Objectives: To evaluate the implementation of clinical guidelines for diabetes mellitus in general practice with a specific computer-based clinical decision support system (CDSS) as part of the intervention.

Methods: Randomized study with health center as unit. General practice in Sør- and Nord-Trøndelag counties in Norway, 380,000 inhabitants. Seventeen health centers with 24 doctors and 499 patients with diabetes mellitus were in the intervention group and 12 health centers with 29 doctors and 535 patients were in the control group. Main outcome measures were group differences in fractions of patients without registrations (process evaluation) and mean group differences for the same variables (patient outcome evaluation).

Results: Statistically significant group differences were experienced for fractions of patients without registration of cigarette smoking (intervention group, 82.6%; control group 94.5%), body mass index (78.2% vs. 93.0%), and sufficient registrations for calculation of risk score for myocardial infarction (91.1% vs. 98.3%); all during 18 months. Large center variations were shown for all variables. The only statistically significant group difference was −2.3 mm Hg (95% CI, −3.8, −0.8) in diastolic blood pressure in favor of the intervention group. Statistically insignificant differences in favor of the intervention group were HbA1c, −0.1% (95% CI, −0.4, 0.1), systolic blood pressure, −1.2 mm Hg (95% CI, −4.4, 2.0). Statistically insignificant differences in favor of the control group were fractions of smokers, +3.0% (95% CI, −4.0, 10.0), body mass index, +0.3 kg/m2 (95% CI, −0.8, 1.4), risk score in female +0.1 (95% CI, −5.1, 5.2), and risk score in male +2.6 (95% CI, −14.2, 19.5).

Conclusions: Implementation of clinical guidelines for diabetes mellitus in general practice, by means of a CDSS and several procedures for implementation, did not result in a clinically significant change in doctors' behavior or in patient outcome.

Decision analysis is used to compare the cost and disability of alternative treatment strategies for asymptomatic mandibular third molars. The analysis shows that extracting only those third molars that remain impacted and become pathologically involved is always associated with less expected cost and disability than prophylactic removal of asymptomatic wisdom teeth.

An economic evaluation was undertaken concurrently with a randomized trial comparing a Caregiver Support Program (CSP) with existing conventional community nursing care for those caring for elderly relatives at home. The differences in resource consumption were compared with changes in caregiver quality of life, as measured by the Caregiver Quality of Life Instrument (CQLI). A 20% difference from baseline in the CQLI favored the experimental (CSP) group, although this did not reach conventional levels of statistical significance. A comparison of improvement in quality of life with costs implies an incremental cost per quality-adjusted life year gained of Canadian $20,000 for the CSP, which compares favorably with other health care interventions. Further, larger studies are required to confirm this result.

Background: Health systems face rising patient expectations and economic pressures; decision makers seek to enhance efficiency to improve access to appropriate care. There is international interest in the role of HTA to support decisions to optimize use of established technologies, particularly in “disinvesting” from low-benefit uses.

Methods: This study summarizes main points from an HTAi Policy Forum meeting on this topic, drawing on presentations, discussions among attendees, and an advance background paper.

Results and Conclusions: Optimization involves assessment or re-assessment of a technology, a decision on optimal use, and decision implementation. This may occur within a routine process to improve safety and quality and create “headroom” for new technologies, or ad hoc in response to financial constraints. The term “disinvestment” is not always helpful in describing these processes. HTA contributes to optimization, but there is scope to increase its role in many systems. Stakeholders may have strong views on access to technology, and stakeholder involvement is essential. Optimization faces challenges including loss aversion and entitlement, stakeholder inertia and entrenchment, heterogeneity in patient outcomes, and the need to demonstrate convincingly absence of benefit. While basic HTA principles remain applicable, methodological developments are needed better to support optimization. These include mechanisms for candidate technology identification and prioritization, enhanced collection and analysis of routine data, and clinician engagement. To maximize value to decision makers, HTA should consider implementation strategies and barriers. Improving optimization processes calls for a coordinated approach, and actions are identified for system leaders, HTA and other health organizations, and industry.

There are inherent limitations in using assessments of patient satisfaction to make inferences about the quality of medical care. Such evaluations tend to be subjective, subject to reporting biases, and difficult to interpret when they are being used to motivate and guide quality improvement efforts. Newer methods of eliciting both reports and ratings from consumers, such as the Consumer Assessment of Health Plans (CAHPS) project, can provide reliable, valid, interpretable, and actionable data about selected aspects of health care. The use of these methods and continued use of new qualitative methods, such as cognitive interviewing, should allow us to continue increasing the prominence of consumer-based information in quality assessment and improvement efforts.

Objectives: The aim of this study was to assess whether a literature review of a technology can allow a learning curve to be quantified.

Methods: The literature for fiberoptic intubation was searched for studies reporting information relevant to the learning curve. The Cochrane Library, Medline, Embase, and Science Citation index were searched. Studies that reported a procedure time were included. Data were abstracted on the three features of learning: initial level, rate of learning, and asymptote level. Random effects meta-analysis was performed.

Results: Only twenty-one studies gave explicit information concerning the previous experience of the operator(s). There were thirty-two different definitions of procedure time. From four studies of fiberoptic nasotracheal intubation, the mean starting level and time for the 10th procedure was estimated to be 133 seconds (95 percent confidence interval, 113–153) and 71 seconds (95 percent confidence interval, 62–79), respectively.

Conclusions: The review approach allowed learning to be quantified for our example technology. Poor and insufficient reporting constrained formal statistical estimation. Standardized reporting of nondrug techniques with adequate learning curve details is needed to inform trial design and cost-effectiveness analysis.

Objectives: The aim of this study was to get an overview of current theory and practice in early assessments of medical devices, and to identify aims and uses of early assessment methods used in practice.

Methods: A systematic literature review was conducted in September 2013, using computerized databases (PubMed, Science Direct, and Scopus), and references list search. Selected articles were categorized based on their type, objective, and main target audience. The methods used in the application studies were extracted and mapped throughout the early stages of development and for their particular aims.

Results: Of 1,961 articles identified, eighty-three studies passed the inclusion criteria, and thirty were included by searching reference lists. There were thirty-one theoretical papers, and eighty-two application papers included. Most studies investigated potential applications/possible improvement of medical devices, developed early assessment framework or included stakeholder perspective in early development stages. Among multiple qualitative and quantitative methods identified, only few were used more than once. The methods aim to inform strategic considerations (e.g., literature review), economic evaluation (e.g., cost-effectiveness analysis), and clinical effectiveness (e.g., clinical trials). Medical devices were often in the prototype product development stage, and the results were usually aimed at informing manufacturers.

Conclusions: This study showed converging aims yet widely diverging methods for early assessment during medical device development. For early assessment to become an integral part of activities in the development of medical devices, methods need to be clarified and standardized, and the aims and value of assessment itself must be demonstrated to the main stakeholders for assuring effective and efficient medical device development.

Objectives: To compare the cost-effectiveness of alternative methods of screening for retinopathy of prematurity (ROP) in the United Kingdom, including the existing method of indirect ophthalmoscopy by ophthalmologists and digital photographic screening by nurses.

Methods: A decision tree model was used to compare five screening modalities for the UK population of preterm babies, using a health service perspective. Data were taken from published sources, observation at a neonatal intensive care unit (NICU), and expert judgment.

Results: We estimated that use of standard digital cameras by nurses in NICUs would cost more than current methods (£371 compared with £321 per baby screened). However, a specialist nurse visiting units with a portable camera would be cheaper (£172 per baby). These estimates rely on nurses capturing and interpreting the images, with suitable training and supervision. Alternatively, nurses could capture the images then transmit them to a central unit for interpretation by ophthalmologists, although we estimate that this would be rather more expensive (£390 and £201, respectively, for NICU and visiting nurses). Sensitivity analysis was used to examine the robustness of estimates.

Conclusions: It is likely that there is an opportunity to improve the efficiency of the ROP screening program. We estimate that screening by specialist nurses trained in image capture and interpretation using portable digital cameras is a cost-effective alternative to the current program of direct visualization by ophthalmologists. This option would require the development of a suitable portable machine. Direct comparative research is strongly needed to establish the accuracy of the various screening options.

Objectives: The aim of this study is to evaluate the cost-effectiveness of Magnetic Resonance Guided Focused Ultrasound (MRgFUS) compared with alternative treatments for uterine fibroids in the United States.

Methods: We used techniques of decision analysis and data from secondary sources to develop and estimate an economic model of the management of uterine fibroids among premenopausal women. Patients in the model receive treatment with MRgFUS, uterine artery embolization (UAE), abdominal myomectomy, hysterectomy, or pharmacotherapy. The model predicts total costs (including subsequent procedures) and quality-adjusted life-years (QALYs) for each treatment strategy over a lifetime horizon, discounted at 3 percent, from a societal perspective. Data on treatment efficacy and safety were obtained from published and unpublished studies. Costs (2005 US$) were obtained from an analysis of a large administrative database and other secondary sources. Lost productivity costs were included in the base-case analysis, but excluded in a sensitivity analysis.

Results: UAE was associated with the most QALYs (17.39), followed by MRgFUS (17.36), myomectomy (17.31), hysterectomy (17.18), and pharmacotherapy (16.70). Pharmacotherapy was the least costly strategy ($9,200 per patient), followed by hysterectomy ($19,800), MRgFUS ($27,300), UAE ($28,900), and myomectomy ($35,100). Incremental cost-effectiveness ratios (cost per QALY gained) were $21,800 for hysterectomy, $41,400 for MRgFUS, and $54,200 for UAE; myomectomy was more costly and less effective than both MRgFUS and UAE. Results were sensitive to MRgFUS recurrence rates, MRgFUS procedure costs, and assumptions about quality of life following hysterectomy.

Conclusions: Our findings suggest that MRgFUS is in the range of currently accepted criteria for cost-effectiveness, along with hysterectomy and UAE.

Objectives: While most studies have focused on analyzing the results of telemedicine use, it is crucial to consider the determinants of its use to fully understand the issue. This article aims to provide evidence on the determinants of telemedicine use in clinical practice.

Methods: The survey targeted a total population of 398 medical professionals from a healthcare institution in Spain. The study sample was formed by the ninety-three primary care physicians who responded. Using an extended Technology Acceptance Model and microdata for the ninety-six physicians, binary logistic regression analysis was carried out.

Results: The analysis performed confirmed the model's goodness-of-fit, which allowed 48.1 percent of the dependent variable's variance to be explained. The outcomes revealed that the physicians at the healthcare institution placed greater importance on telemedicine's potential to reduce costs, and on its usefulness to the medical profession. The perception of medical information security and confidentiality and the patients’ predisposition toward telemedicine were the second explanatory factors in order of importance. A third set of moderating effects would appear to corroborate the importance of the physicians’ own opinions.

Conclusions: These results have revealed the need for a dynamic approach to the design of telemedicine use, especially when it targets a variety of end-users. Hence, the importance of conducting studies before using telemedicine, and attempting to identify which of the above-mentioned predictors exert an influence and how.

Background: Hyperbaric oxygen therapy (HBOT) has been proposed as an adjunct to standard methods of care for diabetic foot ulcers (DFU). Its use may decrease the risk of infection and lower extremity amputations (LEAs). As part of a Canadian assessment, we estimated the cost-effectiveness and budget impact of HBOT in this application.

Methods: We developed a decision model comparing adjunctive HBOT with standard care alone. The population was a 65-year-old cohort with DFU. The time horizon was 12 years taken from a Ministry of Health perspective. The health states were a healed wound with or without a minor LEA, an unhealed wound with no related surgery, and a major LEA. Efficacy data were based on outcomes reported in studies included in a literature review. Cost and capacity needs for treating DFU patients in Canada were estimated using prevalence data from the literature, and cost and utilization data from government records.

Results: The 12-year cost for patients receiving HBOT was CND$40,695 compared with CND$49,786 for standard care alone. Outcomes were 3.64 quality-adjusted life-years (QALYs) for those receiving HBOT and 3.01 QALYs for controls. Estimated cost to treat all prevalent DFU cases in Canada was CND$14.4–19.7 million/year over 4 years. If seven-person HBOT chambers were used, a further nineteen to thirty-five machines would be required nationally.

Conclusions: Adjunctive HBOT for DFU is cost-effective compared with standard care. Additional HBOT capacity would be needed if it were to be adopted as the standard of care throughout Canada.

Little is known about the consumption of medical and surgical services by the most informed consumer in the health care market: the physician-patient. Such knowledge should be important for the understanding of the role of information on consumption, supplier-induced demand, the doctor-patient relationship, unnecessary medical services, and the adequacy of professional practices to the real health needs of the “ordinary patient.” We measured by questionnaire the standardized consumption of seven common surgical procedures. Except for appendectomy, the age- and sex-standardized consumption for each of the common surgical procedures was always significantly higher in the general population than for the “gold standard” of physician-patients. The data suggest that (a) contrary to prior research, doctors have much lower rates of surgery than does the general population; and (b) in a fee-for-services health care market without financial barriers to medical care, less-informed patients are greater consumers of common surgical procedures.

Objectives: This study describes the development of a framework for health technology decisions, for Ontario Health Technology Advisory Committee (OHTAC) in Ontario, Canada.

Methods: OHTAC convened a “Decision Determinants Sub-Committee” in January 2007, which undertook a systematic literature review and conducted key informant interviews to develop an explicit decision-making framework.

Results: The “Decision Determinants Sub-Committee” offered recommendations about decision criteria, and the process by which decisions are made. Decision criteria include (i) overall clinical benefit, (ii) consistency with societal and ethical values, (iii) value for money, and (iv) feasibility of adoption into the health system. The decision process should be transparent and fair and should use a deliberative process in delivering recommendations.

Conclusions: This methodology is currently being pilot tested in a live environment: OHTAC. It will be evaluated and revised according to its feasibility, acceptability, and perceived usefulness.

Objectives: The purpose of this project was to evaluate local decision support tools used in the Danish hospital sector from a theoretical and an empirical point of view.

Methods: The use of local decision support was evaluated through questionnaires sent to all county health directors, all hospital managers, and all heads of clinical departments in cardiology, orthopedic surgery, and intensive care. In addition, respondents were asked to submit whatever decision support tools they were using (including mini-HTAs, other forms or checklists, and special procedures for decision making concerning new health technologies). A theoretical analysis of the decision support tools (decision theory) was performed as well as a comparison with the business case method used in private companies. Finally, the Danish mini-HTA was compared with foreign production and use of HTA and HTA-like assessments as local decision support.

Results: The response rate was high (87 percent, 94 percent, 85 percent, respectively). We collected sixty different forms (of which forty-nine were mini-HTAs) and twenty variants of written procedures. We found theoretical and empirical evidence that local involvement in the process of making the HTA could be important for the use of the results from the HTA and for the process of implementing the new technology.

Conclusions: Doing mini-HTA in hospitals seems to balance the need for quality and depth with the limited time and resources for assessment.

Ernest Amory Codman, M.D., was one of the most important figures in the history of outcomes research in medicine. While his contemporaries scorned his efforts to create systematic procedures to evaluate the end results of medical care, his work foreshadowed many of today's most pressing issues in technology assessment. This arti traces Codman's career as an innovator and political gadfly at the Massachusetts General Hospital during the first three decades of this century, and examines the development and demise of his end-result system.

This study analyses why ethical aspects play a minor role in health technology assessment (HTA) studies, even when comprehensive approaches of technology assessment are advocated. Technology is often regarded as a value-neutral tool. At the same time, bioethics is dominated by an engineering model. Ethical contributions to evaluation of medical technology should go beyond issues of application in clinical practice and focus also on the definition of problems, the demarcation of technical and nontechnical issues, and the morally problematic implications of technologies.

Objectives: To consider the impact of rapid health technology assessments undertaken as part of a program in a provincial healthcare system in response to urgent requests for advice.

Methods: Review of the development and preparation of 20 rapid assessment reports, communication with decision makers within the healthcare system, and appraisal of data subsequent to preparation of the reports.

Results: Fourteen of the assessments were judged to have had an influence on policy and other decisions, as judged by responses from those who had requested advice. Another four were considered to have provided guidance, while having less immediate influence on decisions, and two others had no apparent impact. Quality of the assessments was considered acceptable, on the basis of literature that subsequently became available and from comments received.

Conclusions: These brief reports are considered to be a useful component of a health technology assessment program. However, they should be regarded as provisional appraisals and followed up with more detailed evaluation where possible.

Computer networks serve as convenient, efficient, and enduring vehicles for delivering nursing services to patients at home. The ComputerLink, a specialized computer network, provided nurse-supervised information, decision support, and communication services to home-dwelling persons living with AIDS (PWAs). During a 26-week randomized field experiment, 26 PWAs accessed the ComputerLink on more than 8,664 occasions. The communications area was used most often; the public communication area functioned like a support group. Multiple behavioral measures of use provide a rich picture of how these PWAs, none of whom had had prior computer experience, adopted and adapted to this innovative nursing care delivery system. Meeting the needs of a rapidly growing and diverse population of home-care clients demands that nurses make effective use of existing technologies such as cable television and telephone triage systems. Computer networks combine the best features of cable television and telephone systems—broadcast distribution and interaction; therefore, computer networks represent an ideal technology for the delivery of certain nursing services to the home.

Objectives: Health technology assessment (HTA) agencies assessing the cost-effectiveness of healthcare technologies seek evidence from economic evaluations. As well as searching economic evaluation databases, researchers often search MEDLINE and EMBASE, using search filters whose current performance is unclear. We assessed the performance of search filters in identifying economic evaluations from MEDLINE and EMBASE.

Methods: A gold standard of economic evaluations was compiled from National Health Service Economic Evaluation Database (NHS EED) records for 2000, 2003, and 2006. Corresponding records were retrieved in MEDLINE and EMBASE. Search filters were identified from the InterTASC Information Specialists’ SubGroup Web site and from Canadian Agency for Drugs and Technologies in Health (CADTH) Information Services. The sensitivity and precision of search filters in retrieving gold standard records from MEDLINE and EMBASE were tested.

Results: A total of 2,070 full economic evaluations were identified from NHS EED. Of these, 1,955 records were available in Ovid MEDLINE and 1,873 were available in Ovid EMBASE. Thirteen MEDLINE and eight EMBASE filters were identified. NHS Quality Improvement Scotland (full and brief filters), the NHS EED and Royle and Waugh filters achieved over 0.99 sensitivity in MEDLINE. NHS Quality Improvement Scotland, CADTH, Royle and Waugh, and NHS EED filters achieved greater than 0.99 sensitivity in EMBASE. Filters demonstrated low precision.

Conclusions: This research provided new performance data on search filters to identify economic evaluations in MEDLINE and EMBASE. It demonstrated that highly sensitive economic evaluation filters are available, but that precision is low, yielding perhaps 5 relevant records per 100 records scanned.

Clinicians make judgments under conditions of uncertainty. Decision research has shown that in uncertain situations individuals do not always act rationally, coherently, or to maximize their expected utility. Advocates of clinical guidelines believe that these guidelines will eliminate some of the cognitive biases that the practitioner may introduce into the medical decision-making process in an attempt to reduce its uncertainty. Other physicians have grave doubts about guidelines' application in practice. Guideline implementation lags well behind their development. Studies of practicing physicians and a survey of clinicians in one specialty and setting indicate that experienced clinicians may be implementing guidelines selectively. Many clinicians are concerned that guidelines are based on randomized trials and do not reflect the complexity of the real world, in which a decision's context and framework are important. Their reluctance also may be due to the difficulty of applying general guidelines to specific clinical situations. The problem will only increase in the future. The patients of the 21st century will be older and have more complex disease states. Physicians will have more patient-specific therapies and need to exercise more sophisticated clinical judgment. They may be more willing to use guidelines in making those judgments if research can demonstrate guidelines' effectiveness in improving decision making for individual patients.