Search

Background: The efficacy of virtual reality for people living with a terminal illness is unclear. Aim: To determine the feasibility and effectiveness of virtual reality use within a palliative care setting. Design: Systematic review and meta-analysis. PROSPERO (CRD42021240395). Data sources: Medline, Embase, AMED, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials and Web of Science were searched from inception to March 2021. Search terms included 'virtual reality' and 'palliative care'. Eligibility: (1) adult (>18 years old) with a terminal illness (2) at least one virtual reality session and (3) feasibility data and/or at least one patient outcome reported. The ROB-2 and ROBINS tools assessed risk of bias. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool assessed the quality of the evidence. Standardised mean differences (Hedges's g) were calculated from the pre- and post-data. A DerSimonian-Laird random effects model meta-analysis was conducted. Results: Eight studies were included, of which five were in the meta-analysis. All studies had at least some concern for risk of bias. Virtual reality statistically significantly improved pain (p = 0.0363), tiredness (p = 0.0030), drowsiness (p = 0.0051), shortness of breath (p = 0.0284), depression (p = 0.0091) and psychological well-being (p = 0.0201). The quality of the evidence was graded as very low due to small sample sizes, non-randomisation methods and a lack of a comparator arm. Conclusions: Virtual reality in palliative care is feasible and acceptable. However, limited sample sizes and very low-quality studies mean that the efficacy of virtual reality needs further research. [ABSTRACT FROM AUTHOR]

Objectives: To (1) describe the prescription and administration of regular and 'as required' (pro re nata [PRN]) analgesics in English care homes, (2) investigate individual and care home factors associated with analgesic use. Methods: We collected data (2014–2016) at 0‐, 4‐, and 12‐months nested in a longitudinal cohort study of 86 English care homes about residents with diagnosed or probable dementia. We describe analgesics prescribed as regular or PRN medication, by class, and PRN administration. We explored individual differences (sociodemographic; dementia severity [Clinical Dementia Rating]), and care home differences (type; ownership; number of beds; dementia‐registered/specialist; Care Quality Commission rating) in prescription and administration using multilevel regression models. Results: Data were available for 1483 residents. At baseline, 967 residents (67.9%) were prescribed analgesics: 426 residents (28.7%) prescribed regular analgesics and 670 (45.2%) prescribed PRN. Paracetamol was the most prescribed analgesic (56.7%), with PRN prescriptions more common than regular (39.7% vs. 16.6%). Across all study visits, 344 residents (mean = 41.9%) with a PRN prescription did not receive any analgesic in the 2 weeks prior to data collection. Male residents and those with severe dementia received fewer analgesics. Care homes differences in PRN administration were not explained by the modelled variables. Conclusions: Pain management in English care homes largely relies on PRN paracetamol that is frequently prescribed but infrequently administered. Care homes differ in how often they administer PRN analgesics. Some care home residents particularly those with more severe dementia are likely to have untreated pain. Key points: English care home residents with dementia are frequently prescribed pro re nata (PRN) analgesics but these are infrequently administered.Some groups of residents (male, more severe dementia) receive fewer analgesics and may be at risk of undertreatment for pain.Before prescribing pain relief, clinicians need to consider the risk that PRN analgesics may not be administered.Pragmatic pain management guidelines specifically for care home residents with dementia and improving medication documentation may optimise analgesic use. [ABSTRACT FROM AUTHOR]

To determine the efficacy of repeat selective laser trabeculoplasty (SLT) in medication-naive open-angle glaucoma (OAG) and ocular hypertensive (OHT) patients requiring repeat treatment for early to medium-term failure during the Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. Post hoc analysis of SLT treatment arm of a multicenter prospective randomized controlled trial. Treatment-naive OAG or OHT requiring repeat 360-degree SLT within 18 months. Retreatment was triggered by predefined IOP and disease-progression criteria (using objective individualized target IOPs). After SLT at baseline, patients were followed for a minimum of 18 months after second (repeat) SLT. A mixed-model analysis was performed with the eye as the unit of analysis, with crossed random effects to adjust for correlation between fellow eyes and repeated measures within eyes. Kaplan–Meier curves plot the duration of effect. Initial (early) IOP lowering at 2 months and duration of effect after initial and repeat SLT. A total of 115 eyes of 90 patients received repeat SLT during the first 18 months of the trial. Pretreatment IOP before initial SLT was significantly higher than before retreatment IOP of repeat SLT (mean difference, 3.4 mmHg; 95% confidence interval [CI], 2.6–4.3 mmHg; P < 0.001). Absolute IOP reduction at 2 months was greater after initial SLT compared with repeat SLT (mean difference, 1.0 mmHg; 95% CI, 0.2–1.8 mmHg; P = 0.02). Adjusted absolute IOP reduction at 2 months (adjusting for IOP before initial or repeat laser) was greater after repeat SLT (adjusted mean difference, −1.1 mmHg, 95% CI, −1.7 to −0.5 mmHg; P = 0.001). A total of 34 eyes were early failures (retreatment 2 months after initial SLT) versus 81 later failures (retreatment >2 months after initial SLT). No significant difference in early absolute IOP reduction at 2 months after repeat SLT was noted between early and later failures (mean difference, 0.3 mmHg; 95% CI, −1.1 to 1.8 mmHg; P = 0.655). Repeat SLT maintained drop-free IOP control in 67% of 115 eyes at 18 months, with no clinically relevant adverse events. These exploratory analyses demonstrate that repeat SLT can maintain IOP at or below target IOP in medication-naive OAG and OHT eyes requiring retreatment with at least an equivalent duration of effect to initial laser. [ABSTRACT FROM AUTHOR]

Background: As both epilepsy and challenging behaviour are highly prevalent in adults with intellectual disability (ID) it is important to explore any potential relationships between the two to inform patient care. The aim of the present study was to investigate the relationship between epilepsy factors and challenging behaviour in adults with ID. Method: The sample was drawn from a clinical trial cohort (n = 246), with all participants displaying challenging behaviour across the range of ID. We described sociodemographic and clinical status (seizure types, seizure frequency and drug burden) in 70 participants with epilepsy (EP). We investigated differences in and predictors of challenging behaviour and mental ill-health, measured by the Aberrant Behaviour Checklist-Community and the Mini Psychiatric Assessment Schedule for Adults with Developmental Disabilities respectively, between participants with and without epilepsy (NEP). Results: More male participants were identified with epilepsy (EP = 76% and NEP = 61%, p =.026) and the EP group had lower adaptive behaviour scores than their NEP counterparts (Mean (SD) EP = 44.4 (24.1), NEP = 51.7 (25.0), p =.04). EP participants showed significantly less lethargy as measured by the Aberrant Behaviour Checklist-Community than NEP participants (Mean (SD) EP = 11.9 (7.4) and NEP = 15.1 (9.9); t-test p =.02). Younger age and poorer adaptive functioning were associated with challenging behaviour (beta=−.520, p <.001 and beta=−0.30, p <.001, respectively). Conclusions: These findings indicate that epilepsy does not appear to be associated with challenging behaviour in adults with ID. Therefore, while management of epilepsy is very important in a clinical context, it is essential that professionals should further elucidate reasons for the presentation of such behaviours in order to provide timely and targeted interventions. [ABSTRACT FROM AUTHOR]

To report clinical efficacy, predictors of success, and safety of primary selective laser trabeculoplasty (SLT) used in treatment-naive patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Post hoc analysis of a multicenter, prospective, randomized, controlled trial. Treatment-naive patients with OAG or OHT. Patients randomized to SLT or topical medication and treated to predefined target intraocular pressures (IOPs) requiring ≥20% IOP reduction from baseline for all disease severity levels. Initial (early) absolute IOP-lowering at 2 months. Achievement of drop-free disease-control: meeting target IOP without disease progression or need for additional topical medication over 36 months after SLT. Predictors of early absolute IOP-lowering and drop-free disease-control after single initial SLT. Frequency of laser-related complications. A total of 611 eyes (195 OHT and 416 OAG) of 355 patients received SLT, and 622 eyes (185 OHT and 437 OAG) of 362 patients received topical medication at baseline. Early absolute IOP-lowering after SLT was no different between OHT and OAG eyes (adjusted mean difference = −0.05 mmHg; 95% confidence interval [CI], −0.6 to 0.5 mmHg; P = 0.85). No difference was noted in early absolute IOP-lowering between topical medication and primary SLT (adjusted mean difference = −0.1 mmHg; 95% CI, −0.6 to 0.4 mmHg; P = 0.67). Early absolute IOP-lowering with primary SLT was positively associated with baseline IOP (coefficient 0.58; 95% CI, 0.53–0.63; P < 0.001) and negatively with female gender (coefficient −0.63; 95% CI, −1.23 to −0.02; P = 0.04). At 36 months, 536 eyes (87.7% of 611 eyes) of 314 patients (88.5% of 355 patients) were available for analysis. Some 74.6% of eyes (400 eyes) treated with primary SLT achieved drop-free disease-control at 36 months; 58.2% (312 eyes) after single SLT. Total SLT power and 2-month IOP were predictors of drop-free disease-control at 36 months after single SLT. Six eyes of 6 patients experienced immediate post-laser IOP spike (>5 mmHg from pretreatment IOP) with 1 eye requiring treatment. Primary SLT achieved comparable early absolute IOP-lowering in OHT versus OAG eyes. Drop-free disease-control was achieved in approximately 75% eyes at 36 months after 1 or 2 SLTs, the majority of these after single SLT. These analyses are exploratory but support primary SLT to be effective and safe in treatment-naive OAG and OHT eyes. [ABSTRACT FROM AUTHOR]

Background: Inadequate description of non-pharmacological complex interventions in trial publications means that they cannot be replicated or assessed for generalisability. There are published guidelines on how to describe an intervention, such as those from the CONSORT Group. However, there have been few evaluations of whether intervention reporting is improving.Methods: We aimed to assess whether descriptions of multicomponent, non-pharmacological interventions evaluated in randomised trials are improving. To do so, we chose trials of educational and psychotherapeutic interventions to promote adherence to therapy, and compared those published between 2002 and 2007 (Time-1) with those between 2010 and 2015 (Time-2). These time periods were chosen to concord with the publication in 2008 of the CONSORT extension statement of reporting guidelines for non-pharmacological treatment which included items on intervention description. We assessed 19 items, based on the CONSORT Statement and the more recent Template for Intervention Description and Replication Checklist (TIDieR). Two reviewers independently extracted data. We created a quality score of the eight items we considered key information for replication and assessment of generalisability (setting, provider, recipient, comparator, intervention intensity, how it was conducted, existence of a manual or protocol, and detail of whether there was an assessment of fidelity). Score per item was '1' if reported adequately and '0' if not.Results: Of the eligible trials, 42 were published in Time-1 and 134 published in Time-2. The trials included were published in 112 peer-reviewed journals, 52 of these journals currently require authors to follow the CONSORT Statements, while only one recommended adherence to the TIDieR. Most items of CONSORT and TIDieR were reported by more than half of the trials at both time points. Few trials reported fidelity. A large proportion of the trials did not report the existence of a manual or protocol, or what the comparator group received. We found no statistically significant improvement in the eight-item quality score (Time-1: mean 5.71 (standard deviation (SD) 1.09), Time-2: 5.87 (SD 1.28), p = 0.49).Conclusions: We found no overall evidence that reporting the specifics of multicomponent, non-pharmacological interventions is improving. Details to replicate interventions remain lacking, impairing best implementation or meaningful further research. Editorial endorsement of reporting checklists needs to be more extensive. [ABSTRACT FROM AUTHOR]

Objectives: The Cohen-Mansfield Agitation Inventory (CMAI; (Cohen-Mansfield and Kerin, 1986)) is a well-known tool for assessing agitated behaviours in people with dementia who reside in long-term care. No studies have evaluated the psychometric qualities and factor structure of the CMAI in acute general hospitals, a setting where people with demand may become agitated.Method: Longitudinal study investigating pain, agitation and behavioural problems in 230 people with dementia admitted to acute general hospitals in 2011-2012. Cohen-Mansfield Agitation Inventory was completed as part of a battery of assessments including PAINAD to measure pain.Results: A nine-item two-factor model of aggressive and nonaggressive behaviours proved to be the best-fitting measurement model in this sample, (χ2  = 96.3, df = 26, p<0.001; BIC [Bayesian Information Criterion] = 4593.06, CFI [Comparative Fit Index] = 0.884, TLI [Tucker Lewis Index] = 0.839, RMSEA [Root Mean Square Error of the Approximation] = 0.108). Although similar to the original factor structure, the new model resulted in the elimination of item 13 (screaming). Validity was confirmed with the shortened CMAI showing similar associations with pain as the original version of the CMAI, in particular the link between aggressive behaviours and pain.Conclusion: The factor structure of the CMAI was broadly consistent with the original solution although a large number of items were removed. Scales reflecting physical and verbal aggression were combined to form an Aggressive factor, and physical and verbal nonaggressive behaviours were combined to form the Nonaggressive factor. A shorter, more concise version of the CMAI was developed for use in acute general hospital settings. Copyright © 2017 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Habit-interventions are designed to promote the automaticity of healthy behaviours and may also enhance self-regulatory skills during the habit-formation process. A recent trial of habit-based advice for weight loss (10 Top Tips; 10TT), found that patients allocated to 10TT lost significantly more weight over 3 months than those allocated to usual care, and reported greater increases in automaticity for the target behaviours. The current study aimed to test the hypothesis that i) 10TT increased self-regulatory skills more than usual care, and ii) that self-regulatory skills and automaticity changes mediated the effect of 10TT on weight loss. Methods: 537 obese patients from 14 primary care practices in the UK were randomized to receive 10TT or usual care. Patients in the 10TT group received a leaflet containing tips for weight loss and healthy habits formation, a self-monitoring log book and a wallet-sized shopping guide on how to read food labels. Patients were weighed and completed validated questionnaires for self-regulation and automaticity at baseline and 3-month follow-up. Within-group and Between-group effects were explored using Paired T-test and ANCOVA, respectively. Mediation was assessed using bootstrapping to estimate indirect effects and the sobel test. Results: Over 3 months patients who were given 10TT reported greater increases in self-regulatory skills (Mean difference: .08; 95% CI .01; .15) than those who received usual care. Changes in self-regulatory skills and automaticity over 3 months mediated the effect of the intervention on weight loss (β = .52, 95% Bias Corrected CI .17; .91). Conclusions: As hypothesised, 10TT enhanced self-regulatory skills and changes in self-regulatory skills and automaticity mediated the effect of the intervention on weight loss. This supports the proposition that self-regulatory training and habit formation are important features of weight loss interventions. Trial registration: This study was prospectively registered with the International Standard Randomised Controlled Trials () on 26 September 2011. [ABSTRACT FROM AUTHOR]

Introduction: The Resident Choice Assessment Scale (RCAS) is used to assess choice availability for adults with intellectual disabilities (ID). The aim of the study was to explore the factor structure, construct validity, and internal consistency of the measure in community settings to further validate this tool. Method: 108 paid carers of adults with ID living in supported accommodation and residential care facilities in urban, rural, and semirural areas in England completed the RCAS. Exploratory factor analyses were performed and the construct validity and internal consistency of the emerging factors were assessed. Results: Principal axis factoring with oblique rotations suggested a scale with two factors (Everyday Choices and Participation in Household Activities) which explained 45% of the variance; the factors showed favorable construct validity as they identified significant differences between those living in residential care homes compared with supported living; the factors also differentiated between people with different levels of intellectual impairment with less choice and participation in domestic activities for those with more severe ID compared to their counterparts with moderate and mild impairment. Five items did not load onto any factor, suggesting that these could be dropped from the scale when administered in community settings, thus resulting in an 18-item measure (RCAS-18). Conclusion: The RCAS-18 may provide a useful measure to assess choice availability for people with ID supported by paid carers in the community. The revised measure may be more suitable in capturing choice than the original version for use in community samples. [ABSTRACT FROM AUTHOR]

Background: The LiGHT trial (Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial) is a multicentre randomised controlled trial of two treatment pathways for patients who are newly diagnosed with open-angle glaucoma (OAG) and ocular hypertension (OHT). The main hypothesis for the trial is that lowering intraocular pressure (IOP) with selective laser trabeculoplasty (SLT) as the primary treatment ('Laser-1st') leads to a better health-related quality of life than for those started on IOP-lowering drops as their primary treatment ('Medicine-1st') and that this is associated with reduced costs and improved tolerability of treatment. This paper describes the statistical analysis plan for the study.Methods/design: The LiGHT trial is an unmasked, multi-centre randomised controlled trial. A total of 718 patients (359 per arm) are being randomised to two groups: medicine-first or laser-first treatment. Outcomes are recorded at baseline and at 6-month intervals up to 36 months. The primary outcome measure is health-related quality of life (HRQL) at 36 months measured using the EQ-5D-5L. The main secondary outcome is the Glaucoma Utility Index. We plan to analyse the patient outcome data according to the group to which the patient was originally assigned. Methods of statistical analysis are described, including the handling of missing data, the covariates used in the adjusted analyses and the planned sensitivity analyses.Trial Registration: The trial was registered with the ISRCTN register on 23/07/2012, number ISRCTN32038223 . [ABSTRACT FROM AUTHOR]

Objectives To review how multiple primary outcomes are currently considered in the analysis of randomised controlled trials. We briefly describe the methods available to safeguard the inferences and to raise awareness of the potential problems caused by multiple outcomes. Methods/design We reviewed randomised controlled trials (RCTs) in neurology and psychiatry disease areas, as these frequently analyse multiple outcomes. We reviewed all published RCTs from July 2011 to June 2014 inclusive in the following high impact journals: The New England Journal of Medicine, The Lancet, The American Journal of Psychiatry, JAMA Psychiatry, The Lancet Neurology and Neurology. We examined the information presented in the abstract and the methods used for sample size calculation and statistical analysis. We recorded the number of primary outcomes, the methods used to account for multiple primary outcomes, the number of outcomes discussed in the abstract and the number of outcomes used in the sample size calculation. Results Of the 209 RCTs that we identified, 60 (29%) analysed multiple primary outcomes. Of these, 45 (75%) did not adjust for multiplicity in their analyses. Had multiplicity been addressed, some of the trial conclusions would have changed. Of the 15 (25%) trials which accounted for multiplicity, Bonferroni's correction was the most commonly used method. Conclusions Our review shows that trials with multiple primary outcomes are common. However, appropriate steps are not usually taken in most of the analyses to safeguard the inferences against multiplicity. Authors should state their chosen primary outcomes clearly and justify their methods of analysis. [ABSTRACT FROM AUTHOR]

Background: Advance care planning in dementia does not always happen. As dementia progresses, decisions are often left for family carers to make with professionals. Aim: To test the feasibility and acceptability of the delivery and use of a decision aid for family carers of people with severe dementia or towards the end-of-life. Design: Feasibility study using a before-after design of a paper-based decision aid with family carers of people with severe dementia or towards the end-of-life. Criteria for whether to progress to full evaluation included achieving: 70% recruitment rate of target of 30 people, and retention of 70% at 6 months. Outcome measures at baseline, 3 and 6 months, included: the Decisional Conflict Scale (DCS), Kessler Psychological Distress Scale (K10), EQ5D-5L and Satisfaction with Care at the End of Life (SWC-EOLD). Participants: Twenty-eight family carers were recruited (93% of target), 26 completed baseline assessment and 20 (71%) of those were followed-up at 6 months. Results: Almost all outcomes changed indicating improvement over 6 months. The DCS and K10 scores decreased indicating less decisional conflict and less psychological distress. The decision aid was acceptable, 25% found it very helpful and 55% a little helpful at 6 months. Conclusion: We met the success criteria demonstrating this study was feasible and acceptable to carers. Future research should test the effectiveness of the decision aid in a full scale evaluation. [ABSTRACT FROM AUTHOR]

Background: The Surprise Question ('Would I be surprised if this patient died within 12 months?') identifies patients in the last year of life. It is unclear if 'surprised' means the same for each clinician, and whether their responses are internally consistent. Aim: To determine the consistency with which the Surprise Question is used. Design: A cross-sectional online study of participants located in Belgium, Germany, Italy, The Netherlands, Switzerland and UK. Participants completed 20 hypothetical patient summaries ('vignettes'). Primary outcome measure: continuous estimate of probability of death within 12 months (0% [certain survival]–100% [certain death]). A threshold (probability estimate above which Surprise Question responses were consistently 'no') and an inconsistency range (range of probability estimates where respondents vacillated between responses) were calculated. Univariable and multivariable linear regression explored differences in consistency. Trial registration: NCT03697213. Setting/participants: Registered General Practitioners (GPs). Of the 307 GPs who started the study, 250 completed 15 or more vignettes. Results: Participants had a consistency threshold of 49.8% (SD 22.7) and inconsistency range of 17% (SD 22.4). Italy had a significantly higher threshold than other countries (p = 0.002). There was also a difference in threshold levels depending on age of clinician, for every yearly increase, participants had a higher threshold. There was no difference in inconsistency between countries (p = 0.53). Conclusions: There is variation between clinicians regarding the use of the Surprise Question. Over half of GPs were not internally consistent in their responses to the Surprise Question. Future research with standardised terms and real patients is warranted. [ABSTRACT FROM AUTHOR]

Background: Acute hospital wards can be difficult places for many people living with dementia. Promoting comfort and wellbeing can be challenging in this environment. There is little evidence‐based support for professionals working on acute care wards on how to respond to distress and maximise comfort and wellbeing among patients living with dementia. Objectives: Our overall aim was to codesign an evidence‐based easy‐to‐use heuristic decision‐support framework, which was acceptable and practical but acknowledges the complex and acute nature of caring for patients with dementia in the hospital. This paper presents the development process and resulting framework. Methods: A codesign study was informed by data from (1) a literature review of the care and management of people living with dementia in acute hospitals; (2) a cohort study of comfort and discomfort in people with dementia in acute hospitals; and (3) interviews with family carers and health care professionals. We synthesised evidence from these data sources and presented to key stakeholders through codesign meetings and workshops to produce our decision‐support framework. Results: The framework consists of a series of flowcharts and operates using a three‐stage process of: (1) assess comfort/discomfort; (2) consider causes of discomfort; and (3) address patient needs to manage the discomfort. Conclusion: Working with key stakeholders, synthesising diverse quantitative and qualitative evidence to build a clinical framework is a feasible approach to help address the needs of patients living with dementia in an acute hospital setting. The result is a framework which is now ready for evaluation and implementation. Patient and Public Contribution: We worked closely with people living with dementia and family carers throughout this study, including the development of the study protocol with input on study development and design, through to inclusion in stakeholder workshops and codesign of the decision support framework. [ABSTRACT FROM AUTHOR]

In the original publication of this article [1], "=1 -  = 1 -   ≈ s" was mistakenly added after the sentence " In this method, the unadjusted p-values pj are multiplied by the number of primary outcome" in the Methods section, and should be deleted. [ABSTRACT FROM AUTHOR]

Background: Multiple primary outcomes may be specified in randomised controlled trials (RCTs). When analysing multiple outcomes it's important to control the family wise error rate (FWER). A popular approach to do this is to adjust the p-values corresponding to each statistical test used to investigate the intervention effects by using the Bonferroni correction. It's also important to consider the power of the trial to detect true intervention effects. In the context of multiple outcomes, depending on the clinical objective, the power can be defined as: 'disjunctive power', the probability of detecting at least one true intervention effect across all the outcomes or 'marginal power' the probability of finding a true intervention effect on a nominated outcome. We provide practical recommendations on which method may be used to adjust for multiple comparisons in the sample size calculation and the analysis of RCTs with multiple primary outcomes. We also discuss the implications on the sample size for obtaining 90% disjunctive power and 90% marginal power.Methods: We use simulation studies to investigate the disjunctive power, marginal power and FWER obtained after applying Bonferroni, Holm, Hochberg, Dubey/Armitage-Parmar and Stepdown-minP adjustment methods. Different simulation scenarios were constructed by varying the number of outcomes, degree of correlation between the outcomes, intervention effect sizes and proportion of missing data.Results: The Bonferroni and Holm methods provide the same disjunctive power. The Hochberg and Hommel methods provide power gains for the analysis, albeit small, in comparison to the Bonferroni method. The Stepdown-minP procedure performs well for complete data. However, it removes participants with missing values prior to the analysis resulting in a loss of power when there are missing data. The sample size requirement to achieve the desired disjunctive power may be smaller than that required to achieve the desired marginal power. The choice between whether to specify a disjunctive or marginal power should depend on the clincial objective. [ABSTRACT FROM AUTHOR]

Measuring therapists' adherence to treatment manuals is recommended for evaluating treatment integrity, yet ways to do this are poorly defined, time consuming, and costly. The aims of the study were to develop a Therapy Component Checklist (TCC) to measure adherence to manualised CBT; to test its application in research and clinical practice; to determine its validity; and consider its cost benefits. We conducted a randomised trial in 230 people with cancer evaluating effectiveness of CBT for depression. In this, therapists delivered manualised treatment. Experts agreed on key components of therapy and therapists were asked to record these after therapy sessions by ticking a TCC. Inter-rater reliability was tested using an independent rater. Therapists delivered 543 CBT sessions. TCCs were completed in 293, of which 39 were assessed by the independent rater. Self-reported TCC data suggested close adherence to the manual. Prevalence-adjusted and bias-adjusted kappa scores suggested substantial agreement, (>0.60) in 38 out of 46 items. Self-rating of adherence saved around £96 per rating. In conclusion the TCC provides a quick and cost effective way of evaluating the components of therapy delivered. This approach could be applied to other psychological treatments and may help with linking therapeutic interventions with outcome. [ABSTRACT FROM AUTHOR]

Objectives determine and compare the prevalence of orofacial pain in older nursing home residents with and without dementia and explore the association between orofacial pain and health factors. Methods cross-sectional study conducted in four UK nursing homes. We used the Orofacial-Pain Scale for Non-Verbal Individuals (OPS-NVI) to identify orofacial pain in residents with dementia. Residents who were able to communicate self-reported orofacial pain. A brief oral examination was conducted. Information on demographics, Clinical Dementia Rating, Charlson Comorbidity Index, Cohen Mansfield Agitation Inventory, Barthel Index, 5-level Euroqol 5 Dimension, Oral Health Impact Profile 14, Mini Nutritional Assessment Short Form and medication was collected. Chi-squared tests, independent sample t-tests and Mann-Whitney U-tests were used to compare outcomes between groups. Multivariable logistic regression was used to evaluate predictors of orofacial pain. Results orofacial pain, assessed with the OPS-NVI, was present in 48.8% (95% confidence interval [C.I.] 36.1–50.7) of residents with dementia. Self-reported orofacial pain was present in 37.8% (95% C.I. 20.4–53.7) of residents with dementia and in 14.8% (95% C.I. 0.5–30.4) residents without dementia. Orofacial pain was significantly more prevalent in residents with dementia than those without (OPS-NVI; P  = 0.002, self-report; P  = 0.04). Having a soft diet, xerostomia, being dentate, and poor oral hygiene in dentate residents were significant predictors of orofacial pain in residents with dementia. Conclusion orofacial pain was more prevalent in residents with dementia. Oral health care should be part of routine care for residents, especially for those with dementia, to improve oral health and decrease the risk of developing orofacial pain. [ABSTRACT FROM AUTHOR]

Background: Although Positive Behaviour Support (PBS) is a widely used intervention for ameliorating challenging behaviour (CB), evidence for its use in adults with intellectual disability (ID) and comorbid autism (ASD) is lacking. We report a planned subsidiary analysis of adults with both ASD and ID who participated in a randomised trial of PBS delivered by health professionals. Methods: The study was a multicentre, cluster randomised trial conducted in 23 community ID services in England, participants were randomly allocated to either the delivery of PBS (n = 11 clusters) or to treatment as usual (TAU; n = 12). One-hundred and thirteen participants (46% of all participants in the trial) had a diagnosis of ID, autism spectrum disorder and CB (ASD+); (47 allocated to the intervention arm, and 66 to the control). CB (primary outcome) was measured with the Aberrant Behaviour Checklist total score (ABC-CT). Secondary outcomes included mental health status, psychotropic medication use, health and social care costs and quality adjusted life years (QALYs) over 12 months. Results: There were no statistically significant differences in ABC-CT between ASD+ groups randomised to the two arms over 12 months (adjusted mean difference = − 2.10, 95% CI: − 11.3 7.13, p = 0.655) or other measures. The mean incremental cost of the intervention per participant was £628 (95% CI -£1004 to £2013). There was a difference of 0.039 (95% CI − 0.028 to 0.103) for QALYs and a cost per QALY gained of £16,080. Conclusions: Results suggest lack of clinical effectiveness for PBS delivered by specialist ID clinical teams. Further evidence is needed from larger trials, and development of improved interventions. Trial registration: ClinicalTrials.gov: NCT01680276. [ABSTRACT FROM AUTHOR]

A correction to the article "Statistical analysis plan for the Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial (LiGHT): a multi-centre randomised controlled trial" in the July 2017 issue is presented.

Objective: To understand the feasibility of recruiting people with advanced cancer into a randomised controlled trial of acceptance and commitment therapy (ACT) vs a standardised talking control (TC) and delivering ACT to this population; to explore the acceptability of outcome measures and generate normative data.Methods: This was a feasibility two-arm randomised controlled trial. Participants were attendees with advanced cancer at one of three hospice-based day-therapy units in London, United Kingdom, who demonstrated low scores on the Functional Assessment of Cancer Therapies-General (FACT-G). The primary end point was 3 months.Results: The recruitment target was 54 participants; 42 people were recruited and randomised to up to eight individual sessions of ACT (n = 20) or TC (n = 22). Eighteen out of 42 (43%) of participants completed the primary outcome at 3 months, and at least one follow-up was available in 30/42 (71%) participants. An exploratory analysis revealed a non-significant adjusted mean difference after 3 months in the main outcome FACT-G of -3.41 (CI = -18.61-11.79) with TC having better functioning. Over 6 months, the adjusted mean difference between trial arms was 2.25 (CI = -6.03-10.52) in favour of ACT.Conclusions: It is feasible to recruit people with advanced cancer in a trial of ACT versus TC. Future research should test the effectiveness of ACT in a fully powered trial. [ABSTRACT FROM AUTHOR]

Introduction: There has been global investment of new ways of working to support workforce pressures, including investment in clinical pharmacists working in primary care by the NHS in the England. Clinical pharmacists are well suited to support older adults who have multiple long-term conditions and are on multiple medications. It is important to establish an evidence base for the role of clinical pharmacists in supporting older adults in primary care, to inform strategic and research priorities. The aim of this scoping review is to identify, map and describe existing research and policy/guidance on the role of clinical pharmacists in primary care supporting older adults, and the models of care they provide. Methods and analysis: A scoping review guided by the Joanne Briggs Institute methodology for scoping reviews, using a three-step strategy. We will search Medline, CINAHL, Scopus, EMBASE, Web of Science, PSYCHInfo, and Cochrane for English language articles, from 2015 –present day. Grey literature will be searched using Grey Matters guidelines, the Index of Grey Literature and Alternative Sources and Resources, and Google keyword searching. References of all included sources will be hand searched to identify further resources. Using the Population, Concept and Context framework for inclusion and exclusion criteria, articles will be independently screened by two reviewers. The inclusion and exclusion criteria will be refined after we become familiar with the search results, following the iterative nature of a scoping review. Data will be extracted using a data extraction tool using Microsoft Excel and presented using a narrative synthesis approach. Ethics and dissemination: Ethical approval is not required for this review. Review findings will be disseminated in academic conferences and used to inform subsequent qualitative research. Findings will be published and shared with relevant local and national organisations. [ABSTRACT FROM AUTHOR]

Objectives: To explore global changes in the prescription of analgesic drugs over time in the international long‐term care (LTC) population. Design: Systematic review. Setting: We included original research articles in English, published and unpublished, that included number of participants, country and year(s) of data collection, and prescription of analgesics (analgesics not otherwise specified, opioids, acetaminophen; scheduled only, or scheduled plus as needed (PRN)). Participants: LTC residents. Measurements: We searched PubMed, EMBASE, CINAHL, International Pharmaceutical Abstracts, PsycINFO, Cochrane, Web of Science, Google Scholar, using keywords for LTC facilities and analgesic medication; hand‐searched references of eligible papers; correspondence. Studies were quality rated using an adapted Newcastle‐Ottawa scale. Pearson correlation coefficients were generated between percentage of residents prescribed an analgesic and year of data collection. If available, we investigated changes in acetaminophen and opioid prescriptions. Results: Forty studies met inclusion criteria. A moderate correlation (0.59) suggested that scheduled prescription rates for analgesics have increased over time. Similar findings were reflected in scheduled prescriptions for acetaminophen and opioids. No increase was seen when analyzing scheduled plus PRN analgesics. Use of opioids (scheduled plus PRN) appears to have increased over time. Conclusion: Worldwide, use of opioids and acetaminophen has increased in LTC residents. Research is needed to explore whether this reflects appropriate pain management for LTC residents and if PRN medication is used effectively. [ABSTRACT FROM AUTHOR]

Background: Clinicians are inaccurate at predicting survival. The 'Surprise Question' (SQ) is a screening tool that aims to identify people nearing the end of life. Potentially, its routine use could help identify patients who might benefit from palliative care services. The objective was to assess the accuracy of the SQ by time scale, clinician, and speciality.Methods: Searches were completed on Medline, Embase, CINAHL, AMED, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Open Grey literature (all from inception to November 2016). Studies were included if they reported the SQ and were written in English. Quality was assessed using the Newcastle-Ottawa Scale.Results: A total of 26 papers were included in the review, of which 22 reported a complete data set. There were 25,718 predictions of survival made in response to the SQ. The c-statistic of the SQ ranged from 0.512 to 0.822. In the meta-analysis, the pooled accuracy level was 74.8% (95% CI 68.6-80.5). There was a negligible difference in timescale of the SQ. Doctors appeared to be more accurate than nurses at recognising people in the last year of life (c-statistic = 0.735 vs. 0.688), and the SQ seemed more accurate in an oncology setting 76.1% (95% CI 69.7-86.3).Conclusions: There was a wide degree of accuracy, from poor to reasonable, reported across studies using the SQ. Further work investigating how the SQ could be used alongside other prognostic tools to increase the identification of people who would benefit from palliative care is warranted.Trial Registration: PROSPERO CRD42016046564 . [ABSTRACT FROM AUTHOR]

Background: A second opinion or a prognostic algorithm may increase prognostic accuracy. This study assessed the level to which clinicians integrate advice perceived to be coming from another clinician or a prognostic algorithm into their prognostic estimates, and how participant characteristics and nature of advice received affect this. Methods: An online double‐blind randomised controlled trial was conducted. Palliative doctors, nurses and other types of healthcare professionals were randomised into study arms differing by perceived source of advice (algorithm or another clinician). In fact, the advice was the same in both arms (emanating from the PiPS‐B14 prognostic model). Each participant reviewed five patient summaries. For each summary, participants: (1) provided an initial probability estimate of two‐week survival (0% 'certain death'—100% 'certain survival'); (2) received advice (another estimate); (3) provided a final estimate. Weight of Advice (WOA) was calculated for each summary (0 '100% advice discounting' – 1 '0% discounting') and multilevel linear regression analyses were conducted. Clinical trial registration number: NCT04568629. Results: A total of 283 clinicians were included in the analysis. Clinicians integrated advice from the algorithm more than advice from another clinician (WOA difference = −0.12 [95% CI ‐0.18, −0.07], p < 0.001). There was no interaction between study arm and participant profession, years of palliative care or overall experience. Advice of intermediate strength (75%) was given a lower WOA (0.31) than advice received at either the 50% (WOA 0.40) or 90% level (WOA 0.43). The overall interaction between strength of advice and study arm on WOA was significant (p < 0.001). Conclusion: Clinicians adjusted their prognostic estimates more when advice was perceived to come from a prognostic algorithm than from another clinician. Research is needed to understand how clinicians make prognostic decisions and how algorithms are used in clinical practice. [ABSTRACT FROM AUTHOR]

Objectives: Many family carers of a person with dementia experience pre‐death grief. We aimed to identify strategies that help carers manage pre‐death grief. We hypothesised that emotion and problem focussed styles would be associated with lower, and dysfunctional coping with higher grief intensity. Methods: Mixed methods observational study using structured and semi‐structured interviews with 150 family carers of people with dementia living at home or in a care home. Most participants were female (77%), caring for a parent (48%) or partner/spouse (47%) with mild (25%), moderate (43%) or severe (32%) dementia. They completed the Marwit‐Meuser Caregiver Grief Inventory Short Form and the Brief Coping Orientation to Problems Experienced (Brief‐COPE) questionnaire. We asked carers to identify strategies used for managing grief. We recorded field notes for 150 interviews and audio‐recorded additional interviews with a sub‐sample of 16 participants. Results: Correlations indicated that emotion‐oriented coping was associated with lower grief (R = −0.341), and dysfunctional coping with higher grief (R = 0.435), with a small association with problem‐focused strategies (R = −0.109), partly supporting our hypothesis. Our qualitative themes broadly match the three Brief‐COPE styles. Unhelpful strategies of denial and avoidance align with dysfunctional coping strategies. Psychological strategies (including acceptance and humour) and seeking support were consistent with emotion‐focused strategies, but we did not identify a theme relating to problem‐focused strategies. Conclusion: Most carers identified multiple strategies for processing grief. Carers could readily identify supports and services that they found helpful for managing pre‐death grief, yet current services appear under‐resourced to meet growing demand. [ABSTRACT FROM AUTHOR]

The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial has shown selective laser trabeculoplasty (SLT) to be clinically and cost-effective as a primary treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT) at 3 years. This article reports health-related quality of life (HRQoL) and clinical effectiveness of initial treatment with SLT compared with intraocular pressure (IOP)-lowering eye drops after 6 years of treatment. Prospective, multicenter randomized controlled trial. Treatment-naive eyes with OAG or OHT initially treated with SLT or IOP-lowering drops. Patients were allocated randomly to initial SLT or eye drops. After the initial 3 years of the trial, patients in the SLT arm were permitted a third SLT if necessary; patients in the drops arm were allowed SLT as a treatment switch or escalation. This study is registered at controlled-trials.com (identifier, ISRCTN32038223). The primary outcome was HRQoL at 6 years; secondary outcomes were clinical effectiveness and adverse events. Of the 692 patients completing 3 years in the LiGHT Trial, 633 patients (91.5%) entered the extension, and 524 patients completed 6 years in the trial (82.8% of those entering the extension phase). At 6 years, no significant differences were found for the EuroQol EQ-5D 5 Levels, Glaucoma Utility Index, and Glaucoma Quality of Life-15 (P > 0.05 for all). The SLT arm showed better Glaucoma Symptom Scale scores than the drops arm (83.6 ± 18.1 vs. 81.3 ± 17.3, respectively). Of eyes in the SLT arm, 69.8% remained at or less than the target IOP without the need for medical or surgical treatment. More eyes in the drops arm exhibited disease progression (26.8% vs. 19.6%, respectively; P = 0.006). Trabeculectomy was required in 32 eyes in the drops arm compared with 13 eyes in the SLT arm (P < 0.001); more cataract surgeries occurred in the drops arm (95 compared with 57 eyes; P = 0.03). No serious laser-related adverse events occurred. Selective laser trabeculoplasty is a safe treatment for OAG and OHT, providing better long-term disease control than initial drop therapy, with reduced need for incisional glaucoma and cataract surgery over 6 years. [ABSTRACT FROM AUTHOR]

Background: Prognostic information is important for patients with cancer, their families, and clinicians. In practice, survival predictions are made by clinicians based on their experience, judgement, and intuition. Previous studies have reported that clinicians' survival predictions are often inaccurate. This study reports a secondary analysis of data from the Prognosis in Palliative care Study II (PiPS2) to assess the accuracy of survival estimates made by doctors and nurses. Methods and findings: Adult patients (n = 1833) with incurable, locally advanced or metastatic cancer, recently referred to palliative care services (community teams, hospital teams, and inpatient palliative care units) were recruited. Doctors (n = 431) and nurses (n = 777) provided independent prognostic predictions and an agreed multi-professional prediction for each patient. Clinicians provided prognostic estimates in several formats including predictions about length of survival and probability of surviving to certain time points. There was a minimum follow up of three months or until death (whichever was sooner; maximum follow-up 783 days). Agreed multi-professional predictions about whether patients would survive for days, weeks or months+ were accurate on 61.9% of occasions. The positive predictive value of clinicians' predictions about imminent death (within one week) was 77% for doctors and 79% for nurses. The sensitivity of these predictions was low (37% and 35% respectively). Specific predictions about how many weeks patients would survive were not very accurate but showed good discrimination (patients estimated to survive for shorted periods had worse outcomes). The accuracy of clinicians' probabilistic predictions (assessed using Brier's scores) was consistently better than chance, improved with proximity to death and showed good discrimination between groups of patients with different survival outcomes. Conclusions: Using a variety of different approaches, this study found that clinicians predictions of survival show good discrimination and accuracy, regardless of whether the predictions are about how long or how likely patients are to survive. Accuracy improves with proximity to death. Although the positive predictive value of estimates of imminent death are relatively high, the sensitivity of such predictions is relatively low. Despite limitations, the clinical prediction of survival should remain the benchmark against which any innovations in prognostication are judged. Study registration: ISRCTN13688211. http://www.isrctn.com/ISRCTN13688211. [ABSTRACT FROM AUTHOR]

In patients with advanced cancer, prognosis is usually determined using clinicians' predictions of survival (CPS). The palliative prognostic (PaP) score is a prognostic algorithm that was developed to predict survival in patients with advanced cancer. The score categorises patients into three risk groups in accordance with their probability of surviving for 30 days. The relative accuracy of PaP and CPS is unclear. This was a systematic review of MEDLINE, Embase, AMED, CINAHL Plus and the Cochrane Database of Systematic Reviews and Trials from inception up to June 2021. The inclusion criteria were studies in adults with advanced cancer reporting data on performance of both PaP and CPS. Data were extracted on accuracy of prognoses and where available on discrimination (area under the receiver operating characteristic curve or C-index) and/or diagnostic performance (sensitivity, specificity). Eleven studies were included. One study reported a direct comparison between PaP risk groups and equivalent risk groups defined by CPS and found that PaP was as accurate as CPS. Five studies reported discrimination of PaP as a continuous total score (rather than using the previously validated risk categories) and reported C-statistics that ranged from 0.64 (95% confidence interval [CI] 0.54, 0.74) up to 0.90 (95% CI 0.87, 0.92). Other studies compared PaP against CPS using non-equivalent metrics (e.g. comparing probability estimates against length of survival estimates). PaP risk categories and CPS are equally able to discriminate between patients with different survival probabilities. Total PaP scores show good discrimination between patients in accordance with their length of survival. The role of PaP in clinical practice still needs to be defined. PROSPERO (CRD42021241074, 5th March 2021). • The palliative prognostic (PaP) score predicts the risk of dying within 30 days. • PaP is as accurate as, but not better than, clinical predictions of 30-day survival. • The relative objectivity of PaP may help supplement clinical predictions. [ABSTRACT FROM AUTHOR]

To examine the feasibility and acceptability of NIDUS-Family, a 6–8 session manualised, individually tailored, modular intervention supporting independence at home for people with dementia; and explore participants' and facilitators' experiences of the intervention. In this single group multi-site feasibility study, trained, supervised non-clinically qualified graduates (facilitators) delivered NIDUS-Family to family carer and people living with dementia dyads. We recruited participants from GP practices and memory services in London and Bradford. We completed quantitative outcomes pre- and post-intervention; and conducted qualitative interviews with participants and facilitators. Our pre-specified main outcomes were proportion of potential participants approached who agreed to participate, intervention adherence and acceptability to family carers, and facilitator fidelity to the manual. We recruited 16 dyads (57% of those approached); 12 (75%) completed the intervention. Of 12 participants rating intervention acceptability, 9 (75%) agreed or strongly agreed that it had helped; 2 (18%) neither agreed nor disagreed and 1 (8%) disagreed. Mean facilitator fidelity was high (81.5%). Dyads set on average 3.9 goals; these most commonly related to getting out and about and increasing activity/hobby participation (n = 10); carer wellbeing (n = 6), managing physical complaints (n = 6); meal preparation/cooking (n = 5); and reducing irritability, frustration or aggression (n = 5). Almost all secondary outcomes changed in a direction indicating improvement. In our qualitative analysis we identified three overarching themes; relationships facilitate change, goal-focused versus manualised approach and balancing the needs of carers and people with dementia. NIDUS-Family was feasible and acceptable to participants. Following refinements, testing in a pragmatic trial is underway. [ABSTRACT FROM AUTHOR]

Background: Anticholinergic burden (ACB) is associated with an increased risk of delirium in the older population outside of the acute hospital setting. In acute settings, delirium is associated with increased mortality, and this association is greater with full syndromal delirium (FSD) than with subsyndromal delirium (SSD). Little is known about the impact of ACB on delirium prevalence or subtype in hospitalized older adults or the impact on mortality in this population. Objectives: Our objectives were to determine whether ACB moderates associations between the subtype of delirium experienced by hospitalized older adults and to explore factors (including ACB) that might moderate consequent associations between delirium and mortality in hospital inpatients. Methods: We conducted a retrospective analysis of a cohort of 784 older adults with unplanned admission to a North London acute medical unit between June and December 2007. Univariate regression analyses were performed to explore associations between ACB, as represented by the Anticholinergic Burden Scale (ACBS), delirium subtype (FSD vs. SSD), and mortality. Results: The mean age of the sample was 83 ± standard deviation (SD) 7.4 years, and the majority of patients were female (59%), lived in their own homes (71%), were without dementia (75%), and died between hospital admission and the end of the 2-year follow-up period (59%). Mean length of admission was 13.2 ± 14.4 days. Prescription data revealed an ACBS score of 1 in 26% of the cohort, of 2 in 12%, and of ≥ 3 in 16%. The mean total ACBS score for the cohort was 1.1 ± 1.4 (range 0–9). Patients with high ACB on admission were more likely to have severe dementia, to have multiple comorbidities, and to live in residential care. Higher ACB was not associated with delirium of either subtype in hospitalized older adults. Delirium itself was associated with increased mortality, and greater associations were seen in FSD (hazard ratio [HR] 2.27; 95% confidence interval [CI] 1.70–3.01) than in SSD (HR 1.58; 95% CI 1.2–2.09); however, ACB had no impact on this relationship. Conclusions: ACB was not found to be associated with increased delirium of either subtype or to have a demonstrable impact on mortality in delirium. Prior suggestions of links between ACB and mortality in similar populations may be mediated by higher levels of functional dependence, greater levels of residential home residence, or an increased prevalence of dementia in this population. [ABSTRACT FROM AUTHOR]

This correction notice is for an article titled "Clinical and cost-effectiveness of a New psychosocial intervention to support Independence in Dementia (NIDUS-family) for family carers and people living with dementia in their own homes: a randomised controlled trial." The correction states that the 9th author's name is Victoria Vickerstaff, not Jessica Vickerstaff, and their affiliation is the "Research Department of Primary Care and Population Health, University College London, London, UK" instead of the "Division of Psychiatry, University College London, London, UK" as originally published. The original article has been corrected. The authors of the article are Alexandra Burton, Penny Rapaport, Marina Palomo, Kathryn Lord, Jessica Budgett, Julie Barber, Rachael Hunter, Laurie Butler, Victoria Vickerstaff, Kenneth Rockwood, Margaret Ogden, Debs Smith, Iain Lang, Gill Livingston, Briony Dow, Helen Kales, Jill Manthorpe, Kate Walters, Juanita Hoe, Vasiliki Orgeta, Quincy Samus, and Claudia Cooper. [Extracted from the article]

Background: Palliative Care Day Services (PCDS) offer supportive care to people with advanced, progressive illness who may be approaching the end of life. Despite the growth of PCDS in recent years, evidence of their costs and effects is scarce. It is important to establish the value of such services so that health and care decision-makers can make evidence-based resource allocation decisions. This study examines and estimates the costs and effects of PCDS with different service configurations in three centres across the UK in England, Scotland and Northern Ireland. Methods: People who had been referred to PCDS were recruited between June 2017 and September 2018. A pragmatic before-and-after descriptive cohort study design analysed data on costs and outcomes. Data on costs were collected on health and care use in the 4 weeks preceding PCDS attendance using adapted versions of the Client Service Receipt Inventory (CSRI). Outcomes, cost per attendee/day and volunteer contribution to PCDS were also estimated. Outcomes included quality of life (MQOL-E), health status (EQ-5D-5L) and capability wellbeing (ICECAP-SCM). Results: Thirty-eight attendees were recruited and provided data at baseline and 4 weeks (centre 1: n = 8; centre 2: n = 8, centre 3: n = 22). The cost per attendee/day ranged from £121–£190 (excluding volunteer contribution) to £172–£264 (including volunteer contribution) across the three sites. Volunteering constituted between 28 and 38% of the total cost of PCDS provision. There was no significant mean change at 4 week follow-up from baseline for health and care costs (centre 1: £570, centre 2: -£1127, centre 3: £65), or outcomes: MQOL-E (centre 1: − 0.48, centre 2: 0.01, centre 3: 0.24); EQ-5D-5L (centre 1: 0.05, centre 2: 0.03, centre 3: − 0.03) and ICECAP-SCM (centre 1:0.00, centre 2: − 0.01, centre 3: 0.03). Centre costs variation is almost double per attendee when attendance rates are held constant in scenario analysis. Conclusions: This study highlights the contribution made by volunteers to PCDS provision. There is insufficient evidence on whether outcomes improved, or costs were reduced, in the three different service configurations for PCDS. We suggest how future research may overcome some of the challenges we encountered, to better address questions of cost-effectiveness in PCDS. [ABSTRACT FROM AUTHOR]

Following publication of the original article [1], an error in reference 18 was reported. [ABSTRACT FROM AUTHOR]

Background: Aromatherapy, massage and reflexology are widely used in palliative care. Despite this, there are questions about their suitability for inclusion in clinical guidelines. The need to understand their benefits is a public priority, especially in light of funding pressures. Aim: To synthesise current evidence on the effectiveness of aromatherapy, massage and reflexology in people with palliative care needs. Design: A systematic review of randomised controlled trials (PROSPERO CRD42017081409) was undertaken following international standards including Cochrane guidelines. The quality of trials and their pooled evidence were appraised. Primary outcomes on effect were anxiety, pain and quality-of-life. Data sources: Eight citation databases and three trial registries were searched to June 2018. Results: Twenty-two trials, involving 1956 participants were identified. Compared with a control, four evaluated aromatherapy, eight massage and six reflexology. A further four evaluated massage compared with aromatherapy. Trials were at an unclear risk of bias. Many had small samples. Heterogeneity prevented meta-analysis. In comparison with usual care, another therapy or an active control, evidence on the effectiveness of massage and aromatherapy in reducing anxiety, pain and improving quality-of-life was inconclusive. There was some evidence (low quality) that compared to an active control, reflexology reduced pain. Conclusions: This review identified a relatively large number of trials, but with poor and heterogeneous evidence. New clinical recommendations cannot be made based on current evidence. To help provide more definitive trial findings, it may be useful first to understand more about the best way to measure the effectiveness of these therapies in palliative care. [ABSTRACT FROM AUTHOR]

Background: The Surprise Question (SQ) "would I be surprised if this patient were to die in the next 12 months?" has been suggested to help clinicians, and especially General Practitioners (GPs), identify people who might benefit from palliative care. The prognostic accuracy of this approach is unclear and little is known about how GPs use this tool in practice. Are GPs consistent, individually and as a group? Are there international differences in the use of the tool? Does including the alternative Surprise Question ("Would I be surprised if the patient were still alive after 12 months?") alter the response? What is the impact on the treatment plan in response to the SQ? This study aims to address these questions. Methods: An online study will be completed by 600 (100 per country) registered GPs. They will be asked to review 20 hypothetical patient vignettes. For each vignette they will be asked to provide a response to the following four questions: (1) the SQ [Yes/No]; (2) the alternative SQ [Yes/No]; (3) the percentage probability of dying [0% no chance – 100% certain death]; and (4) the proposed treatment plan [multiple choice]. A "surprise threshold" for each participant will be calculated by comparing the responses to the SQ with the probability estimates of death. We will use linear regression to explore any differences in thresholds between countries and other clinician-related factors, such as years of experience. We will describe the actions taken by the clinicians and explore the differences between groups. We will also investigate the relationship between the alternative SQ and the other responses. Participants will receive a certificate of completion and the option to receive feedback on their performance. Discussion: This study explores the extent to which the SQ is consistently used at an individual, group, and national level. The findings of this study will help to understand the clinical value of using the SQ in routine practice. Trial registration: Clinicaltrials.gov NCT03697213 (05/10/2018). Prospectively registered. [ABSTRACT FROM AUTHOR]

Background: Primary open angle glaucoma and ocular hypertension are habitually treated with eye drops that lower intraocular pressure. Selective laser trabeculoplasty is a safe alternative but is rarely used as first-line treatment. We compared the two.Methods: In this observer-masked, randomised controlled trial treatment-naive patients with open angle glaucoma or ocular hypertension and no ocular comorbidities were recruited between 2012 and 2014 at six UK hospitals. They were randomly allocated (web-based randomisation) to initial selective laser trabeculoplasty or to eye drops. An objective target intraocular pressure was set according to glaucoma severity. The primary outcome was health-related quality of life (HRQoL) at 3 years (assessed by EQ-5D). Secondary outcomes were cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness, and safety. Analysis was by intention to treat. This study is registered at controlled-trials.com (ISRCTN32038223).Findings: Of 718 patients enrolled, 356 were randomised to the selective laser trabeculoplasty and 362 to the eye drops group. 652 (91%) returned the primary outcome questionnaire at 36 months. Average EQ-5D score was 0·89 (SD 0·18) in the selective laser trabeculoplasty group versus 0·90 (SD 0·16) in the eye drops group, with no significant difference (difference 0·01, 95% CI -0·01 to 0·03; p=0·23). At 36 months, 74·2% (95% CI 69·3-78·6) of patients in the selective laser trabeculoplasty group required no drops to maintain intraocular pressure at target. Eyes of patients in the selective laser trabeculoplasty group were within target intracoluar pressure at more visits (93·0%) than in the eye drops group (91·3%), with glaucoma surgery to lower intraocular pressure required in none versus 11 patients. Over 36 months, from an ophthalmology cost perspective, there was a 97% probability of selective laser trabeculoplasty as first treatment being more cost-effective than eye drops first at a willingness to pay of £20 000 per quality-adjusted life-year gained.Interpretation: Selective laser trabeculoplasty should be offered as a first-line treatment for open angle glaucoma and ocular hypertension, supporting a change in clinical practice.Funding: National Institute for Health Research, Health and Technology Assessment Programme. [ABSTRACT FROM AUTHOR]

Background Pain and delirium are common in people with dementia admitted to hospitals. These are often under-diagnosed and under-treated. Pain is implicated as a cause of delirium but this association has not been investigated in this setting. Objective To investigate the relationship between pain and delirium in people with dementia, on admission and throughout a hospital admission. Design Exploratory secondary analysis of observational prospective longitudinal cohort data. Setting Two acute hospitals in the UK. Methodology Two-hundred and thirty participants aged ≥70 years were assessed for dementia severity, delirium ((Confusion Assessment Method (CAM), pain (Pain Assessment in Advanced Dementia (PAINAD)) scale and prescription of analgesics. Logistic and linear regressions explored the relationship between pain and delirium using cross-sectional data. Results Pain at rest developed in 49%, and pain during activity for 26% of participants during their inpatient stay. Incident delirium developed in 15%, of participants, and 42% remained delirious for at least two assessments. Of the 35% of participants who were delirious and unable to self-report pain, 33% of these participants experienced pain at rest, and 56 experienced pain during activity. The odds of being delirious were 3.26 times higher in participants experiencing pain at rest (95% Confidence Interval 1.03–10.25, P = 0.044). Conclusion An association between pain at rest and delirium was found, suggesting pain may be a risk factor for delirium. Since pain and delirium were found to persist and develop during an inpatient stay, regular pain and delirium assessments are required to manage pain and delirium effectively. [ABSTRACT FROM AUTHOR]

Background: Increasing number of people are dying with advanced dementia. Comfort and quality of life are key goals of care. Aims: To describe (1) physical and psychological symptoms, (2) health and social care service utilisation and (3) care at end of life in people with advanced dementia. Design: 9-month prospective cohort study. Setting and participants: Greater London, England, people with advanced dementia (Functional Assessment Staging Scale 6e and above) from 14 nursing homes or their own homes. Main outcome measures: At study entry and monthly: prescriptions, Charlson Comorbidity Index, pressure sore risk/severity (Waterlow Scale/Stirling Scale, respectively), acute medical events, pain (Pain Assessment in Advanced Dementia), neuropsychiatric symptoms (Neuropsychiatric Inventory), quality of life (Quality of Life in Late-Stage Dementia Scale), resource use (Resource Utilization in Dementia Questionnaire and Client Services Receipt Inventory), presence/type of advance care plans, interventions, mortality, place of death and comfort (Symptom Management at End of Life in Dementia Scale). Results: Of 159 potential participants, 85 were recruited (62% alive at end of follow-up). Pain (11% at rest, 61% on movement) and significant agitation (54%) were common and persistent. Aspiration, dyspnoea, septicaemia and pneumonia were more frequent in those who died. In total, 76% had 'do not resuscitate' statements, less than 40% advance care plans. Most received primary care visits, there was little input from geriatrics or mental health but contact with emergency paramedics was common. Conclusion: People with advanced dementia lived with distressing symptoms. Service provision was not tailored to their needs. Longitudinal multidisciplinary input could optimise symptom control and quality of life. [ABSTRACT FROM AUTHOR]

Background: Researchers report difficulties in conducting research with children and young people with life-limiting conditions or life-threatening illnesses and their families. Recruitment is challenged by barriers including ethical, logistical and clinical considerations. Aim: To explore how children and young people (aged 0-25 years) with life-limiting conditions or life-threatening illnesses and their families were identified, invited and consented to research published in the last 5 years. Design: Systematic review. Data sources: MEDLINE, PsycINFO, Web of Science, Sciences Citation Index and SCOPUS were searched for original English language research published between 2009 and 2014, recruiting children and young people with life-limiting conditions or lifethreatening illness and their families. Results: A total of 215 studies - 152 qualitative, 54 quantitative and 9 mixed methods - were included. Limited recruitment information but a range of strategies and difficulties were provided. The proportion of eligible participants from those screened could not be calculated in 80% of studies. Recruitment rates could not be calculated in 77%. A total of 31% of studies recruited less than 50% of eligible participants. Reasons given for non-invitation included missing clinical or contact data, or clinician judgements of participant unsuitability. Reasons for non-participation included lack of interest and participants' perceptions of potential burdens. Conclusion: All stages of recruitment were under reported. Transparency in reporting of participant identification, invitation and consent is needed to enable researchers to understand research implications, bias risk and to whom results apply. Research is needed to explore why consenting participants decide to take part or not and their experiences of research recruitment. [ABSTRACT FROM AUTHOR]

Background: The prevalence of dementia is rising worldwide and many people will die with the disease. Symptoms towards the end of life may be inadequately managed and informal and professional carers poorly supported. There are few evidence-based interventions to improve end-of-life care in advanced dementia. Aim: To develop an integrated, whole systems, evidence-based intervention that is pragmatic and feasible to improve end-of-life care for people with advanced dementia and support those close to them. Design: A realist-based approach in which qualitative and quantitative data assisted the development of statements. These were incorporated into the RAND/UCLA appropriateness method to achieve consensus on intervention components. Components were mapped to underlying theory of whole systems change and the intervention described in a detailed manual. Setting/participants: Data were collected from people with dementia, carers and health and social care professionals in England, from expert opinion and existing literature. Professional stakeholders in all four countries of the United Kingdom contributed to the RAND/UCLA appropriateness method process. Results: A total of 29 statements were agreed and mapped to individual, group, organisational and economic/political levels of healthcare systems. The resulting main intervention components are as follows: (1) influencing local service organisation through facilitation of integrated multi-disciplinary care, (2) providing training and support for formal and informal carers and (3) influencing local healthcare commissioning and priorities of service providers. Conclusion: Use of in-depth data, consensus methods and theoretical understanding of the intervention components produced an evidence-based intervention for further testing in end-of-life care in advanced dementia. [ABSTRACT FROM AUTHOR]

Background: One-third of people with cancer experience psychological distress and may suppress distressing thoughts, emotions, and concerns, leading to further problems. Conventional psychological treatments reduce distress by problem solving, but in advanced cancer, when ill health is progressive and death may be approaching, physical and psychological difficulties are complex and have no simple solutions. Acceptance and Commitment Therapy encourages acknowledgement and acceptance of mental experiences, increasing people's ability to work with problems that cannot be solved. Previous pilot work in advanced cancer confirms that distress can be associated with an avoidance of experiencing uncomfortable thoughts and emotions.Methods/design: This feasibility randomised controlled trial of Acceptance Commitment Therapy aims to establish parameters for a larger trial. Fifty-four participants with advanced cancer will be randomly allocated to up to eight sessions (each 1 hour) of Acceptance Commitment Therapy or a talking control. Participants will be recruited from those attending outpatient services and hospice day care at three specialist palliative care units in North and East London, United Kingdom. The primary outcome is a measure of functioning in four areas of life (physical, social/family, emotional, and general activity) using the Functional Assessment of Cancer Therapies--General questionnaire at 3 months after randomisation. Secondary outcomes are (i) acceptance using the Acceptance and Action Questionnaire; (ii) psychological distress using the Kessler Psychological Distress Scale; (iii) physical functioning using a timed walk and sit-to-stand test; and (iv) quality of life measures including the Euroqol-5 Dimensions and ICECAP Supportive Care measures. Qualitative data will be collected at 3 months to explore the participants' experiences of the trial and therapy. Data will be collected on the costs of care.Discussion: Data generated on the recruitment, retention, and experience of the interventions and the usefulness of the outcome measures will inform the adaptations required and whether changes in function are consistent with existing data when planning for a sufficiently powered randomised controlled trial.Trial Registration: ISRCTN13841211 (registered 22 July 2015). [ABSTRACT FROM AUTHOR]

Background: Globally, the number of people who die with dementia is increasing. The importance of a palliative approach in the care of people with dementia is recognised and there are national polices to enhance current care. In the UK implementation of these polices is promoted by the National Institute for Health and Care Excellence (NICE) Dementia Quality Standards (QS). Since publication of the QS new care interventions have been developed. Aim: To explore critically the current international research evidence on effect available to inform NICE Dementia QS relevant to end of life (EOL) care. Design: We used systematic review methods to seek the research evidence for three statements within the Dementia QS. These are those that recommend: (1) a case management approach, (2) discussing and consideration of making a statement about future care (SFC) and (3) a palliative care assessment (PCA). We included evaluative studies of relevant interventions that used a comparative design, such as trials and cohort studies, and measured EOL care outcomes for persons dying with moderate to severe dementia. Our primary outcome of interest was whether the intervention led to a measurable impact on wellbeing for the person with dementia and their family. We assessed included studies for quality using a scale by Higginson and colleagues (2002) for assessment of quality of studies in palliative care, and two authors undertook key review processes. Data sources included Cinahl, Embase, and PsychINFO from 2001 to August 2014. Our search strategy included free text and medical subject headings relevant to population and recommended care. Results: We found seven studies evaluating a care intervention; four assessed SFC, three PCA. None assessed case management. Studies were of weak design; all used retrospective data and relied on others for precise record keeping and for accurate recall of events. There was limited overlap in outcome measurements. Overall reported benefits were mixed. Conclusions: Quality statements relevant to EOL care are useful to advance practice however they have a limited evidence base. High quality empirical work is needed to establish that the recommendations in these statements are best practice. [ABSTRACT FROM AUTHOR]

Pain is underdetected and undertreated in people with dementia. We aimed to investigate the prevalence of pain in people with dementia admitted to general hospitals and explore the association between pain and behavioural and psychiatric symptoms of dementia (BPSD). We conducted a longitudinal cohort study of 230 people, aged above 70, with dementia and unplanned medical admissions to 2 UK hospitals. Participants were assessed at baseline and every 4 days for self-reported pain (yes/no question and FACES scale) and observed pain (Pain Assessment in Advanced Dementia scale [PAINAD]) atmovement and at rest, for agitation (Cohen-Mansfield Agitating Inventory [CMAI]) and BPSD (Behavioural Pathology in Alzheimer Disease Scale [BEHAVE-AD]). On admission, 27% of participants self-reported pain rising to 39% on at least 1 occasion during admission. Half of them were able to complete the FACES scale, this proportion decreasing with more severe dementia. Using the PAINAD,19%had pain at rest and 57%had pain on movement on at least 1 occasion (in 16%, this was persistent throughout the admission). In controlled analyses, pain was not associated with CMAI scores but was strongly associated with total BEHAVE-AD scores, both when pain was assessed on movement (α = 0.20, 95% confidence interval [CI] = 0.07-0.32, P = 0.002) and at rest (β = 0.41, 95% CI = 0.14-0.69, P = 0.003). The association was the strongest for aggression and anxiety. Pain was common in people with dementia admitted to the acute hospital and associated with BPSD. Improved pain management may reduce distressing behaviours and improve the quality of hospital care for people with dementia. [ABSTRACT FROM AUTHOR]

Background: Many people with intellectual disability present with challenging behaviour which often has serious consequences such as the prescription of long term medication, in-patient admissions and disruption of normal daily activities. Small scale studies of Positive Behaviour Support (PBS) delivered by paid carers suggest that it reduces challenging behaviour and costs of care and improves quality of life. This study aims to investigate whether professionals training in the delivery of PBS as part of routine practice is clinically and cost effective compared to treatment as usual in community intellectual disability services. Method: The study is a multi-centre cluster randomised controlled trial involving community intellectual disability services in England and service users with mild to severe intellectual disability and challenging behaviour. The teams will be randomly allocated into one of two conditions, either training and support to deliver PBS or treatment as usual. We will carry out assessments of challenging behaviour, use of services, quality of life, mental health, and family and paid carer burden at six and 12 months. We will monitor treatment fidelity and we will interview a sample of paid and family carers, service users, staff and managers about what they think of the treatment and how best we can deliver it in routine care. The main outcome is reduction in challenging behaviour at one year after randomisation. We will also carry out a health economic evaluation to examine the costs and consequences of staff training in PBS. Discussion: The study findings will have significant implications for the delivery of PBS in community based services with the potential for reducing inpatient admissions and out-of-area placements for adults with intellectual disability and challenging behaviour. [ABSTRACT FROM AUTHOR]