Cost-effectiveness of laparoscopic disease assessment in patients with newly diagnosed advanced ovarian cancer.

OBJECTIVE: To determine if laparoscopy is a cost-effective way to assess disease resectability in patients with newly diagnosed advanced ovarian cancer. METHODS: A cost-effectiveness analysis from a health care payer perspective was performed comparing two strategies: (1) a standard evaluation strategy, where a conventional approach to treatment planning was used to assign patients to either primary cytoreduction (PCS) or neoadjuvant chemotherapy with interval cytoreduction (NACT), and (2) a laparoscopy strategy, where patients considered candidates for PCS would undergo laparoscopy to triage between PCS or NACT based on the laparoscopy-predicted likelihood of complete gross resection. A microsimulation model was developed that included diagnostic work-up, surgical and adjuvant treatment, perioperative complications, and progression-free survival (PFS). Model parameters were derived from the literature and our published data. Effectiveness was defined in quality-adjusted PFS years. Results were tested with deterministic and probabilistic sensitivity analysis (PSA). The willingness-to-pay (WTP) threshold was set at $50,000 per year of quality-adjusted PFS. RESULTS: The laparoscopy strategy led to additional costs (average additional cost $7034) but was also more effective (average 4.1 months of additional quality-adjusted PFS). The incremental cost-effectiveness ratio (ICER) of laparoscopy was $20,376 per additional year of quality-adjusted PFS. The laparoscopy strategy remained cost-effective even as the cost added by laparoscopy increased. The benefit of laparoscopy was influenced by mitigation of serious complications and their associated costs. The laparoscopy strategy was cost-effective across a range of WTP thresholds. CONCLUSIONS: Performing laparoscopy is a cost-effective way to improve primary treatment planning for patients with untreated advanced ovarian cancer.

Usefulness of surveillance imaging in patients with head and neck cancer who are treated with definitive radiotherapy.

BACKGROUND: The current study was performed to assess the efficacy of surveillance imaging in patients with head and neck cancer (HNC) who are treated definitively with radiotherapy. METHODS: Eligible patients included those with a demonstrable disease-free interval (≥1 follow-up imaging procedure without evidence of disease and a subsequent visit/imaging procedure) who underwent treatment of HNC from 2000 through 2010. RESULTS: A total of 1508 patients were included. The median overall survival was 99 months, with a median imaging follow-up period of 59 months. Of the 1508 patients, 190 patients (12.6%) experienced disease recurrence (107 patients had locoregional and 83 had distant disease recurrence). A total of 119 patients (62.6%) in the group with disease recurrence were symptomatic and/or had an adverse clinical finding associated with the recurrence. Approximately 80% of patients with locoregional disease recurrences presented with a clinical finding, whereas 60% of distant disease recurrences were detected by imaging in asymptomatic patients. Despite the earlier detection of disease recurrence via imaging, those patients in the group of patients with clinically detected disease recurrence were significantly more likely to undergo salvage therapy compared with those whose recurrence was detected on imaging (odds ratio, 0.35). There was no difference in overall survival noted between those patients with disease recurrences that were detected clinically or with imaging alone. Approximately 70% of disease recurrences occurred within the first 2 years. In those patients who developed disease recurrence after 2 years, the median time to recurrence was 51 months. After 2 years, the average number of imaging procedures per patient for the detection of a salvageable recurrence for the imaging-detected group was 1539. CONCLUSIONS: Surveillance imaging in asymptomatic patients with HNC who are treated definitively with radiotherapy without clinically suspicious findings beyond 2 years has a low yield and a high cost. Physicians ordering these studies must use judicious consideration and discretion.

Cost-effectiveness analysis of smoking cessation interventions using cell phones in a low-income population.

BACKGROUND: The prevalence of cigarette smoking is significantly higher among those living at or below the federal poverty level. Cell phone-based interventions among such populations have the potential to reduce smoking rates and be cost-effective. METHODS: We performed a cost-effectiveness analysis of three smoking cessation interventions: Standard Care (SC) (brief advice to quit, nicotine replacement therapy and self-help written materials), Enhanced Care (EC) (SC plus cell phone-delivered messaging) and Intensive Care (IC) (EC plus cell phone-delivered counselling). Quit rates were obtained from Project ACTION (Adult smoking Cessation Treatment through Innovative Outreach to Neighborhoods). We evaluated shorter-term outcomes of cost per quit and long-term outcomes using cost per quality-adjusted life year (QALY). RESULTS: For men, EC cost an additional $541 per quit vs SC; however, IC cost an additional $5232 per quit vs EC. For women, EC was weakly dominated by IC-IC cost an additional $1092 per quit vs SC. Similarly, for men, EC had incremental cost-effectiveness ratio (ICER) of $426 per QALY gained vs SC; however, IC resulted in ICER of $4127 per QALY gained vs EC. For women, EC was weakly dominated; the ICER of IC vs SC was $1251 per QALY gained. The ICER was below maximum acceptable willingness-to-pay threshold of $50 000 per QALY under all alternative modelling assumptions. DISCUSSION: Cell phone interventions for low socioeconomic groups are a cost-effective use of healthcare resources. Intensive Care was the most cost-effective strategy both for men and women. TRIAL REGISTRATION NUMBER: NCT00948129; Results.

Potentially inappropriate medication use in older patients with breast and colorectal cancer.

BACKGROUND: The objective of this study was to determine patient characteristics associated with potentially inappropriate medication (PIM) use and its impact on outcomes for patients with breast or colorectal cancer receiving adjuvant chemotherapy. METHODS: The Surveillance, Epidemiology, and End Results database, linked to Medicare claims, was used. The cohort included patients who were 66 years old or older and were diagnosed with stage II or III breast or colorectal cancer between July 1, 2007, and December 31, 2009. The Drugs to Avoid in the Elderly (DAE) list and the Beers criteria were used to identify PIM use. Univariate/multivariate logistic regression determined the association of baseline PIMs with covariates. Event-free survival (EFS) was defined as the time from chemotherapy initiation to the first emergency room (ER) visit, hospitalization, death, or a composite until 3 months after chemotherapy. Cox proportional hazards modeling determined the association of PIMs with EFS. RESULTS: The analysis included 1595 patients with breast cancer and 1528 patients with colorectal cancer. The baseline PIM frequencies were 22.2% (according to the DAE list) and 27.6% (according to the Beers criteria) in the breast cohort and 15.5% (according to the DAE list) and 24.8% (according to the Beers criteria) in the colorectal cohort. Among patients with breast cancer, 37.5% had at least 1 adverse outcome; associations included the use of ≥5 medications, an advanced stage, higher comorbidity, and prior ER visits/hospitalizations. Baseline PIM use according to the DAE list was associated with an increased risk of death in patients with breast cancer. Among patients with colorectal cancer, 45% had at least 1 adverse outcome, and associations included the use of ≥5 medications, older age, female sex, and higher comorbidity. A time-to-event analysis revealed no association between baseline PIM use and most outcomes. CONCLUSIONS: These findings require further prospective confirmation, but they support a correlation between polypharmacy and adverse outcomes for cancer patients and call into question the association with PIMs. Cancer 2018;124:3000-7. © 2018 American Cancer Society.

Management of precancerous anal intraepithelial lesions in human immunodeficiency virus-positive men who have sex with men: Clinical effectiveness and cost-effectiveness.

BACKGROUND: Human immunodeficiency virus (HIV)-positive men who have sex with men (MSM) are at disproportionately high risk for anal cancer. There is no definitive approach to the management of high-grade squamous intraepithelial lesions (HSIL), which are precursors of anal cancer, and evidence suggests that posttreatment adjuvant quadrivalent human papillomavirus (qHPV) vaccination improves HSIL treatment effectiveness. The objectives of this study were to evaluate the optimal HSIL management strategy with respect to clinical effectiveness and cost-effectiveness and to identify the optimal age for initiating HSIL management. METHODS: A decision analytic model of the natural history of anal carcinoma and HSIL management strategies was constructed for HIV-positive MSM who were 27 years old or older. The model was informed by the Surveillance, Epidemiology, and End Results-Medicare database and published studies. Outcomes included the lifetime cost, life expectancy, quality-adjusted life expectancy, cumulative risk of cancer and cancer-related deaths, and cost-effectiveness from a societal perspective. RESULTS: Active monitoring was the most effective approach in patients 29 years or younger; thereafter, HSIL treatment plus adjuvant qHPV vaccination became most effective. When cost-effectiveness was considered (ie, an incremental cost-effectiveness ratio [ICER] < $100,000/quality-adjusted life-year), do nothing was cost-effective until the age of 38 years, and HSIL treatment plus adjuvant qHPV vaccination was cost-effective beyond the age of 38 years (95% confidence interval, 34-43 years). The ICER decreased as the age at HSIL management increased. Outcomes were sensitive to the rate of HSIL regression or progression and the cost of high-resolution anoscopy and biopsy. CONCLUSIONS: The management of HSIL in HIV-positive MSM who are 38 years old or older with treatment plus adjuvant qHPV vaccination is likely to be cost-effective. The conservative approach of no treatment is likely to be cost-effective in younger patients. Cancer 2017;123:4709-4719. © 2017 American Cancer Society.

Impact of the timing of hepatitis B virus identification and anti-hepatitis B virus therapy initiation on the risk of adverse liver outcomes for patients receiving cancer therapy.

BACKGROUND: Data on the incidence of adverse liver outcomes are limited for cancer patients with chronic (hepatitis B surface antigen [HBsAg]-positive/hepatitis B core antibody [anti-HBc]-positive) or past (HBsAg-negative/anti-HBc-positive) hepatitis B virus (HBV) after chemotherapy. This study was aimed at determining the impact of test timing and anti-HBV therapy on adverse liver outcomes in these patients. METHODS: Patients with solid or hematologic malignancies who received chemotherapy between 2004 and 2011 were retrospectively studied. HBV testing and anti-HBV therapy were defined as early at the initiation of cancer therapy and as late after initiation. Outcomes included hepatitis flares, hepatic impairment, liver failure, and death. Time-to-event analysis was used to determine incidence, and multivariate hazard models were used to determine predictors of outcomes. RESULTS: There were 18,688 study patients (80.4% with solid tumors). The prevalence of chronic HBV was 1.1% (52 of 4905), and the prevalence of past HBV was 7.1% (350 of 4905). Among patients with solid tumors, late identification of chronic HBV was associated with a higher risk of hepatitis flare (hazard ratio [HR], 4.02; 95% confidence interval [CI], 1.26-12.86), hepatic impairment (HR, 8.48; 95% CI, 1.86-38.66), liver failure (HR, 9.38; 95% CI, 1.50-58.86), and death (HR, 3.90; 95% CI, 1.19-12.83) in comparison with early identification. Among patients with hematologic malignancies and chronic HBV, the risk of death was 7.8 (95% CI, 1.73-35.27) times higher for persons with late initiation of anti-HBV therapy versus early initiation. Patients with late identification of chronic HBV had late or no anti-HBV therapy. Chronic HBV predicted liver failure in patients with solid or hematologic malignancies, whereas male sex and late identification were predictors for patients with solid tumors. CONCLUSIONS: Early identification correlates with early anti-HBV therapy and reduces the risk of liver failure and death in chronic HBV patients receiving chemotherapy. Cancer 2017;123:3367-76. © 2017 American Cancer Society.

Outcomes of contralateral prophylactic mastectomy in relation to familial history: a decision analysis (BRCR-D-16-00033).

BACKGROUND: Family history of breast cancer is associated with an increased risk of contralateral breast cancer (CBC) even in the absence of mutations in the breast cancer susceptibility genes BRCA1/2. We compared quality-adjusted survival after contralateral prophylactic mastectomy (CPM) with surveillance only (no CPM) among women with breast cancer incorporating the degree of family history. METHODS: We created a microsimulation model for women with first-degree, second-degree, and no family history treated for a stage I, II, or III estrogen receptor (ER)-positive or ER-negative breast cancer at the ages of 40, 50, 60, and 70. The model incorporated a 10-year posttreatment period for risk of developing CBC and/or dying of the primary cancer or CBC. For each patient profile, we used 100,000 microsimulation trials to estimate quality-adjusted life expectancy for the clinical strategies CPM and no CPM. RESULTS: CPM showed minimal improvement on quality-adjusted life expectancy among women age 50-60 with no or a unilateral first-degree or second-degree family history (decreasing from 0.31 to -0.06 quality-adjusted life-years (QALYs)) and was unfavorable for most subgroups of women age 70 with stage III breast cancer regardless of degree of family history (range -0.08 to -0.02 QALYs). Sensitivity analysis showed that the highest predicted benefit of CPM assuming 95 % risk reduction in CBC was 0.57 QALYs for a 40-year-old woman with stage I breast cancer who had a first-degree relative with bilateral breast cancer. CONCLUSIONS: Women age 40 with stage I breast cancer and a first-degree relative with bilateral breast cancer have a QALY benefit from CPM similar to that reported for BRCA1/2 mutation carriers. For most subgroups of women, CPM has a minimal to no effect on quality-adjusted life expectancy, irrespective of family history of breast cancer.

Prospective Study of Surgical Decision-making Processes for Contralateral Prophylactic Mastectomy in Women With Breast Cancer.

OBJECTIVE: We prospectively examined the psychosocial predictors and the decision-making process regarding contralateral prophylactic mastectomy (CPM) among women with sporadic breast cancer. BACKGROUND: Increasing numbers of women with breast cancer are seeking CPM. Data are limited about the surgical decision-making process and the psychosocial factors that influence interest in CPM. METHODS: Women with early-stage unilateral breast cancer (n = 117) were recruited before their first surgical visit at MD Anderson and completed questionnaires assessing knowledge of and interest in CPM and associated psychosocial factors. After the appointment, women and their surgeons completed questions about the extent that various surgical options (including CPM) were discussed; also, the women rated their perceived likelihood of having CPM and the surgeons rated the appropriateness of CPM. RESULTS: Before their first visit, 50% of women were moderately to extremely interested in CPM and 12 (10%) of women had CPM at the time of their primary breast cancer surgery. Less knowledge about breast cancer (P = 0.02) and greater cancer worry (P = 0.03) predicted interest in CPM. Greater cancer worry predicted who had CPM (P = 0.02). Interest in CPM before surgical visit and the likelihood of having CPM after the visit differed (P ≤ 0.001). Surgeons' rating of the appropriateness of CPM and the patient's reported likelihood of having CPM were not significantly different (P = 0.49). CONCLUSIONS: Interest in CPM is common among women with sporadic breast cancer. The informational and emotional aspects of CPM may affect the decision to have CPM and should be addressed when discussing surgical options.

Long-Term Outcomes of Adding HPV Vaccine to the Anal Intraepithelial Neoplasia Treatment Regimen in HIV-Positive Men Who Have Sex With Men.

BACKGROUND: Recent evidence shows that quadrivalent human papillomavirus (qHPV) vaccination in men who have sex with men (MSM) who have a history of high-grade anal intraepithelial neoplasia (HGAIN) was associated with a 50% reduction in the risk of recurrent HGAIN. We evaluated the long-term clinical and economic outcomes of adding the qHPV vaccine to the treatment regimen for HGAIN in human immunodeficiency virus (HIV)-positive MSM aged ≥27 years. METHODS: We constructed a Markov model based on anal histology in HIV-positive MSM comparing qHPV vaccination with no vaccination after treatment for HGAIN, the current practice. The model parameters, including baseline prevalence, disease transitions, costs, and utilities, were either obtained from the literature or calibrated using a natural history model of anal carcinogenesis. The model outputs included lifetime costs, quality-adjusted life years, and lifetime risk of developing anal cancer. We estimated the incremental cost-effectiveness ratio of qHPV vaccination compared to no qHPV vaccination and decrease in lifetime risk of anal cancer. We also conducted deterministic and probabilistic sensitivity analyses to evaluate the robustness of the results. RESULTS: Use of qHPV vaccination after treatment for HGAIN decreased the lifetime risk of anal cancer by 63% compared with no vaccination. The qHPV vaccination strategy was cost saving; it decreased lifetime costs by $419 and increased quality-adjusted life years by 0.16. Results were robust to the sensitivity analysis. CONCLUSIONS: Vaccinating HIV-positive MSM aged ≥27 years with qHPV vaccine after treatment for HGAIN is a cost-saving strategy. Therefore, expansion of current vaccination guidelines to include this population should be a high priority.

A framework for evaluating the cost-effectiveness of patient decision aids: A case study using colorectal cancer screening.

OBJECTIVE: Patient decision aids are important tools for facilitating balanced, evidence-based decision making. However, the potential of decision aids to lower health care utilization and costs is uncertain; few studies have investigated the cost-effectiveness of decision aids that change patient behavior. Using an example of a decision aid for colorectal cancer screening, we provide a framework for analyzing the cost-effectiveness of decision aids. METHODS: A decision-analytic model with two strategies (decision aid or no decision aid) was used to calculate expected costs in U.S. dollars and benefits measured in life-years saved (LYS). Data from a systematic review of ten studies about decision aid effectiveness was used to calculate the percentage increase in the number of people choosing screening instead of no screening. We then calculated the incremental cost per LYS with the use of the decision aid. RESULTS: The no decision aid strategy had an expected cost of $3023 and yielded 18.19 LYS. The decision aid strategy cost $3249 and yielded 18.20 LYS. The incremental cost-effectiveness ratio for the decision aid strategy was $36,126 per LYS. Results were sensitive to the cost of the decision aid and the percentage change in behavior caused by the decision aid. CONCLUSIONS: This study provides proof-of-concept evidence for future studies examining the cost-effectiveness of decision aids. The results suggest that decision aids can be beneficial and cost-effective.

Use of forecasted assessment of quality of life to validate time-trade-off utilities and a prostate cancer screening decision-analytic model.

PURPOSE: To determine whether the forecasted assessment of how someone would feel in a future health state can be predictive of utilities (e.g. as elicited by the time-trade-off method) and also predictive of optimal decisions as determined by a decision-analytic model. METHODS: We elicited time-trade-off utilities for prostate cancer treatment outcomes from 168 men. We also elicited forecasted assessments, that is, an informal, non-quantitative, descriptive evaluation, of impotence and incontinence from these men. We used multivariate regression analysis to explore the relationship between forecasted assessment and reluctance to trade length for improved quality of life, that is, the unwillingness to trade length of life for improved quality of life in the time-trade-off utility assessment and the relationship between the forecasted assessments and the optimal decision of whether to undergo screening for prostate cancer as determined from a previously published decision-analytic model. RESULTS: Importance of sexual function was strongly related to impotence utilities (P < 0.05). Based on the multivariate analysis, significant predictors for the utility of severe incontinence were family income, family history of prostate cancer, work status and attitude towards needing to wear an incontinence pad. However, no variables were statistically significant predictors for the utility of complete impotence. The importance of sexual functioning was a significant predictor of the optimal decision. CONCLUSION: Anticipated difficulty adjusting to adverse health effects were highly related to preferences and could be used as a proxy measure of utility. Similarly, the importance of sexual functioning, a future preference, was highly related to the optimal decision, which validates our previously published decision-analytic model.

Treatment decisions for localized prostate cancer: a concept mapping approach.

OBJECTIVE: Few decision aids emphasize active surveillance (AS) for localized prostate cancer. Concept mapping was used to produce a conceptual framework incorporating AS and treatment. METHODS: Fifty-four statements about what men need to make a decision for localized prostate cancer were derived from focus groups with African American, Latino and white men previously screened for prostate cancer and partners (n = 80). In the second phase, 89 participants sorted and rated the importance of statements. RESULTS: An eight cluster map was produced for the overall sample. Clusters were labelled Doctor-patient exchange, Big picture comparisons, Weighing the options, Seeking and using information, Spirituality and inner strength, Related to active treatment, Side-effects and Family concerns. A major division was between medical and home-based clusters. Ethnic groups and genders had similar sorting, but some variation in importance. Latinos rated Big picture comparisons as less important. African Americans saw Spirituality and inner strength most important, followed by Latinos, then whites. Ethnic- and gender-specific concept maps were not analysed because of high similarity in their sorting patterns. CONCLUSIONS: We identified a conceptual framework for management of early-stage prostate cancer that included coverage of AS. Eliciting the conceptual framework is an important step in constructing decision aids which will address gaps related to AS.

Designing Normative Messages About Active Surveillance for Men With Localized Prostate Cancer.

Active surveillance is increasingly recognized as a reasonable option for men with low-risk, localized prostate cancer, yet few men who might benefit from conservative management receive it. The authors examined the acceptability of normative messages about active surveillance as a management option for patients with low-risk prostate cancer. Men with a diagnosis of localized prostate cancer who were recruited through prostate cancer support organizations completed a web-based survey (N = 331). They rated messages about active surveillance for believability, accuracy, and importance for men to hear when making treatment decisions. The message "You don't have to panic … you have time to think about your options" was perceived as believable, accurate, and important by more than 80% of the survivors. In contrast, messages about trust in the active surveillance protocol and "knowing in plenty of time" if treatment is needed were rated as accurate by only about 36% of respondents. For active surveillance to be viewed as a reasonable alternative, men will need reassurance that following an active surveillance protocol is likely to allow time for curative treatment if the cancer progresses.

Postoperative chemotherapy use after neoadjuvant chemoradiotherapy for rectal cancer: Analysis of Surveillance, Epidemiology, and End Results-Medicare data, 1998-2007.

BACKGROUND: Neoadjuvant chemoradiotherapy followed by tumor resection and postoperative chemotherapy is the standard of care for patients with clinical stage II or III adenocarcinoma of the rectum. Significant variation exists in the receipt of postoperative chemotherapy after resection in this population. The objective of this study was to determine the demographic and clinicopathologic factors associated with the initiation of postoperative chemotherapy in elderly patients with rectal cancer and to identify potential targets for reducing treatment variation. METHODS: A retrospective cohort study was performed of patients with rectal cancer ages 66 to 80 years who received neoadjuvant chemoradiotherapy and underwent radical resection in the Surveillance, Epidemiology, and End Results-linked Medicare database (1998-2007). Multivariate logistic regression was used to assess chemotherapy use in relation to patient, tumor, and treatment response characteristics. RESULTS: Among 1492 patients who met the study criteria, 61.5% received adjuvant therapy with 5-fluorouracil. Pathologic stage was the strongest determinant of whether patients received postoperative chemotherapy (48.3% of patients with stage I disease, 59.6% of patients with stage II disease, and 77.6% of patients with stage III disease). Increasing age and postoperative readmission also were associated significantly with a decreased rate of adjuvant therapy initiation. CONCLUSIONS: Although standard treatment guidelines for locally advanced rectal cancer include postoperative chemotherapy for all patients after neoadjuvant chemoradiotherapy and radical resection, greater than 1 in 3 patients failed to receive adjuvant therapy. Despite the absence of established evidence, treatment decisions appear to be influenced by the findings at surgical pathology.

Cost of contralateral prophylactic mastectomy.

PURPOSE: To compare the healthcare costs of women with unilateral breast cancer who underwent contralateral prophylactic mastectomy (CPM) with those of women who did not. METHODS: We conducted a retrospective study of 904 women treated for stage I-III breast cancer with or without CPM. Women were matched according to age, year at diagnosis, stage, and receipt of chemotherapy. We included healthcare costs starting from the date of surgery to 24 months. We identified whether care was immediate or delayed (CPM within 6 months or 6-24 months after initial surgery, respectively). Costs were converted to approximate Medicare reimbursement values and adjusted for inflation. Multivariable regression analysis was performed to evaluate the effect of CPM on total breast cancer care costs adjusting for patient characteristics and accounting for matched pairs. RESULTS: The mean difference between the CPM and no-CPM matched groups was $3,573 (standard error [SE] $455) for professional costs, $4,176 (SE $1,724) for technical costs, and $7,749 (SE $2,069) for total costs. For immediate and delayed CPM, the mean difference for total costs was $6,528 (SE $2,243) and $16,744 (SE $5,017), respectively. In multivariable analysis, the CPM group had a statistically significant increase of 16.9 % in mean total costs compared with the no-CPM group (p < 0.0001). Human epidermal growth factor receptor 2/neu-positive status, receipt of radiation, and reconstruction were associated with increases in total costs. CONCLUSIONS: CPM significantly increases short-term healthcare costs for women with unilateral breast cancer. These patient-level cost results can be used for future studies that evaluate the influence of costs of CPM on decision making.

Impact of ileostomy-related complications on the multidisciplinary treatment of rectal cancer.

BACKGROUND: Radical resection is the primary treatment for rectal cancer. When anastomosis is possible, a temporary ileostomy is used to decrease morbidity from a poorly healed anastomosis. However, ileostomies are associated with complications, dehydration, and need for a second operation. We sought to evaluate the impact of ileostomy-related complications on the treatment of rectal cancer. METHODS: We conducted a retrospective study of patients who underwent sphincter-preserving surgery between January 2005 and December 2010 at a tertiary cancer center. The primary outcome was the overall rate of ileostomy-related complications. Secondary outcomes included complications related to ileostomy status, ileostomy closure, anastomotic complications at primary resection, rate of stoma closure, and completion of adjuvant chemotherapy assessed by multivariate logistic regression. RESULTS: Of 294 patients analyzed, 32% (n = 95) were women. Two hundred seventy-one (92%) received neoadjuvant chemoradiation. The median tumor distance from the anal verge was 7 cm (interquartile range 5-10 cm). Two hundred eighty-one (96%) underwent stoma closure at a median of 7 months (interquartile range 5.4-8.3 months). The most common complication related to readmission was dehydration (n = 32-11%). Readmission within 60 days of primary resection was associated with delay in initiating adjuvant chemotherapy (odds ratio 3.01, 95% confidence interval 1.42-6.38, p = 0.004). CONCLUSIONS: Diverting ileostomies created during surgical treatment of rectal cancers are associated with morbidity; however, this is balanced against the risk of anastomosis-related morbidity at rectal resection. Given the potential benefit of fecal diversion, patient-oriented interventions to improve ostomy management, particularly during adjuvant chemotherapy, can be expected to yield marked benefits.

'It's not like you just had a heart attack': decision-making about active surveillance by men with localized prostate cancer.

BACKGROUND: Growing recognition that active surveillance (AS) is a reasonable management option for many men diagnosed with localized prostate cancer led us to describe patients' conceptualizations of AS and reasons for their treatment decisions. METHODS: Men were patients of a multidisciplinary prostate cancer clinic at a large tertiary cancer center where patients are routinely briefed on treatment options, including AS. We conducted a thematic analysis of interviews with 15 men who had chosen AS and 15 men who received radiation or surgery. RESULTS: Men who chose AS described it as an organized process with a rigorous and reassuring protocol of periodic testing, with potential for subsequent and timely decision-making about treatment. AS was seen as prolonging their current good health and function with treatment still possible later. Rationales for choosing AS included trusting their physician's monitoring, 'buying time' without experiencing adverse effects of treatment, waiting for better treatments, and seeing their cancer as very low risk. Men recognized the need to justify their choice to others because it seemed contrary to the impulse to immediately treat cancer. Descriptions of AS by men who chose surgery or radiation were less specific about the testing regimen. Getting rid of the cancer and having a cure were paramount for them. CONCLUSIONS: Men fully informed of their treatment options for localized prostate cancer have a comprehensive understanding of the purpose of AS. Slowing the decision-making process may enhance the acceptability of AS.

Cost-effectiveness analysis of a low-cost bubble CPAP device in providing ventilatory support for neonates in Malawi - a preliminary report.

BACKGROUND: A low-cost bubble continuous positive airway pressure (bCPAP) device has been shown to be an excellent clinical alternative to nasal oxygen for the care of neonates with respiratory difficulty. However, the delivery of bCPAP requires more resources than the current routine care using nasal oxygen. We performed an economic evaluation to determine the cost-effectiveness of a low-cost bCPAP device in providing ventilatory support for neonates in Malawi. METHODS: We used patient-level clinical data from a previously published non-randomized controlled study. Economic data were based on the purchase price of supplies and equipment, adjusted for shelf life, as well as hospital cost data from the World Health Organization. Costs and benefits were discounted at 3%. The outcomes were measured in terms of cost, discounted life expectancy, cost/life year gained and net benefits of using bCPAP or nasal oxygen. The incremental cost-effectiveness ratio and incremental net benefits determined the value of one intervention compared to the other. Subgroup analysis on several parameters (birth weight categories, diagnosis of respiratory distress syndrome, and comorbidity of sepsis) was conducted to evaluate the effect of these parameters on the cost-effectiveness. RESULTS: Nasal oxygen therapy was less costly (US$29.29) than the low-cost bCPAP device ($57.78). Incremental effectiveness associated with bCPAP was 6.78 life years (LYs). In the base case analysis, the incremental cost-effectiveness ratio for bCPAP relative to nasal oxygen therapy was determined to be $4.20 (95% confidence interval, US$2.29-US$16.67) per LY gained. The results were highly sensitive for all tested subgroups, particularly for neonates with birth weight 1- < 1.5 kg, respiratory distress syndrome, or comorbidity of sepsis; these subgroups had a higher probability that bCPAP would be cost effective. CONCLUSION: The bCPAP is a highly cost-effective strategy in providing ventilatory support for neonates in Malawi.

Comparative effectiveness research in pediatric radiology.

Comparative effectiveness research is designed to help patients, physicians and policymakers choose the best medical option among alternative diagnostic and interventional strategies. In this commentary, we provide a brief overview of comparative effectiveness research, discuss some of the challenges to applying it in pediatric radiology, and give several reasons behind the continued push for more comparative effectiveness research by governmental and other funding agencies.