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: 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: 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.

To better understand technology diffusion in an ambulatory care setting, we analyzed adult outpatients’ use of magnetic resonance (MR) and computed tomography (CT) imaging in a group-model HMO between 1986 and 1989. The use of MR, but not CT, Increased at a rapid pace with only a small proportion of the scans being accounted for by primary care physicians.

Objectives: Long-term follow-up of the Caries Management System (CMS) protocol demonstrated that regular monitoring and noninvasive management of dental caries is effective in reducing the number of caries-related events over a 7-year period. This analysis complements the authors’ original economic evaluation of the CMS by re-evaluating the per-protocol cost-effectiveness of the CMS approach.

Methods: An individual patient-simulation Markov model was developed previously, based on 3-year randomized-controlled trial (RCT) data, to simulate the incidence and progression of dental caries, and resultant interventions, and to evaluate the lifetime cost-effectiveness of the CMS versus standard dental care from the Australian private dental practitioner perspective (in which the baseline age distribution was similar to that of the Australian population). The 4-year posttrial follow-up data are used to re-evaluate the long-term cost-effectiveness of the CMS in a more real-life setting.

Results: The reduction in caries risk was maintained among those practices within which the CMS protocols were adhered to. The per-protocol model appears to be reasonably accurate at predicting the risk of restorative events in the posttrial follow-up period. The per-protocol lifetime cost per restorative event avoided is AUD1,980 (USD1,409; 1 AUD = 0.71 USD).

Conclusions: The current analysis confirms that the CMS approach is both effective, when the protocols are adhered to appropriately, and cost-effective compared with standard care in the Australian private practice setting.

Objectives: The healthcare transformation program in Turkey has shown its success with improvements in important health indicators, increased access to healthcare services and expansion of coverage to all citizens. Turkey has been relatively able to bear the burdens associated with this due to rapid economic growth. The need for health technology assessment (HTA) was believed as a result of the expansion of coverage, pressure of new technologies, and increased expenditures. This study outlines the background and current formalization of HTA and shares the current use of HTA in decision making, while summarizing the transformation of the Turkish healthcare system for developing a high-quality, equal, and accessible care system.

Methods: We reviewed and analyzed policy changes in the Turkish healthcare system, universal health coverage, healthcare expenditures, and pricing and reimbursement policies to identify the changes leading to HTA. We reviewed existing HTA functions in Turkey and outlined their activities. Finally, we outlined a set of major challenges for HTA in Turkey over the next decade.

Results: HTA was formalized in Turkey in 2012–2013 with three national HTA structures and one hospital-based HTA unit. These functions currently run independent from each other. There are three major challenges in this country for HTA in the next decade: clarification of the assessment scope and methods, building a strong supporting system for HTA, and defining the role of HTA in the future vision of Turkish healthcare policy.

Conclusion: HTA, despite challenges, has a good opportunity to develop further with clear action plans and strong political will.

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.

Objectives: Developing a search strategy for use in a systematic review is a time-consuming process requiring construction of detailed search strings using complicated syntax, followed by iterative fine-tuning and trial-and-error testing of these strings in online biomedical search engines.

Methods: Building upon limitations of existing online-only search builders, a user-friendly computer-based tool was created to expedite search strategy development as part of production of a systematic review.

Results: Search Builder 1.0 is a Microsoft Excel®-based tool that automatically assembles search strategy text strings for PubMed (www.pubmed.com) and Embase (www.embase.com), based on a list of user-defined search terms and preferences. With the click of a button, Search Builder 1.0 automatically populates the syntax needed for functional search strings, and copies the string to the clipboard for pasting into Pubmed or Embase. The offline file-based interface of Search Builder 1.0 also allows for searches to be easily shared and saved for future reference.

Conclusions: This novel, user-friendly tool can save considerable time and streamline a cumbersome step in the systematic review process.

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.

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.

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.

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.

This paper describes a content analysis of the statements of 24 Consensus Development Conferences conducted by the Office of Medical Applications of Research (OMAR) of the National Institutes of Health in the years 1979–1983. The goal was to understand the potential influence of the consensus statements by identifying characteristics that might determine whether and how physicians become aware of their findings and adopt their recommendations. Three characteristics emerged, each suggestive of a different style of consensus statement: discursiveness, didacticism, and scholarliness. Variations in style among consensus statements may affect their acceptance by the medical profession

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.