Palliative Care Clinical Trials: Generalizability and Applicability in Hospice and Palliative Care Practice

  • David C. Currow
  • Amy P. Abernethy


Clinical practice in hospice and palliative care is underpinned by a strong evidence base which continues to develop rapidly. High quality clinical studies are being done that can, and should, directly inform practice.

An additional challenge to uptake of new evidence into practice in hospice and palliative care is the wide variation in service delivery models and the populations which are referred to those services. Approximately one in two people in resource-rich countries will be referred to hospice and palliative care but which one in two varies widely even within countries. This chapter sets out some key parameters for considering how to help researchers to describe their research in hospice and palliative care so that the reader can more easily apply the findings to their clinical practice. If this is done more systematically, it is hoped that this will aid the more timely uptake of evidence into practice in order to continue to improve patient outcomes. Such a process requires service and population descriptors for both the researchers and the person applying the research.


Palliative Care Coronary Care Unit Palliative Care Service Health Planner Clinical Discipline 
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  1. Abernethy, A. P., & Arnold, R. M. (2006). PC-FACS: A real-time evidence resource for busy palliative care clinicians. Journal of Palliative Medicine, 9(1), 24–28.PubMedCrossRefGoogle Scholar
  2. Abernethy, A. P., Basch, E., Bull, J., Cleeland, C. S., Currow, D. C., Fairclough, D., et al. (2010). A strategy to advance the evidence base in palliative medicine: Formation of a Palliative Care Research Cooperative group. Journal of Palliative Medicine, 13(12), 1407–1413.PubMedCrossRefGoogle Scholar
  3. Abernethy, A. P., & Currow, D. C. (2008). Culture and financing influence palliative care services, study populations, and generalizability of research findings [letter]. Journal of Palliative Medicine, 11(2), 146.PubMedCrossRefGoogle Scholar
  4. Addington-Hall, J., Altmann, D., & McCarthy, M. (1998). Which terminally ill cancer patients receive hospice in-patient care? Social Science & Medicine, 46, 1011–1016.CrossRefGoogle Scholar
  5. Bakitas, M. A., Lyons, K. D., Dixon, J., & Ahles, T. A. (2006). Palliative care program effectiveness research: Developing rigor in sampling design, conduct, and reporting. Journal of Pain and Symptom Management, 31, 270–284.PubMedCrossRefGoogle Scholar
  6. Bestall, J. C., Ahmed, N., Ahmedzai, S. H., Payne S.A., Noble B., Clark D. (2004). Access and referral to specialist palliative care: Patients’ and professionals’ experiences. International Journal of Palliative Nursing, 10, 381–389.PubMedGoogle Scholar
  7. Borgsteede, S. D., Deliens, L., Francke, A. L., Stalman W. A., Willems D. L., Van Eijk J. T., et al. (2006). Defining the patient population: One of the problems for palliative care research. Palliative Medicine, 20, 63–68.PubMedCrossRefGoogle Scholar
  8. Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis C. A., Glasziou P. P., Irwig L. M., et al. (2003). Towards ­complete and accurate reporting of studies of diagnostic accuracy: The STARD initiative. Clinical Chemistry, 49(1), 1–6.PubMedCrossRefGoogle Scholar
  9. Brouwers, M. C., Kho, M. E., Browman, G. P., Burgers J.S., Cluzeau F., Feder G., et al. (2010). Development of the AGREE II, part 1: Performance, usefulness and areas for improvement. Canadian Medical Association journal, 182(10), 1045–1052.PubMedCrossRefGoogle Scholar
  10. Cherny, N., Strasser, F., Abernethy, A. P., Sapir, R., Currow, D. C., & Zafar, S. Y. (2009). Improving the methodologic and ethical validity of best supportive care studies in oncology: Lessons from a systematic review. Journal of Clinical Oncology, 27(32), 5476–5486.PubMedCrossRefGoogle Scholar
  11. Clarke, M. (2000). The QUORUM statement. Lancet, 355(9205), 756–757.PubMedCrossRefGoogle Scholar
  12. Craig, J. C., Irwig, L. M., & Stockler, M. R. (2001). Evidence based medicine: Useful tools for decision making. The Medical Journal of Australia, 174, 248–253.PubMedGoogle Scholar
  13. Currow, D. C., Abernethy, A. P., & Fazekas, B. S. (2004). Palliative needs of whole populations: A comprehensive population approach to determining need. Palliative Medicine, 18, 239–247.PubMedCrossRefGoogle Scholar
  14. Currow, D. C., Abernethy, A. P., Shelby-James, T., & Phillips, P. A. (2006). Patient and service impacts of conducting a large palliative care clinical trial. Palliative Medicine, 20(8), 735–743.PubMedCrossRefGoogle Scholar
  15. Currow, D. C., Stevenson, J. P., Abernethy, A. P., Plummer, J., & Shelby-James, T. M. (2007). Prescribing in palliative care as death approaches. Journal of the American Geriatrics Society, 55(4), 590–595.PubMedCrossRefGoogle Scholar
  16. Currow, D. C., Wheeler, J., Glare, P., Kaasa S., Abernethy A. P. (2009). A framework for generalizability in palliative care. Journal of Pain and Symptom Management, 37, 373–386.PubMedCrossRefGoogle Scholar
  17. Dhruva, S. S., & Redberg, R. F. (2008). Variations between clinical trial participants and Medicare beneficiaries in evidence used for Medicare national coverage decisions. Archives of Internal Medicine, 168(2), 136–140.PubMedCrossRefGoogle Scholar
  18. Foley, K. M. (2003). Advancing palliative care in the United States. Palliative Medicine, 17(2), 89–91.PubMedCrossRefGoogle Scholar
  19. Francke, A., Smit, M., de Veer, A., Mistiaen P. (2008). Factors influencing the implementation of clinical guidelines for health care professionals: A systematic meta-review. BMC Medical Informatics and Decision Making, 8(1), 38.PubMedCrossRefGoogle Scholar
  20. Franks, P. J., Salisbury, C., Bosanquet, N., Wilkinson E. K., Kite S., Naysmith A., et al. (2000). The level of need for palliative care: A systematic review of the literature. Palliative Medicine, 14, 93–104.PubMedCrossRefGoogle Scholar
  21. Gott, M. C., Ahmedzai, S. H., & Wood, C. (2001). How many inpatients at an acute hospital have palliative care needs? Comparing the perspectives of medical and nursing staff. Palliative Medicine, 15, 451–460.PubMedCrossRefGoogle Scholar
  22. Green, L. W. (2006). Glasgow RE evaluating the relevance, generalization, and applicability of research: Issues in external validation and translation methodology. Evaluation & the Health Professions, 29, 126–152.CrossRefGoogle Scholar
  23. Higginson, I. J., & Addington-Hall, J. M. (1999). Palliative care needs to be provided on basis of need rather than diagnosis [letter]. British Medical Journal, 318, 123.PubMedCrossRefGoogle Scholar
  24. Jordhøy, M. S., Fayers, P. M., Ahlner-Elmqvist, M., Kaasa S. (2002). Lack of concealment may lead to selection bias in cluster randomized trials of palliative care. Palliative Medicine, 16(1), 43–49.PubMedCrossRefGoogle Scholar
  25. Jordhoy, M. S., Saltvedt, I., Fayers, P., Loge J. H., Ahlner-Elmqvist M., Kaasa S. (2003). Which cancer patients die in nursing homes? Quality of life, medical and sociodemographic characteristics. Palliative Medicine, 17, 433–444.PubMedCrossRefGoogle Scholar
  26. Lidstone, V., Butters, E., Seed, P. T., Sinnott C., Beynon T., Richards M. (2003). Symptoms and concerns amongst cancer outpatients: Identifying the need for specialist palliative care. Palliative Medicine, 17, 588–595.PubMedCrossRefGoogle Scholar
  27. O’Brien, M. A., Rogers, S., Jamtvedt, G., Oxman, A. D., Odgaard-Jensen, J., Kristoffersen, D. T., et al. (2007). Educational outreach visits: Effects on professional practice and health care outcomes. Cochrane Database of Systematic Reviews, (4), CD000409. doi:  10.1002/14651858.CD000409.pub2.
  28. Rosenwax, L. K., McNamara, B., Blackmore, A. M., & Holman, C. D. (2005). Estimating the size of a potential palliative care population. Palliative Medicine, 19, 556–562.PubMedCrossRefGoogle Scholar
  29. Sackett, D. L., & Rosenberg, W. M. (1995). On the need for evidence-based medicine. Journal of Public Health Medicine, 17(3), 330–334.PubMedGoogle Scholar
  30. Schulz, K. F., Altman, D. G., Moher, D., & For the CONSORT Group. (2010). CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials. Annals of Internal Medicine, 152, 726–732.PubMedCrossRefGoogle Scholar
  31. Stroup, D. F., Berlin, J. A., Morton, S. C., Olkin I., Williamson D. G., Rennie D., et al. (2000). Meta-analysis of observational studies in epidemiology (MOOSE) group. The Journal of the American Medical Association, 283(15), 2008–2012.CrossRefGoogle Scholar
  32. Tieman, J., Sladek, R., & Currow, D. C. (2008). Changes in the quantity and level of evidence of palliative and hospice care literature: The last century. Journal of Clinical Oncology, 26(35), 5679–5683.PubMedCrossRefGoogle Scholar
  33. Tinetti, M. E., Bogardus, S. T., Jr., & Agostini, J. V. (2004). Potential pitfalls of disease-specific guidelines for patients with multiple conditions. The New England Journal of Medicine, 351(27), 2870–2874.PubMedCrossRefGoogle Scholar
  34. Van Spall, H. G. C., Toren, A., Kiss, A., Fowler R. A. (2007). Eligibility criteria of randomized controlled trials published in high-impact general medical journals: A systematic sampling review. The Journal of the American Medical Association, 297(11), 1233–1240.CrossRefGoogle Scholar
  35. von Elm, E., Altman, D. G., Egger, M., et al. (2007). STROBE initiative. Strengthening the reporting of observational studies in epidemiology (STROBE) statement: Guidelines for reporting observational studies. British Medical Journal, 335(7624), 806–808.CrossRefGoogle Scholar
  36. Waller, A., Girgis, A., Johnson, C., Mitchell, G., Yates, P., Kristjanson, L., Tattersall, M., et al. (2010). Facilitating needs based cancer care for people with a chronic disease: Evaluation of an intervention using a multi-centre interrupted time series design. BMC Palliative Care, 9:2.PubMedCrossRefGoogle Scholar
  37. Wheeler, J. L., Green, A., Tieman, J. J., Abernethy, A. P., Currow, D. C. ( 2011). Characteristics of palliative care ­studies reported in the specialized literature. J Pain Symptom Manage. [Accepted 12 July 2011].PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2013

Authors and Affiliations

  1. 1.Discipline, Palliative and Supportive ServicesFlinders UniversityAdelaideAustralia
  2. 2.Department of Medicine, Division of Medical OncologyDuke University Medical CentreDurhamUSA

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