Objectives: Evaluation is crucial for integration of e-Health/m-Health into healthcare systems and health technology assessment (HTA) could offer sound methodological basis for these evaluations. Aim of this study was to look for HTA reports on e-Health/m-Health technologies and to analyze their transparency, consistency and thoroughness, with the goal to detect areas that need improvement.

Methods: PubMed, ISI-WOS, and University of York – Centre for Reviews and Dissemination–electronic databases were searched to identify reports on e-Health/m-Health technologies, published up until April 1, 2016. The International Network of Agencies for Health Technology Assessment (INAHTA) checklist was used to evaluate transparency and consistency of included reports. Thoroughness was assessed by checking the presence of domains suggested by the European network for Health Technology Assessment (EUnetHTA) HTA Core Model.

Results: Twenty-eight reports published between 1999 and 2015 were included. Most were delivered by non-European countries (71.4 percent) and only 35.7 percent were classified as full reports. All the HTA reports defined the scope of research whereas more than 80 percent provided author details, summary, discussed findings, and conclusion. On the contrary, policy and research questions were clearly defined in around 30 percent and 50 percent of reports. With respect to the EUnetHTA Core Model, around 70 percent of reports dealt with effectiveness and economic evaluation, more than 50 percent described health problem and approximately 40 percent organizational and social aspects.

Conclusions: E-Health/m-Health technologies are increasingly present in the field of HTA. Yet, our review identified several missing elements. Most of the reports failed to respond to relevant assessment components, especially ethical, social and organizational implications.

Health outcome assessment may be used for a variety of purposes: to evaluate the effectiveness of medical practices: to assess the quality of services provided; to educate providers, purchasers, and users of health services about the sequelae of treated and untreated disease; to guide reimbursement and regulatory policy; and to characterize the health status of a population. This article focuses on the use of health outcomes to evaluate the effectiveness of medical practices and to assess the quality of services provided.

A colorimetric instrument for the noninvasive quantification of hemoglobin, designed using color shades resembling those observed in the conjunctiva, was tested. The instrument's colors are contrasted against the color of the conjunctiva to measure hemoglobin content. Sensitivity, specificity, negative predictive value, and false-negative value were estimated to test the instrument's accuracy; kappa coefficients were used to estimate inter- and intraobserver variability. Physician field evaluations of conjunctiva color for the screening of anemia, reported in the literature, have had sensitivities and specificities as high as 70%. Readings with the instrument demonstrated a 63% sensitivity, 72% specificity, and 38% false negatives for screening hemoglobin values of less than or equal to 13 g/dl. The interobserver kappa coefficients for three pairs of readers were good to excellent for the same hemoglobin screening value. Statistically significant differences were noted, however, between observers during the reliability test. The instrument can be used by unskilled personnel to improve their decision-making about whom to send for futher care or for supplementation with iron.

A controversial issue in cost-effectiveness analysis is the discounting of gained life-years. What has not been realized, however, is that the different methods used for discounting this measurement provide fundamentally different results. The method used is seldom explicitly stated. In the present article the four main methods for the discounting of gained life-years are reviewed and compared. The conclusion is that if we wish to continue comparing results, researchers must employ the same methodology.

Objectives: The aim of this investigation was to assess the incremental cost-effectiveness of replacing bare metal coronary stents (BMS) with drug-eluting stents (DES) in the Province of Quebec, Canada.

Methods: The strategy used was a cost-effectiveness analysis from the perspective of the health-care provider, in the province of Quebec, Canada (population 7.5 million). The main outcome measure was the cost per avoided revascularization intervention.

Results: Based on the annual Quebec rate of 14,000 angioplasties with an average of 1.7 stents per procedure and a purchase cost of $2,600 Canadian dollar (CDN) for DES, 100 percent substitution of BMS with DES would require an additional $45.1 million CDN of funding. After the benefits of reduced repeat revascularization interventions are included, the incremental cost would be $35.2 million CDN. The cost per avoided revascularization intervention (18 percent coronary artery bypass graft, 82 percent percutaneous coronary intervention [PCI]) would be $23,067 CDN. If DES were offered selectively to higher risk populations, for example, a 20 percent subgroup with a relative restenosis risk of 2.5 times the current bare metal rate, the incremental cost of the program would be $4.9 million CDN at a cost of $7,800 per avoided revascularization procedure. Break-even costs for the program would occur at DES purchase cost of $1,161 for 100 percent DES use and $1,627 for selective 20 percent DES use for high-risk patients for restenosis (RR = 2.5). Univariate and Monte Carlo sensitivity analyses indicate that the parameters most affecting the analysis are the capacity to select patients at high risk of restenosis, the average number of stents used per PCI, baseline restenosis rates for BMS, the effectiveness ratio of restenosis prevention for DES versus BMS, the cost of DES, and the revascularization rate after initial PCI. Sensitivity analyses suggest little additional health benefits but escalating cost-effectiveness ratios once a DES penetration of 40 percent has been attained.

Conclusions: Under current conditions in Quebec, Canada, selective use of DES in high-risk patients is the most acceptable strategy in terms of cost-effectiveness. Results of such an analysis would be expected to be similar in other countries with key model parameters similar to those used in this model. This model provides an example of how to evaluate the cost-effectiveness of selective use of a new technology in high-risk patients.

Objective: This study investigates the influence of different aspects of methodologic quality on the conclusions of a systematic review concerning treatments of acute lateral ankle sprain.

Method: A data set of a systematic review of 44 trials was used, of which 22 trials could be included in this study. Quality assessment of the individual studies was performed using the Delphi list. We calculated effect sizes of the main outcome measure in each study in order to evaluate the relationship between overall quality scores and outcome. Next, we investigated the impact of design attributes on pooled effect sizes by subgroup analysis.

Results: The quality of most studies (82%) was low; only 4 of 22 trials were of high quality. Studies with proper randomization and blinding procedure produce a slightly higher (not statistically significant) effect estimate compared to the other studies.

Conclusion: Previous research has suggested that methodologically poorly designed studies tend to over-estimate the effect estimate. Our study does not confirm these conclusions.

Objectives: Online Health Communities (OHCs) are increasingly being used by patients in the Web 2.0 era. Today's patients have instant access to a great deal of medical information and contacts. Despite the considerable development of OHCs, little is known regarding the impact on the patient–physician relationship. This research aims at filling this gap and examines how interpersonal trust on peer-to-peer OHCs influences two key relational variables, namely patient trust in the physician and patient satisfaction with the physician. It also investigates their influences on the patient's attitude toward the physician.

Methods: Drawing on both the relational and medical literatures, we propose a research model that brings out the relationships between interpersonal trust in OHCs, and patients’ trust, satisfaction and attitude toward the physician. We then conduct a quantitative survey of 512 OHC users in France, using structural equation modeling to test our hypotheses.

Results: Our findings indicate that interpersonal trust in OHCs exerts a positive influence on both patients’ trust in and satisfaction with their physician. It also highlights that these two relational variables have a positive influence on patient attitude toward the physician. Our findings also indicate that patient trust influences patient satisfaction with the physician.

Conclusions: This research highlights the importance of OHCs, which can be seen as valuable instruments for enhancing patient–physician relationships. It shows that healthcare managers should seek to enhance interpersonal trust among OHC users, because this trust has a positive influence on patient satisfaction with, trust in and attitude toward the physician.

Objectives: This study examines the cost-effectiveness of the OPTI-SCRIPT intervention on potentially inappropriate prescribing in primary care.

Methods: Economic evaluation, using incremental cost-effectiveness and cost utility analyses, conducted alongside a cluster randomized controlled trial of twenty-one general practices and 196 patients, to compare a multifaceted intervention with usual practice in primary care in Ireland. Potentially inappropriate prescriptions (PIPs) were determined by a pharmacist. Incremental costs, PIPs, and quality-adjusted life-years (QALYs) at 12-month follow-up were estimated using multilevel regression. Uncertainty was explored using cost-effectiveness acceptability curves.

Results: The intervention was associated with a nonsignificant mean cost increase of €407 (95 percent CIs, −357–1170), a significant mean reduction in PIPs of 0.379 (95 percent CI, 0.092–0.666), and a nonsignificant mean increase in QALYs of 0.013 (95 percent CIs, −0.016–0.042). The incremental cost per PIP avoided was €1,269 (95 percent CI, −1400–6302) and the incremental cost per QALY gained was €30,535 (95 percent CI, −334,846–289,498). The probability of the intervention being cost-effective was 0.602 at a threshold value of €45,000 per QALY gained and was at least 0.845 at threshold values of €2,500 per PIP avoided and higher.

Conclusions: While the OPTI-SCRIPT intervention was effective in reducing potentially inappropriate prescribing in primary care in Ireland, our findings highlight the uncertainty with respect to its cost-effectiveness. Further studies are required to explore the health and economic implications of interventions targeting potentially inappropriate prescribing.

Objectives: The use of value of information methods to inform trial design has been widely advocated but there have been few empirical applications of these methods and there is little evidence they are widely used in decision making. This study considers the usefulness of value of information models in the context of a real clinical decision problem relating to alternative diagnostic strategies for patients with a recent non-ST elevated myocardial infarction.

Methods: A pretrial economic model is constructed to consider the cost-effectiveness of two competing strategies: coronary angiography alone or in conjunction with fractional flow reserve measurement. A closed-form solution to the expected benefits of information is used with optimal sample size estimated for a range of models reflecting increasingly realistic assumptions and alternative decision contexts.

Results: Fractional flow reserve measurement is expected to be cost-effective with an incremental cost-effectiveness ratio of GBP 1,621, however, there is considerable uncertainty in this estimate and consequently a large expected value to reducing this uncertainty via a trial. The recommended sample size is strongly affected by the reality of the assumptions of the expected value of information (EVI) model and the decision context.

Conclusions: Value of information models can provide a simple and flexible approach to clinical trial design and are more consistent with the constraints and objectives of the healthcare system than traditional frequentist approaches. However, the variation in sample size estimates demonstrates that it is essential that appropriate model parameters and decision contexts are used in their application.

A retrospective study comparing 700 consecutive total hip arthroplasties, utilizing four types of implants, was performed. Questionnaires based on hip scores were sent to 593 living patients. Useful responses were received from 363 (61 %) patients. Hip scores and quality-adjusted life-years were calculated. Multiple regression analysis, controlling for all possible biases, demonstrated one cementless implant as superior to all others. We believe that the use of mailed questionnaires is a simple and convenient system of follow-up, saving patients the need for outpatient clinic visits. The validity of such replies, however, has yet to be established.

This study used data from a multinational phase III randomized, double-blind, vehicle-controlled trial to evaluate the cost-effectiveness of tirilazad mesylate (Freedox®) in the treatment of aneurysmal subarachnoid hemorrhage. In men, therapy with 6 mg/kg per day of tirilazad mesylate was associated with significantly increased survival, increased cost of care, and ratios of cost per death averted that compare favorably with the ratios of other life and death interventions. In women, it appeared to have no effects on costs or survival. Further clinical studies may provide additional information about the cost-effectiveness of this intervention.

Objectives: The aim of this study was to examine open-source electronic health record (EHR) software to determine their level of functionalities according to the International Organization for Standardization (ISO) standards.

Methods: ISO standards were used as a guideline to determine and describe the reference architecture and functionalities of a standard electronic health record system as well the environmental context for which the software has been built. Twelve open-source EHR systems were selected and evaluated according to two-dimensional criteria based on ISO/TS 18308:2004 functional requirements and ISO/TR 20514:2005 context of the EHR system.

Results: Open EHR software programs mostly fulfill structural, procedural, evolutional, and medicolegal requirements at the minimal and full functionality levels. Communication, privacy, and security requirements are accomplished in less than 23 percent of the cases, mainly at minimal functional level. Ethical, cultural, and consumer requirements still need to be fulfilled by free and open-source EHR applications.

Conclusions: Most analyzed systems had several functional limitations. Nevertheless, especially for clinicians and decision makers in developing countries, open-source EHR systems are an option. The limited functionalities are likely to become requirements for further releases of open-source EHR systems.

Objectives: Due to the aging baby boom population, utilization rates of diagnostic imaging (i.e., X-ray, CT, and MRI scanning) have risen rapidly relative to other health services. The aim of this study is to investigate the utilization patterns of outpatient diagnostic imaging services (X-ray, CT, and MRI) across the late life course (65 years and older).

Methods: A population-based retrospective cohort study was conducted for the period April 1, 2005, to March 31, 2006. All Ontario residents aged 65+ and eligible for government health insurance were included in the analysis.

Results: Utilization of diagnostic imaging followed an inverted U-pattern: increasing with advancing age, peaking in the 80–84 age group for CT scans and in the 70–74 age group for MRI and X-rays, and then declining in the later years. Overall, females received significantly more X-rays than males (p < .01), but males received significantly more CT and MRI scans (p < .01). A small proportion of high-users of radiology services accounted for a large proportion of overall utilization. Finally, our analysis revealed that a disproportionately large proportion of high-users of MRI services were in the highest SES quintile. No SES differences were observed for X-ray or CT scans.

Conclusions: Population aging will lead to increased demand for healthcare services. Utilization of outpatient diagnostic imaging services is associated with age, gender, and SES. Given the increasing demand and the limited resources available, there may be a need for programs to target underserved populations to reduce remediable inequities. Whereas patient-level decisions regarding the use of diagnostic imaging are rightfully determined on the basis of clinical factors, allocation decisions should also be informed by the ethical principles of equity and fairness.

Objectives: To describe and explore the reasons for the current health technology assessment (HTA) landscape in the United States.

Methods: Relying on multiple historical literature and other documents as well as drawing on personal experiences and observations, we describe, evaluate, and explain the evolving and dynamic HTA-related evidence landscape.

Results: The present HTA-related landscape is a product of a dynamic, somewhat turbulent path in the United States. Many early aggressive federal efforts beginning in the 1970s were rejected in the 1980s only to be revived by the mid-1990s and continue to strengthen today, likely due to diffusing private sector political opposition from de-linking HTA from policy decisions (e.g., coverage, clinical guidelines) and omitting economic evaluation. Meanwhile, private sector HTA efforts have remained active during the entire period.

Conclusions: The current HTA-related landscape is at least as dynamic as it has been at any point in its turbulent 30-year history and is likely to continue as health reform in the US is debated once again.

The decision whether to enhance diffusion and to reimburse for the fertility treatment in-vitro fertilization (IVF) was postponed in the Netherlands until the results of a cost-effectiveness analysis were known. IVF appeared to be as cost-effective as its most important alternative, tubal surgery. But policy decisions still were not straightforward, obscuring important social and ethical issues.

Aortic stenosis (AS) is caused by age-related calcific degeneration of the aortic valve (1). Initially, cases are asymptomatic but, from the point that symptoms first develop, there is rapid progression and if left untreated survival estimates are low (2–3 years) (1). Therefore, managing AS effectively and efficiently is a priority for health systems with increasing healthcare costs and longer life expectancy.

Objectives: The aim of this study was to describe the characteristics of the introduction and diffusion of health technology assessment (HTA) in Spain.

Methods: A survey to summarize the evolution of HTA was sent to representatives of different HTA initiatives in Spain.

Results: HTA was introduced in the late 1980s. The main factors were the trend to an increase in healthcare expenditure, concerns regarding efficiency in providing health care, as well as in the level of rationality introducing high technology. Spain has direct (i.e., regulation) and indirect (i.e., payment systems, evidence-based programs, HTA) mechanisms to control health technologies. A recent high priority regulation has established the need of HTA to decide the introduction of a new health technology in the lists of public healthcare coverage, although similar regulations existed in the past and were scarcely implemented. HTA initiatives started at the regional government level. Its introduction followed a progressive pattern among regions. In the beginning, resources were scarce and expertise limited, with work done at intramural level. With time, expertise increase, and promotion of commissioned work was implemented. HTA knowledge transfer in the healthcare system has been carried out through courses, publications, and commissioned research. Currently, there are seven HTA units/agencies, which coordinate their work.

Conclusions: HTA in Spain is in its maturity. Facing the unavoidable change of health care environment over time, HTA is also evolving and, currently, there is a trend to broaden the areas of influence of HTA by devolving capacity to hospitals and applying principles to very early phases of health technology development, under the umbrella of regional HTA units/agencies. However, there are two main challenges ahead. One is to have a real impact at the highest level of healthcare policy coordination among Spanish regions, which is done at the Central Ministry of Health. The other is to avoid the influence of political waves in the level of recognition of HTA at the policy decision-making level and to have an adequate and stable funding of HTA initiatives.

Objectives: This study was undertaken to appraise the quality of published pediatric economic evaluations.

Methods: Two independent reviewers appraised 149 randomly selected pediatric health economic studies. Data were collected from full economic evaluations published between 1980 and 1999. Economic evaluations of interventions, programs, and services aimed at neonates to adolescents were included. The Pediatric Quality Appraisal Questionnaire (PQAQ) was used for appraisal. The PQAQ is a 57-item instrument with 13 domains scored from 0 to 1 and one descriptive domain, each corresponding to a key aspect of health economic methodology. The primary outcome was the score for each domain. Additional analyses examined the global rating, the distribution of analytic technique, and the association between domain score and analytic technique.

Results: A total of 38 percent of publications were very good to excellent, whereas 43 percent were fair or worse. Although the Discounting, Target Population, Economic Evaluation, Conclusions, and Comparators domains exhibited good quality (0.74 to 0.78), the papers were of poor quality for Conflict of Interest, Incremental Analysis, and Perspective (0.32 to 0.39). Analytic technique was a significant predictor of quality for study design-related domains, with cost-utility analyses demonstrating the highest domain scores.

Conclusions: Domains closely related to the elements of economic evaluation demonstrated medium to high quality. However, domains related to analysis fared poorly and are worthy of further methodological research to improve the use of health economic methods in children.