Oral cancer screening using mobile phone-based(mHealth) approach versus conventional oral examination approach, protocol of a cluster randomized study with cost-effectiveness analysis.

INTRODUCTION: Oral cancer is a significant health problem in India. Diagnosis is often delayed. The effectiveness of conventional oral screening has been shown in the Trivandrum oral cancer screening study. The present study will be a step forward to test a mobile phone-based (the mHealth approach) comparing it with the conventional approach. The purpose of this paper is to report the protocol for this study. The primary objective will be to compare both methods in diagnosing oral potentially malignant disorders and cancers. The secondary objective would be to study the cost-effectiveness. METHODS AND ANALYSIS: This will be a cluster-randomized clinical trial of the population in Ernakulam district of Kerala state in India. They will undergo oral cancer screening by community health workers, who will be pre-assigned to the randomly allotted intervention (mHealth) or control (conventional method) clusters. We will enrol a minimum of 9696 subjects from all 6 clusters over 18 months. The cost-effectiveness of the two strategies for oral screening will be determined using data from this randomized controlled trial. The incremental cost per oral cancer/high-risk dysplasia detected, and the incremental cost per life saved will be reported. We will conduct sensitivity and scenario analysis to evaluate the robustness of the findings. ETHICS AND DISSEMINATION: When completed, this will be the first cluster randomized population-based study to test the technology-based approach in India. The knowledge from this study will indicate whether specialists can make a remote diagnosis of oral lesions accurately based on the information gathered using a mobile phone health application and whether the mHealth strategy will be cost-effective in Oral cancer screening. The study will follow the ethical guidelines and will be published in an indexed journal.

Economic evaluation of compression stockings for the prevention of venous leg ulcer recurrence in Ontario.

OBJECTIVE: Approximately between 1.5 and 3.0 per 1000 people are affected by venous leg ulcers (VLUs). The treatment and management of VLUs is costly and recurrence is a major concern. There is evidence that compression stockings can reduce the rate of re-ulceration compared with no compression. We present the first cost-effective analysis of compression stockings in preventing recurrence of VLUs from the perspective of the Ontario healthcare system. METHOD: A cost-utility analysis with a five-year time horizon was conducted. Use of compression stockings was compared with usual care (no compression stockings). We simulated a hypothetical cohort of 65-year-old patients with healed VLUs, using a state-transition model. Model input parameters were obtained mainly from the published literature. We estimated quality-adjusted life years (QALYs) gained and direct medical costs. We conducted various sensitivity analyses. RESULTS: Compared with usual care, compression stockings were associated with higher costs and increased QALYs. Cost-utility analysis showed that the incremental cost-effectiveness ratio of compression stockings was $23,864 per QALY gained compared with no compression stockings. The most influential drivers of cost-effectiveness were the utility value of healed VLUs, cost of stockings, number of stocking replacements, monthly prevention cost and the risk of VLU recurrence. CONCLUSION: Compared with usual care, compression stockings were cost-effective in preventing VLUs, using a willingness-to-pay threshold of $50,000. These observations were consistent even when uncertainty in model inputs and parameters were considered.

A Comparison of Different Analysis Methods for Reconstructed Survival Data to Inform Cost­Effectiveness Analysis.

OBJECTIVES: The aim of this study was to use Microsoft Excel spreadsheet software to fit parametric survival distributions. We also explain the differences between individual patient data (IPD) and survival data reconstructed in Excel and SAS. METHODS: Three sets of patient data on overall survival were compared using different methods: 'original' IPD, 'reconstructed SAS', and 'reconstructed Excel'. The best-fit distribution was selected using visual observation, supported by linear plots of predicted probabilities, goodness-of-fit coefficients, and the sum of squared error of prediction. Outcomes included the incremental cost-effectiveness ratio (ICER), incremental net benefit (INB), incremental cost, and life-years gained over short-term and lifetime horizons. These were compared for different data sets. RESULTS: In this example, log-normal, log-logistic, and Weibull distributions showed best-fit with the visual tests and goodness-of-fit statistics. Weibull and exponential distributions showed significant differences compared with IPD data. Data on short-term (5 years) time horizons produced by different data re-creation methods showed closeness with data reconstructed from SAS. The ICER and INB results were dependent on the time horizon and selected parametric distribution from the model. CONCLUSIONS: Different approaches used in fitting parametric survival distributions yielded predicted probabilities that substantially differed from those using original IPD. Our study highlights the importance of following guidelines for economic evaluations with a systematic approach to parametric survival analysis techniques in order to select best fitting parametric survival distributions.

Review of Pharmacoeconomic Studies in Russian Cancer Research: An Outside View.

BACKGROUND: There is an increasing number of Russian economic evaluation studies in oncology, the scope and quality of which are unknown. OBJECTIVES: This study aimed to assess the scope and quality of economic evaluations in oncology, with the goal of elucidating implications for improving their use in Russia. METHODS: Online databases were searched for oncologic economic evaluations written in Russian. Data were extracted and assessed with the Quality of Health Economic Studies (QHES) instrument. In addition, the QHES was modified to overcome double-barreled items in a single criterion. RESULTS: Of 29 articles identified, 15 met study criteria and were included in the review. Most studies analyzed cost-effectiveness of first- and second-line therapies for lung and kidney cancer. The others analyzed prostate, breast, and colorectal cancers and lymphoma. The QHES mean quality score for the reviewed studies was 74 (and 69 with the modified tool). Comparison of the quality of different study types revealed that cost utility studies and studies that used decision trees and Markov models had the highest mean quality score. Clear statements regarding bias, study limitations, uncertainty, study perspectives, and funding source were commonly absent in the reviewed studies. CONCLUSION: Our review indicates that oncologic economic evaluations published in Russian are limited in scope and number. In addition, they demonstrate opportunities for improvement in several important technical areas.

Economic evaluation of smoking cessation in Ontario's regional cancer programs.

Quitting smoking after a diagnosis of cancer results in greater response to treatment and decreased risk of disease recurrence and second primary cancers. The objective of this study was to evaluate the potential cost-effectiveness of two smoking cessation approaches: the current basic smoking cessation program consisting of screening for tobacco use, advice, and referral; and a best practice smoking cessation program that includes the current basic program with the addition of pharmacological therapy, counseling, and follow-up. A Markov model was constructed that followed 65-year-old smokers with cancer over a lifetime horizon. Transition probabilities and mortality estimates were obtained from the published literature. Costs were obtained from standard costing sources in Ontario and reports. Probabilistic and deterministic sensitivity analyses were conducted to address parameter uncertainties. For smokers with cancer, the best practice smoking cessation program was more effective and more costly than the basic smoking cessation program. The incremental cost-effectiveness ratio of the best practice smoking cessation program compared to the basic smoking cessation program was $3367 per QALY gained and $5050 per LY gained for males, and $2050 per QALY gained and $4100 per LY gained for females. Results were most sensitive to the hazard ratio of mortality for former and current smokers, the probability of quitting smoking through participation in the program and smoking-attributable costs. The study results suggested that a best practice smoking cessation program could be a cost-effective option. These findings can support and guide implementation of smoking cessation programs.

A Review and Meta-analysis of Colorectal Cancer Utilities.

OBJECTIVE: To perform a systematic review of utility weights for colorectal cancer (CRC) health states reported in the scientific literature and to determine the effects of disease factors, patient characteristics, and utility methods on utility values. METHODS: We identified 26 articles written in English and published from January 1980 to January 2013, providing 351 unique utilities for CRC health states elicited from 6546 unique respondents. The CRC utility data were analyzed using linear mixed-effects models with CRC type, stage, time to or from initial care, utility measurement instrument, and administration method as independent variables. RESULTS: In the base case model, the estimated utility for a patient with stage I to III CRC more than 1 year after surgery, rated using a self-administered time tradeoff instrument, was 0.90. Stage, time to or from initial care, and utility measurement instrument were associated with statistically significant utility differences ranging from -0.19 to 0.02. Utilities for patients with stage IV cancer were 0.19 lower (P < 0.001) than for those with stage I to III cancer. Utilities elicited at more than 1 year after surgery were 0.05 higher than those elicited at 3 months after surgery (P = 0.008). Estimates of differences between utility measurement instruments were sensitive to how repeated scores in the same patient group were treated, and other findings were sensitive to how the disease stage was modeled and method of administration. CONCLUSIONS: Variations in reported utilities are associated with factors such as cancer stage, time to or from initial care, and utility measurement instrument. More research is needed to study why apparently similar patients report different quality of life.

Cost effectiveness of EML4-ALK fusion testing and first-line crizotinib treatment for patients with advanced ALK-positive non-small-cell lung cancer.

PURPOSE: ALK-targeted therapy with crizotinib offers significant improvement in clinical outcomes for the treatment of EML4-ALK fusion-positive non-small-cell lung cancer (NSCLC). We estimated the cost effectiveness of EML4-ALK fusion testing in combination with targeted first-line crizotinib treatment in Ontario. PATIENTS AND METHODS: A cost-effectiveness analysis was conducted using a Markov model from the Canadian Public health (Ontario) perspective and a lifetime horizon in patients with stage IV NSCLC with nonsquamous histology. Transition probabilities and mortality rates were calculated from the Ontario Cancer Registry and Cancer Care Ontario New Drug Funding Program (CCO NDFP). Costs were obtained from the Ontario Case Costing Initiative, CCO NDFP, University Health Network, and literature. RESULTS: Molecular testing with first-line targeted crizotinib treatment in the population with advanced nonsquamous NSCLC resulted in a gain of 0.011 quality-adjusted life-years (QALYs) compared with standard care. The incremental cost was Canadian $2,725 per patient, and the incremental cost-effectiveness ratio (ICER) was $255,970 per QALY gained. Among patients with known EML4-ALK-positive advanced NSCLC, first-line crizotinib therapy provided 0.379 additional QALYs, cost an additional $95,043 compared with standard care, and produced an ICER of $250,632 per QALY gained. The major driver of cost effectiveness was drug price. CONCLUSION: EML4-ALK fusion testing in stage IV nonsquamous NSCLC with crizotinib treatment for ALK-positive patients is not cost effective in the setting of high drug costs and a low biomarker frequency in the population.

Genetic testing in combination with preventive donepezil treatment for patients with amnestic mild cognitive impairment: an exploratory economic evaluation of personalized medicine.

OBJECTIVE: To evaluate the cost effectiveness of genetic screening for the apolipoprotein (APOE) ε4 allele in combination with preventive donepezil treatment in comparison with the standard of care for amnestic mild cognitive impairment (AMCI) patients in Canada. METHODS: We performed a cost-effectiveness analysis using a Markov model with a societal perspective and a time horizon of 30 years. For each strategy, we calculated quality-adjusted life-years (QALYs), using utilities from the literature. Costs were also based on the literature and, when appropriate, Ontario sources. One-way and probabilistic sensitivity analyses were performed. Expected value of perfect information (EVPI) analysis was conducted to explore the value of future research. RESULTS: The base case results in our exploratory study suggest that the combination of genetic testing and preventive donepezil treatment resulted in a gain of 0.027 QALYs and an incremental cost of $1,015 (in 2009 Canadian dollars [Can$]), compared with the standard of care. The incremental cost-effectiveness ratio (ICER) for the base case was Can$38,016 per QALY. The ICER was sensitive to the effectiveness of donepezil in slowing the rate of progression to Alzheimer's disease (AD), utility in AMCI patients, and AD and donepezil treatment costs. EVPI analysis showed that additional information on these parameters would be of value. CONCLUSION: Using presently available clinical evidence, this exploratory study illustrates that genetic testing combined with preventive donepezil treatment for AMCI patients may be economically attractive. Since our results were based on a secondary post hoc analysis, our study alone is insufficient to warrant recommending APOE genotyping in AMCI patients. Future research on the effectiveness of preventive donepezil as a targeted therapy is recommended.

A review of economic evaluations of genetic testing services and interventions (2004-2009).

To review economic evaluations of genetic interventions published between 2004 and 2009 and assess the quality of the identified studies, we searched for economic evaluations of genetic testing and interventions published between 2004 and 2009. Studies that met inclusion criteria were reviewed and their quality then assessed using a validated instrument-the Quality of Health Economic Studies. Of 54 articles identified, 26 met study criteria and were included in the review. These studies span a number of clinical indications, genetic tests, and interventions, but the majority (92%) focuses on genetic interventions for preventive screening and increasing treatment efficacy. The mean quality score for the reviewed studies was 89.8. Comparison of the quality of different study types revealed that cost-utility studies and studies that used a combined decision tree and Markov model had the highest mean quality scores. Clear statements regarding bias, funding source, and study perspective were commonly lacking in the reviewed studies. Although the reviewed studies were of fairly high quality, we found Quality of Health Economic Studies methodology for grading the quality of economic evaluations challenging and observed no statistically significant improvement in quality of studies between the periods of 1995-2004 and 2004-2009.