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Effective Health Care Program

Standardized Library of Depression Outcome Measures

White Paper

Investigators

Richard E. Gliklich, M.D.*

Michelle B. Leavy, M.P.H.*

Fang Li, MD, M.S.*

*OM1

On behalf of the Outcome Measures Framework (OMF) Depression Workgroup.

Abstract

Significant variation exists in both the types and definitions of outcome measures used in patient registries, even within the same clinical area. This variation reduces the utility of registries, making it difficult to compare, link, and aggregate data across the spectrum of clinical care and reporting. To address these limitations, the Agency for Healthcare Research and Quality (AHRQ) developed the Outcome Measures Framework (OMF), a conceptual model for classifying outcomes that are relevant to patients and providers across most conditions; it is intended to serve as a content model for developing harmonized outcome measures for specific clinical areas.1

AHRQ assessed the feasibility of using the OMF to develop standardized libraries of outcome measures in five clinical areas: atrial fibrillation,2 asthma, depression, lung cancer, and lumbar spondylolisthesis. These clinical areas represent diverse populations and care settings, different treatment modalities, and varying levels of harmonization. For each clinical area, the relevant registries and observational studies were identified, and registry sponsors, informaticists, and clinical subject matter experts are invited to participate in a registry group that focused on harmonizing outcome measures through a series of in-person and Web-based meetings. A stakeholder group, including payers, patient representatives, Federal partners, and health system leaders, was also assembled to discuss challenges and provide feedback on the harmonization effort.3

A key goal of this effort4 was to standardize the definitions of the components that make up the outcome measures, so users can understand the level of comparability between measures across different systems and studies. As a final step in the harmonization process, clinical informaticists map the narrative definitions (generated by the workgroups) to standardized terminologies to produce a library of common data definitions.

The narrative definitions for the minimum set of outcome measures produced by the Depression Workgroup are provided below.

Table 1. Harmonized definitions for depression outcome measures

OMF Category Outcome Measure Definition
Survival All-cause mortality Death from any cause, reported in 12-month intervals.
Survival Death from suicide Patient with a diagnosis of major depression or dysthymia who died from suicide, reported in 12-month intervals.

This should be captured where feasible; however, it should be noted that this information may not be recorded accurately or available to all providers.

Clinical Response Improvement in Depressive Symptoms—Remission Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial PHQ-9* score > 9 who demonstrates remission defined as a PHQ-9 score less than 5.

*The PHQ-9 or another brief, publicly available, validated patient-reported instrument with empirically derived cutpoints equivalent to the PHQ-9 cutpoints for remission and response and for which an evidence-based crosswalk to the PHQ-9 exists should be used to measure clinical response. Other measures may be used in addition for research or other purposes.

Timeframe for measurement:

  • 6 months (+/- 60 days)
  • 12 months (+/- 60 days)

In some implementations, it would beneficial to capture earlier responses and remissions and to obtain higher degrees of followup. Additional measurements outside of the windows listed above are recommended as supplemental measures.

Clinical Response Improvement in Depressive Symptoms—Response Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial PHQ-9* score > 9 who demonstrates a response to treatment defined as a PHQ-9 score that is reduced by 50% or greater from the initial PHQ-9 score.

*The PHQ-9 or another brief, publicly available, validated patient-reported instrument with empirically derived cutpoints equivalent to the PHQ-9 cutpoints for remission and response and for which an evidence-based crosswalk to the PHQ-9 exists should be used to measure clinical response. Other measures may be used in addition for research or other purposes.

Timeframe for measurement:

  • 6 months (+/- 60 days)
  • 12 months (+/- 60 days)

In some implementations, it would beneficial to capture earlier responses and remissions and to obtain higher degrees of followup. Additional measurements outside of the windows listed above are recommended as supplemental measures.

Clinical Response Worsening in Depressive Symptoms—Recurrence Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial PHQ-9* > 9 who demonstrates remission (defined as a PHQ-9 score < 5) of at least two months’ duration and subsequently experiences a recurrence of a depressive episode, defined as a 50% increase in PHQ-9 score or defined as a PHQ-9 score > 9 OR hospitalization for depression or suicidality.**

*The PHQ-9 or another brief, publicly available, validated patient-reported instrument with empirically derived cutpoints equivalent to the PHQ-9 cutpoints for remission and response and for which an evidence-based crosswalk to the PHQ-9 exists should be used to measure clinical response. Other measures may be used in addition for research or other purposes.

**This definition was proposed by the workgroup. Data accruing from ongoing registries are needed to assess the feasibility of using this definition to capture recurrence.

Timeframe for measurement:

  • 6 months (+/- 60 days)
  • 12 months (+/- 60 days)

In some implementations, it would beneficial to capture earlier responses and remissions and to obtain higher degrees of followup. Additional measurements outside of the windows listed above are recommended as supplemental measures.

Events of Interest Adverse Events Depression treatment-related adverse events. Use of a brief, publicly available, validated measurement tool to capture adverse events is recommended. Reported in 12-month intervals.
Events of Interest Suicide Ideation & Behavior Selection of "several days," "more than half the days," or "nearly every day" option on PHQ-9 item 9 ("Thoughts that you would be better off dead or of hurting yourself in some way").

Supplemental assessments of suicide ideation and behavior should be completed for patients who screen positive for suicide ideation on the PHQ-9 or when a clinician has concerns about suicidality. Supplemental assessments should be completed using an appropriate, brief, validated instrument, such as the Concise Health Risk Tracking (CHRT) scale. Includes nonfatal suicide attempts/suicide attempt behaviors, planning/preparatory acts, and active suicidal ideation.

Reported in 12-month intervals (in conjunction with the PHQ-9 suicide item).

Patient Reported Depression-specific Quality of Life Depression-specific quality of life should be measured using a brief, validated, publicly available instrument that is appropriate for the population of interest, such as the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Reported in 12-month intervals.
Resource Utilization Depression-related Resource Utilization All resource utilization (as measured by cost) related to treatment or management of depression, including medications, psychotherapy, office visits, urgent care center visits, emergency department visits, and hospitalizations. Reported in 12-month intervals.
Resource Utilization Work Productivity Work productivity loss (overall work impairment/absenteeism plus presenteeism), as measured by the Work Productivity and Activity Impairment Questionnaire (WPAI), reported in 12-month intervals.

 

Notes

  1. Gliklich RE, Leavy MB, Karl J, et al. A framework for creating standardized outcome measures for patient registries. Journal of Comparative Effectiveness Research. 2014;3(5):473-80.
  2. Calkins H, Gliklich RE, Leavy MB, et al. Harmonized outcome measures for use in atrial fibrillation patient registries and clinical practice: endorsed by the Heart Rhythm Society Board of Trustees. Heart Rhythm. 2019 Jan;(16)1:e3-e16.  doi: 10.1016/j.hrthm.2018.09.021.
  3. Leavy MB, Schur C, Kassamali FQ, Johnson ME, Sabharwal R, Wallace P, Gliklich RE. Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned. Final Report. (Prepared by L&M Policy Research, LLC under Contract No. 290-2014-00004-C) AHRQ Publication No. 19-EHC008-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2019.
  4. This work was supported by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund under Interagency Agreement #16-566R-16.