PMID- 38364178
OWN - NLM
STAT- Publisher
LR  - 20240216
IS  - 1557-7740 (Electronic)
IS  - 1557-7740 (Linking)
DP  - 2024 Feb 16
TI  - Palliative Care Interventions for Persons With Neurodegenerative Disease: A 
      Scoping Review of Clinical Trial Study Design Features.
LID - 10.1089/jpm.2023.0603 [doi]
AB  - Background: Within palliative care research, best practice guidelines to conduct 
      scientifically rigorous clinical trials for neurodegenerative diseases are 
      underexplored. This patient population experiences unique challenges, including 
      fluctuations in cognitive capacity, care partner (CP) and proxy involvement, and 
      high adverse events (AEs), that necessitate special consideration when designing 
      clinical trials. Objective: The objective of this study was to describe and 
      identify clinical trial design features that have been documented in studies 
      involving a neuropalliative intervention for persons with neurodegenerative 
      diseases, highlighting features that have been adapted for this unique patient 
      population. Design: We conducted a scoping review of clinical trials with a 
      neuropalliative intervention for persons with neurodegenerative disease. We 
      searched Cochrane, Web of Science, EMBASE, Scopus, and PubMed (MEDLINE) databases 
      for articles published in English between 1950 and 2023. Two reviewers screened, 
      extracted, and synthesized data from the included articles. A third reviewer 
      adjudicated instances of conflict. The data were analyzed using a thematic 
      framework approach. Results: Of 1025 texts, 44 articles were included. Seven 
      study design features were analyzed: (1) consent, (2) proxies and CPs, (3) 
      recruitment strategies, (4) retention strategies, (5) choice of comparator, (6) 
      AEs, and (7) internal validity. This scoping review found disparities in study 
      design features around structured consent, proxies and CPs, comparators, and AEs. 
      Conclusions: To date, neuropalliative care clinical trials have had varied study 
      designs and the majority of research has focused on dementia. Research guideline 
      development for high-quality neuropalliative care clinical trials is greatly 
      needed across the range of neurodegenerative diseases. To increase the scientific 
      rigor of clinical trials and neuropalliative care, we recommend a standardized 
      capacity assessment for consent, defining conditions for the CP, proxy, and AEs, 
      systematizing appropriate comparators, and outlining preemptive recruitment and 
      retention strategies to address the broader unpredictable challenges of 
      palliative care research.
FAU - Ding, Jessica L
AU  - Ding JL
AD  - Division of Palliative Care and Geriatric Medicine, Mongan Institute Center for 
      Aging and Serious Illness, Massachusetts General Hospital, Boston, Massachusetts, 
      USA.
AD  - MD-PhD Program, Michigan State University, East Lansing, Michigan, USA.
FAU - Ritchie, Christine S
AU  - Ritchie CS
AD  - Division of Palliative Care and Geriatric Medicine, Mongan Institute Center for 
      Aging and Serious Illness, Massachusetts General Hospital, Boston, Massachusetts, 
      USA.
AD  - Harvard Medical School, Boston, Massachusetts, USA.
FAU - Vranceanu, Ana-Maria
AU  - Vranceanu AM
AD  - Harvard Medical School, Boston, Massachusetts, USA.
AD  - Center for Health Outcomes and Interdisciplinary Research, Department of 
      Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.
FAU - Mace, Ryan A
AU  - Mace RA
AD  - Harvard Medical School, Boston, Massachusetts, USA.
AD  - Center for Health Outcomes and Interdisciplinary Research, Department of 
      Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20240216
PL  - United States
TA  - J Palliat Med
JT  - Journal of palliative medicine
JID - 9808462
SB  - IM
OTO - NOTNLM
OT  - clinical trials
OT  - methods
OT  - neurodegenerative diseases
OT  - palliative care
OT  - study design
EDAT- 2024/02/16 18:44
MHDA- 2024/02/16 18:44
CRDT- 2024/02/16 15:43
PHST- 2024/02/16 18:44 [medline]
PHST- 2024/02/16 18:44 [pubmed]
PHST- 2024/02/16 15:43 [entrez]
AID - 10.1089/jpm.2023.0603 [doi]
PST - aheadofprint
SO  - J Palliat Med. 2024 Feb 16. doi: 10.1089/jpm.2023.0603.