Using normalization process theory to evaluate the use of patient-centred outcome measures in specialist palliative home care-a qualitative interview study.

BACKGROUND: Standardised use of patient-centred outcome measures (PCOMs) improves aspects of quality of care. Normalization Process Theory (NPT) considers the social (inter-)actions of implementation processes operationalised through four constructs: coherence-building, cognitive participation, collective action and reflexive monitoring. The aim of the study was to identify barriers and enablers for the successful use of PCOMs in specialist palliative home care (SPHC) using NPT, to collect clinically meaningful and reliable data to improve patient outcomes. METHODS: Qualitative study using semi-structured interviews with palliative care professionals from German SPHC teams who participated in a study using PCOMs. Data were analysed using Framework analysis, and contextualised within NPT. RESULTS: Seventeen interviews across five teams were conducted. Some teams already had an understanding of what PCOMs are and how to use them, based on previous experience. In other teams, this understanding developed through the perception of the benefits (coherence). Participation and engagement depended on individuals and was decisive for coherence-building. The attitude of the management level also played a major role (cognitive participation). Integration of PCOMs into everyday clinical practice varied and depended on the manifestation of the first two constructs and other already established routines (collective action). In the context of appraisal, both positive (e.g. focus on patient) and negative aspects (e.g. additional work) of using PCOMs were mentioned (reflexive monitoring). CONCLUSIONS: Although benefits of using PCOMs were partly recognised, not all teams continued standardised use. Here, not only the social (inter-)actions, but also the influence of the context (working environment) were decisive. Future implementation strategies should consider integrating PCOMs in existing electronic patient records, education sessions supporting coherence-building, internal facilitators/local champions, and ensuring frequent data analyses as it is beneficial and increases the readiness of using PCOMs.

Effects of preoperative nutritional status on postoperative quality of recovery: a prospective observational study.

Quality of Recovery-15 (QoR-15) has received attention as a postoperative patient-reported outcome measure. Preoperative nutritional status has negative effects on postoperative outcomes; however, these associations have not yet been investigated. We included inpatients aged ≥ 65 years who underwent elective abdominal cancer surgery under general anaesthesia between 1 June 2021 and 7 April 2022 at our hospital. Preoperative nutritional status was assessed using the Mini Nutritional Assessment Short-Form (MNA-SF), and patients with an MNA-SF score ≤ 11 were categorised into the poor nutritional group. The outcomes in this study were the QoR-15 scores at 2 d, 4 d and 7 d after surgery, which were compared between groups by unpaired t test. Multiple regression analysis was applied to assess the effects of poor preoperative nutritional status on the QoR-15 score on postoperative day 2 (POD 2). Of the 230 included patients, 33·9 % (78/230) were categorised into the poor nutritional status group. The mean QoR-15 value was significantly lower in the poor nutritional group than in the normal nutritional group at all postoperative time points (POD 2:117 v. 99, P = 0·002; POD 4:124 v. 113, P < 0·001; POD 7:133 v. 115, P < 0·001). Multiple analyses showed that poor preoperative nutritional status was associated with the QoR-15 score on POD 2 (adjusted partial regression coefficient, -7·8; 95 % CI -14·9, -0·72). We conclude that patients with a poor preoperative nutritional status were more likely to have a lower QoR-15 score after abdominal cancer surgery.

Dexamethasone and persistent wound pain: a prespecified analysis of the randomised Perioperative Administration of Dexamethasone and Infection (PADDI) trial.

BACKGROUND: Dexamethasone is commonly administered intraoperatively to prevent postoperative nausea and vomiting and is believed to have analgesic properties. It is unknown whether it has an impact on chronic wound pain. METHODS: In this prespecified embedded superiority substudy of the randomised PADDI trial, patients undergoing non-urgent noncardiac surgery received dexamethasone 8 mg or placebo intravenously after induction of anaesthesia, and were followed up for 6 months postoperatively. The primary outcome was the incidence of pain in the surgical wound at 6 months. Secondary outcomes included acute postoperative pain and correlates of chronic postsurgical pain. RESULTS: We included 8478 participants in the modified intention-to-treat population (4258 in the dexamethasone group and 4220 in the matched placebo group). The primary outcome occurred in 491 subjects (11.5%) in the dexamethasone arm and 404 (9.6%) subjects in the placebo arm (relative risk 1.2, 95% confidence interval 1.06-1.41, P=0.003). Maximum pain scores at rest and on movement in the first 3 postoperative days were lower in the dexamethasone group compared with the control group {median 5 (inter-quartile range [IQR] 3.0-8.0) vs 6 (IQR 3.0-8.0) and median 7 (IQR 5.0-9.0) vs 8 (IQR 6.0-9.0), P<0.001 for both}. Severity of postoperative pain was not predictive of chronic postsurgical pain. The severity of chronic postsurgical pain and the frequency of neuropathic features did not differ between treatment groups. CONCLUSION: Administration of dexamethasone 8 mg i.v. was associated with an increase in the risk of pain in the surgical wound 6 months after surgery. CLINICAL TRIAL REGISTRATION: ACTRN12614001226695.

The GOAL-Hem journey: Shared decision making and patient-centred outcomes.

INTRODUCTION: GOAL-Hem is a novel, haemophilia-specific, patient-centred outcome measure (PCOM) based on goal attainment scaling, allowing people with haemophilia (PwH) to set and monitor the attainment of individualized goals for treatment. AIM: To provide a thorough overview of the creation, validation, and development of GOAL-Hem. METHODS: Clinician workshops were held to develop a haemophilia-specific goal menu. Qualitative data from semistructured interviews with PwH and their caregivers guided further revisions to the goal menu (i.e., goal domains and descriptors). A feasibility study was performed including a 12-week, prospective, noninterventional evaluation involving clinicians and PwH at four US haemophilia treatment centres. Finally, the Patient Voice Study gathered feedback from PwH and their caregivers via an online survey, interviews, and a focus group. RESULTS: The feasibility study validated GOAL-Hem with successful outcomes in construct/content validity and responsiveness, including a large effect in patient- and clinician-rated goal attainments. The Patient Voice Study led to significant refinement of GOAL-Hem goals and descriptors, resulting in a more straightforward and relatable menu for PwH and their caregivers. Overall, GOAL-Hem captured qualitative data in areas important to PwH and employed quantitative methods to evaluate meaningful changes in those areas. The individualized tool was well equipped to handle the complex and chronic nature of haemophilia and was endorsed by PwH, their caregivers, and clinicians. CONCLUSION: The GOAL-Hem development journey may serve as a roadmap for other PCOMs in a variety of settings, including clinical studies, haemophilia treatment centres for care planning, and as a tool to gather real-world evidence.

Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC): a modified Delphi process to develop a core outcome set for trials in perioperative care and anaesthesia.

BACKGROUND: Outcome selection underpins clinical trial interpretation. Inconsistency in outcome selection and reporting hinders comparison of different trials' results, reducing the utility of research findings. METHODS: We conducted an iterative consensus process to develop a set of Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC), following the established Core Outcome Measures for Effectiveness Trials (COMET) methodology. First, we undertook a systematic review of RCTs in high-impact journals to describe current outcome reporting trends. We then surveyed patients, carers, researchers, and perioperative clinicians about important outcomes after surgery. Finally, a purposive stakeholder sample participated in a modified Delphi process to develop a core outcome set for perioperative and anaesthesia trials. RESULTS: Our systematic review revealed widespread inconsistency in outcome reporting, with variable or absent definitions, levels of detail, and temporal criteria. In the survey, almost all patients, carers, and clinicians rated clinical outcome measures critically important, but clinicians rated patient-centred outcomes less highly than patients and carers. The final core outcome set was: (i) mortality/survival (postoperative mortality, long-term survival); (ii) perioperative complications (major postoperative complications/adverse events; complications/adverse events causing permanent harm); (iii) resource use (length of hospital stay, unplanned readmission within 30 days); (iv) short-term recovery (discharge destination, level of dependence, or both); and (v) longer-term recovery (overall health-related quality of life). CONCLUSIONS: This core set, incorporating important outcomes for both clinicians and patients, should guide outcome selection in future perioperative medicine or anaesthesia trials. Mapping these alongside standardised endpoint definitions will yield a comprehensive perioperative outcome framework.

Association of frailty with days alive at home in critically ill patients undergoing emergency general surgery: a population-based cohort study.

BACKGROUND: Frailty is an established risk factor for morbidity and mortality in older patients undergoing surgery. In people with critical illness before surgery, few data describe patient-centred outcomes. Our objective was to estimate the association of frailty with postoperative days alive at home in older critically ill patients requiring emergency general surgery. METHODS: A retrospective population-based cohort study was conducted using linked administrative health data in Ontario, Canada from 2009 to 2019. All individuals aged ≥66 yr with an ICU admission before emergency general surgery were included. We compared the count of days alive at home at 30 and 365 days after surgery based on frailty status using a validated, multidimensional index. Unadjusted and multilevel, multivariable adjusted effect estimates were calculated. A sensitivity analysis based on early recovery category was performed. RESULTS: We identified 7003 eligible patients; 2063 (29.5%) lived with frailty. At 30 days, mean days alive at home with frailty were 4.5 (standard deviation 8.2) and 7.6 (standard deviation 10.2) in those without frailty. In adjusted analysis, frailty was associated with fewer days alive at home at 30 (ratio of means [RoM] 0.68; 95% confidence interval [CI]: 0.60-0.78; P<0.001) and 365 days (RoM 0.72; 95% CI: 0.64-0.82; P<0.001). Individuals with frailty had a higher probability of poor recovery status, with effects increasing across the first postoperative month. CONCLUSIONS: In patients with critical illness requiring emergency general surgery, frailty is associated with fewer days alive at home. This information should be discussed with critically ill patients before emergent surgical intervention to better inform decision-making.

Frailty and perioperative patient-reported disability in patients undergoing cardiac surgery: a pilot study.

BACKGROUND: Preoperative frailty may predispose patients to poorer outcomes in cardiac surgery; however, there are limited data concerning how preoperative frailty predicts patient-centred outcomes, such as patient-reported disability. Our objective was to evaluate the association between preoperative frailty and postoperative disability. METHODS: Patients were prospectively evaluated using the Comprehensive Assessment of Frailty score, separating patients into frail and non-frail cohorts. Disability levels were quantified using the WHO Disability Assessment Schedule (WHODAS) 2.0 in percentage of the maximum disability score, with disability defined as a value ≥25%. RESULTS: Frail patients had increased median [inter-quartile range] disability scores of 31 [16-45]% preoperatively, 29 [9-54]% at 1 month, and 15 [3-31]% at 3 months postoperatively, compared with disability scores in non-frail patients of 10 [5-17]%, 17 [6-29]%, and 2.1 [0-12.0]%, respectively. Preoperative frailty was associated with a reduced likelihood of patients being free of disability and alive at 3 months; adjusted odds ratio 0.51 (for age, European System for Cardiac Operative Risk Evaluation II, and WHODAS 2.0: 12-Part Questionnaire score); P=0.045. The trajectory of disability scores, assessed in percentage change from the preoperative baseline, showed non-frail patients had increased disability burden at 1 month, whereas frail patients had reduced disability burden (+4.2% vs -2.1%; P=0.04). Although the disability burden decreased for both groups at 3 months, this was most marked for frail patients (-6.3% vs -10.4%; P=0.02). CONCLUSIONS: Disability burden in frail patients improves continuously postoperatively, whereas in non-frail patients, it worsens at 1 month before improving at 3 months postoperatively. This positive trajectory of patient-centred outcomes in frail patients should be considered in preoperative decision-making.

Dexamethasone and clinically significant postoperative nausea and vomiting: a prespecified substudy of the randomised perioperative administration of dexamethasone and infection (PADDI) trial.

BACKGROUND: Clinically significant postoperative nausea and vomiting (PONV) is a patient-reported outcome which reflects patient experience. Although dexamethasone prevents PONV, it is unknown what impact it has on this experience. METHODS: In this prespecified embedded superiority substudy of the randomised Perioperative Administration of Dexamethasone and Infection (PADDI) trial, patients undergoing non-urgent noncardiac surgery received dexamethasone 8 mg or placebo intravenously after induction of anaesthesia, and completed a validated PONV questionnaire. The primary outcome was the incidence of clinically significant PONV on day 1 or day 2 postoperatively. Secondary outcomes included the incidence of clinically significant PONV and severe PONV on days 1 and 2 considered separately. RESULTS: A total of 1466 participants were included, with 733 patients allocated to the dexamethasone arm and 733 to matched placebo. The primary outcome occurred in 52 patients (7.1%) in the dexamethasone arm and 66 (9%) patients in the placebo arm (relative risk [RR]=0.79; 95% confidence interval [CI], 0.56-1.11; P=0.18). Severe PONV occurred on day 2 in 27 patients (3.9%) in the dexamethasone arm and 47 patients (6.7%) in the placebo arm (RR=0.58; 95% CI, 0.37-0.92; P=0.02; number needed-to-treat (NNT)=36.7; 95% CI, 20-202). In the entire cohort of 8880 PADDI patients, lower nausea scores, less frequent administration of antiemetics, and fewer vomiting events were recorded by patients in the dexamethasone arm up to day 2 after surgery. CONCLUSIONS: Administration of dexamethasone 8 mg i.v. did not influence clinically significant PONV. Dexamethasone administration did, however, decrease the incidence and severity of PONV, and was associated with less frequent administration of antiemetic agents. CLINICAL TRIAL REGISTRATION: ACTRN12614001226695.

Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis.

BACKGROUND: There are very few patient-centred global outcome measures of recovery in the days or weeks after surgery. This meta-analysis evaluated the psychometric properties and clinical acceptability of the 15-item quality of recovery (QoR-15) scale. METHODS: We searched bibliographic databases for studies undertaking psychometric evaluation of the QoR-15 or using the QoR-15 as an outcome measure after surgery. Record screening, data extraction, and quality assessments were independently done by two researchers. Weighted averages estimating overall summary statistics across all the studies were calculated using random-effects meta-analysis. Pooled correlation coefficients were transformed using a Fisher z-transformation and then back-transformed to calculate pooled results. The four co-primary endpoints were validity, reliability, responsiveness, and clinical utility of the QoR-15 scale. RESULTS: A total of 26 unique studies met the eligibility criteria, yielding up to 22 847 patients across 16 countries, in 15 languages. A further 172 studies in a further 18 countries and six languages used the QoR-15 as an outcome measure. The QoR-15 had excellent discriminant validity, with the mean difference in QoR-15 scores in patients with and without postoperative complications (9.6; 95% confidence interval [CI], 5.9-13.3; P<0.001), and good convergent validity (for a global visual analogue recovery scale, pooled r=0.63; 95% CI, 0.54-0.71). There was excellent reliability: internal consistency (pooled α=0.85; 95% CI, 0.83-0.87), split-half reliability=0.80 (95% CI, 0.75-0.84), and test-retest reliability=0.97 (95% CI, 0.95-0.98). There was also high responsiveness (pooled standardised response mean=0.87; 95% CI, 0.65-1.08), patient recruitment into evaluation studies (96%; 95% CI, 93-99), and excellent completion and return rates (91%; 95% CI, 84-96). The mean time to complete the QoR-15 was 2.7 (95% CI, 2.2-3.1) min. CONCLUSIONS: The QoR-15 is a valid, reliable, and responsive patient-centred outcome metric in surgical patients. It is highly acceptable to both patients and clinicians. REGISTRATION: Open Science Framework Identifier: DOI 10.17605/OSF.IO/78HTA.

Minimal clinically important difference in days at home up to 30 days after surgery.

Patient-centred outcomes are increasingly recognised as crucial measures of healthcare quality. Days alive and at home up to 30 days after surgery (DAH30 ) is a validated and readily obtainable patient-centred outcome measure that integrates much of the peri-operative patient journey. However, the minimal difference in DAH30 that is clinically important to patients is unknown. We designed and administered a 28-item survey to evaluate the minimal clinically important difference in DAH30 among adult patients undergoing inpatient surgery. Patients were approached pre-operatively or within 2 days postoperatively. We did not study patients undergoing day surgery or nursing home residents. Patients ranked their opinions on the importance of discharge home using a Likert scale (from 1, not important at all to 6, extremely important) and the minimum number of extra days at home that would be meaningful using this scale. We recruited 104 patients; the survey was administered pre-operatively to 45 patients and postoperatively to 59 patients. The mean (SD) age was 53.5 (16.5) years, and 51 (49%) patients were male. Patients underwent a broad range of surgery of mainly intermediate (55%) to major (33%) severity. The median minimal clinically important difference for DAH30 was 3 days; this was consistent across a broad range of scenarios, including earlier discharge home, complications delaying hospital discharge and the requirement for admission to a rehabilitation unit. Discharge home earlier than anticipated and discharge home rather than to a rehabilitation facility were both rated as important (median score = 5). Empirical data on the minimal clinically important difference for DAH30 may be useful to determine sample size and to guide the non-inferiority margin for future clinical trials.

An evaluation of the outcome metric 'days alive and at home' in older patients after hip fracture surgery.

'Days alive and at home' is a validated measure that estimates the time spent at home, defined as the place of residence before admission to hospital. We evaluated this metric in older adults after hip fracture surgery and assessed two follow-up durations, 30 and 90 days. Patients aged ≥ 70 years who underwent hip fracture surgery were identified retrospectively via hospital admission and government mortality records. Patients who successfully returned home and were still alive within 90 days of surgery were distinguished from those who were not. Regression models were used to examine which variables were associated with failure to return home and number of days at home among those who did return, within 90 days of surgery. We analysed the records of 825 patients. Median (IQR [range]) number of days at home within 90 days (n = 788) was 54 (0-76 [0-88]) days and within 30 days (n = 797) it was 2 (0-21 [0-28]) days. Out of these, 274 (35%) patients did not return home within 90 days and 374 (47%) within 30 days after surgery. Known peri-operative risk-factors such as older age, pre-operative anaemia and postoperative acute renal impairment were associated with failure to return home. This study supports days alive and at home as a useful patient-centred outcome measure in older adults after hip fracture surgery. We recommend that this metric should be used in clinical trials and measured at 90, rather than 30, postoperative days. As nearly half of this patient population did not return home within 30 days, the shorter time-period catches fewer meaningful events.

Construct validity of the enfranchisement scale of the community participation indicators.

OBJECTIVE: This study examined the construct validity of the Enfranchisement scale of the Community Participation Indicators. DESIGN: We conducted a secondary analysis of data collected in a cross-sectional study of rehabilitation outcomes. SUBJECTS: The parent study included 604 community-dwelling adults with chronic traumatic brain injury, stroke, or spinal cord injury. The sample had a mean age of 64.1 years, was two-thirds male, and included a high proportion of racial minorities (n = 250, 41.4%). MAIN MEASURES: The Enfranchisement scale contains two subscales: the Control subscale and the Importance subscale. We examined correlations between each Enfranchisement subscale and measures of participation, environment, and impairments. The current analyses included cases with at least 80% of items completed on each subscale (Control subscale: n = 391; Importance subscale: n = 219). Missing values were imputed using multiple imputation. RESULTS: The sample demonstrated high scores, indicating poor enfranchisement (Control subscale: M = 51.7; Importance subscale: M = 43.0). Both subscales were most strongly associated with measures of participation (Control subscale: r = 0.56; Importance subscale: r = 0.52), and least strongly associated with measures of cognition (Control subscale: r = 0.03; Importance subscale: r = 0.03). The Importance subscale was closely associated with depression (r = 0.54), and systems, services, and policies (r = 0.50). Both subscales were associated with social attitudes (Control subscale: r = 0.44; Importance subscale: r = 0.44) and social support (Control subscale: r = 0.49; Importance subscale: r = 0.41). CONCLUSIONS: We found evidence of convergent validity between the Enfranchisement scale and measures of participation, and discriminant validity between the Enfranchisement scale and measures of disability-related impairments. The analyses also revealed the importance of the environment to enfranchisement outcomes.

Patient and caregiver perspectives on sleep in dialysis.

Sleep disturbances are common among patients receiving dialysis and are associated with an increased risk of mortality and morbidity, and impaired quality of life. Despite being highly prioritised by patients, sleep problems remain under-diagnosed and inadequately managed. The aim of the present study was to describe the perspectives of patients receiving dialysis and their caregivers on sleep. We extracted qualitative data on sleep from 26 focus groups, two international Delphi surveys, and two consensus workshops involving 644 patients and caregivers from 86 countries as part of the Standardised Outcomes in Nephrology-Haemodialysis and -Peritoneal Dialysis (SONG-HD/SONG-PD) initiatives. The responses were from patients aged ≥18 years receiving haemodialysis or peritoneal dialysis, and their caregivers. We analysed the data using thematic analysis with five themes identified: constraining daily living (with subthemes of: battling intrusive tiredness, exacerbating debilitating conditions, broken and incapacitated); roadblocks in relationships (unable to meet family needs, antipathy due to misunderstanding, wreaking emotional havoc); burden on caregivers (stress on support persons, remaining alert to help); losing enjoyment (limiting social contact, disempowerment in life); and undermining mental resilience (aggravating low mood, diminishing coping skills, reducing functional ability). Sleep disturbances are exhausting for patients on dialysis and pervade all aspects of their lives including the ability to do daily tasks, and maintaining relationships, mental and emotional well-being. Better assessment and management of sleep problems in dialysis is needed, which may lead to improvements in overall health and quality of life.

Validation and cultural adaptation of the Integrated Palliative care Outcome Scale (IPOS) for the Portuguese population.

BACKGROUND: To culturally adapt and validate the Integrated Palliative care Outcome Scale to European Portuguese. METHODS: Multi-centred observational study with 2 assessment points. Data were collected in nine centres using consecutive sampling. All patients were screened for eligibility. INCLUSION CRITERIA: ≥18 years, mentally fit to give consent, diagnosed with an incurable, potentially life-threatening illness, read, write and understand Portuguese. Translation and back translation with independent native speakers blind to the original measure created a Portuguese version, which was culturally adapted using cognitive interviews. For psychometric testing, the COSMIN checklist was followed. Reliability and content validity were assessed for patient and staff versions. Construct and criterion validity were tested for patient version. RESULTS: 1703 individuals were screened between July 1st 2015 and February 2016, 135 (7.9%) were included. Mean age was 66.8 years (SD 12.7), 58 (43%) were female. Most patients (109; 80.7%) had a cancer diagnosis. Cronbach's alpha showed good internal consistency, 0.657 for patient, 0.705 for staff versions. Intraclass correlation coefficient testing reproducibility revealed very good reliability, 0.794-0.950 for patient and 0.456-0.925 for staff versions. There was good content validity and significant results for construct validity. Physical symptoms were better detected by females. IPOS could discriminate: practical issues in different places of care, based on cancer diagnosis, physical and emotional symptoms based on life expectancy both for patient and professional dimensions, physical and emotional symptoms based on phase of illness, for professional dimensions, and physical symptoms from the patients' viewpoint. CONCLUSIONS: The Portuguese IPOS is a reliable and valid measure.

Determining the prevalence of palliative needs and exploring screening accuracy of depression and anxiety items of the integrated palliative care outcome scale - a multi-centre study.

BACKGROUND: patients with palliative needs often experience high symptom burden which causes suffering to themselves and their families. Depression and psychological distress should not be considered a "normal event" in advanced disease patients and should be screened, diagnosed, acted on and followed-up. Psychological distress has been associated with greater physical symptom severity, suffering, and mortality in cancer patients. A holistic, but short measure should be used for physical and non-physical needs assessment. The Integrated Palliative care Outcome Scale is one such measure. This work aims to determine palliative needs of patients and explore screening accuracy of two items pertaining to psychological needs. METHODS: multi-centred observational study using convenience sampling. Data were collected in 9 Portuguese centres. INCLUSION CRITERIA: ≥18 years, mentally fit to give consent, diagnosed with an incurable, potentially life-threatening illness. EXCLUSION CRITERIA: patient in distress ("unable to converse for a period of time"), cognitively impaired. Descriptive statistics used for demographics. Receiving Operator Characteristics curves and Area Under the Curve for anxiety and depression discriminant properties against the Hospital Anxiety and Depression Scale. RESULTS: 1703 individuals were screened between July 1st, 2015 and February 2016. A total of 135 (7.9%) were included. Main reason for exclusion was being healthy (75.2%). The primary care centre screened most individuals, as they have the highest rates of daily patients and the majority are healthy. Mean age is 66.8 years (SD 12.7), 58 (43%) are female. Most patients had a cancer diagnosis 109 (80.7%). Items scoring highest (=4) were: family or friends anxious or worried (36.3%); feeling anxious or worried about illness (13.3%); feeling depressed (9.6%). Using a cut-off score of 2/3, Area Under the Curve for depression and anxiety items were above 70%. CONCLUSIONS: main palliative needs were psychological, family related and spiritual. This suggests that clinical teams may better manage physical issues and there is room for improvement regarding non-physical needs. Using the Integrated Palliative care Outcome Scale systematically could aid clinical teams screening patients for distressing needs and track their progress in assisting patients and families with those issues.

The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial.

OBJECTIVE: To compare the clinical- and cost-effectiveness of ankle-foot orthoses (AFOs) and functional electrical stimulation (FES) over 12 months in people with Multiple Sclerosis with foot drop. DESIGN: Multicentre, powered, non-blinded, randomized trial. SETTING: Seven Multiple Sclerosis outpatient centres across Scotland. SUBJECTS: Eighty-five treatment-naïve people with Multiple Sclerosis with persistent (>three months) foot drop. INTERVENTIONS: Participants randomized to receive a custom-made, AFO (n = 43) or FES device (n = 42). OUTCOME MEASURES: Assessed at 0, 3, 6 and 12 months; 5-minute self-selected walk test (primary), Timed 25 Foot Walk, oxygen cost of walking, Multiple Sclerosis Impact Scale-29, Multiple Sclerosis Walking Scale-12, Modified Fatigue Impact Scale, Euroqol five-dimension five-level questionnaire, Activities-specific Balance and Confidence Scale, Psychological Impact of Assistive Devices Score, and equipment and National Health Service staff time costs of interventions. RESULTS: Groups were similar for age (AFO, 51.4 (11.2); FES, 50.4(10.4) years) and baseline walking speed (AFO, 0.62 (0.21); FES 0.73 (0.27) m/s). In all, 38% dropped out by 12 months (AFO, n = 21; FES, n = 11). Both groups walked faster at 12 months with device (P < 0.001; AFO, 0.73 (0.24); FES, 0.79 (0.24) m/s) but no difference between groups. Significantly higher Psychological Impact of Assistive Devices Scores were found for FES for Competence (P = 0.016; AFO, 0.85(1.05); FES, 1.53(1.05)), Adaptability (P = 0.001; AFO, 0.38(0.97); FES 1.53 (0.98)) and Self-Esteem (P = 0.006; AFO, 0.45 (0.67); FES 1 (0.68)). Effects were comparable for other measures. FES may offer value for money alternative to usual care. CONCLUSION: AFOs and FES have comparable effects on walking performance and patient-reported outcomes; however, high drop-outs introduces uncertainty.

Phase of Illness in palliative care: Cross-sectional analysis of clinical data from community, hospital and hospice patients.

BACKGROUND: Phase of Illness describes stages of advanced illness according to care needs of the individual, family and suitability of care plan. There is limited evidence on its association with other measures of symptoms, and health-related needs, in palliative care. AIMS: The aims of the study are as follows. (1) Describe function, pain, other physical problems, psycho-spiritual problems and family and carer support needs by Phase of Illness. (2) Consider strength of associations between these measures and Phase of Illness. DESIGN AND SETTING: Secondary analysis of patient-level data; a total of 1317 patients in three settings. Function measured using Australia-modified Karnofsky Performance Scale. Pain, other physical problems, psycho-spiritual problems and family and carer support needs measured using items on Palliative Care Problem Severity Scale. RESULTS: Australia-modified Karnofsky Performance Scale and Palliative Care Problem Severity Scale items varied significantly by Phase of Illness. Mean function was highest in stable phase (65.9, 95% confidence interval = 63.4-68.3) and lowest in dying phase (16.6, 95% confidence interval = 15.3-17.8). Mean pain was highest in unstable phase (1.43, 95% confidence interval = 1.36-1.51). Multinomial regression: psycho-spiritual problems were not associated with Phase of Illness ( χ2 = 2.940, df = 3, p = 0.401). Family and carer support needs were greater in deteriorating phase than unstable phase (odds ratio (deteriorating vs unstable) = 1.23, 95% confidence interval = 1.01-1.49). Forty-nine percent of the variance in Phase of Illness is explained by Australia-modified Karnofsky Performance Scale and Palliative Care Problem Severity Scale. CONCLUSION: Phase of Illness has value as a clinical measure of overall palliative need, capturing additional information beyond Australia-modified Karnofsky Performance Scale and Palliative Care Problem Severity Scale. Lack of significant association between psycho-spiritual problems and Phase of Illness warrants further investigation.

Measurement properties of the Haem-A-QoL in haemophilia clinical trials.

INTRODUCTION: Patients with haemophilia on long-acting prophylactic treatment may experience an improvement in health-related quality of life (HRQoL) through reductions in breakthrough bleeds and associated complications, including long-term joint damage, compared with episodic treatment. AIM: This analysis examined clinical trial data to understand the psychometric characteristics (reliability, validity and sensitivity to change over time) of the Haem-A-QoL Questionnaire in adult males with haemophilia. METHODS: Two recent, multinational, Phase 3 clinical trials of new, long-acting factor concentrates (A-LONG: rFVIIIFc; B-LONG: rFIXFc) assessed HRQoL in adolescent and adult males with severe haemophilia A or B respectively. The adults' baseline assessments, via the 46-item Haem-A-QoL Questionnaire, and change over time at the 6-month assessment were used in the psychometric analyses. RESULTS: Internal consistency reliability was adequate (Cronbach's alpha > 0.70) for nine of the 10 Haem-A-QoL domains and for 'Total Score' in both trials at baseline (A-LONG, n = 133; B-LONG, n = 73). At baseline, several Haem-A-QoL domains and 'Total Score' demonstrated known-groups and convergent validity when compared with other trial measures, including the EQ-5D (items and total scores) and joint impairment. Change score correlations (baseline to 28 weeks) between the EQ-5D and the Haem-A-QoL 'Total Score', and 'Physical Health' and 'Feelings' domains were moderate in magnitude (│r│ ≥ 0.33; P < 0.03), demonstrating sensitivity to change for these outcome measures in A-LONG. CONCLUSION: These psychometric analyses provide evidence of the reliability, validity and ability to detect change of the Haem-A-QoL to assess the HRQoL of adult males with severe haemophilia A and B in longitudinal clinical trials.

The impact of quality-of-life data in relative effectiveness assessments of new anti-cancer drugs in European countries.

PURPOSE: The aim of this study is to investigate the role of health-related quality-of-life (QoL) data in relative effectiveness assessments (REAs) of new anti-cancer drugs across European jurisdictions, during health technology assessment procedures. METHODS: Comparative analysis of guidelines and publicly available REAs in six European jurisdictions of anti-cancer drugs approved by EMA between 2011 and 2013. RESULTS: Fourteen anti-cancer drugs were included, adding up to 79 REAs. Whilst all guidelines state that QoL is a relevant endpoint to determine the relative effectiveness of new cancer drugs, QoL data were included in only 54% of the 79 reports and their impact on the recommendations was limited. CONCLUSIONS: Whilst national guidelines recognize the relevance of QoL to determine the relative effectiveness of new anti-cancer drugs, this is not well-reflected in current assessments. Developing and implementing into REAs specific evidence requirements for QoL data would improve the use of this patient-centred outcome in future reimbursement and pricing decisions.

Implementing a patient-centred outcome measure in daily routine in a specialist palliative care inpatient hospital unit: An observational study.

BACKGROUND: Gathering clinical evidence data on patients' palliative care needs is paramount to identify changes in outcomes over time and maintaining on-going quality improvement. Implementation of patient-centred outcome measures has been widely recommended. The routine use of these instruments in daily practice is challenging and not widespread. AIM: To implement a patient-centred outcome measure in daily practice and fulfil one quality indicator: improve pain during the 72 h after admission, in at least 75% of patients. DESIGN: An observational prospective study. The Palliative care Outcome Scale was used at admission (T0), third day (T1) and weekly. SETTING/PARTICIPANTS: Hospital palliative care unit with 17 individual rooms. All patients admitted to the unit were included in the study. RESULTS: Preliminary results ( N = 84) revealed inconsistent and missing data (14%). Symptoms were sub-optimally controlled by T1. Processes changed, and only a team member could apply Palliative care Outcome Scale. Doctors were encouraged to grasp the meaning of Palliative care Outcome Scale results for each patient. The post-pilot included 317 patients. No missing data occurred. There was an improvement in most items between T0 and T1: 'pain' and 'other symptoms' presented statistical significant differences ( p < 0.05). CONCLUSION: Implementing a patient-centred outcome measure in a hospital palliative care service is feasible and improves quality of care. Controlling high pain at T0 improved (>80%) by T1. Results became more consistent and symptom control was improved overall. Patients are evaluated based on holistic domains by an interdisciplinary team and we have added a much needed measure to help guide improvement of the quality of care provided.