Objectives: This study aimed to investigate the technical documentation of manufacturers on issues of safe use of their device in a home setting.

Methods: Three categories of equipment were selected: infusion pumps, ventilators, and dialysis systems. Risk analyses, instructions for use, labels, and post market surveillance procedures were requested from manufacturers. Additionally, they were asked to fill out a questionnaire on collection of field experience, on incidents, and training activities.

Results: Specific risks of device operation by lay users in a home setting were incompletely addressed in the risk analyses. A substantial number of user manuals were designed for professionals, rather than for patients or lay carers. Risk analyses and user information often showed incomplete coherence. Post market surveillance was mainly based on passive collection of field experiences.

Conclusions: Manufacturers of infusion pumps, ventilators, and dialysis systems pay insufficient attention to the specific risks of use by lay persons in home settings. It is expected that this conclusion is also applicable for other medical equipment for treatment at home. Manufacturers of medical equipment for home use should pay more attention to use errors, lay use and home-specific risks in design, risk analysis, and user information. Field experiences should be collected more actively. Coherence between risk analysis and user information should be improved. Notified bodies should address these aspects in their assessment. User manuals issued by institutions supervising a specific home therapy should be drawn up in consultation with the manufacturer.

Objectives: This study was carried out to evaluate the opinions of stakeholders on their roles in health technology assessment (HTA) in Iran and to determine the barriers and facilitators existing in the organizations to help increase their involvement in the HTA program.

Methods: The study was conducted in two stages, semi-structured interviews, and “policy dialogue” with stakeholders. The data were analyzed through the framework approach.

Results: The interviews were held with ten stakeholder representatives from various organizations. In addition, Twenty-one representatives participated in the policy dialogue. Based on the findings, all the stakeholder organizations considered themselves as interest groups in all the stages of the HTA process; however, their tendencies and methods of involvement differed from one another. According to the participants, the most important issue to be considered in the context of HTA was that the structures, stages, and procedures of the HTA process must be made transparent.

Conclusions: Stakeholder involvement in the HTA program cannot readily take place. Various stakeholders have different interests, responsibilities, infrastructures, and barriers. If a program does not meet these considerations, its chances of succeeding will substantially decrease. Therefore, to prevent overlooking the needs and expectations of stakeholders from the HTA process, it is essential to create opportunities in which their thoughts and ideas are taken into account.

Objectives: Rapid reviews can be conducted in a narrower time frame, as compared to systematic reviews, by featuring restrictions. To estimate the validity of the results, assessment of methodological quality is required. Our aim was to analyze the methodological restrictions of rapid reviews compared with systematic reviews using the AMSTAR checklist and assess its feasibility for rapid reviews.

Methods: A systematic search for literature on rapid reviews of surgical interventions was conducted in three databases: Medline, Embase, and the Cochrane library. Additionally, health technology assessment (HTA) databases were searched. We analyzed reviews using AMSTAR and additionally compared the results with those of an overview of reviews on the same topic.

Results: Items found more frequently in rapid reviews were search for gray literature (65 percent versus 33 percent), listing of excluded studies (59 percent versus 37 percent), and provision of study characteristics (77 percent versus 44 percent), whereas consideration of study quality in formulating conclusions, conduct of meta-analysis, and statement of conflicts of interest were less frequent. Median time between search and publication was 8 months, with a range between 1 and 27.

Conclusions: With some adjustments, AMSTAR can be used as a checklist for rapid reviews to describe methodological restrictions in comparison to systematic reviews and to roughly estimate the validity of the results. Strikingly, only 14.3 percent of rapid reviews were published within 3 months.

Background: The classic cut and sew surgical Maze procedure has been shown to reduce atrial fibrillation (AF), and recently newer surgical ablation techniques with reduced technical complexity have been introduced. This study sought to systematically review the efficacy and safety of these newer techniques and to evaluate their long-term cost-effectiveness at the time of scheduled mitral valve (MV) surgery.

Methods: A systematic literature search and meta-analysis was performed to generate the most reliable efficacy and safety parameter estimates for a Markov decision analysis model comparing MV surgery alone to MV surgery plus an ablation Maze procedure. Both basic and probabilistic sensitivity analyses were conducted.

Results: Based on the six randomized controlled trials (RCTs) identified, the pooled 1-year estimate of AF after surgery alone was 71 percent (95 percent confidence interval [CI], 64 percent to 78 percent). The pooled risk ratio of AF after surgical ablation treatment at the time of mitral valve surgery relative to valve surgery alone was 0.33 (95 percent CI, 0.19 to 0.55). The pooled analyses showed that no statistical significant increases in operative mortality, permanent pacemaker implantation, and postoperative bleeding with the ablative Maze procedures. An ablation-based Maze procedure at the time of mitral valve surgery had an incremental cost-effectiveness ratio (ICER) of $4,446CAD ($3,850US) per quality-adjusted life-year (QALY) compared with valve surgery alone. Specifically costs were an extra $900CAD but with improved clinical outcomes (0.20 QALYs), including a prolonged life expectancy of 0.10 life-years. In one-way sensitivity analyses, survival time after MV surgery had the largest impact on ICER. Other variables influencing the ICER included the risk ratio of AF, utility, and cost estimates. Probabilistic sensitivity analysis suggests that 58.1 percent, 73.9 percent, and 89.3 percent of the simulations of the Maze strategy are cost-effective at willingness to pay thresholds of $20,000, $50,000, and $100,000CAD per QALY gained, respectively.

Conclusions: Our meta-analysis suggests that a Maze surgical ablation procedure at the time of MV surgery is associated with a reduced postoperative AF risk. Our economic model further suggests that the surgical ablation strategy at the time of mitral valve surgery is likely a cost-effective intervention, provided patients have a good long-term postsurgical prognosis.

Objectives: To collect and summarize information published by INAHTA agencies on the indications, habitual attitudes and practices, and economic and legal implications of preoperative evaluation in elective surgeries.

Method: The authors appraised the information contained in six papers published between 1989 and 1999 in Sweden, France, Basque Country, the Netherlands, United Kingdom, and Catalonia. The section on indications in preoperative evaluation does not present global conclusions. The sections addressing habitual attitudes and practices among physicians and those addressing economic and legal considerations cover only the similarities among the reports and the main ideas relating to these issues.

Results: The conclusions found in the reports about indications in preoperative evaluation are similar or differ slightly, e.g., as regards age limits in patients for whom the tests are recommended. However, more important differences are shown in other areas, especially in reports where consensus methods were used. In some instances, the opinions, attitudes, and customary practices of professionals during the preoperative stage do not concur with the recommendations extracted from the assessment reports and the customary practice of doctors. In relation to economic considerations, a substantial quantity of resources could be liberated if the recommended general clinical practices were followed. From the point of view of civil law, the evidence-based recommendations could be considered as a kind of coded lex artis.

Background: Oncotype DX (ODX), a tumor gene profiling test, has been incorporated into clinical guidelines to aid in adjuvant chemotherapy decision making for early-stage, hormone receptor positive breast cancer patients. Despite United States (U.S.) guidelines, less than half of eligible women receive testing. Reasons for low usage are unclear: Our objective was to better understand U.S. oncologists’ ODX uptake and how they use ODX during adjuvant chemotherapy decision making.

Methods: We conducted semi-structured, ~30-minute phone interviews with medical and surgical oncologists in one U.S. State using purposive sampling. Oncologists were included if they saw greater than or equal to five breast cancer patients per week. Recruitment ended upon thematic saturation. Interviews were recorded, transcribed, and double-coded using template analysis.

Results: During analysis, themes emerged across three domains. First, organizational factors (i.e., departmental structure, ODX marketing, and medical/insurance guidelines) influenced ease of ODX use. Second, oncologists referenced the influence of interpersonal factors (e.g., normative beliefs and peer use of ODX) over their own practices and recommendations. Third, intrapersonal factors (e.g., oncologist attitudes, perceived barriers, and research gaps) were discussed: although oncologists largely held positive attitudes about ODX, they reported challenges with interpreting intermediate scores for treatment decisions and explaining test results to patients. Finally, oncologists identified several research gaps.

Conclusions: As more tumor gene profiling tests are incorporated into cancer care for treatment decision making, it is important to understand their use in clinical practice. This study identified multi-level factors that influence ODX uptake into clinical practice, providing insights into facilitators and modifiable barriers that can be leveraged for improving ODX uptake to aid treatment decision making.

Objectives: The aim of this study is to perform a comparative costs analysis of brachytherapy (BT) and radical retropubic prostatectomy (RRP) for clinically localized prostate cancer and to shed light on the difficulties of comparing their relative economic effectiveness.

Methods: A systematic literature review of costing studies available in the Medline, Embase, DARE, and INAHTA databases.

Results: There is a lack of homogeneity among published studies in this field. Differences in the reported costs are related to different environments in which the two techniques (BT and RRP) are applied, and in particular due to the use of different methodology, cost items included, time frames, and different price levels in different settings.

Conclusion: Published studies of costing data of BT and RRP do not provide clear-cut evidence for a conclusion about which treatment may be more effective from an economic point of view.

Objectives: The aim of this study was to estimate the time and travel costs generated by women when attending for Papanicolaou (Pap) smear tests or colposcopy appointments in the United Kingdom, both absolutely and relative to the health service cost of the national cervical cancer screening programs.

Methods: Data were obtained from questionnaires completed by two samples of women participating in a three-center trial of management of low-grade abnormalities detected by screening (n = 1,106 for Pap smears and n = 1,203 for colposcopy appointments). Women were 20 to 59 years of age and resident in Grampian or Tayside, Scotland, or Nottingham, England. Questionnaire data were supplemented with sociodemographic information previously collected at the time of recruitment to the trial.

Results: The mean total time and travel costs per attendance at a smear test and at a colposcopy appointment were estimated to be £9.2 and £27.4, respectively, averaged across the three trial areas (valued at 2002 prices). Statistically significant intercenter disparities in time and travel costs were identified, particularly with respect to colposcopy appointments. For these, time and travel costs in Nottingham were substantially less than those in Grampian and Tayside (£22.9, £30.2, and £32.1, respectively). Time and travel costs amount to 26 and 33 percent, approximately, over and above the direct health service costs of the English and Scottish screening programs, respectively.

Conclusions: The time and travel costs associated with participation in the UK cervical cancer screening programs are substantial and are not spatially uniform across the country.

Objective: Somatic gene therapy is a new method in the rapidly expanding field of molecular medicine. Due to recent encouraging results and the promising prospect for some disease groups, Norwegian health authorities wanted to assess somatic therapy with evidence-based standards for strategic use. This article presents the results of this assessment, discussed in the context of the policy-making process in Norway, including ethical and legislational considerations.

Methods: Clinical gene therapy protocols, ongoing or completed with published results, where available, were identified through a systematic survey of descriptive protocols and publications. Preclinical literature was also reviewed.

Results: Gene therapy is dominated by preclinical and clinical research. Most of the gene therapy protocols identified are in early phases (phases I and II) with only a few patients in each study. Of the protocols included in the assessment, only three phase III studies are represented. Except for the use of soluble antisense oligonucleotides against cytomegalovirus eye infection, gene therapy is presently not an established treatment modality. Promising results have been observed in treatment of cancer and cardiovascular diseases and, most recently, in inherited severe combined immunodeficiency and hemophilia. Several interesting principles addressing a large panel of conditions are currently being developed and tested.

Conclusions: Gene therapy is developing into an important medical concept that needs to be included within the Norwegian healthcare system. It is recommended that the Norwegian Ministry of Health and Social Affairs fund a national program to boost infrastructure in selected scientific groups both in preclinical and clinical research. The national procedures regulating approval of gene therapy trials should be made more efficient while at the same time allowing for proper control and ethical considerations. It is emphasized that gene therapy trials should be carefully monitored for side effects.

The French healthcare system combines freedom of medical practice with nationwide social security. It is compulsory for every legal resident. A range of public and private institutions provide care, and patients have free access to physicians. The health coverage system is characterized by solidarity and universal responsibility. Although the French system is highly regulated, funding of health-related expenses is a chronic social problem. Since the 1996 healthcare reform, the national objective for reimbursed healthcare expenditures is voted by the parliament, and the annual increase of hospital funding is controlled at the regional level. An agency for hospitals has been established in every region, and it quantifies needs indexes for future equipment and beds. However, establishing appropriate reference ratios based on objective assessment is difficult. The idea of basing policy and practice decisions on objective assessment grew for years, until the National Agency for the Development of Medical Evaluation was established in 1989. The 1996 healthcare reform expanded this agency to encompass hospital accreditation and renamed it the National Agency for Accreditation and Evaluation in Health. In March 1999, the National Agency for Health Products was established. It controls the safety of medical products and evaluates products' medical benefits before reimbursement decisions. Health technology assessment is now related to virtually every health policy process in France, and its role increases continually.

Objectives: Herpes zoster (HZ) is characterized by a painful skin rash. Its main complication is postherpetic neuralgia (PHN), pain persisting or occurring after the rash onset. HZ treatment aims to reduce acute pain, impede the onset complications, and disease progression. The aim of this study was to assess the cost-effectiveness of HZ vaccination compared with no vaccination strategy, within the Italian context.

Methods: The natural history of HZ and PHN was mapped through a Markov model with lifetime horizon. A population of patients aged between 60 and 79 years was hypothesized. Third party payer (Italian National Health Service, I-NHS) and societal perspectives were adopted. Data were derived from literature.

Results and Conclusions: The incremental cost-effectiveness ratio of the vaccination equaled EUR 11,943 per quality-adjusted life-year (QALY) under the I-NHS perspective and EUR 11,248 per QALY under the societal perspective. Considering a cost-effectiveness threshold of EUR 30,000/QALY, the multi-way sensitivity analysis showed that vaccination is cost-effective regardless of the perspective adopted, in 99 percent of simulations.

There are several techniques for estimating health state utility values, each of which presents pros and cons in the context of rare diseases (RDs). Direct approaches (e.g. standard gamble and time trade-off) may be too demanding for patients with RDs, since most of them affect young children or cause cognitive impairment. The alternatives are using “vignettes” that describe hypothetical health states for the general public, which may not reflect the heterogeneous manifestations of RDs, or multi-attribute utility instruments (i.e. indirect techniques), such as EQ-5D, which may be less sensitive in capturing the specificities of RDs. The “rule of rescue” approach is a promising alternative in RDs, since it prioritizes identifiable patients with life-threatening or disabling conditions. However, it raises measurement challenges and ethical issues. Furthermore, the literature reports on relevant implications of choosing a technique over others for health technology assessment, which should be considered in relation to individual RDs.

Objectives: The aim of this study was to evaluate the diagnostic accuracy of sensitivity and specificity of cervical lesions by the low-cost, portable Gynocular colposcope and a stationary colposcope, in women referred for colposcopy with abnormal cervical cytology.

Methods: A randomized cross-over clinical trial for evaluating the diagnostic accuracy in detecting cervical lesions by the Gynocular and a stationary colposcope. The Swede score systematic colposcopy system was used for evaluation of colposcopic abnormalities. Directed punch biopsy and excisional cone biopsy were used as the “gold-standard” by histologically confirmed high grade cervical lesions CIN2+ (CIN2, CIN3, CIN3+). In total, 123 women referred for colposcopy due to abnormal cervical cytology were recruited at the Department of Obstetrics and Gynecology, Danderyd Hospital, Stockholm, Sweden. The percentage agreement and the kappa statistic were calculated for Swede score by the Gynocular and a stationary colposcope. Swede scores were compared with the results from directed punch biopsy and excisional cone biopsy.

Results: The Gynocular and the stationary colposcope had a high agreement of Swede scores with a Kappa statistic of 0.947, p < .0001. Punch biopsy diagnosed CIN2+ (CIN2, CIN3, and invasive cancer) in 44 (35.7 percent) women while cytology detected CIN2+ in 34 (27.6 percent) women. There were no significant differences of the sensitivity and specificity for different Swede scores by the Gynocular or a stationary colposcope in detecting CIN 2+.

Conclusions: There were no significant differences in sensitivity or specificity in detecting cervical lesions by the Gynocular or stationary colposcope. The Gynocular is as accurate in diagnosing cervical lesions as a stationary colposcope.

Objectives: To assess the annual direct and indirect costs of skin diseases caused by ultraviolet radiation.

Methods: A model for cost-of-illness, including costs for hospital care, primary care, pharmaceuticals, mortality, and morbidity, for approximately 1.8 million inhabitants in Stockholm.

Results: The total annual discounted cost-of-illness in Stockholm was approximately 162 million SEK (MSEK; approximate 2002 exchange rate: 1 U.S. dollar=10 SEK). The indirect costs were predominant and constituted approximately 91 MSEK (56% of total costs), mainly due to an estimated cost of mortality for cutaneous malignant melanoma of 84 MSEK. The direct costs of these diseases, approximately 71 MSEK, were predominated by hospital ambulatory care costs of approximately 33 MSEK. The direct costs constituted approximately 0.4% of the overall health-care costs for hospital care and primary health care in the area.

Conclusions: Skin diseases caused by ultraviolet radiation result in moderate economic losses in the community. Therefore, it may not be easy to make successful prevention of these diseases economically beneficial.

This study examines the parameters crucial to cost-effectiveness of universal hepatitis B immunization in India. An incremental cost-effectiveness analysis was done using a decision tree (Markov model) to follow up a hypothetical cohort of 100,000 newborns for the effects of hepatitis B acquired vertically at birth. The measure of effectiveness was disability-adjusted life-years gained. Uncertainty analysis and Scenario analysis were done using Latin hypercube sampling. Hepatitis B endemicity is the most important factor, followed by the cost of vaccine. Other factors of some influence are vaccination coverage, vaccine efficacy, HBeAg positivity, and vaccine wastage.

Objectives: Summary physical health scores for the Short Form (SF) measures are computing using positive weights for physical items and negative weights for mental health items. Mental health summary scores use positive weights for mental items and negative weights for physical. The RAND Health Status Inventory (HSI) measures do not use negative weights. Do these different approaches to scoring matter? The objective was to compare summary scores using both the SF and RAND-HSI.

Methods: SF-36 and the Health Utilities Index Mark 3 (HUI3) were administered to a cohort of patients waiting for elective total hip arthroplasty (THA). SF-12 and HUI3 were administered to a cohort of high-risk primary-care patients. Summary scores were generated and compared. Single-attribute utility scores for emotion in HUI3 were also computed. Canadian and US norms for SF, RAND-HSI, and HUI3 were used to interpret results.

Results: For THA patients, mean physical health scores were 28 and 36 for SF and RAND-HSI. Mean mental health scores were 55 and 42. For the primary-care patients, the scores were 34 and 36 for physical and 46 and 40 for mental health.

Conclusions: SF and RAND-HSI provided somewhat similar summary scores in the THA study. However, SF and RAND-HSI mental health scores differed in the primary-care patient cohort and results from HUI3 corroborate the mental health deficits identified by the RAND-HSI. It may be wise for investigators to use both SF and RAND-HSI scoring systems.