Clinical Effectiveness of Traditional and Complementary Medicine Interventions in Combination with Nicotine Replacement Therapy on Smoking Cessation: A Randomized Controlled Pilot Trial.

Background: Smoking is associated with many preventable diseases and deaths. Globally, more than 6 million deaths per year are related to smoking. This study aimed to evaluate the pragmatic effectiveness of traditional and complementary medicine (T&CM) interventions for the smoking cessation treatment and to calculate the incremental cost-effectiveness ratio (ICER) of these interventions. Methods: The study design was a pragmatic, open-label randomized trial. The hypothesis of this trial was that the smoking cessation success rate increases with the addition of T&CM methods. The intervention group was provided T&CM interventions in addition to nicotine replacement therapy (NRT) and counseling, whereas the control group was treated with only NRT and counseling. Individuals received treatment for 4 weeks, then follow-up care for 20 weeks. Results: Forty-one participants were enrolled and assigned to either an intervention group or a control group at a ratio of 1:1. The odds ratio values at 4 weeks were 1.96 (0.51-8.51) in intention-to-treat analysis and 3.27 (0.75-17.75) in per-protocol analysis. The amount of smoking (cigarettes) decreased in both groups: from 17.2 ± 10.31 (baseline) to 1.7 ± 3.02 (4 weeks) in the intervention group and from 12.9 ± 5.47 (baseline) to 3.3 ± 5.96 (4 weeks) in the control group. The total medical costs per patient were $212.20 USD in the intervention group and $170.80 in the control group. The adjusted ICER of T&CM interventions was $13,355. Conclusions: This pilot study evaluated the clinical feasibility of T&CM used in conjunction with NRT and counseling for the smoking cessation treatment. However, there was no statistically significant effectiveness of T&CM interventions to raise cessation success rate. This study demonstrates the necessity for further studies based on large-scale randomized controlled trials.

Developing a laboratory model of smoking lapse targeting stress and brief nicotine deprivation.

Stress plays a significant role in the maintenance of, and relapse to, smoking. The current study aims to develop a human laboratory model examining stress-precipitated tobacco lapse following brief nicotine deprivation. Daily smokers (N = 48; 50% female) who were nicotine deprived for 3 hr received a personalized imagery induction (stress or neutral, within-subject, counterbalanced) on 2 separate days. Following imagery induction, participants were instructed that they could smoke or receive monetary reinforcement ($0.25, $0.50, $1.00; between-subjects) for every 5 min they chose to delay tobacco self-administration during a 50-min delay period. After the delay period, participants engaged in a 1-hr ad libitum smoking period. Tobacco craving and mood were assessed throughout. The primary aim was to determine whether stress imagery would reduce the ability to resist following a brief nicotine deprivation in a laboratory setting. A secondary goal identified which level of monetary reinforcement highlighted the effect of stress on reduced ability to resist smoking (i.e., resisting ∼25 min of the 50-min window). Overall, stress versus neutral imagery decreased the ability to resist smoking, increased craving and negative mood states, decreased positive mood, but did not change ad libitum smoking. Increased monetary reinforcement increased the ability to resist smoking. Planned comparisons examining lapse behavior within each monetary condition demonstrated that $0.50 produced the only significant difference between stress and neutral imagery, demonstrating target model behavior. Findings highlight that stress negatively impacts smoking lapse behavior and can be effectively modeled in the human laboratory with a brief, 3-hr deprivation window. (PsycINFO Database Record

Costs of the Smoking Cessation Program in Brazil.

OBJECTIVE: To assess the costs of the Smoking Cessation Program in the Brazilian Unified Health System and estimate the cost of its full implementation in a Brazilian municipality. METHODS: The intensive behavioral therapy and treatment for smoking cessation includes consultations, cognitive-behavioral group therapy sessions, and use of medicines. The costs of care and management of the program were estimated using micro-costing methods. The full implementation of the program in the municipality of Goiania, Goias was set as its expansion to meet the demand of all smokers motivated to quit in the municipality that would seek care at Brazilian Unified Health System. We considered direct medical and non-medical costs: human resources, medicines, consumables, general expenses, transport, travels, events, and capital costs. We included costs of federal, state, and municipal levels. The perspective of the analysis was that from the Brazilian Unified Health System. Sensitivity analysis was performed by varying parameters concerning the amount of activities and resources used. Data sources included a sample of primary care health units, municipal and state secretariats of health, and the Brazilian Ministry of Health. The costs were estimated in Brazilian Real (R$) for the year of 2010. RESULTS: The cost of the program in Goiania was R$429,079, with 78.0% regarding behavioral therapy and treatment of smoking. The cost per patient was R$534, and, per quitter, R$1,435. The full implementation of the program in the municipality of Goiania would generate a cost of R$20.28 million to attend 35,323 smokers. CONCLUSIONS: The Smoking Cessation Program has good performance in terms of cost per patient that quit smoking. In view of the burden of smoking in Brazil, the treatment for smoking cessation must be considered as a priority in allocating health resources. OBJETIVO: Analisar os custos do Programa de Tratamento do Tabagismo no Sistema Único de Saúde e estimar o custo de sua implementação plena em um município brasileiro. MÉTODOS: A abordagem intensiva e tratamento do tabagismo engloba consultas, sessões de terapia cognitivo-comportamental em grupo e uso de medicamentos. Os custos do atendimento e gerenciamento do programa foram estimados utilizando a metodologia do microcusteio. A implementação plena do programa no município de Goiânia, Goiás, foi definida como sua expansão para suprir a demanda de todos os fumantes motivados a parar de fumar no município que seriam atendidos pelo Sistema Único de Saúde. Foram considerados custos médicos e não médicos diretos: recursos humanos, medicamentos, material de consumo, despesas gerais, transporte, viagens, eventos e custos de capital. Foram incluídos custos dos níveis federal, estadual e municipal de gestão. A perspectiva da análise foi a do Sistema Único de Saúde. Análise de sensibilidade foi realizada variando parâmetros referentes à quantidade de atividades e aos recursos utilizados. As fontes de dados incluíram uma amostra de unidades de saúde da Atenção Primária, secretarias de saúde municipal e estadual e Ministério da Saúde. Os custos foram estimados em reais (R$) para o ano de 2010. RESULTADOS: O custo do programa em Goiânia foi de R$429.079, sendo 78,0% referentes à abordagem e tratamento do tabagismo. O custo por paciente foi de R$534 e, por paciente que deixou de fumar, de R$1.435. A implementação plena do programa no município de Goiânia geraria custo de R$20,28 milhões, para atender 35.323 fumantes. CONCLUSÕES: O Programa de Tratamento do Tabagismo tem bom desempenho em termos de custo por paciente que deixa de fumar. Tendo em vista a carga do tabagismo no Brasil, o tratamento para cessação de fumar deve ser considerado prioritário ao se programar a alocação de recursos de saúde.

An organisational change intervention for increasing the delivery of smoking cessation support in addiction treatment centres: study protocol for a randomized controlled trial.

BACKGROUND: The provision of smoking cessation support in Australian drug and alcohol treatment services is sub-optimal. This study examines the cost-effectiveness of an organisational change intervention to reduce smoking amongst clients attending drug and alcohol treatment services. METHODS/DESIGN: A cluster-randomised controlled trial will be conducted with drug and alcohol treatment centres as the unit of randomisation. Biochemically verified (carbon monoxide by breath analysis) client 7-day-point prevalence of smoking cessation at 6 weeks will be the primary outcome measure. The study will be conducted in 33 drug and alcohol treatment services in four mainland states and territories of Australia: New South Wales, Australian Capital Territory, Queensland, and South Australia. Eligible services are those with ongoing client contact and that include pharmacotherapy services, withdrawal management services, residential rehabilitation, counselling services, and case management services. Eligible clients are those aged over 16 years who are attending their first of a number of expected visits, are self-reported current smokers, proficient in the English language, and do not have severe untreated mental illness as identified by the service staff. Control services will continue to provide usual care to the clients. Intervention group services will receive an organisational change intervention, including assistance in developing smoke-free policies, nomination of champions, staff training and educational client and service resources, and free nicotine replacement therapy in order to integrate smoking cessation support as part of usual client care. DISCUSSION: If effective, the organisational change intervention has clear potential for implementation as part of the standard care in drug and alcohol treatment centres. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12615000204549 . Registered on 3 March 2015.

Costs of the Smoking Cessation Program in Brazil / Custos do Programa de Tratamento do Tabagismo no Brasil

ABSTRACT OBJECTIVE To assess the costs of the Smoking Cessation Program in the Brazilian Unified Health System and estimate the cost of its full implementation in a Brazilian municipality. METHODS The intensive behavioral therapy and treatment for smoking cessation includes consultations, cognitive-behavioral group therapy sessions, and use of medicines. The costs of care and management of the program were estimated using micro-costing methods. The full implementation of the program in the municipality of Goiania, Goias was set as its expansion to meet the demand of all smokers motivated to quit in the municipality that would seek care at Brazilian Unified Health System. We considered direct medical and non-medical costs: human resources, medicines, consumables, general expenses, transport, travels, events, and capital costs. We included costs of federal, state, and municipal levels. The perspective of the analysis was that from the Brazilian Unified Health System. Sensitivity analysis was performed by varying parameters concerning the amount of activities and resources used. Data sources included a sample of primary care health units, municipal and state secretariats of health, and the Brazilian Ministry of Health. The costs were estimated in Brazilian Real (R$) for the year of 2010. RESULTS The cost of the program in Goiania was R$429,079, with 78.0% regarding behavioral therapy and treatment of smoking. The cost per patient was R$534, and, per quitter, R$1,435. The full implementation of the program in the municipality of Goiania would generate a cost of R$20.28 million to attend 35,323 smokers. CONCLUSIONS The Smoking Cessation Program has good performance in terms of cost per patient that quit smoking. In view of the burden of smoking in Brazil, the treatment for smoking cessation must be considered as a priority in allocating health resources.

RESUMO OBJETIVO Analisar os custos do Programa de Tratamento do Tabagismo no Sistema Único de Saúde e estimar o custo de sua implementação plena em um município brasileiro. MÉTODOS A abordagem intensiva e tratamento do tabagismo engloba consultas, sessões de terapia cognitivo-comportamental em grupo e uso de medicamentos. Os custos do atendimento e gerenciamento do programa foram estimados utilizando a metodologia do microcusteio. A implementação plena do programa no município de Goiânia, Goiás, foi definida como sua expansão para suprir a demanda de todos os fumantes motivados a parar de fumar no município que seriam atendidos pelo Sistema Único de Saúde. Foram considerados custos médicos e não médicos diretos: recursos humanos, medicamentos, material de consumo, despesas gerais, transporte, viagens, eventos e custos de capital. Foram incluídos custos dos níveis federal, estadual e municipal de gestão. A perspectiva da análise foi a do Sistema Único de Saúde. Análise de sensibilidade foi realizada variando parâmetros referentes à quantidade de atividades e aos recursos utilizados. As fontes de dados incluíram uma amostra de unidades de saúde da Atenção Primária, secretarias de saúde municipal e estadual e Ministério da Saúde. Os custos foram estimados em reais (R$) para o ano de 2010. RESULTADOS O custo do programa em Goiânia foi de R$429.079, sendo 78,0% referentes à abordagem e tratamento do tabagismo. O custo por paciente foi de R$534 e, por paciente que deixou de fumar, de R$1.435. A implementação plena do programa no município de Goiânia geraria custo de R$20,28 milhões, para atender 35.323 fumantes. CONCLUSÕES O Programa de Tratamento do Tabagismo tem bom desempenho em termos de custo por paciente que deixa de fumar. Tendo em vista a carga do tabagismo no Brasil, o tratamento para cessação de fumar deve ser considerado prioritário ao se programar a alocação de recursos de saúde.

The effect of quitting smoking on costs and healthcare utilization in patients with chronic obstructive pulmonary disease: a comparison of current smokers versus ex-smokers in routine clinical practice.

PURPOSE: Chronic obstructive pulmonary disease (COPD) is a prevalent condition mainly related to smoking, which is associated with a substantial economic burden. The purpose was to compare healthcare resource utilization and costs according to smoking status in patients with COPD in routine clinical practice. METHODS: A retrospective cohort nested case-control study was designed. The cohort was composed of male and female COPD outpatients, 40 years or older, covered by the Badalona Serveis Assistencials (a health provider) health plan. Cases were current smokers with COPD and controls (two per case) were former smokers with COPD (at least 12 months without smoking), matched for age, sex, duration of COPD, and burden of comorbidity. The index date was the last visit recorded in the database, and the analysis was performed retrospectively on healthcare resource utilization data for the 12 months before the index date. RESULTS: A total of 930 COPD records were analyzed: 310 current and 620 former smokers [mean age 69.4 years (84.6 % male)]. Cases had more exacerbations, physician visits of any type, and drug therapies related to COPD were more common. As a consequence, current smokers had higher average annual healthcare costs: €3,784 (1,888) versus €2,302 (2,451), p < 0.001. This difference persisted after adjusting for severity of COPD. CONCLUSIONS: Current smokers with COPD had significantly higher use of healthcare resources, mainly COPD drugs and physician visits, compared with former smokers who had abstained for at least 12 months. As a consequence, current smokers had higher healthcare costs to the National Health System in Spain than ex-smokers.

Cost effectiveness of full coverage of the medical management of smoking cessation in France.

OBJECTIVE: To estimate the incremental cost effectiveness of full coverage of the medical management of smoking cessation from the perspective of statutory health insurance (SHI) in France. DESIGN AND POPULATION: Cost-effectiveness analysis based on a Markov state-transition decision analytic model was used to compare full SHI coverage of smoking cessation and actual coverage based on an annual €50 lump sum per insured person among current French smokers aged 15-75 years. We used a scenario approach to take into account the many different behaviours of smokers and the likely variability of SHI policy choices in terms of participation rate and number and frequency of attempts covered. INTERVENTIONS: Drug treatments for smoking cessation combined with six medical consultations including individual counselling. MAIN OUTCOMES MEASURES: The cost effectiveness of full coverage was expressed by the incremental cost-effectiveness ratio (ICER) in 2009 euros per life-year gained (LYG) at the lifetime horizon. RESULTS: The cost effectiveness per LYG for smokers ranged from €1786 to €2012, with an average value of €1911. The minimum value was very close to the maximum value with a difference of only €226. The cost-effectiveness ratio was only minimally sensitive to the participation rate, the number of attempts covered and the cessation rate. CONCLUSIONS: Compared to other health measures in primary and secondary prevention of cardiovascular disease already covered by SHI, full coverage of smoking cessation is the most cost-effective approach.

Neurolinguistic programming: a systematic review of the effects on health outcomes.

BACKGROUND: Neurolinguistic programming (NLP) in health care has captured the interest of doctors, healthcare professionals, and managers. AIM: To evaluate the effects of NLP on health-related outcomes. DESIGN AND SETTING: Systematic review of experimental studies. METHOD: The following data sources were searched: MEDLINE, PsycINFO, ASSIA, AMED, CINAHL, Web of Knowledge, CENTRAL, NLP specialist databases, reference lists, review articles, and NLP professional associations, training providers, and research groups. RESULTS: Searches revealed 1459 titles from which 10 experimental studies were included. Five studies were randomised controlled trials (RCTs) and five were pre-post studies. Targeted health conditions were anxiety disorders, weight maintenance, morning sickness, substance misuse, and claustrophobia during MRI scanning. NLP interventions were mainly delivered across 4-20 sessions although three were single session. Eighteen outcomes were reported and the RCT sample sizes ranged from 22 to 106. Four RCTs reported no significant between group differences with the fifth finding in favour of the NLP arm (F = 8.114, P<0.001). Three RCTs and five pre-post studies reported within group improvements. Risk of bias across all studies was high or uncertain. CONCLUSION: There is little evidence that NLP interventions improve health-related outcomes. This conclusion reflects the limited quantity and quality of NLP research, rather than robust evidence of no effect. There is currently insufficient evidence to support the allocation of NHS resources to NLP activities outside of research purposes.

[Smoking cessation interventions in Mexico: analysis of the willingness to pay for an effective method to quit]. / Intervenciones para dejar de fumar en México: análisis de disponibilidad a pagar por un método efectivo de cesación.

OBJECTIVE: To identify environmental, demographic and socioeconomic factors associated with the desire to quit, estimate the willingness to pay (WTP) for smoking cessation treatments (SCT) and to identify associated factors with this valuation. MATERIALS AND METHODS: Using the Global Adult Tobacco Survey, Mexico 2009, we characterized 1 626 smokers. Logistic and multiple lineal regression models allowed to identify associated factors with the desire to quit and the WTP for SCT. RESULTS: 82.2 % of the current smokers who did not want to quit were men. Between those who wanted to quit, 49.8 % had been consuming tobacco every day, for more than 16 years, 57 % had made cessation attempts in the past, and around 10% knew about the existence of centers to help quit smoking. Average WTP was 2 708 Mexican pesos (MXP), with differences by educational and socioeconomic levels. CONCLUSIONS: This evidence supports policymakers in the design of smoking cessation interventions improving national health system interventions for quit smoking.

Intervenciones para dejar de fumar en México: análisis de disponibilidad a pagar por un método efectivo de cesación / Smoking cessation interventions in Mexico: analysis of the willingness to pay for an effective method to quit

OBJETIVO: Identificar factores socioeconómicos, demográficos, historia de tabaquismo y contextuales asociados con el deseo de dejar de fumar, estimar la disponibilidad a pagar (DAP) por tratamientos de cesación tabáquica (TCT) efectivos, e identificar sus factores asociados. MATERIAL Y MÉTODOS: Mediante la Encuesta Global de Tabaquismo en Adultos, México 2009, caracterizamos a 1 626 fumadores. Modelos logit y de regresión lineal múltiple permitieron identificar factores asociados con el deseo de dejar de fumar y la DAP. RESULTADOS: 82.2% de los fumadores que no deseaban dejar de fumar fueron hombres. Entre quienes deseaban dejar de fumar, 49.8% fumaba diariamente y reportó más de 16 años de fumar, 57% manifestó intentos previos de cesación y 10% conocer centros de ayuda. La DAP promedio fue 2 708 MXN, destacando diferencias por nivel socioeconómico y educativo. CONCLUSIONES: Se contribuye al diseño de estrategias de cesación diferenciadas, propiciando mejoras en la respuesta del sistema de salud al combate del tabaquismo en México.

OBJECTIVE: To identify environmental, demographic and socioeconomic factors associated with the desire to quit, estimate the willingness to pay (WTP) for smoking cessation treatments (SCT) and to identify associated factors with this valuation. MATERIALS AND METHODS: Using the Global Adult Tobacco Survey, Mexico 2009, we characterized 1 626 smokers. Logistic and multiple lineal regression models allowed to identify associated factors with the desire to quit and the WTP for SCT. RESULTS: 82.2 % of the current smokers who did not want to quit were men. Between those who wanted to quit, 49.8 % had been consuming tobacco every day, for more than 16 years, 57 % had made cessation attempts in the past, and around 10% knew about the existence of centers to help quit smoking. Average WTP was 2 708 Mexican pesos (MXP), with differences by educational and socioeconomic levels. CONCLUSIONS: This evidence supports policymakers in the design of smoking cessation interventions improving national health system interventions for quit smoking.

Reimbursing dentists for smoking cessation treatment: views from dental insurers.

INTRODUCTION: Screening and delivery of evidence-based interventions by dentists is an effective way to reduce tobacco use. However, dental visits remain an underutilized opportunity for the treatment of tobacco dependence. This is, in part, because the current reimbursement structure does not support expansion of dental providers' role in this arena. The purpose of this study was to interview dental insurers to assess attitudes toward tobacco use treatment in dental practice, pros and cons of offering dental provider reimbursement, and barriers to instituting a tobacco use treatment-related payment policy for dental providers. METHODS: Semi-structured interviews were conducted with 11 dental insurance company executives. Participants were identified using a targeted sampling method and represented viewpoints from a significant share of companies within the dental insurance industry. RESULTS: All insurers believed that screening and intervention for tobacco use was an appropriate part of routine care during a dental visit. Several indicated a need for more evidence of clinical and cost-effectiveness before reimbursement for these services could be actualized. Lack of purchaser demand, questionable returns on investment, and segregation of the medical and dental insurance markets were cited as additional barriers to coverage. CONCLUSIONS: Dissemination of findings on efficacy and additional research on financial returns could help to promote uptake of coverage by insurers. Wider issues of integration between dental and medical care and payment systems must be addressed in order to expand opportunities for preventive services in dental care settings.

The cost-effectiveness of an extended course (12+12 weeks) of varenicline plus brief counselling compared with other reimbursed smoking cessation interventions in Belgium, from a public payer perspective.

OBJECTIVE: To evaluate the cost-effectiveness of an extended (12+12 weeks) course of varenicline plus brief counselling compared with the currently reimbursed smoking cessation interventions (in combination with brief counselling) in Belgium, from a public payer perspective. METHODS: The previously published version of the BENESCO model which included the extended course of varenicline was updated with recent publically available demographic and cost data from Belgium. RESULTS: The extended course of varenicline plus brief counselling has an incremental cost per quality adjusted life year gained of 1101€ compared with a nonextended 12-week course of varenicline (plus brief counselling). The extended course of varenicline dominates all other comparators in this analysis. CONCLUSIONS: The extended course of varenicline (12 weeks followed by 12 weeks maintenance therapy in successful quitters) plus brief counselling is a highly cost-effective alternative to a non-extended (12 weeks only) course of varenicline plus brief counselling. This strategy dominates the other alternative smoking cessation interventions currently reimbursed in Belgium.

Development and validation of a microsimulation economic model to evaluate the disease burden associated with smoking and the cost-effectiveness of tobacco control interventions in Latin America.

OBJECTIVE: To describe the development and validation of a health economic model (HEM) to address the tobacco disease burden and the cost-effectiveness of smoking cessation interventions (SCI) in seven Latin American countries. METHODS: The preparatory stage included the organization of the research network, analysis of availability of epidemiologic data, and a survey to health decision makers to explore country-specific information needs. The development stage involved the harmonization of a methodology to retrieve local relevant parameters and develop the model structure. Calibration and validation was performed using a selected country dataset (Argentina 2005). Predicted event rates were compared to the published rates used as model inputs. External validation was undertaken against epidemiologic studies that were not used to provide input data. RESULTS: Sixty-eight decision makers were surveyed. A microsimulation HEM was built considering the availability and quality of epidemiologic data and relevant outcomes conceived to suit the identified information needs of decision makers. It considers all tobacco-related diseases (i.e., heart, cerebrovascular and chronic obstructive pulmonary disease, pneumonia/influenza, lung cancer, and nine other neoplasms) and can incorporate individual- and population-level interventions. The calibrated model showed all simulated event rates falling within ± 10% of the sources (-9%-+5%). External validation showed a high correlation between published data and model results. CONCLUSIONS: This evidence-based, internally and externally valid HEM for the assessment of the effects of smoking and SCIs incorporates a broad spectrum of tobacco related diseases, SCI, and benefit measures. It could be a useful policy-making tool to estimate tobacco burden and cost-effectiveness of SCI.

Predictors of what smokers say they will do in response to future price increases. Findings from the International Tobacco Control (ITC) Four Country Survey.

INTRODUCTION: Given the impact of higher tobacco prices on smoking cessation, we studied the role of future cigarette prices on forming expectation about smoking behavior. METHODS: Using a random sample of 9,058 adult cigarette smokers from the United States, Canada, Australia, and the United Kingdom collected in 2002, we examined predictors of what smokers say they will do in response to a hypothetical 50% increase in the price they paid for their last cigarette purchase. A series of regression analyses examined factors associated with intentions that have a positive impact on health, that is, intentions to quit and/or to consume fewer cigarettes. RESULTS: The quit and/or smoke less intentions were more pronounced among those who lived in areas with higher average cigarette prices and who paid higher prices for their brand of choice during the last purchase. The magnitude of the price increase is a more important predictor of an intention to quit/smoke less compared with the average cigarette price. CONCLUSIONS: The availability of alternative (cheaper) cigarette sources may reduce but would not eliminate the impact of higher prices/taxes on smokers' expected behavior that has been linked to actual quit intentions and quitting in follow-up surveys.

Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial.

BACKGROUND: Telephone quit lines are accessible to many smokers and are used to engage motivated smokers to make quit attempts. Smoking cessation counselling provided via telephone can either be reactive (i.e. primarily involving the provision of evidence-based information), or proactive (i.e. primarily involving repeated, sequenced calls from and interaction with trained cessation counsellors). Some studies have found proactive telephone counselling more effective and this trial will investigate whether or not proactive telephone support for smoking cessation, delivered through the National Health Service (NHS) Smoking Helpline is more effective or cost-effective than reactive support. It will also investigate whether or not providing nicotine replacement therapy (NRT), in addition to telephone counselling, has an adjunctive impact on smoking cessation rates and whether or not this is cost effective. METHODS: This will be a parallel group, factorial design RCT, conducted through the English national NHS Smoking Helpline which is run from headquarters in Glasgow. Participants will be smokers who call the helpline from any location in England and who wish to stop smoking. If 644 participants are recruited to four equally-sized trial groups (total sample size = 2576), the trial will have 90% power for detecting a treatment effect (Odds Ratio) of 1.5 for each of the two interventions: i) proactive versus reactive support and ii) the offer of NRT versus no offer. The primary outcome measure for the study is self-reported, prolonged abstinence from smoking for at least six months following an agreed quit date. A concurrent health economic evaluation will investigate the cost effectiveness of the two interventions when delivered via a telephone helpline. DISCUSSION: The PORTSSS trial will provide high quality evidence to determine the most appropriate kind of counselling which should be provided via the NHS Smoking Helpline and also whether or not an additional offer of cost-free NRT is effective and cost effective for smoking cessation.

Changes in health care costs before and after smoking cessation.

Previous research on health care costs among former smokers suggests that quitters incur greater health care costs for up to 4 years after cessation compared with continuing smokers. However, little is known about the relationship between health care costs and utilization in the periods before as well as after cessation. The present study used a retrospective cohort design with automated health plan and primary data to examine the health care costs and clinical experiences before and after smoking cessation among former smokers compared with a sample of continuing smokers. Subjects were a random sample of adults (aged 25 and older) whose smoking status was identified by a physician during a primary care visit to the Group Health Cooperative (GHC), a nonprofit, integrated health care delivery system in western Washington state. Total direct health care costs among former smokers began to rise in the quarter prior to cessation and were significantly greater (p < .001) than those of continuing smokers in the quarter immediately following cessation. This difference dissipated within one quarter following cessation. We replicated the postquit cost spike among former smokers found by other research and showed that this spike dissipated within the first year postquit. Smoking cessation did not result in sustained cost increases among former smokers.

Creating standard cost measures across integrated health care delivery systems.

BACKGROUND: Economic analyses are increasingly important in medical research. Accuracy often requires that they include large, diverse populations, which requires data from multiple sources. The difficulty is in making the data comparable across different settings. This article focuses on how to create comparable measures of health care resource use and cost using data from seven health plans and delivery systems participating in the Cancer Research Network's HMOs Investigating Tobacco study. METHODS: We used a data inventory to identify variation in data capture across sites and used data dictionaries to develop algorithms for assigning standardized cost to the three major components of health care use: outpatient, inpatient, and pharmacy. RESULTS: The plans included in this study varied from fully integrated, closed-panel models to plans and delivery systems that include network or independent physician association components. Information derived from the data inventory and data dictionary instruments demonstrated a substantial variation in both the content and capture of data across all sites and across all components of usage. The methods we employed for cost allocation varied by usage component and were based on our ability to leverage the data points available to best reflect actual resource use. CONCLUSIONS: The importance of this article is the method of ascertaining, cataloging, and addressing the within- and between-plan differences in health care resource use. Second, the decisions we made to address the differences between health plans provide other researchers a starting point when creating a cost algorithm for multisite retrospective research.