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      Study protocol: delayed intervention randomised controlled trial within the Medical Research Council (MRC) Framework to assess the effectiveness of a new palliative care service

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          Abstract

          Background

          Palliative care has been proposed to help meet the needs of patients who suffer progressive non-cancer conditions but there have been few evaluations of service development initiatives. We report here a novel protocol for the evaluation of a new palliative care service in this context.

          Methods/Design

          Using the MRC Framework for the Evaluation of Complex Interventions we modelled a new palliative care and neurology service for patients severely affected by Multiple Sclerosis (MS). We conducted qualitative interviews with patients, families and staff, plus a literature review to model and pilot the service. Then we designed a delayed intervention randomised controlled trial to test its effectiveness as part of phase II of the MRC framework. Inclusion criteria for the trial were patients identified by referring clinicians as having unresolved symptoms or psychological concerns. Referrers were advised to use a score of greater than 8 on the Expanded Disability Scale was a benchmark. Consenting patients newly referred to the new service were randomised to either receive the palliative care service immediately (fast-track) or after a 12-week wait (standard best practice). Face to face interviews were conducted at baseline (before intervention), and at 4–6, 10–12 (before intervention for the standard-practice group), 16–18 and 22–24 weeks with patients and their carers using standard questionnaires to assess symptoms, palliative care outcomes, function, service use and open comments. Ethics committee approval was granted separately for the qualitative phase and then for the trial.

          Discussion

          We publish the protocol trial here, to allow methods to be reviewed in advance of publication of the results. The MRC Framework for the Evaluation of Complex Interventions was helpful in both the design of the service, methods for evaluation in convincing staff and the ethics committee to accept the trial. The research will provide valuable information on the effects of palliative care among non-cancer patients and a method to evaluate palliative care in this context.

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          Most cited references37

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          Development and validation of a core outcome measure for palliative care: the palliative care outcome scale. Palliative Care Core Audit Project Advisory Group.

          To develop an outcome measure for patients with advanced cancer and their families which would cover more than either physical symptoms or quality of life related questions. To validate the measure in various specialist and non-specialist palliative care settings throughout the UK. A systematic literature review of measures appropriate for use in palliative care settings was conducted. In conjunction with a multidisciplinary project advisory group, questions were chosen for inclusion into the scale based on whether they measured aspects of physical, psychological, or spiritual domains pertinent to palliative care, and whether similar items had shown to be valid as part of another measure. A staff completed version was developed to facilitate data collection on all patients throughout their care, and a patient completed version was designed to enable the patient to contribute to the assessment of their outcomes when possible. A full validation study was conducted to evaluate construct validity, internal consistency, responsiveness to change over time, and test-retest reliability. Assessments were timed. Eight centres in England and Scotland providing palliative care, including inpatient care, outpatient care, day care, home care, and primary care. A total of 450 patients entered care during the study period. Staff collected data routinely on patients in care long enough to be assessed (n = 337). Of these, 262 were eligible for patient participation; 148 (33%) went on to complete a questionnaire. The Palliative Care Outcome Scale (POS), the European Organisation for Research on Cancer Treatment, and the Support Team Assessment Schedule. The POS consists of two almost identical measures, one of which is completed by staff, the other by patients. Agreement between staff and patient ratings was found to be acceptable for eight out of 10 items at the first assessment. The measure demonstrated construct validity (Spearman rho = 0.43 to 0.80). Test/re-test reliability was acceptable for seven items. Internal consistency was good (Cronbach's alpha = 0.65 (patients), 0.70 (staff)). Change over time was shown, but did not reach statistical significance. The questionnaire did not take more than 10 minutes to complete by staff or patients. The POS has acceptable validity and reliability. It can be used to assess prospectively palliative care for patients with advanced cancer.
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            Validity and reliability comparison of 4 mobility measures in patients presenting with neurologic impairment.

            To establish the reliability and validity of 4 mobility measures in neurologically impaired adults undergoing rehabilitation. Repeated assessment of same patients. Two specialized neurologic centers in England. Forty-six patients with neurologic disabilities selected from inpatient and outpatient rehabilitation centers who were able to stand and walk at least 10 meters, with some aid if needed. Patients were assessed twice, at an interval of 7 days, by the same person at the same location. Validity and reliability of each measure were compared by means of scatterplots, Bland-Altman method, and correlation coefficients. Validity was also established by comparing groups of patients expected to differ in mobility. The Rivermead Mobility Index (RMI) standard version and a version with 4 levels of answer, the 10-meter timed walk, and the 2-minute walk test. The measures showed significant intercorrelation, suggesting that all were valid mobility measures. Each was reasonably reliable, with no evidence of systematic bias. The revised RMI was less sensitive to differences. The distance covered in the 2-minute walk test was significantly decreased for patients using aids (p <.0005) and those with impaired leg sensation (p =.02). All 4 measures tested (2 RMI versions, 1-meter timed walk, 2-minute walk test) showed similar validity and reliability, and the 4-level RMI version failed to show an increased ability to detect differences. All measures showed more disability in patients using aids and those with sensory impairment.
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              Methodologic issues in effectiveness research on palliative cancer care: a systematic review.

              The objective of this report is to explore methodologic issues on the basis of a systematic review of the literature of effectiveness research on palliative cancer care with regard to selection and characteristics of a study population, interventions, and outcome assessment. A systematic review was performed of randomized clinical trials on comprehensive palliative care with quality assessment of the studies by three independent observers, using predefined quality criteria. In the literature search, 11 relevant studies were identified. Without exception, methodologic problems were experienced. In two studies, the problems were so severe that no results were reported. Problems were associated with the recruitment of a study population in 10 studies, its homogeneity in six, patient attrition in four, defining and maintaining the contrast between the strategies in six, and selection of the outcome variables in four. Effectiveness research in palliative care is complex and has many pitfalls. To enhance the quality of future palliative care trials and the validity of their results, we particularly stress the importance of careful case finding, strict eligibility criteria, precise documentation of the process of care, and comprehensive outcome measurement. The relation of structure, process, and outcome variables in comprehensive palliative care should be further explored. It is a challenge for future research to link patient outcomes to the quality of care, independent from the autonomous course of the disease and from personal characteristics.
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                Author and article information

                Journal
                BMC Palliat Care
                BMC Palliative Care
                BioMed Central (London )
                1472-684X
                2006
                2 October 2006
                : 5
                : 7
                Affiliations
                [1 ]Department of Palliative Care, Policy and Rehabilitation, King's College London, Weston Education Centre, Cutcombe Rd, London, SE5 9RJ, UK
                [2 ]School of Health Science and Social Care, Brunel University, Isleworth, Middlesex, UK
                [3 ]Department of Neurology, King's College Hospital, Denmark Hill, London SE5 9RS, UK
                Article
                1472-684X-5-7
                10.1186/1472-684X-5-7
                1615868
                17014714
                4869ea06-a908-4879-ad9c-abeb245d181b
                Copyright © 2006 Higginson et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 3 August 2006
                : 2 October 2006
                Categories
                Study Protocol

                Anesthesiology & Pain management
                Anesthesiology & Pain management

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