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Practice-based research network solutions to methodological challenges encountered in a national, prospective cohort study of mothers and newborns

Authors

  • Stacia A. Finch,

    1. Pediatric Research in Office Settings (PROS), Department of Research, American Academy of Pediatrics, Elk Grove Village, IL, Departments of
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  • Christina Lalama,

    1. Biostatistics and
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  • Cathie Spino,

    1. Department of Biostatistics, University of Michigan, Ann Arbor, MI,
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  • Heidi C. Schwartz,

    1. Pediatric Research in Office Settings (PROS), Department of Research, American Academy of Pediatrics, Elk Grove Village, IL, Departments of
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  • Richard C. Wasserman,

    1. Pediatric Research in Office Settings (PROS), Department of Research, American Academy of Pediatrics, Elk Grove Village, IL, Departments of
    2. Department of Pediatrics, University of Vermont, Burlington, VT, and
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  • Marie C. McCormick,

    1. Maternal and Child Health, Harvard School of Public Health, Boston, MA,
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  • Henry H. Bernstein

    Corresponding author
    1. General Pediatrics, Dartmouth Medical School, Children's Hospital at Dartmouth, Lebanon, NH, USA
      Henry H. Bernstein, D.O., Chief, General Academic Pediatrics, Dartmouth Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756, USA. E-mail: henry.bernstein@hitchcock.org
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Henry H. Bernstein, D.O., Chief, General Academic Pediatrics, Dartmouth Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756, USA. E-mail: henry.bernstein@hitchcock.org

Summary

The emergence of practice-based research networks (PBRN) has facilitated the execution of multifaceted community-based studies. As study complexity increases, so does the number of methodological barriers encountered. This paper's goal was to delineate methodological barriers and to evaluate the effectiveness of selected strategies and approaches developed and implemented in allowing a prospective, national PBRN cohort study to succeed in enrolling geographically dispersed mother/healthy term infant dyads (n = 4300) on the day of post-partum discharge. Specific methodological barriers included: (1) obtaining multiple Institutional Review Board (IRB) approvals; (2) gathering longitudinal data from multiple individuals; (3) soliciting multiple perspectives on discharge decision making; and (4) bolstering minority enrolment. The most effective strategies and approaches we employed to address these methodological challenges were: (1) preparing and distributing the ‘IRB Packet’; (2) recruiting multiple practices covered by the same IRB; and (3) obtaining supplemental funding for increasing minority enrolment. We expect that other PBRN investigators can benefit from our experience and solutions in the successful conduct of this multifaceted community-based study.

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