Economic Impact of Financial Incentives and Mailing Nicotine Patches to Help Medicaid Smokers Quit Smoking: A Cost-Benefit Analysis.

An RCT designed to increase Medicaid smokers' quitting success was conducted in California during 2012-2013. In the trial, alternative cessation treatment strategies were embedded in the state's ongoing quitline services. It found that modest financial incentives of up to $60 per participant and sending nicotine patches induced significantly higher cessation rates compared with usual care alone and usual care plus nicotine patches. Building upon that study, this study assessed potential population-level costs and benefits of integrating financial incentives and nicotine patches in a quitline setting for Medicaid smokers. A cost-benefit analysis was undertaken from the Medicaid program's perspective. The Cardiovascular Disease Policy Model was used to simulate future healthcare expenditures over a 10-year horizon for each treatment strategy for a study cohort of California Medicaid enrollees who were aged 35-64 years in 2014 (n=2,452,000). To simulate potential population-level benefits under each treatment strategy, each treatment was applied to all active smokers in the study cohort (n=478,300). Sensitivity analyses were conducted by varying key parameters, such as cessation costs, discount rate, relapse rates, and time horizon. Adding both financial incentives and nicotine patches to usual quitline care would result in $15 million net savings over 10 years, with a benefit-cost ratio of 1.30 compared with the usual care plus nicotine patches strategy. It would yield $44 million net savings, with a benefit-cost ratio of 1.90 compared with usual care alone. The strategy of providing financial incentives and mailing nicotine patches directly to Medicaid smokers who call the quitline is cost saving. 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.

Receipt of Tobacco Direct Mail Coupons and Changes in Smoking Status in a Nationally Representative Sample of US Adults.

Introduction: Direct-to-consumer tobacco marketing, including direct mail and email coupons, is a potentially influential marketing strategy. We examined the associations between receipt of tobacco direct mail/email coupons and trajectories of smoking behavior among US adults. Methods: Data were from the US Population Assessment on Tobacco and Health (PATH) Study adult sample (n = 32160) collected during 2013-2014. Participants self-reported their smoking status (every day, some days, not at all) 12 months prior to the survey (T0) and at the time of the survey (T1). Three smoking trajectories were identified: nonsmokers progressing to current smokers, current smokers continuing to smoke, and among current smokers at T0, progressing to or continuing with daily smoking. Participants also reported receipt of direct mail/email tobacco coupons in the 6 months preceding T1 (yes/no). Weighted multiple logistic regression models were used to test the associations between receiving direct mail/email tobacco coupons and different smoking trajectories adjusted for demographic characteristics. Results: One in eight (12.4%) US adult nonsmokers and 36.2% adult smokers at T0 reported receiving tobacco coupons. Receipt of tobacco coupons was negatively associated with poverty status. Receipt of tobacco coupons was associated with increased odds of progression to current smoking (AOR = 1.76, 95% CI = 1.45 to 2.12), continuation of smoking (AOR = 1.34, 95% CI = 1.09 to 1.65), and current smokers' progression to or continuation with daily smoking (AOR = 1.70, 95% CI = 1.50 to 1.91). Conclusions: Direct-to-consumer tobacco coupons may promote progression of smoking among nonsmokers, and continuation of smoking and progression to daily smoking among smokers in US adults. Implications: Distributing direct mail coupons is a strategy employed by tobacco companies to promote their products. We found, in a US national study, that many adults received tobacco coupons, and receiving these coupons was associated with subsequent progression of smoking among nonsmokers, and continuation of smoking and daily smoking among smokers. Scrutiny over the use of direct mail coupons and its effects on population health is warranted. Future research is needed to evaluate the effect of different interventions to reduce the impact of these coupons on smoking behaviors.

Remote biochemical verification of tobacco use: Reducing costs and improving methodological rigor with mailed oral cotinine swabs.

INTRODUCTION: Multi-site tobacco cessation trials could benefit from remote biochemical verification for tobacco use without invasive, time-consuming, or expensive collection processes. To the authors' knowledge, there have been no previous studies examining the predictive validity of oral fluid swabs for the detection of cotinine levels with samples collected off-site and mailed for on-site interpretation. METHODS: Tobacco users were recruited through an online survey and participants who met the initial eligibility criteria were invited to take part. Those who elected to enroll provided two positive iScreen Oral Fluid Device (OFD) cotinine test samples during an in-office visit. One sample was used as a control and stored in a temperature-regulated location, while the other was mailed from one of ten surrounding counties. Mailing method and time from collection to mailing were varied, and results were assessed against control samples. RESULTS: Twenty tobacco users enrolled in the study. Participants ranged in age from 18 to 31 (M = 16.45, SD = 1.54). Several types of tobacco use were reported, with electronic cigarettes the most commonly reported product. None of the mailed sample interpretations changed from pre- to post-mailing, with up to twenty-one days from sample collection to results confirmation. CONCLUSIONS: Results indicate that the use of mailed oral swabs may be an easy to use, reliable, and low-cost option for the detection of cotinine in tobacco users when in-person collection is not feasible. Test result interpretations were found to be unchanged after mailing, and after extended post-collection time gaps.

An analysis of response rate and economic costs between mail and web-based surveys among practicing dentists: a randomized trial.

This study explored the economic costs and response rate of mail and web-based surveys with practicing dentists. A random sample of 6,000 practicing dentists was randomly assigned into three groups of 2,000: choice (mail or web-based), postal mail, or web-based. The Florida Tobacco Control Survey 2009, which is composed of 28 questions (including subject demographic questions), served as the survey instrument. A total of 1,232 surveys were returned by the three different groups (21% overall response rate). Response rates were best for the mail (26%) with the worst response rate coming from the Web group (11%). However, a cost-effectiveness analysis revealed that web surveys were 2.68 times more cost effective.

Association between prescription co-payment amount and compliance with adjuvant hormonal therapy in women with early-stage breast cancer.

PURPOSE: Noncompliance with adjuvant hormonal therapy among women with breast cancer is common. Little is known about the impact of financial factors, such as co-payments, on noncompliance. PATIENTS AND METHODS: We conducted a retrospective cohort study by using the pharmacy and medical claims database at Medco Health Solutions. Women older than age 50 years who were taking aromatase inhibitors (AIs) for resected breast cancer with two or more mail-order prescriptions, from January 1, 2007, to December 31, 2008, were identified. Patients who were eligible for Medicare were analyzed separately. Nonpersistence was defined as a prescription supply gap of more than 45 days without subsequent refill. Nonadherence was defined as a medication possession ratio less than 80% of eligible days. RESULTS: Of 8110 women younger than age 65 years, 1721 (21.1%) were nonpersistent and 863 (10.6%) were nonadherent. Among 14,050 women age 65 years or older, 3476 (24.7%) were nonpersistent and 1248 (8.9%) were nonadherent. In a multivariate analysis, nonpersistence (ever/never) in both age groups was associated with older age, having a non-oncologist write the prescription, and having a higher number of other prescriptions. Compared with a co-payment of less than $30, a co-payment of $30 to $89.99 for a 90-day prescription was associated with less persistence in women age 65 years or older (odds ratio [OR], 0.69; 95% CI, 0.62 to 0.75) but not among women younger than age 65, although a co-payment of more than $90 was associated with less persistence both in women younger than age 65 (OR, 0.82; 95% CI, 0.72 to 0.94) and those age 65 years or older (OR, 0.72; 95% CI, 0.65 to 0.80). Similar results were seen with nonadherence. CONCLUSION: We found that higher prescription co-payments were associated with both nonpersistence and nonadherence to AIs. This relationship was stronger in older women. Because noncompliance is associated with worse outcomes, future policy efforts should be directed toward interventions that would help patients with financial difficulties obtain life-saving medications.

Informed consent and research with stored biological samples.

OBJECTIVE: To report practical experience in obtaining consent for a retrospective study conducted at the Brazilian National Cancer Institute (INCA). The study involved review of medical records and analysis of paraffin blocks of patients surgically treated for colon cancer between 2000 and 2004. Attempts to obtain informed consent were made in compliance with the resolution 196/96 of the Brazilian National Health Council and determination of INCA Research Ethics Committee. METHODS: At scheduled appointments, we could approach only four patients for consent during three months. After attempting contact by phone, an information sheet summarizing the content of informed consent, two copies of the consent form and a prepaid return envelope were then mailed to the patients. RESULTS: Of the 155 consent forms mailed, 115 were returned (74%). Of these, 111 patients gave consent to participate in the study, one refused consent, and we were informed that three patients had died. The time course of return of these forms ranged from 2 to 89 days (median: 10 days). Attempts to contact patients by phone were successful in 60 out of 160 cases (37.5%). The Research Ethics Committee waived the requirement of consent for those who had died or not responded. Overall mailing cost was R$ 1,004.40. CONCLUSION: Obtaining consent from patients by phone and mail for a retrospective clinical study is feasible. Most patients responded to contact and gave consent to participate. However, the process entails costs and risks that cannot be overlooked.

Termo de consentimento e análise de material biológico armazenado / Consent procedures and research on stored biological samples

OBJETIVO: Relatar uma experiência envolvendo a obtenção de termo de consentimento livre e esclarecido (TCLE) para estudo retrospectivo realizado no Instituto Nacional de Câncer (INCA). O mesmo envolvia a revisão de prontuários e a análise de blocos de parafina de pacientes com câncer de cólon operados entre 2000 e 2004. Respeitando a resolução 196/96 do Conselho Nacional de Saúde e a determinação do Comitê de Ética em Pesquisa (CEP) do INCA, buscou-se obter o consentimento informado. MÉTODOS: Nas consultas agendadas, conseguiu-se aplicar o termo a apenas quatro pacientes, durante três meses. Foram enviadas então pelo correio duas cópias do TCLE, juntamente com um sumário e um envelope selado para o re-envio aos pesquisadores. Antes da postagem, tentou-se contato telefônico. RESULTADOS: Obteve-se retorno de 115 dos 155 TCLE enviados (74 por cento). Dentre as respostas recebidas, 111 consentiram participar do estudo, houve uma recusa e foi informado que três pacientes haviam falecido. O tempo entre o envio da correspondência e o recebimento da resposta variou entre 2 e 89 dias (mediana: 10 dias). Houve sucesso no contato telefônico com 60 dos 160 pacientes (37,5 por cento). Para os que já haviam falecido e para os que não retornaram o TCLE, o CEP aprovou a dispensa do mesmo. O custo final do envio dos envelopes foi de R$1.004,40. CONCLUSÃO: A busca de comunicação telefônica e postal com pacientes para a obtenção de TCLE de estudo clínico retrospectivo é factível. A maioria respondeu ao contato e consentiu participar. Há, porém, custos e riscos agregados que não podem ser desprezados.

OBJECTIVE: To present practical experience in obtaining consent form (CF) for a study performed at the "Instituto Nacional de Câncer" involving research on stored biologic samples from patients operated for colon cancer from 2000 to 2004. According to the Brazilian National Health Council resolution nº196/96, researchers must make every effort to obtain consent from patients participating in clinical studies, which is reinforced by the Research Ethics Committee (REC). METHODS: After attempting phone contact, two copies and a synopsis of the CF were posted to each patient, with a stampedreturn envelope. RESULTS: 160 patients were included in the study. The attempt of phone contact was successful with 60 of them (37.5 percent). The consent form was mailed to 155 patients: 115 posted it back (74 percent) Three patients had already passed away, 111 accepted and one refused to participate. The median time between posting and receiving the CF back was 10 days (interval: 2-89). The REC waived the requirement of CF for those who died and for the ones who did not reply. The final cost for sending the CF was R$1,004.40. CONCLUSION: Obtaining consent by postal and phone communication for retrospective genetic research with stored tissue samples is feasible. Most responded to contact and consented to participate, but there were costs and risks that cannot be neglected.

Direct mailing was a successful recruitment strategy for a lung-cancer screening trial.

OBJECTIVE: To analyze advertising, recruitment methods, and study participant demographics for the National Lung Screening Trial (NLST) site at Wake Forest University School of Medicine to define efficient ways to recruit participants for general clinical trials. STUDY DESIGN AND SETTING: Recruitment method data, demographics, geographic location, and date of enrollment were collected from all 1,112 NLST participants. Marketing data and financial records were analyzed to determine the effectiveness of each recruitment method. RESULTS: The total amount spent on advertising was $144,668, with the cost of enrollment per participant averaging $130. For black participants, the recruitment cost per person was $406, whereas for white and other race participants, the cost was $122 (P<0.0001). To encourage minority enrollment, $13,192 was spent on television advertising geared toward black viewers, resulting in eight black participants at an average cost per person of $1,649. Direct mailing cost $143 per participant recruited, whereas TV ads cost $382 per participant. CONCLUSION: Direct mailing to a targeted group was the most efficient way to recruit participants. Printed advertising methods, that is, newspaper ads and brochures, were quite effective, whereas television ads were expensive. Appropriate minority recruitment needs sufficient attention and resources to ensure census groups are adequately represented.

Cost effectiveness analysis of a population based screening programme for asymptomatic Chlamydia trachomatis infections in women by means of home obtained urine specimens.

OBJECTIVES: To evaluate the cost effectiveness of a systematic screening programme for asymptomatic Chlamydia trachomatis infections in a female inner city population. To determine the sensitivity of the cost effectiveness analysis to variation in the probability of developing sequelae. METHODS: A decision tree was constructed to evaluate health effects of the programme, such as averted sequelae of chlamydial infection. Cost effectiveness from a societal perspective was estimated for screening by means of a ligase chain reaction on mailed, home obtained urine specimens, in a population with a C trachomatis test prevalence of 2.9%. An extensive sensitivity analysis was performed for the probability of sequelae, the percentage of preventable pelvic inflammatory disease (PID), and the discount rate. RESULTS: The estimated net cost of curing one woman, aged 15-40 years, of a C trachomatis infection is US$1210. To prevent one major outcome (PID, tubal factor infertility, ectopic pregnancy, chronic pelvic pain, or neonatal pneumonia), 479 women would have to be screened. The net cost of preventing one major outcome is $15 800. Changing the probability of PID after chlamydial infection from 5% to 25% decreases the net cost per major outcome averted from $28 300 to $6380, a reduction of 78%. Results were less sensitive to variations in estimates for other sequelae. The breakeven prevalence of the programme ranges from 6.4% for the scenario with all probabilities for complications set at the maximum value to a prevalence of 100% for probabilities set at the minimum value. CONCLUSIONS: Systematic screening of all women aged 15-40 years for asymptomatic C trachomatis infections is not cost effective. Although the results of the analyses are sensitive to variation in the assumptions, the costs exceed the benefits, even in the most optimistic scenario.

A mail survey of United States hematologists and oncologists: a comparison of business reply versus stamped return envelopes.

Mailed surveys are a popular means of obtaining data on large populations. In July 1999 a mail survey was conducted among 3000 randomly selected members of the American Society of Hematology to assess their approach to diagnosis and treatment of polycythemia vera. Because the researchers and the study population are members of the same professional organization with a vested interest in the results, we anticipated that the advantages of return stamped postage seen in previous studies would be less significant. The response rate for stamped return envelopes was 38% versus 32% for business reply envelopes. This statistically significant difference (P =.0005) of six percentage points is comparable to previous research. Excluding labor, the total cost per returned survey was $2.62 for business reply envelopes versus $1.82 for stamped return envelopes. We conclude that stamped return envelopes are a more effective and cost-efficient means of procuring data from physician specialists.