Evidence map›Paper›PMID 31610273›Full record

ArticleJournal of pain and symptom management2020

Challenges in Implementing Hospice Clinical Trials: Preserving Scientific Integrity While Facing Change.

Debra Parker Oliver, Karla T Washington, George Demiris, Patrick White

Abstract read
In one paragraph

Article in Journal of pain and symptom management, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Cancer-Related Fatigue in Hospice: A Nudge to Action?Journal of pain and symptom management · 2023
    Article
  7. Article
  8. Older Adult Engagement With FacebookJournal of gerontological nursing · 2022
    Article
  9. Article
  10. Article
  11. Mixed methods analysis of hospice staff perceptions and shared decision making practices in hospice.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  12. Pediatric Concurrent Hospice Care: A Scoping Review and Directions for Future Nursing Research.Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association · 2020
    Article
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Debra Parker OliverDepartment of Family and Community Medicine, University of Missouri, Columbia, Missouri, USA. Electronic address: oliverdr@missouri.edu.
Karla T WashingtonDepartment of Family and Community Medicine, University of Missouri, Columbia, Missouri, USA.
George DemirisPenn Innovates Knowledge Professor, Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Patrick WhitePalliative Medicine and Supportive Care, Division of Palliative Medicine, Department of Internal Medicine, Washington University School of Medicine, Washington University, St. Louis, Missouri, USA.

Funding

ACCESS_Access for Cancer Caregivers to Education and Support for Shared decisionmakingR01CA203999 · NCI · WASHINGTON UNIVERSITY · PI PARKER OLIVER, DEBRA · 2017 to 2021
$3.6M
NCI NIH HHS R01 CA203999
6 · The paper itself

Abstract

BACKGROUND/

aimsNumerous changes can occur between the original design plans for clinical trials, the submission of funding proposals, and the implementation of the clinical trial. In the hospice setting, environmental changes can present significant obstacles, which require changes to the original plan designs, recruitment, and staffing. The purpose of the study was to share lessons and problem-solving strategies that can assist in future hospice trials.

methodsThis study uses one hospice clinical trial as an exemplar to demonstrate challenges for clinical trial research in this setting. Using preliminary data collected during the first months of a trial, the research team details the many ways their current protocol reflects changes from the originally proposed plans. Experiences are used as an exemplar to address the following questions: 1) How do research environments change between the initial submission of a funding proposal and the eventual award? 2) How can investigators maintain the integrity of the research and accommodate unexpected changes in the research environment?

resultsThe changing environment within the hospice setting required design, sampling, and recruitment changes within the first year. The decision-making process resulted in a stronger design with greater generalization. As a result of necessary protocol changes, the study results are positioned to be translational following the study conclusion.

conclusionResearchers would do well to review their protocol and statistics early in a clinical trial. They should be prepared for adjustments to accommodate market and environmental changes outside their control. Ongoing data monitoring, specifically related to recruitment, is advised.

Indexed as

Hospice CareHospicesHumanscluster crossover designs in hospiceHospice clinical trialpragmatic randomized clinical trials

Identifiers

PMID31610273
PMCPMC6989375

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.