Tracking medication changes to assess outcomes in comparative effectiveness research

A bipolar CHOICE study

Noreen A. Reilly-Harrington, Louisa G. Sylvia, Dustin J. Rabideau, Alexandra K. Gold, Thilo Deckersbach, Charles L. Bowden, William V. Bobo, Vivek Singh, Joseph R. Calabrese, Richard C. Shelton, Edward S. Friedman, Michael E. Thase, Masoud Kamali, Mauricio Tohen, Melvin G. McInnis, Susan L. McElroy, Terence A. Ketter, James H. Kocsis, Gustavo Kinrys, Andrew A. Nierenberg

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background Comparative effectiveness research uses multiple tools, but lacks outcome measures to assess large electronic medical records and claims data. Aggregate changes in medications in response to clinical need may serve as a surrogate outcome measure. We developed the Medication Recommendation Tracking Form (MRTF) to record the frequency, types, and reasons for medication adjustments in order to calculate Necessary Clinical Adjustments (NCAs), medication adjustments to reduce symptoms, maximize treatment response, or address problematic side effects. Methods The MRTF was completed at every visit for 482 adult patients in Bipolar CHOICE, a 6-month randomized comparative effectiveness trial. Results Responders had significantly fewer NCAs compared to non-responders. NCAs predicted subsequent response status such that every additional NCA during the previous visit decreased a patient's odds of response by approximately 30%. Patients with more severe symptoms had a greater number of NCAs at the subsequent visit. Patients with a comorbid anxiety disorder demonstrated a significantly higher rate of NCAs per month than those without a comorbid anxiety disorder. Patients with greater frequency, intensity, and interference of side effects had higher rates of NCAs. Participants with fewer NCAs reported a higher quality of life and decreased functional impairment. Limitations The MRTF has not been examined in community clinic settings and did not predict response more efficiently than the Clinical Global Impression-Bipolar Version (CGI-BP). Conclusions The MRTF is a feasible proxy of clinical outcome, with implications for clinical training and decision-making. Analyses of big data could use changes in medications as a surrogate outcome measure.

Original languageEnglish (US)
Pages (from-to)159-164
Number of pages6
JournalJournal of Affective Disorders
Volume205
DOIs
StatePublished - Nov 15 2016

Fingerprint

Comparative Effectiveness Research
Social Adjustment
Outcome Assessment (Health Care)
Anxiety Disorders
Electronic Health Records
Proxy

Keywords

  • Big data
  • Bipolar disorder
  • Comparative effectiveness
  • Electronic medical record
  • Medication

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology

Cite this

Reilly-Harrington, N. A., Sylvia, L. G., Rabideau, D. J., Gold, A. K., Deckersbach, T., Bowden, C. L., ... Nierenberg, A. A. (2016). Tracking medication changes to assess outcomes in comparative effectiveness research: A bipolar CHOICE study. Journal of Affective Disorders, 205, 159-164. https://doi.org/10.1016/j.jad.2016.07.007

Tracking medication changes to assess outcomes in comparative effectiveness research : A bipolar CHOICE study. / Reilly-Harrington, Noreen A.; Sylvia, Louisa G.; Rabideau, Dustin J.; Gold, Alexandra K.; Deckersbach, Thilo; Bowden, Charles L.; Bobo, William V.; Singh, Vivek; Calabrese, Joseph R.; Shelton, Richard C.; Friedman, Edward S.; Thase, Michael E.; Kamali, Masoud; Tohen, Mauricio; McInnis, Melvin G.; McElroy, Susan L.; Ketter, Terence A.; Kocsis, James H.; Kinrys, Gustavo; Nierenberg, Andrew A.

In: Journal of Affective Disorders, Vol. 205, 15.11.2016, p. 159-164.

Research output: Contribution to journalArticle

Reilly-Harrington, NA, Sylvia, LG, Rabideau, DJ, Gold, AK, Deckersbach, T, Bowden, CL, Bobo, WV, Singh, V, Calabrese, JR, Shelton, RC, Friedman, ES, Thase, ME, Kamali, M, Tohen, M, McInnis, MG, McElroy, SL, Ketter, TA, Kocsis, JH, Kinrys, G & Nierenberg, AA 2016, 'Tracking medication changes to assess outcomes in comparative effectiveness research: A bipolar CHOICE study', Journal of Affective Disorders, vol. 205, pp. 159-164. https://doi.org/10.1016/j.jad.2016.07.007
Reilly-Harrington, Noreen A. ; Sylvia, Louisa G. ; Rabideau, Dustin J. ; Gold, Alexandra K. ; Deckersbach, Thilo ; Bowden, Charles L. ; Bobo, William V. ; Singh, Vivek ; Calabrese, Joseph R. ; Shelton, Richard C. ; Friedman, Edward S. ; Thase, Michael E. ; Kamali, Masoud ; Tohen, Mauricio ; McInnis, Melvin G. ; McElroy, Susan L. ; Ketter, Terence A. ; Kocsis, James H. ; Kinrys, Gustavo ; Nierenberg, Andrew A. / Tracking medication changes to assess outcomes in comparative effectiveness research : A bipolar CHOICE study. In: Journal of Affective Disorders. 2016 ; Vol. 205. pp. 159-164.
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abstract = "Background Comparative effectiveness research uses multiple tools, but lacks outcome measures to assess large electronic medical records and claims data. Aggregate changes in medications in response to clinical need may serve as a surrogate outcome measure. We developed the Medication Recommendation Tracking Form (MRTF) to record the frequency, types, and reasons for medication adjustments in order to calculate Necessary Clinical Adjustments (NCAs), medication adjustments to reduce symptoms, maximize treatment response, or address problematic side effects. Methods The MRTF was completed at every visit for 482 adult patients in Bipolar CHOICE, a 6-month randomized comparative effectiveness trial. Results Responders had significantly fewer NCAs compared to non-responders. NCAs predicted subsequent response status such that every additional NCA during the previous visit decreased a patient's odds of response by approximately 30{\%}. Patients with more severe symptoms had a greater number of NCAs at the subsequent visit. Patients with a comorbid anxiety disorder demonstrated a significantly higher rate of NCAs per month than those without a comorbid anxiety disorder. Patients with greater frequency, intensity, and interference of side effects had higher rates of NCAs. Participants with fewer NCAs reported a higher quality of life and decreased functional impairment. Limitations The MRTF has not been examined in community clinic settings and did not predict response more efficiently than the Clinical Global Impression-Bipolar Version (CGI-BP). Conclusions The MRTF is a feasible proxy of clinical outcome, with implications for clinical training and decision-making. Analyses of big data could use changes in medications as a surrogate outcome measure.",
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T1 - Tracking medication changes to assess outcomes in comparative effectiveness research

T2 - A bipolar CHOICE study

AU - Reilly-Harrington, Noreen A.

AU - Sylvia, Louisa G.

AU - Rabideau, Dustin J.

AU - Gold, Alexandra K.

AU - Deckersbach, Thilo

AU - Bowden, Charles L.

AU - Bobo, William V.

AU - Singh, Vivek

AU - Calabrese, Joseph R.

AU - Shelton, Richard C.

AU - Friedman, Edward S.

AU - Thase, Michael E.

AU - Kamali, Masoud

AU - Tohen, Mauricio

AU - McInnis, Melvin G.

AU - McElroy, Susan L.

AU - Ketter, Terence A.

AU - Kocsis, James H.

AU - Kinrys, Gustavo

AU - Nierenberg, Andrew A.

PY - 2016/11/15

Y1 - 2016/11/15

N2 - Background Comparative effectiveness research uses multiple tools, but lacks outcome measures to assess large electronic medical records and claims data. Aggregate changes in medications in response to clinical need may serve as a surrogate outcome measure. We developed the Medication Recommendation Tracking Form (MRTF) to record the frequency, types, and reasons for medication adjustments in order to calculate Necessary Clinical Adjustments (NCAs), medication adjustments to reduce symptoms, maximize treatment response, or address problematic side effects. Methods The MRTF was completed at every visit for 482 adult patients in Bipolar CHOICE, a 6-month randomized comparative effectiveness trial. Results Responders had significantly fewer NCAs compared to non-responders. NCAs predicted subsequent response status such that every additional NCA during the previous visit decreased a patient's odds of response by approximately 30%. Patients with more severe symptoms had a greater number of NCAs at the subsequent visit. Patients with a comorbid anxiety disorder demonstrated a significantly higher rate of NCAs per month than those without a comorbid anxiety disorder. Patients with greater frequency, intensity, and interference of side effects had higher rates of NCAs. Participants with fewer NCAs reported a higher quality of life and decreased functional impairment. Limitations The MRTF has not been examined in community clinic settings and did not predict response more efficiently than the Clinical Global Impression-Bipolar Version (CGI-BP). Conclusions The MRTF is a feasible proxy of clinical outcome, with implications for clinical training and decision-making. Analyses of big data could use changes in medications as a surrogate outcome measure.

AB - Background Comparative effectiveness research uses multiple tools, but lacks outcome measures to assess large electronic medical records and claims data. Aggregate changes in medications in response to clinical need may serve as a surrogate outcome measure. We developed the Medication Recommendation Tracking Form (MRTF) to record the frequency, types, and reasons for medication adjustments in order to calculate Necessary Clinical Adjustments (NCAs), medication adjustments to reduce symptoms, maximize treatment response, or address problematic side effects. Methods The MRTF was completed at every visit for 482 adult patients in Bipolar CHOICE, a 6-month randomized comparative effectiveness trial. Results Responders had significantly fewer NCAs compared to non-responders. NCAs predicted subsequent response status such that every additional NCA during the previous visit decreased a patient's odds of response by approximately 30%. Patients with more severe symptoms had a greater number of NCAs at the subsequent visit. Patients with a comorbid anxiety disorder demonstrated a significantly higher rate of NCAs per month than those without a comorbid anxiety disorder. Patients with greater frequency, intensity, and interference of side effects had higher rates of NCAs. Participants with fewer NCAs reported a higher quality of life and decreased functional impairment. Limitations The MRTF has not been examined in community clinic settings and did not predict response more efficiently than the Clinical Global Impression-Bipolar Version (CGI-BP). Conclusions The MRTF is a feasible proxy of clinical outcome, with implications for clinical training and decision-making. Analyses of big data could use changes in medications as a surrogate outcome measure.

KW - Big data

KW - Bipolar disorder

KW - Comparative effectiveness

KW - Electronic medical record

KW - Medication

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