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Compliance testing of patients in ADHD treatment with lisdexamphetamine (Elvanse®) using oral fluid as specimen.

ABSTRACT: Pharmacological treatment of the attention-deficit/hyperactivity disorder (ADHD) includes use of the psychostimulant amphetamine. Non-adherence to medication is a well-documented problem in ADHD treatment and a cause of treatment failure. The study evaluated the possibility of using oral fluid for compliance monitoring during treatment with lisdexamphetamine (Elvanse®). UPLC-MS/MS methods for general oral fluid drug testing, lisdexamphetamine and amphetamine quantification and chiral analysis of amphetamine were used. The applied measuring ranges were 1-500 ng/mL for amphetamine and 0.01-15 ng/mL for lisdexamphetamine. Amphetamine (racemic) was detected and quantified in 98 (96%) of the 102 samples. The concentrations ranged from 2 to 8410 ng/mL. In 17 of these, the chiral analysis demonstrated intake of illicit amphetamine because L-amphetamine was present. The median D- + L-amphetamine concentration in the compliant group was 280 ng/mL, while the median concentration in the non-compliant group was statistically higher, 1677 ng/mL. In the non-compliant cases where L-amphetamine was detected, the L/D-amphetamine ratios ranged from 0.75 to 13.1 with a median of 1.0. Lisdexamphetamine was detected and quantified in 76 of the 102 cases, which represent 79% of the 98 cases with detected oral fluid amphetamine. The concentrations ranged from 0.01 to 6895 ng/mL. Drug testing had a positive rate of 23% in patients not taking illicit amphetamine and 82% among non-compliant patients with detected L-amphetamine. In conclusion, the study demonstrated the value of measuring amphetamine with a chiral method to detect intake of illicit amphetamine and to perform drug testing in oral fluid as a mean for compliance monitoring.

SUBMITTER: Bottcher M

PROVIDER: S-EPMC8669447 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Considering the high clinical and forensic relevance of pharmaco-adherence during lisdexamphetamine (LDX) treatment for attention-deficit/hyperactivity disorder (ADHD), the aim here was to evaluate hair analysis as a tool for monitoring compliance in patients currently undergoing long term treatment with LDX, by detecting possible interruptions of medication intake or changes in dosage. For this purpose, a total of 24 patients from an outpatient clinic for ADHD were recruited. Hair and urine samples were taken after three consecutive therapy sessions over a 7-month period and analyzed for amphetamine (AMP) enantiomers and other drugs, using chiral and achiral liquid chromatography-tandem mass spectrometry (LC-MS/MS). Participants also provided information on the condition of their hair, the consumption of illegal psychotropic substances and the regularity of taking LDX. Two participants withdrew from the study early. Urine analyses were positive for D-AMP in all urine samples and therapy sessions, except in two patients who did not take LDX on a daily basis. D-AMP was detected in all hair samples; however, no correlation was found between prescribed dose/day and D-AMP concentrations in proximal hair segments. Qualitative interpretation of hair analysis showed that 18 of the 22 study completers were compliant concerning the intake of LDX without additional consumption of illegal D,L-AMP. Analysis of urine taken during the therapy sessions showed no correlation between D-AMP concentrations and prescribed dosage, with or without normalization for creatinine. In conclusion, chiral LC-MS/MS hair analysis might represent a non-invasive way to confirm LDX use within the approximate period covered by the hair segment tested, but it does not allow for quantitative therapeutic drug monitoring because of interindividual variability of concentrations in hair. Drug concentrations in hair at different stages of long-term treatment should thus be interpreted with caution by clinicians and forensic experts alike when making assessments of treatment adherence.

Project description:BackgroundThe United States FDA approved an over-the-counter HIV self-test, to facilitate increased HIV testing and earlier linkage to care. We assessed the accuracy of self-testing by untrained participants compared to healthcare worker (HCW) testing, participants' ability to interpret sample results and user-acceptability of self-tests in Singapore.Methodology/principal findingsA cross-sectional study, involving 200 known HIV-positive patients and 794 unknown HIV status at-risk participants was conducted. Participants (all without prior self-test experience) performed self-testing guided solely by visual instructions, followed by HCW testing, both using the OraQuick ADVANCE Rapid HIV 1/2 Antibody Test, with both results interpreted by the HCW. To assess ability to interpret results, participants were provided 3 sample results (positive, negative, and invalid) to interpret. Of 192 participants who tested positive on HCW testing, self-testing was positive in 186 (96.9%), negative in 5 (2.6%), and invalid in 1 (0.5%). Of 794 participants who tested negative on HCW testing, self-testing was negative in 791 (99.6%), positive in 1 (0.1%), and invalid in 2 (0.3%). Excluding invalid tests, self-testing had sensitivity of 97.4% (95% CI 95.1% to 99.7%) and specificity of 99.9% (95% CI: 99.6% to 100%). When interpreting results, 96%, 93.1% and 95.2% correctly read the positive, negative and invalid respectively. There were no significant demographic predictors for false negative self-testing or wrongly interpreting positive or invalid sample results as negative. Eighty-seven percent would purchase the kit over-the-counter; 89% preferred to take HIV tests in private. 72.5% and 74.9% felt the need for pre- and post-test counseling respectively. Only 28% would pay at least USD15 for the test.Conclusions/significanceSelf-testing was associated with high specificity, and a small but significant number of false negatives. Incorrectly identifying model results as invalid was a major reason for incorrect result interpretation. Survey responses were supportive of making self-testing available.

Project description:INTRODUCTION:HIV self-testing can increase coverage of essential HIV services. This study aimed to establish the acceptability, concordance and feasibility of supervised HIV self-testing among pregnant women in rural India. METHODS:A cross-sectional, mixed methods study was conducted among 202 consenting pregnant women in a rural Indian hospital between August 2014 and January 2015. Participants were provided with instructions on how to self-test using OraQuick(®) HIV antibody test, and subsequently asked to self-test under supervision of a community health worker. Test results were confirmed at a government-run integrated counselling and testing centre. A questionnaire was used to obtain information on patient demographics and the ease, acceptability and difficulties of self-testing. In-depth interviews were conducted with a sub-sample of 35 participants to understand their experiences. RESULTS:In total, 202 participants performed the non-invasive, oral fluid-based, rapid test under supervision for HIV screening. Acceptance rate was 100%. Motivators for self-testing included: ease of testing (43.4%), quick results (27.3%) and non-invasive procedure (23.2%). Sensitivity and specificity were 100% for 201 tests, and one test was invalid. Concordance of test result interpretation between community health workers and participants was 98.5% with a Cohen's Kappa (k) value of k=0.566 with p<0.001 for inter-rater agreement. Although 92.6% participants reported that the instructions for the test were easy to understand, 18.7% required the assistance of a supervisor to self-test. Major themes that emerged from the qualitative interviews indicated the importance of the following factors in influencing acceptability of self-testing: clarity and accessibility of test instructions; time-efficiency and convenience of testing; non-invasiveness of the test; and fear of incorrect results. Overall, 96.5% of the participants recommended that the OraQuick(®) test kits should become publicly available. CONCLUSIONS:Self-testing for HIV status using an oral fluid-based rapid test under the supervision of a community health worker was acceptable and feasible among pregnant women in rural India. Participants were supportive of making self-testing publicly available. Policy guidelines and implementation research are required to advance HIV self-testing for larger populations at scale.

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Compliance testing of patients in ADHD treatment with lisdexamphetamine (Elvanse®) using oral fluid as specimen.

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