No abstract

Background There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including: adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues. Methods Half of the participants recruited from our rural, US comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including a bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, QOL, mood, and functional status were assessed every 3 months until death. Results Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and "usual care" control group contamination are described. Conclusions It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.

The Outlook intervention was acceptable to patients from a variety of educational and ethnic backgrounds and offers a brief, manualized, intervention for emotional and spiritual concerns.

When provided by a skilled, multidisciplinary team, palliative care is highly effective at addressing the physical, psychological, social, and spiritual needs of dying patients and their families. However, some patients who have witnessed harsh death want reassurance that they can escape if their suffering becomes intolerable. In addition, a small percentage of terminally ill patients receiving comprehensive care reach a point at which their suffering becomes severe and unacceptable despite unrestrained palliative efforts; some of these patients request that death be hastened. This paper presents terminal sedation and voluntary refusal of hydration and nutrition as potential last resorts that can be used to address the needs of such patients. These two practices allow clinicians to address a much wider range of intractable end-of-life suffering than physician-assisted suicide (even if it were legal) and can also provide alternatives for patients, families, and clinicians who are morally opposed to physician-assisted suicide. This paper will define the two practices, distinguish them from more standard palliative care interventions and from physician-assisted suicide, illustrate them with a real clinical scenario, provide potential guidelines and practicalities, and explore their moral and legal status. Although medicine cannot sanitize dying or provide perfect answers for all challenging end-of-life clinical problems, terminal sedation and voluntary refusal of hydration and nutrition substantially increase patients' choices at this inherently challenging time.

Quality of life (QOL) is an important outcome measure in caring for terminally ill patients. The Missoula-VITAS Quality of Life index (MVQOLI) has been developed to provide a measure of quality of life that is meaningful to both clinicians and patients. Unique features of the instrument include its focus on the terminal phase of life, the item structure and a scoring system that allows the weighting of each dimension of QOL by the respondent, and the subjective wording of the items that allows respondents to interpret the measured elements according to their own experience. The validity and reliability of the patient-reported survey instrument were tested by administering the 25-item questionnaire to 257 patients in 10 community-based hospices. Participants were incurably ill with predicted survival of six months or less. Exclusion criteria included inability to communicate, dementia, or psychological symptoms that might be intensified by completing the index. Reliability and validity of the new index were examined using standard statistical and psychometrical analyses. The MVQOLI demonstrated internal consistency (Cronbach's alpha = 0.77). MVQOLI total scores were correlated with scores on the Multidimensional Quality of Life Scale--Cancer 2 and with patient-reported global QOL ratings. MVQOLI scores did not correlate with observer-rated functional status scores indicating divergent validity. The MVQOLI could be completed by patients of varied educational level, age, functional status, and length of time with a terminal illness. The instrument is designed to contribute to the task of planning care by evaluating patient-identified sources of distress, strength and satisfaction, including issues of life closure. This information contributes to crafting highly specific interventions. Further studies are necessary to determine the usefulness of the instrument in measuring outcomes of end-of-life care in nonhospice settings, and for racial and diagnostic groups under-represented in this sample.