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The development of a mobile app-focused deduplication strategy for the Apple Heart Study that informs recommendations for future digital trials.

Publication ,  Journal Article
Garcia, A; Lee, J; Balasubramanian, V; Gardner, R; Gummidipundi, SE; Hung, G; Ferris, T; Cheung, L; Desai, S; Granger, CB; Hills, MT; Kowey, P ...
Published in: Stat (Int Stat Inst)
December 2022

An app-based clinical trial enrolment process can contribute to duplicated records, carrying data management implications. Our objective was to identify duplicated records in real time in the Apple Heart Study (AHS). We leveraged personal identifiable information (PII) to develop a dissimilarity score (DS) using the Damerau-Levenshtein distance. For computational efficiency, we focused on four types of records at the highest risk of duplication. We used the receiver operating curve (ROC) and resampling methods to derive and validate a decision rule to classify duplicated records. We identified 16,398 (4%) duplicated participants, resulting in 419,297 unique participants out of a total of 438,435 possible. Our decision rule yielded a high positive predictive value (96%) with negligible impact on the trial's original findings. Our findings provide principled solutions for future digital trials. When establishing deduplication procedures for digital trials, we recommend collecting device identifiers in addition to participant identifiers; collecting and ensuring secure access to PII; conducting a pilot study to identify reasons for duplicated records; establishing an initial deduplication algorithm that can be refined; creating a data quality plan that informs refinement; and embedding the initial deduplication algorithm in the enrolment platform to ensure unique enrolment and linkage to previous records.

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Published In

Stat (Int Stat Inst)

DOI

ISSN

2049-1573

Publication Date

December 2022

Volume

11

Issue

1

Start / End Page

e470

Location

United States

Related Subject Headings

  • 4905 Statistics
  • 0104 Statistics
 

Citation

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ICMJE
MLA
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Garcia, A., Lee, J., Balasubramanian, V., Gardner, R., Gummidipundi, S. E., Hung, G., … Apple Heart Study Investigators, . (2022). The development of a mobile app-focused deduplication strategy for the Apple Heart Study that informs recommendations for future digital trials. Stat (Int Stat Inst), 11(1), e470. https://doi.org/10.1002/sta4.470
Garcia, Ariadna, Justin Lee, Vidhya Balasubramanian, Rebecca Gardner, Santosh E. Gummidipundi, Grace Hung, Todd Ferris, et al. “The development of a mobile app-focused deduplication strategy for the Apple Heart Study that informs recommendations for future digital trials.Stat (Int Stat Inst) 11, no. 1 (December 2022): e470. https://doi.org/10.1002/sta4.470.
Garcia A, Lee J, Balasubramanian V, Gardner R, Gummidipundi SE, Hung G, et al. The development of a mobile app-focused deduplication strategy for the Apple Heart Study that informs recommendations for future digital trials. Stat (Int Stat Inst). 2022 Dec;11(1):e470.
Garcia, Ariadna, et al. “The development of a mobile app-focused deduplication strategy for the Apple Heart Study that informs recommendations for future digital trials.Stat (Int Stat Inst), vol. 11, no. 1, Dec. 2022, p. e470. Pubmed, doi:10.1002/sta4.470.
Garcia A, Lee J, Balasubramanian V, Gardner R, Gummidipundi SE, Hung G, Ferris T, Cheung L, Desai S, Granger CB, Hills MT, Kowey P, Nag D, Rumsfeld JS, Russo AM, Stein JW, Talati N, Tsay D, Mahaffey KW, Perez MV, Turakhia MP, Hedlin H, Desai M, Apple Heart Study Investigators. The development of a mobile app-focused deduplication strategy for the Apple Heart Study that informs recommendations for future digital trials. Stat (Int Stat Inst). 2022 Dec;11(1):e470.

Published In

Stat (Int Stat Inst)

DOI

ISSN

2049-1573

Publication Date

December 2022

Volume

11

Issue

1

Start / End Page

e470

Location

United States

Related Subject Headings

  • 4905 Statistics
  • 0104 Statistics