Geriatric assessment with management for older patients with cancer receiving radiotherapy: a cluster-randomised controlled pilot study.

BACKGROUND: Geriatric assessment and management (GAM) improve outcomes in older patients with cancer treated with surgery or chemotherapy. It is unclear whether GAM may provide better function and quality of life (QoL), or be cost-effective, in a radiotherapy (RT) setting. METHODS: In this Norwegian cluster-randomised controlled pilot study, we assessed the impact of a GAM intervention involving specialist and primary health services. It was initiated in-hospital at the start of RT by assessing somatic and mental health, function, and social situation, followed by individually adapted management plans and systematic follow-up in the municipalities until 8 weeks after the end of RT, managed by municipal nurses as patients' care coordinators. Thirty-two municipal/city districts were 1:1 randomised to intervention or conventional care. Patients with cancer ≥ 65 years, referred for RT, were enrolled irrespective of cancer type, treatment intent, and frailty status, and followed the allocation of their residential district. The primary outcome was physical function measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30). Secondary outcomes were overall quality of life (QoL), physical performance, use and costs of health services. Analyses followed the intention-to-treat principle. Study registration at ClinicalTrials.gov ID NCT03881137. RESULTS: We included 178 patients, 89 in each group with comparable age (mean 74.1), sex (female 38.2%), and Edmonton Frail Scale scores (mean 3.4 [scale 0-17], scores 0-3 [fit] in 57%). More intervention patients received curative RT (76.4 vs 61.8%), had higher irradiation doses (mean 54.1 vs 45.5 Gy), and longer lasting RT (mean 4.4 vs 3.6 weeks). The primary outcome was completed by 91% (intervention) vs 88% (control) of patients. No significant differences between groups on predefined outcomes were observed. GAM costs represented 3% of health service costs for the intervention group during the study period. CONCLUSIONS: In this heterogeneous cohort of older patients receiving RT, the majority was fit. We found no impact of the intervention on patient-centred outcomes or the cost of health services. Targeting a more homogeneous group of only pre-frail and frail patients is strongly recommended in future studies needed to clarify the role and organisation of GAM in RT settings.

Geriatric assessment with management for older patients with cancer receiving radiotherapy. Protocol of a Norwegian cluster-randomised controlled pilot study.

About 50% of patients with cancer are expected to need radiotherapy (RT), and the majority of these are older. To improve outcomes for older patients with cancer, geriatric assessment (GA) with management (GAM) is highly recommended. Evidence for its benefits is still scarce, in particular for patients receiving RT. We report the protocol of a cluster-randomised pilot study designed to test the effect, feasibility and health economic impact of a GAM intervention for patients ≥65 years, referred for palliative or curative RT. The randomising units are municipalities and city districts. The intervention is municipality-based and carried out in collaboration between hospital and municipal health services from the start of RT to eight weeks after the end of RT. Its main constituents are an initial GA followed by measures adapted to individual patients' impairments and needs, systematic symptom assessments and regular follow-up by municipal cancer nurses, appointed to coordinate the patient's care. Follow-up includes at least one weekly phone call, and a house call four weeks after the end of RT. All patients receive an individually adapted physical exercise program and nutritional counselling. Detailed guidelines for management of patients' impairments are provided. Patients allocated to the intervention group will be compared to controls receiving standard care. The primary outcome is physical function assessed by the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire C-30. Secondary outcomes are global quality of life, objectively tested physical performance and use of health care services. Economic evaluation will be based on a comparison of costs and effects (measured by the main outcome measures). Feasibility will be assessed with mixed methodology, based on log notes and questionnaires filled in by the municipal nurses and interviews with patients and nurses. The study is carried out at two Norwegian RT centres. It was opened in May 2019. Follow-up will proceed until June 2022. Statistical analyses will start by the end of 2021. We expect the trial to provide important new knowledge about the effect, feasibility and costs of a GAM intervention for older patients receiving RT. Trial registration: ClinTrials.gov, ID NCT03881137, initial release 13th of March 2019.

Test Accuracy of the Montreal Cognitive Assessment in Screening for Early Poststroke Neurocognitive Disorder: The Nor-COAST Study.

BACKGROUND AND PURPOSE: We determined the diagnostic accuracy of the Montreal Cognitive Assessment (MoCA) for poststroke neurocognitive disorder defined according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria in a prospective observational study. METHODS: Consecutive participants able to complete a cognitive test battery and MoCA 3 months poststroke were included. The reference standard of neurocognitive disorder was defined as a score of ≥1.5 SD below the normative mean in ≥1 cognitive domain on the cognitive test battery. RESULTS: Among 521 participants (43.6% women; mean age/SD, 71.5/12.0 years; mean education/SD, 12.4/3.8 years), the area under the receiver operating characteristic curve of MoCA for neurocognitive disorder was 0.80 (95% CI, 0.76-0.84). Using the standard MoCA cutoff <26, sensitivity was 0.71 (0.69-0.79) with specificity of 0.73 (0.66-0.76). MoCA cutoff of <27 gave higher sensitivity (0.82 [0.77-0.85]) at the expense of specificity (0.60 [0.53-0.66]). DISCUSSION: MoCA has reasonable accuracy for poststroke neurocognitive disorder diagnosed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02650531.

Short and long-term clinical effectiveness and cost-effectiveness of a late-phase community-based balance and gait exercise program following hip fracture. The EVA-Hip Randomised Controlled Trial.

The aim of this trial was to evaluate the clinical effectiveness and cost-effectiveness of a home-based exercise program delivered four months following hip-fracture surgery. In the two-armed randomized, single blinded clinical trial we included persons who lived in the catchment area, were 70 years or older, and community-dwelling at time of the fracture. We excluded persons who were unable to walk ten meters prior to the fracture, and those who were bedridden or had medical contraindications for exercise at baseline (ie. four months after the fracture). All participants underwent routine treatment and rehabilitation. The intervention group received additional 20 sessions (10 weeks) structured, home exercise targeting gait and balance, delivered by physiotherapists in primary health care. Gait speed was the primary outcome. Secondary outcomes included physical activity, gait characteristics, cognitive function, activities of daily living, health-related quality of life, and health care costs extracted from hospital and municipality records. In total, 223 participants were included. Four months post surgery 143 were randomized for the exercise trial (70% women, mean age 83.4 (SD 6.1) years, mean gait speed 0.6 (SD 0.2) m/sec). Estimated between group difference in gait speed was 0.09 m/sec (95% CI: 0.04 to 0.14, p<0.001) at posttest and 0.07 m/sec (95% CI: 0.02 to 0.12, p = 0.009) 12 months post surgery. The mean between-group QALY difference was -0.009 (95% CI: -0.061 to 0.038). The mean between-group total cost difference was +242.9 EUR (95% CI: -8397 to 8584). Our findings suggest that gait recovery after hip fracture can be improved by introducing a home-based balance and gait exercise program four months post surgery, without increasing total health care costs. Future research should focus on how to implement gait and balance exercise in comprehensive interventions that increase adherence among the most vulnerable persons and have an effect on daily life activities and patient-centred outcomes. Trial registration: ClinicalTrials.gov NCT01379456.

Comprehensive geriatric assessment for older adults admitted to hospital.

BACKGROUND: Comprehensive geriatric assessment (CGA) is a multi-dimensional, multi-disciplinary diagnostic and therapeutic process conducted to determine the medical, mental, and functional problems of older people with frailty so that a co-ordinated and integrated plan for treatment and follow-up can be developed. This is an update of a previously published Cochrane review. OBJECTIVES: We sought to critically appraise and summarise current evidence on the effectiveness and resource use of CGA for older adults admitted to hospital, and to use these data to estimate its cost-effectiveness. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, three other databases, and two trials registers on 5 October 2016; we also checked reference lists and contacted study authors. SELECTION CRITERIA: We included randomised trials that compared inpatient CGA (delivered on geriatric wards or by mobile teams) versus usual care on a general medical ward or on a ward for older people, usually admitted to hospital for acute care or for inpatient rehabilitation after an acute admission. DATA COLLECTION AND ANALYSIS: We followed standard methodological procedures expected by Cochrane and Effective Practice and Organisation of Care (EPOC). We used the GRADE approach to assess the certainty of evidence for the most important outcomes. For this update, we requested individual patient data (IPD) from trialists, and we conducted a survey of trialists to obtain details of delivery of CGA. We calculated risk ratios (RRs), mean differences (MDs), or standardised mean differences (SMDs), and combined data using fixed-effect meta-analysis. We estimated cost-effectiveness by comparing inpatient CGA versus hospital admission without CGA in terms of cost per quality-adjusted life year (QALY) gained, cost per life year (LY) gained, and cost per life year living at home (LYLAH) gained. MAIN RESULTS: We included 29 trials recruiting 13,766 participants across nine, mostly high-income countries. CGA increases the likelihood that patients will be alive and in their own homes at 3 to 12 months' follow-up (risk ratio (RR) 1.06, 95% confidence interval (CI) 1.01 to 1.10; 16 trials, 6799 participants; high-certainty evidence), results in little or no difference in mortality at 3 to 12 months' follow-up (RR 1.00, 95% CI 0.93 to 1.07; 21 trials, 10,023 participants; high-certainty evidence), decreases the likelihood that patients will be admitted to a nursing home at 3 to 12 months follow-up (RR 0.80, 95% CI 0.72 to 0.89; 14 trials, 6285 participants; high-certainty evidence) and results in little or no difference in dependence (RR 0.97, 95% CI 0.89 to 1.04; 14 trials, 6551 participants; high-certainty evidence). CGA may make little or no difference to cognitive function (SMD ranged from -0.22 to 0.35 (5 trials, 3534 participants; low-certainty evidence)). Mean length of stay ranged from 1.63 days to 40.7 days in the intervention group, and ranged from 1.8 days to 42.8 days in the comparison group. Healthcare costs per participant in the CGA group were on average GBP 234 (95% CI GBP -144 to GBP 605) higher than in the usual care group (17 trials, 5303 participants; low-certainty evidence). CGA may lead to a slight increase in QALYs of 0.012 (95% CI -0.024 to 0.048) at GBP 19,802 per QALY gained (3 trials; low-certainty evidence), a slight increase in LYs of 0.037 (95% CI 0.001 to 0.073), at GBP 6305 per LY gained (4 trials; low-certainty evidence), and a slight increase in LYLAH of 0.019 (95% CI -0.019 to 0.155) at GBP 12,568 per LYLAH gained (2 trials; low-certainty evidence). The probability that CGA would be cost-effective at a GBP 20,000 ceiling ratio for QALY, LY, and LYLAH was 0.50, 0.89, and 0.47, respectively (17 trials, 5303 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: Older patients are more likely to be alive and in their own homes at follow-up if they received CGA on admission to hospital. We are uncertain whether data show a difference in effect between wards and teams, as this analysis was underpowered. CGA may lead to a small increase in costs, and evidence for cost-effectiveness is of low-certainty due to imprecision and inconsistency among studies. Further research that reports cost estimates that are setting-specific across different sectors of care are required.

One-year health and care costs after hip fracture for home-dwelling elderly patients in Norway: Results from the Trondheim Hip Fracture Trial.

AIM: The aim of this study was to estimate the one-year health and care costs related to hip fracture for home-dwelling patients aged 70 years and older in Norway, paying specific attention to the status of the patients at the time of fracture and cost differences due to various patient pathways after fracture. METHODS: Data on health and care service provision were extracted from hospital and municipal records and from national registries; data on unit costs were collected from the municipalities, hospital administrations and previously published studies. Four different patient pathways were identified and the total costs for subgroups of patients according to age, sex, fracture type and instrumental activity of daily living at fracture incidence were calculated. Descriptive statistics were used to identify cost estimates. RESULTS: The mean total one-year costs per patient were EUR 68,376 and the costs for patients alive one year after hip fracture were EUR 71,719. The patients' age and pre-fracture functional status contributed most to the total cost. CONCLUSIONS: On average, care costs accounted for more than 50% of the total cost; even for patients with good functional status before hip fracture, care costs accounted for 40% of the total cost compared with hospital costs of 38%. To reduce the financial costs of hip fractures in the care sector, the results point to the importance of preventive programmes to reduce the risk of hip fracture, but also to the importance of comprehensive geriatric care in the initial phase after a hip fracture.

Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial.

BACKGROUND: Most patients with hip fractures are characterised by older age (>70 years), frailty, and functional deterioration, and their long-term outcomes are poor with increased costs. We compared the effectiveness and cost-effectiveness of giving these patients comprehensive geriatric care in a dedicated geriatric ward versus the usual orthopaedic care. METHODS: We did a prospective, single-centre, randomised, parallel-group, controlled trial. Between April 18, 2008, and Dec 30, 2010, we randomly assigned home-dwelling patients with hip-fractures aged 70 years or older who were able to walk 10 m before their fracture, to either comprehensive geriatric care or orthopaedic care in the emergency department, to achieve the required sample of 400 patients. Randomisation was achieved via a web-based, computer-generated, block method with unknown block sizes. The primary outcome, analysed by intention to treat, was mobility measured with the Short Physical Performance Battery (SPPB) 4 months after surgery for the fracture. The type of treatment was not concealed from the patients or staff delivering the care, and assessors were only partly masked to the treatment during follow-up. This trial is registered with ClinicalTrials.gov, number NCT00667914. FINDINGS: We assessed 1077 patients for eligibility, and excluded 680, mainly for not meeting the inclusion criteria such as living in a nursing home or being aged less than 70 years. Of the remaining patients, we randomly assigned 198 to comprehensive geriatric care and 199 to orthopaedic care. At 4 months, 174 patients remained in the comprehensive geriatric care group and 170 in the orthopaedic care group; the main reason for dropout was death. Mean SPPB scores at 4 months were 5·12 (SE 0·20) for comprehensive geriatric care and 4·38 (SE 0·20) for orthopaedic care (between-group difference 0·74, 95% CI 0·18-1·30, p=0·010). INTERPRETATION: Immediate admission of patients aged 70 years or more with a hip fracture to comprehensive geriatric care in a dedicated ward improved mobility at 4 months, compared with the usual orthopaedic care. The results suggest that the treatment of older patients with hip fractures should be organised as orthogeriatric care. FUNDING: Norwegian Research Council, Central Norway Regional Health Authority, St Olav Hospital Trust and Fund for Research and Innovation, Liaison Committee between Central Norway Regional Health Authority and the Norwegian University of Science and Technology, the Department of Neuroscience at the Norwegian University of Science and Technology, Foundation for Scientific and Industrial Research at the Norwegian Institute of Technology (SINTEF), and the Municipality of Trondheim.

Effectiveness of task specific gait and balance exercise 4 months after hip fracture: protocol of a randomized controlled trial--the Eva-hip study.

BACKGROUND AND PURPOSE: Regular rehabilitation is not sufficient for regaining function after a hip fracture, and more targeted interventions for home-dwelling elderly hip-fracture patients are needed. This paper describes the protocol of a study assessing the effectiveness and cost effectiveness of a task specific progressive gait and balance exercise programme for hip-fracture patients, performed 4 months after the fracture. METHODS/DESIGN: A single blind two-arm pragmatic randomised controlled trial was conducted with 142 hip-fracture patients randomized to a 10-week home-based exercise programme or to practice as usual 4 months following the surgery. Inclusion criteria were age >70 years and being home dwelling prior to the fracture. Exclusion criteria are life expectancy <3 months and inability to walk 10 m prior to the fracture. The content and organization of the programme was developed in collaboration between physiotherapy researchers and primary health-care physiotherapists. Participants were followed for 1 year post-surgery, evaluating short-term and long-term effects of the programme. The primary outcome is gait speed, and the secondary outcomes are spatial and temporal gait parameters, free living physical behaviour by activity monitoring, mobility performance, activities of daily living, fear of falling, cognitive function, depression and health-related quality of life. Cost-effectiveness analysis is planned. DISCUSSION: This paper describes a task specific exercise programme aimed to improve gait and balance after a hip fracture. Inclusion started in February 2011, and the last 1-year follow-up is performed in March 2014. Broad inclusion criteria and physiotherapy-guided home-based exercises may facilitate the participation from frail patients and thereby increase the generalizability of the findings. Development and completion of the intervention within routine clinical practice will enlighten the implementation of results into clinical practice. Results may add new insight into how physiotherapy can improve gait and thereby activity and functioning in everyday life and have implications on future content and organization of physiotherapy after a hip fracture.

Effect of in-hospital comprehensive geriatric assessment (CGA) in older people with hip fracture. The protocol of the Trondheim Hip Fracture trial.

BACKGROUND: Hip fractures in older people are associated with high morbidity, mortality, disability and reduction in quality of life. Traditionally people with hip fracture are cared for in orthopaedic departments without additional geriatric assessment. However, studies of postoperative rehabilitation indicate improved efficiency of multidisciplinary geriatric rehabilitation as compared to traditional care. This randomized controlled trial (RCT) aims to investigate whether an additional comprehensive geriatric assessment of hip fracture patients in a special orthogeriatric unit during the acute in-hospital phase may improve outcomes as compared to treatment as usual in an orthopaedic unit. METHODS/DESIGN: The intervention of interest, a comprehensive geriatric assessment is compared with traditional care in an orthopaedic ward. The study includes 401 home-dwelling older persons >70 years of age, previously able to walk 10 meters and now treated for hip fracture at St. Olav Hospital, Trondheim, Norway. The participants are enrolled and randomised during the stay in the Emergency Department. Primary outcome measure is mobility measured by the Short Physical Performance Battery (SPPB) at 4 months after surgery. Secondary outcomes measured at 1, 4 and 12 months postoperatively are place of residence, activities of daily living, balance and gait, falls and fear of falling, quality of life and depressive symptoms, as well as use of health care resources and survival. DISCUSSION: We believe that the design of the study, the randomisation procedure and outcome measurements will be of sufficient strength and quality to evaluate the impact of comprehensive geriatric assessment on mobility and other relevant outcomes in hip fracture patients. TRIALS REGISTRATION: ClinicalTrials.gov, NCT00667914.

Doloplus-2, a valid tool for behavioural pain assessment?

BACKGROUND: The Doloplus-2 is used for behavioural pain assessment in cognitively impaired patients. Little data exists on the psychometric properties of the Doloplus-2. Our objectives were to test the criterion validity and inter-rater reliability of the Doloplus-2, and to explore a design for validations of behavioural pain assessment tools. METHODS: Fifty-one nursing home patients and 22 patients admitted to a geriatric hospital ward were included. All were cognitively impaired and unable to self-report pain. Each patient was examined by an expert in pain evaluation and treatment, who rated the pain on a numerical rating scale. The ratings were based on information from the medical record, reports from nurses and patients (if possible) about pain during the past 24 hours, and a clinical examination. These ratings were used as pain criterion. The Doloplus-2 was administered by the attending nurse. Regression analyses were used to estimate the ability of the Doloplus-2 to explain the expert's ratings. The inter-rater reliability of the Doloplus-2 was evaluated in 16 patients by comparing the ratings of two nurses administrating the Doloplus-2. RESULTS: There was no association between the Doloplus-2 and the expert's pain ratings (R2 = 0.02). There was an association (R2 = 0.54) between the expert's ratings and the Doloplus-2 scores in a subgroup of 16 patients assessed by a geriatric expert nurse (the most experienced Doloplus-2 administrator). The inter-rater reliability between the Doloplus-2 administrators assessed by the intra-class coefficient was 0.77. The pain expert's ratings were compared with ratings of two independent geriatricians in a sub sample of 15, and were found satisfactory (intra-class correlation 0.74). CONCLUSION: It was challenging to conduct such a study in patients with cognitive impairment and the study has several limitations. The results do not support the validity of the Doloplus-2 in its present version and they indicate that it demands specific administration skills.

The Norwegian Doloplus-2, a tool for behavioural pain assessment: translation and pilot-validation in nursing home patients with cognitive impairment.

BACKGROUND: Pain assessment is challenging in cognitively impaired (CI) patients due to inadequate self-report skills and observational ratings are an alternative. The Doloplus-2 is developed for pain assessment in the CI and rates somatic, psychomotor and psychosocial behaviours as indicators of pain. AIMS: To translate the Doloplus-2 into Norwegian, to test the Doloplus-2 with regard to criterion validity and to obtain the administrators' evaluation of the clinical performance of the Doloplus-2. METHODS: Nurses at three nursing homes, in collaboration with two research assistants, administered the Doloplus-2 to 59 patients with dementia. The results were compared against experienced clinicians' pain ratings. Regression analyses were performed to explore each different item's contribution to the total pain score. The administrators also completed a debriefing questionnaire. RESULTS: The instrument was translated according to international guidelines. Regression analyses demonstrate that the Doloplus-2 score accounts for 62% (R2) of the expert score and that the four most informative items could explain 68% of the expert score. Analyses of the different Doloplus-2 items indicate that facial expressions explain most and social life least of the expert's pain ratings. The administrators reported that Doloplus-2 was helpful and easy to administer, but questioned the validity of the psychosocial domain. CONCLUSIONS: The Norwegian Doloplus-2 demonstrates satisfactory criterion validity and clinical value in this pilot study. However, the content of the instrument needs a general re-evaluation, especially with regard to the psychosocial items.

[Pain assessment in cognitively impaired elderly patients]. / Smertemålinger hos eldre med kognitiv svikt.

BACKGROUND: Pain assessment in nursing home patients is often challenging because of cognitive failure. Demented patients receive less optimal pain treatment than those who are cognitively intact. Inappropriate pain assessment is likely to be an important reason for problems with proper diagnosis and treatment of pain in the cognitively impaired. Self-report of pain by standardized questionnaires is recommended for those with mild cognitive failure. For those who are unable to self-report, observational assessment is an alternative. MATERIALS AND METHODS: Structured pain assessment tools are reviewed, with emphasis on their feasibility in cognitively impaired patients. RESULTS: Several assessment tools for observational pain assessment are available, but none of them is satisfactory validated. Observational tools are used by a trained observer who rates behaviour indicative of pain according to pre-defined clues. The Checklist of Non-verbal Pain Indicators (CNPI) and the Doloplus-2 are both observational tools that are translated into Norwegian. The Norwegian CNPI is in an early phase of validation, while the Doloplus-2 is tested in a Norwegian pilot validation study with promising results. INTERPRETATION: It is important to establish a common standard for systematic pain assessment in the cognitively impaired, both clinically and in research. Further validation of the CNPI and the Doloplus-2 is recommended.