Designing Research With Hospice and Palliative Care Populations

Wohleber, Ashley M.; McKitrick, Daniel S.; Davis, Shawn

doi:10.1177/1049909111427139

Cited by 51 publications

(62 citation statements)

References 48 publications

(275 reference statements)

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“…First, it is a particular challenge to recruit patients to studies of palliative care, [42][43][44] and the patients being recruited into the HOT study were necessarily very unwell and reaching the end of their lives. Some centres found it difficult to approach such patients and, in some centres, the patients being recruited were predominantly cared for by other groups of health-care workers in their area, commonly in the areas of palliative care, elderly care and primary care.…”

Section: Synopsis Of Trial Evolutionmentioning

confidence: 99%

Does home oxygen therapy (HOT) in addition to standard care reduce disease severity and improve symptoms in people with chronic heart failure? A randomised trial of home oxygen therapy for patients with chronic heart failure

Clark

Johnson

Fairhurst

et al. 2015

Health Technol Assess

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BackgroundHome oxygen therapy (HOT) is commonly used for patients with severe chronic heart failure (CHF) who have intractable breathlessness. There is no trial evidence to support its use.ObjectivesTo detect whether or not there was a quality-of-life benefit from HOT given as long-term oxygen therapy (LTOT) for at least 15 hours per day in the home, including overnight hours, compared with best medical therapy (BMT) in patients with severely symptomatic CHF.DesignA pragmatic, two-arm, randomised controlled trial recruiting patients with severe CHF. It included a linked qualitative substudy to assess the views of patients using home oxygen, and a free-standing substudy to assess the haemodynamic effects of acute oxygen administration.SettingHeart failure outpatient clinics in hospital or the community, in a range of urban and rural settings.ParticipantsPatients had to have heart failure from any aetiology, New York Heart Association (NYHA) class III/IV symptoms, at least moderate left ventricular systolic dysfunction, and be receiving maximally tolerated medical management. Patients were excluded if they had had a cardiac resynchronisation therapy device implanted within the past 3 months, chronic obstructive pulmonary disease fulfilling the criteria for LTOT or malignant disease that would impair survival or were using a device or medication that would impede their ability to use LTOT.InterventionsPatients received BMT and were randomised (unblinded) to open-label LTOT, prescribed for 15 hours per day including overnight hours, or no oxygen therapy.Main outcome measuresThe primary end point was quality of life as measured by the Minnesota Living with Heart Failure (MLwHF) questionnaire score at 6 months. Secondary outcomes included assessing the effect of LTOT on patient symptoms and disease severity, and assessing its acceptability to patients and carers.ResultsBetween April 2012 and February 2014, 114 patients were randomised to receive either LTOT or BMT. The mean age was 72.3 years [standard deviation (SD) 11.3 years] and 70% were male. Ischaemic heart disease was the cause of heart failure in 84%; 95% were in NYHA class III; the mean left ventricular ejection fraction was 27.8%; and the median N-terminal pro-B-type natriuretic hormone was 2203 ng/l. The primary analysis used a covariance pattern mixed model which included patients only if they provided data for all baseline covariates adjusted for in the model and outcome data for at least one post-randomisation time point (n = 102: intervention,n = 51; control,n = 51). There was no difference in the MLwHF questionnaire score at 6 months between the two arms [at baseline the mean score was 54.0 (SD 18.4) for LTOT and 54.0 (SD 17.9) for BMT; at 6 months the mean score was 48.1 (SD 18.5) for LTOT and 49.0 (SD 20.2) for BMT; adjusted mean difference –0.10, 95% confidence interval (CI) –6.88 to 6.69;p = 0.98]. At 3 months, the adjusted mean MLwHF questionnaire score was lower in the LTOT group (–5.47, 95% CI –10.54 to –0.41;p = 0.03) and breathlessness scores improved, although the effect did not persist to 6 months. There was no effect of LTOT on any secondary measure. There was a greater number of deaths in the BMT arm (n = 12 vs.n = 6). Adherence was poor, with only 11% of patients reporting using the oxygen as prescribed.ConclusionsAlthough the study was significantly underpowered, HOT prescribed for 15 hours per day and subsequently used for a mean of 5.4 hours per day has no impact on quality of life as measured by the MLwHF questionnaire score at 6 months. Suggestions for future research include (1) a trial of patients with severe heart failure randomised to have emergency oxygen supply in the house, supplied by cylinders rather than an oxygen concentrator, powered to detect a reduction in admissions to hospital, and (2) a study of bed-bound patients with heart failure who are in the last few weeks of life, powered to detect changes in symptom severity.Trial registrationCurrent Controlled Trials ISRCTN60260702.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 75. See the NIHR Journals Library website for further project information.

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Section: Synopsis Of Trial Evolutionmentioning

confidence: 99%

Does home oxygen therapy (HOT) in addition to standard care reduce disease severity and improve symptoms in people with chronic heart failure? A randomised trial of home oxygen therapy for patients with chronic heart failure

Clark

Johnson

Fairhurst

et al. 2015

Health Technol Assess

View full text Add to dashboard Cite

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“…Questionnaires should be tested for example for test-retest reliability, inter-rater reliability, internal con-sistency, and face-and construct validity. Test-retest reliability is used to evaluate for stability over time but may be difficult if many traits change over time (Polit, Beck 2012), for instance for patients in palliative care with progressive diseases and sudden changes in symptoms (Wohleber, McKitrick et al 2012). A pilot study in a palliative care setting was performed.…”

Section: Methodological Issues and Limitationsmentioning

confidence: 99%

“…Patients may feel forced to participate in research, due to gratitude or dependence, which may affect voluntariness (Casarett, Karlawish 2000). Still, many patients willingly participate in order to help other patients (Wohleber, McKitrick et al 2012) and may also feel that they are able to make a useful contribution, despite their terminal illness (Terry, Olson et al 2006). A questionnaire survey may also cause discomfort and be burdensome (Wohleber, McKitrick et al 2012).…”

Section: Ethical Considerationsmentioning

confidence: 99%

“…It may be considered unethical not to include palliative care patients in research and to underestimate their capability to decide to participate in studies and give informed consent (Wohleber, McKitrick et al 2012). The risks and benefits of studies on patients in palliative care are not easy to assess (Casarett, Karlawish 2000) so research must carefully incorporate patients' preferences and expectations.…”

Section: Ethical Considerationsmentioning

confidence: 99%

“…Still, many patients willingly participate in order to help other patients (Wohleber, McKitrick et al 2012) and may also feel that they are able to make a useful contribution, despite their terminal illness (Terry, Olson et al 2006). A questionnaire survey may also cause discomfort and be burdensome (Wohleber, McKitrick et al 2012). Therefore, patients in current studies were encouraged to fill out the questionnaire with another person present.…”

Section: Ethical Considerationsmentioning

confidence: 99%

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Constipation in palliative care : Prevalence, definitions, symptom distress and risk-factors

Erichsén¹

2015

Linköping Studies in Health Sciences. Thesis

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Background and aims: Constipation for patients in palliative care is common and described with variations in prevalence. Side -effects from opioid- treatment, is considered to be one of the main factors leading to constipation. The overall aim of the thesis was to study constipation among patients admitted to specialized palliative care- settings in Sweden. The specific aims of the thesis were 1) To describe and explore the prevalence, definition and symptom distress of constipation by applying different definitions of constipation, in patients admitted to specialized palliative care settings in Sweden. 2) To identify factors related to constipation in patients in specialized palliative care and comparing these factors for patients with different types of constipation to patients without constipation. Methods: A literature- search were conducted where prevalence of- and factors related to constipation was explored and included in a questionnaire, developed for this thesis. Data was collected in a cross- sectional design with a response rate of 50% and analysed with logistic regression. Results: A total of 485 patients from 38 specialized palliative care- units in Sweden participated. Prevalence of constipation for patients in specialized palliative care varied between 7- 43 % depending on definition used. Two different constipation- groups were identified: Medical constipation- group 23% (MCG) and Perceived constipation- group 35% (PCG). Three sub- groups was also identified: patients with i) only ≤ 3 defecations/week, 7%, ii) only perception of being constipated, 19%, and iii) patients with both ≤ 3 defecations/ week and perception of being constipated,16%. Several factors were found to be related to constipation as hospitalisation, absence of laxative- treatment, haemorrhoids, poor appetite, hard stool form and opioids. Conclusions: Prevalence of constipation may differ depending on definitions used. Distress from constipation and other factors related to constipation, than opioids, needs to be incorporated into the clinical constipation- assessment. Validated constipation assessment tool needs to be developed.

The series name Linköping University, Studies in Health Sciences, Thesis in the Licentiate thesis is incorrect. The correct name is Linköping Studies in Health Sciences. Thesis.

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