PMID- 34615680
OWN - NLM
STAT- MEDLINE
DCOM- 20211103
LR  - 20231107
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 11
IP  - 10
DP  - 2021 Oct 6
TI  - Audit of data redaction practices in NICE technology appraisals from 1999 to 
      2019.
PG  - e051812
LID - 10.1136/bmjopen-2021-051812 [doi]
LID - e051812
AB  - OBJECTIVES: To assess the extent and type of data redaction in all active 
      technology appraisals (TA) and highly specialised technology (HST) evaluations 
      issued by the National Institute for Health and Care Excellence (NICE) from its 
      conception of the institute to September 2019. To propose policy recommendations 
      for transparency. METHODS: Structured audit to establish extent of data 
      redaction-proportion of appraisals and specific data categories and assess 
      redaction by: indication, appraisal process, manufacturer, type of data-price, 
      adverse events (AEs), clinical (excluding AEs), incremental quality-adjusted 
      life-years. Longitudinal analysis over 20 years. RESULTS: All TAs with available 
      documentation and active recommendations (n=408) and HSTs (n=10) published from 
      March 2000 to 11 September 2019 have been assessed for data redaction. Overall, 
      333 TAs (81.6%) have data redaction, 86 (25.8%) of them are heavily redacted. 
      Clinical data (excluding AEs) are redacted in 268 (65.7%) appraisals, AE data in 
      128 (31.4%), price in 238 (58.3%). In total, 87% of oncology appraisals have 
      redacted data vs 78% of non-oncology appraisals. 91% of single TAs have redacted 
      data vs 59% of multiple TAs. 25% of final guidance documents (e.g. Final 
      Appraisal Determination - FAD) do not report one or more instance of clinical 
      data. Data redaction increased substantially over time, and is currently at its 
      highest level with 100% of TAs having at least some data redaction in 2019/2020, 
      96% of appraisals in 2018/2019% and 94% of appraisals in 2017/2018. All 10 HST 
      evaluations have redacted data, with 4 of them being heavily redacted. 
      CONCLUSIONS: Documents supporting NICE TA and HST recommendations are 
      significantly redacted, thereby concealing clinical and economic data of 
      importance to patients, clinicians and researchers. Documents remain redacted on 
      the NICE website for years. Policy change is required to ensure transparency of 
      data underpinning NICE's decisions.
CI  - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Osipenko, Leeza
AU  - Osipenko L
AUID- ORCID: 0000-0002-7758-509X
AD  - Health Policy, London School of Economics and Political Science, London, UK 
      l.osipenko@lse.ac.uk.
LA  - eng
PT  - Journal Article
DEP - 20211006
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - *Biomedical Technology
MH  - Cost-Benefit Analysis
MH  - Humans
MH  - Policy
MH  - *Technology Assessment, Biomedical
MH  - United Kingdom
PMC - PMC8496400
OTO - NOTNLM
OT  - ethics (see medical ethics)
OT  - health policy
OT  - public health
OT  - quality in health care
COIS- Competing interests: None declared.
EDAT- 2021/10/08 06:00
MHDA- 2021/11/04 06:00
PMCR- 2021/10/06
CRDT- 2021/10/07 05:59
PHST- 2021/10/07 05:59 [entrez]
PHST- 2021/10/08 06:00 [pubmed]
PHST- 2021/11/04 06:00 [medline]
PHST- 2021/10/06 00:00 [pmc-release]
AID - bmjopen-2021-051812 [pii]
AID - 10.1136/bmjopen-2021-051812 [doi]
PST - epublish
SO  - BMJ Open. 2021 Oct 6;11(10):e051812. doi: 10.1136/bmjopen-2021-051812.