PMID- 35252009
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220502
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 12
DP  - 2022
TI  - Adverse Events Reporting of Clinical Trials in Exercise Oncology Research 
      (ADVANCE): Protocol for a Scoping Review.
PG  - 841266
LID - 10.3389/fonc.2022.841266 [doi]
LID - 841266
AB  - INTRODUCTION: Adequate, transparent, and consistent reporting of adverse events 
      (AEs) in exercise oncology trials is critical to assess the safety of exercise 
      interventions for people following a cancer diagnosis. However, there is little 
      understanding of how AEs are reported in exercise oncology trials. Thus, we 
      propose to conduct a scoping review to summarise and evaluate current practice of 
      reporting of AEs in published exercise oncology trials with further exploration 
      of factors associated with inadequate reporting of AEs. The study findings will 
      serve to inform the need for future research on standardisation of the 
      definition, collection, and reporting of AEs for exercise oncology research. 
      MATERIALS AND METHODS: The ADVANCE (ADverse eVents reporting of clinicAl trials 
      iN exerCise oncology rEsearch) study will be conducted and reported following the 
      PRISMA extension for scoping reviews guideline. Any type of clinical trial 
      involving an exercise intervention in people living with and beyond cancer with a 
      full-text report in English will be included. Six electronic databases (Embase, 
      PubMed, Google Scholar, Web of Science Core Collection, SPORTDiscus, and CINAHL 
      Plus) will be searched for studies. Two independent review authors will assess 
      eligibility of identified studies, chart data using pre-established extraction 
      forms, and evaluate adequacy of reporting of AEs-related data against a 20-item 
      scoring checklist derived from the CONSORT (Consolidated Standards of Reporting 
      Trials) harms extension. We will summarise results using descriptive and 
      inferential analysis methods. ETHICS AND DISSEMINATION: No ethics approval will 
      be required to conduct the ADVANCE study owing to inclusion of only published 
      data. The study results will be disseminated via publications in peer-reviewed 
      journals and presentations at national and internationa  conferences. SYSTEMATIC 
      REVIEW REGISTRATION: Open Science Framework: https://osf.io/NXEJD/ 
      (doi:10.17605/OSF.IO/NXEJD).
CI  - Copyright (c) 2022 Luo, Schumacher, Galvao, Newton and Taaffe.
FAU - Luo, Hao
AU  - Luo H
AD  - Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, 
      Australia.
AD  - School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, 
      Australia.
FAU - Schumacher, Oliver
AU  - Schumacher O
AD  - Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, 
      Australia.
AD  - School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, 
      Australia.
FAU - Galvao, Daniel A
AU  - Galvao DA
AD  - Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, 
      Australia.
AD  - School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, 
      Australia.
FAU - Newton, Robert U
AU  - Newton RU
AD  - Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, 
      Australia.
AD  - School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, 
      Australia.
FAU - Taaffe, Dennis R
AU  - Taaffe DR
AD  - Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, 
      Australia.
AD  - School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, 
      Australia.
LA  - eng
PT  - Journal Article
DEP - 20220216
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC8889497
OTO - NOTNLM
OT  - adverse events
OT  - completeness of reporting
OT  - exercise
OT  - harms
OT  - knowledge synthesis
OT  - oncology
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/03/08 06:00
MHDA- 2022/03/08 06:01
PMCR- 2022/01/01
CRDT- 2022/03/07 06:07
PHST- 2021/12/22 00:00 [received]
PHST- 2022/01/18 00:00 [accepted]
PHST- 2022/03/07 06:07 [entrez]
PHST- 2022/03/08 06:00 [pubmed]
PHST- 2022/03/08 06:01 [medline]
PHST- 2022/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2022.841266 [doi]
PST - epublish
SO  - Front Oncol. 2022 Feb 16;12:841266. doi: 10.3389/fonc.2022.841266. eCollection 
      2022.