Development and Use of a Flexible Data Harmonization Platform to Facilitate the Harmonization of Individual Patient Data for Meta-analyses

Overview

Journal BMC Res Notes

Publisher Biomed Central

Specialties Biology
General Medicine

Date 2019 Mar 24

PMID 30902064

Citations 6

Authors

Joeri Kalter

Maike G Sweegers

Irma M Verdonck-de Leeuw

Johannes Brug

Laurien M Buffart

Affiliations

Soon will be listed here.

Abstract

Objective: Harmonizing individual patient data (IPD) for meta-analysis has clinical and statistical advantages. Harmonizing IPD from multiple studies may benefit from a flexible data harmonization platform (DHP) that allows harmonization of IPD already during data collection. This paper describes the development and use of a flexible DHP that was initially developed for the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) study.

Results: The DHP that we developed (I) allows IPD harmonization with a flexible approach, (II) has the ability to store data in a centralized and secured database server with large capacity, (III) is transparent and easy in use, and (IV) has the ability to export harmonized IPD and corresponding data dictionary to a statistical program. The DHP uses Microsoft Access as front-end application and requires a relational database management system such as Microsoft Structured Query Language (SQL) Server or MySQL as back-end application. The DHP consists of five user friendly interfaces which support the user to import original study data, to harmonize the data with a master data dictionary, and to export the harmonized data into a statistical software program of choice for further analyses. The DHP is now also adopted in two other studies.

Citing Articles

A General Primer for Data Harmonization.

Cheng C, Messerschmidt L, Bravo I, Waldbauer M, Bhavikatti R, Schenk C Sci Data. 2024; 11(1):152.

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Harmonization-Information Trade-Offs for Sharing Individual Participant Data in Biomedicine.

Torres-Espin A, Ferguson A Harv Data Sci Rev. 2022; 4(3).

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Spinal manipulative therapy in older adults with chronic low back pain: an individual participant data meta-analysis.

Jenks A, de Zoete A, van Tulder M, Rubinstein S Eur Spine J. 2022; 31(7):1821-1845.

PMID: 35633383 DOI: 10.1007/s00586-022-07210-1.

A Secure and Reusable Software Architecture for Supporting Online Data Harmonization.

Feric Z, Bohm Agostini N, Beene D, Signes-Pastor A, Halchenko Y, Watkins D Proc IEEE Int Conf Big Data. 2022; 2021:2801-2812.

PMID: 35449545 PMC: 9020435. DOI: 10.1109/bigdata52589.2021.9671538.

A Semi-Automated Term Harmonization Pipeline Applied to Pulmonary Arterial Hypertension Clinical Trials.

Urbanowicz R, Holmes J, Appleby D, Narasimhan V, Durborow S, Al-Naamani N Methods Inf Med. 2021; 61(1-02):3-10.

PMID: 34820791 PMC: 9978994. DOI: 10.1055/s-0041-1739361.

References

Stevens K . Systematic reviews: the heart of evidence-based practice. AACN Clin Issues. 2002; 12(4):529-38. DOI: 10.1097/00044067-200111000-00009. View

Riley R, Lambert P, Abo-Zaid G . Meta-analysis of individual participant data: rationale, conduct, and reporting. BMJ. 2010; 340:c221. DOI: 10.1136/bmj.c221. View

Griffith L, Shannon H, Wells R, Walter S, Cole D, Cote P . Individual participant data meta-analysis of mechanical workplace risk factors and low back pain. Am J Public Health. 2012; 102(2):309-18. PMC: 3483985. DOI: 10.2105/AJPH.2011.300343. View

Buffart L, Kalter J, Chinapaw M, Heymans M, Aaronson N, Courneya K . Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS): rationale and design for meta-analyses of individual patient data of randomized controlled trials that evaluate the effect of physical activity and psychosocial interventions on.... Syst Rev. 2013; 2:75. PMC: 3848838. DOI: 10.1186/2046-4053-2-75. View

Tudur Smith C, Dwan K, Altman D, Clarke M, Riley R, Williamson P . Sharing individual participant data from clinical trials: an opinion survey regarding the establishment of a central repository. PLoS One. 2014; 9(5):e97886. PMC: 4038514. DOI: 10.1371/journal.pone.0097886. View

Gaye A, Marcon Y, Isaeva J, Laflamme P, Turner A, Jones E . DataSHIELD: taking the analysis to the data, not the data to the analysis. Int J Epidemiol. 2014; 43(6):1929-44. PMC: 4276062. DOI: 10.1093/ije/dyu188. View

Tierney J, Vale C, Riley R, Tudur Smith C, Stewart L, Clarke M . Individual Participant Data (IPD) Meta-analyses of Randomised Controlled Trials: Guidance on Their Use. PLoS Med. 2015; 12(7):e1001855. PMC: 4510878. DOI: 10.1371/journal.pmed.1001855. View

Carter K, Francis R, Carter K, Francis R, Bresnahan M, Gissler M . ViPAR: a software platform for the Virtual Pooling and Analysis of Research Data. Int J Epidemiol. 2015; 45(2):408-416. PMC: 4864874. DOI: 10.1093/ije/dyv193. View

Buffart L, Kalter J, Sweegers M, Courneya K, Newton R, Aaronson N . Effects and moderators of exercise on quality of life and physical function in patients with cancer: An individual patient data meta-analysis of 34 RCTs. Cancer Treat Rev. 2016; 52:91-104. DOI: 10.1016/j.ctrv.2016.11.010. View

10.

de Zoete A, de Boer M, van Tulder M, Rubinstein S, Underwood M, Hayden J . Rational and design of an individual participant data meta-analysis of spinal manipulative therapy for chronic low back pain-a protocol. Syst Rev. 2017; 6(1):21. PMC: 5267437. DOI: 10.1186/s13643-017-0413-y. View

11.

Lakerveld J, Loyen A, Ling F, De Craemer M, van der Ploeg H, OGorman D . Identifying and sharing data for secondary data analysis of physical activity, sedentary behaviour and their determinants across the life course in Europe: general principles and an example from DEDIPAC. BMJ Open. 2017; 7(10):e017489. PMC: 5665252. DOI: 10.1136/bmjopen-2017-017489. View

12.

Kalter J, Verdonck-de Leeuw I, Sweegers M, Aaronson N, Jacobsen P, Newton R . Effects and moderators of psychosocial interventions on quality of life, and emotional and social function in patients with cancer: An individual patient data meta-analysis of 22 RCTs. Psychooncology. 2018; 27(4):1150-1161. PMC: 5947559. DOI: 10.1002/pon.4648. View

13.

Chalmers I . The Cochrane collaboration: preparing, maintaining, and disseminating systematic reviews of the effects of health care. Ann N Y Acad Sci. 1993; 703:156-63; discussion 163-5. DOI: 10.1111/j.1749-6632.1993.tb26345.x. View