Recommendations for managing missing data, attrition and response shift in palliative and end-of-life care research: part of the MORECare research method guidance on statistical issues.

BACKGROUND: Statistical analysis in palliative and end-of-life care research can be problematic due to high levels of missing data, attrition and response shift as disease progresses. AIM: To develop recommendations about managing missing data, attrition and response shift in palliative and end-of-life care research data. DESIGN: We used the MORECare Transparent Expert Consultation approach to conduct a consultation workshop with experts in statistical methods in palliative and end-of-life care research. Following presentations and discussion, nominal group techniques were used to produce recommendations about attrition, missing data and response shift. These were rated online by experts and analysed using descriptive statistics for consensus and importance. RESULTS: In total, 20 participants attended the workshop and 19 recommendations were subsequently ranked. There was broad agreement across recommendations. The top five recommendations were as follows: A taxonomy should be devised to define types of attrition. Types and amount of missing data should be reported with details of imputation methods. The pattern of missing data should be investigated to inform the imputation approach. A statistical analysis plan should be pre-specified in the protocol. High rates of attrition should be assumed when planning studies and specifying analyses. The leading recommendation for response shift was for more research. CONCLUSIONS: When designing studies in palliative and end-of-life care, it is recommended that high rates of attrition should not be seen as indicative of poor design and that a clear statistical analysis plan is in place to account for missing data and attrition.

MORECare research methods guidance development: recommendations for ethical issues in palliative and end-of-life care research.

BACKGROUND: There is little guidance on the particular ethical concerns that research raises with a palliative care population. AIM: To present the process and outcomes of a workshop and consensus exercise on agreed best practice to accommodate ethical issues in research on palliative care. DESIGN: Consultation workshop using the MORECare Transparent Expert Consultation approach. Prior to workshops, participants were sent overviews of ethical issues in palliative care. Following the workshop, nominal group techniques were used to produce candidate recommendations. These were rated online by participating experts. Descriptive statistics were used to analyse agreement and consensus. Narrative comments were collated. SETTING/PARTICIPANTS: Experts in ethical issues and palliative care research were invited to the Cicely Saunders Institute in London. They included senior researchers, service providers, commissioners, researchers, members of ethics committees and policy makers. RESULTS: The workshop comprised 28 participants. A total of 16 recommendations were developed. There was high agreement on the issue of research participation and high to moderate agreement on applications to research ethics committees. The recommendations on obtaining and maintaining consent from patients and families were the most contentious. Nine recommendations were refined on the basis of the comments from the online consultation. CONCLUSIONS: The culture surrounding palliative care research needs to change by fostering collaborative approaches between all those involved in the research process. Changes to the legal framework governing the research process are required to enhance the ethical conduct of research in palliative care. The recommendations are relevant to all areas of research involving vulnerable adults.

Cross-cultural validation of the Falls Efficacy Scale International (FES-I) in older people: results from Germany, the Netherlands and the UK were satisfactory.

PURPOSE: To carry out a cross-cultural validation of the Falls Efficacy Scale International (FES-I), a 16-item modified version of the Falls Efficacy Scale that was developed to assess both easy and more complex physical and social activities, in a range of languages and different cultural contexts. METHOD: Data were collected in Germany (n = 94), The Netherlands (n = 193), and the UK (n = 178) in samples of older people living in the community. Four-week FES-I re-test data were collected in Germany and The Netherlands. Descriptive statistics and reliability estimates were computed as well as FES-I sum scores according to age, sex, falls history and fear of falling. RESULTS: Mean inter-item correlations were all above 0.38 and internal reliability estimates were all 0.90 or above. The intra-class correlation coefficients in the German and the Dutch sample were 0.79 and 0.82, respectively. As expected, FES-I scores were associated with age, sex, falls history and fear of falling. In addition, the FES-I discriminated between sub-groups somewhat better than the original ten-item FES scale. CONCLUSIONS: The FES-I has been shown to have acceptable reliability and construct validity in different samples in different countries and may be used in cross-cultural rehabilitation research and clinical trials.

Older people's views of falls-prevention interventions in six European countries.

PURPOSE: Our study identified factors common to a variety of populations and settings that may promote or inhibit uptake and adherence to falls-related interventions. DESIGN AND METHODS: Semistructured interviews to assess perceived advantages and barriers to taking part in falls-related interventions were carried out in six European countries with 69 people aged 68 to 97 years. The sample was selected to include people with very different experiences of participation or nonparticipation in falls-related interventions, but all individuals were asked about interventions that included strength and balance training. RESULTS: Attitudes were similar in all countries and contexts. People were motivated to participate in strength and balance training by a wide range of perceived benefits (interest and enjoyment, improved health, mood, and independence) and not just reduction of falling risk. Participation also was encouraged by a personal invitation from a health practitioner and social approval from family and friends. Barriers to participation included denial of falling risk, the belief that no additional falls-prevention measures were necessary, practical barriers to attendance at groups (e.g., transport, effort, and cost), and a dislike of group activities. IMPLICATIONS: Because many older people reject the idea that they are at risk of falling, the uptake of strength and balance training programs may be promoted more effectively by maximizing and emphasizing their multiple positive benefits for health and well-being. A personal invitation from a health professional to participate is important, and it also may be helpful to provide home-based programs for those who dislike or find it difficult to attend groups.

The clinical and cost effectiveness of a Breathlessness Intervention Service for patients with advanced non-malignant disease and their informal carers: mixed findings of a mixed method randomised controlled trial.

BACKGROUND: Breathlessness is the most common and intrusive symptom of advanced non-malignant respiratory and cardiac conditions. The Breathlessness Intervention Service (BIS) is a multi-disciplinary complex intervention, theoretically underpinned by a palliative care approach, utilising evidence-based non-pharmacological and pharmacological interventions to support patients with advanced disease in managing their breathlessness. Having published the effectiveness and cost effectiveness of BIS for patients with advanced cancer and their carers, we sought to establish its effectiveness, and cost effectiveness, in advanced non-malignant conditions. METHODS: This was a single-centre Phase III fast-track single-blind mixed method RCT of BIS versus standard care for breathless patients with non-malignant conditions and their carers. Randomisation was to one of two groups (randomly permuted blocks). Eighty-seven patients referred to BIS were randomised (intervention arm n = 44; control arm n = 43 received BIS after four-week wait); 79 (91 %) completed to key outcome measurement. The primary outcome measure was 0-10 numeric rating scale for patient distress due to breathlessness at four weeks. Secondary outcome measures were Chronic Respiratory Questionnaire, Hospital Anxiety and Depression Scale, Client Service Receipt Inventory, EQ-5D and topic-guided interviews. RESULTS: Qualitative analyses showed the positive impact of BIS on patients with non-malignant conditions and their carers; quantitative analyses showed a non-significant greater reduction in the primary outcome ('distress due to breathlessness'), when compared to standard care, of -0.24 (95 % CI: -1.30, 0.82). BIS resulted in extra mean costs of £799, reducing to £100 when outliers were excluded; neither difference was statistically significant. The quantitative findings contrasted with those previously reported for patients with cancer and their carers, which showed BIS to be both clinically and cost effective. For patients with non-malignant conditions there was a notable trend of improvement over both trial arms to the key measurement point; participants may have experienced a therapeutic effect from the research interviews, diluting the intervention's impact. CONCLUSIONS: BIS had a statistically non-significant effect for patients with non-malignant conditions, and slightly increased service costs, but had a qualitatively positive impact consistent with findings for advanced cancer. Trials of palliative care interventions should consider multiple, mixed method, primary outcomes and ensure that protocols limit potential contaminating therapeutic effects in study designs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN04119516 (December 2008); ClinicalTrials.gov NCT00678405 (May 2008).

Valued aspects of primary palliative care: content analysis of bereaved carers' descriptions.

BACKGROUND: Informal carers provide the bulk of palliative home care. They largely rely on general practitioners (GPs) and district nurses to support them in this role, yet little is known about what carers themselves consider important in this support. AIM: To identify what informal carers valued in the palliative support provided by GPs and district nurses by using carers' own descriptions of such support. DESIGN OF STUDY: Retrospective interviews. SETTING: Primary care in Cambridgeshire. METHOD: Semi-structured interviews with bereaved carers of 48 patients with cancer and 12 patients with non-cancer diagnoses. Content analysis of carers' evaluative descriptions of GP and district nurse support. RESULTS: The accessibility of the GP and district nurse emerged as the most important aspect of support. Enlistment of help from other agencies was also extensively mentioned, together with provision of equipment. Attitude or approach during interactions, and relationship with the professional were important, particularly regarding GP support, whereas support for the carer, information, and symptom control were mentioned less often. Data suggested that support was not as good for older patients (> or =75 years), but this finding requires further investigation. CONCLUSION: Results largely confirmed findings of previous, quantitative research and the importance of a patient-centred approach. What emerged most strongly, however, was the central importance of accessibility of support services for lay carers responsible for end-of-life home care. This mainly concerned GP and district nurse support, but accessibility of additional care and equipment were also important. In short, carers' main focus was the basic support that enabled them to sustain care in the home.

Place of death and use of health services in the last year of life.

AIM: To investigate whether health service input in the last year of life differs between cancer patients who die at home versus those dying in inpatient care. METHODS: Post hoc exploratory case-control study of 127 home deaths and 200 inpatient deaths. Retrospective electronic record linkage of patients' community and inpatient care during the last year of life. RESULTS: Patients who died at home began their home nursing care closer to death than those who died as inpatients. Their first contact with inpatient hospice care began further from death. Before their final month, home death patients also had more specialist and district nursing than patients who died in inpatient care. CONCLUSIONS: Patients who began their home nursing early were less likely to die at home than those who began such care late. This suggests that it may be difficult to sustain end-of-life care at home for an extended period. Further research incorporating assessment of informal care input and disease trajectory is required to investigate this issue.

Caregiver bereavement outcome: relationship with hospice at home, satisfaction with care, and home death.

This study used a randomized controlled trial design to investigate the impact of hospice at home (HAH) on caregiver bereavement outcome. Secondary analyses considered the association between bereavement, place of death, and carers' assessment of support. Ninety-six informal carers of patients referred to HAH were surveyed six weeks post-bereavement about the quality of terminal care. Carers next completed measures of their own bereavement response and general health six months post-bereavement. There was no evidence that HAH had an impact on bereavement outcome. In contrast, perceptions of inadequate terminal support and high symptom severity were associated with worse carer bereavement response. However, it remains unclear whether carers' retrospective ratings constitute an accurate account of symptoms and care. Home deaths were associated with both better bereavement response and better physical health post-bereavement than were inpatient deaths. Further research is needed to investigate the implications of death at home for the carer.

What terminally ill patients value in the support provided by GPs, district and Macmillan nurses.

The aim of this project was to investigate how patients view the care and support provided by their doctors and nurses. Forty-three patients with a life expectancy of 1 year or less who were being looked after in their own homes were asked to give their views of the support given by general practitioners, district nurses and Macmillan nurses. Patients had predominantly positive views of the support received. The content of their positive statements suggested that psychosocial aspects of support, including communication and kindness and consideration shown, were valued most. Actions in the form of helpfulness, organization of support and being accessible were also important, while clinical aspects received less emphasis. Clinical aspects of care were emphasized more when patients expressed negative views of support. Patients' statements suggested that emotional support and information were provided predominantly by Macmillan nurses.

The quality of English-language websites offering falls-prevention advice to older members of the public and their families.

Falls among older people are a major public health issue. Increasing numbers of older people are accessing the internet for health-related information, including information on falls risk and prevention. However, we are aware of no study that has assessed the quality of such websites. Using techniques for conducting systematic literature reviews, we evaluated English-language websites offering falls-related advice to members of the public. Forty-two websites were identified using popular search engines; these were assessed using evidence-based guidelines and codes of conduct on coverage of falls-related information, credibility and senior friendliness. Overall, scores were poor for coverage of falls information and credibility, although they were higher for senior friendliness. Few of the websites had been recently updated and none provided individually-tailored advice. We conclude that websites have fallen short of their potential to provide accessible, evidence-based information on the risks of falls and their prevention.

The influence of patient and carer age in access to palliative care services.

BACKGROUND: Older patients are less likely to receive palliative care than younger patients. As patient and primary carer age correlate positively, patterns may be due to carer rather than patient age, and reflect better ability to obtain support among younger carers. OBJECTIVE: To investigate how both patient and carer age relate to palliative care use, controlling for relevant variables. DESIGN: Comparison of patients who received community Macmillan nurse specialist advice, Marie Curie nursing or inpatient hospice care with patients who did not, using univariate analysis and multivariate logistic regression. Patient and carer data were collected through electronic service record linkage and carer post-bereavement interviews. SAMPLE: patients referred to a hospice at home service whose primary carer could be interviewed (n = 123). RESULTS: Whilst a cancer diagnosis was an important determinant of access for all services considered, logistic regression shows that carer age, but not patient age, and hospice at home access predicted Marie Curie nursing use. Both patient and carer age predicted use of Macmillan nurse advice. Age of the patient, but not carer age, predicted admission to inpatient hospice, alongside requiring care for over a month (all P < 0.05). CONCLUSIONS: Carer age may be as important a predictor of palliative home care use as patient age. We need to investigate whether younger carers have greater support needs or show greater effectiveness in obtaining help and to assess whether older carers need more assistance in recruitment of support.

Prediction of appropriate timing of palliative care for older adults with non-malignant life-threatening disease: a systematic review.

BACKGROUND: most people in contemporary western society die of the chronic diseases of old age. Whilst palliative care is appropriate for elderly patients with chronic, non-malignant disease, few of these patients access such care compared with cancer patients. Objective referral criteria based on accurate estimation of survival may facilitate more timely referral of non-cancer patients most appropriate for specialist palliative care. OBJECTIVE: to identify tools and predictor variables that might aid clinicians estimate survival and assess palliative status in non-cancer patients aged 65 years and older. METHODS: systematic review and quality assessment using criteria modified from the literature. RESULTS: 11 studies that evaluated prognoses in hospitalised and community-based older adults with non-malignant disease were identified. Key generic predictors of survival were increased dependency of activities of daily living, presence of comorbidities, poor nutritional status and weight loss, and abnormal vital signs and laboratory values. Disease-specific predictors of survival were identified for dementia, chronic obstructive pulmonary disorder and congestive heart failure. No study evaluated the relationship between survival and palliative status. CONCLUSION: prognostic models that attempt to estimate survival of < or = 6 months in non-cancer patients have generally poor discrimination, reflecting the unpredictable nature of most non-malignant disease. However, a number of generic and disease-specific predictor variables were identified that may help clinicians identify older, non-cancer patients with poor prognoses and palliative care needs. Simple, well-validated prognostic models that provide clinicians with objective measures of palliative status in non-cancer patients are needed. Additionally, research that evaluates the effect of general and specialist palliative care on psychosocial outcomes in non-cancer patients and their carers is needed.

Case studies: a research strategy appropriate for palliative care?

Selecting an appropriate research strategy is key to ensuring that research questions are addressed in a way which has value and is congruent with the overall topic, questions and purpose of the research. This paper will argue that there are situations when a case study strategy is appropriate to use in palliative care research. These include: when complex situations need to be addressed; when context is central to the study; when multiple perspectives need to be recognized; when the design needs to be flexible; when the research needs to be congruent with clinical practice; when there is no strong theory to which to appeal; and when other methodologies could be difficult to conduct. Using case study strategies rigorously and appropriately can contribute to knowledge in a way which is sensitive to the complex, context-dependent and multiprofessional nature of palliative care.