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Cardiovascular health technology assessment: recommendations to improve the quality of evidence.

ABSTRACT: The aim of this article is to review the role of Health Technology Assessment (HTA) organisations in appraising and recommending innovative cardiovascular technologies. We consider how bias impairs the quality of evidence from clinical trials involving cardiovascular healthcare technologies. Finally, we provide recommendations to HTA organisations to take account of bias when making guideline recommendations. Clinical research studies of medical devices, diagnostics and interventions in cardiovascular healthcare are susceptible to impairment through bias. While HTA organisations, such as the National Institute of Health and Care Excellence, may require reviewers to take account of bias, there are uncertainties as to how this is achieved, especially in cardiovascular technology trials. This becomes more relevant given that large trials are few in number; therefore, the quality of evidence from an individual trial may have a large bearing on guideline recommendations and clinical practice. HTA organisations should drive improvements in the design and rigour of randomised trials. The evolving landscape of cardiovascular healthcare technologies and related trials presents a challenge for HTA organisations and healthcare providers. The rapid turnover of evidence is externally relevant because the period from the trial publication to implementation of HTA guideline recommendations by healthcare providers may be prolonged, by which time new evidence may have emerged from subsequent trials. Implementation of a cardiovascular healthcare technology including be it a medical device, diagnostic or intervention may have profound implications for healthcare providers. These technologies may have high absolute costs and access may be influenced by socioeconomic and geographic factors.

SUBMITTER: Berry C

PROVIDER: S-EPMC6443128 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Cardiovascular health technology assessment: recommendations to improve the quality of evidence.

Berry Colin C Corcoran David D Mangion Kenneth K

Open heart 20190227 1

The aim of this article is to review the role of Health Technology Assessment (HTA) organisations in appraising and recommending innovative cardiovascular technologies. We consider how bias impairs the quality of evidence from clinical trials involving cardiovascular healthcare technologies. Finally, we provide recommendations to HTA organisations to take account of bias when making guideline recommendations. Clinical research studies of medical devices, diagnostics and interventions in cardiova ...[more]

PMID: 30997126

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Project description:BackgroundThe Government of Indonesia implemented health technology assessment (HTA) to ensure quality and cost control in the National Health Insurance Program (Jaminan Kesehatan Nasional/JKN). The current aim of the study was to improve the usefulness of future economic evaluation for resource allocation by appraising current methodology, reporting, and source of evidence quality of studies.MethodsThe inclusion and exclusion criteria were applied to search for relevant studies using a systematic review. The methodology and reporting adherence were appraised according to Indonesia's HTA Guideline issued in 2017. The differences in adherence before and after the guideline dissemination were compared using Chi-square and Fisher's exact tests for methodology adherence wherever appropriate, and the Mann-Whitney test for reporting adherence. The source of evidence quality was assessed using evidence hierarchy. Two scenarios of the study start date and the guideline dissemination period were tested using sensitivity analyses.FindingsEighty-four studies were obtained from PubMed, Embase, Ovid, and two local journals. Only two articles cited the guideline. No statistically significant difference (P > 0.05) was found between the pre-dissemination and post-dissemination period with respect to methodology adherence, except for outcome choice. Studies during the post-dissemination period showed a higher score for reporting which was statistically significant (P = 0.01). However, the sensitivity analyses revealed no statistically significant difference (P > 0.05) in methodology (except for modelling type, P = 0.03) and reporting adherence between the two periods.InterpretationThe guideline did not impact the methodology and reporting standard used in the included studies. Recommendations were provided to improve the usefulness of economic evaluations for Indonesia.FundingThe Access and Delivery Partnership (ADP) hosted by the United Nations Development Programme (UNDP) and the Health Systems Research Institute (HSRI).

Project description:ImportanceIt is challenging to ensure timely performance of radiologist-recommended additional imaging when radiologist recommendation language is incomplete or ambiguous.ObjectiveTo evaluate whether voluntary use of an information technology tool with forced structured entry of recommendation attributes was associated with improved completeness of recommendations for additional imaging over time.Design, setting, and participantsThis cohort study of imaging report data was performed at an academic quaternary care center in Boston, Massachusetts, and included consecutive adults with radiology examinations performed from September 12 to 13, 2019 (taxonomy validation), October 14 to 17, 2019 (before intervention), April 5 to 7, 2021 (1 week after intervention), and April 4 to 7, 2022 (1 year after intervention), with reports containing recommendations for additional imaging. A radiologist scored the 3 groups (preintervention group, 1-week postintervention group, and 1-year postintervention group) of 336 consecutive radiology reports (n = 1008) with recommendations for additional imaging.InterventionFinal implementation on March 27, 2021, of a voluntary closed-loop communication tool embedded in radiologist clinical workflow that required structured entry of recommendation attributes.Main outcomes and measuresThe a priori primary outcome was completeness of recommendations for additional imaging, defined in a taxonomy created by a multidisciplinary expert panel. To validate the taxonomy, 2 radiologists independently reviewed and scored language attributes as present or absent in 247 consecutive radiology reports containing recommendations for additional imaging. Agreement was assessed with Cohen κ. Recommendation completeness over time was compared with with 1-sided Fisher exact tests and significance set at P < .05.ResultsRadiology-related information for consecutive radiology reports from the 4 time periods was collected from the radiology department data warehouse, which does not include data on patient demographic characteristics or other nonimaging patient medical information. The panel defined 5 recommendation language attributes: complete (contains imaging modality, time frame, and rationale), ambiguous (equivocal, vague language), conditional (qualifying language), multiplicity (multiple options), and alternate (language favoring a different examination to that ordered). Two radiologists had more than 90% agreement (κ > 0.8) for these attributes. Completeness with use of the tool increased more than 3-fold, from 14% (46 of 336) before the intervention to 46% (153 of 336) (P < .001) 1 year after intervention; completeness in the corresponding free-text report language increased from 14% (46 of 336) before the intervention to 25% (85 of 336) (P < .001) 1 year after the intervention.Conclusions and relevanceThis study suggests that supplementing free-text dictation with voluntary use of a structured entry tool was associated with improved completeness of radiologist recommendations for additional imaging as assessed by an internally validated taxonomy. Future research is needed to assess the association with timely performance of clinically necessary recommendations and diagnostic errors. The taxonomy can be used to evaluate and build interventions to modify radiologist reporting behaviors.

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Cardiovascular health technology assessment: recommendations to improve the quality of evidence.

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Cardiovascular health technology assessment: recommendations to improve the quality of evidence.

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