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Patient-Centered Research to Support the Development of the Symptoms of Major Depressive Disorder Scale (SMDDS): Initial Qualitative Research

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Abstract

Background

Content valid, patient-reported outcome (PRO) measures of major depressive disorder (MDD) symptoms are needed to assess MDD treatment benefit. While a range of questionnaires are currently available to evaluate aspects of depression from the patient’s perspective, their comprehensiveness and qualitative development histories are unclear.

Objective

The objective of this study was to describe the process and results of the preliminary qualitative development of a new symptom-based PRO measure intended to assess treatment benefit in MDD clinical trials.

Methods

Qualitative interviews were conducted with adult MDD patients in the USA who recently experienced a major depressive episode. Experienced interviewers conducted concept elicitation (CE) and cognitive interviews using semi-structured interview guides. The CE interview guide was used to elicit spontaneous reports of symptom experiences along with probing to further explore and confirm concepts. The cognitive interview guide was developed to evaluate concept relevance, understandability, and structure of the draft items, and to facilitate further instrument refinement.

Results

Forty patients participated in the CE interviews. A total of 3022 symptom codes, representing 84 different concepts were derived from the transcripts. Data from the CE interviews were considered alongside existing literature and clinical expert opinion during an item-generation process, leading to development of a preliminary version of the Symptoms of Major Depressive Disorder Scale (SMDDS). Fifteen patients participated in three waves of cognitive interviews, during which the SMDDS was further refined.

Conclusions

The SMDDS is a 35-item PRO measure intended for use as an endpoint in MDD clinical trials to support medical product labeling. The SMDDS uses a 7-day recall period and verbal rating scales. It was developed in accordance with the US Food and Drug Administration (FDA)’s PRO Guidance and best practices. Qualitative interviews have provided evidence for content validity. Future quantitative studies will confirm the SMDDS’s measurement properties and support FDA qualification.

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Acknowledgments

This research was funded by the following members of the PRO Consortium: AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, Forest Research Institute, Janssen, Pfizer, Roche Products Limited, Shire, Sunovion, and Takeda. The PRO Consortium receives support through Grant U01FD003865 from the United States Food and Drug Administration to the Critical Path Institute.

The authors would like to thank Linda Carpenter, MD and Madhukar Trivedi, MD for providing their clinical experience and insight to the development process as members of the clinical expert panel (in addition to Dr. Michael E. Thase, who also participated as an author). We would also like to thank Carla Ascoytia, Cecilia Dedios, and Matthew Wolfe for their valuable contributions to the study’s data collection and analysis efforts.

Conflict of interest disclosures

Linda S. Deal (Shire: employee, travel support, holder of stock/stock options), Lucy Abraham (Pfizer: employee, travel support, holder of stock/stock options), Steven I. Blum (Actavis/Forest Research Institute: employee, travel support, and stock/stock options), and Elizabeth N. Bush (Eli Lilly: employee, travel support, holder of stock/stock options) disclose their employment and other financial relationships with their respective firms.

Michael E. Thase has provided scientific consultation to Alkermes, AstraZeneca, Bristol-Myers Squibb Company, Dey Pharma, L.P., Eli Lilly and Company, Forest Pharmaceuticals, Inc., Gerson Lehman Group, GlaxoSmithKline, Guidepoint Global, H. Lundbeck A/S, Janssen Pharmaceuticals; MedAvante, Inc., Merck and Co. Inc., Neuronetics, Inc., Novartis, Otsuka, Ortho-McNeil Pharmaceuticals, PamLab, L.L.C., Pfizer (formerly Wyeth-Ayerst Laboratories), Schering-Plough (formerly Organon, Inc.), Shire US Inc., Sunovion Pharmaceuticals, Inc., Takeda (Lundbeck), and Transcept Pharmaceuticals. Dr. Thase receives grant funding from the Agency for Healthcare Research and Quality, Eli Lilly and Company, the National Institute of Mental Health, Otsuka Pharmaceuticals, and Sepracor, Inc. He has equity holdings in MedAvante, Inc. and receives royalty income from the American Psychiatric Foundation, Inc., Guilford Publications, Herald House, Oxford University Press, and W.W. Norton & Company. His wife is employed as the Group Scientific Director for Embryon—formerly Advogent, which does business with BMS and Pfizer/Wyeth.

Kelly P. McCarrier, Mona L. Martin, and Stephen Joel Coons declare no conflicts of interest.

Author contributions

All authors were involved in the conception and planning of the work that led to the manuscript, as well as interpretation of the data. Kelly P. McCarrier and Mona L. Martin also led the collection and analyses of the study data. All authors participated in drafting or critical revisions of the manuscript and approval of the final submitted version. Kelly P. McCarrier acts as overall guarantor for this study.

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Authors and Affiliations

  1. Health Research Associates, Inc., 6505 216th St. SW - Suite 105, Mountlake Terrace, WA, 98043, USA

    Kelly P. McCarrier & Mona L. Martin

  2. Clinical Outcomes Assessment, Shire, Wayne, PA, USA

    Linda S. Deal

  3. Outcomes and Evidence, Pfizer Ltd, Tadworth, Surrey, UK

    Lucy Abraham

  4. Patient Reported Outcomes, GlaxoSmithKline, King of Prussia, PA, USA

    Steven I. Blum

  5. PRO Center of Expertise, Eli Lilly and Company, Indianapolis, IN, USA

    Elizabeth Nicole Bush

  6. Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA

    Michael E. Thase

  7. Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, USA

    Michael E. Thase

  8. Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, AZ, USA

    Stephen Joel Coons

Authors
  1. Kelly P. McCarrier
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  2. Linda S. Deal
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  3. Lucy Abraham
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  4. Steven I. Blum
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  5. Elizabeth Nicole Bush
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  6. Mona L. Martin
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  7. Michael E. Thase
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  8. Stephen Joel Coons
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Consortia

On behalf of the PRO Consortium’s Depression Working Group

Corresponding author

Correspondence to Kelly P. McCarrier.

Additional information

Steven I. Blum was affiliated with Forest Research Institute, Jersey City, NJ, USA (now part of Actavis) at the time of his involvement in the study.

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McCarrier, K.P., Deal, L.S., Abraham, L. et al. Patient-Centered Research to Support the Development of the Symptoms of Major Depressive Disorder Scale (SMDDS): Initial Qualitative Research. Patient 9, 117–134 (2016). https://doi.org/10.1007/s40271-015-0132-1

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  • DOI: https://doi.org/10.1007/s40271-015-0132-1

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