Health technology assessment to optimize health technology utilization: using implementation initiatives and monitoring processes.

BACKGROUND: The way in which a health technology is used in any particular health system depends on the decisions and actions of a variety of stakeholders, the local culture, and context. In 2009, the HTAi Policy Forum considered how health technology assessment (HTA) could be improved to optimize the use of technologies (in terms of uptake, change in use, or disinvestment) in such complex systems. METHODS: In scoping, it was agreed to focus on initiatives to implement evidence-based guidance and monitoring activities. A review identified systematic reviews of implementation initiatives and monitoring activities. A two-day deliberative workshop was held to discuss key papers, members' experiences, and collectively address key questions. This consensus paper was developed by email and finalized at a postworkshop meeting. RESULTS: Evidence suggests that the impact and use of HTA could be increased by ensuring timely delivery of relevant reports to clearly determined policy receptor (decision-making) points. To achieve this, the breadth of assessment, implementation initiatives such as incentives and targeted, intelligent dissemination of HTA result, needs to be considered. HTA stakeholders undertake a variety of monitoring activities, which could inform optimal use of a technology. However, the quality of these data varies and is often not submitted to an HTA. CONCLUSIONS: Monitoring data should be sufficiently robust so that they can be used in HTA to inform optimal use of technology. Evidence-based implementation initiatives should be developed for HTA, to better inform decision makers at all levels in a health system about the optimal use of technology.

The HTA core model: a novel method for producing and reporting health technology assessments.

OBJECTIVES: The aim of this study was to develop and test a generic framework to enable international collaboration for producing and sharing results of health technology assessments (HTAs). METHODS: Ten international teams constructed the HTA Core Model, dividing information contained in a comprehensive HTA into standardized pieces, the assessment elements. Each element contains a generic issue that is translated into practical research questions while performing an assessment. Elements were described in detail in element cards. Two pilot assessments, designated as Core HTAs were also produced. The Model and Core HTAs were both validated. Guidance on the use of the HTA Core Model was compiled into a Handbook. RESULTS: The HTA Core Model considers health technologies through nine domains. Two applications of the Model were developed, one for medical and surgical interventions and another for diagnostic technologies. Two Core HTAs were produced in parallel with developing the model, providing the first real-life testing of the Model and input for further development. The results of formal validation and public feedback were primarily positive. Development needs were also identified and considered. An online Handbook is available. CONCLUSIONS: The HTA Core Model is a novel approach to HTA. It enables effective international production and sharing of HTA results in a structured format. The face validity of the Model was confirmed during the project, but further testing and refining are needed to ensure optimal usefulness and user-friendliness. Core HTAs are intended to serve as a basis for local HTA reports. Core HTAs do not contain recommendations on technology use.

Rapid versus full systematic reviews: validity in clinical practice?

INTRODUCTION: Rapid reviews are being produced with greater frequency by health technology assessment (HTA) agencies in response to increased pressure from end-user clinicians and policy-makers for rapid, evidence-based advice on health-care technologies. This comparative study examines the differences in methodologies and essential conclusions between rapid and full reviews on the same topic, with the aim of determining the validity of rapid reviews in the clinical context and making recommendations for their future application. METHODS: Rapid reviews were located by Internet searching of international HTA agency websites, with any ambiguities resolved by further communication with the agencies. Comparator full systematic reviews were identified using the University of York Centre for Reviews and Dissemination HTA database. Data on a number of review components were extracted using standardized data extraction tables, then analysed and reported narratively. RESULTS: Axiomatic differences between all the rapid and full reviews were identified; however, the essential conclusions of the rapid and full reviews did not differ extensively across the topics. For each of the four topics examined, it was clear that the scope of the rapid reviews was substantially narrower than that of full reviews. The methodology underpinning the rapid reviews was often inadequately described. CONCLUSIONS: Rapid reviews do not adhere to any single validated methodology. They frequently provide adequate advice on which to base clinical and policy decisions; however, their scope is limited, which may compromise their appropriateness for evaluating technologies in certain circumstances.

Early identification and assessment of new and emerging health technologies: actions, progress, and the future direction of an international collaboration--EuroScan.

OBJECTIVES: To report on a workshop, and subsequent discussions, that reviewed the achievements and progress of the EuroScan collaboration since its establishment in 1999 to share information on the methods and results of early identification and assessment of new and emerging health technologies; considered challenges to the collaboration; and discussed its possible future direction. METHODS: A workshop was held in Stockholm in September 2006, with thirty-two participants from ten countries and representatives from EuroScan member agencies, policy makers involved in policy or decision making relating to new technologies, and invited external commentators from international HTA networks. The workshop used a mix of presentations, panel and audience discussions, and small group work to consider the achievements and challenges put forward. RESULTS: EuroScan has developed as a sustainable network, and has made progress on all tasks in its initial action plan, with the EuroScan information sharing database on new and emerging technologies being one of the collaboration's key achievements. Identified immediate concerns for the network included consideration of the impact of its current name and membership model; acknowledgement and publication of the full range of benefits of membership; contribution to and development of the database to encourage increased information sharing; and EuroScan's ongoing interaction with the wider HTA world. CONCLUSIONS: The workshop was a useful mechanism for reviewing the work of EuroScan and for creating a platform to take the collaboration forward. The workshop affirmed the benefits of the network to individual members; posed some significant challenges to the network to consider; and acted as a stimulus for an interim name change to better represent the global membership, and a major review of the EuroScan database of identified and assessed emerging health technologies.

Rapid reviews versus full systematic reviews: an inventory of current methods and practice in health technology assessment.

OBJECTIVES: This review assessed current practice in the preparation of rapid reviews by health technology assessment (HTA) organizations, both internationally and in the Australian context, and evaluated the available peer-reviewed literature pertaining to the methodology used in the preparation of these reviews. METHODS: A survey tool was developed and distributed to a total of fifty International Network of Agencies for Health Technology Assessment (INAHTA) members and other selected HTA organizations. Data on a broad range of themes related to the conduct of rapid reviews were collated, discussed narratively, and subjected to simple statistical analysis where appropriate. Systematic searches of the Cochrane Library, EMBASE, MEDLINE, and the Australian Medical Index were undertaken in March 2007 to identify literature pertaining to rapid review methodology. Comparative studies, guidelines, program evaluations, methods studies, commentaries, and surveys were considered for inclusion. RESULTS: Twenty-three surveys were returned (46 percent), with eighteen agencies reporting on thirty-six rapid review products. Axiomatic trends were identified, but there was little cohesion between organizations regarding the contents, methods, and definition of a rapid review. The twelve studies identified by the systematic literature search did not specifically address the methodology underpinning rapid review; rather, many highlighted the complexity of the area. Authors suggested restricted research questions and truncated search strategies as methods to limit the time taken to complete a review. CONCLUSIONS: Rather than developing a formalized methodology by which to conduct rapid reviews, agencies should work toward increasing the transparency of the methods used for each review. It is perhaps the appropriate use, not the appropriate methodology, of a rapid review that requires future consideration.

Curative ablation for atrial fibrillation: a systematic review.

OBJECTIVE: To perform a systematic review of randomized controlled trials (RCTs) on catheter ablation for atrial fibrillation (AF). BACKGROUND: Radiofrequency catheter (RF)-ablation around pulmonary vein ostia and in left atrium may reduce or prevent recurrence of AF, as documented in observational studies and registry reports; however, few RCTs are available. METHODS: Using relevant search phrases, Cochrane Library, MEDLINE and EMBASE were searched for RCTs, last time in May 2007. Titles and abstracts were screened. When entry criteria were fulfilled, full-text papers were read and graded according to quality and relevance. RESULTS: One thousand and ninety four abstracts were evaluated, and five RCTs included (578 randomized patients). The studies had moderate quality and relevance, but the results were consistent: ablation is better than drug treatment in preventing AF recurrence; the relative risk (95% CI)) one year after ablation ranged from 0.20 (0.08-0.51) to 0.62 (0.39-0.99). CONCLUSIONS: Results from observational and registry studies are confirmed: RF-ablation reduces recurrence rate of AF, and can be done with few serious complications. Limitations are few patients>70 years, and only one year follow-up.

Proton therapy - a systematic review of clinical effectiveness.

BACKGROUND AND PURPOSE: Proton therapy is an emerging treatment modality for cancer that may have distinct advantages over conventional radiotherapy. This relates to its ability to confine the high-dose treatment area to the tumour volume and thus minimizing radiation dose to surrounding normal tissue. Several proton facilities are currently operating or under planning world-wide - in the United States, Asia and Europe. Until now no systematic review assessing the clinical effectiveness of this treatment modality has been published. MATERIALS AND METHODS: A systematic review of published studies that investigated clinical efficacy of proton therapy of cancer. RESULTS: We included 54 publications: 4 randomized controlled trials (RCTs) reported in 5 publications, 5 comparative studies and 44 case series. Two RCTs addressed proton irradiation as a boost following conventional radiation therapy for prostate cancer, where one demonstrated improved biochemical local control for the highest dose group without increased serious complication rates. Proton therapy has been used to treat a large number of patients with ocular tumours, but except for one low quality RCT, no proper comparison with other treatment alternatives has been undertaken. Proton therapy offers the option to deliver higher radiation doses and/or better confinement of the treatment of intracranial tumours in children and adults, but reported studies are heterogeneous in design and do not allow for strict conclusions. CONCLUSION: The evidence on clinical efficacy of proton therapy relies to a large extent on non-controlled studies, and thus is associated with low level of evidence according to standard heath technology assessment and evidence based medicine criteria.

[Dissemination of evidence-based information about PSA test and prostatic cancer to physicians]. / Formidling av kunnskapsbasert informasjon om PSA-test og prostatakreft til leger.

BACKGROUND: This paper describes the evaluation of an initiative to disseminate to general practitioners, urologists and patients in Norway evidence from systematic reviews on the clinical effectiveness of prostate cancer screening. Nine systematic reviews concluded that there is no evidence that early detection and treatment of prostate cancer reduces mortality or morbidity or improve patients' quality of life. MATERIALS AND METHODS: Evidence-based information about prostrate-specific antigen and prostate cancer, including patient information leaflets, was disseminated to 4100 general practitioners and specialists in urology in Norway in March 2001. One year later they were mailed a questionnaire aimed at evaluating how they had perceived and implemented this information. RESULTS: The results of the survey (response rate 41%) showed a marked contrast between general practitioners and urologists. 91% of general practitioners versus 61% of urologists agreed to the recommendation that prostrate-specific antigen tests should not be taken by healthy men. 87% of general practitioners but only 33% of urologists followed up the recommendations in their practice. INTERPRETATION: Dissemination of evidence-based information about prostrate-specific antigen and prostate cancer was appreciated by general practitioners, had the power to convince and contributed to enhanced knowledge of a controversial issue, thereby increasing their confidence in their clinical decision making.

Brachytherapy for prostate cancer: a systematic review of clinical and cost effectiveness.

OBJECTIVES: Brachytherapy is emerging as a new treatment option for prostate cancer, and is increasingly being used in Europe and North America. METHODS: A systematic review of studies that compared clinical or cost effectiveness of prostate brachytherapy with radical prostatectomy or external beam radiation for patients with localised prostate cancer. RESULTS: No randomised controlled trials were identified, but five observational studies with comparable patient groups were included in the review. There were no valid data on overall or disease-free survival. There was no difference in disease-free survival based on PSA as a surrogate measure, or in rates of complications. No cost effectiveness studies were found. Based on Norwegian data, the one-year cost of the three treatment options seem fairly similar, while long term cost data are lacking due to lack of data on long term clinical outcome. CONCLUSION: The evidence on the clinical effectiveness of therapies for localised prostate cancer is scarce, but the outcome appears to be comparable for radical prostatectomy, external beam radiotherapy and brachytherapy.

[Brachytherapy in prostatic cancer]. / Brakyterapi ved prostatakreft.

BACKGROUND: Brachytherapy is increasingly used in the treatment of early prostate cancer, but has not been implemented as a treatment option in Norway. Recent advances in imaging techniques and the radiation technology itself has facilitated improvements in and better standardisation of brachytherapy. MATERIAL AND METHODS: An group of expert assisted the Norwegian Centre for Health Technology Assessment (SMM) in a systematic review of the evidence on the clinical effectiveness of prostate brachytherapy. The literature was identified by a defined search strategy, and assessed for relevance and validity. Only controlled or comparative studies were included in the review. RESULTS: There were no randomized controlled trials or large prospective studies. Many of the relevant studies were of poor validity. None of the included studies had sufficient follow-up for overall or disease free survival. There were no differences between brachytherapy, external beam therapy or radical prostatectomy in disease free survival (PSA measures) or in rates of complications. INTERPRETATION: There is a lack of valid data from large prospective studies on the clinical effectiveness of brachytherapy. On the other hand, the clinical effectiveness of radical prostatectomy and external beam radiotherapy is also poorly documented. Results from one large randomized controlled trial comparing radical prostatectomy with brachytherapy in the USA will not be available within the next ten years.