analyzed imaging trends of men with prostate cancer who were a part of Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) (1998-2006), were insured by Medicare (1998-2006), or privately insured (Ingenix database, 2002-2006). The rates of computed tomography (CT), magnetic resonance imaging (MRI) and bone scan (BS) were determined and time trends were analyzed by linear regression. For men in CaPSURE, demographic and clinical predictors of test use were explored using a multivariable regression model. RESULTS: Since 1998, there was a significant downward trend in BS (16%) use in the CaPSURE cohort (N=5156). There were slight downward trends (2.4 and 1.7%, respectively) in the use of CT and MRI. Among 54 322 Medicare patients, BS, CT and MRI use increased by 2.1, 10.8 and 2.2% and among 16 161 privately insured patients, use increased by 7.9, 8.9 and 3.7%, respectively. In CaPSURE, the use of any imaging test was greater in men with higher-risk disease. In addition, type of insurance and treatment affected the use of imaging tests in this population. CONCLUSIONS: There is widespread misuse of imaging tests in men with low-risk prostate cancer, particularly for CT. These findings highlight the need for examination of factors that drive decision making with respect to imaging in this setting.

Use of patient ethnography to support quality improvement in benign prostatic hyperplasia.

BACKGROUND: Patient-centeredness is a primary aim of quality improvement (QI) but optimal strategies to achieve that goal remain elusive. Benign prostatic hyperplasia (BPH) is one of the commonest urologic diagnoses and significantly affects quality of life. Patient ethnography is an emerging qualitative method of observation and dynamic interviews to understand the context through which the patient experiences care. We implemented patient ethnography to support our QI infrastructure and improve patient-centeredness in BPH. PROBLEM: Little is known about how to measure whether processes of care are patient-centered. We did not know whether the care processes our patients experienced provided value from their perspective. GOALS: We sought to discover previously unrecognized components of care that patients perceived to be of low value. Our primary goal was to develop QI initiatives that targeted low-value themes identified in the ethnography. Our secondary goal was a rapid rollout of three targeted initiatives. STRATEGY: We used a 4-step patient ethnography: (1) created detailed process maps to define phases of care, (2) interviewed patients, (3) synthesized transcript data in focus groups using the Crawford Slip method, and (4) targeted undesirable components of care for QI. Semi-structured interviews with seven representative patients identified low-value themes. Focus groups, comprised of primary care physicians, case coordinators, nurses, and urologists, evaluated the interview transcripts and generated improvement opportunities prioritized based on feasibility, patient value, scalability, and innovation. We used affinity mapping and priority matrix techniques to prioritize QI opportunities. RESULTS: We identified five low-value themes from the patient interviews and developed corresponding QI opportunities. These included issues surrounding the referral and consultation process as well as postoperative care, especially home urinary catheter maintenance. Six months after completing the ethnography three of five targeted improvement opportunities had been implemented.

Men with diabetes may require more aggressive treatment for erectile dysfunction.

Diabetes mellitus (DM) and erectile dysfunction (ED) are common health problems that markedly increase in prevalence and incidence with advancing age. DM is a known risk factor for developing ED; however, among men with ED it is unknown if DM alters the need for more invasive therapies. We sought to determine whether DM is associated with increased ED severity, reduced effectiveness of first-line (oral) therapies, and therefore higher utilization of second- and third-line therapies. The Inovus I3 database was queried to identify men with ED. Claims were followed for 48 months. Men with incomplete follow-up data and those diagnosed with DM after ED diagnosis were excluded from analysis. Rates of second-line (penile suppositories or injectables) and third-line (penile prostheses) ED therapies were compared between men with and without preexisting DM. Risk of progressing to second- and third-line therapies associated with DM was assessed with logistic regression and Kaplan-Meier analysis. From 1 January 2002 to 31 December 2006, 136 306 men were identified with prevalent and incident ED. Among this group, 19 236 men had DM that preceded their ED diagnosis. Men with DM were more than 50% more likely to be prescribed secondary ED treatments over the 2-year observation period, and more than twice as likely to undergo penile prosthesis surgery. Among a large population-based cohort of men with ED, those with DM are more likely to require more aggressive treatments. These data suggest that ED among men with diabetes may be less responsive to first-line treatments (oral agents), worsen more rapidly, or both.

Health-related quality of life in men with metastatic prostate cancer: the misleading effect of lead-time bias.

OBJECTIVE: To ascertain whether the difference in health-related quality of life, which appears to be worse in men with metastatic prostate cancer when the metastases are noted at initial diagnosis than during follow-up after treatment for clinically localized disease, can be attributed to previous local control or to some form of measurement bias. PATIENTS AND METHODS: We analysed by univariate and multivariate methods 375 men with metastatic prostate cancer who were enrolled in CaPSURE, a national observational cohort of patients with prostate cancer treated in community and academic settings throughout the USA. In particular, we assessed whether group differences in health-related quality of life were explained by the timing of metastatic diagnosis in the course of their disease. Health-related quality of life was measured with the RAND 36-Item Health Survey (SF-36). RESULTS: After controlling for relevant covariates (age, comorbidity and ethnicity), multivariate models suggested that men whose metastases were noted at the time of initial diagnosis scored 5-15 points worse in all eight domains of the SF-36. CONCLUSION: Men who are diagnosed with metastatic prostate cancer during the follow-up after treatment for clinically localized disease report a better quality of life than those who are metastatic at the time of diagnosis, not because the primary treatment confers any benefit but because they are followed more closely over time and diagnosed with metastases earlier in the course of their disease. This apparent difference in quality of life is an effect of lead-time bias in the diagnosis of metastasis.

Predictors of utilities for health states in early stage prostate cancer.

PURPOSE: When faced with treatment choices for early stage prostate cancer, patients must balance the survival benefit of a treatment with its morbidity. Little is known about how patients balance these trade-offs. To further our understanding of patient decision making we assessed patient utilities for prostate cancer treatment related morbidities. We determined whether patient utilities were predicted by sociodemographic characteristics or baseline genitourinary function. MATERIALS AND METHODS: We evaluated 401 men undergoing prostate needle biopsy for suspicion of prostate cancer at university, Veterans Affairs and public hospitals. Study design included a prospective cross-sectional cohort with correlation and multivariate analysis. Subjects were studied with 2 established health related quality of life instruments. Patient utilities were assessed with an interactive software application. RESULTS: On multivariate analysis utility for current general health was a significant predictor of utilities for treatment related morbidities. Surprisingly baseline urinary, sexual and bowel function scores did not correlate well with respective utilities for potential incontinence, impotence or radiation proctitis. In other words, men with good and imperfect baseline function were equally willing to risk impairment to preserve life. CONCLUSIONS: Men who perceived that general health was better appear to place higher value on quantity of life, while those who already are suffering from poor general health place higher value on quality of life. Ethnicity appears to modify some effects of other variables on patient preference. Utility assessment provides a quantitative tool to aid physicians in counseling patients when making treatment decisions for localized prostate cancer.