Alex Z. Fu

Purpose This study aimed to assess whether prostate cancer survivors who received a behavioral intervention to urinary incontinence had experienced a significant mood improvement. Methods One hundred fifty-three prostate cancer survivors with persistent incontinence were included in this secondary data analysis. They were randomly assigned to usual care or interventions that provided pelvic floor muscle exercises and self-management skills. All subjects had measures of anxiety, depression, and anger at baseline, 3 months (post-intervention), and 6 months (follow-up). Negative binomial regression analysis was performed to examine the group status, daily leakage frequency at 3 months, and their interactions at 3 months as predictors for mood outcomes at 6 months, controlling for demographic and medical variables. Results The main effect of daily leakage frequency at 3 months significantly predicted anxiety at 6 months (p < .01). The group main effect on any mood outcomes at 6 months was not statistically significant. The interaction between the group and 3-month leakage had a significant effect on anxiety; intervention subjects achieving a significant leakage reduction at 3 months exhibited significantly less anxiety at 6 months than other subjects (p = .04). Age, employment status, and receiving surgery at baseline were significantly associated with less anxiety, depression, and anger at 6 months. Conclusions Reduced urinary incontinence significantly predicted less anxiety, especially among the intervention subjects. The findings suggest a significant association between a behavioral therapy of urinary incontinence and anxiety reduction in prostate cancer survivors.

Androgen deprivation therapy is often used as salvage treatment in men with rising prostate specific antigen after initial radical prostatectomy or radiotherapy for clinically localized prostate cancer. Given the lack of evidence from general practice, we examined the association of salvage androgen deprivation therapy with mortality in an observational cohort study. From 3 managed care organizations we assembled a retrospective cohort of all 5,804 men with newly diagnosed localized prostate cancer from 1995 to 2009 who had a prostate specific antigen increase (biochemical recurrence) after primary radical prostatectomy or radiotherapy. The main outcomes were all-cause and prostate cancer specific mortality. We used Cox proportional hazards models to estimate mortality with salvage androgen deprivation therapy as a time dependent predictor. Overall salvage androgen deprivation therapy was not associated with all-cause or prostate cancer specific mortality in the prostatectomy cohort (HR 0.97, 95% CI 0.70-1.35 or HR 1.18, 95% CI 0.68-2.07) or in the radiotherapy cohort (HR 0.84, 95% CI 0.70-1.01 or HR 1.06, 95% CI 0.80-1.40, respectively). Among men with prostate specific antigen doubling time less than 9 months after the prostate specific antigen rise, salvage androgen deprivation therapy was statistically significantly associated with a decreased risk of all-cause and prostate cancer specific mortality in the prostatectomy cohort (HR 0.35, 95% CI 0.20-0.63 and HR 0.43, 95% CI 0.21-0.91) and in the radiotherapy cohort (HR 0.62, 95% CI 0.48-0.80 and HR 0.65, 95% CI 0.47-0.90, respectively). We found no association of salvage androgen deprivation therapy with all-cause or cause specific mortality in most men with biochemical recurrence after primary radical prostatectomy or radiotherapy for clinically localized prostate cancer. Men with quickly progressed disease may derive a clinical benefit from salvage androgen deprivation therapy.

Objective: We conducted a retrospective cohort study to investigate the HbA1c change associated with treatment intensification in a real-world population of patients with type 2 diabetes (T2D). Methods: Using a large US insurance claims database, patients aged ≥18 years with a T2D diagnosis and HbA1c ≥8.0% (64 mmol/mol) after ≥3 months of oral pharmacotherapy with metformin (± other oral antidiabetes agents) were identified (index date). Continuous enrollment was required for ≥12 months before (baseline) and after the index date with no baseline use of injectable antidiabetes drugs. We defined treatment intensification as prescriptions for injectable or additional oral antidiabetes drugs. Time to intensification was classified as timely (within 6 months) or not (≥6 months or not intensified). Linear regression models with propensity score 1:1 matching were performed to assess the effect of timely intensification on HbA1c. Results: Of the 11,525 patients meeting the inclusion criteria, only 37% had treatment intensified within 6 months. Mean age at index date was 57 years, 40% of the sample was female. The mean baseline A1C was 9.4% and 9.0%, while post-index A1C was 7.9% and 8.2% for timely intensified patients versus not, respectively. Patients with timely intensification had significantly greater HbA1c reduction compared with others (−0.33%, 95% CI: −0.41% to −0.25%) within 1 year of follow up. Conclusions: In this analysis of patients with T2D and treatment failure in a real-world setting, earlier treatment intensification was associated with better glycemic control as indicated by lower HbA1c values.

Aims: To identify the time to and patient characteristics associated with treatment intensification in patients with type 2 diabetes ( T2D ) and poor glycaemic control. Methods: Using a large US insurance claims database, we conducted a retrospective cohort study among adult patients with T2D and glycated haemoglobin ( HbA1c ) ≥8% (index date) after ≥3 months of therapy including metformin. Patients were required to have continuous enrolment for at least 12 months before (baseline) and after index date, and no injectable antidiabetes medications. We defined treatment intensification as prescription fill for injectable or additional oral antidiabetic drugs ( OADs ). Cox modelling was performed to identify factors associated with time to treatment intensification. Results: For the 11 525 patients meeting the inclusion criteria, the mean age at index date was 57 years, 40% were female and the mean index HbA1c was 9.1%. Overall, 37% of patients had their treatment intensified <6 months after, 11% had their treatment intensified 6–12 months after, and 52% did not have their treatment intensified <12 months after the index date. A higher index HbA1c was associated with early intensification [hazard ratio ( HR ) 1.18 for HbA1c ≥9 to <10% and HR 1.41 for HbA1c ≥10% compared with HbA1c ≥8 to <9%; p < 0.0001), and later line of therapy was associated with late intensification ( HR 0.78 for metformin with one OAD and HR 0.68 for metformin with ≥2 OADs compared with metformin monotherapy; p < 0.0001). Conclusions: Fewer than half of patients with T2D and treatment failure received intensification within 12 months in a real‐world US population. Factors associated with treatment inertia can be used to target clinical care for these patients.

Objective: To better manage type 2 diabetes mellitus (T2DM), the tradeoff between improved glycemic control and hypoglycemia should be evaluated. The purpose of this study was to assess the relationship between hypoglycemia and hemoglobin A1c (HbA1c) in a real-world population. Research design and methods: Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) was a multi-center, observational study. Patients ≥30 years old using any oral anti-hyperglycemic agent were recruited from seven European and five Asian countries between 2006 and 2007. Hypoglycemia events were collected through patient-reported questionnaires. HbA1c data was collected through chart review. Logistic regression was performed to assess the relationship between hypoglycemia and the most proximate HbA1c levels adjusting for potential confounders (demographics, clinical variables, other medication use, and comorbid conditions). Results: A total of 4399 patients were recruited and analyzed. Mean age was 60 years, 52% were male, and 75% were on sulfonylureas (S.U.s). Respectively, 37% or 42% of patients reported hypoglycemia in the past 6 (Asia) or 12 months (Europe) before recruitment. Prevalence of hypoglycemia increased significantly (33% to 40%) as HbA1c decreased (p = 0.035). The same trend was also observed among S.U.-treated patients (p < 0.01). After adjusting for confounders, hypoglycemia prevalence was significantly higher for HbA1c p = 0.002) vs. HbA1c ≥10.0%. Limitations: Our analyses pooled data from Asia and Europe, which differed in terms of the recall period for ascertaining hypoglycemia symptoms and the timing of latest HbA1c measure. Conclusions: Lower HbA1c level was associated with higher hypoglycemia prevalence among S.U.-treated patients. HbA1c level should be taken into consideration when reporting hypoglycemia prevalence.

Purpose The optimal use of androgen deprivation therapy as salvage treatment (sADT) for men after initial prostatectomy or radiotherapy for clinically localized prostate cancer is undefined. We describe patterns of sADT use and investigate clinical and sociodemographic characteristics of insured men who received sADT versus surveillance in managed care settings. Methods Using comprehensive electronic health records and cancer registry data from three integrated health plans, we identified all men with newly diagnosed clinically localized prostate cancer between 1995 and 2009 who received either prostatectomy (n = 16,445) or radiotherapy (n = 19,531) as their primary therapy. We defined sADT based on the timing of ADT following primary therapy and stage of cancer. We fit Cox proportional hazard models to identify sociodemographic characteristics and clinical factors associated with sADT. Results With a median follow-up of 6 years (range 2–15 years), 13 % of men who underwent primary prostatectomy or radiotherapy received sADT. After adjusting for selected covariates, sADT was more likely to be used in men who were older (e.g., HR 1.70, 95 % CI 1.48–1.96 or HR 1.33, 95 % CI 1.17–1.52 for age 70+ relative to age 35–59 for primary prostatectomy or radiotherapy, respectively), were African-American, had a short PSA doubling time, had a higher pre-treatment risk of progression, had more comorbidities, and received adjuvant ADT for initial disease. Conclusions In men with localized prostate cancer in community practice initially treated with prostatectomy or radiotherapy, sADT after primary treatment was more frequent for men at greater risk of death from prostate cancer, consistent with practice guidelines.

Purpose Some medical treatment for metastatic colorectal cancer (CRC) may have marginal survival benefit, but cause toxicities. The purpose of this study is to determine metastatic CRC patients’ tradeoffs in making a decision to undergo new medical treatment. Methods We conducted a survey of patients with a diagnosis of advanced CRC who were currently receiving or completed one chemotherapy regimen. First, patients were asked to rate the importance of 15 medical treatment-related adverse events that may arise as a consequence of chemotherapy or biological therapy in their treatment decision-making. Then, the patient identified his or her top five most important events and solicited preferences in hypothetical metastatic CRC treatment vignettes using the standard gamble technique. Results A total of 107 patients responded to the survey. From the list of medical treatment-related adverse events, patients identified clinically serious ones such as stroke, heart attack, and gastrointestinal perforation as the most important in their medical treatment decision-making, yet placed lower willingness to tolerate symptom-related events such as pain, fatigue, and depression. Generally, patients who were older, stage III versus IV and who had prior radiotherapy, lower educational attainment, and lower household income (all p <0.05) were less willing to tolerate any medical treatment-related adverse events after adjusting for other demographic and clinical characteristics. Conclusions Variations in patients’ willingness to tolerate different treatment-related adverse events underscore the need for improved communications between physicians and patients about the risks and benefits of their medical treatment, which helps make a more personalized decision for metastatic CRC treatment.

Objective: The aim of this study was to evaluate the cost‐effectiveness of a behavioral intervention for urinary incontinence of prostate cancer patients. Study subjects were either participating in or eligible but declined (i.e., nonparticipating) the active intervention study.Methods: The intervention‐participating subjects were randomized into three groups, including two intervention groups (support and telephone groups) and a usual care reference group. Intervention‐nonparticipating subjects were concurrently enrolled. Intervention effectiveness was assessed on the EQ‐5D measure. The costs included direct healthcare cost from medical billing data, patient out‐of‐pocket expense, caregiver expense, patient loss‐of‐work cost, and intervention cost. We calculated incremental cost‐effectiveness ratios (ICERs) from societal, provider, and patient perspectives.Results: Two hundred and sixty‐seven intervention‐participating and 69 intervention‐nonparticipating post‐cancer treatment patients were included. The support and telephone groups, but not the usual care group, had significantly higher EQ‐5D index scores (0.054, p = 0.033, and 0.057, p = 0.026, respectively) than the intervention‐nonparticipating group at month 6. Within 6 months, intervention cost per subject was $252 and $484, respectively, for providers, and $564 and $203, respectively, for the support and phone group subjects. The final ICERs were $16,759 per quality‐adjusted life year (QALY) and $12,561/QALY for support and telephone groups, compared with those of the intervention‐nonparticipating group. These ICERs are much smaller than $50,000/QALY, the consensus threshold to determine cost‐effectiveness for society.Conclusions: The study interventions are cost‐effective in consideration of eligible patients who declined the interventions. The interventions can provide meaningful outcome improvement on urinary continence at a low cost. This evidence provides critical information for future health policy decision‐making of healthcare providers and payers. Copyright © 2015 John Wiley & Sons, Ltd.