PMID- 31595803
OWN - NLM
STAT- MEDLINE
DCOM- 20201210
LR  - 20201214
IS  - 1941-837X (Electronic)
IS  - 1369-6998 (Linking)
VI  - 23
IP  - 3
DP  - 2020 Mar
TI  - Value of clinical trial narrative data to estimate the costs of adverse event 
      management: a feasibility study.
PG  - 213-220
LID - 10.1080/13696998.2019.1678479 [doi]
AB  - Aims: The objective of this feasibility study was to determine the extent to 
      which data from randomized controlled trials (RCTs) may serve as a useful source 
      for collecting health care resource use (HCRU) for the purposes of estimating 
      costs of managing adverse events (AEs), specifically, grade 3-4 nausea and 
      thrombocytopenia, which may be experienced during chemotherapy 
      treatment.Materials and Methods: The feasibility study was conducted in four 
      steps: (1) HCRU data were extracted from patient narratives in four phase 3 RCTs 
      in non-small cell lung cancer; (2) missing HCRU data were imputed; (3) unit costs 
      were applied to the resulting HCRU data set and costs of managing AEs were 
      estimated; and (4) the overall utility of using RCT data as a source for 
      estimating costs of AEs was evaluated.Results: 33 nausea and 68 thrombocytopenia 
      AEs met eligibility criteria and were evaluated in this study. Medication usage 
      was recorded as a treatment in 76% of nausea AEs, although only 14% of the 
      instances of medication usage included the minimum data elements required for 
      costing. Platelet transfusions were provided in 24% of thrombocytopenia AEs; 
      however, in only one instance were the minimum data elements recorded. Of nausea 
      and thrombocytopenia AEs, 18% and 72%, respectively, required no missing data 
      assumptions or imputation.Limitations: Only two AEs were considered, and they may 
      not be representative of all AEs in terms of suitability for use in estimating 
      HCRU and costs of managing AEs. Not all grade 3-4 AEs met the criteria for 
      requiring a patient narrative. HCRU data in the narratives were 
      incomplete.Conclusions: The usefulness of RCTs for estimating the costs of AEs 
      may be improved by using a standardized form to collect HCRU data for key AEs, 
      including an appropriate level of detail required to estimate costs of managing 
      the AEs.
FAU - Mladsi, Deirdre
AU  - Mladsi D
AUID- ORCID: 0000-0001-8113-1149
AD  - Health Economics, RTI Health Solutions, Research Triangle Park, NC, USA.
FAU - Hess, Lisa M
AU  - Hess LM
AUID- ORCID: 0000-0003-3631-3941
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Barnett, Christine L
AU  - Barnett CL
AD  - Health Economics, RTI Health Solutions, Research Triangle Park, NC, USA.
FAU - Njue, Annete
AU  - Njue A
AD  - Health Economics, RTI Health Solutions, Research Triangle Park, NC, USA.
FAU - Huang, Yu-Jing
AU  - Huang YJ
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Cui, Zhanglin Lin
AU  - Cui ZL
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Bowman, Lee
AU  - Bowman L
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20191023
PL  - England
TA  - J Med Econ
JT  - Journal of medical economics
JID - 9892255
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Antineoplastic Agents/*adverse effects/therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy
MH  - Costs and Cost Analysis
MH  - Feasibility Studies
MH  - Health Resources/*economics/*statistics & numerical data
MH  - Humans
MH  - Lung Neoplasms/*drug therapy
MH  - Nausea/chemically induced/economics
MH  - Platelet Count
MH  - Platelet Transfusion
MH  - Thrombocytopenia/chemically induced/economics
OTO - NOTNLM
OT  - I00
OT  - I10
OT  - Oncology
OT  - adverse event management
OT  - cancer
OT  - cost
OT  - health care resource use
OT  - nausea
OT  - thrombocytopenia
EDAT- 2019/10/10 06:00
MHDA- 2020/12/15 06:00
CRDT- 2019/10/10 06:00
PHST- 2019/10/10 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2019/10/10 06:00 [entrez]
AID - 10.1080/13696998.2019.1678479 [doi]
PST - ppublish
SO  - J Med Econ. 2020 Mar;23(3):213-220. doi: 10.1080/13696998.2019.1678479. Epub 2019 
      Oct 23.