Long-term changes in management following n-of-1 trials of stimulants in attention-deficit/hyperactivity disorder

C. Jane Nikles, Geoffrey K. Mitchell, Chris B. Del Mar, Norma McNairn, Alexandra Clavarino

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13 Citations (Scopus)

Abstract

Objective: Our objective was to evaluate the long-term impact of n-of-1 trials-within-patient randomised, double-blind, cross-over comparisons of stimulant versus placebo or stimulant-on ADHD management. Methods: Telephone surveys at 3, 6 and 12 months. Main outcome measures included (1) changes in treatment before and after the n-of-1 trial, (2) congruence of management at follow-up with trial result, (3) reasons for any non-congruence, and (4) persistence of the joint patient-doctor decision over 12 months. Patients were children with clinically diagnosed ADHD, aged 5-16 years. Results: A total of 76 patients were followed up; 12 months' data were available for 67 (88%). Management changed from baseline for 46, 48 and 51% at 3, 6 and 12 months respectively. Most responders, 21/37 (57%), remained on the same stimulant at 12 months, compared to 9/24 (37%) non-responders. Of the remaining non-responders, 15/24 (62%) either switched (2/24, 8%) or ceased stimulants (13/24, 54%). The rate of congruence with the test result was 45/65 (69%) at 3 months, 44/67 (66%) at 6 months and 40/67 (60%) at 12 months. Persistence with the post-trial decision over 12 months was high (79-85%) whether the decision was to continue or to cease stimulants. Conclusions: Although not conclusive because there was no control group, our results suggest that n-of-1 trials may improve rational treatment of ADHD.

Original languageEnglish
Pages (from-to)985-989
Number of pages5
JournalEuropean Journal of Clinical Pharmacology
Volume63
Issue number11
DOIs
Publication statusPublished - Nov 2007

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Attention Deficit Disorder with Hyperactivity
Telephone
Joints
Placebos
Outcome Assessment (Health Care)
Control Groups
Therapeutics

Cite this

Nikles, C. Jane ; Mitchell, Geoffrey K. ; Del Mar, Chris B. ; McNairn, Norma ; Clavarino, Alexandra. / Long-term changes in management following n-of-1 trials of stimulants in attention-deficit/hyperactivity disorder. In: European Journal of Clinical Pharmacology. 2007 ; Vol. 63, No. 11. pp. 985-989.
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abstract = "Objective: Our objective was to evaluate the long-term impact of n-of-1 trials-within-patient randomised, double-blind, cross-over comparisons of stimulant versus placebo or stimulant-on ADHD management. Methods: Telephone surveys at 3, 6 and 12 months. Main outcome measures included (1) changes in treatment before and after the n-of-1 trial, (2) congruence of management at follow-up with trial result, (3) reasons for any non-congruence, and (4) persistence of the joint patient-doctor decision over 12 months. Patients were children with clinically diagnosed ADHD, aged 5-16 years. Results: A total of 76 patients were followed up; 12 months' data were available for 67 (88{\%}). Management changed from baseline for 46, 48 and 51{\%} at 3, 6 and 12 months respectively. Most responders, 21/37 (57{\%}), remained on the same stimulant at 12 months, compared to 9/24 (37{\%}) non-responders. Of the remaining non-responders, 15/24 (62{\%}) either switched (2/24, 8{\%}) or ceased stimulants (13/24, 54{\%}). The rate of congruence with the test result was 45/65 (69{\%}) at 3 months, 44/67 (66{\%}) at 6 months and 40/67 (60{\%}) at 12 months. Persistence with the post-trial decision over 12 months was high (79-85{\%}) whether the decision was to continue or to cease stimulants. Conclusions: Although not conclusive because there was no control group, our results suggest that n-of-1 trials may improve rational treatment of ADHD.",
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Long-term changes in management following n-of-1 trials of stimulants in attention-deficit/hyperactivity disorder. / Nikles, C. Jane; Mitchell, Geoffrey K.; Del Mar, Chris B.; McNairn, Norma; Clavarino, Alexandra.

In: European Journal of Clinical Pharmacology, Vol. 63, No. 11, 11.2007, p. 985-989.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Nikles, C. Jane

AU - Mitchell, Geoffrey K.

AU - Del Mar, Chris B.

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AU - Clavarino, Alexandra

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N2 - Objective: Our objective was to evaluate the long-term impact of n-of-1 trials-within-patient randomised, double-blind, cross-over comparisons of stimulant versus placebo or stimulant-on ADHD management. Methods: Telephone surveys at 3, 6 and 12 months. Main outcome measures included (1) changes in treatment before and after the n-of-1 trial, (2) congruence of management at follow-up with trial result, (3) reasons for any non-congruence, and (4) persistence of the joint patient-doctor decision over 12 months. Patients were children with clinically diagnosed ADHD, aged 5-16 years. Results: A total of 76 patients were followed up; 12 months' data were available for 67 (88%). Management changed from baseline for 46, 48 and 51% at 3, 6 and 12 months respectively. Most responders, 21/37 (57%), remained on the same stimulant at 12 months, compared to 9/24 (37%) non-responders. Of the remaining non-responders, 15/24 (62%) either switched (2/24, 8%) or ceased stimulants (13/24, 54%). The rate of congruence with the test result was 45/65 (69%) at 3 months, 44/67 (66%) at 6 months and 40/67 (60%) at 12 months. Persistence with the post-trial decision over 12 months was high (79-85%) whether the decision was to continue or to cease stimulants. Conclusions: Although not conclusive because there was no control group, our results suggest that n-of-1 trials may improve rational treatment of ADHD.

AB - Objective: Our objective was to evaluate the long-term impact of n-of-1 trials-within-patient randomised, double-blind, cross-over comparisons of stimulant versus placebo or stimulant-on ADHD management. Methods: Telephone surveys at 3, 6 and 12 months. Main outcome measures included (1) changes in treatment before and after the n-of-1 trial, (2) congruence of management at follow-up with trial result, (3) reasons for any non-congruence, and (4) persistence of the joint patient-doctor decision over 12 months. Patients were children with clinically diagnosed ADHD, aged 5-16 years. Results: A total of 76 patients were followed up; 12 months' data were available for 67 (88%). Management changed from baseline for 46, 48 and 51% at 3, 6 and 12 months respectively. Most responders, 21/37 (57%), remained on the same stimulant at 12 months, compared to 9/24 (37%) non-responders. Of the remaining non-responders, 15/24 (62%) either switched (2/24, 8%) or ceased stimulants (13/24, 54%). The rate of congruence with the test result was 45/65 (69%) at 3 months, 44/67 (66%) at 6 months and 40/67 (60%) at 12 months. Persistence with the post-trial decision over 12 months was high (79-85%) whether the decision was to continue or to cease stimulants. Conclusions: Although not conclusive because there was no control group, our results suggest that n-of-1 trials may improve rational treatment of ADHD.

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JO - European Journal of Clinical Pharmacology

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