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1.  EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring 
European Heart Journal  2014;36(3):158-169.
Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated.
Methods and results
A total of 312 patients with VVI- or DDD-ICD implants from 17 centres in six EU countries were randomised to HM ON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar- or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 ± 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 ± 1.67 vs. 5.53 ± 2.32; P < 0.001) despite a small increase of unscheduled visits (0.95 ± 1.50 vs. 0.62 ± 1.25; P < 0.005), more non-office-based contacts (1.95 ± 3.29 vs. 1.01 ± 2.64; P < 0.001), more Internet sessions (11.02 ± 15.28 vs. 0.06 ± 0.31; P < 0.001) and more in-clinic discussions (1.84 ± 4.20 vs. 1.28 ± 2.92; P < 0.03), but with numerically fewer hospitalizations (0.67 ± 1.18 vs. 0.85 ± 1.43, P = 0.23) and shorter length-of-stay (6.31 ± 15.5 vs. 8.26 ± 18.6; P = 0.27), although not significant. For the whole study population, the total FU cost for providers was not different for HM ON vs. OFF [mean (95% CI): €204 (169–238) vs. €213 (182–243); range for difference (€−36 to 54), NS]. From a payer perspective, FU-related costs were similar while the total cost per patient (including other physician visits, examinations, and hospitalizations) was numerically (but not significantly) lower. There was no difference in the net financial impact on providers [profit of €408 (327–489) vs. €400 (345–455); range for difference (€−104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different.
For all the patients as a whole, FU-related costs for providers are not different for remote FU vs. purely in-office FU, despite reorganized care. However, disparity in the impact on provider budget among different countries illustrates the need for proper reimbursement to ensure effective remote FU implementation.
PMCID: PMC4297469  PMID: 25179766
Implantable cardioverter defibrillator; Remote monitoring; Devices; Follow-up; Health economics
2.  Cost-effectiveness of health promotion targeting physical activity and healthy eating in mental health care 
BMC Public Health  2014;14(1):856.
There is a higher prevalence of obesity in individuals with mental disorders compared to the general population. The results of several studies suggested that weight reduction in this population is possible following psycho-educational and/or behavioural weight management interventions. Evidence of the effectiveness alone is however inadequate for policy making. The aim of the current study was to evaluate the cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders.
A Markov decision-analytic model using a public payer perspective was applied, projecting the one-year results of a 10-week intervention over a time horizon of 20 years, assuming a repeated yearly implementation of the programme. Scenario analysis was applied evaluating the effects on the results of alternative modelling assumptions. One-way sensitivity analysis was performed to assess the effects on the results of varying key input parameters.
An incremental cost-effectiveness ratio of 27,096€/quality-adjusted life years (QALY) in men, and 40,139€/QALY in women was found in the base case. Scenario analysis assuming an increase in health-related quality of life as a result of the body mass index decrease resulted in much better cost-effectiveness in both men (3,357€/QALY) and women (3,766€/QALY). The uncertainty associated with the intervention effect had the greatest impact on the model.
As far as is known to the authors, this is the first health economic evaluation of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders. Such research is important as it provides payers and governments with better insights how to spend the available resources in the most efficient way. Further research examining the cost-effectiveness of health promotion targeting physical activity and healthy eating in individuals with mental disorders is required.
PMCID: PMC4150981  PMID: 25134636
Mental disorders; Cost-effectiveness; Health promotion; Physical activity; Healthy eating
3.  Hospital-physician relations: the relative importance of economic, relational and professional attributes to organizational attractiveness 
Belgian hospitals face a growing shortage of physicians and increasingly competitive market conditions. In this challenging environment hospitals are struggling to build effective hospital-physician relationships which are considered to be a critical determinant of organizational success.
Employed physicians of a University hospital were surveyed. Organizational attributes were identified through the literature and two focus groups. Variables were measured using validated questionnaires. Descriptive analyses and linear regression were used to test the model and relative importance analyses were performed.
The selected attributes predict hospital attractiveness significantly (79.3%). The relative importance analysis revealed that hospital attractiveness is most strongly predicted by professional attributes (35.3%) and relational attributes (29.7%). In particular, professional development opportunities (18.8%), hospital prestige (16.5%), organizational support (17.2%) and leader support (9.3%) were found to be most important. Besides these non-economic aspects, the employed physicians indicated pay and financial benefits (7.4%) as a significant predictor of hospital attractiveness. Work-life balance and job security were not significantly related to hospital attractiveness.
This study shows that initiatives aimed at strengthening physicians’ positive perceptions of professional and relational aspects of practicing medicine in hospitals, while assuring satisfactory financial conditions, may offer useful avenues for increasing the level of perceived hospital attractiveness. Overall, hospitals are advised to use a differentiated approach to increase their attractiveness to physicians.
PMCID: PMC4055796  PMID: 24884491
4.  Cost-Effectiveness Analysis of Pharmaceutical Treatment Options in the First-Line Management of Major Depressive Disorder in Belgium 
Pharmacoeconomics  2014;32(5):479-493.
The objective of this study was to assess the cost effectiveness of commonly used antidepressants as first-line treatment of major depressive disorder (MDD) in Belgium.
The model structure was based on a decision tree developed by the Swedish TLV (Tandvårds- och läkemedelsförmånsverket) and adapted to the Belgium healthcare setting, using primary local data on the patterns of treatment and following KCE [Federal Knowledge Center (Federaal Kenniscentrum voor de Gezondheidszorg)] recommendations. Comparators were escitalopram, citalopram, fluoxetine, paroxetine, sertraline, duloxetine, venlafaxine, and mirtazapine. In the model, patients not achieving remission or relapsing after remission on the assessed treatment moved to a second therapeutic step (titration, switch, add-on, or transfer to a specialist). In case of failure in the second step or following a suicide attempt, patients were assumed to be referred to secondary care. The time horizon was 1 year and the analysis was conducted from the National Institute for Health and Disability Insurance (NIHDI; national health insurance) and societal perspectives. Remission rates were obtained from the TLV network meta-analysis and risk of relapse, efficacy following therapeutic change, risk of suicide attempts and related death, utilities, costs (2012), and resources were derived from the published literature and expert opinion. The effect of uncertainty in model parameters was estimated through scenario analyses and a probabilistic sensitivity analysis (PSA).
In the base-case analysis, escitalopram was identified as the optimal strategy: it dominated all other treatments except venlafaxine from the NIHDI perspective, against which it was cost effective with an incremental cost-effectiveness ratio of €6,352 per quality-adjusted life-year (QALY). Escitalopram also dominated all other treatments from the societal perspective. At a threshold of €30,000 per QALY and from the NIHDI perspective, the PSA showed that the probability of escitalopram being identified as the optimal strategy ranged from 61 % (vs. venlafaxine) to 100 % (vs. fluoxetine).
Escitalopram was associated with the highest probability of being the optimal treatment from the NIHDI and societal perspectives. This analysis, based on new Belgian clinical practice data and following KCE requirements, provides additional information that may be used to guide the choice of treatments in the management of MDD in Belgium.
Electronic supplementary material
The online version of this article (doi:10.1007/s40273-014-0138-x) contains supplementary material, which is available to authorized users.
PMCID: PMC4013445  PMID: 24554474
5.  Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial 
BMC Family Practice  2014;15:24.
Despite the efforts of the healthcare community to improve the quality of diabetes care, about 50% of people with type 2 diabetes do not reach their treatment targets, increasing the risk of future micro-and macro-vascular complications. Diabetes self-management education has been shown to contribute to better disease control. However, it is not known which strategies involving educational programs are cost-effective. Telehealth applications might support chronic disease management. Transferability of successful distant patient self-management support programs to the Belgian setting needs to be confirmed by studies of a high methodological quality. “The COACH Program” was developed in Australia as target driven educational telephone delivered intervention to support people with different chronic conditions. It proved to be effective in patients with coronary heart disease after hospitalization. Clinical and cost-effectiveness of The COACH Program in people with type 2 diabetes in Belgium needs to be assessed.
Randomized controlled trial in patients with type 2 diabetes. Patients were selected based on their medication consumption data and were recruited by their sickness fund. They were randomized to receive either usual care plus “The COACH Program” or usual care alone. The study will assess the difference in outcomes between groups. The primary outcome measure is the level of HbA1c. The secondary outcomes are: Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Blood Pressure, body mass index, smoking status; proportion of people at target for HbA1c, LDL-Cholesterol and Blood Pressure; self-perceived health status, diabetes-specific emotional distress and satisfaction with diabetes care. The follow-up period is 18 months. Within-trial and modeled cost-utility analyses, to project effects over life-time horizon beyond the trial duration, will be undertaken from the perspective of the health care system if the intervention is effective.
The study will enhance our understanding of the potential of telehealth in diabetes management in Belgium. Research on the clinical effectiveness and the cost-effectiveness is essential to support policy makers in future reimbursement and implementation decisions.
Trial registration
Belgian number: B322201213625. Identifier: NCT01612520
PMCID: PMC3922086  PMID: 24495633
Type 2 diabetes mellitus; Telenursing; RCT; Economic analysis
6.  Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study) 
Trials  2013;14:376.
Although results of case series support the use of spinal cord stimulation in failed back surgery syndrome patients with predominant low back pain, no confirmatory randomized controlled trial has been undertaken in this patient group to date. PROMISE is a multicenter, prospective, randomized, open-label, parallel-group study designed to compare the clinical effectiveness of spinal cord stimulation plus optimal medical management with optimal medical management alone in patients with failed back surgery syndrome and predominant low back pain.
Patients will be recruited in approximately 30 centers across Canada, Europe, and the United States. Eligible patients with low back pain exceeding leg pain and an average Numeric Pain Rating Scale score ≥5 for low back pain will be randomized 1:1 to spinal cord stimulation plus optimal medical management or to optimal medical management alone. The investigators will tailor individual optimal medical management treatment plans to their patients. Excluded from study treatments are intrathecal drug delivery, peripheral nerve stimulation, back surgery related to the original back pain complaint, and experimental therapies. Patients randomized to the spinal cord stimulation group will undergo trial stimulation, and if they achieve adequate low back pain relief a neurostimulation system using the Specify® 5-6-5 multi-column lead (Medtronic Inc., Minneapolis, MN, USA) will be implanted to capture low back pain preferentially in these patients. Outcome assessment will occur at baseline (pre-randomization) and at 1, 3, 6, 9, 12, 18, and 24 months post randomization. After the 6-month visit, patients can change treatment to that received by the other randomized group. The primary outcome is the proportion of patients with ≥50% reduction in low back pain at the 6-month visit. Additional outcomes include changes in low back and leg pain, functional disability, health-related quality of life, return to work, healthcare utilization including medication usage, and patient satisfaction. Data on adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Healthcare use data will be used to assess costs and long-term cost-effectiveness.
Recruitment began in January 2013 and will continue until 2016.
Trial registration NCT01697358 (
PMCID: PMC4226255  PMID: 24195916
Low back pain; Neuropathic pain; Failed back surgery syndrome; Spinal cord stimulation; Randomized controlled trial
7.  Evidence-Based Health Care Policy in Reimbursement Decisions: Lessons from a Series of Six Equivocal Case-Studies 
PLoS ONE  2013;8(10):e78662.
Health care technological evolution through new drugs, implants and other interventions is a key driver of healthcare spending. Policy makers are currently challenged to strengthen the evidence for and cost-effectiveness of reimbursement decisions, while not reducing the capacity for real innovations. This article examines six cases of reimbursement decision making at the national health insurance authority in Belgium, with outcomes that were contested from an evidence-based perspective in scientific or public media.
In depth interviews with key stakeholders based on the adapted framework of Davies allowed us to identify the relative impact of clinical and health economic evidence; experience, expertise & judgment; financial impact & resources; values, ideology & political beliefs; habit & tradition; lobbyists & pressure groups; pragmatics & contingencies; media attention; and adoption from other payers & countries.
Evidence was not the sole criterion on which reimbursement decisions were based. Across six equivocal cases numerous other criteria were perceived to influence reimbursement policy. These included other considerations that stakeholders deemed crucial in this area, such as taking into account the cost to the patient, and managing crisis scenarios. However, negative impacts were also reported, in the form of bypassing regular procedures unnecessarily, dominance of an opinion leader, using information selectively, and influential conflicts of interest.
‘Evidence’ and ‘negotiation’ are both essential inputs of reimbursement policy. Yet, purposely selected equivocal cases in Belgium provide a rich source to learn from and to improve the interaction between both. We formulated policy recommendations to reconcile the impact of all factors identified. A more systematic approach to reimburse new care may be one of many instruments to resolve the budgetary crisis in health care in other countries as well, by separating what is truly innovative and value for money from additional ‘waste’.
PMCID: PMC3813690  PMID: 24205290
8.  Health promotion in individuals with mental disorders: a cluster preference randomized controlled trial 
BMC Public Health  2013;13:657.
The existing literature on weight management interventions targeting physical activity and healthy eating in mental health care appears to provide only limited evidence. The aim of the study was to examine the effectiveness of a 10-week health promotion intervention, followed by a 6-month follow-up period in individuals with mental disorders living in sheltered housing in the Flanders region (Belgium).
The study had a cluster preference randomized controlled design. Twenty-five sheltered housing organisations agreed to participate (16 in the intervention group, nine in the control group). In the intervention group, 225 individuals agreed to participate, while in the control group 99 individuals entered into the study. The main outcomes were changes in body weight, Body Mass Index, waist circumference and fat mass. Secondary outcomes consisted of changes in physical activity levels, eating habits, health-related quality of life and psychiatric symptom severity.
A significant difference was found between the intervention group and the control group regarding body weight (−0.35 vs. +0.22 kg; p=0.04), Body Mass Index (−0.12 vs. +0.08 kg/m2; p=0.04), waist circumference (−0.29 vs. + 0.55 cm; p<0.01), and fat mass (−0.99 vs. −0.12%; p<0.01). The decrease in these outcomes in the intervention group disappeared during the follow up period, except for fat mass. Within the intervention group, a larger decrease in the primary outcomes was found in the participants who completed the intervention. No significant differences between the two groups in changes in the secondary outcomes were found, except for the pedometer-determined steps/day. In the intervention group, the mean number of daily steps increased, while it decreased in the control group.
The study demonstrated that small significant improvements in the primary outcomes are possible in individuals with mental disorders. Integration of health promotion activities targeting physical activity and healthy eating into daily care are, however, necessary to maintain the promising results.
Trial registration
This study is registered at NCT 01336946
PMCID: PMC3721998  PMID: 23855449
Mental health care; Health promotion; Physical activity; Healthy eating; Intervention
9.  Preoperative chemosensitivity testing as Predictor of Treatment benefit in Adjuvant stage III colon cancer (PePiTA): Protocol of a prospective BGDO (Belgian Group for Digestive Oncology) multicentric study 
BMC Cancer  2013;13:190.
Surgery is a curative treatment for patients with locally advanced colon cancer, but recurrences are frequent for those with stage III disease. FOLFOX adjuvant chemotherapy has been shown to improve recurrence-free survival and overall survival by more than 20% and is nowadays considered a standard of care. However, the vast majority of patients will not benefit from receiving cytotoxic drugs because they have either already been cured by surgery or because their tumor cells are resistant to the chemotherapy, for which predictive factors are still not available.
Identifying which patients are unlikely to respond to adjuvant chemotherapy from among those who are eligible for such treatment would be a major step towards treatment personalization. It would spare such patients from unnecessary toxicities and would improve the allocation of societal healthcare resources.
PePiTA is a prospective, multicenter, non-randomised trial built on the hypothesis that preoperative chemosensitivity testing using FDG-PET/CT before and after one course of FOLFOX can identify the patients who are unlikely to benefit from 6 months of adjuvant FOLFOX treatment for stage III colon cancer.
The study’s primary objective is to examine the ability of PET/CT-assessed tumor FDG uptake after one course of preoperative chemotherapy to predict the outcome of adjuvant therapy, as measured by 3-year disease-free survival.
Secondary objectives are to examine the predictive value of changes in PET/CT-assessed tumor FDG uptake on overall survival, to define the best cut-off value of FDG uptake for predicting treatment outcome, and to analyse the cost-effectiveness of such preoperative chemo-sensitivity testing.
At study planning, exploratory translational research objectives were 1) to assess the predictive value of circulating tumor cells for disease-free survival, 2) to examine the predictive value of single nucleotide polymorphisms for disease-free survival with respect to genes related either to toxicity or to drug targets, 3) to assess genomic rearrangements associated with response or resistance to FOLFOX treatment, 4) to identify an immunologic signature associated with metabolic tumor response to FOLFOX therapy and, finally, 5) to create a bank of frozen tumor samples for future studies.
PePiTA is the first study to use the primitive tumor chemosensitivity assessed by metabolic imaging as a guidance for adjuvant therapy in colon cancer. It could pave the way for tailoring the treatment and avoiding useless toxicities for the patients and inadequate expenses for the society. It could also give an interesting insight into tumoral heterogeneity, resistance to chemotherapy, genetic predisposants to oxaliplatin toxicity and immune response to cancer.
EudraCT number
Trial registration number, NCT00994864
PMCID: PMC3637567  PMID: 23587148
Colon cancer; Adjuvant; Early assessment; Chemosensitivity; FDG-PET; PET/CT
10.  Health promotion intervention in mental health care: design and baseline findings of a cluster preference randomized controlled trial 
BMC Public Health  2012;12:431.
Growing attention is given to the effects of health promotion programs targeting physical activity and healthy eating in individuals with mental disorders. The design of evaluation studies of public health interventions poses several problems and the current literature appears to provide only limited evidence on the effectiveness of such programs. The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders living in sheltered housing. In this paper, the design of the study and baseline findings are described.
The design consists of a cluster preference randomized controlled trial. All sheltered housing organisations in the Flanders region (Belgium) were asked if they were interested to participate in the study and if they were having a preference to serve as intervention or control group. Those without a preference were randomly assigned to the intervention or control group. Individuals in the intervention group receive a 10-week health promotion intervention above their treatment as usual. Outcome assessments occur at baseline, at 10 and at 36 weeks. The primary outcomes include body weight, Body Mass Index, waist circumference, and fat mass. Secondary outcomes consist of physical activity levels, eating habits, health-related quality of life and psychiatric symptom severity. Cost-effectiveness of the intervention will be examined by calculating the Cost-Effectiveness ratio and through economic modeling.Twenty-five sheltered housing organisations agreed to participate. On the individual level 324 patients were willing to participate, including 225 individuals in the intervention group and 99 individuals in the control group. At baseline, no statistical significant differences between the two groups were found for the primary outcome variables.
This is the first trial evaluating both the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in mental health care using a cluster preference randomized controlled design. The baseline characteristics already demonstrate the unhealthy condition of the study population.
Trial registration
This study is registered at – NCT 01336946
PMCID: PMC3408350  PMID: 22694796
Health promotion; Intervention study; Physical activity; Eating habits; Mental health care
11.  The economic impact of enoxaparin versus unfractionated heparin for prevention of venous thromboembolism in acute ischemic stroke patients 
Venous thromboembolism (VTE) is a common complication after acute ischemic stroke that can be prevented by the use of anticoagulants. Current guidelines from the American College of Chest Physicians recommend that patients with acute ischemic stroke and restricted mobility receive prophylactic low-dose unfractionated heparin or a low-molecular-weight heparin. Results from clinical studies, most recently from PREVAIL (PREvention of Venous Thromboembolism After Acute Ischemic Stroke with LMWH and unfractionated heparin), suggest that the low-molecular-weight heparin, enoxaparin, is preferable to unfractionated heparin for VTE prophylaxis in patients with acute ischemic stroke and restricted mobility. This is due to a better clinical benefit-to-risk ratio, with the added convenience of once-daily administration. In line with findings from modeling studies and real-world data in acutely ill medical patients, recent economic data indicate that the higher drug cost of enoxaparin is offset by the reduction in clinical events as compared with the use of unfractionated heparin for the prevention of VTE after acute ischemic stroke, particularly in patients with severe stroke. With national performance measures highlighting the need for hospitals to examine their VTE practices, the relative costs of different regimens are of particular importance to health care decision-makers. The data reviewed here suggest that preferential use of enoxaparin over unfractionated heparin for the prevention of VTE after acute ischemic stroke may lead to reduced VTE rates and concomitant cost savings in clinical practice.
PMCID: PMC3345934  PMID: 22570556
acute ischemic stroke; cost savings; enoxaparin; unfractionated heparin; venous thromboembolism
12.  Cost-effectiveness of ranibizumab in treatment of diabetic macular oedema (DME) causing visual impairment: evidence from the RESTORE trial 
To evaluate the cost-effectiveness of ranibizumab as either monotherapy or combined with laser therapy, compared with laser monotherapy, in the treatment of diabetic macular oedema (DME) causing visual impairment from a UK healthcare payer perspective.
A Markov model simulated long-term outcomes and costs of treating DME in one eye (BCVA ≤75 letters) based on data from the RESTORE Phase III trial. Outcomes measured in quality-adjusted life-years (QALYs) were simulated for a 15-year time horizon based on 12-month follow-up from RESTORE and published long-term data. Costs included treatment, disease monitoring, visual impairment and blindness (at 2010 price levels).
Ranibizumab monotherapy resulted in a 0.17 QALY gain at an incremental cost of £4191 relative to laser monotherapy, yielding an incremental cost-effectiveness ratio (ICER) of £24 028. Probabilistic sensitivity analysis showed a 64% probability of being cost-effective at a threshold of £30 000 per QALY. Combined ranibizumab and laser therapy resulted in a 0.13 QALY gain at an incremental cost of £4695 relative to laser monotherapy (ICER £36 106; 42% probability of ICER <£30 000).
Based on RESTORE 1-year follow-up data, ranibizumab monotherapy appears to be cost-effective relative to laser monotherapy, the current standard of care. Cost-effectiveness of combination therapy is less certain. Ongoing studies will further inform on disease progression and the need for additional ranibizumab treatment.
PMCID: PMC3329632  PMID: 22399690
Ranibizumab; diabetic macular oedema; visual impairment; cost-effectiveness; macula; treatment medical; clinical trial; epidemiology; public health; vision; retina
13.  Valorising and Creating Access to Innovative Medicines in the European Union 
This Perspective describes (a) the current situation, (b) challenges and initiatives, (c) and formulates recommendations to valorize and create access to innovative medicines in the EU. We are currently still far away from optimal assessment of value for money in the EU. On the one hand, valorizing innovative medicines involves a local appraisal by health technology assessment (HTA) bodies and competent authorities about the value for money, the budget impact, and the local medical need that can be filled with new medicines. Therefore, local priorities and national health care policy environments should be reflected in the processes and criteria used for assessing value for money and ultimately for reimbursement decisions. On the other hand, a pan-European assessment of both relative effectiveness and medical need (including general ethical and social considerations) should be envisaged in order to feed part of the data needed for the local decisions in an efficient way. This could be the task of the European Medicines Agency, HTA bodies, and competent authorities together.
PMCID: PMC3190181  PMID: 22013421
pharmaceutical innovation; health technology assessment; cost–effectiveness; relative effectiveness; budget impact; medical need; access
14.  The equity dimension in evaluations of the quality and outcomes framework: A systematic review 
Pay-for-performance systems raise concerns regarding inequity in health care because providers might select patients for whom targets can easily be reached. This paper aims to describe the evolution of pre-existing (in)equity in health care in the period after the introduction of the Quality and Outcomes Framework (QOF) in the UK and to describe (in)equities in exception reporting. In this evaluation, a theory-based framework conceptualising equity in terms of equal access, equal treatment and equal treatment outcomes for people in equal need is used to guide the work.
A systematic MEDLINE and Econlit search identified 317 studies. Of these, 290 were excluded because they were not related to the evaluation of QOF, they lacked an equity dimension in the evaluation, their qualitative research focused on experiences or on the nature of the consultation, or unsuitable methodology was used to pronounce upon equity after the introduction of QOF.
None of the publications (n = 27) assessed equity in access to health care. Concerning equity in treatment and (intermediate) treatment outcomes, overall quality scores generally improved. For the majority of the observed indicators, all citizens benefit from this improvement, yet the extent to which different patient groups benefit tends to vary and to be highly dependent on the type and complexity of the indicator(s) under study, the observed patient group(s) and the characteristics of the study. In general, the introduction of QOF was favourable for the aged and for males. Total QOF scores did not seem to vary according to ethnicity. For deprivation, small but significant residual differences were observed after the introduction of QOF favouring less deprived groups. These differences are mainly due to differences at the practice level. The variance in exception reporting according to gender and socio-economic position is low.
Although QOF seems not to be socially selective at first glance, this does not mean QOF does not contribute to the inverse care law. Introducing different targets for specific patient groups and including appropriate, non-disease specific and patient-centred indicators that grasp the complexity of primary care might refine the equity dimension of the evaluation of QOF. Also, information on the actual uptake of care, information at the patient level and monitoring of individuals' health care utilisation tracks could make large contributions to an in-depth evaluation. Finally, evaluating pay-for-quality initiatives in a broader health systems impact assessment strategy with equity as a full assessment criterion is of utmost importance.
PMCID: PMC3182892  PMID: 21880136
15.  Effectiveness and cost-effectiveness of lifestyle interventions on physical activity and eating habits in persons with severe mental disorders: A systematic review 
There is a high prevalence of overweight and obesity in persons with severe mental disorders and this has serious implications on the short and long term health outcomes of these patients. The aim of this review was to evaluate the effectiveness of lifestyle interventions targeting physical activity and eating habits in persons with severe mental disorders. Special attention was given if any of the included studies in the review also examined the cost-effectiveness of these health promotion interventions.
A systematic search through the electronic databases Medline, Web of Science, CINAHL and Cohrane Library was conducted, and by hand-searching the reference lists of the retrieved articles from the electronic databases. Studies were included if they examined effectiveness and/or cost-effectiveness of lifestyle interventions targeting physical activity and eating habits in persons with severe mental disorders, with primary outcome changes in Body Mass Index and body weight.
Fourteen studies met the inclusion criteria. Weight loss and Body Mass Index decrease were observed in intervention groups in 11 studies. The difference in weight change between intervention and control groups was statistically significant in nine studies. Differences in mean Body Mass Index between intervention and control groups were statistically significant in eight studies. Five studies reported improvements in quality of life and general health. In none of the studies cost-effectiveness of lifestyle interventions was examined.
Further research on both effectiveness and cost-effectiveness of lifestyle interventions targeting physical activity and eating habits in persons with severe mental disorders is required to assist in the development of new health promotion interventions in this population.
PMCID: PMC3094265  PMID: 21481247
17.  The ties that bind: an integrative framework of physician-hospital alignment 
Alignment between physicians and hospitals is of major importance to the health care sector. Two distinct approaches to align the medical staff with the hospital have characterized previous research. The first approach, economic integration, is rooted in the economic literature, in which alignment is realized by financial means. The second approach, noneconomic integration, represents a sociological perspective emphasizing the cooperative nature of their relationship.
Empirical studies and management theory (agency theory and social exchange theory) are used to increase holistic understanding of physician hospital alignment. On the one hand, noneconomic integration is identified as a means to realize a cooperative relationship. On the other hand, economic integration is studied as a way to align financial incentives. The framework is developed around two key antecedent factors which play an important role in aligning the medical staff. First, provider financial risk bearing is identified as a driving force towards closer integration. Second, organizational trust is believed to be important in explaining the causal relation between noneconomic and economic integration.
Hospital financial risk bearing creates a greater need for closer cooperation with the medical staff and alignment of financial incentives. Noneconomic integration lies at the very basis of alignment. It contributes directly to alignment through the norm of reciprocity and indirectly by building trust with the medical staff, laying the foundation for alignment of financial incentives.
PMCID: PMC3048489  PMID: 21324128
18.  Systematic review: Effects, design choices, and context of pay-for-performance in health care 
Pay-for-performance (P4P) is one of the primary tools used to support healthcare delivery reform. Substantial heterogeneity exists in the development and implementation of P4P in health care and its effects. This paper summarizes evidence, obtained from studies published between January 1990 and July 2009, concerning P4P effects, as well as evidence on the impact of design choices and contextual mediators on these effects. Effect domains include clinical effectiveness, access and equity, coordination and continuity, patient-centeredness, and cost-effectiveness.
The systematic review made use of electronic database searching, reference screening, forward citation tracking and expert consultation. The following databases were searched: Cochrane Library, EconLit, Embase, Medline, PsychINFO, and Web of Science. Studies that evaluate P4P effects in primary care or acute hospital care medicine were included. Papers concerning other target groups or settings, having no empirical evaluation design or not complying with the P4P definition were excluded. According to study design nine validated quality appraisal tools and reporting statements were applied. Data were extracted and summarized into evidence tables independently by two reviewers.
One hundred twenty-eight evaluation studies provide a large body of evidence -to be interpreted with caution- concerning the effects of P4P on clinical effectiveness and equity of care. However, less evidence on the impact on coordination, continuity, patient-centeredness and cost-effectiveness was found. P4P effects can be judged to be encouraging or disappointing, depending on the primary mission of the P4P program: supporting minimal quality standards and/or boosting quality improvement. Moreover, the effects of P4P interventions varied according to design choices and characteristics of the context in which it was introduced.
Future P4P programs should (1) select and define P4P targets on the basis of baseline room for improvement, (2) make use of process and (intermediary) outcome indicators as target measures, (3) involve stakeholders and communicate information about the programs thoroughly and directly, (4) implement a uniform P4P design across payers, (5) focus on both quality improvement and achievement, and (6) distribute incentives to the individual and/or team level.
P4P programs result in the full spectrum of possible effects for specific targets, from absent or negligible to strongly beneficial. Based on the evidence the review has provided further indications on how effect findings are likely to relate to P4P design choices and context. The provided best practice hypotheses should be tested in future research.
PMCID: PMC2936378  PMID: 20731816

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