Objectives: Interventions to support patient self-care of their condition aim to improve patient health and reduce health service costs. Consequently, they have attracted considerable policy interest. There is some evidence of clinical effectiveness but less attention has been paid to whether these interventions are cost-effective. This study examines the quality and quantity of existing evidence of the cost-effectiveness.

Methods: A systematic review was carried out to assess the extent and quality of economic evaluations of self-care support interventions. Thirty-nine economic evaluations were assessed against a quality checklist developed to reflect the special features of these interventions.

Results: The majority of the studies claimed that self-care support interventions were cost-effective or cost saving. The overall quality of economic evaluations was poor because of flaws in study designs, especially a narrow definition of relevant costs and short follow-up periods.

Conclusions: The current evidence base does not support any general conclusion that self-care support interventions are cost-effective, but ongoing trials may provide clearer evidence.

Objectives: The use of economic evaluation studies (EE) in the decision-making process within the health-care system of nine Latin American (LA) and three European countries was investigated. The aim was to identify the opportunities, obstacles, and changes needed to facilitate the introduction of EE as a formal tool in health-care decision-making processes in LA.

Methods: A comparative study was conducted based on existing literature and information provided through a questionnaire applied to decision makers in Argentina, Brazil, Colombia, Cuba, Mexico, Nicaragua, Peru, Portugal Spain, United Kingdom, Uruguay, and Venezuela. Systematic electronic searches of HEED, NHS EED, and LILACS were conducted to identify published economic evaluation studies in LA from 1982 onward.

Results: There is relatively little evidence of the conduct and use of EE within the health care systems in LA. Electronic searches retrieved 554 records; however, only 93 were EE. In the nine LA participating countries, broad allocation of health-care resources is primarily based on political criteria, historical records, geographical areas, and specific groups of patients and diseases. Public-health provision and inclusion of services in health-insurance package are responsibilities of the Ministry of Health. Decisions regarding the purchase of medicines are primarily made through public tenders, and mainly based on differences in clinical efficacy and the price of health technologies of interest.

Conclusions: To expedite the process of incorporating EE as a formal tool to inform decision-making processes within the health-care systems in LA countries, two main conditions need to be fulfilled. First, adequate resources and skills need to be available to conduct EE of good quality. Second, decision-making procedures need to be modified to accommodate “evidence-based” approaches such as EE.

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.

Objectives: Case series constitute a weak form of evidence for effectiveness of health technologies. However, for a variety of reasons, such studies may be included in health technology assessments. There are no clear criteria for assessing the quality of case series. We carried out an empirical investigation of the association between outcome frequency and methodological characteristics in a sample of health technology assessments.

Methods: Systematic reviews of functional endoscopic sinus surgery for nasal polyps, spinal cord stimulation for chronic back pain, and percutaneous transluminal coronary angioplasty and coronary artery bypass grafting for chronic stable angina were identified as containing more than forty case series. Data were extracted by one reviewer and checked by a second on population characteristics, outcomes, and the following methodological features: sample size, prospective/retrospective approach, consecutive recruitment, multi- or single-center organization, length of follow-up, independence of outcome measurement, and date of publication. Association between methodological features and outcome were explored in univariate and multivariate analyses using parametric and nonparametric tests and robust regression or analysis of variance/analysis of covariance, as appropriate.

Results: Included reviews contained between forty-two and seventy-six case series studies, involving 5 to 172,283 participants. Reporting of methodological features was poor and limited the analyses. In general, we found little evidence of any association between methodological characteristics and outcome. Sample size is used as an inclusion criterion in many reviews of case series but was consistently shown to have no relationship to outcome in all analyses. A prospective approach was not associated with outcome. Insufficient data were available to explore consecutive recruitment. Mixed results were shown for length of follow-up, independence of outcome measurement, and publication date.

Conclusion: We found little evidence to support the use of many of the factors included in tools used for quality assessment of case series. Importantly, we found no relationship between study size and outcome across the four examples studied. Isolated examples of a potentially important relationship between other methodological factors and outcome were shown, for example, blinding of outcome measurement, but these examples were not shown consistently across the small number of examples studied. Further research into the determinants of quality in case series studies is required to support health technology assessment.

Objectives: Health needs has attracted the interest of policy-makers, health economists, and health professionals as modern health services try to satisfy individual and population health needs to optimize resource utilization. Health needs can be assessed by administering various types of survey or interview-based instruments. If health needs are to be satisfied in changing health agendas in developed and developing countries, it is essential to employ valid and reliable tools. Despite the importance of needs assessment, no comprehensive review of tools is currently available. We carried out a literature search to define and categorize existing health needs assessment tools.

Methods: We reviewed medical and social search engines for items containing specific health needs–related words to identify needs tools across a range of specialties. Papers were reviewed in terms of design, subject matter, psychometric features, and method of administration method.

Results: Thirty-one employed in 52 studies including cancer, mental health, palliative care, multiple sclerosis, and cardiovascular disease tools were identified.

Conclusions: This report summarizes available health needs instruments in a range of diseases to assist researchers in accessing health needs resources more easily and to encourage further research in this field.

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.

Objectives: The purpose of the study is to reassess the cost-effectiveness of hormone replacement therapy (HRT) based on new medical evidence found in the Women's Health Initiative (WHI). Within a model framework using an individual state transition model, the cost-effectiveness of 50- to 60-year-old women with menopausal symptoms is assessed based on a societal perspective in Sweden.

Methods: The model has a 50-year time horizon divided into a cycle length of 1 year. The model consists of the following disease states: coronary heart disease, stroke, venous thromboembolic events, breast cancer, colorectal cancer, hip fracture, vertebral fracture, and wrist fracture. An intervention is modeled by its impact on the disease risks during and after the cessation of therapy. The model calculates costs and quality-adjusted life years (QALYs) with and without intervention. The resulting cost per QALY gained is compared with the value of a QALY gained, which is set to SEK 600,000. The model requires data on clinical effects, risks, mortality rates, quality of life weights, and costs valid for Sweden.

Results: The cost-effectiveness ratios are estimated at approximately SEK 10,000, which is below the threshold value of cost-effectiveness. On the condition that HRT increases the quality of life weight more than 0.013 units, the therapy is cost-effective.

Conclusions: In conclusion, given the new evidence in WHI, there is still a high probability that HRT is a cost-effective strategy for women with menopausal symptoms.

Objectives: Given the resource-intensive nature of stroke rehabilitation, it is important that services be delivered in an evidence-based and cost-efficient manner. The objective of this review was to assess the evidence on the relative cost or cost-effectiveness of three rehabilitation services after stroke: stroke unit care versus care on another hospital ward, early supported discharge (ESD) services versus “usual care,” and community or home-based rehabilitation versus “usual care.”

Methods: A systematic literature review of cost analyses or economic evaluations was performed. Study characteristics and results (including mean total cost per patient) were summarized. The level of evidence concerning relative cost or cost-effectiveness for each service type was determined qualitatively.

Results: Fifteen studies met the inclusion criteria: three on stroke unit care, eight on ESD services, and four on community-based rehabilitation. All were classified as cost-consequences analysis or cost analysis. The time horizon was generally short (1 year or less). The comparators and the scope of costs varied between studies.

Conclusions: There was “some” evidence that the mean total cost per patient of rehabilitation in a stroke unit is comparable to care provided in another hospital ward. There is “moderate” evidence that ESD services provide care at modestly lower total costs than usual care for stroke patients with mild or moderate disability. There was “insufficient” evidence concerning the cost of community-based rehabilitation compared with usual care. Several methodological problems were encountered when analyzing the economic evidence.

Objectives: Cost studies of positron emission tomography (PET) imaging are important for resource and operational planning; the most relevant cost analysis in this regard is the marginal cost. Operating within a regulatory environment can add considerably to the costs of providing PET services. Previously published research has not examined the marginal cost structure of PET nor have they described the implications of regulatory compliance to operational costs. The purpose of this study was to conduct a comprehensive cost estimation of PET imaging with 18F-fluorodeoxyglucose (18F-FDG) to better identify the fixed and variable cost components, the marginal cost structure, and the added costs of satisfying regulatory requirements.

Methods: Financial data on capital and operating expenses were collected for the PET center at the Cross Cancer Institute in Edmonton, Alberta, Canada.

Results: The total per-service cost for clinical operations ranged between $7,869 (400 annual scans) and $1,231 (3,200 annual scans). The marginal cost for the center remained steady as volume increased up to the throughput capacity.

Conclusions: Results indicate that economies from increased volumes did not arise. Regulatory requirements added significant costs to operating an 18F-FDG-PET center.

Objectives: The feasibility and convergent validity of a cost diary and a cost questionnaire was investigated.

Methods: Data were obtained as part of a cost-utility analysis alongside a multicenter clinical trial in patients with resectable rectal cancer. A sample of 107 patients from 30 hospitals was asked to keep a weekly diary during the first 3 months after surgery, and a monthly diary from 3 to 12 months after surgery. A second sample of seventy-two patients from twenty-eight hospitals in the trial received a questionnaire at 3, 6, and 12 months after surgery, referring to the previous 3 or 6 months. Format and items of the questions were similar and included a wide range of medical and nonmedical items and costs after hospitalization for surgery.

Results: Small differences were found with respect to nonresponse (range, 79 to 86 percent) and missing questions (range, 1 to 6 percent between the diary and questionnaire). For most estimates of volumes of care and of costs, the diary and questionnaire did not differ significantly. Total 3-month nonhospital costs were €1,860, €1,280, and €1,050 in the diary sample and €1,860, €1,090, and €840 in the questionnaire sample at 3, 6, and 12 months after surgery, respectively (p =.50). However, with respect to open questions, the diary sample tended to report significantly more care.

Conclusions: For the assessment of health-care utilization in economic evaluations alongside clinical trials, a cost questionnaire with structured closed questions may replace a cost diary for recall periods up to 6 months.

Objectives: Whether cost-effectiveness of secondary health care can be measured in a simple, yet commensurate way was studied.

Methods: Approximately 4,900 patients' health-related quality of life scores before and after treatment were measured. Used were a combination of quality of life data with diagnostic and financial indicators routinely collected in the hospital.

Results: Seventy percent of patients returned the first questionnaire and the informed written consent to participate. Of these patients, 80 percent also returned the second questionnaire sent out 3 to 12 months after treatment, depending on clinical specialty and diagnostic category. The routine of sending out questionnaires could be automated in such a way that data collection required only a limited amount of extra work. Patients were generally satisfied with the fact that the hospital was interested in their well-being also after treatment. No physician offered the chance to participate refused data collection in the patient group he or she was responsible for. The attitudes of the nursing staff were generally positive toward data collection, although it caused some extra work for some of them. The possibility of relating already routinely collected financial performance indicators with a relevant measure of treatment effectiveness, opened prospects for refined analysis of cost-effectiveness of secondary health care.

Conclusions: Routine collection of health-related quality of life data as an indicator of treatment effectiveness is feasible, requires only a small amount of extra work, and is potentially very useful when combined with existing measures of hospital performance.

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.

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.

Objectives: The purpose of this study was to determine and inform clinicians, managers, and budget allocators of the costs incurred to the British National Health Service (NHS), patient, and society when attending clinic-based physiotherapy compared with not attending clinic-based physiotherapy after arthroscopic partial meniscectomy surgery.

Methods: The valuation principle used in this study was the economic concept of opportunity cost. Costs were referred to as direct medical (NHS), direct nonmedical (patient), and indirect (societal) costs. Due to the difficulties of their measurement and valuation, intangible costs, in the form of pain and anxiety related to the effect of receiving or not receiving treatment, have not been considered in this analysis.

Results: Providing clinic-based physiotherapy after knee arthroscopic partial meniscectomy surgery is more costly to the NHS and patient, but no more costly to society than when not providing it and does not result in reduced contact with the NHS.

Conclusions: Clinic-based physiotherapy after knee arthroscopic partial meniscectomy surgery is costly and evidence is needed that its effectiveness is high enough to support its use.

Objectives: The aim of the study was to investigate the feasibility and effectiveness of searching selected databases to identify information required to populate a decision-analytic model.

Methods: Methods of searching for information to populate a decision-analytic model were piloted using a case study of prophylactic antibiotics to prevent recurrent urinary tract infections in children. This study explored how the information requirements for a decision-analytic model could be developed into searchable questions and how search strategies could be derived to answer these questions. The study also assessed the usefulness of three published search filters and explored which resources might produce relevant information for the various model parameters.

Results: Based on the data requirements for this case study, 42 questions were developed for searching. These questions related to baseline event rates, health-related quality of life and outcomes, relative treatment effects, resource use and unit costs, and antibiotic resistance. A total of 1,237 records were assessed by the modeler, and of these, 48 were found to be relevant to the model. Search precision ranged from 0 percent to 38 percent, and no single database proved the most useful for all the questions.

Conclusions: The process of conducting specific searches to address each of the model questions provided information that was useful in populating the case study model. The most appropriate resources to search were dependent on the question, and multiple database searching using focused search strategies may prove more effective in finding relevant data than thorough searches of a single database.

Background: During 2001, over 32,000 patients in the United Kingdom received renal replacement therapy (RRT). Approximately half had a functioning transplant, with the remainder receiving dialysis therapy. The main form of dialysis is hemodialysis (HD), which is provided to 37.1 percent of the RRT population. HD is provided in three main settings: hospital (24.5 percent), satellite (10.9 percent), or home (1.7 percent). The objective of this study is to explore the cost-effectiveness of these different modalities.

Methods: By using clinical and cost data from a systematic review, a Markov model was developed to assess the costs and benefits of the three different modalities. The model included direct health service costs and quality-adjusted life years (QALYs). Sensitivity analyses were performed to assess the robustness of the results.

Results: Satellite HD has lower costs £46,000 and £62,050 at 5 and 10 years than home HD £47,660 and £63,540. The total effectiveness of home HD was slightly greater than for satellite HD, so the incremental cost per QALY of home versus satellite HD was modest at £6,665 at 5 years and £3,943 at 10 years. Both modalities dominated hospital HD.

Conclusions: Results from the study reveal that satellite HD was less costly than home HD, and home HD was less costly than hospital HD. The lack of robust data on the effectiveness and new dialysis equipment, which were not included in this review, throws some caution on these results. Nonetheless, the results are supportive of a shift from hospital HD to satellite and home HD.

Objectives: As part of a review of guidelines for sleep laboratories, this study summarizes the quality and relevance of evidence cited in support of recommendations on investigations for individuals with sleep disorders.

Methods: Quality of evidence in support of each recommendation was rated as A (from well-conducted, prospective controlled studies), B (from controlled studies and case series, with minor shortcomings), or C (from case series or case series plus controlled studies with substantial limitations). Relevance of the cited evidence was also rated from A to C, in decreasing order of merit.

Results: Of eighty-one recommendations from thirty-seven guidelines, forty-six were supported by evidence from primary studies. Six recommendations were supported by category A evidence, fifteen by category B, and twenty-five recommendations by category C. The cited evidence was highly relevant to eighteen recommendations, of some relevance for twenty-two and of little or no relevance to six. Four recommendations were informed by an absence of available evidence. For the other thirty-one, no evidence was provided in support.

Conclusions: The approach used provided a concise overview of recommendations and supporting evidence for decision-makers. Guidelines on the use of sleep laboratory investigations contain much detailed information, but evidence supporting several recommendations is of limited quality and relevance. Furthermore, good-quality studies of many sleep laboratory applications are needed to assist both health policy formulation and clinical practice.

Objectives: Although ethics has been on the agenda in health technology assessment (HTA) since its inception, the integration of moral issues is still not standard and is performed in a vast variety of ways. Therefore, there is a need for a procedure for integrating moral issues in HTA.

Methods: Literature review of existing approaches together with application of various theories in moral philosophy and axiology.

Results: The article develops a set of questions that addresses a wide range of moral issues related to the assessment and implementation of health technology. The issues include general moral issues and moral issues related to stakeholders, methodology, characteristics of technology, and to the HTA process itself. The questions form a kind of checklist for use in HTAs.

Conclusions: The presented approach for integrating moral issues in HTA has a broad theoretical foundation and has shown to be useful in practice. Integrating ethical issues in HTAs can be of great importance with respect to the dissemination of HTA results and in efficient health policy making.

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.

Objectives: Hemodialysis is a well-established treatment for 74 percent of end-stage renal disease (ESRD) patients in Greece. The purpose of this study is to provide an estimate of the direct cost of dialysis in a public hospital setting and an estimate of the loss of production for ESRD patients. The results will be useful for public health facility planning purposes.

Methods: A socioeconomic prevalence-based analysis was performed using micro-economic evaluation of health-care resources consumed to provide hemodialysis for ESRD patients in 2000. Lost productivity costs due to illness were estimated for the patient and family using the human capital approach and the friction method. Indirect morbidity costs due to absence from work and long-term were estimated, as well as mortality costs. Mean gross income was used for both patient and family.

Results: Total health-sector cost for hemodialysis in Greece exceeds €171 million, or €182 per session and €229 per inpatient day. There were 2,046 years lost due to mortality, and the potential productivity cost was estimated at €9.9 million, according to the human capital approach, and €303.000, according to the friction method. Total morbidity cost due to absence from work and early retirement was estimated at more than €273 million, according to the human capital approach, and €12.5, according to the friction method.

Conclusions: Providing hemodialysis care for 0.05 percent of the population suffering from ESRD absorbs approximately 2 percent of total health expenditure in Greece. In addition to the cost for the National Health System, production loss due to mortality and morbidity from the disease are also considerable. Promoting alternative technologies such as organ transplantation and home dialysis as well as improving hemodialysis efficiency through satellite units are strategies that may prove more cost-effective and psychologically advantageous for the patients.