A comprehensive model for measuring real-life cost-effectiveness in eyecare: automation in care and evaluation of system (aces-rwm™).

This paper describes a holistic, yet simple and comprehensible, ecosystem model to deal with multiple and complex challenges in eyecare. It aims at producing the best possible wellbeing and eyesight with the available resources. When targeting to improve the real-world cost-effectiveness, what gets done in everyday practice needs be measured routinely, efficiently and unselectively. Collection of all real-world data of all patients will enable evaluation and comparison of eyecare systems and departments between themselves nationally and internationally. The concept advocates a strategy to optimize real-life effectiveness, sustainability and outcomes of the service delivery in ophthalmology. The model consists of three components: (1) resource-governing principles (i.e., to deal with increasing demand and limited resources), (2) real-world monitoring (i.e., to collect structured real-world data utilizing automation and visualization of clinical parameters, health-related quality of life and costs), and (3) digital innovation strategy (i.e., to evaluate and benchmark real-world outcomes and cost-effectiveness). The core value and strength of the model lies in the consensus and collaboration of all Finnish university eye clinics to collect and evaluate the uniformly structured real-world outcomes data. In addition to ophthalmology, the approach is adaptable to any medical discipline to efficiently generate real-world insights and resilience in health systems.

Effectiveness of training in guideline-oriented biopsychosocial management of low-back pain in occupational health services - a cluster randomized controlled trial.

OBJECTIVE: This study aimed to investigate the effectiveness of brief training in the guideline-oriented biopsychosocial management of low-back pain (LBP) in occupational health services using a cluster-randomized design. A small sample of physiotherapists and physicians from the intervention units (N=12) were given three- to seven-day training focusing on the biopsychosocial management of LBP, while professionals in the control units (N=15) received no such training. METHODS: Eligible patients with LBP, with or without radicular pain, aged 18-65, were invited to participate. A web-based questionnaire was sent to all recruited patients at baseline, three months and one year. The primary outcome measure was disability (Oswestry Disability Index, ODI) over one year. Between-group differences were analyzed using linear and generalized linear mixed models adjusted for baseline-response delay as well as variables showing between-group imbalance at baseline. RESULTS: The final study sample comprised 234 and 81 patients in the intervention and control groups, respectively at baseline, and 137 and 47 patients, respectively, at one year. At baseline, the mean duration of pain was longer in the intervention group (P=0.017), and pain-related fear concerning physical activity was lower (P=0.012). We observed no significant difference between the groups' primary outcome measure (adjusted one-year mean difference in the ODI: 2.3; 95% confidence interval -1.0-5.7; P=0.175) or most secondary outcomes. CONCLUSIONS: Brief training in guideline-oriented biopsychosocial management of LBP for occupational health professionals did not appear to be effective in reducing patients' symptom over one-year follow-up compared to treatment as usual.

Evaluation of training in guideline-oriented biopsychosocial management of low back pain in occupational health services: Protocol of a cluster randomized trial.

BACKGROUND: To prevent low back pain (LBP) from developing into a prolonged disabling condition, clinical guidelines advocate early stage assessment, risk-screening, and tailored interventions. Occupational health services recommend guideline-oriented biopsychosocial screening and individualized assessment and management. However, it is not known whether training a limited number of health care professionals improves the management process. The primary objective of this study is to investigate whether training in the biopsychosocial practice model is effective in reducing disability. Furthermore, we aim to evaluate health-economic impacts of the training intervention in comparison to usual medical care. METHODS: The occupational health service units will be allocated into a training or control arm in a two-arm cluster randomized controlled design. The training of occupational physiotherapists and physicians will include the assessment of pain-related psychosocial factors using the STarT Back Tool and the short version of the Örebro Musculoskeletal Pain Screening Questionnaire, the use of an evidence-based patient education booklet as part of the management of LBP, and tailored individualized management of LBP according to risk stratification. The control units will receive no training. The study population will include patients aged 18-65 with nonspecific LBP. The primary outcome is a patient-reported Oswestry Disability Index from baseline to 12 months. By estimating group differences over time, we aim to evaluate the effectiveness of the training intervention in comparison to usual medical care, and to undertake an economic evaluation using individual patients' health care records (participant-level data) and the participating units' registries (cluster-level data). In addition, through interviews and questionnaires, we will explore the health care professionals' conceptions of the adoption of, the barriers to, and the facilitators of the implementation of the practice model. DISCUSSION: The evaluation of training in the guideline-oriented biopsychosocial management of LBP in occupational health services is justified because LBP represents an enormous burden in terms of work disability.

Potential cost savings for selected non-pharmacological treatment strategies for patients with Alzheimer's disease in Finland.

OBJECTIVE: To compare the costs and monetary benefits of non-pharmacological interventions for patients with Alzheimer's disease in real-world settings. METHODS: A systematic review was performed to determine the most effective treatment strategies for being able to stay at home for patients with Alzheimer's disease. Care-management, family support, and multidisciplinary rehabilitation were identified as effective interventions applicable in the Finnish healthcare setting. Data on medical and social service costs, and the costs of residential care for all patients newly diagnosed with Alzheimer's disease in 2 major cities in Finland were analysed in a 4-year follow-up study. The potential cost savings of the different treatment strategies were assessed. RESULTS: The annual cost increased from €9,481 to €28,400 (mean per patient) during the 4-year follow-up. Cost savings were achieved in care-management, family support programmes, and rehabil-itative cognitive and social activation if the patients' transition to long-term care was delayed by 2.8, 1.8 and 43.0 days, respectively. CONCLUSION: Care-management and informal caregiver support for patients with Alzheimer's disease may benefit patients and result in concurrent cost savings. Delaying the decline in cognitive and social functioning through rehabilitation is indicated for more severe phases of Alzheimer's disease, and the costs appear to be compensated by savings in the cost of long-term care.

Vision and strategy for healthcare: Competence is a necessity.

Well-designed, evidence-based vision and strategy are fundamental requirements for successful healthcare. This paper reviews previous comprehensive healthcare strategies (Institute of Medicine statement, Value-based healthcare, and Triple aim strategy) published in peer-reviewed scientific journals, and presents an alternative proposal for healthcare vision and strategy. The proposed strategy includes, as prerequisites, competence of staff, healthcare leaders and leaders of health policy, and a well-functioning healthcare system. It is necessary to optimize the financing, reimbursement and incentives, organization, and regulation of the healthcare system. Strategic means to successful healthcare are to improve staff competence, implement current scientific evidence, document clinical and system-related issues, improve quality, and carry out benchmarking with peers. The vision for healthcare is to provide continuous improvement in services, in terms of accessibility, quality, fairness, effectiveness, safety and efficiency, to the patients (customers) and to the population. The new proposal shares many issues with strategies published previously. This paper sets out the prerequisites for the proposed strategy. A common vision, high levels of integrity, and a commitment to providing the best for patients and the population, are of fundamental importance. Competence at all levels of healthcare is a necessity.

Generalizability of findings from randomized controlled trials is limited in the leading general medical journals.

OBJECTIVES: To document reporting of study characteristics of randomized controlled trials (RCTs) in the four leading general medical journals and to appraise the generalizability of the evidence. STUDY DESIGN AND SETTING: All RCTs in BMJ, JAMA, Lancet, and NEJM from January 1, 2017 to September 30, 2017 were searched by hand, and data were extracted according to the benchmarking method. RESULTS: Hundred sixty-one RCTs were found; 67% assessed pharmacological therapy. The percentages of adequate documentation were patients' path before randomization 3% to 33% of trials; characteristics of the health care settings 0% to 75%; at least two comorbid conditions 25% to 50%; at least one measure was reported of functioning 42% to 54%, of behavioral factors 25% to 58%, of environmental factors 3% to 25%, and of inequity-related factors 28% to 68%; cointerventions 6% to 25%; and reasons for dropping out of follow-up 39% to 100%. CONCLUSION: Almost all RCTs showed deficiencies in description of patient selection and study setting and in reporting of patient characteristics related to functioning, comorbidities, and to behavioral, environmental, and inequity factors. The findings indicate that generalizability of this evidence may be limited. The benchmarking method can be used for planning and appraisal of clinical trials and systematic reviews.

Pure intervention effect or effect in routine health care - blinded or non-blinded randomized controlled trial.

BACKGROUND: Randomized trials provide the most valid evidence of effectiveness of interventions. The study aims to determine the primary study question for randomized controlled trials; to evaluate the study questions in trials on effectiveness of arthroscopic meniscectomy for meniscal rupture of the knee; and to explore the clinical and research implications. METHODS: Previous studies on benchmarking controlled trials were utilized. A literature search was undertaken to find the trials on arthroscopic surgery for meniscal rupture of the knee, data was extracted, and checked for accuracy twice. RESULTS: The first question in RCTs is whether to assess the pure intervention effect, or intervention effect in routine health care circumstances. The former necessitates a double blinded design and the latter a non-blind design. The trials on arthroscopic meniscectomy of the knee showed considerable differences in study characteristics. CONCLUSIONS: The study question in RCTs on pure intervention effect dictates use of blinded design, while question of intervention effect in routine health care dictates use of non-blinded design. Blinding should not be considered a validity criterion when study question is on effectiveness in routine health care. When informing patients, the potential for other effects besides the pure intervention effect should be considered.

DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as short-term and long-term treatment strategies in Dupuytren's contracture.

INTRODUCTION: Dupuytren's contracture (DC) is a chronic fibroproliferative disorder of the palmar fascia which leads to flexion contracture in one or more fingers. There is no definitive cure for DC, and treatment aims at relieving symptoms by releasing the contracture using percutaneous or operative techniques. METHODS AND ANALYSIS: We planned a prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of (1) collagenase clostridium histolyticum injection followed by limited fasciectomy in non-responsive cases, (2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and (3) primary limited fasciectomy during short-term and long-term follow-up for Tubiana I-III stages DC. We will recruit participants from seven national centres in Finland. Primary outcome is the rate of success in the treatment arm at 5 years after recruitment. Success is a composite outcome comprising (1) at least 50% contracture release from the date of recruitment and (2) participants in a patient-accepted symptom state (PASS). Secondary outcomes are (1) angle of contracture, (2) quick disabilities of the arm, a shoulder and hand outcome measure (QuickDASH), (3) perceived hand function, (4) EQ-5D-3L, (5) rate of major adverse events, (6) patient's trust of the treatment, (7) global rating, (8) rate of PASS, (9) rate of minimal clinically important improvement, (10) expenses, (11) progression of disease, (12) progression-free survival, (13) favoured treatment modality, (14) patients achieving full contracture release and >50% improvement and (15) patient satisfaction with the treatment effect. Predictive factors for achieving the PASS will also be analysed. ETHICS AND DISSEMINATION: The protocol was approved by the Tampere University Hospital Institutional Review Board and Finnish Medicine Agency. The study will be performed according to the principles of good clinical practice. The results of the trial will be disseminated as published articles in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03192020; Pre-results.

Clinical Impact Research - how to choose experimental or observational intervention study?

BACKGROUND: Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. AIMS: This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. METHODS: The new concept is based on a narrative review of the literature and on author's idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author's previous work on the concepts benchmarking controlled trial and system impact research (SIR). RESULTS: The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. CONCLUSIONS: CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messages The new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals. The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental) and benchmarking controlled trials (BCTs) (observational). Suggestions on how to choose between RCT and BCT as the most suitable study design are presented. Simple way of determining the study question in CIR based on the PICO (patient, intervention, control intervention, outcome) framework is presented. CIR creates the scientific basis for clinical decisions. Clinicians and leaders at all levels of health care and those working for public health can use the evidence from CIR for the benefit of patients and the population.

System impact research - increasing public health and health care system performance.

BACKGROUND: Interventions directed to system features of public health and health care should increase health and welfare of patients and population. AIMS: To build a new framework for studies aiming to assess the impact of public health or health care system, and to consider the role of Randomized Controlled Trials (RCTs) and of Benchmarking Controlled Trials (BCTs). METHODS: The new concept is partly based on the author's previous paper on the Benchmarking Controlled Trial. The validity and generalizability considerations were based on previous methodological studies on RCTs and BCTs. RESULTS: The new concept System Impact Research (SIR) covers all the studies which aim to assess the impact of the public health system or of the health care system on patients or on population. There are two kinds of studies in System Impact Research: Benchmarking Controlled Trials (observational) and Randomized Controlled Trials (experimental). The term impact covers in particular accessibility, quality, effectiveness, safety, efficiency, and equality. CONCLUSIONS: System Impact Research - creating the scientific basis for policy decision making - should be given a high priority in medical, public health and health economic research, and should also be used for improving performance. Leaders at all levels of health and social care can use the evidence from System Impact Research for the benefit of patients and population. Key messages The new concept of SIR is defined as a research field aiming at assessing the impacts on patients and on populations of features of public health and health and social care systems or of interventions trying to change these features. SIR covers all features of public health and health and social care system, and actions upon these features. The term impact refers to all effects caused by the public health and health and social care system or parts of it, with particular emphasis on accessibility, quality, effectiveness, adverse effects, efficiency, and equality of services. SIR creates the scientific basis for policy decisions. Leaders at all levels of health and social care can use the evidence from SIR for the benefit of the patients and the population.

Individual and Regional-level Factors Contributing to Variation in Length of Stay After Cerebral Infarction in Six European Countries.

Using patient-level data for cerebral infarction cases in 2007, gathered from Finland, Hungary, Italy, the Netherlands, Scotland and Sweden, we studied the variation in risk-adjusted length of stay (LoS) of acute hospital care and 1-year mortality, both within and between countries. In addition, we analysed the variance of LoS and associations of selected regional-level factors with LoS and 1-year mortality after cerebral infarction. The data show that LoS distributions are surprisingly different across countries and that there is significant deviation in the risk-adjusted regional-level LoS in all of the countries studied. We used negative binomial regression to model the individual-level LoS, and random intercept models and ordinary least squares regression for the regional-level analysis of risk-adjusted LoS, variance of LoS, 1-year risk-adjusted mortality and crude mortality for a period of 31-365 days. The observed variations between regions and countries in both LoS and mortality were not fully explained by either patient-level or regional-level factors. The results indicate that there may exist potential for efficiency gains in acute hospital care of cerebral infarction and that healthcare managers could learn from best practices.

Benchmarking Controlled Trial--a novel concept covering all observational effectiveness studies.

The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals.

On decreasing inequality in health care in a cost-effective way.

BACKGROUND: Scientific evidence indicates that access to health care services shown effective is often poorer among the disadvantaged people than among the non-disadvantaged. Advancing cost-effectiveness and equality in obtaining services shown effective are often stated as the two main objectives for health care. DISCUSSION: The important question is how to decrease inequality in a most cost-effective way. Some evidence indicates that effectiveness and cost-effectiveness of interventions may be high among the disadvantaged patient groups. However, the relationship between decreasing inequality and cost-effectiveness is complex and depend e.g. on clinical and health care system factors. SUMMARY: To expand the knowledge base for advancing equality in a cost-effective way, scientific efforts on four levels are suggested: research into ways how practitioners can provide efficient services for the disadvantaged patients, widening of scope at all levels of evidence based medicine to account also for the disadvantaged, research on quality improvement and evidence implementation, as well as benchmarking research including documentation of services among the disadvantaged.

Analysing current trends in care of acute myocardial infarction using PERFECT data.

INTRODUCTION: This article in the supplement issue on the Performance, Effectiveness, and Costs of Treatment episodes (PERFECT)-project describes the PERFECT AMI (acute myocardial infarction) Database, which is developed to measure the performance of hospitals and hospital districts in Finland. We analyse annual trends and regional differences in performance indicators and whether the utilisation of services and costs of hospital care are related to improvement in survival of AMI patients. MATERIAL AND METHODS: The study population consists of ten annual cohorts (1998-2007) of patients hospitalised for AMI. RESULTS: Since 1998 the treatment pattern has changed rather radically, the utilisation rate of percutaneous coronary intervention (PCI) has increased and coronary procedures have been performed earlier after myocardial infarction. Outcome measured by various measures of mortality has improved considerably. However, trends in the development of the use of services and outcomes are not similar between hospital districts. An increase in cost was positively and statistically significantly related to decrease in mortality, but the effect was not very strong. CONCLUSION: There is potential for decreased mortality from actions that do not increase the costs and for enhancing performance in the regions and hospitals with poor performance.

Regional and hospital variance in performance of total hip and knee replacements: a national population-based study.

INTRODUCTION: This article in the supplement on the Performance, Effectiveness, and Costs of Treatment episodes (PERFECT)-project describes the PERFECT Hip and Knee Replacement Database and its possibilities by evaluating regional and hospital-level differences in length of stay (LOS), costs and complication rates of total hip arthroplasty (THA) and total knee arthroplasty (TKA) in Finland. MATERIAL AND METHODS: All hip and knee arthroplasties are recorded in the Finnish Hospital Discharge Register (FHDR) and Finnish Arthroplasty Register (FAR). LOS, length of uninterrupted institutional care (LUIC), complication rates and other parameters of treatment were determined by region and hospital during 1998-2008 based on these. RESULTS: LOS and LUIC following THA and TKA diminished during the follow-up period. In 1998 average LOS after THA and TKA was 9.9 and 10 days. In 2008, these had shortened to 5.2 and 5.3 days, respectively. There was a 5.0 and 7.5 percentage point difference in revision rate between regions in THAs and TKAs, respectively, performed during 2005-2007 and followed to the end of 2009. DISCUSSION: The Finnish health care registers provide a monitoring system for evaluating hospital- and regional-level differences in THA and TKA. The differences in LOS, LUIC and revision rates between hospitals and regions are considerable.

Ethical issues of obesity surgery--a health technology assessment.

New surgical technologies may challenge societal values, and their adoption may lead to ethical challenges. Despite proven cost-effectiveness, obesity (bariatric) surgery and its public funding have been questioned on ethical arguments relating to, for example, the self-inflicted or non-disease nature of obesity. Our aim was to analyze the ethical issues relevant to bariatric surgery. A comprehensive health technology assessment was conducted on bariatric surgery for morbid obesity using the EUnetHTA method, including a fully integrated ethical analysis. The ethical arguments suggesting that obesity should not be surgically treated because it is self-inflicted were rejected. Medicalization of obesity may have both positive and negative effects that impact the various stakeholders differently, thus being difficult to balance. Informing bariatric surgery patients and actively supporting their autonomy is exceptionally important, as the benefits and harms of both obesity and bariatric surgery are complex, and the outcome depends on how well the patient understands and adheres to the life-long changes in eating habits required. Justice considerations are important in organizing surgical treatment of obesity, as the obese are discriminated against in many ways and obesity is more common in socioeconomically disadvantaged populations who might have problems of access to treatments. Obesity should be treated like other diseases in health care, and obesity surgery rationed like other cost-effective treatments. Positive actions to ensure patient autonomy and just access to surgical treatments may be warranted.

A pragmatic randomized controlled study of the effectiveness and cost consequences of exercise therapy in hip osteoarthritis.

OBJECTIVE: To evaluate the short- and long-term effectiveness of exercise training in relation to pain, function and direct costs to health care systems attributable to hip osteoarthritis. DESIGN: Prospective, two-year randomized controlled trial. SETTING: An outpatient primary health care setting. SUBJECTS: One hundred and twenty men and women aged from 55 to 80, with radiologically diagnosed hip osteoarthritis with associated clinical symptoms. INTERVENTIONS: The combined exercise and general practitioner (GP) care group received 12 supervised (once per week) exercise sessions at the baseline and four additional booster sessions one year later. Both groups received standard GP care. MAIN MEASURES: The WOMAC Osteoarthritis Index, physical functioning score of RAND-36 (SF-36), the use and health care system costs of doctor visits and physiotherapy associated with hip osteoarthritis, number of total hip replacements, the use of analgesic and non-steroidal anti-inflammatory drugs (NSAIDs), performance-based outcome scores and body mass index (BMI). RESULTS: There were no differences between the groups with respect to WOMAC hip pain, physical functioning score of RAND-36, performance-based outcome scores or BMI. The effect of the exercise intervention on WOMAC function was statistically significant at 6 months (mean = -7.5; 95% confidence interval (CI) -13.9 to -1.0; P = 0.02) and 18 months (mean = -7.9; 95% CI -15.3 to -0.4; P = 0.04). There were no statistically significant differences in the total health care system costs between the groups. CONCLUSION: The mostly home-based exercise training programme provided in this study did not result in reduced hip pain over the two-year follow-up period.

European Conference on Health Economics.

The biennial European Conference on Health Economics was held in Finland this year, at the Finlandia Hall in the centre of Helsinki. The European conferences rotate among European countries and fall between the biennial world congresses organized by the International Health Economics Association (iHEA). A record attendance of approximately 800 delegates from 50 countries around the world were present at the Helsinki conference. The theme of the conference was 'Connecting Health and Economics'. All major topics of health economics were covered in the sessions. For the first time, social care economics was included in the agenda of the European Conference as a session of its own.

The HTA core model: a novel method for producing and reporting health technology assessments.

OBJECTIVES: The aim of this study was to develop and test a generic framework to enable international collaboration for producing and sharing results of health technology assessments (HTAs). METHODS: Ten international teams constructed the HTA Core Model, dividing information contained in a comprehensive HTA into standardized pieces, the assessment elements. Each element contains a generic issue that is translated into practical research questions while performing an assessment. Elements were described in detail in element cards. Two pilot assessments, designated as Core HTAs were also produced. The Model and Core HTAs were both validated. Guidance on the use of the HTA Core Model was compiled into a Handbook. RESULTS: The HTA Core Model considers health technologies through nine domains. Two applications of the Model were developed, one for medical and surgical interventions and another for diagnostic technologies. Two Core HTAs were produced in parallel with developing the model, providing the first real-life testing of the Model and input for further development. The results of formal validation and public feedback were primarily positive. Development needs were also identified and considered. An online Handbook is available. CONCLUSIONS: The HTA Core Model is a novel approach to HTA. It enables effective international production and sharing of HTA results in a structured format. The face validity of the Model was confirmed during the project, but further testing and refining are needed to ensure optimal usefulness and user-friendliness. Core HTAs are intended to serve as a basis for local HTA reports. Core HTAs do not contain recommendations on technology use.