Roadmap to improve the organized cancer screening programs - The case of colorectal cancer screening in Montenegro.

BACKGROUND: Implementation of organized cancer screening programs comes with many challenges and barriers, which may inhibit the achievement of the screening activities' desired benefits. In this paper we outline a plan for improving the colorectal cancer (CRC) screening system in Montenegro. METHODS: We formulated a roadmap, which was generally defined as a country-specific strategic plan to improve cancer screening programs. The roadmap development was an iterative, step-by-step process. First, we described the current screening program, then identified and described key barriers, and finally proposed actions to overcome them. Multiple sources of information (e.g., documents, expert opinions) were collected and processed by local and international stakeholders. RESULTS: The CRC screening program was implemented between 2013-2019 by gradually increasing the invitation of the target population. Key barriers of the implementation were defined: 1) Lack of colonoscopy capacity in the northern part of the country; 2) Inadequate information technology systems; 3) Inadequate public promotion of screening. The defined actions were related to overcoming lack of available resources (e.g., financial, human and technological), to improve the policy environment and the knowledge, and to facilitate information sharing. CONCLUSION: The collaboration between local stakeholders of CRC screening and researchers experienced in planning and evaluating screening programs resulted in the first comprehensive description of CRC screening in Montenegro, detailed understanding of key barriers that emerged during implementation and a carefully designed list of actions. The implementation of these actions and the evaluation of whether barriers were solved will be captured in the upcoming period by maintaining this collaboration.

Efficacy of repetitive transcranial magnetic stimulation (rTMS) adjunctive therapy for major depressive disorder (MDD) after two antidepressant treatment failures: meta-analysis of randomized sham-controlled trials.

BACKGROUND: Several meta-analyses demonstrated the efficacy of unilateral High-Frequency Left-sided (HFL) repetitive Transcranial Magnetic Stimulation (rTMS) for individuals with Major Depressive Disorder (MDD); however, results are contradictory due to heterogeneity of the included studies. METHODS: A systematic literature review (SLR) of English language articles published since 2000 was performed in March 2022 on PubMed and Scopus databases. Empirical evidence on the relative efficacy of rTMS treatment compared with standard pharmacotherapy in Treatment-Resistant Depression (TRD) were extracted. Random effects models were used to assess the effects of rTMS on response and remission rates. RESULTS: 19 randomized double-blinded sham-controlled studies were included for quantitative analysis for response (n = 854 patients) and 9 studies for remission (n = 551 patients). The risk ratio (RR) for response and remission are 2.25 and 2.78, respectively for patients after two treatment failures using rTMS as add-on treatment compared to standard pharmacotherapy. Cochrane's Q test showed no significant heterogeneity. No publication bias was detected. CONCLUSIONS: rTMS is significantly more effective than sham rTMS in TRD in response and remission outcomes and may be beneficial as an adjunctive treatment in patients with MDD after two treatment failures. This finding is consistent with previous meta-analyses; however, the effect size was smaller than in the formerly published literature.

Repetitive transcranial magnetic stimulation may be a cost-effective alternative to antidepressant therapy after two treatment failures in patients with major depressive disorder.

BACKGROUND: The cost-effectiveness of treatment strategies for patients with Major Depressive Disorder (MDD) who have not responded to two adequate treatments with antidepressants (TRD) are still unclear. The aim of this analysis was to evaluate the cost-effectiveness of add-on repetitive Transcranial Magnetic Stimulation (rTMS) compared with standard treatment. METHODS: A Markov-model simulated clinical events over one year from the perspective of healthcare payer. Third- and fourth-line treatment pathways (augmentation, antidepressant switch or combination, and Electro-Convulsive Therapy (ECT)) were defined based on medical practice guidelines. Transition probabilities were derived from a recent meta-analysis and scientific publications. Resource utilization and cost estimates were based on the patient-level database of a large university hospital. RESULTS: Incremental Quality-Adjusted Life Years (QALYs) and costs were 0.053 and 785 €, respectively, corresponding to an Incremental Cost-Effectiveness Ratio (ICER) of 14,670 € per QALY. The difference in cost between standard treatment and rTMS is explained by the rTMS sessions used in acute (€660) and maintenance (€57/month) treatments, partly offset by lower hospital costs due to higher remission rates in the rTMS arm. Key parameters driving the ICER were incremental utility of remission, unit cost of rTMS treatment and remission rate. At a threshold of €22,243 add-on rTMS is a cost-effective alternative to pharmacotherapy. Evidence on long-term effectiveness is not yet available, so results are estimated for a one-year period. CONCLUSION: Not only does rTMS treatment have beneficial clinical effects compared with drug therapy in TRD, but it also appears to offer good value-for-money, especially in centres with larger numbers of patients where unit costs can be kept low.

Estimates of costs for modelling return on investment from smoking cessation interventions.

BACKGROUND AND AIMS: Modelling return on investment (ROI) from smoking cessation interventions requires estimates of their costs and benefits. This paper describes a standardized method developed to source both economic costs of tobacco smoking and costs of implementing cessation interventions for a Europe-wide ROI model [European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD)]. DESIGN: Focused search of administrative and published data. A standardized checklist was developed in order to ensure consistency in methods of data collection. SETTING AND PARTICIPANTS: Adult population (15+ years) in Hungary, Netherlands, Germany, Spain and England. For passive smoking-related costs, child population (0-15 years) was also included. MEASUREMENTS: Costs of treating smoking-attributable diseases; productivity losses due to smoking-attributable absenteeism; and costs of implementing smoking cessation interventions. FINDINGS: Annual costs (per case) of treating smoking attributable lung cancer were between €5074 (Hungary) and €52 106 (Germany); coronary heart disease between €1521 (Spain) and €3955 (Netherlands); chronic obstructive pulmonary disease between €1280 (England) and €4199 (Spain); stroke between €1829 (Hungary) and €14 880 (Netherlands). Costs (per recipient) of smoking cessation medications were estimated to be: for standard duration of varenicline between €225 (England) and €465 (Hungary); for bupropion between €25 (Hungary) and €220 (Germany). Costs (per recipient) of providing behavioural support were also wide-ranging: one-to-one behavioural support between €34 (Hungary) and €474 (Netherlands); and group-based behavioural support between €12 (Hungary) and €257 (Germany). The costs (per recipient) of delivering brief physician advice were: €24 (England); €9 (Germany); €4 (Hungary); €33 (Netherlands); and €27 (Spain). CONCLUSIONS: Costs of treating smoking-attributable diseases as well as the costs of implementing smoking cessation interventions vary substantially across Hungary, Netherlands, Germany, Spain and England. Estimates for the costs of these diseases and interventions can contribute to return on investment estimates in support of national or regional policy decisions.

OPTIMIZING USABILITY OF AN ECONOMIC DECISION SUPPORT TOOL: PROTOTYPE OF THE EQUIPT TOOL.

OBJECTIVES: Economic decision-support tools can provide valuable information for tobacco control stakeholders, but their usability may impact the adoption of such tools. This study aims to illustrate a mixed-method usability evaluation of an economic decision-support tool for tobacco control, using the EQUIPT ROI tool prototype as a case study. METHODS: A cross-sectional mixed methods design was used, including a heuristic evaluation, a thinking aloud approach, and a questionnaire testing and exploring the usability of the Return of Investment tool. RESULTS: A total of sixty-six users evaluated the tool (thinking aloud) and completed the questionnaire. For the heuristic evaluation, four experts evaluated the interface. In total twenty-one percent of the respondents perceived good usability. A total of 118 usability problems were identified, from which twenty-six problems were categorized as most severe, indicating high priority to fix them before implementation. CONCLUSIONS: Combining user-based and expert-based evaluation methods is recommended as these were shown to identify unique usability problems. The evaluation provides input to optimize usability of a decision-support tool, and may serve as a vantage point for other developers to conduct usability evaluations to refine similar tools before wide-scale implementation. Such studies could reduce implementation gaps by optimizing usability, enhancing in turn the research impact of such interventions.

Cost-effectiveness of possible future smoking cessation strategies in Hungary: results from the EQUIPTMOD.

AIMS: To evaluate potential health and economic returns from implementing smoking cessation interventions in Hungary. METHODS: The EQUIPTMOD, a Markov-based economic model, was used to assess the cost-effectiveness of three implementation scenarios: (a) introducing a social marketing campaign; (b) doubling the reach of existing group-based behavioural support therapies and proactive telephone support; and (c) a combination of the two scenarios. All three scenarios were compared with current practice. The scenarios were chosen as feasible options available for Hungary based on the outcome of interviews with local stakeholders. Life-time costs and quality-adjusted life years (QALYs) were calculated from a health-care perspective. The analyses used various return on investment (ROI) estimates, including incremental cost-effectiveness ratios (ICERs), to compare the scenarios. Probabilistic sensitivity analyses assessed the extent to which the estimated mean ICERs were sensitive to the model input values. RESULTS: Introducing a social marketing campaign resulted in an increase of 0.3014 additional quitters per 1 000 smokers, translating to health-care cost-savings of €0.6495 per smoker compared with current practice. When the value of QALY gains was considered, cost-savings increased to €14.1598 per smoker. Doubling the reach of existing group-based behavioural support therapies and proactive telephone support resulted in health-care savings of €0.2539 per smoker (€3.9620 with the value of QALY gains), compared with current practice. The respective figures for the combined scenario were €0.8960 and €18.0062. Results were sensitive to model input values. CONCLUSIONS: According to the EQUIPTMOD modelling tool, it would be cost-effective for the Hungarian authorities introduce a social marketing campaign and double the reach of existing group-based behavioural support therapies and proactive telephone support. Such policies would more than pay for themselves in the long term.

Similarities and differences between stakeholders' opinions on using Health Technology Assessment (HTA) information across five European countries: results from the EQUIPT survey.

BACKGROUND: The European-study on Quantifying Utility of Investment in Protection from Tobacco (EQUIPT) project aimed to study transferability of economic evidence by co-creating the Tobacco Return On Investment (ROI) tool, previously developed in the United Kingdom, for four sample countries (Germany, Hungary, Spain and the Netherlands). The EQUIPT tool provides policymakers and stakeholders with customized information about the economic and wider returns on the investment in evidence-based tobacco control, including smoking cessation interventions. A Stakeholder Interview Survey was developed to engage with the stakeholders in early phases of the development and country adaptation of the ROI tool. The survey assessed stakeholders' information needs, awareness about underlying principles used in economic analyses, opinion about the importance, effectiveness and cost-effectiveness of tobacco control interventions, and willingness to use a Health Technology Assessment (HTA) tool such as the ROI tool. METHODS: A cross sectional study using a mixed method approach was conducted among participating stakeholders in the sample countries and the United Kingdom. The individual questionnaire contained open-ended questions as well as single choice and 7- or 3-point Likert-scale questions. The results corresponding to the priority and needs assessment and to the awareness of stakeholders about underlying principles used in economic analysis are analysed by country and stakeholder categories. RESULTS: Stakeholders considered it important that the decisions on the investments in tobacco control interventions should be supported by scientific evidence, including prevalence of smoking, cost of smoking, quality of life, mortality due to smoking, and effectiveness, cost-effectiveness and budget impact of smoking cessation interventions. The proposed ROI tool was required to provide this granularity of information. The majority of the stakeholders were aware of the general principles of economic analyses used in decision making contexts but they did not appear to have in-depth knowledge about specific technical details. Generally, stakeholders' answers showed larger variability by country than by stakeholder category. CONCLUSIONS: Stakeholders across different European countries viewed the use of HTA evidence to be an important factor in their decision-making process. Further, they considered themselves to be capable of interpreting the results from a ROI tool and were highly motivated to use it.

Understanding the stakeholders' intention to use economic decision-support tools: A cross-sectional study with the tobacco return on investment tool.

BACKGROUND: Despite an increased number of economic evaluations of tobacco control interventions, the uptake by stakeholders continues to be limited. Understanding the underlying mechanism in adopting such economic decision-support tools by stakeholders is therefore important. By applying the I-Change Model, this study aims to identify which factors determine potential uptake of an economic decision-support tool, i.e., the Return on Investment tool. METHODS: Stakeholders (decision-makers, purchasers of services/pharma products, professionals/service providers, evidence generators and advocates of health promotion) were interviewed in five countries, using an I-Change based questionnaire. MANOVA's were conducted to assess differences between intenders and non-intenders regarding beliefs. A multiple regression analysis was conducted to identify the main explanatory variables of intention to use an economic decision-support tool. FINDINGS: Ninety-three stakeholders participated. Significant differences in beliefs were found between non-intenders and intenders: risk perception, attitude, social support, and self-efficacy towards using the tool. Regression showed that demographics, pre-motivational, and motivational factors explained 69% of the variation in intention. DISCUSSION: This study is the first to provide a theoretical framework to understand differences in beliefs between stakeholders who do or do not intend to use economic decision-support tools, and empirically corroborating the framework. This contributes to our understanding of the facilitators and barriers to the uptake of these studies.

The cost-effectiveness of ulipristal acetate tablets in treating patients with moderate to severe symptoms of uterine fibroids.

OBJECTIVES: Ulipristal acetate is a selective progesterone receptor modulator that has been demonstrated to be an effective 3-month pre-operative treatment for moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The aim of this analysis was to assess the cost-effectiveness of 5mg ulipristal as an add-on therapy to standard pre-surgical observation and treatment in Hungary. STUDY DESIGN: A Markov model was developed using a 10-year time horizon. Ulipristal was compared with pre-surgical observation and immediate hysterectomy. The model comprised the following mutually exclusive health states: mild, moderate, severe, or persistent severe excessive bleeding disorder; myomectomy; post-myomectomy with mildly to moderately excessive bleeding disorder; post-myomectomy with severely excessive bleeding disorder; hysterectomy; post-hysterectomy; post-menopause; and death. Transition probabilities and utility values were obtained from clinical trials and the scientific literature. Resource utilisation and unit costs were derived from a consensus panel of clinical experts, National Health Insurance Fund tariffs, and publications. RESULTS: Adding a 3-month course of ulipristal to pre-operative observation was predicted to achieve an additional 0.021 quality-adjusted life years (QALYs) at an estimated incremental cost of €397, which would result in an incremental cost of €19,200/QALY. When 3 months of ulipristal therapy was compared with immediate hysterectomy, the incremental cost-effectiveness ratio was reduced to €3575/QALY. The results were most sensitive to the utility value of the post-hysterectomy health state but responsive to changes in other model parameters. CONCLUSIONS: The results of this analysis suggest that adding ulipristal treatment to standard pre-surgical therapy represents a good value for money in Hungary. The inclusion of societal benefits may considerably reduce the cost-effectiveness ratio.