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Promoting evidence-based management of anemia in cancer patients: concurrent and discriminant validity of RESPOND, a web-based clinical guidance system based on the EORTC guidelines for supportive care in cancer

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Abstract

Goal of work

The goal of this study is to test the validity of RESPOND, a web-based decision support system to assess and manage anemia in cancer patients as per the European Organisation for Research and Treatment of Cancer (EORTC) guidelines. The intraclass correlation metrics for the algorithmic definitions were reported previously. Reported here are the concurrent validity, the extent to which clinicians' anemia management is guidelines-congruent when using the system; and discriminant validity, the extent to which clinicians practice in congruence with guidelines when vs. when not using the system.

Patients and methods

Hybrid matched design with precohort (retrospective; clinicians not using RESPOND) and postcohort (prospective; clinicians using RESPOND) of anemic patients matched on cancer type and chemotherapy regimen and followed up over 4 months after treatment initiation with erythropoietic proteins (34 patients per cohort; total N = 68). Congruence scores quantified the extent to which anemia management was congruent with the EORTC guidelines (range 0–10).

Main results

Hemoglobin (Hb) increased significantly for both cohorts, but the postcohort group showed more rapid rate of Hb increase over time (p < 0.006), higher Hb by visit 4 (p = 0.007), and greater Hb increase by visit 4 (p = 0.006). Concurrent validity was high with mean postcohort congruence scores of 8.18 ± 1.38. Discriminant validity was inferred from statistically significant differences in mean congruence scores between cohorts (p < 0.001) and from the postcohort having odds ratios of 3.64 for patients to reach Hb ≥ 11 g/dL and 2.91 to achieve Hb ≥ 12 g/dL.

Conclusions

RESPOND, a validated computerized clinical guidance system with an incremental effect beyond the pharmacotherapeutic effect of erythropoietic proteins, offers clinicians accurate and safe guidance in managing anemia in cancer patients.

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Acknowledgments

This study was supported by grants from F. Hoffmann-La Roche AG. The authors thank Matthew Abraham for the editorial and proofreading support.

Disclosures

Section I: Contributions to the Project

Project concept—methodological aspects and study paradigm: I. Abraham, K. MacDonald, M. Turner.

Project concept—application to oncology: M. Aapro, P. Soubeyran, M. Turner, H. Warrinnier.

Project concept—application to evidence-based medicine: J. Van Erps, M. Aapro, P. Soubeyran, M. Turner, K. MacDonald, T. Albrecht, I. Abraham.

Study design: I. Abraham, M. Aapro, K. MacDonald, M. Turner, H. Warrinnier.

Supervision of study implementation: K. MacDonald, I. Abraham, M. Turner, T. Albrecht, H. Warrinnier.

Quality assurance: K. MacDonald, T. Albrecht, I. Abraham.

Statistical plan: I. Abraham.

Manuscript preparation: I. Abraham.

Critical review of manuscript for intellectual content: J. Van Erps, M. Aapro, P. Soubeyran, M. Turner, K. MacDonald, T. Albrecht, I Abraham.

Section II: Conflict of Interest

J. Van Erps has consulted with, received research grants and contracts from, and/or served as a sponsored speaker for the following companies: Roche and Novartis. She declares no conflict with regard to the work described in this manuscript.

M. Aapro has consulted with, received research grants and contracts from, and/or served as a sponsored speaker for the following companies: Roche, Amgen, and Novartis. He declares no conflict of interest with regard to the work described in this manuscript.

I. Abraham and K. MacDonald have consulted with, received research grants and contracts from, and/or served as a sponsored speaker for the following companies and, as applicable, their subsidiaries: Novartis (including Novartis Oncology and Sandoz), Johnson & Johnson (including Centocor, Ortho-Biotech, Janssen Pharmaceutica, Janssen-Cilag, and Janssen-Ortho), Eli Lilly, Roche, Pfizer, Amgen, Merck, Bristol-Meyers Squibb, Schering-Plough, Astra-Zeneca, Bayer, GlaxoSmithKline, Lundbeck, and Innogenetics (including Xcellentis). Matrix45 has been contracted by sponsor to provide support and project conceptualization, project design, protocol development, development of project materials, training, project management and implementation, development of statistical plan, and quality assurance. Matrix45 provides similar services to other pharmaceutical companies. T. Albrecht is a part-time employee of Matrix45. Per company policy, I. Abraham, K. MacDonald, and T. Albrecht are barred from holding equity in any client companies and are subjected to internal and external review of their work to assure objectivity and transparency. They have taken the necessary steps to assure independence and do not declare a conflict of interest with regard to the work described in this manuscript.

P. Soubeyran has consulted with, received research grants and contracts from, and/or served as a sponsored speaker for the following companies: Roche, Amgen, Johnson & Johnson, Sanofi-Aventis, Schering AG, Schering-Plough, Pfizer, Chugai, and Baxter Oncology. He declares no conflict with regard to the work described in this manuscript.

M. Turner and Hans Warrinnier are employees of F. Hoffmann-La Roche and its subsidiaries. They have refrained from undue influence throughout the project and manuscript preparation.

Section III: Sponsor and Role of Sponsor

Sponsor: F. Hoffman-La Roche AG (Basel, Switzerland) and its subsidiaries provided financial support for the project. The sponsor has also committed internal resources to support the project.

Role or the sponsor: The study paradigm was developed independently and proposed to sponsor by I. Abraham and K. MacDonald. The application to cancer-related anemia was identified by the sponsor. The independent oncology experts (J. Van Erps, M. Aapro, and P. Soubeyran) were proposed by the sponsor. Collectively, the authors constituted the project team; employees of F. Hoffmann-La Roche AG and its subsidiaries listed as authors participated as members of the team. The manuscript was developed by members of the research team not affiliated with the sponsor. The sponsor had the right of review and comment. All final decisions regarding the content of the manuscript were made by the external members of the team. See also Section 1 supra.

Section IV: Role of the Medical Writer or Editor

No medical writer or editor was retained in the preparation of this manuscript. M. Abraham provided proofreading support and was funded under the manuscript preparation subcontract by the sponsor to Matrix45.

Author information

Authors and Affiliations

  1. Afdeling Oncologie en Hematologie, Algemeen Stedelijk Ziekenhuis Aalst, Merestraat 80, 9300, Aalst, Belgium

    Joanna Van Erps

  2. Institut Multidisciplinaire d’Oncologie, Clinique de Genolier, 1 Route du Muids, 1272, Genolier, Switzerland

    Matti Aapro

  3. Matrix45, 620 Frays Ridge Road, Earlysville, VA, 22936, USA

    Karen MacDonald & Ivo Abraham

  4. Institut Bergonié, 229 cours de l’Argonne, 33076, Bordeaux, France

    Pierre Soubeyran

  5. Université Victor Segalen Bordeaux 2, 146 rue Léo Saignat, 33076, Bordeaux, France

    Pierre Soubeyran

  6. F. Hoffmann-La Roche AG, Grenzacherstrasse, Bau 74, 4070, Basel, Switzerland

    Matthew Turner

  7. Roche, Dantestraat 75, 1070, Brussels, Belgium

    Hans Warrinnier

  8. School of Nursing, University of Virginia, 202 Jeanette Lancaster Way, Charlottesville, VA, 22903, USA

    Tara Albrecht

  9. Department of Pharmacy Practice and Science and Center for Health Outcomes and PharmacoEconomic Research, College of Pharmacy, University of Arizona, 1295 N. Martin Road, Tucson, AZ, 85721, USA

    Ivo Abraham

Authors
  1. Joanna Van Erps
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  7. Tara Albrecht
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Corresponding author

Correspondence to Ivo Abraham.

Additional information

Author Matthew Turner has left F. Hoffmann-La Roche, but was employed by this company at the time of the study.

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Van Erps, J., Aapro, M., MacDonald, K. et al. Promoting evidence-based management of anemia in cancer patients: concurrent and discriminant validity of RESPOND, a web-based clinical guidance system based on the EORTC guidelines for supportive care in cancer. Support Care Cancer 18, 847–858 (2010). https://doi.org/10.1007/s00520-009-0718-z

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