Assessing Postsurgical Outcomes with Prepectoral Breast Reconstruction: A Literature Review and Meta-analysis Update.

BACKGROUND: Prepectoral implant-based breast reconstruction is an alternative to subpectoral/dual-plane reconstruction. METHODS: This study examined outcomes of prepectoral reconstruction using a meta-analysis of data pooled with data from our previous review. Thirty studies were included. RESULTS: Explantation, seroma, and infection were the most common complications with no animation deformity reported. Significantly lower odds of infection were observed with prepectoral compared with dual-plane reconstruction. CONCLUSIONS: Current literature suggests that prepectoral reconstruction may be associated with lower rates of postsurgical infections.

Multistakeholder Collaborative Effort to Enhance Long-Term Follow-Up in the Abdominal Core Health Quality Collaborative.

Objective: To determine the effectiveness of a clinical call center in performing focused long-term patient reported outcome (PRO)-based follow-up for ventral hernia patients in routine practice. Background: Long-term follow-up remains the mainstay of assessing quality of care in hernia management. Achieving acceptable rates of long-term follow-up outside of clinical trials in the routine care of patients has been very difficult to achieve. Methods: A prospective quality improvement intervention using a clinical call center in 1000 random patients eligible for long-term (1 year or greater) follow-up after ventral hernia repair in the Abdominal Core Health Quality Collaborative was performed. The primary outcome measure was the proportion of patients with successfully completed PRO-based long-term follow-up. Results: Between 2013 and 2017, the baseline long-term follow-up PRO completion rate was 2167/13,950 (15.5%). For the Focus on Follow-Up initiative, 890 patients were eligible for contact; a completion rate of 450/890 (50.6%, P < 0.001) was achieved. Conclusions: Clinical call center-based patient contact can greatly facilitate the completion of PROs utilized for long-term follow-up in ventral hernia repair. This has important implications for quality improvement programs and postmarket device surveillance.

What Drives Patient Choice: Preferences for Approaches to Surgical Treatments for Breast Cancer Beyond Traditional Clinical Benchmarks.

IMPORTANCE: Understanding what drives breast cancer (BC) patient's surgical decision-making and why, as survival continues to improve, are women continuing to choose mastectomy in increasing numbers. OBJECTIVE: We sought to understand better what drives patient choice in surgical decision-making regarding BC treatment options. DESIGN: We used a dynamic model, adaptive conjoint-based survey experiment, to assess multiple factors concurrently impacting patient choice, conducted from December 2016 to January 2017 using the Army of Women. SETTING: Army of Women, is a U.S.-based nation-wide registry of women, both healthy and previous BC patients. PARTICIPANTS: An e-mail invitation was sent to the AWOL's 108,933 members, with 1,233 signing up to participate and 858 responding (548 healthy, 310 previous BC). Two hundred thirty-nine BC patients who underwent treatment > 5 years were excluded due to potential recall bias and changes in BC treatment paradigms. All subjects who did not complete the adaptive conjoint-based survey were also excluded due to inability to calculate preferences. The final sample consisted of 522 healthy women and 71 previous BC patients. INTERVENTIONS OR EXPOSURES: Study of patient preference and decision drivers, without, interventions or exposures. MAIN OUTCOMES AND MEASURES: Shares of preferences for various surgical treatment options were calculated using the highest-ranked factors, by the importance that drove patient decision-making. RESULTS: Survey response rate was 69.5%. Among healthy women, the most important of the 9 factors in making a surgical choice were doctor's recommendation at 21.4% (SD, 13.6%) and overall survival (OS) at 20.5% (SD, 9.8%) while among previous BC patients, the most important factor was OS at 19% (SD, 9%) and doctor's recommendation at 17.2% (SD, 10.3%). CONCLUSION AND RELEVANCE: While OS accounted for the largest single driver of patient choice at ~20 %, it is notable that 80% of patient decision-making was driven by factors unrelated to survival such as cost, intensity and recovery time, and breast image. By understanding what drives choice, we can provide better patient-centric education and treatments.

Early assessment of post-surgical outcomes with pre-pectoral breast reconstruction: A literature review and meta-analysis.

BACKGROUND: Pre-pectoral breast reconstruction is an emerging surgical approach. This study provides an early assessment of outcomes with the technique. METHODS: A comprehensive literature review was performed through searches of PubMed® /MEDLINE® to identify studies on pre-pectoral reconstruction. Patient characteristics and outcomes were extracted from studies and pooled. Linear relationships between complication rates and patient characteristics with pre-pectoral reconstruction were analyzed. A meta-analysis compared complication rates between pre-pectoral and dual-plane reconstruction. RESULTS: Fourteen studies (406 women/654 breasts) were included. The most common complications with pre-pectoral reconstruction were flap necrosis (7.8%), seroma (6.7%), capsular contracture (5.8%), and explantation (4.6%). No hyperanimation was reported. Significant correlation between previous radiation and flap necrosis, post-operative chemotherapy and infection, hypertension and flap necrosis, diabetes and dehiscence, and smoking and explantation were found. A meta-analysis of four studies comparing pre-pectoral (135 women/219 breasts) and dual-plane (230/408) reconstruction found no significant difference for likelihood of infection (odds ratio, 0.46; 95% confidence interval, 0.16-1.30), explantation (0.83; 0.29-2.38), necrosis (1.61; 0.77-3.36), seroma (1.88; 0.71-5.02), dehiscence (1.84; 0.68-4.95), or capsular contracture (0.14; 0.02-1.14). CONCLUSIONS: Complication rates are comparable following pre-pectoral and dual-plane reconstruction, indicating the pre-pectoral technique may be a feasible option for appropriate patients.

Corrigendum to "Prevalence of Fracture Risk Factors in Postmenopausal Women Enrolled in the POSSIBLE US Treatment Cohort".

[This corrects the article DOI: 10.1155/2013/715025.].

A Comparison of Two Fat Grafting Methods on Operating Room Efficiency and Costs.

BACKGROUND: Centrifugation (Cf) is a common method of fat processing but may be time consuming, especially when processing large volumes. OBJECTIVES: To determine the effects on fat grafting time, volume efficiency, reoperations, and complication rates of Cf vs an autologous fat processing system (Rv) that incorporates fat harvesting and processing in a single unit. METHODS: We performed a retrospective cohort study of consecutive patients who underwent autologous fat grafting during reconstructive breast surgery with Rv or Cf. Endpoints measured were volume of fat harvested (lipoaspirate) and volume injected after processing, time to complete processing, reoperations, and complications. A budget impact model was used to estimate cost of Rv vs Cf. RESULTS: Ninety-eight patients underwent fat grafting with Rv, and 96 patients received Cf. Mean volumes of lipoaspirate (506.0 vs 126.1 mL) and fat injected (177.3 vs 79.2 mL) were significantly higher (P < .0001) in the Rv vs Cf group, respectively. Mean time to complete fat grafting was significantly shorter in the Rv vs Cf group (34.6 vs 90.1 minutes, respectively; P < .0001). Proportions of patients with nodule and cyst formation and/or who received reoperations were significantly less in the Rv vs Cf group. Based on these outcomes and an assumed per minute operating room cost, an average per patient cost savings of $2,870.08 was estimated with Rv vs Cf. CONCLUSIONS: Compared to Cf, the Rv fat processing system allowed for a larger volume of fat to be processed for injection and decreased operative time in these patients, potentially translating to cost savings. LEVEL OF EVIDENCE 3.

The Safety, Effectiveness, and Efficiency of Autologous Fat Grafting in Breast Surgery.

BACKGROUND: For years, the safety and effectiveness of autologous fat grafting (AFG) for breast reconstruction have been in question, with particular concern over fat necrosis, calcifications, cyst formation, and interfering with the detection of breast cancer. However, increasing evidence suggests that the complication rates and clinical results are generally acceptable to both clinicians and patients. The emerging challenge is the numerous AFG techniques and systems, where there are limited knowledge and data. The objective of this study was to conduct a literature review that focuses on the safety, effectiveness, and efficiency of various AFG techniques as applied to the breast. METHODS: A PubMed search using terms related to AFG was performed over a 5-year period (April 1, 2010-April 30, 2015). Original articles focused on AFG to the breast, with outcomes on safety, effectiveness, and efficiency, were included. RESULTS: Five hundred ninety-eight articles were identified with 36 articles included (n = 4306 patients). Satisfaction rates were high although the prevalence of complications was low-similar to previous findings. Seven studies reported average operating room time with an overall mean of 125 minutes (range: 40-210). The mean volume of fat harvested was 558 mL (range: 120-1299), and fat injected was 145 mL (range: 20-607). A positive association between injection volume and operating time was observed. CONCLUSIONS: This review validates previous findings on the safety and effectiveness of AFG to the breast and highlights its efficiency. The efficiency data available, although limited, suggest that there is an opportunity to achieve time and cost savings while not sacrificing safety and effectiveness.

A Meta-analysis Assessing Postsurgical Outcomes between Aseptic and Sterile AlloDerm Regenerative Tissue Matrix.

BACKGROUND: AlloDerm, a human acellular dermal matrix, is available in a ready-to-use (RTU) or freeze-dried (FD) form. A limited number of studies have compared complication rates between RTU and FD in implant-based breast reconstruction. The objective of this report was to conduct a meta-analysis of previously reported complication rates between RTU and FD. METHODS: A systematic literature review was conducted from 2010 to 2014 and supplemented by hand searches. Included studies compared both RTU and FD. Odds ratios and relative risks (RRs) with 95% confidence interval (CI), taking into account study heterogeneity, were calculated. Studies reporting patient-level results as opposed to breast-level results were excluded from the primary analysis but included in subsequent sensitivity analyses. Variable follow-up time within and between studies was also considered in a sensitivity analysis. RESULTS: Of the 275 identified studies, 115 studies were eligible for detailed review. Only 5 studies compared RTU with FD, and of these, 2 studies had breast-level data and 1 study had patient-level data appropriate for meta-analysis. The 2 studies included in the primary meta-analysis had a pooled sample size: n = 116 RTU and n = 109 FD patients, or 205 and 186 breasts, respectively. Age and body mass index were similar between groups. Across all meta-analyses, there were no differences in complication rates between RTU and FD: cellulitis (RR = 0.863; 95% CI, 0.272-2.740), seroma (RR = 0.553; 95% CI, 0.026-11.830), and explantation (RR = 0.593; 95% CI, 0.247-1.425). Results remained nonsignificant even after adjustment for variable follow-up time. CONCLUSION: The results suggest that there are no differences in complication rates between RTU and FD forms.

Cost-Utility Analysis: Sartorius Flap versus Negative Pressure Therapy for Infected Vascular Groin Graft Managment.

BACKGROUND: Sartorius flap coverage and adjunctive negative pressure wound therapy (NPWT) have been described in managing infected vascular groin grafts with varying cost and clinical success. We performed a cost-utility analysis comparing sartorius flap with NPWT in managing an infected vascular groin graft. METHODS: A literature review compiling outcomes for sartorius flap and NPWT interventions was conducted from peer-reviewed journals in MEDLINE (PubMed) and EMBASE. Utility scores were derived from expert opinion and used to estimate quality-adjusted life years (QALYs). Medicare current procedure terminology and diagnosis-related groups codes were used to assess the costs for successful graft salvage with the associated complications. Incremental cost-effectiveness was assessed at $50,000/QALY, and both univariate and probabilistic sensitivity analyses were conducted to assess robustness of the conclusions. RESULTS: Thirty-two studies were used pooling 384 patients (234 sartorius flaps and 150 NPWT). NPWT had better clinical outcomes (86.7% success rate, 0.9% minor complication rate, and 13.3% major complication rate) than sartorius flap (81.6% success rate, 8.0% minor complication rate, and 18.4% major complication rate). NPWT was less costly ($12,366 versus $23,516) and slightly more effective (12.06 QALY versus 12.05 QALY) compared with sartorius flap. Sensitivity analyses confirmed the robustness of the base case findings; NPWT was either cost-effective at $50,000/QALY or dominated sartorius flap in 81.6% of all probabilistic sensitivity analyses. CONCLUSION: In our cost-utility analysis, use of adjunctive NPWT, along with debridement and antibiotic treatment, for managing infected vascular groin graft wounds was found to be a more cost-effective option when compared with sartorius flaps.

Influence of patient perceptions and preferences for osteoporosis medication on adherence behavior in the Denosumab Adherence Preference Satisfaction study.

OBJECTIVE: This study aims to evaluate patient perceptions of subcutaneous denosumab or oral alendronate in postmenopausal women with or at risk for osteoporosis and how these perceptions influence adherence. METHODS: Postmenopausal women with low bone mass were randomized to denosumab 60 mg every 6 months for 1 year (treatment period 1 [TP1]) followed by alendronate 70 mg once weekly for 1 year (treatment period 2 [TP2]), or vice versa. Beliefs about Medicines Questionnaire data were collected at baseline and at 6, 12, 18, and 24 months; a necessity-concerns differential (NCD) was calculated for each time point. Logistic regression analyses were performed to evaluate the influences of baseline characteristics on nonadherence. RESULTS: Participants included 250 women (alendronate/denosumab, n = 124; denosumab/alendronate, n = 126). During TP1, the NCD at month 6 was higher with denosumab than with alendronate (P = 0.0076). In TP2, the NCD was higher for women switched to denosumab than for women switched to alendronate at 6 months (P = 0.0126) and 12 months (P = 0.4605). Denosumab was preferred to alendronate regardless of treatment sequence (P < 0.0001). Covariate analysis revealed that higher TP2 baseline necessity scores were associated with lower odds of nonadherence (P = 0.0055), whereas higher concerns about medication scores were associated with higher odds of nonadherence (P = 0.0247). Higher NCD scores were also associated with lower odds of nonadherence (P = 0.0015). CONCLUSIONS: Participants preferred denosumab to alendronate while on treatment and had more positive perceptions of denosumab than alendronate. These perceptions were associated with better adherence.

Prevalence of Fracture Risk Factors in Postmenopausal Women Enrolled in the POSSIBLE US Treatment Cohort.

Subject- and physician-reported data from 4,429 postmenopausal women receiving osteoporosis treatment in the Prospective Observational Scientific Study Investigating Bone Loss Experience (POSSIBLE US) were used to assess the prevalence of risk factors (RFs) and on-study fracture. RFs assessed at study entry were age >70 years; fracture since age 50; minimum T-score (hip/spine) ≤-2.5 at diagnosis; body mass index <18.5 kg/m(2); rheumatoid arthritis; parental history of hip fracture; current smoking; and recent oral glucocorticoid use. Data were collected with semiannual self-administered questionnaires. Results were stratified by physician-reported osteoporosis/osteopenia diagnosis. Low T-score and age >70 years were the most common RFs in the osteoporosis group, and age >70 years and prior fracture were the most common risk factors in the osteopenia group. Multiple RFs were more common than a single RF in osteoporotic women (54.2% versus 34.6%; P < 0.0001) but not osteopenic women (13.8% versus 33.6%; P < 0.0001). Women with multiple RFs had more on-study osteoporosis-related fractures than women with a single RF (osteoporosis group: 9.9% versus 6.2%; P = 0.0092; osteopenia group: 11.2% versus 4.7%; P < 0.0001). In postmenopausal women receiving osteoporosis treatment, multiple RFs increased fracture risk. RFs, in addition to bone mineral density, can help identify candidates for osteoporosis treatment.

The relationship between joint damage and functional disability in rheumatoid arthritis: a systematic review.

OBJECTIVE: To summarise the relationship between joint damage and functional disability in rheumatoid arthritis (RA) patients. METHODS: A systematic review of the literature from 1990 to 2008 was conducted using MEDLINE and EMBASE databases. The search strategy focused on RA, joint damage and disability. Only longitudinal studies or randomised clinical trials with 1 year or more of follow-up containing data correlating joint damage and disability were included. The comparisons were categorised in four ways: baseline damage versus disability at end of follow-up (correlation A); damage versus disability measured cross-sectionally at each of several time points (correlation B); changes in damage versus final disability (correlation C) and changes in damage versus changes in disability (correlation D). RESULTS: From a total of 1902 abstracts, 42 studies met the inclusion/exclusion criteria. More than 50% of the studies that measured baseline damage to later disability (A) reported a statistically significant association. Correlation was significant when measured at multiple time points over time (B; 16/19 studies). Statistically significant associations between changes in damage and either disability at end of follow-up or changes in disability were also found (C and D; 11/13 studies). CONCLUSIONS: While many of the studies did not include multivariate analysis with confounder adjustment, the published evidence indicates a link between joint damage and functional disability and that an increase in joint damage is associated with an increase in disability over time. Treatments to limit progressive joint damage may lead to better joint function and improved patient outcome with less disability.

Development, reliability, and validity of a new Preference and Satisfaction Questionnaire.

OBJECTIVES: Existing questionnaires that assess preference and/or satisfaction with postmenopausal bone loss treatments were reviewed and determined to be inadequate for the assessment of an oral pill versus a subcutaneous injection. The Preference and Satisfaction Questionnaire (PSQ) was developed to assess preference, satisfaction, and bother with a weekly oral tablet versus a once every 6 months subcutaneous injection for treatment of postmenopausal bone loss. METHODS: Questions were developed based on literature review and expert input. Content validity of the PSQ in this patient population was assessed among current or previous bisphosphonate users in group interviews, and item comprehension and readability were also evaluated. Reliability, validity, and structure of the questionnaire were assessed in two phase 3 randomized clinical trials. RESULTS: Twenty-four women participated in cognitive interviews and found the PSQ understandable and acceptable. Subsequently, 1583 trial participants took the PSQ. Interitem correlations, ranging from 0.50 to 0.97 for preference items, 0.85 to 0.94 for pill-satisfaction items, and 0.84 to 0.92 for injection-satisfaction items, and a well-fitting confirmatory factor analysis (root mean square error of approximation 0.04, nonnormed fit index 0.99, and root mean square residual 0.08) supported the structure of the instrument. Cronbach's alpha reliability values for pill satisfaction, injection satisfaction, pill bother, and injection bother were 0.93, 0.89, 0.82, and 0.61, respectively. Discriminative validity was indicated with better satisfaction and bother scores being related to adherence and the absence of adverse events. CONCLUSIONS: The PSQ is a valid and reliable measure and may be a valuable tool to assess patient preference and satisfaction with a weekly oral tablet and 6-month subcutaneous injection for postmenopausal bone loss.

Impact of medication adherence on health care utilization and productivity: self-reported data from a cohort of postmenopausal women on osteoporosis therapy.

BACKGROUND: Many pharmacologic agents are approved for the prevention and treatment of osteoporosis, which is common among postmenopausal women. Evidence exists relating treatment persistence to fracture risk. Less is known about treatment persistence and the use of health care service and individual productivity. OBJECTIVE: This study was undertaken to describe health care use and productivity loss relative to osteoporosis medication persistence using women's self-reported data from the Prospective Observational Scientific Study Investigating Bone Loss Experience (POSSIBLE US™), a large, longitudinal (October 2004-December 2009) osteoporosis cohort study of postmenopausal women. METHODS: Analyses included women on pharmacologic osteoporosis therapy (alendronate, risedronate, ibandronate, calcitonin, raloxifene, or teriparatide) who provided health care use/productivity data collected using semiannual questionnaires over 1 year of follow-up. Participant characteristics, use, and productivity metrics were summarized. Logistic regression models and generalized linear models were used to examine use, time missed from usual activities, number of days spent in bed, and lost work time relative to treatment persistence, adjusting for potential confounders. RESULTS: At entry, of the 2528 women studied (91% white, 3.1% Hispanic/Latino, 2.3% African American/black, 1.1% Asian, and 2.1% American Indian/Native Alaskan, Native Hawaiian/Pacific Islander, or other; mean age, 64.6 [range, 37-97] years), 43.1% had osteoporosis and 23.4% had a previous fracture. After adjustment, subjects who switched therapies during follow-up were more likely to have had any kind of diagnostic testing (95.2% of switchers vs 91.2% of persistent subjects and 88.9% of discontinuers, P < 0.05). Discontinuers were less likely than persistent subjects to visit their primary care physicians (92.0% vs 94.4%, P = 0.0337). Variations in the number of days spent in bed, time missed from usual activities, and work loss (n = 852 employed subjects) by treatment persistence were not significant. CONCLUSIONS: Use of diagnostic testing differed significantly by osteoporosis treatment status. Compared with women who persisted with treatment, primary care provider visits were less common among those who discontinued treatment. Treatment persistence was not associated with significant differences in productivity measures.

The association of adherence to osteoporosis therapies with fracture, all-cause medical costs, and all-cause hospitalizations: a retrospective claims analysis of female health plan enrollees with osteoporosis.

BACKGROUND: Osteoporosis affects approximately 10 million people in the United States and is associated with increased fracture risk and fracture-related costs. Poor adherence to osteoporosis medications is associated with higher general burden of illness compared with optimal adherence. OBJECTIVE: To examine the associations of adherence to osteoporosis therapies with (a) occurrence of closed fracture, (b) all-cause medical costs, and (c) all-cause hospitalizations. METHODS: This retrospective analysis of administrative claims data examined women with osteoporosis initiating therapy with alendronate, risedronate, ibandronate, or raloxifene from July 1, 2002, to March 10, 2006. Data were from a large, geographically diverse U.S. health plan that covered about 12.6 million females during the identification period. Commercially insured and Medicare Advantage plan enrollees were observed for 1 year before (baseline period) and 540 days after therapy initiation (follow-up period). Outcomes included closed fractures, all-cause medical costs, and all-cause hospitalizations; all outcomes were measured starting 180 days after therapy initiation through follow-up. All subjects had at least 2 pharmacy claims for any of the targeted osteoporosis medications. Adherence was measured with a medication possession ratio (MPR) and accounted for all osteoporosis treatment. High adherence was MPR of at least 0.80; low adherence was MPR less than 0.50. Covariates included baseline fracture, "early" fracture (in the first 180 days of follow-up), baseline corticosteroid or thyroid hormone use, health status indicators, and demographic characteristics. Outcome fractures were modeled with Cox survival regression with time-dependent cumulative MPR. All-cause medical costs and all-cause hospitalizations were modeled, respectively, with generalized linear model regression (gamma distribution, log link) and negative binomial regression. RESULTS: The sample comprised 21,655 patients--16,295 (75.2%) commercial and 5,360 (24.8%) Medicare Advantage. During the entire follow-up period, 5,406 (33.2%) and 2,253 (42.0%) of commercial and Medicare Advantage patients, respectively, had low adherence. Adherence tended to decrease over the follow-up period. The Cox regression showed that commercial plan patients with low versus high adherence had 37% higher risk of fracture (hazard ratio = 1.37, 95% CI = 1.12-1.68). Adherence was not significantly associated with fracture in the Medicare Advantage cohort. Commercial and Medicare Advantage patients with low versus high adherence had 12% (exponentiated coefficient = 1.12, 95% CI = 1.02-1.24) and 18% (exponentiated coefficient = 1.18, 95% CI = 1.04-1.35) higher all-cause medical costs during months 7 through 18 of follow-up. Commercial and Medicare Advantage patients with low versus high adherence had 59% (incidence rate ratio [IRR] = 1.59, 95% CI = 1.38-1.83) and 34% (IRR = 1.34, 95% CI = 1.13-1.58) more all-cause hospitalizations during months 7 through 18 of follow-up, respectively. CONCLUSIONS: Low adherence to osteoporosis pharmacotherapy was associated with higher risk of fracture for commercially insured but not Medicare Advantage patients and with higher all-cause medical costs and more all-cause hospitalizations in both groups. These results are consistent with the literature and highlight the importance of promoting better adherence among patients with osteoporosis.

Health care cost associated with prostate cancer, androgen deprivation therapy and bone complications.

PURPOSE: We ascertained the health care costs of androgen deprivation therapy and related skeletal events. MATERIALS AND METHODS: Using data from the MarketScan Medicare Supplemental and Coordination of Benefits Database, we identified cases with International Classification of Disease, 9th Revision codes indicating a diagnosis of prostate cancer who initiated androgen deprivation therapy between 1999 and 2002. The control group consisted of patients with prostate cancer with no androgen deprivation therapy use, matched by age, geographic region, insurance plan and index year. All had followup data for at least 36 months. The occurrence and cost of osteoporosis and any bone fracture were assessed using a propensity score matched sample. RESULTS: Of the 8,577 eligible men with prostate cancer, 3,055 initiated androgen deprivation therapy and 5,522 did not. At the time of androgen deprivation therapy initiation those on androgen deprivation therapy had more severe comorbidity (3.1 vs 2.6, p <0.001) and proportionally more bone metastases (2.8% vs less than 0.6%, p <0.001) but no difference in fracture rate. After 3 years of followup the androgen deprivation therapy group experienced significantly more fractures (18.7% vs 14.6%, p <0.001). The mean unadjusted total cost of health care during the 36-month period was $48,350 per person for cases and $26,097 for controls. CONCLUSIONS: Among men with prostate cancer, those on androgen deprivation therapy cost the health care system almost twice as much as those not on androgen deprivation therapy. After controlling for differences in health status, the majority of the excess cost is attributable to androgen deprivation therapy and then to a lesser extent, the fractures. These results suggest that the bone complications of osteoporosis and fractures in men on androgen deprivation therapy have important economic consequences.

Costs associated with erythropoiesis-stimulating agent administration to hemodialysis patients.

BACKGROUND: Treatment of anemia in hemodialysis patients usually requires the use of expensive erythropoietic proteins. Cost analyses usually focus on drug acquisition costs. Other costs associated with anemia therapy include resources for anemia monitoring as well as preparation and administration of an erythropoiesis-stimulating agent. METHODS: The nonacquisition costs associated with subcutaneous administration of epoetin alfa were determined in a Canadian hemodialysis unit. A time-and-motion technique was used to determine the nursing time for preparation and administration. Fixed anemia costs were inventory control, monitoring, blood sampling, and laboratory analysis. Variable costs were those which varied with dosing frequency. The costs are expressed in Canadian dollars (2005). RESULTS: The mean time associated with preparation and administration was 3.2 min/injection. The annual nonacquisition per patient cost was CAD 2,290.04. Fixed costs were CAD 1,946.01, while the variable costs were CAD 344.03/year. Sensitivity analysis showed a decrease in cost to CAD 1,611.34, if iron monitoring were decreased from monthly to 3 monthly, and to CAD 2,090.66, if patients were converted to less frequent dosing using darbepoetin alfa. CONCLUSIONS: The nonacquisition costs associated with anemia therapy in hemodialysis patients are considerable. Less frequent monitoring of iron therapy and less frequent dosing could decrease costs by CAD 678.40 and CAD 199.38/patient/year, respectively.