Methodological challenges in conducting instrumentation research in non-communicative palliative care patients.

Autor: Kaiser KS; Corporate Education, University of Maryland Capital Region Health, 3001 Hospital Drive, Cheverly, MD 20785-1189, United States of America. Electronic address: Karen.Kaiser@umm.edu., McGuire DB; Professor Emeritus, Virginia Commonwealth University School of Nursing, 1100 East Leigh St., Richmond, VA 23298-0567, United States of America., Keay TJ; Formerly: Department of Family and Community Medicine, Palliative Care, University of Maryland School of Medicine Baltimore, MD 21201, United States of America., Haisfield-Wolfe ME; Formerly: University of Maryland Baltimore School of Nursing, Baltimore, MD 21201, United States of America.
Jazyk: angličtina
Zdroj: Applied nursing research : ANR [Appl Nurs Res] 2020 Feb; Vol. 51, pp. 151199. Date of Electronic Publication: 2019 Nov 06.
DOI: 10.1016/j.apnr.2019.151199
Abstrakt: Well-designed, rigorously implemented instrumentation studies are essential to develop valid, reliable pain assessment tools in non-communicative (non-self-reporting) palliative care patients. When conducting a pain instrumentation study, a research team identified methodologic challenges surrounding informed consent, eligibility criteria, acute pain operational definitions, patient recruitment, missing data, and study-related training during a run-in phase at the beginning of the project and during the conduct of the study. The team dealt with these challenges through identifying root causes, implementing remedial measures, and collecting data to demonstrate improvement or resolution. Effective strategies included obtaining Institutional Review Board (IRB) approval for a waiver of informed consent, modifying eligibility criteria, ensuring that operational definitions and study procedures were consistent with clinical practice, decreasing time from screening to data collection to improve recruitment, increasing study nurse staffing by re-budgeting grant funds, focusing time and resources on high accruing clinical units, revising processes to minimize missing data, and developing detailed training for users of the instrument. With these multi-pronged solutions, the team exceeded the patient accrual target by 25% within the funding period and reduced missing data. While pain instrumentation studies in non-communicative patients have similar challenges to other palliative care studies, some of the solutions may be unique and several are applicable to other palliative care studies, particularly instrumentation research. The team's experience may also be useful for funders and IRBs.
(Copyright © 2019 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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