Patients' Preferences for Androgen Deprivation Therapy in the Treatment of Intermediate-Risk Prostate Cancer.

Background. For men with intermediate-risk prostate cancer (IRPC), adding short-term androgen deprivation therapy (ADT) to external beam radiation therapy (EBRT) has shown efficacy, but men are often reluctant to accept it because of its impact on quality of life. Methods. We conducted time tradeoffs (score of 1 = perfect health and 0 = death) and probability tradeoffs with patients aged 51 to 78 y who had received EBRT for IRPC within the past 2 y. Of 40 patients, 20 had received 6 mo of ADT and 20 had declined. Utility assessments explored 4 ADT-related side effects: hot flashes, fatigue, loss of libido/erectile dysfunction, and weight gain. Results. The most commonly reported "worst" treatment-related complication of ADT was fatigue (50% in both cohorts) followed by reduced libido/erectile dysfunction (40% in both cohorts). The utilities for fatigue were mean = 0.71 and median = 0.92 and for reduced libido/erectile dysfunction were mean = 0.81 and median = 0.92. Utilities did not differ significantly between cohorts. Assuming a 6-mo course of ADT, men reported being willing to trade 3 mo of life expectancy to avoid fatigue due to ADT and 1.8 mo to avoid sexual side effects. Patients in the ADT cohort were willing to accept the side effects of ADT in exchange for a mean 8% absolute increase in survival, whereas patients in the no ADT cohort required a 16% increase (P < 0.001). Conclusions. When considering treatment with ADT, men with IRPC identified fatigue and sexual dysfunction as the most bothersome side effects. Patients who declined ADT expected a larger survival benefit than those who opted for treatment. Both groups expected a survival benefit exceeding that shown by recent trials, suggesting some men may be selecting treatments inconsistent with their preferences. Highlights: This study demonstrates that prostate cancer patients receiving radiation therapy are reluctant to receive androgen deprivation therapy (ADT) most commonly due to anticipated fatigue and loss of libido/erectile dysfunction.Men who had received ADT reported they would require an average 8% absolute increase in survival to tolerate its side effects, whereas those who declined ADT would require an average 16% increase.Required thresholds are well above the estimated absolute survival benefit for ADT demonstrated in recent clinical trials, suggesting an unmet need for improved patient education regarding the risks and benefits of ADT.

Optimizing Diagnostic and Staging Pathways for Suspected Lung Cancer: A Decision Analysis.

BACKGROUND: The optimal diagnostic and staging strategy for patients with suspected lung cancer is not known. RESEARCH QUESTION: What diagnostic and staging strategies are most cost-effective for lung cancer? STUDY DESIGN AND METHODS: A decision model was developed by using a hypothetical patient with a high probability of lung cancer. Sixteen unique permutations of bronchoscopy with fluoroscopy, radial endobronchial ultrasound, electromagnetic navigation, convex endobronchial ultrasound with or without rapid-onsite evaluation (ROSE), CT-guided biopsy (CTBx), and surgery were evaluated. Outcomes included cost, complications, mortality, time to complete the evaluation, rate of undetected N2-3 disease at surgery, incremental cost-complication ratio, and willingness-to-pay thresholds. Sensitivity analyses were performed on primary outcomes. RESULTS: For a peripheral lung lesion and radiographic N0 disease, the best bronchoscopy strategy costs $1,694 more than the best CTBx strategy but resulted in fewer complications (risk difference, 14%). The additional cost of bronchoscopy to avoid one complication from a CTBx strategy was $12,037. The cost and cumulative complications of bronchoscopy strategies increased compared with CTBx strategies for small lesions. The cost and cumulative complications of bronchoscopy strategies decreased compared with CTBx strategies when a bronchus sign was present, but bronchoscopy remained more costly overall. For a central lesion and/or radiographic N1-3 disease, convex endobronchial ultrasound with ROSE followed by lung biopsy with incremental cost-effectiveness ratio, if required, was more cost-effective than any CTBx strategy across all outcomes. Strategies with ROSE were always more cost-effective than those without, irrespective of scenario. Trade-offs also exist between different bronchoscopy strategies, and optimal choices depend on the value placed on individual outcomes and willingness-to-pay. INTERPRETATION: The most cost-effective strategies depend on nodal stage, lesion location, type of peripheral bronchoscopic biopsy, and the use of ROSE. For most clinical scenarios, many strategies can be eliminated, and trade-offs between the remaining competitive strategies can be quantified.

The Reality of Randomized Controlled Trials for Assessing the Benefit of Proton Therapy: Critically Examining the Intent-to-Treat Principle in the Presence of Insurance Denial.

PURPOSE: This study hypothesized that insurance denial would lead to bias and loss of statistical power when evaluating the results from an intent-to-treat (ITT), per-protocol, and as-treated analyses using a simulated randomized clinical trial comparing proton therapy to intensity modulated radiation therapy where patients incurred increasing rates of insurance denial. METHODS AND MATERIALS: Simulations used a binary endpoint to assess differences between treatment arms after applying ITT, per-protocol, and as-treated analyses. Two scenarios were developed: 1 with clinical success independent of age and another assuming dependence on age. Insurance denial was assumed possible for patients <65 years. All scenarios considered an age distribution with mean ± standard deviation: 55 ± 15 years, rates of insurance denial ranging from 0%-40%, and a sample of N = 300 patients (150 per arm). Clinical success rates were defined as 70% for proton therapy and 50% for intensity modulated radiation therapy. The average treatment effect, bias, and power were compared after applying 5000 simulations. RESULTS: Increasing rates of insurance denial demonstrated inherent weaknesses among all 3 analytical approaches. With clinical success independent of age, a per-protocol analysis demonstrated the least bias and loss of power. When clinical success was dependent on age, the per-protocol and ITT analyses resulted in a similar trend with respect to bias and loss of power, with both outperforming the as-treated analysis. CONCLUSIONS: Insurance denial leads to misclassification bias in the ITT analysis, a missing data problem in the per-protocol analysis, and covariate imbalance between treatment arms in the as-treated analysis. Moreover, insurance denial forces the critical appraisal of patient features (eg, age) affected by the denial and potentially influencing clinical success. In the presence of insurance denial, our study suggests cautious reporting of ITT and as-treated analyses, and placing primary emphasis on the results of the per-protocol analysis.

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.

Cost-utility analysis of treatment options after initial tumor necrosis factor inhibitor therapy discontinuation in patients with rheumatoid arthritis.

BACKGROUND: For patients with rheumatoid arthritis (RA) who discontinued initial treatment with tumor necrosis factor inhibitor (TNFi), 2 approaches are commonly used: cycling to another TNFi or switching to a drug with another mechanism of action. Currently, there is no consensus on which approach to use first. A report from the IBM MarketScan Research administrative claims database showed adalimumab (cycling strategy) and abatacept (switching strategy) were more commonly prescribed after the first TNFi discontinuation. OBJECTIVE: To evaluate the cost-utility of adalimumab versus abatacept in patients with RA whose initial TNFi therapy failed. METHODS: A probabilistic cost-utility microsimulation state-transition model was used. Our target population was commercially insured adults with RA, the time horizon was 10 years, and we used a payer perspective. Patients not responding to adalimumab or abatacept were moved to the next drug in a sequence of 3 and, finally, to conventional synthetic therapy. Incremental cost-utility ratios (2016 USD per quality-adjusted-life-year gained [QALY)] were calculated. Utilities were derived from a formula based on the Health Assessment Questionnaire Disability Index and age-adjusted comorbidity score. RESULTS: Switching to abatacept after the first TNFi showed an incremental cost of just more than $11,300 over 10 years and achieved a QALY benefit of 0.16 compared with adalimumab. The incremental cost-effectiveness ratio was $68,950 per QALY. Scenario analysis produced an incremental cost-effectiveness ratio range of $44,573 per QALY to $148,558 per QALY. Probabilistic sensitivity analysis showed that switching to abatacept after TNFi therapy failure had an 80.6% likelihood of being cost-effective at a willingness-to-pay threshold of $100,000 per QALY. CONCLUSIONS: Switching to abatacept is a cost-effective strategy for patients with RA whose discontinue initial therapy with TNFi. DISCLOSURES: Funding for this project was provided by a Rheumatology Research Foundation Investigator Award (principal investigator: Maria A. Lopez-Olivo). Karpes Matusevich's work was supported by a Doctoral Dissertation Research Award from the University of Texas, School of Public Health Office of Research. Lal reports competing interests outside of the submitted work (employed by Optum). Suarez-Almazor reports competing interests outside of the submitted work (consulting fees from Pfizer, AbbVie, Eli Lilly, Agile Therapeutics, Amag Pharmaceuticals, and Gilead). Chan, Swint, and Cantor have nothing to disclose.

Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial.

BACKGROUND: Almost 20% of U.S. women remain at risk for cervical cancer due to their inability or unwillingness to participate in periodic clinic-based screening. Self-sampling has been shown to be an effective strategy for screening women for high-risk human papillomavirus (HR-HPV) infection in specific contexts. However, its effectiveness among medically underserved women in safety net health systems has not been evaluated. Furthermore, it is also unclear whether implementation strategies such as patient navigation can be used to improve the success of self-sample screening programs by addressing patient-level barriers to participation. METHODS/DESIGN: The Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) trial is a hybrid type 2 effectiveness-implementation pragmatic randomized controlled trial of mailed self-sample HPV testing. The aim is to assess the effectiveness of mailed self-sample HPV testing kits to improve cervical cancer screening participation among patients in a safety net health system who are overdue for clinic-based screening, while simultaneously assessing patient navigation as an implementation strategy. Its setting is a large, urban safety net health system that serves a predominantly racial/ethnic minority patient population. The trial targets recruitment of 2268 participants randomized to telephone recall (enhanced usual care, n = 756), telephone recall with mailed self-sample HPV testing kit (intervention, n = 756), or telephone recall with mailed self-sample HPV testing kit and patient navigation (intervention + implementation strategy, n = 756). The primary effectiveness outcome is completion of primary screening, defined as completion and return of mailed self-sample kit or completion of a clinic-based Pap test. Secondary effectiveness outcomes are predictors of screening and attendance for clinical follow-up among women with a positive screening test. Implementation outcomes are reach, acceptability, fidelity, adaptations, and cost-effectiveness. DISCUSSION: Hybrid designs are needed to evaluate the clinical effectiveness of self-sample HPV testing in specific populations and settings, while incorporating and evaluating methods to optimize its real-world implementation. The current manuscript describes the rationale and design of a hybrid type 2 trial of self-sample HPV testing in a safety net health system. Trial findings are expected to provide meaningful data to inform screening strategies to ultimately realize the global goal of eliminating cervical cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT03898167 . Registered on 01 April 2019. TRIAL STATUS: Study start data: February 13, 2020. Recruitment status: Enrolling by invitation. Estimated primary completion date: February 15, 2023. Estimated study completion date: May 31, 2024. Protocol version 1.6 (February 25, 2020).

Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial.

Importance: Lung cancer screening with low-dose computed tomography lowers lung cancer mortality but has potential harms. Current guidelines support patients receiving information about the benefits and harms of lung cancer screening during decision-making. Objective: To examine the effect of a patient decision aid (PDA) about lung cancer screening compared with a standard educational material (EDU) on decision-making outcomes among smokers. Design, Setting, and Participants: This randomized clinical trial was conducted using 13 state tobacco quitlines. Current and recent tobacco quitline clients who met age and smoking history eligibility for lung cancer screening were enrolled from March 30, 2015, to September 12, 2016, and followed up for 6 months until May 5, 2017. Data analysis was conducted between May 5, 2017, and September 30, 2018. Interventions: Participants were randomized to the PDA video Lung Cancer Screening: Is It Right for Me? (n = 259) or to EDU (n = 257). Main Outcomes and Measures: The primary outcomes were preparation for decision-making and decisional conflict measured at 1 week. Secondary outcomes included knowledge, intentions, and completion of screening within 6 months of receiving the intervention measured by patient report. Results: Of 516 quit line clients enrolled, 370 (71.7%) were younger than 65 years, 320 (62.0%) were female, 138 (26.7%) identified as black, 47 (9.1%) did not have health insurance, and 226 (43.8%) had a high school or lower educational level. Of participants using the PDA, 153 of 227 (67.4%) were well prepared to make a screening decision compared with 108 of 224 participants (48.2%) using EDU (odds ratio [OR], 2.31; 95% CI, 1.56-3.44; P < .001). Feeling informed about their screening choice was reported by 117 of 234 participants (50.0%) using a PDA compared with 66 of 233 participants (28.3%) using EDU (OR, 2.56; 95% CI, 1.72-3.79; P < .001); 159 of 234 participants (68.0%) using a PDA compared with 110 of 232 (47.4%) participants using EDU reported being clear about their values related to the harms and benefits of screening (OR, 2.37; 95% CI, 1.60-3.51; P < .001). Participants using a PDA were more knowledgeable about lung cancer screening than participants using EDU at each follow-up assessment. Intentions to be screened and screening behaviors did not differ between groups. Conclusions and Relevance: In this study, a PDA delivered to clients of tobacco quit lines improved informed decision-making about lung cancer screening. Many smokers eligible for lung cancer screening can be reached through tobacco quit lines. Trial Registration: ClinicalTrials.gov identifier: NCT02286713.

Systematic Review of Economic Evaluations of Cycling Versus Swapping Medications in Patients With Rheumatoid Arthritis After Failure to Respond to Tumor Necrosis Factor Inhibitors.

OBJECTIVE: To systematically review the modeling approaches and quality of economic analyses comparing cycling tumor necrosis factor inhibitors (TNFi) to swapping to a therapy with a different mode of action in patients with rheumatoid arthritis whose initial TNFi failed. METHODS: We searched electronic databases, gray literature, and references of included publications until July 2017. Two reviewers independently screened citations. Reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Data regarding modeling methodology were extracted. RESULTS: We included 7 articles comprising 19 comparisons. Three studies scored ≥16 of 24 on the CHEERS checklist. Most models used a lifetime horizon, took a payer perspective, employed a 6-month cycle length, and measured treatment efficacy in terms of the American College of Rheumatology improvement criteria. We noted possible sources of bias in terms of transparency and study sponsorship. In the cost-utility comparisons, the median incremental cost-effectiveness ratio was US $70,332 per quality-adjusted life-year for swapping versus cycling strategies. Rituximab was more effective and less expensive than TNFi in 7 of 11 comparisons. Abatacept (intravenous) compared to TNFi was less cost-effective than rituximab. Common influential parameters in sensitivity analyses were the rituximab dosing schedule, assumptions regarding disease progression, and the estimation of utilities. CONCLUSION: Differences in the design, key assumptions, and model structure chosen had a major impact on the individual study conclusions. Despite the existence of multiple reporting standards, there continues to be a need for more uniformity in the methodology reported in economic evaluations of cycling versus swapping strategies after TNFi in patients with rheumatoid arthritis.

Does Animation Improve Comprehension of Risk Information in Patients with Low Health Literacy? A Randomized Trial.

Introduction. Enhanced visual effects, like animation, have the potential to improve comprehension of probabilistic risk information, particularly for those with lower health literacy. We tested the effect of presentation format on comprehension of colorectal cancer (CRC) screening probabilities to identify optimal risk communication strategies. Methods. Participants from a community foodbank and a cancer prevention center were randomized to 1 of 3 CRC screening risk presentations. The presentations used identical content but varied in format: 1) video with animated pictographs, 2) video with static pictographs, and 3) audiobooklet with static pictographs. Participants completed pre- and postpresentation surveys. The primary outcome was knowledge of probability/risk information regarding CRC screening, calculated as total, verbatim, and gist scores. Results. In total, 187 participants completed the study and were included in this analysis. Median age was 58 years (interquartile range [IQR]: 14 years), most participants were women (63%), and almost half had a high school education or less (46%). Approximately one-quarter had inadequate health literacy (Short Test of Functional Health Literacy in Adults marginal/inadequate: 28%; Brief Health Literacy Screener low: 18%), and about half had low numeracy (Subjective Numeracy Scale low: 54%; Graphical Literacy Measure low: 50%). We found no significant differences in total, verbatim, or gist knowledge across presentation formats (all P > 0.05). Discussion. Use of an animated pictograph to communicate risk does not appear to augment or impede knowledge of risk information. Regardless of health literacy level, difficulty understanding pictographs presenting numerical information persists. There may be a benefit to teaching or priming individuals on how to interpret numerical information presented in pictographs before communicating risk using visual methods. Trial Registry: NCT02151032.

Cost-Effectiveness Analysis of Hepatitis B Virus Screening and Management in Patients With Hematologic or Solid Malignancies Anticipating Immunosuppressive Cancer Therapy.

PURPOSE: National hepatitis B virus (HBV) screening recommendations for patients with cancer anticipating systemic anticancer therapy range from universal screening to screening based on risk of HBV infection, cancer therapy-specific risk of HBV reactivation, or both. We conducted cost-effectiveness analyses to identify optimal HBV screening strategies. PATIENTS AND METHODS: We constructed decision-analytic models to analyze three strategies (no screening, universal screening, and selective screening based on use of an HBV infection risk tool) for hypothetic cohorts of patients anticipating anticancer therapy at high or lower risk for HBV reactivation. Model parameters were drawn from previously published studies, the SEER-Medicare database, and other online resources. Outcomes included lifetime expected cost, quality-adjusted life expectancy, and incremental cost-effectiveness ratio, measured in US dollars required to gain an additional quality-adjusted life-year (QALY). RESULTS: For patients at high reactivation risk, universal screening dominated (ie, was cheaper and more effective than) the other two strategies. Universal screening was associated with a gain in life expectancy of 0.01 QALY compared with no screening and cost $76.06 less than no screening and $4.34 less than selective screening. For those at lower reactivation risk, universal screening still dominated selective screening; however, the incremental cost-effectiveness ratio of the universal screening strategy compared with no screening was $186,917 per QALY gained. CONCLUSION: Universal HBV screening is cost effective and cheaper for patients receiving anticancer therapy associated with a high reactivation risk. For patients receiving anticancer therapy associated with a lower reactivation risk, universal screening is not cost effective.

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.

Potentially inappropriate medications defined by STOPP criteria in older patients with breast and colorectal cancer.

PURPOSE: Screening for potentially inappropriate medications (PIM) is recommended in older patients with cancer receiving chemotherapy, given the concern for adverse drug reactions, drug-drug interactions and non-adherence. Our objective was to determine the impact of PIM on outcomes in patients with breast and colorectal cancers receiving chemotherapy. METHODS: We used data from the SEER-Medicare database, including patients >/= 66 years old with a diagnosis of Stage II/III breast and colorectal cancer made between 7/1/2007-12/31/2009. We used modified STOPP criteria to define baseline PIM as a dichotomous variable in the 4 months prior to diagnosis. STOPP criteria was used based on its performance as a robust measure of PIM. Outcomes measures included ER visits, hospitalizations, and death within 3 months from the last chemotherapy, and a composite of the three. We used Chi-square or Fisher's exact test to determine associations of PIM with covariates and outcomes, and Cox proportional hazards (PH) model for the time-to-event analysis. RESULTS: Final analysis included 1,595 patients with breast cancer and 1,528 patients with colorectal cancer. Frequency of baseline PIM by STOPP was 31.5% in the breast and 30.9% in the colorectal cohort. In the breast cohort, associations with the composite outcome in the Cox PH model included disease stage, comorbidity, medication number and baseline ER visits/hospitalization. Age, gender, race, comorbidity and baseline ER visits/hospitalization were associated in the colorectal cohort. PIM was not associated with outcomes in either cohort, aside from hospitalization in the breast. CONCLUSIONS: We found no consistent association between pre-chemotherapy PIM defined by STOPP and outcomes.

Considering Breast Reconstruction after Mastectomy: A Patient Decision Aid Video and Workbook.

Women report difficulty understanding and personalizing breast reconstruction information during the complex and time-limited period of cancer treatment planning. Patient decision aids can help patients become well informed, form realistic expectations, prepare to communicate with the surgical team, and be more satisfied with their decision-making process. METHODS: We engaged patients, providers, and stakeholders in a user-centered design process to develop an online patient decision aid video and interactive workbook for breast reconstruction after mastectomy. The video and workbook introduce breast reconstruction and compare the risks and benefits of 3 key decisions: reconstruction versus no reconstruction, immediate versus delayed, and tissue- versus implant based. Pilot testing using cognitive interviews and pre-/postdecision aid questionnaires assessed acceptability, knowledge, and decision-making values. RESULTS: After viewing the decision aid, patients (n = 20) scored 97.5% correct on a knowledge test; however, the factors driving their decisions were varied. All (n = 40) patients and providers/stakeholders provided over 80% positive acceptability ratings. 97.5% said they would recommend the video and workbook to other women with breast cancer. CONCLUSIONS: The Considering Breast Reconstruction after Mastectomy patient decision aid video and workbook show potential for improving informed decision-making. Delivery before the initial plastic surgery consultation was well supported as a way to give women time to process the information and prepare to talk with the surgical team about their options. The Personal Decision Worksheet shows potential for assessing patients' knowledge and the factors driving their personal decision-making process.

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.

Efficacy of Mobile Phone-Delivered Smoking Cessation Interventions for Socioeconomically Disadvantaged Individuals: A Randomized Clinical Trial.

Importance: Limited evidence supports mobile phone-delivered cessation interventions for socioeconomically disadvantaged individuals. Objective: To assess the efficacy of mobile phone-delivered cessation interventions targeted to smokers at neighborhood sites serving racial/ethnic minority and socioeconomically disadvantaged individuals. Design, Setting, and Participants: This group-randomized clinical trial with neighborhood site serving as the sampling unit compared smoking cessation interventions that included (1) nicotine replacement therapy (NRT), (2) NRT plus text messaging, and (3) NRT plus text messaging plus proactive counseling via mobile phone. Recruitment took place at churches, public housing complexes, and community centers located throughout the Houston, Texas, area. A total of 624 current cigarette smokers 18 years or older were enrolled at neighborhood sites from August 13, 2011, through December 12, 2014. Final follow-up was completed on June 12, 2015, and data were analyzed from August 17, 2017, through May 10, 2018, based on intention to treat. Interventions: Nicotine replacement therapy consisted of transdermal nicotine patches; NRT plus text messages, transdermal nicotine patches and individually tailored mobile phone text messages; and NRT plus text plus call, transdermal patches, individually tailored mobile phone text messages, and proactive counseling via mobile phone. Main Outcomes and Measures: The primary outcome was smoking abstinence at 6 months, defined as (1) biochemically verified smoking abstinence (calculated among a subgroup of 377 participants) as determined by saliva cotinine level; and (2) self-reported 30-day abstinence (calculated among all 624 participants). Results: The study sample included 624 current cigarette smokers (50.6% female; mean [SD] age, 45.8 [12.8] years). Among the 377 participants eligible for biochemical verification, 127 self-reported 30-day abstinence and were asked to provide saliva samples. Of these, 98 samples were returned (participants who did not return samples were coded as smoking). Biochemically verified abstinence rates were 12.0% for NRT, 12.0% for NRT plus text, and 25.5% for NRT plus text plus call. Participants in the NRT plus text plus call group were 2.11 (95% CI, 1.00-4.48) times more likely to be biochemically verified as abstinent compared with the NRT group. No differences in biochemically verified abstinence between the NRT plus text group and the NRT group were observed. Similar associations were observed with the self-report cessation outcomes. Conclusions and Relevance: Findings indicate that assignment to an intervention consisting of text messaging alone may not increase cessation rates for socioeconomically disadvantaged smokers. However, text messaging plus proactive counseling may be an efficacious option. Trial Registration: ClinicalTrials.gov identifier: NCT00948129.

Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned.

PURPOSE: We describe the methods, stakeholder engagement, and lessons learned from a study comparing a video decision aid to standard educational materials on lung cancer screening decisions. METHODS: The study followed rigorous methodology standards from the Patient-Centered Outcomes Research Institute. The importance of patient-centeredness and patient/stakeholder engagement are reflected across the study's conceptualization, execution, interpretation, and dissemination efforts. Advisory groups of current and former smokers, quitline service providers, clinicians, and patient advocates were formed for the project. The study used both retrospective and prospective recruitment strategies. Randomization of patients occurred within state-based quitlines, with aggressive tracking of participants. We collected data at baseline and 1-week, 3-month and 6-months after receiving the intervention. The patient-centered outcomes included whether patients' receiving the decision aid a) felt better prepared to make a decision, b) felt more informed about the screening decision, c) had more clarity on their values regarding the benefits and harms of lung cancer screening, and d) were more knowledgeable about lung cancer screening than patients receiving the standard education materials. Exploratory outcomes included making an appointment with a health care provider to discuss screening, scheduling and completing lung cancer screening. RESULTS: We have enrolled and randomized 516 quitline patients and learned many lessons about executing the trial based on significant patient and stakeholder engagement. CONCLUSIONS: Conducting patient-centered outcomes research requires new ways of thinking and continuously checking-in with patients/stakeholders. The engagement of quitline service providers and patient advisors has been key to successful recruitment and dissemination planning. PCORI- CER-1306-03385 ClinicalTrials.gov NCT ID: NCT02286713.

Prospective Study of Psychosocial Outcomes of Having Contralateral Prophylactic Mastectomy Among Women With Nonhereditary Breast Cancer.

Purpose The incidence of contralateral prophylactic mastectomy (CPM) has continued to increase. We prospectively examined psychosocial outcomes before and up to 18 months after surgery in women who did or did not have CPM. Methods Women with unilateral, nonhereditary breast cancer completed questionnaires before and 1, 6, 12, and 18 months after surgery. Primary psychosocial measures were cancer worry and cancer-specific distress. Secondary measures were body image, quality of life (QOL), decisional satisfaction, and decisional regret. Results A total of 288 women (mean age, 56 years; 58% non-Hispanic white) provided questionnaire data, of whom 50 underwent CPM. Before surgery, women who subsequently received CPM had higher cancer distress ( P = .04), cancer worry ( P < .001), and body image concerns ( P < .001) than women who did not have CPM. In a multivariable repeated measures model adjusted for time, age, race/ethnicity, and stage, CPM was associated with more body image distress ( P < .001) and poorer QOL ( P = .02). There was a significant interaction between time point and CPM group for cancer worry ( Pinteraction < .001), suggesting that CPM patients had higher presurgery cancer worry, but their postsurgery worry decreased over time and was similar to the worry of patients who did not have CPM. QOL was similar between CPM groups before surgery but declined 1 month after surgery and remained lower than patients who did not have CPM after surgery ( Pinteraction = .05). Conclusion These results may facilitate informed discussions between women and their physicians regarding CPM. Fear and worry may be foremost concerns at the time surgical decisions are made, when women may not anticipate the adverse future effect of CPM on body image and QOL.

Three Lymphadenectomy Strategies in Low-Risk Endometrial Carcinoma: A Cost-Effectiveness Analysis.

OBJECTIVE: To evaluate the cost-utility of three lymphadenectomy strategies in the management of low-risk endometrial carcinoma. METHODS: A decision analysis model compared three lymphadenectomy strategies in women undergoing minimally invasive surgery for low-risk endometrial carcinoma: 1) routine lymphadenectomy in all patients, 2) selective lymphadenectomy based on intraoperative frozen section criteria, and 3) sentinel lymph node mapping. Costs and outcomes were obtained from published literature and Medicare reimbursement rates. Costs categories consisted of hospital, physician, operating room, pathology, and lymphedema treatment. Effectiveness was defined as 3-year disease-specific survival adjusted for the effect of lymphedema (utility=0.8) on quality of life. A cost-utility analysis was performed comparing the different strategies. Multiple deterministic sensitivity analyses were done. RESULTS: In the base-case scenario, routine lymphadenectomy had a cost of $18,041 and an effectiveness of 2.79 quality-adjusted life-years (QALYs). Selective lymphadenectomy had a cost of $17,036 and an effectiveness of 2.81 QALYs, whereas sentinel lymph node mapping had a cost of $16,401 and an effectiveness of 2.87 QALYs. With a difference of $1,005 and 0.02 QALYs, selective lymphadenectomy was both less costly and more effective than routine lymphadenectomy, dominating it. However, with the lowest cost and highest effectiveness, sentinel lymph node mapping dominated the other modalities and was the most cost-effective strategy. These findings were robust to multiple sensitivity analyses varying the rates of lymphedema and lymphadenectomy, surgical approach (open or minimally invasive surgery), lymphedema utility, and costs. For the estimated 40,000 women undergoing surgery for low-risk endometrial carcinoma each year in the United States, the annual cost of routine lymphadenectomy, selective lymphadenectomy, and sentinel lymph node mapping would be $722 million, $681 million, and $656 million, respectively. CONCLUSION: Compared with routine and selective lymphadenectomy, sentinel lymph node mapping had the lowest costs and highest quality-adjusted survival, making it the most cost-effective strategy in the management of low-risk endometrial carcinoma.