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Workshop Schedule

Workshop Schedule

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Workshop Schedule

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  1. Workshop Schedule

  2. Data Quality Year in Review Very short and high level Meredith Nahm Zozus, PhD, CCDM Sunday November 4, 2018 Department of Biomedical Informatics

  3. 2018 DQ Year In Review (“information quality" OR “data quality”) AND (“clinical trial” OR "clinical trials" OR “clinical study” OR registry OR registries OR “observational study” OR “interventional study” OR “phase 1” OR “phase 2” OR “phase 3” OR “phase 4” OR “phase I” OR “phase II” OR “phase III” OR “phase IV” OR “first in man” OR “clinical research” OR “device study” OR “interventional trial” OR “phase 1 trial” OR “phase 2 trial” OR “phase 3 trial” OR “phase 4 trial” OR “phase I trial” OR “phase II trial” OR “phase III trial” OR “phase IV trial” OR RCT OR “randomized clinical trial” OR “non-interventional” OR “post authorization” OR “adaptive trials” OR “feasibility study” OR “phase 2/3” OR “phase II/III” OR “phase 2a” OR “phase 2b” OR “phase IIa” OR “phase IIb”) 396 last 5 years, 37 Nov 2017- present 21/37 “Included” Exclusions: Not in English-7 Not about DQ-8 Methods not specified-1

  4. Type of Study / Assessment DQA Methods 9

  5. Opinion / Tutorial • Sean Khozin, Gideon M. Blumenthal, Richard Pazdur, Real-world Data for Clinical Evidence Generation in Oncology, JNCI 2017

  6. Surveys Including DQ • Fredriksson, Mio (11/2017). Are data from national quality registries used in quality improvement at Swedish hospital clinics?. International journal for quality in health care (1353-4505), 29 (7), p. 909. • MdEmdadulHoque D, Ruseckaite R, Lorgelly P, McNeil JJ, Evans SM, Cross-sectional study of characteristics of clinical registries in Australia: a resource for clinicians and policy makers. IntJ Qual Health Care. 2018 Apr 1;30(3):192-199. • Houston L, Probst Y, Yu P, Martin A., Exploring Data Quality Management within Clinical Trials. ApplClin Inform. 2018 Jan;9(1):72-81. • Solli P, Bertolaccini L, Droghetti A, Bertani A, Gonfiotti A, Nosotti M, Migliore M, Crisci R, Vats Group I. 2016 Annual report from the Italian VATS Group. Future Oncol. 2018 Mar;14(6s):23-28.

  7. DQ Report Accompanying Research Results • Allemani C, Harewood R, Johnson CJ, Carreira H, Spika D, Bonaventure A, Ward K, Weir HK, Coleman MP, Population-based cancer survival in the United States: Data, quality control, and statistical methods. Cancer. 2017 Dec 15;123 Suppl 24:4982-4993. • TsivgoulisG, Patousi A, Pikilidou M, Birbilis T, Katsanos AH, Mantatzis M, Asimis A, Papanas N, Skendros P, Terzoudi A, Karamanli A, Kouroumichakis I, Zebekakis P, Maltezos E, Piperidou C, Vadikolias K, HeliopoulosI., Stroke Incidence and Outcomes in Northeastern Greece: The Evros Stroke Registry. Stroke. 2018 Feb;49(2):288-295. • von Niederhäusern B, Saccilotto R, Schädelin S, Ziesenitz V, Benkert P, Decker ML, Hammann A, Bielicki J, Pfister M, Pauli-Magnus C., Validity of mobile electronic data capture in clinical studies: a pilot study in a pediatric population. BMC Med Res Methodol. 2017 Dec 8;17(1):163. • Sutherland G, Milner A, Dwyer J, Bugeja L, Woodward A, Robinson J, PirkisJ., Implementation and evaluation of the Victorian Suicide Register. AustN Z J Public Health. 2018 Jun;42(3):296-302. • Diani CA, Rock A, Moll P., An evaluation of the effectiveness of a risk-based monitoring approach implemented with clinical trials involving implantable cardiac medical devices. Clin Trials. 2017 Dec;14(6):575-583. • Heino A, Niinimäki M, Mentula M, GisslerM., How reliable are health registers? Registration of induced abortions and sterilizations in Finland. Inform Health Soc Care. 2018 Sep;43(3):310-319. • Cendales R, PardoC., Quality of death certification in Colombia. ColombMed (Cali). 2018 Mar 30;49(1):121-127. • Lim YMF, Yusof M, SivasampuS., Assessing primary care data quality. IntJ Health Care QualAssur. 2018 Apr 16;31(3):203-213.

  8. Primary Data Quality Assessment • Rajagopal S, Booth SJ, Brown TP, Ji C, Hawkes C, Siriwardena AN, Kirby K, Black S, Spaight R, Gunson I, Brace-McDonnell SJ, Perkins GD; OHCAO collaborators, Data quality and 30-day survival for out-of-hospital cardiac arrest in the UK out-of-hospital cardiac arrest registry: a data linkage study. BMJ Open. 2017 Nov 20;7(11):e017784. • Kilburn LS, Aresu M, Banerji J, Barrett-Lee P, Ellis P, Bliss JM, Can routine data be used to support cancer clinical trials? A historical baseline on which to build: retrospective linkage of data from the TACT (CRUK 01/001) breast cancer trial and the National Cancer Data Repository. Trials. 2017 Nov 23;18(1):561. • Rosenberg P, Kjølhede P, Staf C, Bjurberg M, Borgfeldt C, Dahm-Kähler P, Hellman K, Hjerpe E, Holmberg E, Stålberg K, Tholander B, ÅvallLundqvist E, HögbergT., Data quality in the Swedish Quality Register of Gynecologic Cancer - a Swedish Gynecologic Cancer Group (SweGCG) study. ActaOncol. 2018 Mar;57(3):346-353. • Merriel SWD, Turner EL, Walsh E, Young GJ, Metcalfe C, Hounsome L, Tudge I, Donovan J, Hamdy F, Neal D, Martin RM., Cross-sectional study evaluating data quality of the National Cancer Registration and Analysis Service (NCRAS) prostate cancer registry data using the Cluster randomised trial of PSA testing for Prostate cancer (CAP). BMJ Open. 2017 Nov 14;7(11):e015994. • Takahashi A, Kumamaru H, Tomotaki A, Matsumura G, Fukuchi E, Hirata Y, Murakami A, Hashimoto H, Ono M, Miyata H. Verification of Data Accuracy in Japan Congenital Cardiovascular Surgery Database Including Its Postprocedural Complication Reports. World J PediatrCongenit Heart Surg. 2018 Mar;9(2):150-156. • Rangé G, Chassaing S, Marcollet P, Saint-Étienne C, Dequenne P, Goralski M, Bardiére P, Beverilli F, Godillon L, Sabine B, Laure C, Gautier S, Hakim R, Albert F, Angoulvant D, Grammatico-GuillonL., The CRAC cohort model: A computerized low cost registry of interventional cardiology with daily update and long-term follow-up. Rev EpidemiolSantePublique. 2018 May;66(3):209-216. • Brink C, Lorenzen EL, Krogh SL, Westberg J, Berg M, Jensen I, Thomsen MS, Yates ES, OffersenBV., DBCG hypo trial validation of radiotherapy parameters from a national data bank versus manual reporting. ActaOncol. 2018 Jan;57(1):107-112.

  9. Data Quality Intervention • Fleischmann R, Decker AM, Kraft A, Mai K, Schmidt S., Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial. BMC Med Res Methodol. 2017 Dec 1;17(1):153.

  10. Therapeutic Area

  11. Source for Comparison Data Assessed

  12. DQ Dimensions Assessed Assessment Method

  13. DQA Methods • Huser V, Kahn MG, Brown JS, GouripeddiR., Methods for examining data quality in healthcare integrated data repositories. Pac SympBiocomput. 2018;23:628-633. • Estiri H, Stephens KA, Klann JG, Murphy SN., Exploring completeness in clinical data research networks with DQe-c. J Am Med Inform Assoc. 2018 Jan 1;25(1):17-24. • Khare R, Utidjian L, Ruth BJ, Kahn MG, Burrows E, Marsolo K, Patibandla N, Razzaghi H, Colvin R, Ranade D, Kitzmiller M, Eckrich D, Bailey LC. A longitudinal analysis of data quality in a large pediatric data research network. J Am Med Inform Assoc. 2017 Nov 1;24(6):1072-1079. • Ronquillo JG, Weng C, Lester WT., Assessing the readiness of precision medicine interoperabilty: An exploratory study of the National Institutes of Health genetic testing registry. J Innov Health Inform. 2017 Nov 17;24(4):918. • Lee K, Weiskopf N, PathakJ., A Framework for Data Quality Assessment in Clinical Research Datasets. AMIA AnnuSymp Proc. 2018 Apr 16;2017:1080-1089. • Cholan RA, Weiskopf NG, Rhoton DL, Colin NV, Ross RL, Marzullo MN, Sachdeva B, Dorr DA., Specifications of Clinical Quality Measures and Value Set Vocabularies Shift Over Time: A Study of Change through Implementation Differences. AMIA AnnuSymp Proc. 2018 Apr 16;2017:575-584. • Gebauer SL, WeiskopfNG. Feasibility and Limitations of Quality Measurement of Hospital-Based Palliative Care. J Palliat Med. 2017 Dec;20(12):1307-1308. • Schuemie MJ, Ryan PB, Hripcsak G, Madigan D, Suchard MA. • Improving reproducibility by using high-throughput observational studies with empirical calibration. PhilosTrans A Math PhysEng Sci. 2018 Sep 13;376(2128).

  14. Thank you ! And Sincere Apology for Important Work Missed by this Preliminary Review