Health Technology Assessment Review Research Articles

Choosing health technology assessment and systematic review topics: the development of priority-setting criteria for patients' and consumers' interests.

The Institute for Quality and Efficiency in Health Care (IQWiG) was established in 2003 by the German parliament. Its legislative responsibilities are health technology assessment, mostly to support policy making and reimbursement decisions. It also has a mandate to serve patients' interests directly, by assessing and communicating evidence for the general public. To develop a priority-setting framework based on the interests of patients and the general public. A theoretical framework for priority setting from a patient/consumer perspective was developed. The process of development began with a poll to determine level of lay and health professional interest in the conclusions of 124 systematic reviews (194 responses). Data sources to identify patients' and consumers' information needs and interests were identified. IQWiG's theoretical framework encompasses criteria for quality of evidence and interest, as well as being explicit about editorial considerations, including potential for harm. Dimensions of "patient interest" were identified, such as patients' concerns, information seeking, and use. Rather than being a single item capable of measurement by one means, the concept of "patients' interests" requires consideration of data and opinions from various sources. The best evidence to communicate to patients/consumers is right, relevant and likely to be considered interesting and/or important to the people affected. What is likely to be interesting for the community generally is sufficient evidence for a concrete conclusion, in a common condition. More research is needed on characteristics of information that interest patients and consumers, methods of evaluating the effectiveness of priority setting, and methods to determine priorities for disinvestment.

Comment on: Polonsky et al. Structured Self-Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated Type 2 Diabetes: Results From the Structured Testing Program Study. Diabetes Care 2011;34:262–267

We read with interest the article by Polonsky et al. (1) reporting that self-monitoring of blood glucose (SMBG) improves glycemic control in noninsulin-treated type 2 diabetes. In the U.K., SMBG is recommended for insulin-treated diabetes (2), and controversy exists in relation to treatment with lifestyle advice or oral hypoglycemic agents (OHAs). A Cochrane review concluded that there is insufficient evidence to support the use of SMBG in noninsulin-treated type 2 diabetes (3). Furthermore, a health technology assessment review suggests that SMBG has limited clinical effectiveness in improving glycemic control in noninsulin-treated type 2 diabetes (4). In view of the widespread use of SMBG, cost implications, and the fact that U.K. management algorithms are based on HbA …

Information retrieval for health technology assessment: Standardization of search methods

In the theme section on information retrieval for health technology assessment (HTA), we are pleased to present a series of high-quality articles. The articles address various approaches to HTA searching and information management. Information retrieval and management is an integral part of the HTA review process. Those conducting searches must, therefore, understand the nature of the different domains of HTA, know what kind of information is needed for each domain, and know how to find it. These articles describe developments in HTA searching and other information-related activities.

Screening for hyperglycaemia in pregnancy: a rapid update for the National Screening Committee

Screening for gestational diabetes has long been a controversial topic. A previous Health Technology Assessment (HTA) report reviewed literature on screening for gestational diabetes mellitus (GDM) and assessed the case for screening against the criteria set by the National Screening Committee. To update a previous HTA report which reviewed the literature on screening for GDM by examining evidence that has emerged since that last report, including the Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS), the Maternal and Fetal Medicine Units Network (MFMUN) trial and the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study. To review data on recent trends in maternal age at birth and on the prevalence of overweight and obesity and the effect on prevalence of GDM. A systematic review and meta-analysis of the literature was carried out. The bibliographic databases used were MEDLINE (1996 to January 2009), EMBASE (1996 to December 2009), the Cochrane Library 2008 issue 4, the Centre for Reviews and Dissemination database and the Web of Science. For the review of treatment with oral drugs versus insulin, a full systematic review and meta-analysis was carried out. The results of the ACHOIS, MFMUN and HAPO studies were summarised and their implications discussed. Findings of a selection of other recent studies, relevant to the continuum issue, were summarised. Some recent screening studies were reviewed, including a particular focus on studies of screening earlier in pregnancy. The HAPO results showed a linear relationship between plasma glucose and adverse outcomes - there is a continuum of risk with no clear threshold which could divide women into those with gestational diabetes and those without. There was good evidence from trials and the meta-analysis that women who fail to control hyperglycaemic in pregnancy on lifestyle measures alone can be safely and effectively be treated with oral agents, metformin or glibenclamide, rather than going directly to insulin. Evidence showed few differences in results between glibenclamide and insulin and metformin and insulin. The exceptions were that there was less maternal hypoglycaemia with glibenclamide, but less neonatal hypoglycaemia and lower birthweight with insulin, and there was less maternal weight gain with metformin. The ACHOIS and MFMUN trials showed reductions in perinatal complications among infants born to mothers who were provided with more intensive dietary advice, blood glucose monitoring and insulin when required. The HAPO study demonstrated adverse outcomes over a much wider range of blood glucose (BG) than the traditional definition of GDM. In the HAPO study, no one measure of BG came out as being clearly the best, although fasting plasma glucose (FPG) was as good as any, and had advantages of being more convenient than an oral glucose tolerance test (OGTT), but correlations between fasting and post-load levels were quite poor. Two screening strategies dominated; (1) selection by the American Diabetes Association criteria followed by the 75-g OGTT [incremental cost-effectiveness ratio (ICER) 3678 pounds], and (2) selection by high-risk ethnicity followed by the 75-g OGTT (ICER 21,739 pounds). Studies indicated that costs are about 1833 pounds higher for pregnancies complicated by gestational diabetes, suggesting that prevention would be worthwhile. Not all of the HAPO results have been published, and none of the reviewed economic studies resolved the most difficult issue - at what level of BG does intervention become cost-effective? The evidence base has improved since the last HTA review in 2002. There is now good evidence for treatment of oral drugs instead of insulin and it looks increasingly as if FPG could be the test of choice. However some key uncertainties remain to be resolved, which can be done by further analysis of the already collected HAPO data and by using the UK model used in developing the NICE guidelines to assess the cost-effectiveness of intervention in each of the seven HAPO categories.

Issues facing the Australian Health Technology Assessment Review of medical technology funding

The Australian Health Technology Assessment Review has the potential to have a major effect on the availability of new medical technology and the listing of associated medical procedures on the Medicare Benefits Schedule. Despite this, only about 15% of submissions to the Review came from "medical associations". Pharmaceutical and medical technologies are inherently different, and there are a number of difficulties associated with evaluating medical technology using the same process and evidence levels as those used for pharmaceuticals. The current sequential and lengthy processing of new medical technology and procedures is delaying access to beneficial medical technology and could be substantially reduced. There is currently no effective funding process for medical technology classified as capital equipment or consumables and disposables. This has created a perverse incentive in favour of using funded implantable prostheses based on access to funding rather than superior clinical effectiveness. The existing horizon scanning process could be better used to not only identify all potentially cost-effective new and emerging medical technology and procedures as early as possible, but also to identify gaps in the evidence.

Identification of factors driving differences in cost effectiveness of first-line pharmacological therapy for uncomplicated hypertension

Published practice guidelines and economic evaluations have come to different conclusions regarding optimal pharmacotherapy for the treatment of uncomplicated hypertension. The drivers of these disparities are not clear. Greater understanding is needed for clinicians, researchers and policy makers to determine the most effective and sustainable strategies. To identify how cost and cost-effectiveness considerations are used to generate recommendations by major hypertension guidelines, and determine key drivers of cost-effectiveness conclusions in available economic evaluations. A systematic search and narrative review of major hypertension guidelines and health technology assessments of first-line antihypertensive therapy were performed. Of the eight guidelines identified, formal cost-effectiveness analysis was rarely integrated in the formulation of recommendations. When guidelines considered costs, recommendations remained incongruent. Two economic evaluations were identified (United Kingdom and Canada); however, these differed in their conclusion of the most cost-effective agent and attractiveness of calcium channel blockers. Review of these economic evaluations suggests that cost-effectiveness conclusions are strongly influenced by relative costs of drug classes; when relative differences in drug costs are lower, the impact on associated conditions such as heart failure and diabetes influences cost-effectiveness conclusions. In the setting of finite health care resources and significant budget impact due to high population prevalence, cost effectiveness is an important consideration in the treatment of uncomplicated hypertension. Identification of key drivers of cost effectiveness will assist interpretation and conduct of current and future economic evaluations.

Health technology assessment review: Remote monitoring of vital signs - current status and future challenges

Recent developments in communications technologies and associated computing and digital electronics now permit patient data, including routine vital signs, to be surveyed at a distance. Remote monitoring, or telemonitoring, can be regarded as a subdivision of telemedicine - the use of electronic and telecommunications technologies to provide and support health care when distance separates the participants. Depending on environment and purpose, the patient and the carer/system surveying, analysing or interpreting the data could be separated by as little as a few feet or be on different continents. Most telemonitoring systems will incorporate five components: data acquisition using an appropriate sensor; transmission of data from patient to clinician; integration of data with other data describing the state of the patient; synthesis of an appropriate action, or response or escalation in the care of the patient, and associated decision support; and storage of data. Telemonitoring is currently being used in community-based healthcare, at the scene of medical emergencies, by ambulance services and in hospitals. Current challenges in telemonitoring include: the lack of a full range of appropriate sensors, the bulk weight and size of the whole system or its components, battery life, available bandwidth, network coverage, and the costs of data transmission via public networks. Telemonitoring also has the ability to produce a mass of data - but this requires interpretation to be of clinical use and much necessary research work remains to be done.

Health technology assessment review: Computerized glucose regulation in the intensive care unit - how to create artificial control

Current care guidelines recommend glucose control (GC) in critically ill patients. To achieve GC, many ICUs have implemented a (nurse-based) protocol on paper. However, such protocols are often complex, time-consuming, and can cause iatrogenic hypoglycemia. Computerized glucose regulation protocols may improve patient safety, efficiency, and nurse compliance. Such computerized clinical decision support systems (Cuss) use more complex logic to provide an insulin infusion rate based on previous blood glucose levels and other parameters. A computerized CDSS for glucose control has the potential to reduce overall workload, reduce the chance of human cognitive failure, and improve glucose control. Several computer-assisted glucose regulation programs have been published recently. In order of increasing complexity, the three main types of algorithms used are computerized flowcharts, Proportional-Integral-Derivative (PID), and Model Predictive Control (MPC). PID is essentially a closed-loop feedback system, whereas MPC models the behavior of glucose and insulin in ICU patients. Although the best approach has not yet been determined, it should be noted that PID controllers are generally thought to be more robust than MPC systems. The computerized Cuss that are most likely to emerge are those that are fully a part of the routine workflow, use patient-specific characteristics and apply variable sampling intervals.

Systematic review of economic evaluations of laparoscopic surgery for colorectal cancer

Colorectal cancer is one of the most common cancers and the standard surgical treatment for this cancer is open resection (OS), but laparoscopic surgery (LS) may be an alternative treatment. In 2000, a Health Technology Assessment (HTA) review found little evidence on costs and cost-effectiveness in comparing the two methods. The evidence base has since expanded and this study systematically reviews the economic evaluations on the subject published since 2000. Systematic review of studies reporting costs and outcomes of LS vs OS for colorectal cancer. National Health Service Economic Evaluation Database (NHS EED) methods for abstract writing were followed. Studies were summarized and incremental cost-effectiveness ratios (ICER) for common outcomes were calculated. Five studies met the inclusion criteria. LS generally had higher healthcare costs. Most studies reported longer operational time and shorter length of stay and similar long-term outcomes with LS vs OS. Only one outcome, complications, was common across all studies but results lacked consistency (e.g. in two studies, OS was less costly but more effective; in another study, LS was less costly but more effective; and in the further two studies, LS could potentially be cost effective depending on the decision-makers' willingness to pay for the health gain). The evidence on cost-effectiveness is not consistent. LS was generally more costly than OS. However, the effectiveness data used in individual economic evaluation were imprecise and unreliable when compared with data from systematic reviews of effectiveness. Nevertheless, short-term benefits of LS (e.g. shorter recovery) may make LS appear less costly when productivity gains are considered.

Evidence-Based Decision-Making and Health Technology Assessment in South Korea

South Korea’s social security system is a social insur-ance system similar to those in France, Germany,Japan, and Taiwan [1]. By law, South Korean citizensare covered by health insurance. In addition, health-care providers must contract with the National HealthInsurance Corporation. This unified social healthinsurance system provides almost all South Koreanswith health insurance.During the last 50 years, medical breakthroughsand significant health-care advances have improvedthe quality of health care and the management ofdisease and chronic illness. With this progress hascome markedly increased health-care costs. Currently,these expenditures are exceeding Korea’s economicgrowth rate [2]. Consequently, there has been a signifi-cant amount of research on the rational use of health-care resources and interest in other countries’ means ofcontrolling costs [3].Prioritizationofreimbursementhasbecomeamajorissue within South Korea’s national health insurancesystem. The current presiding principle behind reim-bursement is that all medically necessary health-careservices are covered and reimbursed with the exceptionof those on the negative or noncovered list of health-care technologies.Health-care policymakers decide whether a technol-ogy is medically appropriate for patients and thereforereimbursed as daily practice or not. Health-caredecision-making for what are considered medicallyappropriate health-care services has been based onopinion or opinion-based information. Because reim-bursement decisions are opinion-based, they are notonly subjective, but can be significantly delayed bydissenting opinion [4].Consequently, evidence-based medicine consistingof clinical expertise and patient preferences or valuescombined with clinical research is being introduced tomake health-care decisions reasonably, objectively, andclearly as well as to reduce conflicts among stakehold-ers [5–7]. This process, combined with considera-tion of affordability, should improve reimbursementdecisions.The Health Insurance Review & AssessmentService (HIRA) also utilizes scientific evidence in thedecision-making process. HIRA’s goal is to maintainand improve national health through health-carereview and quality assessment. HIRA is responsiblefor reviewing medical fees and evaluating at whatlevel and cost health-care services are delivered tobeneficiaries [8]. In addition to health-care servicesreview and evaluation, HIRA supports governmentcoverage decisions and pricing.Since 2006, the evidence-based decision-makingsystem has been introduced progressively. An EvidenceBased Review Manual, with methods of appropriatequestioning, searching, extracting data, classificationof articles, and presentation, has been used by HIRAfor policy coverage.Another challenging issue for policymakers is theuncertainty with regard to how much improvementin health-care quality can be expected with the intro-duction of expensive new health technology. Toaddress this issue, the South Korean National Assem-bly passed legislation that allows heath technologyassessment of new health technologies, with theexception of medications. Because this legislation isnot part of the Health Insurance Act, health-careproviders are not obligated to apply health technol-ogy assessment (HTA) to new technologies, but ifHTA reports become mandatory for reimbursement,it is likely to become a requirement.The legislature is establishing an advisory commit-tee for new health technology assessment review(NHTAC) and a special subcommittee responsible forsystemic literature review and draft reports. NHTACwill conduct the final review of the new technologyand state the results of assessment based on its twomajor criteria for health technology assessment, safetyand effectiveness.For medications, Korean FDA (KFDA) focuses onsafety and efficacy. Although there is a strong need fordrug evaluation based on effectiveness and cost-effectiveness, the review process for new health tech-nologies does not include new medications. However,South Korea has introduced pharmacoeconomicanalysis for drug evaluation in the health insurancedecision-making process.South Korea has a relatively higher cost and growthrate of pharmaceutical expenditure than other coun-

Searching for and use of conference abstracts in health technology assessments: Policy and practice

Current policy and practice regarding identification of and extent of use of data from conference abstracts in health technology assessment reviews (TARs) are examined. The methods used were (i) survey of TAR groups to identify general policy and experience related to use of abstract data, and (ii) audit of TARs commissioned by the National Institute for Health and Clinical Excellence (NICE) and published between January 2000 and October 2004. Five of seven TAR groups reported a general policy that included searching for and including studies available as conference abstracts and presentations. A total of sixty-three published HTA reports for NICE were identified. Of these reports, thirty-eight identified at least one randomized controlled trial available as an abstract/presentation. Twenty-six (68 percent) of these thirty-eight TARs included studies available as abstracts. There are variations in policy and practice across TAR groups regarding the searching for and inclusion of studies available as conference abstracts. There is a need for clarity and transparency for review teams regarding how abstract data are managed. If conference abstracts are to be included, reviewers need to allocate additional time for searching and managing data from these sources. Review teams should also be encouraged to state explicitly their search strategies for identifying conference abstracts, their methods for assessing these abstracts for inclusion and, where appropriate, how the data were used and their effect on the results.

Case study of the comparison of data from conference abstracts and full-text articles in health technology assessment of rapidly evolving technologies: Does it make a difference?

The aim of this study was to examine (i) the consistency of reporting research findings presented in conference abstracts and presentations and subsequent full publications, (ii) the ability to judge methodological quality of trials from conference abstracts and presentations, and (iii) the effect of inclusion or exclusion of data from these sources on the pooled effect estimates in a meta-analysis. This report is a case study of a selected health technology assessment review (TAR) of a rapidly evolving technology that had identified and included a meta-analysis of trial data from conference abstracts and presentations. The overall quality of reporting in abstracts and presentations was poor, especially in abstracts. There was incomplete or inconsistent reporting of data in the abstract/presentations. Most often inconsistencies were between conference slide presentations and data reported in published full-text articles. Sensitivity analyses indicated that using data only from published papers would not have altered the direction of any of the results when compared with those using published and abstract data. However, the statistical significance of three of ten results would have changed. If conference abstracts and presentations were excluded from the early analysis, the direction of effect and statistical significance would have changed in one result. The overall conclusions of the original analysis would not have been altered. There are inconsistencies in data presented as conference abstracts/presentations and those reported in subsequent published reports. These inconsistencies could impact the final assessment results. Data discrepancies identified across sources included in TARs should be highlighted and their impact assessed and discussed. Sensitivity analyses should be carried out with and without abstract/presentation data included in the analysis. Incomplete reporting in conference abstracts and presentations limits the ability of reviewers to assess confidently the methodological quality of trials.

Intraclass correlation coefficient and outcome prevalence are associated in clustered binary data

Background and objectiveTo describe the association between values for a proportion and the intraclass correlation coefficient (ICC). MethodsAnalysis of data obtained from the General Practice Research Database (GPRD) for variation between United Kingdom general practices and results from a Health Technology Assessment (HTA) review for a range of outcomes in community and health services settings. ResultsThere were 188 ICCs from the GPRD, the median prevalence was 13.1% (interquartile range IQR 3.5 to 28.4%) and median ICC 0.051 (IQR 0.011 to 0.094). There were 136 ICCs from the HTA review, with median prevalence 6.5% (IQR 0.4 to 20.7%) and median ICC 0.006 (IQR 0.0003 to 0.036). There was a linear association of log ICC with log prevalence in both datasets (GPRD, regression coefficient 0.61, 95% confidence interval 0.53 to 0.69, P < 0.001; HTA, 0.91, 0.81 to 1.01, P < 0.001). When the prevalence was 1% the predicted ICC was 0.008 from the GPRD or 0.002 from the HTA, but when the prevalence was 40% the predicted ICC was 0.075 (GPRD) or 0.046 (HTA). ConclusionThe prevalence of an outcome may be used to make an informed assumption about the magnitude of the intraclass correlation coefficient.

Identification and assessment of ongoing trials in health technology assessment reviews

To assess the importance of ongoing trials in health technology assessment reviews (HTARs) for the National Institute for Clinical Excellence and to provide practical recommendations for identifying ongoing trials and assessing their possible impact. Electronic databases. Ongoing trials (or trials in progress) were defined as any trials that have started but where the results are not yet available or only interim results are available for HTARs. This methodological review included: (1) an assessment of ongoing trials in HTARs completed by the end of August 2002, (2) a survey and assessment of trial registers and other sources of ongoing trials and (3) a summary and assessment of available methods for assessing the possible impacts of ongoing trials. The identification of ongoing trials is a common phenomenon in reviews of health technology assessment. Twenty-three of the 32 HTARs identified one or more ongoing trials and in eight of these the information on identified ongoing trials was not considered in the evidence synthesis and research recommendations. All but one HTAR that considered the potential impact of ongoing trials adopted a narrative approach. Trial registers and grey literature are important sources of information on ongoing trials. All 32 HTARs explicitly or implicitly searched for unpublished studies, and/or ongoing trials and/or grey literature and trial registers. The assessment of six commonly used trial registers suggested that most registers provided sufficient information for reviewers to decide the relevance of identified ongoing trials. However, it is sometimes extremely difficult to know whether ongoing trials identified from different sources (registers) are the same trials or belong to the same multicentre trials. The ISRCTN (the International Standard Randomised Controlled Trial Number) is the most reliable system but it has not been widely adopted. The qualitative assessment of ongoing trials compared major features of completed and ongoing trials, providing information about the possible impact of ongoing trials in terms of relevance, validity, reliability and generalisability. Quantitative methods to assess the impact of ongoing trials include cumulative meta-analysis related methods, fail-safe N, Bayesian data monitoring, and Bayesian interim predictions. The most useful method may be the Bayesian predictive probability, which estimates predictive probabilities for any possible values of treatment effect. A case study indicated that the appropriate use of quantitative methods would strengthen findings from narrative assessment of possible impact of ongoing trials. Identification of ongoing trials is common in HTARs. Searching for ongoing trials in effectiveness reviews should be more thorough and explicit. Conversely, primary researchers, in particular those working with in multicentre trials, should label ongoing trials more clearly, preferably by ISRCTN. Qualitative assessment of identified ongoing trials is crucial and informative. Available quantitative methods could be used to strengthen findings from narrative assessment, although further research and more empirical examples are required. Information from ongoing trials may contribute to syntheses of results, conclusions and recommendations for future research. Future research is suggested into the identification and assessment of ongoing trials in other systematic reviews of effectiveness of health care interventions; existing and new methods for incorporating information on ongoing trials; comparing estimated impacts with the actual results of ongoing trials; and to incorporate findings from the assessment of ongoing trials into decision models.