Protocol - Hydroxyurea Adherence - Prospective Studies
Description
The protocol from THromboprophylaxis In Sickle cell disease with central venous catheters (THIS-1) study includes six items to be completed by a staff member/interviewer utilizing pill-counting, mathematical calculations, and medical record access to confirm the number of pills previously dispensed. If the participant is taking hydroxyurea, the interviewer completes the date and quantitative items in order to calculate the percent adherence.
Specific Instructions
The Sickle Cell Disease Pregnancy Working Group (WG) notes that participants are asked to bring their current hydroxyurea medication with them at the time of their appointment. The interviewer records the name of the medication, the strength, the number of pills dispensed, and the actual amount of pills taken since the previous visit. The interviewer calculates the amount taken by subtracting the number of tablets remaining from the number dispensed. The interviewer calculates the drug adherence percentage by dividing the amount taken by the amount dispensed and multiplying by 100%.
This is one way to measure hydroxyurea adherence for a prospective study. The WG suggests that investigators review this protocol as well: Adherence to Medication Regimens
Availability
Protocol
Hydroxyurea Adherence
1. Hydroxyurea
[ ] No
[ ] Yes
2. Tablets dispensed at last visit ___________
3. Date tablets returned ___________
4. Indicate number of tablets returned ___________
5. Tablets taken ___________
6. Drug adherence ___________%
Personnel and Training Required
Interviewer or other staff must assist participant by verifying the amount taken and calculating percent adherence.
Equipment Needs
None
Requirements
| Requirement Category | Required |
|---|---|
| Major equipment | No |
| Specialized training | No |
| Specialized requirements for biospecimen collection | No |
| Average time of greater than 15 minutes in an unaffected individual | No |
Mode of Administration
Interviewer-administered question, Medical record abstraction
Lifestage
Adolescent, Adult
Participants
Adult or adolescent with sickle cell disease and on hydroxyurea therapy.
Selection Rationale
These quantitative items from the THromboprophylaxis In Sickle cell disease with central venous catheters (THIS-1) protocol were selected as a straightforward measure of adherence in individuals taking hydroxyurea tablets.
Language
English
Standards
| Standard | Name | ID | Source |
|---|
Derived Variables
None
Process and Review
[include]
Protocol Name from Source
THromboprophylaxis In Sickle cell disease with central venous catheters (THIS-1)
Source
Abdulrehman, J., Forté, S., Tomlinson, G., Solh, Z., Bolster, L., Sun, H., Bartolucci, P., & Kuo, K. H. M. (2024). THromboprophylaxis In sickle cell disease with central venous catheters (THIS): An internal pilot randomised controlled trial protocol. BMJ Open, 14(1), e079363.
General References
Yang, M., Elmuti, L., & Badawy, S. M. (2022). Health-related quality of life and adherence to hydroxyurea and other disease-modifying therapies among individuals with sickle cell disease: a systematic review. BioMed Research International, 2022, 2122056. doi:10.1155/2022/2122056
Reddy, P. S., Cai, S. W., Barrera, L., King, K., & Badawy, S. M. (2022). Higher hydroxyurea adherence among young adults with sickle cell disease compared to children and adolescents. Annals of Medicine, 54(1), 683-693. doi:10.1080/07853890.2022.2044509
Badawy, S. M., Thompson, A. A., Lai, J. S., Penedo, F. J., Rychlik, K., & Liem, R. I. (2017). Adherence to hydroxyurea, health-related quality of life domains, and patients perceptions of sickle cell disease and hydroxyurea: A cross-sectional study in adolescents and young adults. Health and Quality of Life Outcomes, 15(1), 136. doi:10.1186/s12955-017-0713-x
Chan, A.H.Y., Horne, R., Hankins, M., & Chisari, C. (2020). The Medication Adherence Report Scale: A measurement tool for eliciting patients reports of nonadherence. Br J Clin Pharmacol, 86:1281-1288. https://doi.org/10.1111/bcp.14193
Protocol ID
890801
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX890801_Hydroxyurea_Adherence_Prospective_Studies_Adherence | ||||
| PX890801060000 | Drug adherence | N/A | ||
| PX890801_Hydroxyurea_Adherence_Prospective_Studies_Date_Returned | ||||
| PX890801030000 | Date tablets returned | N/A | ||
| PX890801_Hydroxyurea_Adherence_Prospective_Studies_Hydroxyurea | ||||
| PX890801010000 | Hydroxyurea | N/A | ||
| PX890801_Hydroxyurea_Adherence_Prospective_Studies_Qty_Returned | ||||
| PX890801040000 | Indicate number of tablets returned | N/A | ||
| PX890801_Hydroxyurea_Adherence_Prospective_Studies_Qty_Tablets | ||||
| PX890801020000 | Tablets dispensed at last visit | N/A | ||
| PX890801_Hydroxyurea_Adherence_Prospective_Studies_Taken | ||||
| PX890801050000 | Tablets taken | N/A | ||
Measure Name
Hydroxyurea Adherence - Prospective Studies
Release Date
August 5, 2024
Definition
This is a measure of adherence, the extent to which an individual’s behavior (such as medication taking) corresponds with agreed recommendations from a healthcare provider.
Purpose
Generally, adherence to medication is an important aspect of patient care. Nonadherence may lead to poor clinical outcomes, increased morbidity and mortality, and increased healthcare costs. Measuring adherence is also important to researchers because inaccurate estimates may lead to problems such as effective treatments judged as ineffective, treatment efficacy and dose-response relationships miscalculated, and results of clinical trials misinterpreted.
Keywords
Hydroxyurea, sickle cell disease therapy, medication adherence, medication compliance, drug adherence
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 890801 | Hydroxyurea Adherence - Prospective Studies |
Publications
There are no publications listed for this protocol.