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

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          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.

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          Most cited references 15

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          Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI.

          Coronary revascularization guided by fractional flow reserve (FFR) is associated with better patient outcomes after the procedure than revascularization guided by angiography alone. It is unknown whether the instantaneous wave-free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR.
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            Reporting bias in medical research - a narrative review

            Reporting bias represents a major problem in the assessment of health care interventions. Several prominent cases have been described in the literature, for example, in the reporting of trials of antidepressants, Class I anti-arrhythmic drugs, and selective COX-2 inhibitors. The aim of this narrative review is to gain an overview of reporting bias in the medical literature, focussing on publication bias and selective outcome reporting. We explore whether these types of bias have been shown in areas beyond the well-known cases noted above, in order to gain an impression of how widespread the problem is. For this purpose, we screened relevant articles on reporting bias that had previously been obtained by the German Institute for Quality and Efficiency in Health Care in the context of its health technology assessment reports and other research work, together with the reference lists of these articles. We identified reporting bias in 40 indications comprising around 50 different pharmacological, surgical (e.g. vacuum-assisted closure therapy), diagnostic (e.g. ultrasound), and preventive (e.g. cancer vaccines) interventions. Regarding pharmacological interventions, cases of reporting bias were, for example, identified in the treatment of the following conditions: depression, bipolar disorder, schizophrenia, anxiety disorder, attention-deficit hyperactivity disorder, Alzheimer's disease, pain, migraine, cardiovascular disease, gastric ulcers, irritable bowel syndrome, urinary incontinence, atopic dermatitis, diabetes mellitus type 2, hypercholesterolaemia, thyroid disorders, menopausal symptoms, various types of cancer (e.g. ovarian cancer and melanoma), various types of infections (e.g. HIV, influenza and Hepatitis B), and acute trauma. Many cases involved the withholding of study data by manufacturers and regulatory agencies or the active attempt by manufacturers to suppress publication. The ascertained effects of reporting bias included the overestimation of efficacy and the underestimation of safety risks of interventions. In conclusion, reporting bias is a widespread phenomenon in the medical literature. Mandatory prospective registration of trials and public access to study data via results databases need to be introduced on a worldwide scale. This will allow for an independent review of research data, help fulfil ethical obligations towards patients, and ensure a basis for fully-informed decision making in the health care system.
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              Assessing the quality of randomized trials: reliability of the Jadad scale.

              An instrument was developed and validated by Jadad, et al. to assess the quality of clinical trials using studies from the pain literature. Our study determined the reliability of the Jadad scale and the effect of blinding on interrater agreement in another group of primary studies. Four raters independently assessed blinded and unblinded versions of 76 randomized trials. Interrater agreement was calculated among combinations of four raters for blinded and unblinded versions of the studies. A 4 x 2 x 2 repeated measures design was employed to evaluate the effect of blinding. The interrater agreement for the Jadad scale was poor (kappa 0.37 to 0.39), but agreement improved substantially (kappa 0.53 to 0.59) with removal of the third item (an explanation of withdrawals). Blinding did not significantly affect the Jadad scale scores. A more precise description of how to score the withdrawal item and careful conduct of a practice set of articles might improve interrater agreement. In contrast with the conclusions reached by Jadad, we were unable to demonstrate a significant effect of blinding on the quality scores.

                Author and article information

                Open Heart
                Open Heart
                Open Heart
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                27 February 2019
                : 6
                : 1
                [1 ] departmentBHF Glasgow Cardiovascular Research Centre , Institute of Cardiovascular and Medical Sciences, University of Glasgow , Glasgow, UK
                [2 ] departmentWest of Scotland Heart and Lung Centre , Golden Jubilee National Hospital , Clydebank, UK
                [3 ] departmentInstitute of Cardiovascular and Medical Sciences , University of Glasgow , Glasgow, UK
                Author notes
                [Correspondence to ] Professor Colin Berry; colin.berry@
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:

                Funded by: FundRef, British Heart Foundation;
                Award ID: FS/14/15/30661
                Award ID: FS/15/54/31639
                Award ID: PG/14/64/31043
                Award ID: RE/13/5/30177
                Health Care Delivery, Economics and Global Health Care
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