References
- Evans RS. Electronic health records: then, now, and in the future. Yearb Med Inform. 2016 May 20;(Suppl 1):S48–S61. doi:10.15265/IYS-2016-s006.
- Hlatky MA, Owens DK, Sanders GD. Cost-effectiveness as an outcome in randomized clinical trials. Clin Trials. 2006;3(6):543–551. doi:10.1177/1740774506073105.
- Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review. Contemp Clin Trials Commun. 2018 Aug 7;11:156–164. doi:10.1016/j.conctc.2018.08.001.
- Duncan A, Halim D, El Kholy K. The RECOVERY trial: an analysis and reflection two years on. Eur J Intern Med. 2022;105:111–112. doi:10.1016/j.ejim.2022.09.018.
- Fröbert O, Lagerqvist B, Gudnason T, et al. Thrombus aspiration in ST-elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale. Am Heart J. 2010;160(6):1042–1048. doi:10.1016/j.ahj.2010.08.040.
- Godolphin PJ, Bath PM, Partlett C, et al. Outcome assessment by Central adjudicators in randomised stroke trials: simulation of differential and non-differential misclassification. Eur Stroke J. 2020;5(2):174–183. doi:10.1177/2396987320910047.
- Blecker S, Adhikari S, Zhang H, et al. Validation of EHR medication fill data obtained through electronic linkage with pharmacies. J Manag Care Spec Pharm. 2021;27(10):1482–1487. doi:10.18553/jmcp.2021.27.10.1482.
- MHRA guideline on randomised controlled trials using real-world data to support regulatory decisions. www.gov.uk. Retrieved January 28, 2023, from https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guideline-on-randomised-controlled-trials-using-real-world-data-to-support-regulatory-decisions#types-of-rwd-trials-and-points-to-consider.
- MHRA Position Statement and Guidance Electronic Health Records. Assets.Publishing.Service.gov.uk. Retrieved January 28, 2023, from https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/470228/Electronic_Health_Records_MHRA_Position_Statement.pdf.
- The Wellcome Trust. The One-Way Mirror: Public attitudes to commercial access to health data, 2016: 1–161.
- Majority of NHS trusts yet to fully embrace digital patient records. www.Buildingbetterhealthcare.com. Retrieved January 28, 2023, from https://www.buildingbetterhealthcare.com/news/article_page/Majority_of_NHS_trusts_yet_to_fully_embrace_digital_patient_records/154911.
- A plan for Digital Health and Social Care. GOV.UK.Retrieved January 28, 2023, fromhttps://www.gov.uk/government/publications/a-plan-for-digital-health-and-social-care/a-plan-for-digital-health-and-social-care.
- Department of Health and Social Care. 2023, February 3). Medical Technology strategy. Retrieved March 7, 2024, from https://assets.publishing.service.gov.uk/media/63dbe1f68fa8f57fbfff3db3/medical-technology-strategy.pdf.
- Macnair A, Love SB, Murray ML, et al. Accessing routinely collected health data to improve clinical trials: recent experience of access. Trials. 2021;22(1):340. doi:10.1186/s13063-021-05295-5.
- HDRUK Innovation Gateway | Our mission and purpose. HDRUK Innovation Gateway. Retrieved January 28, 2023, from https://www.healthdatagateway.org/about/our-mission-and-purpose.
- Fearon A. 2020, February 25). The researchers’ experience when attempting to access health data for research. NCRI. Retrieved January 28, 2023, from https://www.ncri.org.uk/accessing-health-data-for-research/.
- Applying for UK Hospital Episode Statistics (HES) and Recent History - IgniteData. 2020, September 24). IgniteData. Retrieved January 28, 2023, from https://www.ignitedata.co.uk/applying-for-uk-hospital-episode-statistics-hes-and-recent-history/.
- Wachtell K, Lagerqvist B, Olivecrona GK, et al. Novel trial designs: lessons learned from thrombus aspiration during ST-segment elevation myocardial infarction in Scandinavia (TASTE) trial. Curr Cardiol Rep. 2016 Jan;18(1):11. doi:10.1007/s11886-015-0677-6.
- Shore BJ, Nasreddine AY, Kocher MS. Overcoming the funding challenge: the cost of randomized controlled trials in the next decade. J Bone Joint Surg Am. 2012 Jul 18;94 Suppl 1:101–106. doi:10.2106/JBJS.L.00193.
- Strengthening cause of death information system in India. 2022, September 21). WHO. Retrieved January, 28, 2023, from https://www.who.int/india/news/detail/21-09-2022-strengthening-cause-of-death-information-system-in-india#:∼:text=India%20has%20made%20significant%20progress,2011%20to%2092%25%20in%202019.
- Rao C, Gupta M. The civil registration system is a potentially viable data source for reliable subnational mortality measurement in India. BMJ Glob Health. 2020;5(8):e002586. doi:10.1136/bmjgh-2020-002586.
- Pessoa-Amorim G, Campbell M, Fletcher L, et al. Making trials part of good clinical care: lessons from the RECOVERY trial. Future Healthc J. 2021 Jul;8(2):e243–e250. doi:10.7861/fhj.2021-0083.
- Spertus JA, Birmingham MC, Nassif M, et al. The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial. Nat Med. 2022;28(4):809–813. doi:10.1038/s41591-022-01703-8.
- Batko K, Ślęzak A. The use of big data analytics in healthcare. J Big Data. 2022;9(1):3. doi:10.1186/s40537-021-00553-4.
- Ehrenstein V, Nielsen H, Pedersen AB, et al. Clinical epidemiology in the era of big data: new opportunities, familiar challenges. Clin Epidemiol. 2017;9:245–250. doi:10.2147/CLEP.S129779.
- Akl EA, Briel M, You JJ, et al. Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review. BMJ. 2012;344:e2809–e2809. doi:10.1136/bmj.e2809.
- Fong LCW, Ford TJ, da Costa BR, et al. Bias and loss to follow-up in cardiovascular randomized trials: a systematic review. J Am Heart Assoc. 2020;9(14):e015361. doi:10.1161/JAHA.119.015361.
- Miller AB, Wall C, Baines CJ, et al. Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National breast screening study: randomised screening trial. BMJ. 2014 Feb 11;348:g366–g366. doi:10.1136/bmj.g366.
- Edwards RT, Hounsome B, Linck P, et al. Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units. Trials. 2008;9(1):64. doi:10.1186/1745-6215-9-64.
- Franklin M, Thorn J. Self-reported and routinely collected electronic healthcare resource-use data for trial-based economic evaluations: the current state of play in England and considerations for the future. BMC Med Res Methodol. 2019;19(1):8. doi:10.1186/s12874-018-0649-9.
- Page P. Beyond statistical significance: clinical interpretation of rehabilitation research literature. Int J Sports Phys Ther. 2014;9(5):726–736.
- Saura C, Oliveira M, Feng YH, , et al. Neratinib plus capecitabine versus lapatinib plus capecitabine in HER2-positive metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: phase III NALA trial. J Clin Oncol. 2020;38(27):3138–3149. doi:10.1200/JCO.20.00147.
- The quality of clinical coding in the NHS. 2014, September). Retrieved January 28, 2023, from https://www.chks.co.uk/userfiles/files/The_quality_of_clinical_coding_in_the_NHS.pdf.
- 2022 Update on the National Diabetes Foot Care Audit - DiabetesontheNet. 2022, November 30). DiabetesontheNet. Retrieved January 28, 2023, from https://diabetesonthenet.com/diabetic-foot-journal/2022-update-on-the-national-diabetes-foot-care-audit/.
- A randomised open label trial to assess change in respiratory function for people with cystic fibrosis (pwCF) established on triple combination therapy (KaftrioTM) after rationalisation of nebulised mucoactive therapies (the CF STORM trial). 2021, January 7). Retrieved January 28, 2023, from https://njl-admin.nihr.ac.uk/document/download/2036273.
- van Staa T-P, Dyson L, McCann G, et al. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials. Southampton (UK): NIHR Journals Library; 2014. Available from: https://www.ncbi.nlm.nih.gov/books/NBK262223/.
- Lugg-Widger FV, Angel L, Cannings-John R, et al. Challenges in accessing routinely collected data from multiple providers in the UK for primary studies: managing the morass. Int J Popul Data Sci. 2018;3(3):432. Retrieved January 28, 2023, from https://ijpds.org/article/view/432 doi:10.23889/ijpds.v3i3.432.
- Lauer MS, D'Agostino RB. Sr. The randomized registry trial–the next disruptive technology in clinical research? N Engl J Med. 2013;369(17):1579–1581. doi:10.1056/NEJMp1310102.
- Eden R, Burton-Jones A, Scott I, et al. Effects of eHealth on hospital practice: synthesis of the current literature. Aust Health Rev. 2018;42(5):568–578. doi:10.1071/AH17255.
- Laugesen K, Ludvigsson JF, Schmidt M, et al. Nordic health registry-based research: a review of health care systems and key registries. Clin Epidemiol. 2021;13:533–554. doi:10.2147/CLEP.S314959.