Healthcare Policy Decision Makers Research Articles

Healthcare coverage affects survival of EGFR-mutant Thai lung cancer patients.

Despite significant benefits of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment in patients with EGFR-mutated NSCLC, access remains limited in Thailand and elsewhere. Retrospective analysis of patients with locally advanced/recurrent NSCLC and known EGFR mutation (EGFRm) status treated at Ramathibodi Hospital (2012-2017). Prognostic factors for overall survival (OS), including treatment type and healthcare coverage, were analyzed using Cox regression. Of 750 patients, 56.3% were EGFRm-positive. After first-line therapy (n=646), 29.4% received no subsequent (second-line) treatment. EGFR-TKI-treated EGFRm-positive patients survived significantly longer than EGFRm-negative patients without EGFR-TKIs (median OS [mOS] 36.4 vs. 11.9 months; hazard ratio HR=0.38 [95%CI 0.32-0.46], P<0.001). Cox regression indicated significantly longer OS in patients with comprehensive healthcare coverage that included reimbursement of EGFR-TKIs, versus basic coverage (mOS 27.2 vs. 18.3 months; adjusted HR=0.73 [95%CI 0.59-0.90]). Compared with best supportive care (BSC; reference), EGFR-TKI-treated patients survived significantly longer (mOS 36.5 months; adjusted HR (aHR)=0.26 [95%CI 0.19-0.34]), and versus chemotherapy alone (14.5 months; aHR=0.60 [95%CI 0.47-0.78]). In EGFRm-positive patients (n=422), relative survival benefit of EGFR-TKI treatment remained highly significant (aHR[EGFR-TKI]=0.19 [95%CI 0.12-0.29]; aHR(chemotherapy only)=0.50 [95%CI 0.30-0.85]; reference:BSC), indicating that healthcare coverage (reimbursement) affected treatment choice and survival. Our analysis describes EGFRm prevalence and survival benefit of EGFR-TKI therapy for EGFRm-positive NSCLC patients treated from 2012-2017, one of the largest such Thai datasets. Together with research by others, these findings contributed evidence supporting the decision to broaden erlotinib access on healthcare schemes in Thailand from 2021, demonstrating the value of local real-world outcome data for healthcare policy decision-making.

Use of Personal Protective Equipment during Surgical Procedures Including Aerosol-Generating Procedures in Reducing the Risk of SARS-CoV-2 Viral Transmission: A Rapid Review

Introduction. COVID-19 infection spreads through respiratory droplets, contact, and airborne transmission. During aerosol-generating procedures (AGPs), the risk of spreading SARS-CoV-2 via aerosols is increased significantly. This rapid review determined the association between using personal protective equipment (PPE) during AGPs, including those during surgery, among confirmed or suspected patients with COVID-19 and the risk of infection among healthcare workers.&#x0D; Method. A systematic search of electronic databases MEDLINE, EBSCO, Science Direct, Google Scholar, and Cochrane CENTRAL base was performed last March 21, 2021, using the Boolean combination of keywords for SARS-CoV-2, PPE, and surgery. Two reviewers screened the articles for relevance and extracted the data from the included studies. We critically appraised the included studies using criteria from the Painless Evidence-Based Medicine Evaluation of Articles on Harm. We used RevMan for data pooling, with a 40% heterogeneity cut-off score. GRADEpro guideline development tool determined the quality of evidence of the included studies.&#x0D; Results. Five observational studies investigated the effectiveness of PPE use in reducing SARS-CoV-2 transmission among healthcare workers during any AGPs. The use of N95 masks (OR 0.37 [95% CI 0.21, 0.67], 1 study, n=195), surgical gown (OR 0.59 [95% CI 0.46, 0.77] I2= 0%, 2 studies, n= 941) and gloves (OR 0.42 [95% CI 0.43, 0.55] I2=34%, 3 studies, n=978) versus their non-use significantly reduced the odds of SARS-COV-2 transmission among healthcare workers involved in AGP. Albeit inconclusive due to the very low quality of evidence, using face shields or goggles was not associated with a significant reduction in the odds of SARS-CoV-2 transmission (OR 0.70 [95% CI 0.31, 1.59]) than the non-use of face shields or goggles. The certainty of the overall body of evidence on PPE use in reducing SARS-CoV-2 transmission during AGP procedures was rated very low. In addition, confounders in the assessment could have been using individual PPE with the other standard PPE, compliance of healthcare worker on properly wearing it, and observing other preventive measures.&#x0D; Conclusion. There were lower odds of COVID-19 infection among healthcare workers using appropriate PPE, including N95 respirators, surgical gowns, and gloves during AGPs in suspected or confirmed COVID-19 patients. Several guidelines recommended using enhanced PPE among healthcare workers during surgery despite limited and low-quality evidence. The findings should help in developing recommendations in reducing SARS-CoV-2 transmission in the Philippines. The findings should provide the information needed for healthcare policy decision-making.

Non-Institutional Independent Tumor Boards Beneficial Impact on Post-Graduate Medical Training

The doctors who are going through our postgraduate residency training programs are tomorrow’s specialists who will be playing pivotal roles as healthcare policy decision-makers. To establish site-specific multidisciplinary tumor boards, we have to rely on our present-day resident’s leadership skills. We intend to provide meaningful specific patient-centered goals to our postgraduate students who are our future specialist healthcare providers. We are witnessing a slow positive change towards shared care and the implementation of multidisciplinary culture. This is high time to develop modules with a specific learning objective of providing high-quality leadership skills to all our postgraduate trainees. Effective and efficient team-building skills will enable them to initiate and maintain multidisciplinary professional processes complying with international standards [1].

"Making It Work": A Preliminary Mixed Methods Study of Rural Trauma Care Access and Resources in New Mexico.

IntroductionPatients in the rural western United States face challenges accessing trauma and surgical services and are more likely to succumb to their injuries. New Mexico, a rural and medically underresourced state, is a salient space to study these disparities. We examine how travel distance from trauma centers impacts injured patient outcomes and describe care delivery obstacles.Materials and MethodsWe conducted an explanatory mixed methods study by creating geospatial maps of New Mexico’s trauma data, incorporating linear regression analyses on patient outcomes as a function of estimated travel distance from trauma centers. We also conducted qualitative semi-structured interviews with trauma providers to illuminate and provide context for the geospatial findings utilizing a systematic, collaborative, iterative transcript analysis process. We constructed a conceptual framework describing rural trauma care delivery obstacles.ResultsGeospatial analyses revealed that most New Mexicans face long travel times to trauma centers. Comparing regression analyses using different data sources suggests that solely hospital-derived data may undercount rural trauma deaths. Interviews with 10 providers suggest that elements that may contribute to these findings include on-the-ground resource-based challenges and those related to broader healthcare systems-based issues. Our conceptual framework denotes how these elements collectively may impact rural trauma outcomes and proposes potential solutions.ConclusionsIn addressing rural patients’ needs, healthcare policy decision-makers should ensure that their datasets are comprehensive and inclusive. They must also take into account the particular challenges of underserved rural patients and providers who care for them by eliciting their perspectives, as presented in our conceptual framework.

PMU21 Incorporating Preference Heterogeneity in Public Healthcare Policy Decision-Making: A Scoping Review of the Literature

PMU21 Incorporating Preference Heterogeneity in Public Healthcare Policy Decision-Making: A Scoping Review of the Literature

Implementation of shared decision-making in healthcare policy and practice: a complex adaptive systems perspective

Background:Despite the suggested benefits of shared decision-making (SDM), its implementation in policy and practice has been slow and inconsistent. Use of complex adaptive systems (CAS) theory may provide understanding of how healthcare system factors influence implementation of SDM. Methods:Using the example of choice of mode of birth after a previous caesarean section, in-depth, semi-structured interviews were conducted with patients, providers, and decision makers in British Columbia, Canada, to explore the system characteristics and processes that influence implementation of SDM. Implementation and knowledge translation principles guided study design, and constructionist grounded theory informed iterative data collection and analysis. Findings:Analysis of interviews (n=58) revealed that patients formed early preferences for mode of delivery (after the primary caesarean) through careful deliberation of social risks and benefits. Physicians acted as information providers of clinical risks and benefits, while decision makers revealed concerns related to liability and patient safety. These concerns stemmed from perceptions of limited access to surgical resources, which had resulted from budget constraints. Discussion and conclusions:To facilitate the effective implementation of SDM in policy and practice it may be critical to initiate SDM once patients become aware of their healthcare options, assist patients to address the social risks that influence their preferences, manage perceptions of risk related to patient safety and litigation among physicians, and enhance access to healthcare resources.

Risk stratified breast cancer screening: UK healthcare policy decision-making stakeholders\u2019 views on a low-risk breast screening pathway

BackgroundThere is international interest in risk-stratification of breast screening programmes to allow women at higher risk to benefit from more frequent screening and chemoprevention. Risk-stratification also identifies women at low-risk who could be screened less frequently, as the harms of breast screening may outweigh benefits for this group. The present research aimed to elicit the views of national healthcare policy decision-makers regarding implementation of less frequent screening intervals for women at low-risk.MethodsSeventeen professionals were purposively recruited to ensure relevant professional group representation directly or indirectly associated with the UK National Screening Committee and National Institute for Health and Care Excellence (NICE) clinical guidelines. Interviews were analysed using thematic analysis.ResultsThree themes are reported: (1) producing the evidence defining low-risk, describing requirements preceding implementation; (2) the impact of risk stratification on women is complicated, focusing on gaining acceptability from women; and (3) practically implementing a low-risk pathway, where feasibility questions are highlighted.ConclusionsOverall, national healthcare policy decision-makers appear to believe that risk-stratified breast screening is acceptable, in principle. It will however be essential to address key obstacles prior to implementation in national programmes.

Evaluating the credibility of anchor based estimates of minimal important differences for patient reported outcomes: instrument development and reliability study

ObjectiveTo develop an instrument to evaluate the credibility of anchor based minimal important differences (MIDs) for outcome measures reported by patients, and to assess the reliability of the instrument.DesignInstrument development...

Health state utility values (QALY weights) for Huntington\u2019s disease: an analysis of data from the European Huntington\u2019s Disease Network (EHDN)

BackgroundHuntington’s Disease (HD) is a hereditary neurodegenerative disorder which affects individuals’ ability to walk, talk, think, and reason. Onset is usually in the forties, there are no therapies currently available that alter disease course, and life expectancy is 10–20 years from diagnosis. The gene causing HD is fully penetrant, with a 50% probability of passing the disease to offspring. Although the impacts of HD are substantial, there has been little report of the quality of life of people with the condition in a manner that can be used in economic evaluations of treatments for HD. Health state utility values (HSUVs), used to calculate quality-adjusted life-years (QALYs), are the metric commonly used to inform such healthcare policy decision-making.ObjectivesThe aim was to report HSUVs for HD, with specific objectives to use European data to: (i) describe HSUVs by demographic and clinical characteristics; (ii) compare HSUVs of people with HD in the UK with population norms; (iii) identify the relative strength of demographic and clinical characteristics in predicting HSUVs.MethodsEuropean Huntington’s Disease Network REGISTRY study data were used for analysis. This is a multi-centre, multi-national, observational, longitudinal study, which collects six-monthly demographic, clinical, and patient-reported outcome measures, including the SF-36. SF-36 scores were converted to SF-6D HSUVs and described by demographic and clinical characteristics. HSUVs from people with HD in the UK were compared with population norms. Regression analysis was used to estimate the relative strength of age, gender, time since diagnosis, and disease severity (according to the Total Function Capacity (TFC) score, and the UHDRS’s Motor score, Behavioural score, and Cognition score) in predicting HSUVs.Results11,328 questionnaires were completed by 5560 respondents with HD in 12 European countries. Women generally had lower HSUVs than men, and HSUVs were consistently lower than population norms for those with HD in the UK, and dropped with increasing disease severity. The regression model significantly accounted for the variance in SF-6D scores (n = 1939; F [7,1931] = 120.05; p < 0.001; adjusted R-squared 0.3007), with TFC score, Behavioural score, and male gender significant predictors of SF-6D values (p < 0.001).ConclusionTo our knowledge, this is the first report of HSUVs for HD for countries other than the UK, and the first report of SF-6D HSUVs described for 12 European countries, according to demographic and clinical factors. Our analyses provide new insights into the relationships between HD disease characteristics and assessment of health-related quality of life in a form that can be used in policy-relevant economic evaluations.

Factors affecting sustainable adoption of e-health technology in developing countries: an exploratory survey of Nigerian hospitals from the perspective of healthcare professionals.

BackgroundE-health technology applications are essential tools of modern information technology that improve quality of healthcare delivery in hospitals of both developed and developing countries. However, despite its positive benefits, studies indicate that the rate of the e-health adoption in some developing countries is either low or underutilized. This is due in part, to barriers such as resistance from healthcare professionals, poor infrastructure, and low technical expertise among others.ObjectiveThe aim of this study is to investigate, identify and analyze the underlying factors that affect healthcare professionals decision to adopt and use e-health technology applications in developing countries, with particular reference to hospitals in Nigeria.MethodsThe study used a cross sectional approach in the form of a close-ended questionnaire to collect quantitative data from a sample of 465 healthcare professionals randomly selected from 15 hospitals in Nigeria. We used the modified Technology Acceptance Model (TAM) as the dependent variable and external factors as independent variables. The collected data was then analyzed using SPSS statistical analysis such as frequency test, reliability analysis, and correlation coefficient analysis.ResultsThe results obtained, which correspond with findings from other researches published, indicate that perceived usefulness, belief, willingness, as well as attitude of healthcare professionals have significant influence on their intention to adopt and use the e-health technology applications. Other strategic factors identified include low literacy level and experience in using the e-health technology applications, lack of motivation, poor organizational and management policies.ConclusionThe study contributes to the literature by pinpointing significant areas where findings can positively affect, or be found useful by, healthcare policy decision makers in Nigeria and other developing countries. This can help them understand their areas of priorities and weaknesses when planning for e-health technology adoption and implementation.

Use of large healthcare databases for rheumatology clinical research.

Large healthcare databases, which contain data collected during routinely delivered healthcare to patients, can serve as a valuable resource for generating actionable evidence to assist medical and healthcare policy decision-making. In this review, we summarize use of large healthcare databases in rheumatology clinical research. Large healthcare data are critical to evaluate medication safety and effectiveness in patients with rheumatologic conditions. Three major sources of large healthcare data are: first, electronic medical records, second, health insurance claims, and third, patient registries. Each of these sources offers unique advantages, but also has some inherent limitations. To address some of these limitations and maximize the utility of these data sources for evidence generation, recent efforts have focused on linking different data sources. Innovations such as randomized registry trials, which aim to facilitate design of low-cost randomized controlled trials built on existing infrastructure provided by large healthcare databases, are likely to make clinical research more efficient in coming years. Harnessing the power of information contained in large healthcare databases, while paying close attention to their inherent limitations, is critical to generate a rigorous evidence-base for medical decision-making and ultimately enhancing patient care.

Integrating evidence on patient preferences in healthcare policy decisions: protocol of the patient-VIP study.

BackgroundDespite a strong movement towards active patient involvement in healthcare policy decisions, systematic and explicit consideration of evidence of this research on patient preferences seems limited. Furthermore, little is known about the opinions of several stakeholders towards consideration of research evidence on patient preferences in healthcare policy decisions. This paper describes the protocol for an explorative study on the integration of research on patient preferences in healthcare policy decisions. The study questions: to what extent research evidence on patient preferences is considered in current procedures for healthcare policy decisions; opinions of stakeholders regarding the integration of this type of evidence in healthcare policy decisions; and what could be a decision framework for the integration of such research evidence in healthcare policy decisions.Methods/designThe study is divided in three sub-studies, predominantly using qualitative methods. The first sub-study is a scoping review in five European countries to investigate whether and how results of research on patient preferences are considered in current procedures for coverage decisions and clinical practice guideline development. The second sub-study is a qualitative study to explore the opinions of stakeholders with regard to the possibilities for integrating evidence on patient preferences in the process of healthcare decision-making in the Netherlands. The third sub-study is the development of a decision framework for research on patient preferences. The framework will consist of: a process description regarding the place of evidence on patient preferences in the decision-making process; and a taxonomy describing different terminologies and conceptualisations of ‘preferences’ and an overview of existing methodologies for investigating preferences. The concept framework will be presented to and discussed with experts.DiscussionThis study will create awareness regarding the existence and potential value of research evidence on patient preferences for healthcare policy decision-making and provides insight in the methods for investigating patient preferences and the barriers and facilitators for integration of such research in healthcare policy decisions. Results of the study will be useful for researchers, clinical practice guideline developers, healthcare policy makers, and patient representatives.

Psychosocial predictors of parental participation in ultrasound screening for developmental dysplasia of the hip.

Ultrasound screening for developmental dysplasia of the hip (DDH) is an innovation in preventive child health care in the Netherlands. Parental participation in the screening will be essential for the success of implementation of the screening. The aim of the current study was to investigate whether psychosocial factors (attitude, subjective norm, self-efficacy, perceived susceptibility, perceived severity, perceived effectiveness) predicted parental participation in the screening. A cross-sectional survey was conducted. Using a questionnaire, several background variables (organization, sociodemographic variables, and knowledge) and psychosocial variables were collected. Blockwise logistic regression was used to analyze the relations. A total of 703 questionnaires of participating parents (response 61.7%) and 393 questionnaires of nonparticipating parents were received (response 37.2%). When controlling for the background variables, attitude, subjective norm, self-efficacy, perceived susceptibility, and perceived effectiveness predicted parental participation in the screening (p < .05). Perceived severity of the dysplasia did not predict participation (p > .05). Psychosocial determinants influenced parental participation in the ultrasound screening for DDH. Emphasizing the positive aspects of the screening, highlighting the effectiveness, removing practical barriers, and being conscious of the influential role of child health care professionals on decision making are areas to focus on when organizing the ultrasound screening for DDH. Health care policy decision makers and child health care professionals should consider these determinants in order to stimulate parental participation.

Association between hospital volume and outcomes of elderly and non‐elderly patients with acute biliary diseases: A national administrative database analysis

This study aimed to investigate the relationship between hospital volume and clinical outcomes of elderly and non-elderly patients with acute biliary diseases using data from a national administrative database. Overall, 26720 elderly and 33774 non-elderly patients with acute biliary diseases were referred to 820 hospitals in Japan. Hospital volume was categorized into three groups based on the case numbers during the study period: low-volume, medium-volume and high-volume. We compared the risk-adjusted length of stay (LOS) and in-hospital mortality in relation to hospital volume. These analyses were stratified according to the presence of invasive treatments for acute biliary diseases. Multiple linear regression analyses showed that increased hospital volume was significantly associated with shorter LOS in both elderly and non-elderly patients with and without invasive treatments. Increased hospital volume was significantly associated with decreased relative risk of in-hospital mortality in elderly patients. The odds ratio for high-volume hospitals was 0.672 in elderly patients without invasive treatments (95% confidence interval [CI] 0.533-0.847, P=0.001) and 0.715 in those with invasive treatments (95% C, 0.566-0.904, P=0.005). However, no significant differences for in-hospital mortality were seen in non-elderly patients with and without invasive treatments. This study has highlighted that higher volume hospitals significantly reduced LOS and in-hospital mortality for elderly patients with acute biliary diseases, but not non-elderly patients. The current results are of value for elderly healthcare policy decision-making, and highlight the need for further studies into the quality of care for elderly patients.

Painting by numbers: A guide for systematically developing indicators of performance at any level of health care

ObjectivesThere is a need for methods to facilitate selection of robust indicators in health care settings. This research aims to determine the key steps in, and delineate a systematic process for, construction of health care performance indicators. MethodsInformation derived from a review of the published literature and analysis of key informant interviews was synthesised to derive key activities and concepts fundamental to, and essential for, the development of robust and meaningful indicators. These activities and concepts were ordered into a logical sequence. ResultsA sequence of six stages (prioritisation; intent; implementation requirements; measure specifications; indicator assessment; target development), with a series of steps within each stage, was delineated. This sequence comprises the Systematic Indicator Development (SID) Method, which may be utilised by health care policy decision makers, providers, or clinicians in a ‘paint by numbers’ manner to create robust and meaningful indicators, or to refine or amend existing indicators. ConclusionsThe SID Method blends different aspects of indicator art and science and structures it in a logical way to provide transparency, consistency and rigour to indicator construction. The approach ensures that all health care sector stakeholders can make informed decisions when selecting indictors or interpreting obtained results.

Routine infant immunization with the 7- and 13-valent pneumococcal conjugate vaccines: current perspective on reduced-dosage regimens.

The 7 and 13-valent pneumococcal conjugate vaccines are mostly used in routine infant immunizations to prevent the development of pneumococcal disease. Currently, the dosing schedule approved and recommended for PCV7 and PCV13 in infants is 3 primary doses followed by a booster dose in the second year of life. However, a number of countries use a 2-dose only primary series with a booster dose in the second year of life. This review is aimed at providing the reader with a broad perspective on the currently available evidence which supports the clinical use of such reduced dosing schedules for the PCV7 and PCV13 vaccines. Recent evidence has been able to promulgate the immunogenicity and in some cases the effectiveness of the reduced dosing schedule for these vaccines. These findings may reduce costs as well as minimize supply and administration problems relating to the provision of the pneumococcal conjugated vaccines (PCVs). However, some caution is warranted since some inferior data have emerged with regards to the antibody immune response to certain pneumococcal serotypes following the implementation of such reduced dosing regimens. In addition, it is proposed that prospective surveillance be undertaken in all countries which have adopted the reduced-dosage immunization programs. This review may go some way in educating healthcare practitioners and healthcare policy decision makers at large.

We Get It

It is exciting to see the current wisdom focusing on the importance of being actively involved in healthcare policy as a strategy for nursing leadership. This focus is particularly critical at this time in history, since we have a unique opportunity to make inroads at a time when our administration needs and desires nurses' input and expertise. There are nurse leaders who work directly in policy making as legislators or advisors to legislators at both the state and national level. In several states, nurse leaders have assumed critical and visible roles as healthcare policy decision-makers. Our professional organizations have also had a strong role in influencing public policy as it affects nursing and nursing issues. Recently, the scope has expanded to include multiple healthcare issues such as the process and methods of providing universal access. We are experts at understanding the issues of the uninsured and underinsured and the impact of the lack of prevention, as well as the importance of managing chronic illness. Our expertise has expanded to include issues surrounding healthcare financing and delivery; this knowledge has been embraced by nurse leaders at all levels and in all types of setting and is being taught by many universities to aspiring nurse leaders. The role of nursing cannot be understated in determining the direction of and access to healthcare in this country. The concerns are no longer just about what is good for nursing but rather what is the best system for all users to ensure excellent outcomes with a continuing eye on efficiency. No one disputes the indispensible role that nurses have in the design and implementation of a new and better healthcare system. Certainly, President Obama recognizes our expertise and our commitment and will ensure that nurses are deeply involved at all levels from policy making to implementation. Success depends on nurses' involvement in the 3 areas that are the framework for healthcare reform: reducing costs, guaranteeing choice (including a public option), and ensuring quality care for all. AONE, as the major voice for nurse leaders at the management and executive level, has strategically defined its advocacy and legislative priorities in the areas of economic recovery, education, public policy and advocacy, international nurse recruitment, healthcare reform, nursing intensity, pay-for-performance, and disaster preparedness. Being prepared as nurse leaders to carry this agenda forward requires the wisdom to understand and practice ethical politics and acquire knowledge about the legislative process, quality outcomes, and efficient delivery avenues. As we examine future needs, it will take many more nurse leaders who are committed and prepared to address and carry out healthcare reform. Learning business and financial skills for nurses has always been my mantra, for it lays the foundation for equality at the decision-making level of the organization. Adding to this is the critical nature of knowing about and being involved in healthcare policy issues. I have always enjoyed learning and teaching healthcare policy, and when I became a CEO of a public hospital I more directly participated in and was accountable for those policies that impacted under- and uninsured populations. Learning the nuances required a crash course in the political process, but what I really needed to learn was how the informal system worked. I needed a mentor and was fortunate to have one in the chairman of the board. Mentoring to provide this experience to our nursing management staff is essential. We need the preparation to be effective. Our nurse leaders must aspire to become politically savvy on behalf of patients, families, and our profession, and we do get it.

Willingness to Pay for Inhaled Insulin

To determine the willingness to pay (WTP) of patients with diabetes mellitus for inhaled insulin. A contingent valuation survey was administered to 96 diabetic outpatients at St. Michael's Hospital, Toronto, Canada. Standardised information about inhaled insulin and subcutaneous rapid-acting insulin was provided via video. Participants' WTP for their preferred product was elicited in Canadian dollars (Can dollars) using a 'payment-scale' method. The mean age of participants was 51.8 years (SD 13.4). Seventy-seven patients had type 2 and 19 had type 1 diabetes. Significantly more participants preferred inhaled insulin over subcutaneous insulin (85 vs 11; p < 0.01). Mean monthly WTP for inhaled insulin (153.70 Can dollars, SD 99.90) was significantly more than the typical 50 Can dollars per month for subcutaneous insulin (p < 0.01). Significantly more participants with type 2 diabetes using oral drugs than those with type 1 diabetes and using insulin preferred inhaled insulin (98.5% vs 69%, p < 0.001). Diabetic patients who did not use insulin were willing to pay significantly more than were insulin users (p < 0.001). Multiple regression analysis showed that income was significantly associated with WTP for inhaled insulin. Diabetic patients, particularly those who are not using insulin, indicated that they would prefer inhaled insulin over insulin injection and would be willing to pay a substantial amount per month to use it. An economic evaluation of inhaled insulin would provide important information to healthcare policy decision makers and private payers about its economic value.

Cost-effectiveness analysis of pneumococcal vaccination for elderly individuals in The Netherlands.

To assess the cost effectiveness (net costs per life year gained) of pneumococcal vaccination of elderly individuals aged 65 years and over in The Netherlands. A pharmacoeconomic analysis was conducted from the healthcare perspective in The Netherlands. The gender- and age-specific modelling framework linked epidemiological aspects of invasive pneumococcal disease (e.g. incidence, mortality, life years lost) to vaccination and hospital resource use. To derive 90% confidence limits for net costs per life year gained a stochastic analysis was performed. Pneumococcal vaccination in the elderly with the 23-valent vaccine. Effectiveness of the vaccine in preventing invasive pneumococcal disease was derived from international studies. Pneumococcal vaccination in the elderly was not found to be cost saving. At baseline, stochastic and univariate sensitivity analysis net costs per life year gained were estimated to be between 6000 and 16,000 euro (EUR) [EUR1 = 1.1 US dollars; cost level 1995]. A scenario analysis on alternative age-dependent vaccination strategies indicated even higher net costs per life year gained, up to EUR28,000 for vaccinating only those elderly aged 85 years and over. Pneumococcal vaccination is associated with net costs per life year gained of EUR10,100 (at baseline assumptions). These costs are higher than those for influenza vaccination (EUR5500). Our pharmacoeconomic approach, which needs to be considered in conjunction with social, psychological and budgetary issues, is intended to contribute to rational decision-making in healthcare policy.

Rational decision-making in mental health: the role of systematic reviews.

BACKGROUND: "Systematic reviews" have come to be recognized as the most rigorous method of summarizing confusing and often contradictory primary research in a transparent and reproducible manner. Their greatest impact has been in the summarization of epidemiological literature - particularly that relating to clinical effectiveness. Systematic reviews also have a potential to inform rational decision-making in healthcare policy and to form a component of economic evaluation. AIMS OF THE STUDY: This article aims to introduce the rationale behind systematic reviews and, using examples from mental health, to introduce the strengths and limitations of systematic reviews, particularly in informing mental health policy and economic evaluation. METHODS: Examples are selected from recent controversies surrounding the introduction of new psychiatric drugs (anti-depressants and anti-schizophrenia drugs) and methods of delivering psychiatric care in the community (case management and assertive community treatment). The potential for systematic reviews to (i) produce best estimates of clinical efficacy and effectiveness, (ii) aid economic evaluation and policy decision-making and (iii) highlight gaps in the primary research knowledge base are discussed. Lastly examples are selected from outside mental health to show how systematic reviews have a potential to be explicitly used in economic and health policy evaluation. RESULTS: Systematic reviews produce the best estimates of clinical efficacy, which can form an important component of economic evaluation. Importantly, serious methodological flaws and areas of uncertainty in the primary research literature are identified within an explicit framework. Summary indices of clinical effectiveness can be produced, but it is difficult to produce such summary indices of cost effectiveness by pooling economic data from primary studies. Modelling is commonly used in economic and policy evaluation. Here, systematic reviews can provide the best estimates of effectiveness and, importantly, highlight areas of uncertainty that can be used in "sensitivity analysis". DISCUSSION: Systematic reviews are an important recent methodological advance, the potential for which has only begun to be realized in mental health. This use of systematic reviews is probably most advanced in producing critical summaries of clinical effectiveness data. Systematic reviews cannot produce valid and believable conclusions when the primary research literature is of poor quality. An important function of systematic reviews will be in highlighting this poor quality research which is of little use in mental health decision making. IMPLICATIONS FOR HEALTH PROVISION: Health care provision should be both clinically and cost effective. Systematic reviews are a key component in ensuring that this goal is achieved. IMPLICATIONS FOR HEALTH POLICIES: Systematic reviews have potential to inform health policy. Examples presented show that health policy is often made without due consideration of the research evidence. Systematic reviews can provide robust and believable answers, which can help inform rational decision-making. Importantly, systematic reviews can highlight the need for important primary research and can inform the design of this research such that it provides answers that will help in forming healthcare policy. IMPLICATIONS FOR FURTHER RESEARCH: Systematic reviews should precede costly (and often unnecessary) primary research. Many areas of health policy and practice have yet to be evaluated using systematic review methodology. Methods for the summarization of economic data are methodologically complex and deserve further research