GENERAL ESSAYS
Does emotional disclosure have any effects? A systematic review of the literature with meta-analyses
- Catherine Meads, Arie Nouwen
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- Published online by Cambridge University Press:
- 26 April 2005, pp. 153-164
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Objectives: Emotional disclosure has been widely publicized as having beneficial effects on physical and psychological health. A full systematic review was undertaken, with standard health technology appraisal methods, with the aim to assess the effects of emotional disclosure on healthy participants and those with pre-existing morbidity, particularly on longer-term physical health, performance, and psychological outcomes.
Methods: Randomized controlled trials of emotional disclosure were obtained from database searches (Medline (1966–2003), Embase (1980–2003), Cochrane Library (2002, issue 4), Web of Science (1981–2003), Cinahl (1982–2003), and Theses (March 2003), Internet sites (including Professor J.W. Pennebaker's home pages), and personal contacts. Quality was assessed qualitatively and by Jadad score. Meta-analysis was conducted, using Revman 4.1 software, where more than two trials reported the same outcome.
Results: Sixty-one trials were found meeting the inclusion criteria. Most had less than 100 participants and the median Jadad score was 0. A wide variety of physical, physiological, immunological, performance, and psychological outcomes were measured, but fewer were reported. There was no clear improvement for emotional disclosure compared with controls in objectively measured physical health and most other outcomes assessed.
Conclusions: The opinion that this intervention is beneficial needs to be reassessed in light of the totality of evidence available.
Increasing the generalizability of economic evaluations: Recommendations for the design, analysis, and reporting of studies
- Michael Drummond, Andrea Manca, Mark Sculpher
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- Published online by Cambridge University Press:
- 26 April 2005, pp. 165-171
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Objectives: Health technology assessment (HTA) is increasingly an international activity, and HTA agencies collaborate to avoid unnecessary duplication of effort. However, the sharing of the results from HTAs raises questions about their generalizability; namely, are the results of an HTA undertaken in one country relevant to another?
Methods: This study presents recommendations for increasing the generalizability of economic evaluations. They represent an important component of HTAs and are commonly thought to have limited generalizability.
Results: Recommendations are given for studies using patient-level data (i.e., evaluations conducted alongside clinical trials) and for studies using decision analytic modeling.
Conclusions: If implemented, the recommendations would increase the value for investments in HTA.
Health-related quality of life of coronary artery bypass grafting and percutaneous transluminal coronary artery angioplasty patients: 1-year follow-up
- Eija Kattainen, Harri Sintonen, Raimo Kettunen, Pirkko Meriläinen
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- Published online by Cambridge University Press:
- 26 April 2005, pp. 172-179
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Objectives: The aim of the study was to compare the health-related quality of life (HRQoL) of patients undergoing coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) before the interventions and 6 and 12 months afterward, and to compare their HRQoL also with that of the general population.
Methods: The sample (n = 615) consisted of consecutive coronary artery disease patients treated with elective CABG (n = 432) or PTCA (n = 183). The baseline data before the treatments were collected by structured interview, the follow-up data mainly by mailed self-administered questionnaires. HRQoL was measured by the 15D. For comparisons, the groups were standardized for differences in socioeconomic and clinical characteristics with a regression analysis.
Results: At baseline, the average 15D scores of the patient groups were 0.752 (95 percent confidence interval [CI], 0.743–0.761) in CABG and 0.730 (95 percent CI, 0.716–0.744) in PTCA. After standardization, the difference between the groups was statistically significant but not clinically important. These scores were significantly worse (statistically and clinically) than the score of 0.883 (95 percent CI, 0.871–0.879) in the general population sample matched with the gender and age distribution of the patients. By 6 months, the CABG and PTCA patients had experienced a statistically significant and clinically important improvement to 0.858 (95 percent CI, 0.844–0.872) and 0.824 (95 percent CI, 0.806–0.842), respectively. No significant change took place in either group from 6 to 12 months.
Conclusions: Both CABG and PTCA produces an approximately similar, clinically important improvement in HRQoL in 1-year follow-up.
Cost of lipid lowering in patients with coronary artery disease by Case Method Learning
- Anna Kiessling, Niklas Zethraeus, Peter Henriksson
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- Published online by Cambridge University Press:
- 26 April 2005, pp. 180-186
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Objectives: This investigation was undertaken to study the costs of a Case Method Learning (CML) -supported lipid-lowering strategy in secondary prevention of coronary artery disease (CAD) in primary care.
Methods: This prospective randomized controlled trial in primary care with an additional external specialist control group in Södertälje, Stockholm County, Sweden, included 255 consecutive patients with CAD. Guidelines were mailed to all general practitioners (GPs; n=54) and presented at a common lecture. GPs who were randomized to the intervention group participated in recurrent CML dialogues at their primary health-care centers during a 2-year period. A locally well-known cardiologist served as a facilitator. Assessment of low-density lipoprotein (LDL) cholesterol was performed at baseline and after 2 years. Analysis according to intention-to-treat—intervention and control groups (n=88)—was based on group affiliation at baseline. The marginal cost of lipid lowering comprised increased cost of lipid-lowering drugs in the intervention group compared with the primary care control group, cost of attendance of the GP's in the intervention group, and cost of time for preparation, travel, and seminars of the facilitator. Costs are as of 2002 with an exchange rate 1 US$=9.5 SEK (Swedish Crowns).
Results: Patients in the primary care intervention group had their LDL cholesterol reduced by 0.5 (confidence interval [CI], 0.1–0.9) mmol/L compared with the primary care control group (p<.05). No change occurred in controls. LDL cholesterol in the external specialist control group decreased by 0.6 (CI, 0.4–0.8) mmol/L. The cost of the educational intervention represented only 2 percent of the drug cost. The cost of lipid lowering in the intervention group, including the cost of the educational intervention, was actually lower than that of patients treated at the specialist clinic—106 US$ per mmol decrease in LDL cholesterol in the intervention group and 153 US$ per mmol decrease in LDL cholesterol in the specialist group. EuroQol 5D Index, which gives an estimate of global health-related quality of life, was 0.80 (CI, 0.75–0.85) in the present cohort.
Conclusions: The additional cost of CML was only 2 percent of the drug cost. Assuming the same gain in life expectancy per millimole decrease in LDL cholesterol as in the 4S-study gives a cost per gained quality-adjusted life year of US$ 24,000. This finding indicates that the CML-supported lipid-lowering strategy is cost-effective. The low cost of CML in primary care should probably warrant its use in the improvement of the quality of care in other major chronic diseases.
Cost-effectiveness of new drugs: A systematic review of published evidence for new chemical entity drugs introduced on the Swedish market 1987–2000
- Jonas Lundkvist, Bengt Jönsson, Clas Rehnberg
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- 26 April 2005, pp. 187-193
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Objectives: The number of published economic evaluations has increased dramatically during the past decades, but the number of studies performed for different drugs varies substantially. The objective of this study was to analyze the amount of cost-effectiveness evidence for new drugs, by systematically reviewing the published evidence of cost-effectiveness.
Methods: The study included 442 new chemical entities, approved in Sweden between 1987 and 2000. The amount of cost-effectiveness evidence was rated and analyzed together with information about sales and the therapeutic benefit of the drugs. Information about cost-effectiveness was obtained from the Health Economic Evaluation Database.
Results: The results showed that most cost-effectiveness evidence was published approximately 1 to 5 years after the approval year and that very few articles were published before or during the approval year. More than half of the drugs did not have any evidence of their cost-effectiveness. A total of 51 of the evaluated drugs were considered having much evidence of cost-effectiveness, 84 drugs were considered having some evidence, and the remaining 307 drugs had little evidence. The analyses indicated that drugs with improved effectiveness or safety compared with other marked drugs had more evidence of cost-effectiveness and that drugs with low sale were likely to have less evidence of cost-effectiveness than drugs with high sale.
Conclusions: The study indicated that the publication of cost-effectiveness information for new drugs introduced between 1987 and 2000 may be considered rather rational, that is, the economic evaluations were performed for drugs for which this information was most important.
Cost-effectiveness of nutritional counseling for obese patients and patients at risk of ischemic heart disease
- Jens Olsen, Ingrid Willaing, Steen Ladelund, Torben Jørgensen, Jens Gundgaard, Jan Sørensen
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- 26 April 2005, pp. 194-202
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Objectives: Obesity and dyslipidemia are risk factors for ischemic heart disease, and prevention and treatment in primary care can reduce these risks. The objective of this cost-effectiveness analysis was to compare the costs and effects (in terms of life years gained) of providing nutritional counseling by a general practitioner (GP) or a dietician.
Methods: A total of 60 GPs, who accepted to participate, were randomized either to give nutritional counseling or to refer patients to a dietician for counseling. The life years gained was estimated using a Cox regression model. Costs were estimated on the basis of registered use of time (dieticians) or agreed salaries (GPs).
Results: The effect of nutritional counseling comparing GPs and dieticians is greatest when counseling is performed by a GP—0.0919 years versus 0.0274 years. These effects appear to be moderate, but they are significant. It is also proven that the GP group was the most cost-effective—the cost of gaining 1 extra life year was estimated to be 8,213 DKK compared with the dietician group, for which the incremental cost-effectiveness ratio was estimated to be 59,987 DKK.
Conclusions: The effects were moderate, but other studies of other patient groups and interventions report effects within the same magnitude. The GP group was the most cost-effective, but it must be concluded that both counseling strategies were relatively cost-effective. Even though the cost of gaining an extra life year was estimated to be 59,987 DKK in the dietician group, this might be an acceptable price.
Quality appraisal of pediatric health economic evaluations
- Wendy J. Ungar, Maria T. Santos
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- Published online by Cambridge University Press:
- 26 April 2005, pp. 203-210
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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.
Conjoint analysis of preferences for cardiac risk assessment in primary care
- Franco Sassi, David McDaid, Walter Ricciardi
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- 26 April 2005, pp. 211-218
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Objectives: Many evaluations underestimate the utility associated with diagnostic interventions by failing to capture the nonclinical value of diagnostic information. This is a cause of bias in resource allocation decisions. A study was undertaken to investigate preferences for the assessment of cardiac risk, testing the suitability of conjoint analysis, a multiattribute preference elicitation method, in the field of clinical diagnosis.
Methods: Two conjoint analysis models focusing on selected characteristics of cardiac risk assessment in asymptomatic patients 40–50 years of age were applied to elicit preferences for cardiac risk assessment from samples of general practitioners and the general public in the United Kingdom and Italy. Both models were based on rankings of alternative scenarios, and the results were analyzed using multivariate analysis of variance and an ordered probit model.
Results: In both countries, members of the public attached at least three times more importance to prognostic value (relative to clinical value) than did general practitioners. Significantly different patterns were found in the two countries with regard to other characteristics of the assessment. Variation within samples was partly associated with personal characteristics.
Conclusions: Only a fraction of the value of cardiac risk assessment to individuals and physicians in this study was linked to health outcomes. The study confirmed the appropriateness and validity of conjoint analysis in the assessment of preferences for diagnostic interventions. A wider use of this technique might significantly strengthen the existing evidence-base for diagnostic interventions, leading to a more efficient use of health-care resources.
Decisions to adopt new technologies at the hospital level: Insights from Israeli medical centers
- Dan Greenberg, Yitzhak Peterburg, Daniel Vekstein, Joseph S. Pliskin
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- Published online by Cambridge University Press:
- 26 April 2005, pp. 219-227
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Objectives: New medical technologies have been identified as the leading cause of increasing health-care expenditures. Adoption of a new technology is one of the most important decisions in medical centers. The objectives of this study were to map and describe the function of hospital decision-makers within the area of new technology assessment and adoption, and to examine relevant considerations, sources of information, and decision-making processes in the adoption of a new technology.
Methods: A questionnaire was mailed to hospital executives and referred to (i) the considerations for and against adoption of a new technology, (ii) the decision-making process, (iii) information sources used in the decision-making process.
Results: The most frequent criteria favoring adoption included increased cost-effectiveness, increased efficacy, and decrease in complication rates. An increase in complication rates or side effects and decreased efficacy were the top ranked criteria against adoption. The final decision-making responsibility varied among technologies; the medical director frequently made the final decision when a new device was involved, but this responsibility decreased when a new drug or a new procedure was considered. Participation in scientific meetings, opinions of local experts, medical journals, and Food and Drug Administration clearance documents were the most important information sources used in the decision-making process. However, these were not necessarily the optimal sources of information. Significant barriers in adoption decision-making are lack of timely data regarding the safety of the new technology, its cost-effectiveness, and efficacy.
Conclusion: To improve the adoption decisions, hospitals must develop criteria upon which the decision-making will be based.
RESEARCH REPORTS
Effects of the increase in co-payments from 20 to 30 percent on the compliance rate of patients with hypertension or diabetes mellitus in the Employed Health Insurance System
- Akira Babazono, Motonobu Miyazaki, Takuya Imatoh, Hiroshi Une, Eiji Yamamoto, Toshihide Tsuda, Kiyoshi Tanaka, Shinichi Tanihara
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- 26 April 2005, pp. 228-233
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Objectives: How to contain medical expenditures is a universal problem. The Japanese government has increased patient co-payments to control it. The purpose of this study is to clarify whether the increase in co-payments to 30 percent prevented patients with hypertension or diabetes mellitus from receiving necessary care in the Employee Health Insurance System.
Methods: The subjects were 211 patients with hypertension and 66 patients with diabetes mellitus who regularly visited physicians from October 2001 to March 2002 and were defined as a cohort that needed health care, and their medical indicators were examined between April and September 2002 (prestage) and between April and September 2003 (poststage).
Results: In the hypertensive patients with no complications, the compliance rate was 89.9 percent and 88.0 percent in the prestage, and poststage, respectively, showing no significant change. In the hypertensive patients with complications, the compliance rate was 90.5 percent and 92.1 percent in the prestage and poststage, respectively, showing no significant change. In the diabetic patients with complications, the compliance rate was 77.5 percent and 79.2 percent, in the prestage and poststage, respectively, with no significant change. In the diabetic patients with no complications, however, the compliance rate was 83.7 percent and 66.7 percent, in the prestage and poststage, respectively. A significant decrease was observed among diabetic patients without complications.
Conclusions: Increasing co-payments reduced necessary preventive care in diabetic patients without complications.
Economic analysis of the implementation of autologous transfusion technologies throughout England
- Simon Dixon, Virge James, Daniel Hind, Craig J. Currie
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- Published online by Cambridge University Press:
- 26 April 2005, pp. 234-239
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Objectives: This study aims to provide the first estimates of the costs and effects of the large scale introduction of autologous transfusion technologies into the United Kingdom National Health Service.
Methods: A model was constructed to allow disparate data sources to be combined to produce estimates of the scale, costs, and effects of introducing four interventions. The interventions considered were preparing patients for surgery (PPS) clinics, preoperative autologous donation (PAD), intraoperative cell salvage (ICS), and postoperative cell salvage (PoCS).
Results: The key determinants of cost per operation are the anticipated level of reductions in blood use, the mean level of blood use, mean length of stay, and the cost of the technology. The results show the potential for considerable reductions in blood use. The greatest reductions are anticipated to be through the use of PPS and ICS. Vascular surgery, transplant surgery, and cardiothoracic surgery appear to be the specialties that will benefit most from the technologies.
Conclusions: Several simplifications were used in the production of these estimates; consequently, caution should be used in their interpretation and use. Despite the drawbacks in the methods used in the study, the model shows the scale of the issue, the importance of gathering better data, and the form that data must take. Such preliminary modeling exercises are essential for rational policy development and to direct future research and discussion among stakeholders.
Criteria list for assessment of methodological quality of economic evaluations: Consensus on Health Economic Criteria
- Silvia Evers, Mariëlle Goossens, Henrica de Vet, Maurits van Tulder, André Ament
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- 26 April 2005, pp. 240-245
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Objectives: The aim of the Consensus on Health Economic Criteria (CHEC) project is to develop a criteria list for assessment of the methodological quality of economic evaluations in systematic reviews. The criteria list resulting from this CHEC project should be regarded as a minimum standard.
Methods: The criteria list has been developed using a Delphi method. Three Delphi rounds were needed to reach consensus. Twenty-three international experts participated in the Delphi panel.
Results: The Delphi panel achieved consensus over a generic core set of items for the quality assessment of economic evaluations. Each item of the CHEC-list was formulated as a question that can be answered by yes or no. To standardize the interpretation of the list and facilitate its use, the project team also provided an operationalization of the criteria list items.
Conclusions: There was consensus among a group of international experts regarding a core set of items that can be used to assess the quality of economic evaluations in systematic reviews. Using this checklist will make future systematic reviews of economic evaluations more transparent, informative, and comparable. Consequently, researchers and policy-makers might use these systematic reviews more easily. The CHEC-list can be downloaded freely from http://www.beoz.unimaas.nl/chec/.
Data validation in an economic evaluation of surgery for colon cancer
- Martin Janson, Per Carlsson, Eva Haglind, Bo Anderberg
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- 26 April 2005, pp. 246-252
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Objectives: This study aimed to validate the accuracy of data retrieved in a prospective multicenter trial, the purpose of which was an economic evaluation of two techniques of surgery for colon cancer.
Methods: Within the Swedish contribution of the COLOR trial (Colon Cancer Open or Laparoscopic Resection), an economic evaluation of open versus laparoscopic surgical techniques was conducted. Data were collected by case record forms (CRF), patient diaries, and telephone surveys every 2 weeks. The study period was 12 weeks, and the perspective was societal. Data from the first consecutive forty patients to complete the health economic study protocol were validated. Retrieved data were compared with data from medical records and data from local social security offices for agreement.
Results: Statistically significant differences were found for duration of anesthesia, length of surgery, number of outpatient consultations by doctors and district nurses, complication rate, and the use of central venous lines. No significant differences were observed concerning length of hospital stay, disposable instruments cost, and time off work, all of which heavily influence total costs.
Conclusions: The present method of data collection regarding resources used in this setting seems to produce accurate data for economic evaluation; however, relative to complication rates, the method did not retrieve accurate data.
International comparison and review of a health technology assessment skills program
- Margaret I. Wanke, Don Juzwishin
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- Published online by Cambridge University Press:
- 26 April 2005, pp. 253-262
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Objectives: A review of the Alberta Heritage Foundation for Medical Research's (AHFMR) 6-month Health Technology Skills Development Program was undertaken within an international context with the purpose of describing and assessing the current program, further formalizing the program based on identified opportunities for improvement, and enhancing collaborative linkages with other agencies. The objectives of the review were to (i) compare the AHFMR program with similar programs in other health technology assessment (HTA) agencies internationally; (ii) assess the value of the program; (iii) identify program strengths and opportunities for improvement; and (iv) review, critique, and recommend enhancements to the program model and role description.
Methods: The review involved a qualitative study design that included a survey of the Skills Development Program participants' experience and perceptions; semistructured interviews with program stakeholders, and a written survey of HTA agencies/programs in other Canadian and international jurisdictions.
Conclusions: The review concluded that the program was successful and valued by participants, the Foundation, and stakeholders in the policy and research communities. Findings suggest participant products have a potential for broad influence, including impact on funding decisions related to technology diffusion, influence through publications and presentations, and knowledge transfer in the participants' disciplines and employment settings. The main opportunity for enhancement was to differentiate the program into two streams according to different needs of participants, specifically between those who desire to be HTA producers and/or make HTA their careers, and those who desire to apply HTA in their employment capacity as policy or clinical decision-makers.
End-user involvement in health technology assessment (HTA) development: A way to increase impact
- Maurice McGregor, James M. Brophy
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- 26 April 2005, pp. 263-267
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Objectives: A mechanism to increase the influence of Health Technology Assessments (HTAs) on hospital policy decisions was developed.
Methods: We describe the process and results of an experiment in which a local in-hospital HTA unit was created to provide sound evidence on technology acquisition issues, and to formulate locally appropriate policy recommendations. The Unit consists of a small technical staff that accesses and synthesizes the evidence incorporating local health and economic data, and a Policy Committee that develops policy recommendations based on this evidence. It represents administration, health-care professionals, patients, and representatives of the clinical disciplines affected by each issue. The level of success of the Unit was independently evaluated.
Results: To date, 16 reports have been completed, each within 2–4 months. Five recommended unrestricted use, seven recommended rejection, and four recommended very limited use of the technology in question. All have been incorporated into hospital policy. Budget impact is estimated at approximately $3 million of savings per year.
Conclusions: This local in-house HTA agency has had a major impact on the adoption of new technology. Probable reasons for success are (i) relevance (selection of topics by administration with on-site production of HTAs allowing them to incorporate local data and reflect local needs), (ii) timeliness, and (iii) formulation of policy reflecting community values by a local representative committee. Because over one third of all health-care costs are incurred in the hospital, diffusion of this model could have a significant effect on the quantity and quality of health-care spending.
Use of health technology assessment in decision making: Coresponsibility of users and producers?
- Myriam Hivon, Pascale Lehoux, Jean-Louis Denis, Stéphanie Tailliez
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- Published online by Cambridge University Press:
- 26 April 2005, pp. 268-275
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Objectives: Health technology assessment (HTA) is a policy-oriented form of research designed to inform decision-makers on the introduction, use, and dissemination of health technology. Whereas research on knowledge transfer has focused on knowledge producers, little attention has been given to the user's perspective. This study examines how health-care provider, administrator, and patient associations across Canada use HTA reports and the limitations they encounter when accessing and using scientific knowledge.
Methods: This study draws from semistructured interviews (n = 42) conducted with three types of user, located in British Columbia, Alberta, Saskatchewan, Ontario, and Quebec. Applying well-established conceptual categories in knowledge utilization research, our qualitative analyses sought to define more precisely how HTA is used by interviewees as well as the most significant barriers they encounter.
Results: The vast majority of users recognize the usefulness and credibility of HTA reports. Of interest, the way they use HTA takes different forms. Although administrators and health-care providers are in a better position than patient associations to act directly on HTA messages—making an instrumental use of HTA—we also found conceptual and symbolic uses across all groups. Our results also indicate that significant organizational, scientific, and material limitations hinder the use of scientific evidence. Overcoming such barriers requires a greater commitment from both HTA producers and users.
Conclusions: This study argues that, to ensure better uptake of HTA, it should become a shared responsibility between HTA producers and various types of user.