PMID- 35045119
OWN - NLM
STAT- MEDLINE
DCOM- 20220221
LR  - 20230725
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 17
IP  - 1
DP  - 2022
TI  - Effect of adverse events on non-adherence and study non-completion in malaria 
      chemoprevention during pregnancy trial: A nested case control study.
PG  - e0262797
LID - 10.1371/journal.pone.0262797 [doi]
LID - e0262797
AB  - BACKGROUND: In drug trials, adverse events (AEs) burden can induce treatment 
      non-adherence or discontinuation. The non-adherence and discontinuation induce 
      selection bias, affecting drug safety interpretation. Nested case-control (NCC) 
      study can efficiently quantify the impact of the AEs, although choice of sampling 
      approach is challenging. We investigated whether NCC study with incidence density 
      sampling is more efficient than NCC with path sampling under conditional logistic 
      or weighted Cox models in assessing the effect of AEs on treatment non-adherence 
      and participation in preventive antimalarial drug during pregnancy trial. 
      METHODS: Using data from a trial of medication to prevent malaria in pregnancy 
      that randomized 600 women to receive chloroquine or sulfadoxine-pyrimethamine 
      during pregnancy, we conducted a NCC study assessing the role of prospectively 
      collected AEs, as exposure of interest, on treatment non-adherence and study 
      non-completion. We compared estimates from NCC study with incidence density 
      against those from NCC with path sampling under conditional logistic and weighted 
      Cox models. RESULTS: Out of 599 women with the outcomes of interest, 474 (79%) 
      experienced at least one AE before delivery. For conditional logistic model, the 
      hazard ratio for the effect of AE occurrence on treatment non-adherence was 0.70 
      (95% CI: 0.42, 1.17; p = 0.175) under incidence density sampling and 0.68 (95% 
      CI: 0.41, 1.13; p = 0.137) for path sampling. For study non-completion, the 
      hazard ratio was 1.02 (95% CI: 0.56, 1.83; p = 0.955) under incidence density 
      sampling and 0.85 (95% CI: 0.45, 1.60; p = 0.619) under path sampling. We 
      obtained similar hazard ratios and standard errors under incidence density 
      sampling and path sampling whether weighted Cox or conditional logistic models 
      were used. CONCLUSION: NCC with incidence density sampling and NCC with path 
      sampling are practically similar in efficiency whether conditional logistic or 
      weighted Cox analytical methods although path sampling uses more unique controls 
      to achieve the similar estimates. TRIAL REGISTRATION: ClinicalTrials.gov: 
      NCT01443130.
FAU - Patson, Noel
AU  - Patson N
AUID- ORCID: 0000-0002-3159-8207
AD  - School of Public Health, University of the Witwatersrand, Johannesburg, South 
      Africa.
AD  - School of Public Health and Family Medicine, College of Medicine, University of 
      Malawi, Blantyre, Malawi.
FAU - Mukaka, Mavuto
AU  - Mukaka M
AD  - Mahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand.
AD  - Centre for Tropical Medicine, Nuffield Department of Medicine, University of 
      Oxford, Oxford, United Kingdom.
FAU - Peterson, Ingrid
AU  - Peterson I
AD  - Center for Vaccine Development and Global Health, University of Maryland School 
      of Medicine, Baltimore, MD, United States of America.
FAU - Divala, Titus
AU  - Divala T
AUID- ORCID: 0000-0003-3029-9579
AD  - TB Centre, London School of Hygiene and Tropical Medicine, London, United 
      Kingdom.
AD  - Helse Nord Tuberculosis Initiative, College of Medicine, University of Malawi, 
      Blantyre, Malawi.
FAU - Kazembe, Lawrence
AU  - Kazembe L
AD  - Department of Biostatistics, University of Namibia, Windhoek, Namibia.
FAU - Mathanga, Don
AU  - Mathanga D
AD  - School of Public Health and Family Medicine, College of Medicine, University of 
      Malawi, Blantyre, Malawi.
FAU - Laufer, Miriam K
AU  - Laufer MK
AD  - Center for Vaccine Development and Global Health, University of Maryland School 
      of Medicine, Baltimore, MD, United States of America.
FAU - Chirwa, Tobias
AU  - Chirwa T
AD  - School of Public Health, University of the Witwatersrand, Johannesburg, South 
      Africa.
LA  - eng
SI  - ClinicalTrials.gov/NCT01443130
GR  - D43 TW010075/TW/FIC NIH HHS/United States
GR  - K24 AI114996/AI/NIAID NIH HHS/United States
GR  - U01 AI087624/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20220119
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Antimalarials)
RN  - 0 (Drug Combinations)
RN  - 37338-39-9 (fanasil, pyrimethamine drug combination)
RN  - 88463U4SM5 (Sulfadoxine)
RN  - 886U3H6UFF (Chloroquine)
RN  - Z3614QOX8W (Pyrimethamine)
SB  - IM
MH  - Antimalarials/therapeutic use
MH  - Case-Control Studies
MH  - Chemoprevention/methods
MH  - Chloroquine/therapeutic use
MH  - Data Analysis
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Malaria/*drug therapy/epidemiology
MH  - Medication Adherence/*psychology
MH  - Models, Theoretical
MH  - Pregnancy
MH  - Pregnancy Complications, Parasitic/epidemiology
MH  - Pyrimethamine/therapeutic use
MH  - Sulfadoxine/therapeutic use
PMC - PMC8769307
COIS- The authors have declared that no competing interests exist.
EDAT- 2022/01/20 06:00
MHDA- 2022/02/22 06:00
PMCR- 2022/01/19
CRDT- 2022/01/19 19:29
PHST- 2020/12/01 00:00 [received]
PHST- 2021/10/18 00:00 [accepted]
PHST- 2022/01/19 19:29 [entrez]
PHST- 2022/01/20 06:00 [pubmed]
PHST- 2022/02/22 06:00 [medline]
PHST- 2022/01/19 00:00 [pmc-release]
AID - PONE-D-20-37754 [pii]
AID - 10.1371/journal.pone.0262797 [doi]
PST - epublish
SO  - PLoS One. 2022 Jan 19;17(1):e0262797. doi: 10.1371/journal.pone.0262797. 
      eCollection 2022.