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Protocol - Hydroxyurea Adherence - Prospective Studies

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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

Available

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 CategoryRequired
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
StandardNameIDSource
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 IDVariable DescriptiondbGaP 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
SCD Pregnancy
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.