Economic Evaluation of Web- versus Telephone-based Interventions to Simultaneously Increase Colorectal and Breast Cancer Screening Among Women.

Screening for colorectal and breast cancer is considered cost effective, but limited evidence exists on cost-effectiveness of screening promotion interventions that simultaneously target both cancers. Increasing Colorectal and Breast Cancer Screening (Project COBRA), a randomized controlled trial conducted in the community, examined the cost-effectiveness of an innovative tailored web-based intervention compared with tailored telephone counseling and usual care. Screening status at 6 months was obtained by participant surveys plus medical record reviews. Cost was prospectively measured from the patient and provider perspectives using time logs and project invoices. Relative efficiency of the interventions was quantified by the incremental cost-effectiveness ratios. Nonparametric bootstrapping and net benefit regression analysis were used to assess statistical uncertainty of the results. The average cost per participant to implement the Phone counseling, Web-based, and Web + Phone counseling interventions were $277, $314, and $337, respectively. Comparing Phone counseling with usual care resulted in an additional cost of $300 (95% confidence interval [CI]: $283-$320) per cancer screening test and $421 (95% CI: $400-$441) per additional person screened in the target population. Phone counseling alone was more cost-effective than the Web + Phone intervention. Web-based intervention alone was more costly but less effective than the Phone counseling. When simultaneously promoting screening for both colorectal and breast cancer the Web-based intervention was less cost-effective compared with Phone and Web + Phone strategies. The results suggest that targeting multiple cancer screening may improve the cost-effectiveness of cancer screening interventions. PREVENTION RELEVANCE: This study informs researchers, decision makers, healthcare providers, and payers about the improved cost-effectiveness of targeting multiple cancer screenings for cancer early detection programs.

Patient-initiated follow-up after treatment for low risk endometrial cancer: a prospective audit of outcomes and cost benefits.

OBJECTIVE: Recurrence of low-risk endometrioid endometrial cancer is rare, and traditional hospital follow-up has a cost to both the patient and the healthcare system, without evidence of benefit. We examined the uptake of patient-initiated follow-up, pattern of recurrences, and survival for women following surgical treatment of low-risk endometrial cancer and compared estimated costs with hospital follow-up. METHODS: This study was a prospective audit of outcomes following implementation of a patient-initiated follow-up policy in a UK-based gynecological cancer center for women with low-risk endometrial cancer treated surgically (International Federation of Gynecology and Obstetrics (FIGO) stage 1A, G1-2) from January 2010 to December 2015. Women were identified following multidisciplinary team meetings and data were collected from the electronic cancer register, paper, and electronic clinical records. Health service costs were calculated based on standard tariffs for follow-up appointments; patient costs were estimated from mileage traveled from home postcode and parking charges. Progression-free survival and overall survival were assessed. Estimated financial costs to the health service and patients of hospital follow-up were compared with actual patient-initiated follow-up costs. RESULTS: A total of 129 women were offered patient-initiated follow-up (declined by four; accepted by another 11 after hospital follow-up for 6 months to 3.5 years) with median follow-up of 60.7 months (range 1.4-109.1 months). Ten women recurred: four vaginal vault recurrences (all salvaged), three pelvic recurrences (all salvaged), and three distant metastatic disease (all died). Five-year disease-specific survival was 97.3%. Ten women in the cohort died: three from endometrial cancer and seven from unrelated causes. The cost saving to the health service of patient-initiated follow-up compared with a traditional hospital follow-up regimen was £116 403 (median £988.60 per patient,range £0-£1071). Patients saved an estimated £7122 in transport and parking costs (median £57.22 per patient,range £4.98-£147.70). CONCLUSION: Patient-initiated follow-up for low risk endometrial cancer has cost benefits to both health service and patients. Those with pelvic or vault recurrence had salvageable disease, despite patient-initiated follow-up.

Addressing the Financial Burden of Cancer Clinical Trial Participation: Longitudinal Effects of an Equity Intervention.

BACKGROUND: The financial burden experienced by patients with cancer represents a barrier to clinical trial participation, and interventions targeting patients' financial concerns are needed. We sought to assess the impact of an equity intervention on clinical trial patients' financial burden. MATERIALS AND METHODS: We developed an equity intervention to reimburse nonclinical expenses related to trials (e.g., travel and lodging). From July 2015 to July 2017, we surveyed intervention and comparison patients matched by age, sex, cancer type, specific trial, and trial phase. We longitudinally assessed financial burden (e.g., trial-related travel and lodging cost concerns, financial wellbeing [FWB] with the COmprehensive Score for financial Toxicity [COST] measure) at baseline, day 45, and day 90. We used longitudinal models to assess intervention effects over time. RESULTS: Among 260 participants, intervention patients were more likely than comparison patients to have incomes under $60,000 (52% vs. 24%, p < .001) and to report travel-related (41.0% vs. 6.8%, p < 0.001) and lodging-related (32.5% vs. 2.0%, p < .001) cost concerns at baseline. Intervention patients were more likely to report travel to appointments as their most significant financial concern (24.0% vs. 7.0%, p = .001), and they had worse FWB than comparison patients (COST score: 15.32 vs. 23.88, p < .001). Over time, intervention patients experienced greater improvements in their travel-related (-10.0% vs. +1.2%, p = .010) and lodging-related (-3.9% vs. +4.0%, p = .003) cost concerns. Improvements in patients reporting travel to appointments as their most significant financial concern and COST scores were not statistically significant. CONCLUSION: Cancer clinical trial participants may experience substantial financial issues, and this equity intervention demonstrates encouraging results for addressing these patients' longitudinal financial burden. IMPLICATIONS FOR PRACTICE: Clinical trials are critical for developing novel therapies for patients with cancer, yet financial barriers may discourage some patients from participating in cancer clinical trials. This study found that patients who received financial assistance from an equity intervention experienced significant improvements over time in their concerns about the cost of travel and lodging associated with clinical trials compared with comparison patients who did not receive financial assistance from the equity intervention. Among cancer clinical trial participants, an equity intervention shows potential for addressing patients' concerns regarding clinical trial-related travel and lodging expenses.

Incentives and Patches for Medicaid Smokers: An RCT.

INTRODUCTION: Most successful trials of financial incentives for smoking cessation have offered large rewards contingent on outcomes. This study examines whether more modest incentives to encourage engagement, non-contingent on outcomes, also increase cessation; whether sending medications directly to participants boosts quitting; and whether these strategies are effective in Medicaid. STUDY DESIGN: Three-group RCT of usual care (UC); nicotine patch (NP); and NP and financial incentive (NP+FI). SETTING/PARTICIPANTS: Medicaid beneficiaries calling the California Smokers' Helpline, 2012-2013 (N=3,816). Data were analyzed in 2017. INTERVENTION: All participants enrolled in evidence-based, multisession telephone counseling. All received proof of enrollment with which they could obtain free quitting aids at their pharmacy. NP and NP+FI also received nicotine patches sent to their homes. NP+FI received up to $60 for completing counseling calls. MAIN OUTCOME MEASURES: Quit attempt rate, 7-day and 30-day abstinence at 2 and 7 months, and 6-month prolonged abstinence (primary outcome). RESULTS: In both complete-case and intention-to-treat analyses, outcomes trended upward from UC to NP to NP+FI. Differences between NP and UC were generally nonsignificant. By contrast, the NP+FI group significantly outperformed the other groups on all measures. In intention-to-treat analysis, compared with UC, NP+FI was more likely to make a quit attempt (68.4% vs 54.3%, p<0.001); be abstinent for 7 days at 2 months (36.1% vs 25.5%, p<0.001) and 7 months (21.2% vs 16.1%, p=0.002); be abstinent for 30 days at 2 months (30.0% vs 18.9%, p<0.001) and 7 months (21.5% vs 16.7%, p=0.004); and achieve 6-month prolonged abstinence (13.2% vs 9.0%, p=0.001). CONCLUSIONS: Financial incentives increased treatment engagement and short- and long-term smoking cessation, despite being modest and non-contingent on outcomes. The study found that incentives can be effective in a Medicaid population, and can feasibly be integrated into existing quitline services. TRIAL REGISTRATION: The trial is registered at www.clinicaltrials.gov NCT01502306. SUPPLEMENT INFORMATION: This article is part of a supplement entitled Advancing Smoking Cessation in California's Medicaid Population, which is sponsored by the California Department of Public Health.

The Medi-Cal Incentives to Quit Smoking Project: Impact of Statewide Outreach Through Health Channels.

INTRODUCTION: Little is known about how incentives may encourage low income smokers to call for quitline services. This study evaluates the impact of outreach through health channels on California Medicaid (Medi-Cal) quitline caller characteristics, trends, and reach. STUDY DESIGN: Longitudinal study. SETTING/PARTICIPANTS: Medi-Cal quitline callers. INTERVENTION: Statewide outreach was conducted with health providers, Medi-Cal plans (all-household mailings with tracking codes), and public health organizations (March 2012-July 2015). For incentives, Medi-Cal callers could ask for a $20 gift card; in September 2013, callers were offered free nicotine patches. MAIN OUTCOME MEASURES: Caller characteristics were compared with chi-square analyses, joinpoint analysis of call trends was performed accounting for Medi-Cal population growth, referral source among Medi-Cal and non-Medi-Cal callers was documented, and the annual percentage of the population reached who called the Helpline was calculated. Analyses were conducted 2016-2018. RESULTS: Total Medi-Cal callers were 92,900, a 70% increase from prior annual averages: 12.4% asked for the financial incentive, 17.3% reported the mailing code, and 73.3% received nicotine patches while offered. Among the two thirds of callers who completed counseling, 15.5% asked for the financial incentive, and 13.6% reported the mailing code. A joinpoint analysis showed call trends increased 23% above expected for the Medi-Cal population growth after mailings to providers and members began, and decreased after outreach ended. Annual reach increased from 2.3% (95% CI=2.1, 2.6) in 2011 to peak at 4.5% (95% CI=3.6, 5.3) in 2014. Among subgroups with higher reach rates, some also had higher rates of asking for the financial incentive (African Americans, American Indian), reporting the tracking code (whites), or both (aged 45-64 years). Medi-Cal callers were more likely than non-Medi-Cal callers to report providers (32.3% vs 23.8%) and plans (19.7% vs 1.4%) as their referral source, and less likely to cite media (20.2% vs 44.4%, p<0.001). CONCLUSIONS: Statewide outreach through health channels incentivizing Medi-Cal members increased the utilization and reach of quitline services. SUPPLEMENT INFORMATION: This article is part of a supplement entitled Advancing Smoking Cessation in California's Medicaid Population, which is sponsored by the California Department of Public Health.

Racial/Ethnic Differences in the Response to Incentives for Quitline Engagement.

INTRODUCTION: Certain racial and ethnic minorities have lower utilization of tobacco cessation services, such as Helpline counseling and cessation medications. The goal of the California Medicaid (Medi-Cal) Incentives to Quit Smoking Program was to facilitate successful cessation by promoting modest financial and cessation medication-related incentives to increase engagement with the California Smokers' Helpline counseling services. Differences in the response to incentives and outreach on engagement with Helpline services among racial/ethnic groups within the Medi-Cal population were examined. STUDY DESIGN: Analysis of Helpline caller data. SETTING/PARTICIPANTS: African American (n=18,656); English-speaking Latinx (n=12,792); Spanish-speaking Latinx (n=3,254); and white (n=45,907) Medi-Cal callers. INTERVENTION: The Medi-Cal Incentives to Quit Smoking team conducted statewide and community-based outreach and facilitated direct-to-member all-household mailings about the Medi-Cal Incentives to Quit Smoking program to engage with Medi-Cal callers and promote Helpline services between March 2012 and July 2015 (analyzed 2017/2018). Medi-Cal callers could ask for a $20 gift card incentive after having completed a counseling session; in September 2013, callers were offered free nicotine replacement therapy. MAIN OUTCOME MEASURES: Three behavioral outcomes are reported that reflect activated callers and callers who engaged in treatment that is proven to improve chances of quitting smoking: receipt of the $20 incentive, receipt of nicotine replacement therapy, and receipt of counseling. RESULTS: African Americans and English-speaking Latinx had higher engagement with the financial incentive than whites (African American APR=1.66, 95% CI=1.59, 1.73, English-speaking Latinx APR=1.29, 95% CI=1.22, 1.36). Spanish-speaking Latinx had lower initial engagement with the financial incentive (APR=0.75, 95% CI=0.66, 0.85), but higher engagement with Medi-Cal's all-household mailing (Spanish-speaking Latinx 30.6% vs whites 18.2%, p<0.001). Although African Americans and English-speaking Latinx had similar rates of completing counseling and receiving nicotine replacement therapy as whites, Spanish-speaking Latinx had higher rates than whites. CONCLUSIONS: The promotion of modest financial and cessation medication incentives through multiple outreach channels increased callers' engagement with the Helpline and appeared to promote ethnic and linguistic equity with respect to the receipt of counseling and nicotine replacement therapy. Targeted community-based outreach may resonate particularly for African Americans, and language-concordant Medi-Cal insurance plan mailings may have reached newly covered Spanish-speaking Latinx. SUPPLEMENT INFORMATION: This article is part of a supplement entitled Advancing Smoking Cessation in California's Medicaid Population, which is sponsored by the California Department of Public Health.

Effects of Offering Nicotine Patches, Incentives, or Both on Quitline Demand.

INTRODUCTION: Previous studies found that offering free nicotine patches significantly increases calls to quitlines, although most used pre-post designs and did not directly compare the effects of patches and other incentives. The current study with California Medicaid members used a 2 × 2 design to directly assess the effects of offering free patches and incentives on calls to a quitline. The hypotheses were that offering either would make members more likely to call, and that offering both would increase demand even further. METHODS: Flyers were inserted into a mailing sent to 4,268,696 Medicaid households, with one of four offers: (1) free counseling; (2) counseling plus patches; (3) counseling plus a $20 gift card; and (4) counseling plus patches and gift card. Ninety percent received the first offer and 10% received one of the other three offers, in equal proportions. The mailers shipped late 2013 to early 2014. Data were collected 2013-2015 and analyzed 2018. RESULTS: Response rates were 0.029% for counseling, 0.115% for counseling plus patches, 0.122% for counseling plus gift card, and 0.200% for counseling, patches, and gift card. Both patches and gift cards had statistically significant effects (both p<0.001). Promotional costs were 59%-75% lower with an incentive. Non-whites responded more strongly than whites to a gift card offer. CONCLUSIONS: Offering either free patches or a $20 gift card quadrupled the likelihood of Medicaid smokers calling a quitline; offering both had a nearly additive effect. Incentive offers dramatically increased the cost-effectiveness of promotions. Piggybacking on existing Medicaid communications to promote cessation proved very successful. SUPPLEMENT INFORMATION: This article is part of a supplement entitled Advancing Smoking Cessation in California's Medicaid Population, which is sponsored by the California Department of Public Health.

Direct-to-Member Household or Targeted Mailings: Incentivizing Medicaid Calls for Quitline Services.

INTRODUCTION: Innovative methods are needed to promote tobacco cessation services. The Medi-Cal Incentives to Quit Smoking project (2012-2015) promoted modest financial and medication incentives to encourage Medi-Cal smokers to utilize the California Smokers' Helpline (Helpline). This article describes the implementation and impact of two different direct-to-member mailing approaches. METHODS: Medi-Cal Incentives to Quit Smoking promotional materials were mailed directly to members using two approaches: (1) household mailings: households identified through centralized membership divisions and (2) individually targeted mailings: smokers identified by medical codes from Medi-Cal managed care plans. Mailings included messaging on incentives, such as gift cards or nicotine patches. Number of calls per month, calls per unit mailed, and associated printing costs per call were compared during and 1 month after mailings. Activated caller response was based on reporting a household mailing promotional code or based on requesting financial incentives for individually targeted mailings. Analyses were conducted in 2018. RESULTS: Direct-to-member mailings, particularly with incentive messaging, demonstrated an increase in call volumes during and 1 month after mailing, and increased Medi-Cal calls to the Helpline per unit mailed. Mailings with only counseling messages had the lowest percentage of activated calls per unit mailed, whereas the incentive messaging mailings were consistently higher. Although household mailings demonstrated lower printing costs per call, individually targeted mailings had a higher percentage of activated calls per unit mailed. CONCLUSIONS: Household and individually targeted mailings are feasible approaches to increase Medi-Cal calls to the Helpline, particularly with incentive messaging. Choosing an approach and messaging depends on available resources, timing, and purpose. SUPPLEMENT INFORMATION: This article is part of a supplement entitled Advancing Smoking Cessation in California's Medicaid Population, which is sponsored by the California Department of Public Health.

Evaluation of patient-focused interventions to promote colorectal cancer screening among new york state medicaid managed care patients.

BACKGROUND: The objective of this study was to evaluate an ongoing initiative to improve colorectal cancer (CRC) screening uptake in the New York State (NYS) Medicaid managed care population. METHODS: Patients aged 50 to 75 years who were not up to date with CRC screening and resided in 2 NYS regions were randomly assigned to 1 of 3 cohorts: no mailed reminder, mailed reminder, and mailed reminder + incentive (in the form of a $25 cash card). Screening prevalence and the costs of the intervention were summarized. RESULTS: In total, 7123 individuals in the Adirondack Region and 10,943 in the Central Region (including the Syracuse metropolitan area) were included. Screening prevalence in the Adirondack Region was 7.2% in the mailed reminder + incentive cohort, 7.0% in the mailed reminder cohort, and 5.8% in the no mailed reminder cohort. In the Central Region, screening prevalence was 7.2% in the mailed reminder cohort, 6.9% in the mailed reminder + incentive cohort, and 6.5% in the no mailed reminder cohort. The cost of implementing interventions in the Central Region was approximately 53% lower than in the Adirondack Region. CONCLUSIONS: Screening uptake was low and did not differ significantly across the 2 regions or within the 3 cohorts. The incentive payment and mailed reminder did not appear to be effective in increasing CRC screening. The total cost of implementation was lower in the Central Region because of efficiencies generated from lessons learned during the first round of implementation in the Adirondack Region. More varied multicomponent interventions may be required to facilitate the completion of CRC screening among Medicaid beneficiaries.

Economic assessment of patient navigation to colonoscopy-based colorectal cancer screening in the real-world setting at the University of Chicago Medical Center.

BACKGROUND: This report details the cost effectiveness of a non-nurse patient navigation (PN) program that was implemented at the University of Chicago Medical Center to increase colonoscopy-based colorectal cancer (CRC) screening. METHODS: The authors investigated the impact of the PN intervention by collecting process measures. Individuals who received navigation were compared with a historic cohort of non-navigated patients. In addition, a previously validated data-collection instrument was tailored and used to collect all costs related to developing, implementing, and administering the program; and the incremental cost per patient successfully navigated (the cost of the intervention divided by the change in the number who complete screening) was calculated. RESULTS: The screening colonoscopy completion rate was 85.1% among those who were selected to receive PN compared with 74.3% when no navigation was implemented. With navigation, the proportion of no-shows was 8.2% compared with 15.4% of a historic cohort of non-navigated patients. Because the perceived risk of noncompletion was greater among those who received PN (previous no-show or cancellation, poor bowel preparation) than that in the historic cohort, a scenario analysis was performed. Assuming no-show rates between 0% and 50% and using a navigated rate of 85%, the total incremental program cost per patient successfully navigated ranged from $148 to $359, whereas the incremental intervention-only implementation cost ranged from $88 to $215. CONCLUSIONS: The current findings indicate that non-nurse PN can increase colonoscopy completion, and this can be achieved at a minimal incremental cost for an insured population at an urban academic medical center.

A novel patient decision aid for aftercare in breast cancer patients: A promising tool to reduce costs by individualizing aftercare.

OBJECTIVE: A patient decision aid (PtDA), was developed to support breast cancer patients making choices about their aftercare. The aim of this pilot was to test the effects of the PtDA on Shared Decision Making (SDM), Decision Evaluation (DES) in patients, consultation time, choice of aftercare and hospital costs. METHODS: A prospective before-and-after study including a control (no PtDA-usage) and experimental group (PtDA-usage during consultation) was conducted in six hospitals. Patients were offered a choice between intensive (face-to-face consultations) and less intensive (telephonic or on demand consultations) aftercare. All patients filled out three validated questionnaires (baseline (T0), directly after the consultation (T1), three months later (T2)), assessing demographics (T0), SDM(T1) and DES (T1, T2). Hospital costs and choice of aftercare were assessed from the patients' files (T2). Effect sizes ( ɳp2: 0.01 = small; 0.06 = medium; 0.14 = large; φ: 0.1 = small, 0.3 = medium, 0.5 = large) and p-values were calculated using both univariate and multivariate GLMs, a repeated measures GLM and chi-square-tests. RESULTS: A small improvement in SDM ( ɳp2 = 0.02) and an effect ( ɳp2 = 0.10) on DES was found in the experimental group. Significantly more PtDA-users (51% vs. 29%, φ = 0.22) chose less intensive aftercare, leading to a small reduction of hospital costs (122 vs. 92 Euro, ɳp2 = 0.01), and a large increase in average consultation time (12.5 min; ɳp2 = 0.29). CONCLUSION: This pilot study showed promising effects of the PtDA on SDM and hospital costs. The PtDA can be developed further to potentially reduce the increased consultation time.

Challenges in the Regulation of Autologous Stem Cell Interventions in the United States.

The direct-to-consumer marketing of stem cells for unproven therapeutic uses has grown rapidly in the United States in recent years. This development is surprising since the marketing and distribution of human cell-based medical products is stringently regulated in the US. This essay describes ambiguities, gaps, and inconsistencies in the current regulatory system that have enabled such businesses to thrive. In addition to directly challenging the authority of the Food and Drug Administration (FDA) over autologous cell-based products in the courts, stem cell marketing firms have also identified and exploited regulatory loopholes, such as the same surgical procedure exception, which exempts from FDA oversight human cell-based products that are harvested and reimplanted in a single procedure. Many businesses also advertise stem cell clinical studies on a pay-to-participate basis, which requires patients to pay large sums to enroll in clinical research. This business model not only shifts many of the cost and risks of medical experimentation from providers to patients but may also indemnify sellers from fraud litigation. Lastly, stem cell advertisers borrow heavily from the language and concepts of science-based medicine in their marketing. The inaccurate promotion of autologous stem cell injections as a form of "personalized" medicine lends a veneer of credibility and precision that may encourage patients to undergo procedures of uncertain effectiveness and to sympathize with stem cell businesses in their efforts to evade oversight.

Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project.

BACKGROUND: While patient groups, regulators, and sponsors are increasingly considering engaging with patients in the design and conduct of clinical development programs, sponsors are often reluctant to go beyond pilot programs because of uncertainty in the return on investment. We developed an approach to estimate the financial value of patient engagement. METHODS: Expected net present value (ENPV) is a common technique that integrates the key business drivers of cost, time, revenue, and risk into a summary metric for project strategy and portfolio decisions. We assessed the impact of patient engagement on ENPV for a typical oncology development program entering phase 2 or phase 3. RESULTS: For a pre-phase 2 project, the cumulative impact of a patient engagement activity that avoids one protocol amendment and improves enrollment, adherence, and retention is an increase in net present value (NPV) of $62MM ($65MM for pre-phase 3) and an increase in ENPV of $35MM ($75MM for pre-phase 3). Compared with an investment of $100,000 in patient engagement, the NPV and ENPV increases can exceed 500-fold the investment. This ENPV increase is the equivalent of accelerating a pre-phase 2 product launch by 2½ years (1½ years for pre-phase 3). CONCLUSIONS: Risk-adjusted financial models can assess the impact of patient engagement. A combination of empirical data and subjective parameter estimates shows that engagement activities with the potential to avoid protocol amendments and/or improve enrollment, adherence, and retention may add considerable financial value. This approach can help sponsors assess patient engagement investment decisions.

Cost-effectiveness of the BRECONDA decision aid for women with breast cancer: Results from a randomized controlled trial.

OBJECTIVE: To report on the cost-effectiveness of BRECONDA (Breast RECONstruction Decision Aid), a web-based decision aid to facilitate decisions regarding breast reconstruction surgery, with usual care for women with breast cancer. METHODS: The economic evaluation was conducted alongside a randomized controlled trial. Women diagnosed with breast cancer or ductal carcinoma in situ and eligible for breast reconstruction following mastectomy were randomized to access BRECONDA for 6 months + usual care (n = 106) or usual care (n = 116) and were assessed at baseline preintervention, and then 1-month and 6-months post-randomization. Decisional conflict, satisfaction with information, decisional regret, and utilities were assessed by using maximum-likelihood linear mixed effects models. Costs included the fixed costs of BRECONDA, health care provider time, and health care resource use. Nonparametric bootstrapping was used to estimate incremental cost-effectiveness ratios. RESULTS: BRECONDA resulted in significantly less decisional conflict and greater satisfaction with information over time. Quality-adjusted life years did not differ between participants who received the decision aid compared with usual care. The cost of BRECONDA was estimated to be small (AUD$10) relative to other health care interventions and resulted in decreased health care costs overall (AUD$764). Based on the point estimates, the decision aid was more effective and less costly (dominant) for all measures of effectiveness. It was estimated that the decision aid has an 87% probability of being cost-effective at $60 000 per quality-adjusted life year gained. CONCLUSIONS: The BRECONDA web-based intervention designed to facilitate decisions regarding breast reconstruction surgery is likely to be cost-effective compared with usual care for women with breast cancer.

Value of Patient-Directed Brain Magnetic Resonance Imaging Scan with a Diagnosis of Migraine.

BACKGROUND: The objective of this study was to determine whether a brain magnetic resonance imaging (MRI) scan in patients with a diagnosis of migraine, who insist on the performance of imaging, is of more benefit in detecting clinically significant unsuspected structural abnormalities than would be expected by chance. METHODS: This prospective, observational, single-center study was performed from January 1, 2010 to December 31, 2012 and included 100 subjects with a diagnosis of migraine and normal results on neurologic examination. A brain MRI scan was performed on all patients, solely at their request, to detect an unsuspected clinically significant structural lesion. RESULTS: Of the 100 patients, 86 were female, and the average age was 31.5 years. Forty-five patients experienced migraine without aura, 41 chronic migraine, and 14 migraine with aura. All of the patients had normal results on neurologic examination. The duration of headaches ranged from 4 months to 40 years. In all, 82 of the MRI scans showed normal results, and 17 revealed clinically insignificant abnormalities. One MRI in a patient with chronic migraine without aura revealed a meningioma that subsequently required surgery and radiation therapy. The 1% prevalence of tumor in this study was then compared with 2 large cohorts of MRI abnormalities in the general asymptomatic population, in which tumor was found in 35 out of 3000. Fisher's exact test was used to compare the prevalence of tumor in the study population with the combined cohorts, and there was no statistical difference between these rates (P > .99). CONCLUSIONS: Brain MRI obtained at the specific request of patients with a diagnosis of migraine in the presence of normal neurologic examination results has a yield that is equivalent to that of the general asymptomatic population. Patients do not seem to have more insight than the examining clinician with regard to detecting underlying structural abnormalities, and brain MRI should not performed as part of the routine evaluation of migraine without a clear clinical indication.

Barriers and facilitators to participation in clinical trial among lymphoma patients from Sun Yat-sen University Cancer Center in China: An observation study.

Recruitment rate of clinical trials in cancer patients is pretty low in China. Little is known about factors influencing trial recruitment in Chinese cancer patients. The aim of present study is to evaluate the barriers and facilitators to participation in clinical trials among lymphoma patients in China.From December 2014 to August 2015, the survey was carried out in the Department of Medical Oncology in Sun Yat-sen University Cancer Center. A self-made questionnaire was used among lymphoma patients (N = 331) to evaluate their attitude toward clinical trials. The questionnaire included 2 parts: patients' basic information and whether they were willing to participate in future clinical trials and their reasons.There were 53.5% patients willing to participate in clinical trials. The most common reasons were thirst for new treatments, trust on hospital and doctors, the idea that clinical trials may be more effective than conventional therapy, and to get more management and monitoring. The following patients are more likely to participate in clinical trials: patients who have children (P = .019) or spouse (P = .037), cannot afford treatment cost (P = .019), have tumor relapse (P = .045), and cared about the medical development (P = .032). Patients who have little knowledge of clinical trials are less likely to participate in clinical trials (P = .047).Popularization of knowledge about clinical trial is helpful to improve clinical trial participation in Chinese lymphoma patients.

Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program.

INTRODUCTION: Cancer clinical trial (CT) participation rates are low and financial barriers likely play a role. We implemented a cancer care equity program (CCEP) to address financial burden associated with trial participation. We sought to examine the impact of the CCEP on CT enrollment and to assess barriers to participation. METHODS: We used an interrupted time series design to determine trends in CT enrollment before and after CCEP implementation. Linear regression models compared trial enrollment before and after the CCEP. We also compared patient characteristics before and after the CCEP and between CCEP and non-CCEP participants. We surveyed CCEP and non-CCEP participants to compare pre-enrollment financial barriers. RESULTS: After accounting for increased trial availability and the trends in accrual for prior years, we found that enrollment increased after CCEP implementation (18.97 participants per month greater than expected; p < .001). A greater proportion of CCEP participants were younger, female, in phase I trials, lived farther away, had lower incomes, and had metastatic disease. Of 87 participants who completed the financial barriers survey, 49 CCEP and 38 matched, non-CCEP participants responded (63% response rate). CCEP participants were more likely to report concerns regarding finances (56% vs. 11%), medical costs (47% vs. 14%), travel (69% vs. 11%), lodging (60% vs. 9%), and insurance coverage (43% vs. 14%) related to trial participation (all p < .01). CONCLUSION: CT participation increased following implementation of the CCEP and the program enrolled patients experiencing greater financial burden. These findings highlight the need to address the financial burden associated with CT participation. IMPLICATIONS FOR PRACTICE: Financial barriers likely discourage patients from participating in clinical trials. Implementation of a cancer care equity program (CCEP) seeking to reduce financial barriers by assisting with travel and lodging costs was associated with increased trial accrual. The CCEP provided assistance to patients particularly in need, including those living farther away, those with lower incomes, and those reporting financial barriers related to trial participation. These findings suggest that financial concerns represent a major barrier to patient participation in clinical trials and underscore the importance of efforts to address these concerns.