Evidence map›Paper›PMID 38351112›Full record

ArticleBMJ open2024

Assessment of quality of data submitted for NICE technology appraisals over two decades.

Leeza Osipenko, Saba Ajwat Ul-Hasan, Debra Winberg, Kseniia Prudyus, Marina Kousta, Artemis Rizoglou, Isabella Rustignoli, Laurens van der Maas

Abstract read
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. The Pharmaceutical Year that was, 2024.Pharmaceutical medicine · 2024
    Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Leeza OsipenkoThe London School of Economics and Political Science, London, UK l.osipenko@lse.ac.uk.ORCID 0000-0002-7758-509X
Saba Ajwat Ul-HasanThe London School of Economics and Political Science, London, UK.
Debra WinbergTulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, USA.
Kseniia PrudyusThe London School of Economics and Political Science, London, UK.
Marina KoustaKing's College London, London, UK.
Artemis RizoglouThe London School of Economics and Political Science, London, UK.
Isabella RustignoliThe London School of Economics and Political Science, London, UK.
Laurens van der MaasThe London School of Economics and Political Science, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe National Institute for Health and Care Excellence (NICE) pioneered the Health Technology Assessment (HTA) processes and methodologies. Technology appraisals (TAs) focus on pharmaceutical products and clinical and economic data, which are presented by the product manufacturers to the NICE appraisal committee for decision-making. Uncertainty in data reduces the chance of a positive outcome from the HTA process or requires a higher discount.

objectiveTo investigate the quality of clinical data (comparator, quality of life (QoL), randomised controlled trials (RCTs) and overall quality of evidence) submitted by the manufacturers to NICE.

designThis retrospective evaluation analysed active TAs published between 2000 and 2019 (up to TA600).

methodsFor all TAs, we extracted data from the Assessment Group and Evidence Review Group reports and Final Appraisal Determinations on (1) the quality of submitted RCTs and (2) the overall quality of evidence submitted for decision-making. For single TAs, we also extracted data and its critique on QoL and comparators. Each category was scored for quality and analysed using descriptive statistics.

results409 TAs were analysed (multiple technology appraisals (MTA)=104, single technology appraisal (STA)=305). In two-thirds of TAs, the overall quality of evidence was either poor (n=224, 55%) or unacceptable (n=41, 10%). In 39% (n=119) of the STAs, the quality of comparative evidence was considered poor, and in 17% (n=51) unacceptable. In 44% (n=135) of STAs, the quality of QoL data was considered poor, 15% (n=47) unacceptable, 33% (n=102) acceptable and 7% (n=21) as good. Over 20 years of longitudinal analysis did not show improvements in the quality of evidence submitted to NICE.

conclusionWe found that the primary components of clinical evidence influencing NICE's decision-making framework were of poor quality. It is essential to continue to generate robust clinical data for premarket and postmarket introduction of medicines into clinical practice to ensure they deliver benefits to patients.

Indexed as

Technology Assessment, BiomedicalDecision MakingHumansQuality of LifeRandomized Controlled Trials as TopicRetrospective StudiesUnited KingdomClinical TrialHealth policyONCOLOGYQUALITATIVE RESEARCH

Identifiers

PMID38351112
PMCPMC10870012

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.