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Participant-centered adaptations in caregiver trials: strategies for managing confounds.

Publication ,  Journal Article
Davis, LL; Weaver, M; Habermann, B; Buckwalter, K
Published in: Nursing outlook
March 2005

Randomized trials have been criticized for being more protocol than participant-centered, with concerns raised about higher subject attrition and limited generalizability under controlled conditions. Informal caregivers are similar to other participants in community-based trials: many are unlikely to remain in a trial without procedural adaptations to meet some of their needs.This article discusses design and statistical strategies for tracking potential confounds associated with 3 participant-centered adaptations that may be made in community-based caregiver trials: tailoring multi-component interventions, using interpersonal contacts for participant maintenance, and non-blinding of trial participants. The intent of the article is to initiate dialogue on the seldom-discussed issue of participant-centered adaptations in community-based trials.Participant-centered adaptations may reduce subject attrition and enhance generalizability, but protocol adaptation can compromise trial integrity. The challenge for investigators is to develop scientifically sound methods for tracking / controlling potential confounds associated with each adaptation.

Duke Scholars

Published In

Nursing outlook

DOI

EISSN

1528-3968

ISSN

0029-6554

Publication Date

March 2005

Volume

53

Issue

2

Start / End Page

73 / 78

Related Subject Headings

  • Treatment Outcome
  • Research Personnel
  • Research Design
  • Randomized Controlled Trials as Topic
  • Professional-Patient Relations
  • Nursing
  • Morale
  • Linear Models
  • Informed Consent
  • Humans
 

Citation

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ICMJE
MLA
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Davis, L. L., Weaver, M., Habermann, B., & Buckwalter, K. (2005). Participant-centered adaptations in caregiver trials: strategies for managing confounds. Nursing Outlook, 53(2), 73–78. https://doi.org/10.1016/j.outlook.2004.05.005
Davis, Linda Lindsey, Michael Weaver, Barbara Habermann, and Kathleen Buckwalter. “Participant-centered adaptations in caregiver trials: strategies for managing confounds.Nursing Outlook 53, no. 2 (March 2005): 73–78. https://doi.org/10.1016/j.outlook.2004.05.005.
Davis LL, Weaver M, Habermann B, Buckwalter K. Participant-centered adaptations in caregiver trials: strategies for managing confounds. Nursing outlook. 2005 Mar;53(2):73–8.
Davis, Linda Lindsey, et al. “Participant-centered adaptations in caregiver trials: strategies for managing confounds.Nursing Outlook, vol. 53, no. 2, Mar. 2005, pp. 73–78. Epmc, doi:10.1016/j.outlook.2004.05.005.
Davis LL, Weaver M, Habermann B, Buckwalter K. Participant-centered adaptations in caregiver trials: strategies for managing confounds. Nursing outlook. 2005 Mar;53(2):73–78.
Journal cover image

Published In

Nursing outlook

DOI

EISSN

1528-3968

ISSN

0029-6554

Publication Date

March 2005

Volume

53

Issue

2

Start / End Page

73 / 78

Related Subject Headings

  • Treatment Outcome
  • Research Personnel
  • Research Design
  • Randomized Controlled Trials as Topic
  • Professional-Patient Relations
  • Nursing
  • Morale
  • Linear Models
  • Informed Consent
  • Humans