Data cleaning and harmonization of clinical trial data: Medication-assisted treatment for opioid use disorder.
Several large-scale, pragmatic clinical trials on opioid use disorder (OUD) have been completed in the National Drug Abuse Treatment Clinical Trials Network (CTN). However, the resulting data have not been harmonized between the studies to compare the patient characteristics. This paper provides les...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2024-01-01
|
| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0312695 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849468092013346816 |
|---|---|
| author | Raymond R Balise Mei-Chen Hu Anna R Calderon Gabriel J Odom Laura Brandt Sean X Luo Daniel J Feaster |
| author_facet | Raymond R Balise Mei-Chen Hu Anna R Calderon Gabriel J Odom Laura Brandt Sean X Luo Daniel J Feaster |
| author_sort | Raymond R Balise |
| collection | DOAJ |
| description | Several large-scale, pragmatic clinical trials on opioid use disorder (OUD) have been completed in the National Drug Abuse Treatment Clinical Trials Network (CTN). However, the resulting data have not been harmonized between the studies to compare the patient characteristics. This paper provides lessons learned from a large-scale harmonization process that are critical for all biomedical researchers collecting new data and those tasked with combining datasets. We harmonized data from multiple domains from CTN-0027 (N = 1269), which compared methadone and buprenorphine at federally licensed methadone treatment programs; CTN-0030 (N = 653), which recruited patients who used predominantly prescription opioids and were treated with buprenorphine; and CTN-0051 (N = 570), which compared buprenorphine and extended-release naltrexone (XR-NTX) and recruited from inpatient treatment facilities. Patient-level data were harmonized and a total of 23 database tables, with meticulous documentation, covering more than 110 variables, along with three tables with "meta-data" about the study design and treatment arms, were created. Domains included: social and demographic characteristics, medical and psychiatric history, self-reported drug use details and urine drug screening results, withdrawal, and treatment drug details. Here, we summarize the numerous issues with the organization and fidelity of the publicly available data which were noted and resolved, and present results on patient characteristics across the three trials and the harmonized domains, respectively. A systematic harmonization of OUD clinical trial data can be accomplished, despite heterogeneous data coding and classification procedures, by standardizing commonly assessed characteristics. Similar methods, embracing database normalization and/or "tidy" data, should be used for future datasets in other substance use disorder clinical trials. |
| format | Article |
| id | doaj-art-2dde77f1a9714e1e8d5fb68938ca2e9a |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-2dde77f1a9714e1e8d5fb68938ca2e9a2025-08-20T03:25:57ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-011911e031269510.1371/journal.pone.0312695Data cleaning and harmonization of clinical trial data: Medication-assisted treatment for opioid use disorder.Raymond R BaliseMei-Chen HuAnna R CalderonGabriel J OdomLaura BrandtSean X LuoDaniel J FeasterSeveral large-scale, pragmatic clinical trials on opioid use disorder (OUD) have been completed in the National Drug Abuse Treatment Clinical Trials Network (CTN). However, the resulting data have not been harmonized between the studies to compare the patient characteristics. This paper provides lessons learned from a large-scale harmonization process that are critical for all biomedical researchers collecting new data and those tasked with combining datasets. We harmonized data from multiple domains from CTN-0027 (N = 1269), which compared methadone and buprenorphine at federally licensed methadone treatment programs; CTN-0030 (N = 653), which recruited patients who used predominantly prescription opioids and were treated with buprenorphine; and CTN-0051 (N = 570), which compared buprenorphine and extended-release naltrexone (XR-NTX) and recruited from inpatient treatment facilities. Patient-level data were harmonized and a total of 23 database tables, with meticulous documentation, covering more than 110 variables, along with three tables with "meta-data" about the study design and treatment arms, were created. Domains included: social and demographic characteristics, medical and psychiatric history, self-reported drug use details and urine drug screening results, withdrawal, and treatment drug details. Here, we summarize the numerous issues with the organization and fidelity of the publicly available data which were noted and resolved, and present results on patient characteristics across the three trials and the harmonized domains, respectively. A systematic harmonization of OUD clinical trial data can be accomplished, despite heterogeneous data coding and classification procedures, by standardizing commonly assessed characteristics. Similar methods, embracing database normalization and/or "tidy" data, should be used for future datasets in other substance use disorder clinical trials.https://doi.org/10.1371/journal.pone.0312695 |
| spellingShingle | Raymond R Balise Mei-Chen Hu Anna R Calderon Gabriel J Odom Laura Brandt Sean X Luo Daniel J Feaster Data cleaning and harmonization of clinical trial data: Medication-assisted treatment for opioid use disorder. PLoS ONE |
| title | Data cleaning and harmonization of clinical trial data: Medication-assisted treatment for opioid use disorder. |
| title_full | Data cleaning and harmonization of clinical trial data: Medication-assisted treatment for opioid use disorder. |
| title_fullStr | Data cleaning and harmonization of clinical trial data: Medication-assisted treatment for opioid use disorder. |
| title_full_unstemmed | Data cleaning and harmonization of clinical trial data: Medication-assisted treatment for opioid use disorder. |
| title_short | Data cleaning and harmonization of clinical trial data: Medication-assisted treatment for opioid use disorder. |
| title_sort | data cleaning and harmonization of clinical trial data medication assisted treatment for opioid use disorder |
| url | https://doi.org/10.1371/journal.pone.0312695 |
| work_keys_str_mv | AT raymondrbalise datacleaningandharmonizationofclinicaltrialdatamedicationassistedtreatmentforopioidusedisorder AT meichenhu datacleaningandharmonizationofclinicaltrialdatamedicationassistedtreatmentforopioidusedisorder AT annarcalderon datacleaningandharmonizationofclinicaltrialdatamedicationassistedtreatmentforopioidusedisorder AT gabrieljodom datacleaningandharmonizationofclinicaltrialdatamedicationassistedtreatmentforopioidusedisorder AT laurabrandt datacleaningandharmonizationofclinicaltrialdatamedicationassistedtreatmentforopioidusedisorder AT seanxluo datacleaningandharmonizationofclinicaltrialdatamedicationassistedtreatmentforopioidusedisorder AT danieljfeaster datacleaningandharmonizationofclinicaltrialdatamedicationassistedtreatmentforopioidusedisorder |