Objectives: The clinical assessment efficiency of the CAGE questionnaire for alcohol abuse based on diagnostic accuracy has not been fully established to date because of the varied and inconclusive gold standards used as diagnostic criteria. CAGE has also been highlighted to miss almost half of the risk-drinkers due to the use of inadequetly set criteria for the positive recognition of alcohol abuse. This study aims to establish the diagnostic accuracy of CAGE at different treatment settings.

Methods: A hybrid of the receiver operating characteristic (ROC) and the Taguchi method was used, as this approach proved to evaluate the diagnostic performance and accuracy in hypothetical clinical settings. Data were used from three cross-clinical treatment settings, i.e., general medicine outpatients, medical inpatients, and psychiatric inpatients, and analyzed by means of a step-wise application of managable number of statistical indices such as the area under the ROC curve (AUC), leveling factor (p′), and signal-to-noise ratios (S/N; standardized S/N [SS/N]).

Results: The selected settings yielded similar AUCs but portrayed different trade-offs on the ROC curves signaling the presence of different critical CAGE scores. Analysis of the sensitivity and specificity data of i, ii, iii by p′, S/N, SS/N and their dependent relation resulted in the critical CAGE scores of 1,1, and 2; and high diagnostic accuracy levels of 76.84 percent, 86 percent, and 76.84 percent, respectively.

Conclusions: By setting these critical CAGE scores as the minimum detection levels of alcohol abuse, early intervention before the onset of serious alcohol-related problems is possible. This will decrease the health-care costs of the patient and, in addition, reduce the psychological and social burdens inherent to alcohol abuse both on the patient and society. Having its critical scores reliably identified and diagnostic accuracy fully determined, CAGE can now improve the detection rate of problem drinking individuals substantially.

Objectives: Decision analysis is commonly used to perform economic evaluations of new pharmaceuticals. The outcomes of such studies are often reported as an incremental cost per quality-adjusted life year (QALY) gained with the new agent. Decision analysis can also be used in the context of estimating drug cost before market entry. The current study used neurokinin-1 (NK-1) receptor antagonists, a new class of antiemetics for cancer patients, as an example to illustrate the process using an incremental cost of $Can20,000 per QALY gained as the target threshold.

Methods: A decision model was developed to simulate the control of acute and delayed emesis after cisplatin-based chemotherapy. The model compared standard therapy with granisetron and dexamethasone to the same protocol with the addition of an NK-1 before chemotherapy and continued twice daily for five days. The rates of complete emesis control were abstracted from a double-blind randomized trial. Costs of standard antiemetics and therapy for breakthrough vomiting were obtained from hospital sources. Utility estimates characterized as quality-adjusted emesis-free days were determined by interviewing twenty-five oncology nurses and pharmacists by using the Time Trade-Off technique. These data were then used to estimate the unit cost of the new antiemetic using a target threshold of $Can20,000 per QALY gained.

Results: A cost of $Can6.60 per NK-1 dose would generate an incremental cost of $Can20,000 per QALY. The sensitivity analysis on the unit cost identified a range from $Can4.80 to $Can10.00 per dose. For the recommended five days of therapy, the total cost should be $Can66.00 ($Can48.00–$Can100.00) for optimal economic efficiency relative to Canada's publicly funded health-care system.

Conclusions: The use of decision modeling for estimating drug cost before product launch is a powerful technique to ensure value for money. Such information can be of value to both drug manufacturers and formulary committees, because it would facilitate negotiations for optimal pricing in a given jurisdiction.

Several studies have been carried out regarding different interventions in an effort to improve levels of physical activity in people with an intellectual disability (ID). Studies have been carried out regarding physical activity interventions (1), educational interventions (2), and multimodal interventions (3). New technologies are currently being used to carry out changes in daily habits and to promote health in different pathologies but not in people with an ID (4;5). Due to the poor maintenance of physical activity that we have found in people with ID, the objective of the present study is to determine the maintenance of levels of physical activity, quality of life, self-efficacy, and social support in this population through an intervention with an application in their smartphones.

Objectives: Recently, we developed a diagnostic rule for the diagnosis and treatment of children with meningeal signs. This rule may provide the physician with a rationale to decide on the use of diagnostic and treatment procedures in these children and to improve their care. In this study, we estimated cost savings of the rule compared with current practice.

Methods: Routine care data of 360 children visiting the emergency department of the Sophia Children's Hospital with meningeal signs between 1988 and 1998 were used. Costs of diagnostic tests and treatment were estimated by using financial accounts of an academic and a general pediatric hospital. The number of procedures actually performed and the resulting cost estimates (i.e. unit costs×volume) were compared with the estimated figures after application of the decision rule.

Results: The population of children with meningeal signs comprised 99 with bacterial meningitis (27%), 36 with another serious bacterial infection (10%), and 225 with a self-limiting disease (63%). Application of the rule would reduce lumbar punctures by 12% and hospitalizations for empirical treatment by 15% with the same diagnostic accuracy as current practice. Cost savings were estimated at €292 per patient (relative reduction 10%) and were mainly achieved in the treatment course (€259).

Conclusions: A diagnostic decision rule for children with meningeal signs has the potential to improve the appropriate use of medical resources, to be cost-effective, and to ascertain the absence of bacterial meningitis earlier.

Objectives: This paper considers the methodological problems that arise in conducting cost analyses in economic evaluations where only observational (rather than experimental) data are available and where the technology being evaluated is diffuse, such that the unit of analysis has to be the institution rather than the patient.

Methods: A case study is reported that concerns the application of computer technology in radiology: picture archiving and communication systems (PACS). A range of different approaches were used to estimate changes in running costs, including time series analyses of routine data and direct observation of resource use.Results:The analysis illustrates some of the difficulties involved in costing the introduction of a diffuse technology. Nevertheless, it provides a firm indication that, overall, the introduction of PACS was found to be associated with a significant increase in hospital costs, suggesting that the initial expectations of financial savings were unduly optimistic.

Conclusions: The research demonstrates that, using multiple methods, it is possible to estimate cost changes within a single hospital. In addition, the paper discusses the nature of the uncertainties in such analyses and possible ways of representing such uncertainty in terms of confidence intervals.

Objectives: The question addressed here is whether home rehabilitation after stroke is better and/or less expensive than the more conventional alternatives, i.e., rehabilitation during inpatient care, day care, and outpatient visits—alone or in combinations appropriate to disease stage and patient needs. Home rehabilitation is managed by teams of professionals who train patients at home.

Methods: The scientific literature was systematically searched for controlled studies comparing outcomes and costs of home rehabilitation with the more conventional strategies.

Results: The abstracts of 204 papers were evaluated, from which 89 were selected for greater scrutiny. From the 89 studies, we found 7 controlled studies involving 1,487 patients (6 of the 7 were randomized, 4 of the 6 assessed costs). No statistically significant differences, or tendencies toward differences, were revealed as regards the outcome of home rehabilitation versus hospital-based alternatives. Thus, home rehabilitation was neither better nor worse at improving patients' ability to manage on their own or resume social activities. Depression and reduced quality of life were common in all groups of patients and caregivers, irrespective of the rehabilitation strategy. In the four randomized studies that reported on costs, home rehabilitation was found to be less expensive than regular day care, but not less expensive than conventional strategies even though hospital stay was reduced.

Conclusion: The outcomes and costs of home rehabilitation after stroke seem to be comparable to alternative treatment strategies.

This paper tests the null hypothesis of a zero effect of cesarean section rate on health outcome against the alternative of a positive effect. Using data from 59 hospitals in Sweden from 1988–92, we specify two separate linear regression models for health outcome, one with perinatal mortality, and the other with rate of asphyxia, as dependent variable. We estimate the models by single-year cross-section regressions and as pooled data systems. The null hypothesis cannot be rejected, i.e., we do not find any significant positive effect of cesarean section rate on health outcome. Thus, we conclude that an increase in cesarean section rate does not imply lower perinatal mortality or lower rate of asphyxia. This in turn indicates that the minimum cesarean section rate is optimal.

Objective: A basic issue in randomized controlled trials (RCTs) is whether we can safely assume comparability between groups at baseline with respect to all potentially important prognostic factors. In other words, did randomization work sufficiently well? In small trials balanced allocation procedures are employed, whereas in large-scale trials simple randomization will do. The question is: When should balancing be considered?

Methods: We performed a simulation study in which we varied the number of categories in the prognostic factors and the number of patients.

Results: Simulation showed that, in all instances, a balancing procedure almost always led to perfect or almost perfect balance, while the imbalance with simple randomization was larger. To study the effect of balanced and random allocation on subgroup analyses in our OME trial, we compared the quotient of the width of the confidence intervals (CI). The widest CI in random allocation over the 13 hospitals was on average 13% wider than in balanced allocation.

Conclusion: Investigators should always consider balanced allocation, especially in categories with a low number of patients and when subgroup analysis over many categories is requested.

Objectives: Strengthening efforts toward better collaboration plays a pivotal role in the assessment of medical devices to reduce overlap and save resources. This study explored the level of duplication in health technology assessments (HTA) of medical devices in Europe and their respective timing in order to identify areas for better collaboration.

Methods: An analysis of European HTA reports of medical devices regarding overlaps in topics and timing in relation to market authorization was performed. We conducted a systematic search in the ADVANCE, Centre for Reviews and Dissemination, Syngerus, and POP databases, complemented by hand searching, to identify HTA reports published between 01/2003 and 07/2016 for a preselected cohort group of ten technologies. We analyzed the number of annual assessments per technology and evaluated activity patterns and timing in undertaking the HTA of the different institutes in Europe.

Results: The results revealed the amount of duplication in the European HTA production: the number of reports per technology ranged from minimum seven to maximum twenty-two over a time-span of 13.5 years. HTA institutes perform assessments at a similar time range within 5 to 10 years following market authorization. The timing of the initial assessment in relation to the granting of the CE-mark varies according to the particular technology.

Conclusion: The findings suggest that efficient collaboration may help to save scarce resources and time of HTA institutes in Europe. Efficient collaboration as such needs to shift the focus beyond the time span of 1 year, and build on each's others work from previous assessments.

Modeling death rates has been suggested as a potential method to screen hospitals and identify superior and substandard providers. This article begins with a review of one hospital death rate study and focuses upon its findings and limitations. It also explores the inherent limitations in the use of large data sets to assess quality of care.

Large data sets are an attractive source of information for outcome assessment, but their use involves certain problems and risks. Data base evaluations are retrospective and unblinded; they often represent the result of multiple analyses of multiple endpoints, and it is difficult to identify the procedures used and analytic choices made because critical details are often omitted. While data bases can suggest problems and offer answers, they cannot prove them; data base analyses must be followed by trials.

Objectives: The assessment of electronic fetal monitoring (EFM) carried out by the authors in the late 1970s provides an early case of a systematic review of evidence in health technology assessment. This paper identifies lessons pertinent for the present day in this field.

Methods: We reviewed our own files for the description of our assessment and reactions to it. We also reviewed recent literature to evaluate our observations in relation to recent evidence.

Results: Our findings of insufficient evidence of efficacy and concerns about safety have been confirmed by subsequent research. Still, despite findings and recommendations of prominent professional and governmental bodies, EFM continues in widespread use in the United States and Europe and is spreading into developing countries around the world. Aggressive attacks on our assessment as well as our skills and integrity have been mirrored in recent years by criticism of other researchers in health technology assessment.

Conclusions: The case of EFM points to the limitations of assessment without other actions to assure the implementation of results. Health technologies that are accepted by the majority of clinicians in a particular field may require extraordinary efforts to assure appropriate use of technology assessments.

Objectives: The aims of the present study were to investigate the awareness among dentists and dental hygienists of evidence-based reports and guidelines on tobacco cessation activities and the impact these publications had on clinical practice.

Methods: A questionnaire was mailed to dental hygienists and dentists in Stockholm County, Sweden, and the results were compared with a previous investigation.

Results: Among the respondents, awareness of a popular science version of a systematic review on smoking and its effect on oral health was reported by 90 percent of the hygienists and 66 percent of the dentists. The information was used in clinical work by 34 percent of the dentists and 54 percent of the hygienists. Reported changes in patterns of practice were more frequent recommendations to use nicotine replacement therapy and a more widespread use of setting quit dates. Approximately one quarter of the dental professionals reported that they had increased tobacco cessation consultation because of the results from the reports.

Conclusions: Changes in patterns of practice were observed after dissemination of evidence-based information on tobacco cessation. Methods that were proven to be effective in the evidence-based report such as discussing quit dates and recommending nicotine replacement therapy were more commonly used after the publication of the report. Short, popular versions of extensive systematic reviews seem to be useful for implementing evidence-based knowledge and changing clinical practice.

Objectives: The aim of this report was to assess the clinical effectiveness of two Gene expression profiling (GEP) and two expanded immunohistochemistry (IHC) tests compared with current prognostic tools in guiding the use of adjuvant chemotherapy in patients with early breast cancer.

Methods: A systematic review of the evidence on clinical effectiveness of OncotypeDX, IHC4, MammaPrint, and Mammostrat, compared with current clinical practice using clinicopathological parameters, in women with early breast cancer was conducted. Ten databases were searched to include citations to May 2016.

Results: Searches identified 7,064 citations, of which forty-one citations satisfied the criteria for the review. A narrative synthesis was performed. Evidence for OncotypeDX demonstrated the impact of the test on decision making and there was some support for OncotypeDX predicting chemotherapy benefit. There were relatively lower levels of evidence for the other three tests included in the analysis. MammaPrint, Mammostrat, and IHC4 tests were limited to a small number of studies. Limitations in relation to study design were identified for all tests.

Conclusions: The evidence base for OncotypeDX is considered to be the most robust. Methodological weaknesses relating to heterogeneity of patient cohorts and issues arising from the retrospective nature of the evidence were identified. Further evidence is required for all of the tests using prospective randomized controlled trial data.

Objectives: The aim of this study was to describe the process and challenges of developing a decision aid for the national public breast cancer screening program in Finland.

Methods: An expert team with stakeholder representation used European guidelines and other literature as basis for selecting relevant content and format for the decision aid for breast cancer screening. Feedback from women was sought for the draft documents.

Results: A decision aid attached to the invitation letter for screening was considered the best way to ensure access to information. In addition, tailored letter templates for all phases of the screening program, a poster, and a public website were developed. Initial feedback from users (women, professionals, and service providers), was mainly positive. Six months after publishing, the implementation of the decision aid was still incomplete.

Conclusions: Providing balanced information for women invited to breast cancer screening is demanding and requires careful planning. Professionals and service providers need to be engaged in the HTA process to ensure proper dissemination and implementation of the information. End user participation is essential in the formulation of information. There is a need to follow up the implementation of the decision aid.

Background: To our knowledge, there has been no overall systematic review focusing on the methodological quality of full economic evaluation studies of self-management interventions. Our objective was to systematically review the literature of full economic evaluation studies of self-management interventions in adult chronic patients and to investigate their methodological quality and cost-effectiveness.

Methods: A data extraction form was developed to assess general and randomized controlled trial (RCT) -related characteristics, quality, of the RCTs, economic information and quality of the economic evaluation studies by means of a quality assessment (CHEC-list for trial-based studies, adjusted CHEC-list for model-based studies).

Results: Twenty-three reports were found. Sixteen studies (73 percent) lack information on the control intervention(s). Only one study fulfilled all three criteria for quality of RCTs and five studies (23 percent) did not meet any of these criteria. This review included one model-based study; the other studies were trial-based economic evaluation studies based on a RCT. Eight studies (35 percent) used a societal perspective and 12 (60 percent) synthesized costs and effects. Seven studies were categorized into the highest category (<15 score), nine studies into the “moderate” group (9–14 score), six studies received a “low” score (<8) on the CHEC-list. Eighteen studies found the self-management intervention(s) to be cost-effective compared with other interventions

Conclusions: Self-management interventions for adult chronic patients were heterogeneous and there was no clear, well-considered definition of self-management. Overall, the methodological quality of the full economic evaluation studies was moderate and, therefore, cost-effectiveness results must be interpreted with caution. Future research will benefit from further improvements in methodological quality of both economic study design and analysis, as well as a taxonomy for describing self-management interventions and their contents.

Background: Evidence-based policy making is increasingly used for better resource allocation. Queensland Department of Health has developed a new model to introduce innovative health technologies through a health technology assessment (HTA) program.

Structure: A state-wide committee and several sub-committees at health service district level were established to oversee the HTA program and to monitor the uptake of technologies. The committees are supported by a multidisciplinary secretariat comprising staff with key HTA skills.

Process: The process starts with HTA applications, which are then shortlisted according to prespecified criteria. A due diligence process adopting a rapid evidence assessment approach is used to evaluate the applications. Based on the assessment, recommendations are made using a deliberative decision-making process guided by well-recognized tools. With positive recommendation, a technology is piloted in constrained local setting before its system-wide diffusion.

Outcome: The HTA program has assisted health administrators in prioritizing their health technology agendas. It has gained trust and wide support from policy makers and is increasingly used to support funding allocations, indicating the increasing awareness of and confidence in the program.

Conclusions: The HTA program is a valuable process to assist evidence-based policy development and to guide better resource allocation.

Moderate psychosocial problems identified during early pregnancy in 78 women were found to predispose for various “complications” during gestation, but not for prematurity or obstetrical complications during delivery. However, from a normal postnatal status the children of these mothers demonstrated a significantly unfavorable somatic, as well as psychomotoric development, until the age of 4. Pregnant women with certain psychosocial problems must be early identified and property attended to in order to preclude an adverse child development.