#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Optimising medication data collection in a large-scale clinical trial


Autoři: Jessica E. Lockery aff001;  Jason Rigby aff001;  Taya A. Collyer aff001;  Ashley C. Stewart aff001;  Robyn L. Woods aff001;  John J. McNeil aff001;  Christopher M. Reid aff001;  Michael E. Ernst aff003
Působiště autorů: Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria, Australia aff001;  School of Public Health, Curtin University, Perth, Western Australia, Australia aff002;  Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, The University of Iowa, Iowa City, Iowa, United States of America aff003
Vyšlo v časopise: PLoS ONE 14(12)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0226868

Souhrn

Objective

Pharmaceuticals play an important role in clinical care. However, in community-based research, medication data are commonly collected as unstructured free-text, which is prohibitively expensive to code for large-scale studies. The ASPirin in Reducing Events in the Elderly (ASPREE) study developed a two-pronged framework to collect structured medication data for 19,114 individuals. ASPREE provides an opportunity to determine whether medication data can be cost-effectively collected and coded, en masse from the community using this framework.

Methods

The ASPREE framework of type-to-search box with automated coding and linked free text entry was compared to traditional method of free-text only collection and post hoc coding. Reported medications were classified according to their method of collection and analysed by Anatomical Therapeutic Chemical (ATC) group. Relative cost of collecting medications was determined by calculating the time required for database set up and medication coding.

Results

Overall, 122,910 participant structured medication reports were entered using the type-to-search box and 5,983 were entered as free-text. Free-text data contributed 211 unique medications not present in the type-to-search box. Spelling errors and unnecessary provision of additional information were among the top reasons why medications were reported as free-text. The cost per medication using the ASPREE method was approximately USD $0.03 compared with USD $0.20 per medication for the traditional method.

Conclusion

Implementation of this two-pronged framework is a cost-effective alternative to free-text only data collection in community-based research. Higher initial set-up costs of this combined method are justified by long term cost effectiveness and the scientific potential for analysis and discovery gained through collection of detailed, structured medication data.

Klíčová slova:

Cardiology – Clinical trials – Dermatology – Elderly – Endocrinology – Geriatrics – Medicine and health sciences – Oncology


Zdroje

1. Clinical Data Interchange Standards Consortium Electronic Source Data Interchange (eSDI) Group. Leveraging the CDISC standards to facilitate the use of electronic source data within clinical trials; 2006. [Internet]. http://www.cdisc.org/stuff/contentmgr/files/0/2f6eca8f0df7caac5bbd4fadfd76d575/miscdocs/esdi.pdf

2. Richesson RL. An informatics framework for the standardized collection and analysis of medication data in networked research. J Biomed Inform. 2014 Dec 1;52:4–10. doi: 10.1016/j.jbi.2014.01.002 24434192

3. Qato DM, Schumm LP, Johnson M, Mihai A, Lindau ST. Medication Data Collection and Coding in a Home-Based Survey of Older Adults. J Gerontol Ser B. 2009 Nov 1;64B(suppl_1):i86–93.

4. Borad MJ, Curtis KK, Babiker HM, Benjamin M, Tibes R, Ramanathan RK, et al. The Impact of Concomitant Medication Use on Patient Eligibility for Phase I Cancer Clinical Trials. J Cancer. 2012 Aug 17;3:345–53. doi: 10.7150/jca.4714 22962561

5. Meystre SM, Thibault J, Shen S, Hurdle JF, South BR. Automatically Detecting Medications and the Reason for their Prescription in Clinical Narrative Text Documents. Stud Health Technol Inform. 2010;160(Pt 2):944–8. 20841823

6. Pathak J, Richesson RL. Use of Standard Drug Vocabularies in Clinical Research: A Case Study in Pediatrics. AMIA Annu Symp Proc. 2010;2010:607–11. 21347050

7. Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial. Contemp Clin Trials. 2013 Nov 1;36(2):555–64. doi: 10.1016/j.cct.2013.09.014 24113028

8. McNeil JJ, Woods RL, Nelson MR, Reid CM, Kirpach B, Wolfe R, et al. Effect of Aspirin on Disability-free Survival in the Healthy Elderly. N Engl J Med. 2018 Sep 16;0(0):null.

9. Linjakumpu T, Hartikainen S, Klaukka T, Veijola J, Kivelä S-L, Isoaho R. Use of medications and polypharmacy are increasing among the elderly. J Clin Epidemiol. 2002 Aug;55(8):809–17. doi: 10.1016/s0895-4356(02)00411-0 12384196

10. Ahmed B, Nanji K, Mujeeb R, Patel MJ. Effects of Polypharmacy on Adverse Drug Reactions among Geriatric Outpatients at a Tertiary Care Hospital in Karachi: A Prospective Cohort Study. PLOS ONE. 2014 Nov 17;9(11):e112133. doi: 10.1371/journal.pone.0112133 25402452

11. Jyrkkä J, Enlund H, Korhonen MJ, Sulkava R, Hartikainen S. Polypharmacy Status as an Indicator of Mortality in an Elderly Population. Drugs Aging Auckl. 2009 Dec;26(12):1039–48.

12. Gu Q, Dillon CF, Burt VL. Prescription drug use continues to increase: U.S. prescription drug data for 2007–2008. NCHS Data Brief. 2010 Sep;(42):1–8. 20854747

13. McNeil JJ, Woods RL, Nelson MR, Murray AM, Reid CM, Kirpach B, et al. Baseline Characteristics of Participants in the ASPREE (ASPirin in Reducing Events in the Elderly) Study. J Gerontol A Biol Sci Med Sci. 2017 Oct;72(11):1586–93. doi: 10.1093/gerona/glw342 28329340

14. Babre D. Medical Coding in Clinical Trials. Perspect Clin Res. 2010;1(1):29–32. 21829779

15. Schroll JB, Maund E, Gøtzsche PC. Challenges in Coding Adverse Events in Clinical Trials: A Systematic Review. PLOS ONE. 2012 Jul 20;7(7):e41174. doi: 10.1371/journal.pone.0041174 22911755

16. Kennelty KA, Witry MJ, Gehring M, Dattalo M, Rogus-Pulia N. A four-phase approach for systematically collecting data and measuring medication discrepancies when patients transition between health care settings. Res Soc Adm Pharm RSAP. 2016;12(4):548–58.

17. Polnaszek B, Gilmore-Bykovskyi A, Hovanes M, Roiland R, Ferguson P, Brown R, et al. Overcoming the Challenges of Unstructured Data in Multi-site, Electronic Medical Record-based Abstraction. Med Care. 2016 Oct;54(10):e65–72. doi: 10.1097/MLR.0000000000000108 27624585

18. Chhabra PT, Rattinger GB, Dutcher SK, Hare ME, Parsons KL, Zuckerman IH. Medication reconciliation during the transition to and from long-term care settings: A systematic review. Res Soc Adm Pharm. 2012 Jan 1;8(1):60–75.

19. WHS Questionnaires and Data Matrix [Internet]. [cited 2019 Apr 25]. http://whs.bwh.harvard.edu/WHSQuestionnaires.html

20. Chakos MH, Glick ID, Miller AL, Hamner MB, Miller DD, Patel JK, et al. Special Section on CATIE Baseline Data: Baseline Use of Concomitant Psychotropic Medications to Treat Schizophrenia in the CATIE Trial. Psychiatr Serv. 2006 Aug 1;57(8):1094–101. 16870959


Článek vyšel v časopise

PLOS One


2019 Číslo 12
Nejčtenější tento týden
Nejčtenější v tomto čísle
Kurzy

Zvyšte si kvalifikaci online z pohodlí domova

KOST
Koncepce osteologické péče pro gynekology a praktické lékaře
nový kurz
Autoři: MUDr. František Šenk

Sekvenční léčba schizofrenie
Autoři: MUDr. Jana Hořínková

Hypertenze a hypercholesterolémie – synergický efekt léčby
Autoři: prof. MUDr. Hana Rosolová, DrSc.

Svět praktické medicíny 5/2023 (znalostní test z časopisu)

Imunopatologie? … a co my s tím???
Autoři: doc. MUDr. Helena Lahoda Brodská, Ph.D.

Všechny kurzy
Kurzy Podcasty Doporučená témata Časopisy
Přihlášení
Zapomenuté heslo

Zadejte e-mailovou adresu, se kterou jste vytvářel(a) účet, budou Vám na ni zaslány informace k nastavení nového hesla.

Přihlášení

Nemáte účet?  Registrujte se

#ADS_BOTTOM_SCRIPTS#