Measuring Outcomes in Randomized Prospective Trials in Palliative Care

Abstract

Palliative care aims to improve the quality of life of patients and their families and reduce suffering from life-threatening illness. In assessing palliative care efficacy, researchers must consider a broad range of potential outcomes, including those experienced by the patient's family/caregivers, clinicians, and the health care system. The purpose of this article is to summarize the discussions and recommendations of an Outcomes Working Group convened to advance the palliative care research agenda, particularly in the context of randomized controlled trials. These recommendations address the conceptualization of palliative care outcomes, sources of outcomes data, application of outcome measures in clinical trials, and the methodological challenges to outcome measurement in palliative care populations. As other fields have developed and refined methodological approaches that address their particular research needs, palliative care researchers must do the same to answer important clinical questions in rigorous and credible ways.

Family Caregivers and Palliative Care: Current Status and Agenda for the Future

“…22 May significantly enhance the well-being of patients when they are well supported. 41,42 interventions and to allow clinicians to effectively elicit, assess, and monitor caregivers' ongoing needs. 22 A systematic review undertaken to identify articles that described the use of instruments administered to family caregivers of palliative care patients (pre and post-bereavement) found that although a considerable variety of instruments have been administered to family caregivers, their validity is often lacking or is still being determined.…”

Guidelines for the Psychosocial and Bereavement Support of Family Caregivers of Palliative Care Patients

“…5 There are many reasons why family caregivers should be offered psychosocial support. 6 Caregivers typically are prone to physical and psychological morbidity; [7][8][9][10][11][12] are responsible for numerous tasks, such as symptom management; 8 are financially disadvantaged; 8,9,13 become socially isolated; 14 report unmet needs; 15 experience psychological distress at similar levels to patients; 16 are often not aware there is support available to them; 4 have needs equal to and/or greater than the needs of patients; 17 have very limited prior exposure to death and dying; 8,15 are often excluded from information and care planning and consequently feel underprepared for their role; 15,18 can improve the care of palliative care patients; [19][20][21] have the potential (with suitable support) to gain positive outcomes from the role; 9,15,22 are pivotal to achieving 'successful' home care (where most people prefer to die); 21,23,24 and make a very significant economic contribution to health care. 25 Even though there is a requirement for health and psychosocial care professionals to support family caregivers, the reality is that in many instances this support is suboptimal.…”

Reliability and Concurrent Validity of the Palliative Outcome Scale, the Rotterdam Symptom Checklist, and the Brief Pain Inventory

“…4,5 Among the recommendations proposed for measuring outcomes in randomized prospective trials in PC, especially stressed have been to use and to expand the testing of existing instruments for validity and reliability across diseases, settings, and populations. 6 In a previous study performed by the authors 7 to assess the clinical effectiveness of online versus traditional training in PC of primary care physicians, questionnaires were administered to patients to measure their symptom control and QOL through the short version of the Brief Pain Inventory (BPI) 8 and the Rotterdam Symptom Checklist (RSCL) 9 and to capture their global PC concerns though the Palliative Outcome Scale (POS). 10 These questionnaires, internationally recommended because of their adequate psychometric properties to assess the impact of symptoms and QOL upon patients with advanced cancer, 1,5,11 have been previously used to assess the effectiveness of the PC in Spanish clinical settings.…”