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?

2006 ◽  
Vol 22 (3) ◽  
pp. 288-294 ◽  
Author(s):  
Yenal Dundar ◽  
Susanna Dodd ◽  
Paula Williamson ◽  
Rumona Dickson ◽  
Tom Walley

Objectives: 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.Methods: 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.Results: 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.Conclusions: 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.

2017 ◽  
Vol 33 (S1) ◽  
pp. 74-75
Author(s):  
Elke Hausner ◽  
Marco Knelangen ◽  
Laura Sanders ◽  
Siw Waffenschmidt

INTRODUCTION:Health Technology Assessment (HTA) reports may have a major impact on the health care provided in a country. Hence, one would assume that these reports have a high methodological quality and thus represent a potentially important source of information, for instance, for identifying primary studies for inclusion in the evidence syntheses (for example, systematic reviews, Cochrane reviews, HTA reports). The aim of the present analysis is to evaluate the methodological quality of HTA reports used as a literature source for HTA reports produced by the German Institute for Quality and Efficiency in Health Care (IQWiG).METHODS:Eligible IQWiG reports were assessments of drug or non-drug interventions considering HTA reports as the literature source for primary studies and published up to October 2016. An HTA report included in the IQWIG report was considered in the analysis if it was a complete report published in English or German and indexed in the Health Technology Assessment Database (Wiley) or MEDLINE. Only the most current HTA report in an IQWiG report was considered; if more than one current HTA report was available, the one for inclusion in the analysis was randomly selected. The methodological quality of the HTA reports identified was evaluated with the AMSTAR (“Assessment of Multiple Systematic Reviews”) tool (1), which comprises 11 items on methodological quality (meaning a maximum achievable score of 11).RESULTS:A total of fifty eligible IQWiG reports using fourty-one eligible HTA reports as literature sources were identified. The mean AMSTAR score of these HTA reports was 5.3 (95 percent Confidence Interval, CI: 4.3, 6.2). None of the HTA reports achieved a score of 11, nineteen (46 percent) had a score between 6 and 10, and twenty-two had a score below 6.CONCLUSIONS:HTA reports included in IQWiG reports only have an average methodological quality.


Author(s):  
Ida Stadig ◽  
Therese Svanberg

Abstract Objectives This article aims to provide a brief review of information retrieval and hospital-based health technology assessment (HB-HTA) and describe library experiences and working methods at a regional HB-HTA center from the center's inception to the present day. Methods For this brief literature review, searches in PubMed and LISTA were conducted to identify studies reporting on HB-HTA and information retrieval. The description of the library's involvement in the HTA center and its working methods is based on the authors’ experience and internal and/or unpublished documents. Results Region Västra Götaland is the second largest healthcare region in Sweden and has had a regional HB-HTA center since 2007 (HTA-centrum). Assessments are performed by clinicians supported by HTA methodologists. The medical library at Sahlgrenska University Hospital works closely with HTA-centrum, with one HTA librarian responsible for coordinating the work. Conclusion In the literature on HB-HTA, we found limited descriptions of the role librarians and information specialists play in different units. The librarians at HTA-centrum play an important role, not only in literature searching but also in abstract and full-text screening.


Author(s):  
Matheus O. de Almeida ◽  
Thais Montezuma ◽  
Haliton A. de Oliveira Júnior ◽  
Cleusa Pinheiro Ferri

Abstract Introduction Mini health technology assessment (HTA) reports have been used to support policy makers and health systems by providing a timely summary of scientific evidence. The objective of this meta-epidemiologic study was to evaluate the quality of reporting of mini-HTA reports published in Brazil. Methods An electronic search for all mini-HTA reports published between 2014 and March 2019 was conducted in the SISREBRATS and CONITEC databases. The study selection and data extraction were performed by two independent assessors. The following data were extracted: bibliographic data; research question; characteristics of the population, health technologies and outcomes assessed; eligibility criteria; information about searches and study selection; risk of bias assessment; quality of evidence assessment; synthesis of results; and recommendation about the technology evaluated. A descriptive analysis was used to summarize the information retrieved from all the included mini-HTA reports. Results We included 103 mini-HTA reports, the great majority of which (92.3 percent) focused on the coverage of the technologies in the healthcare system, with more than 60 percent being about drugs. Only five mini-HTA reports (4.8 percent) gave reasons for the choice of outcomes, and fifteen (14.5 percent) discriminated between primary and secondary outcomes. All mini-HTAs reported the databases searched and 99 percent of them reported using Medline. Sixty percent of the mini-HTA reported assessing the risk of bias, and 52 percent reported assessing the quality of evidence. Conclusion The quality of reporting of the mini-HTA reports performed in Brazil is insufficient and needs to be improved to guarantee transparency and replicability.


2017 ◽  
Vol 33 (S1) ◽  
pp. 63-64
Author(s):  
Ines Niehaus ◽  
Charalabos-Markos Dintsios

INTRODUCTION:The early benefit assessment of drugs in Germany and their preceded market authorization pursue different objectives, resulting in divergent decision-making strategies. This is reflected inter alia by the diverse inclusion of confirmatory endpoints within the assessments of oncological drugs. The pharmaceutical manufacturers are facing the challenge of meeting the requirements for both evaluation processes by the available evidence and avoiding hereby negative early benefit assessments. This is mainly due to the concept of mutually relevant clinical trials.METHODS:Identification and gathering of the endpoints is based on a specifically developed guide. The extracted data from the documents of completed assessments up to July 2015 are used to estimate both separately and together the impact of explorative in relation to confirmatory endpoints on the drug approval and early benefit assessment, by contrasting the European Medicines Agency's risk-benefit-ratio and the benefit-harm-balancing of the national Health Technology Assessment (HTA) jurisdiction.RESULTS:Twenty-one of fourty-one studies’ oncological assessments could be included in the endpoint analysis. From a procedural point of view both the drug approval and the early benefit assessment seem to be not confirmatory since they include explorative endpoints as well. Yet, drug approval is in terms of quality of endpoints more confirmatory than early benefit assessment since it contains a higher proportion of primary endpoints. The latter implies only in 67 percent of the assessments a primary endpoint to be relevant for the benefit-harm-balancing. Moreover, explorative mortality endpoints reached the highest agreement and explorative endpoints capturing health-related quality of life no agreement, referring to the mutual relevance of endpoints for the risk-benefit-ratio and the benefit-harm-balancing.CONCLUSIONS:The missing information transparency of the assessment reports compared to the information offered within the early benefit assessment makes an assignment of endpoints with respect to the mutually relevant clinical trial sometimes troublesome. To warrant, in the long run, a broader confirmatory basis for decisions in health care supported by HTA, a closer inter-institutional cooperation of approval authorities and German HTA jurisdictions seems favorable.


2017 ◽  
Vol 33 (S1) ◽  
pp. 59-59 ◽  
Author(s):  
Marco Chiumente ◽  
Iñaki Gutiérrez-Ibarluzea ◽  
Jani Mueller

INTRODUCTION:Health Technology Assessment (HTA) is a multidisciplinary activity that systematically examines different dimensions related to the direct and indirect consequences of health technologies when implemented in healthcare systems. HTA is developed by multidisciplinary teams in order to cover all the mentioned dimensions. However, the quality of the processes produced by HTA teams will depend upon the competencies that those teams will acquire and incorporate including knowledge, skills and attitudes (1). The aim of this research was to determine how well these dimensions and competencies are covered in HTA academic Masters degree courses and manuals.METHODS:We analyzed what had been done in terms of competencies definition in HTA: how it has been reflected; theoretically and according to the authors, and how competencies can be structured; know-how and values. We explored HTA manuals and HTA academic Masters degree courses. We searched in Google with specific terms: building capacities, HTA, programs, Masters, diplomas. We used the HTAi vortal and the information related to courses (for example Masters degrees) and HTA agencies and network webpages for programs. The inclusion criteria were formal programs that describe HTA capacity building and not partial teaching of certain aspects of HTA and we excluded non-recognized institutions, or where there was no description of the programs or lack of detail regarding objectives and competencies to be achieved.RESULTS:We found 105 courses or programs and analyzed 8 reports and 3 manuals. The main challenges that we faced were: that information was difficult to retrieve, not similarly structured, difficulties to find key information in webpages, no program description at all in some cases and the need to contact institutions staff or register as a student to receive the information and finally, it was difficult to obtain contact details of key people. We structured the information on competencies in knowledge, skills and attitudes.CONCLUSIONS:The analyzed Masters degree courses and manuals did not cover all of the dimensions of HTA analysis in an equal and standardized way. The ethical, legal, social and organizational aspects were lacking in some of the programs, while, on the contrary, clinical and economic aspects were substantially included. On the basis of the information retrieved it would be good to define core competencies for HTA.


Author(s):  
Carlo Efisio Marras ◽  
Gabriella Colicchio ◽  
Luca De Palma ◽  
Alessandro De Benedictis ◽  
Giancarlo Di Gennaro ◽  
...  

Background: Vagus nerve stimulation (VNS) is a palliative treatment for medical intractable epileptic syndromes not eligible for resective surgery. Health technology assessment (HTA) represents a modern approach to the analysis of technologies used for healthcare. The purpose of this study is to assess the clinical, organizational, financial, and economic impact of VNS therapy in drug-resistant epilepsies and to establish the congruity between costs incurred and health service reimbursement. Methods: The present study used an HTA approach. It is based on an extensive detailed bibliographic search on databases (Medline, Pubmed, Embase and Cochrane, sites of scientific societies and institutional sites). The HTA study includes the following issues: (a) social impact and costs of the disease; (b) VNS eligibility and clinical results; (c) quality of life (QoL) after VNS therapy; (d) economic impact and productivity regained after VNS; and (e) costs of VNS. Results: Literature data indicate VNS as an effective treatment with a potential positive impact on social aspects and on quality of life. The diagnosis-related group (DRG) financing, both on national and regional levels, does not cover the cost of the medical device. There was an evident insufficient coverage of the DRG compared to the full cost of implanting the device. Conclusions: VNS is a palliative treatment for reducing seizure frequency and intensity. Despite its economic cost, VNS should improve patients’ quality of life and reduce care needs.


2007 ◽  
Vol 23 (3) ◽  
pp. 316-323 ◽  
Author(s):  
Margriet Moret-Hartman ◽  
Gert Jan van der Wilt ◽  
John Grin

Objectives:The practical significance of health technology assessment (HTA) in policy decisions or clinical practice has been challenged. Possibly, problem definitions underlying HTA do not concur sufficiently with the problem definitions held by policy makers or clinicians. We performed an in-depth case study on mebeverine, a drug prescribed to patients with irritable bowel syndrome, to explore this hypothesis.Methods:The theoretical framework was provided by the theory of argumentative policy analysis. We analyzed documents and held semistructured interviews to collect data. We reconstructed interpretative frames to analyze actors' argumentation.Results:The funding and usage problems relating to mebeverine were ill-structured. Actors disagreed on the information needed and the norms at stake. As a result, the problem definition shifted, and the resulting problem definitions failed to correspond with the problems perceived by the target populations.Conclusions:To ensure that future studies on healthcare problems are useful, it is imperative that policy makers take the problem definitions of potential users into account.


2017 ◽  
Vol 44 (10) ◽  
pp. 800-826 ◽  
Author(s):  
B. Häggman-Henrikson ◽  
P. Alstergren ◽  
T. Davidson ◽  
E. D. Högestätt ◽  
P. Östlund ◽  
...  

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