Background: Although pharmacoeconomic studies constitute a valuable tool for better managing drug consumption, the conditions under which such studies would be performed in Latin American countries have not been explored.

Objectives: The aim of this paper is to evaluate the potential advantages of and pitfalls in doing pharmacoeconomic research in Latin America and to propose avenues to facilitate the development of this field in the region.

Methods: The Canadian guidelines for the economic evaluation of pharmaceuticals served as a structured framework to assess, both prospectively and retrospectively, the conditions under which the pharmacoeconomic component of a clinical trial held in Mexico and Brazil would be and actually was conducted.

Results: The conditions under which pharmacoeconomic evaluations are conducted must be improved if studies are to contribute to the better management of scarce resources across the entire health care system.

Conclusions: The creation of a public funding agency, the reappraisal of administrative data as a management tool in both the public and the private sectors, and the establishment of national guidelines should be considered within the framework of reforms aimed at allowing healthcare systems to meet their objectives of efficiency and equity.

Objective: To enhance the validity of a well-known expert panel process, we used data from patient surveys to identify and correct rating errors.

Methods: We used the two-round RAND/UCLA panel method to rate indications of harmful (presence of problems), hazardous (at risk for problems), and nonhazardous (no known risks) drinking in older adults. Results from the panel provided guidelines for classifying older individuals as harmful, hazardous, or nonhazardous drinkers, using a survey. The classifications yielded unexpectedly high numbers of harmful and hazardous drinkers. We hypothesized possible misclassifications of drinking risks and used the survey data to identify indications that may have led to invalid ratings. We modified problematic indications and asked three clinician panelists to evaluate the clinical usefulness of the modifications in a third panel round. We revised the indications based on panelist response and reexamined drinking classifications.

Results: Using the original indications, 48% of drinkers in the sample were classified as harmful, 31% as hazardous, and 21% as nonhazardous. A review of the indications revealed framing bias in the original rating task and vague definitions of certain symptoms and conditions. The modified indications resulted in classifications of 22% harmful, 47% hazardous, and 31% nonhazardous drinkers.

Conclusions: Analysis of survey data led to identification and correction of specific errors occurring during the panel-rating process. The validity of the RAND/UCLA method can be enhanced using data-driven modifications.

Objective: To review the assessment of screening in the United Kingdom, focusing on three methods: mammography for breast cancer, screening for prostate cancer, and routine use of ultrasound in pregnancy.

Method: To review policy documents and published papers dealing with prevention and screening in the United Kingdom.

Results: Indicate that the United Kingdom has an active policy concerning the assessment of screening methods. Generally speaking, this assessment policy is part of the national program for health technology assessment (HTA). The government has given HTA an important place within health care in the United Kingdom, and prevention and screening is no exception to this general rule. The assessment of screening is now implemented through the National Screening Committee, established in 1997. The three issues reviewed in this paper have all been assessed within the context of the Department of Health. In the case of mammography, the assessment was done more than 10 years ago and was followed by a rational implementation of a national screening program for breast cancer. In the case of prostate cancer screening, two systematic reviews have concluded that screening should not be carried out. In general, this recommendation has been accepted in the United Kingdom. Use of ultrasound in pregnancy has been assessed by the National Screening Committee. This complex technology is difficult to assess, and the screening procedure is deeply embedded in clinical practice in the United Kingdom, so assessment has not had much impact on the frequency of screening.

Conclusion: HTA and the assessment of screening are well established in the United Kingdom. Policy is generally based on the assessments done, and practice generally follows the results of assessment. Assessment of screening is expected to become increasingly important in the United Kingdom during the next years.

Policy makers in British Columbia (BC) are deliberating whether to implement a comprehensive, province-wide approach to prenatal screening, and consequently required contextspecific data to assist with this issue, taking into account problems of access in remote regions of the province and an increasing scarcity of abortion services.

Objectives: The objective of this study was to assess the effectiveness of government regulation of private pharmacy practice in a low-income country.

Methods: The intervention comprised inspections of the pharmacies, information, and distribution of documents to drug sellers and sanctions. It was implemented at two different intensity levels, active and regular intervention. The methods used to assess the effect of the interventions were interviews with the district drug inspectors, drug sellers and customers, inspection of drug purchases, and indicator surveys of pharmacies. Indicators for pharmacy-specific quality as well as for dispensing quality were developed.

Results: The main finding was one of strong overall improvements from initially low levels. The improvements were particularly marked by increases in the availability of essential materials for dispensing by 34% and in order in the pharmacy by 19%. Information given to customers increased from 35% to 51% and the mixing of different drugs in the same package went down from 17% to 9%. The pharmacies in the active intervention districts showed greater improvements for four of the six indicators, although statistically significant compared with the regular intervention districts only for the essential materials indicator.

Conclusions: It was concluded that the regulatory activities have probably been an important factor behind the service quality improvements. It appeared feasible as well as effective to regulate private pharmacy practice in this particular low-income setting.

Objective: To present a summary of the papers in this volume, illustrating the links between health technology assessment (HTA), health policies and specifically policies toward prevention and screening, and implementation of screening tests in the case of three screening methods: mammography screening for breast cancer, screening for prostate cancer, and routine use of ultrasound in pregnancy.

Method: To commission papers from eight European countries based on a set of questions to be answered, as well as a paper synthesizing the scientific literature on the three screening procedures.

Results: Indicate that few of the countries examined have developed effective links between HTA, health policy, and implementation related to screening procedures. Only Sweden and the Netherlands appear to have developed such links. In the other countries, HTA has a limited role in determining health policy. It also seems to be uncommon for countries to have a specific prevention strategy.

Conclusion: The major conclusion is that countries of Europe need to develop HTA as part of prevention policies.

Objectives: We were interested in health coverage in women's magazines in the United States and how it compared with articles in medical journals, women's health interests, and women's greatest health risks.

Methods: We examined 12 issues of Good Housekeeping (GH) and Woman's Day (WD) and 63 issues of the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA). We tallied the most common health questions of women presenting to the University of Michigan's Women's Health Resource Center (WHRC) during the same period.

Results: Less than a fifth of the magazine articles dealt with health-related topics. Of those, a third dealt with diet, with the majority emphasizing weight loss rather than eating for optimal health. Few of the articles cited research studies, and even fewer included the name of the journal in which the study was published. In JAMA and NEJM, less than one-fifth of original research studies dealt with women's health topics, most commonly pregnancy-related issues, hormone replacement therapy, breast and ovarian cancer, and birth defects. At the same time, the most common requests for information at the WHRC related to pregnancy, fertility, reproductive health, and cancer.

Conclusion: The topics addressed in women's magazines do not appear to coincide with the topics addressed in leading medical journals, nor with women's primary health concerns or greatest health risks. Information from women's magazines may be leading women to focus on aspects of health and health care that will not optimize risk reduction.

SBU SUMMARY AND CONCLUSIONS

Following headache and fatigue, stomach problems represent one of the most common reasons for physician visits. Dyspepsia accounts for approximately 3% of all physician visits. Dyspepsia is a general term to describe prolonged (weeks to months) pain or discomfort localized to the upper abdomen. The word dyspepsia originates from the Greek and means poor (dys) digestion (pepsia).

Objectives: Time costs borne by women when undergoing cervical cancer screening have rarely been elucidated, although such costs may pose substantial barriers to care. The purpose of this project was to quantify the opportunity costs associated with cervical cancer screening in young women attending Planned Parenthood Clinics.

Methods: We conducted a self-report survey of 105 women from six clinics to measure travel, waiting, and exam times associated with cervical cancer screening. Respondents recorded their time of arrival and departure, length of time in the waiting room, age, income level, and hours per week they worked outside of the home. Time costs were valued three ways: through self-reported hourly wage, age- and gender-adjusted minimum earnings, and national age- and gender-adjusted hourly wages.

Results: Respondents were on average 24 years old, worked 29 hours per week outside the home, and earned less than $20,000 per year. Mean time for one-way travel was 18.7 minutes; waiting room time was 16.9 minutes; and exam time was 50.8 minutes. Time costs were estimated to be $14.08 per visit based upon the self-reported hourly wage; $16.46 per visit based upon age- and gender-adjusted minimum earnings; and $19.63 per visit based upon age- and gender-adjusted national wage rates.

Conclusions: Time costs associated with cervical cancer screening represent an important opportunity cost and should be considered in studies attempting to identify barriers to screening adherence. Our results indicate that time costs accounted for up to 25% of cervical cancer screening costs. Time costs should be identified, measured, valued, and included in cost-effectiveness analyses of cervical cancer screening.

SUMMARY POINTS

[bull ] Geriatric service interventions after hip fracture are complex and strongly influenced by local conditions. The effectiveness of rehabilitation programs is uncertain, and comparative studies comparing different treatments and strategies are of poor to moderate quality.

[bull ] Based on the available evidence, geriatric hip fracture and early supported discharge programs are probably cost-effective since they appear to shorten the average length of hospital stay and are associated with significantly increased rates of return to previous residential status. Clinical pathways also appear to reduce total length of stay in hospital.

[bull ] Geriatric orthopedic rehabilitation units are unlikely to be cost-effective, but some frailer patients may benefit in respect of reduced readmission rates and need for nursing home placement.

[bull ] Length of stay may be reduced by the introduction of prospective payment systems, but these have led to increased use of nursing homes in the United States.

[bull ] There is no evidence that any of the programs evaluated are associated with changes in mortality. However, there are insufficient data to assess the impact of any program on level of function, morbidity, quality of life, or impact on carers.

In this article we analyze the influence of the legal regulatory framework in Europe, established by the two directives on medical devices and active implantable devices, on the performance of innovation in a single European market. First, we describe in general the possible influence of a single European market on innovation and the institutional features of the particular harmonization approach (“New Approach”) we are looking at here. The empirical results presented derive from a survey investigation involving 150 firms that we defined as best innovators in the European medical devices industry from a pre-survey. The results confirm that the total impact of the New Approach regulation on firms' innovation in the long term is positive. However, it also becomes clear that the impact of regulation on innovation is limited if the factors are looked at individually and that there is a clear difference regarding short-term effects. To improve the regulatory framework, several policy actions are recommended.

Objectives: While evaluating the effect of a community-wide informational intervention, this study explored access, health, and demographic factors related to the use of medical reference books, telephone advice nurses, and computers for health information.

Methods: A random sample of households in the intervention city (Boise, Idaho) and two control cities were surveyed about their use of health information in 1996. Shortly thereafter, the Healthwise Communities Project (HCP) distributed health information to all Boise residents. A follow-up survey was conducted in 1998. Overall, 5,909 surveys were completed for a 54% response rate.

Results: The HCP intervention was associated with statistically significant increases in the use of medical reference books and telephone advice nurses. The increased use of computers for health information was marginally significant. Few access, health, or demographic factors were consistently associated with using the different resources, except that people with depression used more of all three information resources, and income was not a significant predictor.

Conclusion: Providing free health information led to an increase in use, but access, health, and demographic factors were also important determinants. In particular, poor health status and presence of a chronic illness were associated with health information use. These results suggest that healthy consumers are less interested in health information, and it may take other incentives to motivate them to learn about prevention and healthy behaviors.

Objectives: To assess the extent to which abstracts of methodological research, initially presented at meetings on systematic reviews, have gone on to be published as full articles.

Methods: Full publication was assessed in three ways: a search was carried out of The Cochrane Library; a search was conducted using MEDLINE; and a questionnaire was sent to the contact author of each abstract.

Results: Approximately half of the abstracts had not been, or were unlikely ever to be, published in full.

Conclusions: The rate of full publication of abstracts related to the methodology of systematic reviews seems similar to that for randomized trials.

Objective: This paper presents the method we used in programming research on the efficacy of therapeutic interventions for nine chronic benign pain disorders.

Methods: We started with an inventory to identify commonly applied interventions. For these interventions we searched the literature to identify gaps in evidence. First, we searched for recent reviews, of which we assessed the methodologic quality. If only reviews of poor or moderate quality were found, a new systematic review was recommended. When we found no recent reviews, we searched for randomized controlled trials (RCTs). If there was insufficient or inconsistent evidence, the performance of a new RCT was advised. This structured procedure resulted in a list with topics for which new systematic reviews were recommended and topics for which new RCTs were needed. These lists were the starting points for priority setting by four Centers for Pain Management and Research. All members of the centers were asked to state the priority of each topic. The resulting hierarchy of topics for their own center was discussed in a meeting in each center, giving participants the opportunity to elucidate their views and considerations.

Results: The final result was a robust priority list for the need of research (systematic reviews and RCTs) on chronic benign pain syndromes.

Discussion: The strength and weaknesses of this approach are discussed. This method of priority setting is by no means restricted to treatments for chronic pain; it is also a useful approach for programming research to enable evidence-based medicine in other fields of interest.

Objectives: In a context where sleep laboratories are overwhelmed by a growing demand to diagnose obstructive sleep apnea syndrome (OSAS), efficient substitutive solutions to in-laboratory polysomnography should be found. To compare the effectiveness and costs of home unattended polysomnography (Hpsg) and telemonitored polysomnography (TMpsg), a cost minimization study was performed.

Methods: In a crossover trial, 99 patients underwent on two consecutive nights TMpsg and Hpsg according to a randomized order. A legibility recording criterion was retained to measure effectiveness. A microcosting study of TMpsg and Hpsg was performed. The risks to adopt home strategy or telemonitored strategy, according to different scenario chosen to reach the diagnosis in case of failure of Hpsg or TMpsg, were analyzed.

Results: The recording was considered to be ineffective in 11.2% of TMpsg (95% CI, 4.9–17.4) and in 23.4% (95% CI, 19.12–27.68) of Hpsg. The effectiveness differential was 12.2% (95% CI, 1.8–22.6) (p = .02). Assuming that in case of failure PSGs would be re-realized in the same condition to reach the diagnosis, then TMpsg could be selected if Hc/TMc (cost of Hpsg/cost of TMpsg) > 0.97; Hpsg could be selected if Hc/TMc < 0.76. If 0.76 ≤ Hc/TMc ≤ 0.97, the choice of TMpsg would be ambiguous. TMc was estimated to be $244, while Hc was $153 (Hc/TMc = 0.63).

Conclusion: Unless some specific geographical situations generate significant transport costs, the implementation of a strategy based on unattended polysomnography at home is cost-saving compared to a telemonitoring strategy.

Objective: The aim of this paper is to examine the costs of introducing a nursing-led ward program together with examining the impact this may have on patients' outcomes.

Methods: The study had a sample size of 177 patients with a mean age of 77, and randomized to either a treatment group (care on a nursing-led ward, n = 97) or a control group (standard care usually on a consultant-led acute ward, n = 80). Resource use data including length of stay, tests and investigations performed, and multidisciplinary involvement in care were collected.

Results: There were no significant differences in outcome between the two groups. The inpatient costs for the treatment group were significantly higher, due to the longer length of stay in this group. However, the postdischarge costs were significantly lower for the treatment group.

Conclusions: The provision of nursing-led intermediate care units has been proposed as a solution to inappropriate use of acute medical wards by patients who require additional nursing rather than medical care. Whether the treatment group is ultimately cost-additive is dependent on how long reductions in postdischarge resource use are maintained.

Last year in the summer issue of this journal, Khandker et al. (3) published the results of an interesting modeling study following the cost-effectiveness of various strategies for detecting cases of colon cancer. In addition to the baseline alternative, the authors investigated eight different screening strategies and calculated the incremental cost-effectiveness of these eight strategies. Table 1 contains the results of their study in terms of cost and effectiveness as well as incremental cost-effectiveness (see Table 3, Khandler et al.).

Objective: To determine the actual costs of extracorporeal shock wave therapy (ESWT) in patients with tendinitis of the supraspinatus muscle.

Methods: A comparison of the costs of surgical treatment versus the costs for ESWT was made. The total accrued costs were determined 12 weeks after intervention, using a sample group of 60 patients with calcifying or noncalcifying tendinitis of the supraspinatus muscle.

Results: The costs per case ranged from EUR 2,700 to EUR 4,300 per patient for ESWT and from EUR 13,400 to EUR 23,450 for surgical treatment, dependent on the method of calculation. Approximately 65% of the per-patient cost is attributable to productivity losses in the workplace.

Conclusions: In comparable short-term results, costs for operative treatment are 5–7 times higher than for ESWT. The greater trauma caused by an operative procedure leads to patients being off work for a longer period and thus a correspondingly higher social economic burden.

Objectives: The main objective of this article is to demonstrate the usefulness of dynamic modeling for an economic assessment of technology in health care. Specifically, this approach is applied to assess the impact of the use of hearing aids in Dutch health care.

Methods: The population is divided into different health classes between which, over time, transitions occur. Transition probabilities are derived from exogenous data. The transitions are associated with economic and societal costs and benefits. People who are satisfied with their hearing aids experience benefits. These benefits are expressed by quality-adjusted life-years (QALYs). Costs are made during transitions (mainly the fitting of hearing aids). A cohort analysis is carried out, starting with people in a particular age group. The starting point is a fixed number of people within this age group, who are followed during their whole lifetime.

Results: Costs per QALY ratios are calculated for two health programs. The Fitting Hearing Aid Program describes the present situation in the Netherlands; the Post-purchase Counseling Hearing Aid Program is a hypothetical addition to the first program, where an intervention based on a Dutch study is undertaken to improve satisfaction with hearing aids. Future benefits and costs are discounted at a rate of 5%.

Conclusions: The dynamic modeling approach provides a more realistic picture than a static approach. Particularly, the cost-effectiveness of the Fitting Hearing Aid Program is compared with the Post-purchase Counseling Hearing Aid Program.

Objectives: To assess whether sentinel lymph node biopsy (SLNB), an alternative to axillary lymph node dissection in treating female breast cancer, affords any cost savings.

Methods: We profile cumulative treatment costs of 811 breast cancer patients, 555 of whom received SLNB. Univariate and multivariate statistical tests are used to appraise whether these cost profiles differ between SLNB and other patients.

Results: The statistical results are mixed. However, none supports the conjecture that SLNB necessarily lowers the cost of treating the average breast patient.

Conclusions: SLNB may be cost-effective, but longer term costs and outcomes must be estimated before firm conclusions can be reached.