Economic evaluation of a trial exploring the effects of a web-based support tool for parents of children with juvenile idiopathic arthritis.

OBJECTIVE: To explore the cost-effectiveness of a web-based support tool for parents of children with Juvenile Idiopathic Arthritis. METHODS: A multi-centred randomised controlled trial was conducted in paediatric rheumatology centres in England. The WebParC intervention consisted of online information about JIA and its treatment and a toolkit using cognitive-behavioural therapy principles to support parents manage their child's JIA. An economic evaluation was performed alongside the trial involving 220 parents. The primary outcome was the self-report Pediatric Inventory for Parents measure of illness-related parenting stress, with two dimensions; difficulty and frequency. These measures along with costs were assessed post intervention at 4 months and 12 months. Costs were calculated for healthcare usage using a UK NHS economic perspective. Data was collected and analysed on the impact of caring costs on families. Uncertainty around cost effectiveness was explored using bootstrapping and cost-effectiveness acceptability curves. RESULTS: The intervention arm showed improved average Pediatric Inventory for Parents scores for the dimensions of frequency and difficulty, of 1.5 and 3.6 respectively at 4 months and. 0.35 and 0.39 at 12 months, representing improved PIP scores for the intervention arm. At both 4 and 12 month follow up the average total cost per case was higher in the control group when compared with the intervention arm with mean differences of £360 (95% CI £29.6 to £691) at 4 months and £203 (95% CI £16 to £390) at 12 months. The probability of the intervention being cost effective ranged between 49% and 54%. CONCLUSION: The WebParC intervention led to reductions in primary and secondary healthcare resource use and costs at 4 and 12 months. The intervention demonstrated particular savings for rheumatology services at both follow ups. Future economies of scale could be realised by health providers with increased opportunities for cost effectiveness over time. TRIAL REGISTRATION: ISRCTN, ISRCTN13159730.

A mixed model approach to estimate the survivor average causal effect in cluster-randomized trials.

In many medical studies, the outcome measure (such as quality of life, QOL) for some study participants becomes informatively truncated (censored, missing, or unobserved) due to death or other forms of dropout, creating a nonignorable missing data problem. In such cases, the use of a composite outcome or imputation methods that fill in unmeasurable QOL values for those who died rely on strong and untestable assumptions and may be conceptually unappealing to certain stakeholders when estimating a treatment effect. The survivor average causal effect (SACE) is an alternative causal estimand that surmounts some of these issues. While principal stratification has been applied to estimate the SACE in individually randomized trials, methods for estimating the SACE in cluster-randomized trials are currently limited. To address this gap, we develop a mixed model approach along with an expectation-maximization algorithm to estimate the SACE in cluster-randomized trials. We model the continuous outcome measure with a random intercept to account for intracluster correlations due to cluster-level randomization, and model the principal strata membership both with and without a random intercept. In simulations, we compare the performance of our approaches with an existing fixed-effects approach to illustrate the importance of accounting for clustering in cluster-randomized trials. The methodology is then illustrated using a cluster-randomized trial of telecare and assistive technology on health-related QOL in the elderly.

Lactobacillus casei Shirota probiotic drinks reduce antibiotic associated diarrhoea in patients with spinal cord injuries who regularly consume proton pump inhibitors: a subgroup analysis of the ECLISP multicentre RCT.

STUDY DESIGN: This was a sub-group analysis of a multicentre, randomised, placebo-controlled, double-blind trial (ECLISP trial) OBJECTIVES: To assess the efficacy of a probiotic containing at least 6.5 × 109 live Lactobacillus casei Shirota (LcS) in preventing antibiotic associated diarrhoea (AAD) in patients with spinal cord injury (SCI) who consumed proton pump inhibitor (PPI) regularly. LcS or placebo was given once daily for the duration of an antibiotic course and continued for 7 days thereafter. The trial was registered with ISRCTN:13119162. SETTING: Three SCI centres (National Spinal Injuries Centre, Midland Centre for Spinal Injuries and Princess Royal Spinal Cord Injuries Centre) in the United Kingdom METHODS: Between November 2014, and November 2019, 95 eligible consenting SCI patients (median age: 57; IQ range: 43-69) were randomly allocated to receive LcS (n = 50) or placebo (n = 45). The primary outcome is the occurrence of AAD up to 30 days after finishing LcS/placebo. RESULTS: The LcS group had a significantly lower incidence of AAD at 30 days after finishing the antibiotic course (28.0 v 53.3%, RR: 95% CI: 0.53, 0.31-0.89; z = 2.5, p = 0.01). Multivariate logistic regression analysis identified that LcS can reduce the risk of AAD at 30 days (OR: 0.36, 95% CI 0.13, 0.99, p < 0.05). No intervention-related adverse events were reported during the study. CONCLUSIONS: LcS has the potential to prevent AAD in what could be considered a defined vulnerable group of SCI patients on regular PPI. A confirmatory, randomised, placebo-controlled study is needed to confirm this apparent therapeutic success to translate it into appropriate clinical outcomes. SPONSORSHIP: Yakult Honsha Co., Ltd.

A Bayesian Approach for Estimating the Survivor Average Causal Effect When Outcomes Are Truncated by Death in Cluster-Randomized Trials.

Many studies encounter clustering due to multicenter enrollment and nonmortality outcomes, such as quality of life, that are truncated due to death-that is, missing not at random and nonignorable. Traditional missing-data methods and target causal estimands are suboptimal for statistical inference in the presence of these combined issues, which are especially common in multicenter studies and cluster-randomized trials (CRTs) carried out among the elderly or seriously ill. Using principal stratification, we developed a Bayesian estimator that jointly identifies the always-survivor principal stratum in a clustered/hierarchical data setting and estimates the average treatment effect among them (i.e., the survivor average causal effect (SACE)). In simulations, we observed low bias and good coverage with our method. In a motivating CRT, the SACE and the estimate from complete-case analysis differed in magnitude, but both were small, and neither was incompatible with a null effect. However, the SACE estimate has a clear causal interpretation. The option to assess the rigorously defined SACE estimand in studies with informative truncation and clustering can provide additional insight into an important subset of study participants. Based on the simulation study and CRT reanalysis, we provide practical recommendations for using the SACE in CRTs and software code to support future research.

The impact of chemotherapy on cognitive performance post-surgery in patients with colorectal cancer: A prospective cohort study.

OBJECTIVES: Subjective reports of cognitive impairment following chemotherapy are frequent in cancer patients. Objective cognitive impairment has been observed in cancer patients regardless of treatment regimen suggesting the relationship between cognitive impairment and chemotherapy is not clear cut. Little research has explored the effects of chemotherapy on cognition following surgery in colorectal cancer (CRC). The present study explored the effects of chemotherapy on cognitive performance in a sample of CRC patients. METHODS: 136 participants were recruited into a prospective cohort study: 78 CRC patients undergoing surgery and adjuvant chemotherapy, 58 CRC patients undergoing surgery only. A battery of neuropsychological tests was administered to participants 4 weeks post-surgery (T1), 12 weeks after first chemotherapy (T2) and 3 months after last chemotherapy (T3) or equivalent time-points. RESULTS: Using the criterion of scoring at least two standard-deviations below the group norm on at least one neuropsychological test, 45%-55% of all CRC patients showed cognitive deficits 10 months after surgery (T3) and 14% on at least 3 tests. However, cognition did not significantly differ between patients who had chemotherapy and those who did not. A time by group interaction effect was found on the composite cognition score using multi-level modelling suggesting a greater improvement in cognition in the surgery only group over time (p < 0.05). CONCLUSIONS: CRC patients display cognitive impairment 10 months after surgery. Chemotherapy did not worsen cognitive impairment but did appear to slow cognitive recovery relative to those undergoing surgery only. The findings demonstrate a clear need for supportive cognitive interventions for all CRC patients following treatment.

Healthcare professionals' perceived barriers and facilitators of implementing clinical practice guidelines for stroke rehabilitation: A systematic review.

OBJECTIVE: To identify healthcare professionals' perceived barriers and facilitators to clinical practice guideline implementation within stroke rehabilitation. DATA SOURCES: CINAHL, MEDLINE, EMBASE, AMED, Cochrane library, Academic Search Complete and Scopus. Additional papers were identified through hand searching. REVIEW METHODS: The review followed the Preferred Reporting Item for Systematic Reviews and Meta-Analysis Protocols systematic review approach. Any empirical research that provided qualitative data on healthcare professionals' perceived factors influencing clinical guideline implementation in stroke rehabilitation was included. One reviewer screened all titles and abstract reviews (n = 669). Another two reviewers independently screened 30% of title and abstract reviews, followed by full-text reviews (n = 61). Study quality was assessed using the mixed-method appraisal tool. RESULTS: Data from 10 qualitative, six quantitative and six mixed-method studies published between 2000 and 2022, involving 1576 participants in total, were analysed and synthesised using modified thematic synthesis approach. The majority of participants were therapists n = 1297 (occupational therapists, physiotherapists, speech and language therapists). Organisational factors (time constraints, resources) alongside healthcare professionals' lack of knowledge and skills were the most cited barriers to guideline implementation. Contradictory attitudes and beliefs towards stroke guidelines applicability to real-life clinical practice and their evidence base were reported. Organisational support in the form of training, local protocols, performance monitoring and leadership were reported as perceived facilitators. CONCLUSION: Barriers and facilitators are multifactorial and were identified at guideline, individual, team and organisational levels. There is a need to translate perceived barriers and facilitators into implementation interventions especially addressing organisational-level barriers.

Psychosocial Risk Factors for Health-Related Quality of Life in Adult Congenital Heart Disease.

BACKGROUND: There is variability in the impact of adult congenital heart disease (ACHD) on health-related quality of life (HRQoL). A greater insight into the impact of ACHD may be gained from investigating HRQoL in various diagnostic groups and considering the importance of psychosocial risk factors for poor HRQoL. OBJECTIVE: We compared the HRQoL of people with ACHD with normative data from the general population and among 4 diagnostic groups and identified risk factors for poor HRQoL in ACHD from a comprehensive set of sociodemographic, clinical, and psychosocial factors. METHODS: We conducted a cross-sectional study with 303 participants from 4 diagnostic groups Simple, Tetralogy of Fallot, Transposition of the Great Arteries, Single Ventricle who completed measures of illness perceptions, coping, social support, mood, and generic and disease-specific HRQoL. Data were analyzed using 1-sample t tests, analysis of variance, and hierarchical multiple regressions. RESULTS: There was diminished psychosocial HRQoL in the Simple group compared with the general population. Consistently significant risk factors for poor HRQoL included younger age, a perception of more severe symptoms due to ACHD, depression, and anxiety. Clinical factors were poor predictors of HRQoL. CONCLUSIONS: The findings highlight the need to develop intervention studies aiming to improve HRQoL in people with ACHD and the routine assessment of illness perceptions and mood problems during key periods in people's lives. This will help address patient misconceptions that could be tackled by clinicians or specialist nurses during routine outpatient appointments and identify people in need of psychological support.

A patient-initiated treatment model for blepharospasm and hemifacial spasm: a randomized controlled trial.

BACKGROUND: To test, in a two-arm, single center, superiority, randomized controlled trial, the effectiveness of and costs associated with a patient-initiated treatment model for people with hemifacial spasm (HFS) and blepharospasm (BEB) in comparison to usual care. METHODS: One hundred and thirty patients with HFS or BEB, aged 18 years or over, were recruited from a nurse-led botulinum toxin type A clinic at an eye hospital in the United Kingdom (UK), completed baseline measures and were randomized (1:1). The intervention group determined their own botulinum toxin type A (BoNT/A) treatment schedule during the trial period (9 months) and received an information leaflet with a "hotline" number to book an appointment. Usual care appointments were scheduled by treating clinicians. Data analysts were blind to study group. The primary outcomes were disease severity and functional disability, as measured by the Jankovic Rating Scale and Blepharospasm Disability Index, respectively. Secondary outcomes included quality of life, anxiety and depression, satisfaction with care, confidence in the service, economic costs and employment days lost. RESULTS: Sixty-five patients were randomized to each group. The intervention demonstrated no statistically significant difference to usual care for any of primary outcomes. On secondary outcomes the levels of anxiety differed significantly (F2, 142.39 = 1.65, p = 0.02), with the intervention arm exhibiting a decrease and the control arm an increase (Hedges' g = - 0.26 [99% CI -0.83, 0.32]). No other statistically significant differences were found for secondary outcomes. Overall healthcare costs and costs to the patient were on average £198.95 less (95% CI -£256.76, £654.67; p = 0.10) per participant for those in the intervention compared to usual care, although this finding was not significant. CONCLUSIONS: We did not observe differences between the patient-initiated treatment model and usual care for people with BEB or HFS, on any primary outcome measure, quality of life, or depression. The patient-initiated treatment model may, however, have the potential to save healthcare costs and reduce anxiety. Patients using this new model were also equally as satisfied in the service and confident in their care as those receiving treatment as usual. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT02577224 , 16th October 2015.

The Effects of a Web-Based Tool for Parents of Children With Juvenile Idiopathic Arthritis: Randomized Controlled Trial.

BACKGROUND: Juvenile idiopathic arthritis (JIA) is a group of autoinflammatory diseases that cause pain and disability if not controlled by treatment. Parenting a child with JIA is stressful for parents, who express concerns about their child's treatment and may experience anxiety and powerlessness concerning their child's illness. Parenting stress is greater in parents of children with chronic illness than in those with healthy children and is related to poorer psychological adjustment in both parents and children. It is therefore important to develop interventions to support parents. This paper reports the evaluation of a web-based tool that provides information and practical skills to help increase parents' confidence in managing their child's illness and reduce parenting stress. OBJECTIVE: The aim of this study is to evaluate the benefits of a web-based tool (WebParC) for parents of children with recently diagnosed JIA. METHODS: A multicentered randomized controlled trial was conducted at pediatric rheumatology centers in England. We recruited parents of children aged ≤12 years who had been diagnosed with JIA within the previous 6 months. They were randomized to the intervention (WebParC access plus standard care) or the control (standard care alone) and followed up 4 months and 12 months after randomization. Where both parents participated, they were randomized by household to the same trial arm. The WebParC intervention consists of information about JIA and its treatment plus a toolkit, based on cognitive behavioral therapy, to help parents develop skills to manage JIA-related issues. The primary outcome was the self-report Pediatric Inventory for Parents measure of illness-related parenting stress. The secondary outcomes were parental mood, self-efficacy, coping, effectiveness of participation in their child's health care, satisfaction with health care, and child's health-related quality of life. RESULTS: A total of 203 households comprising 220 parents were randomized to the intervention (100/203, 49.3%) or control (103/203, 50.7%) arm. Follow-up assessments were completed by 65.5% (133/203) of the households at 4 months (intervention 60/100, 60%, and control 73/103, 70.9%) and 61.1% (124/203) of the households at 12 months (intervention 58/100, 58%, and control 66/103, 64.1%). A main effect of the trial arm was found on the Pediatric Inventory for Parents: the intervention participants reported less frequency (subscales communication F1,120627=5.37; P=.02, and role function F1,27203=5.40; P=.02) and difficulty (subscales communication F1,2237=7.43; P=.006, medical care F1,2907=4.04; P=.04, and role function F1,821=4.37, P=.04) regarding illness-related stressful events than the control participants. CONCLUSIONS: The WebParC website for parents of children with JIA reduced illness-related parenting stress. This web-based intervention offers a feasible preventive approach for parents of children with JIA and potentially could be adapted and evaluated for parents of children with other chronic illnesses. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 13159730; http://www.isrctn.com/ISRCTN13159730.

Investigating the feasibility of MePlusMe, an online intervention to support mental health, well-being, and study skills in higher education students.

INTRODUCTION: While there are several web-based mental health interventions, few target higher education (HE) students. Importantly, more research is needed to establish their effectiveness. Here, we provide a pragmatic evaluation of an online intervention (MePlusMe) specifically designed to improve the mental health, well-being, and study skills of HE students. METHODS: In accordance with the published protocol for a feasibility study, we recruited a convenience sample of 137 HE students to participate in an eight-week intervention, with 26 participants retained at week 8. Validated measures of mood (depression and anxiety), well-being, and self-efficacy were collected at baseline, 2, 4, and 8 weeks, alongside two feedback forms assessing design and functionality (baseline) and engagement (week 4 and 8). RESULTS: We observed significant reductions in levels of anxiety and depression as well as increases in well-being, but no changes in self-efficacy. Participants rated the system design and functionality positively and qualitative findings indicated high levels of satisfaction with MePlusMe. DISCUSSION: Findings support both the acceptability and the effectiveness of MePlusMe. Nonetheless, modest retention rates limit the precision and generalisability of these findings. Further investigation should ascertain optimal duration of engagement, most acceptable means of outcome assessment, and further detail about obstacles to utilisation.

"Now I Am Myself": Exploring How People With Poststroke Aphasia Experienced Solution-Focused Brief Therapy Within the SOFIA Trial.

Aphasia, a language disability, can profoundly affect a person's mood and identity. The experiences of participants who received Solution-Focused Brief Therapy, a psychological intervention, were explored in the Solution-Focused brief therapy In poststroke Aphasia (SOFIA) Trial. Thirty participants with chronic aphasia, 14 with severe aphasia, participated in in-depth interviews that were analyzed using framework analysis. Two overarching themes emerged: valued therapy components (exploring hopes, noticing achievements, companionship, sharing feelings, and relationship with therapist) and perceptions of progress (mood, identity, communication, relationships, and independence). Participants were categorized into four groups: (a) "changed," where therapy had a meaningful impact on a person's life; (b) "connected," where therapy was valued primarily for companionship; (c) "complemental," where therapy complemented a participant's upward trajectory; and (d) "discordant," where therapy misaligned with participants' preference for impairment-based language work. This study suggests that it is feasible to adapt a psychological therapy for people with aphasia, who perceive it as valuable.

Which factors impact on quality of life for adults with blepharospasm and hemifacial spasm?

Purpose: Benign essential blepharospasm (BEB) and hemifacial spasm (HFS) are debilitating conditions causing spasms to the eyes and/or face and can significantly impact on quality of life (QoL). Initial research has highlighted potential factors impacting on QoL in BEB, but there remains a wealth of demographic, clinical, and psychosocial factors that may contribute to QoL but have not received attention. Methods: Cross-sectional baseline data were collected before a single-masked randomised controlled trial from 130 adults with BEB and HFS recruited from botulinum toxin clinics at Moorfields Eye Hospital, London. QoL was measured using the 24-item Craniocervical Dystonia Questionnaire (CDQ24), which provides a total score and five subscale scores relating to Stigma, Emotional state, Pain, Activities of daily living (ADL), and Social/family life. Treating clinicians provided clinical data. Hierarchical multiple regressions were performed on this baseline data to identify significant predictors of QoL. Results: ADL and Stigma were the areas most impacted upon whilst patients experienced better adjustment in relation to Pain, Social/family life, and Emotional state. CDQ24 Total scores were explained by the model (80% variance) and were significantly associated with appearance concerns, emotional representations, perceived negative consequences of the condition, mood, and dose of botulinum toxin. Conclusions: Patients with BEB and HFS report a detrimental impact on ADL and perceived stigma in relation to their condition. Predominantly, individual perceptions and mood are associated with QoL in this population, rather than demographic and clinical factors, signifying areas to target in the design of future healthcare services or interventions.

Nutritional and Post-Transplantation Outcomes of Enteral versus Parenteral Nutrition in Pediatric Hematopoietic Stem Cell Transplantation: A Systematic Review of Randomized and Nonrandomized Studies.

Hematopoietic stem cell transplantation (HSCT) involves the administration of chemotherapy followed by the infusion of donor stem cells. After treatment, children can consequently experience nausea, vomiting, diarrhea, anorexia, and mucositis, which negatively impact oral intake, leading to rapid deterioration in nutritional status and risk of malnutrition. Nutrition support therefore becomes necessary to circumvent these adverse effects. This has traditionally been provided via parenteral nutrition (PN), but pediatric evidence is increasingly advocating enteral nutrition (EN) as a preferential alternative. The objective of this review is to determine the efficacy of any forms of EN versus PN provided during admission to children aged ≤ 18 years undergoing HSCT. Primary outcomes considered efficacy in relation to various nutritional parameters, and secondary outcomes included a range of post-transplantation parameters. Data sources included English and non-English articles from the start date of MEDLINE, EMBASE, AMED, CINAHL and Cochrane Controlled Trials register, up to July 2018. Key journals were also hand searched, reference lists scanned, clinical experts contacted, and gray literature searched using EThOS and Open Grey. Randomized and observational studies comparing any forms of EN versus PN in children aged ≤ 18 years undergoing HSCT investigating nutritional or post-transplantation outcomes were eligible. Data were extracted from included studies using a custom extraction form that had previously been piloted. Because included studies were observational, risk of bias was assessed using Risk of Bias in Non-randomised Studies of Interventions. Because only a small number of heterogenous studies reporting a wide range of differently defined outcomes were included, meta-analyses were not performed and data were presented in narrative form. Conflicting results in favor of either method of nutrition support or no difference between methods were seen for duration of interventions, nutritional intakes, biochemical and anthropometric changes, mortality, infections, length of admission, and neutrophil engraftment. EN may provide favorable benefits over PN regarding acute graft-versus-host-disease (aGVHD) and platelet engraftment. A paucity of studies was found investigating the question posed by this review. Included studies were clinically heterogenous regarding populations, interventions, and outcomes, at moderate to serious risk of bias due to the absence of randomization, confounding parameters, statistical control, retrospective designs, and participant selection. Some studies were more than 15 years old. Despite the limited number and poor quality of identified studies, results support the growing body of pediatric evidence that EN is feasible during HSCT. Similar differences regarding many nutritional and post-transplantation outcomes were seen in both forms of nutrition support, but EN could provide benefits above PN including reduced incidence of aGVHD and faster platelet engraftment.

Cognitive dysfunction in adult CHD with different structural complexity.

OBJECTIVE: We carried out a cross-sectional study to assess cognitive function in a sample of adult CHD patients, within the Functioning in Adult Congenital Heart Disease study London. The association between cognitive functioning and disease complexity was examined. METHODS: A total of 310 patients participated in this study. Patients were classified into four structural complexity groups - tetralogy of Fallot, transposition of the great arteries, single ventricle, and simple conditions. Each patient underwent neuropsychological assessment to evaluate cognitive function, including memory and executive function, and completed questionnaires to assess depression and anxiety. RESULTS: Among all, 41% of the sample showed impaired performance (>1.5 SD below the normative mean) on at least three tests of cognitive function compared with established normative data. This was higher than the 8% that was expected in a normal population. The sample exhibited significant deficits in divided attention, motor function, and executive functioning. There was a significant group difference in divided attention (F=5.01, p=0.002) and the mean total composite score (F=5.19, p=0.002) between different structural complexity groups, with the simple group displaying better cognitive function. CONCLUSION: The results indicate that many adult CHD patients display impaired cognitive function relative to a healthy population, which differs in relation to disease complexity. These findings may have implications for clinical decision making in this group of patients during childhood. Possible mechanisms underlying these deficits and how they may be reduced or prevented are discussed; however, further work is needed to draw conclusive judgements.

A 19-SNP coronary heart disease gene score profile in subjects with type 2 diabetes: the coronary heart disease risk in type 2 diabetes (CoRDia study) study baseline characteristics.

BACKGROUND: The coronary risk in diabetes (CoRDia) trial (n = 211) compares the effectiveness of usual diabetes care with a self-management intervention (SMI), with and without personalised risk information (including genetics), on clinical and behavioural outcomes. Here we present an assessment of randomisation, the cardiac risk genotyping assay, and the genetic characteristics of the recruits. METHODS: Ten-year coronary heart disease (CHD) risk was calculated using the UKPDS score. Genetic CHD risk was determined by genotyping 19 single nucleotide polymorphisms (SNPs) using Randox's Cardiac Risk Prediction Array and calculating a gene score (GS). Accuracy of the array was assessed by genotyping a subset of pre-genotyped samples (n = 185). RESULTS: Overall, 10-year CHD risk ranged from 2-72 % but did not differ between the randomisation groups (p = 0.13). The array results were 99.8 % concordant with the pre-determined genotypes. The GS did not differ between the Caucasian participants in the CoRDia SMI plus risk group (n = 66) (p = 0.80) and a sample of UK healthy men (n = 1360). The GS was also associated with LDL-cholesterol (p = 0.05) and family history (p = 0.03) in a sample of UK healthy men (n = 1360). CONCLUSIONS: CHD risk is high in this group of T2D subjects. The risk array is an accurate genotyping assay, and is suitable for estimating an individual's genetic CHD risk. Trial registration This study has been registered at ClinicalTrials.gov; registration identifier NCT01891786.

The Psychosocial and Clinical Outcomes of Orbital Decompression Surgery for Thyroid Eye Disease and Predictors of Change in Quality of Life.

PURPOSE: Thyroid eye disease (TED) has been found to reduce quality of life for many patients because of changes in their appearance and vision, although some seem to adjust better than others. This study was designed to investigate whether a patient's quality of life changes after having orbital decompression for improvement of appearance, vision, or both, and whether any demographic, clinical, or psychosocial factors can predict which patients might benefit from this surgery. DESIGN: This study used a within-subjects repeated-measures design, in which patients were assessed before and at 6 weeks and 6 months after surgery. PARTICIPANTS: A total of 123 adults (aged >18 years) with TED and undergoing orbital decompression surgery were recruited at Moorfields Eye Hospital. METHODS: Participants received lateral wall, medial wall, 2.5 wall, or 3 wall decompression and were followed up after surgery with a range of psychosocial and clinical assessments. MAIN OUTCOME MEASURES: The Graves' Ophthalmopathy Quality of Life (GO-QOL) scale was completed at each time point, and this was used as the dependent variable in each hierarchical multiple regression model. RESULTS: Significant improvements were found in all clinical characteristics after orbital decompression and in most psychosocial variables. The GO-QOL visual function scores did not change significantly until 6 months after surgery. In contrast, GO-QOL appearance scores changed significantly by 6 weeks after surgery and continued to increase to 6 months, reaching a minimal clinically important difference for this scale. None of the changes in clinical or psychosocial outcomes significantly predicted change in GO-QOL visual function. However, the hierarchical regression model explained 79% of the variance in change in GO-QOL appearance, with change in subjective evaluation of appearance being the only unique predictor of change in appearance-related quality of life. CONCLUSIONS: This study highlights the importance of appearance-related cognitions in predicting quality of life outcomes after surgery. Implications for clinical practice need to be considered in light of the limitations of this study, but it is suggested that psychosocial interventions targeting appearance-related cognitive processes, in particular personal evaluation of appearance, could enhance the quality of life outcomes for patients with TED undergoing orbital decompression surgery.

Cerebral venous system and anatomical predisposition to high-altitude headache.

OBJECTIVE: As inspired oxygen availability falls with ascent to altitude, some individuals develop high-altitude headache (HAH). We postulated that HAH results when hypoxia-associated increases in cerebral blood flow occur in the context of restricted venous drainage, and is worsened when cerebral compliance is reduced. We explored this hypothesis in 3 studies. METHODS: In high-altitude studies, retinal venous distension (RVD) was ophthalmoscopically assessed in 24 subjects (6 female) and sea-level cranial magnetic resonance imaging was performed in 12 subjects ascending to 5,300m. Correlation of headache burden (summed severity scores [0-4]≤24 hours from arrival at each altitude) with RVD, and with cerebral/cerebrospinal fluid (CSF)/venous compartment volumes, was sought. In a sea-level hypoxic study, 11 subjects underwent gadolinium-enhanced magnetic resonance venography before and during hypoxic challenge (fraction of inspired oxygen=0.11, 1 hour). RESULTS: In the high-altitude studies, headache burden correlated with both RVD (Spearman rho=0.55, p=0.005) and with the degree of narrowing of 1 or both transverse venous sinuses (r=-0.56, p=0.03). It also related inversely to both the lateral+third ventricle summed volumes (Spearman rho=-0.5, p=0.05) and pericerebellar CSF volume (r=-0.56, p=0.03). In the hypoxic study, cerebral and retinal vein engorgement were correlated, and rose as the combined conduit score fell (a measure of venous outflow restriction; r=-0.66, p<0.05 and r=-0.75, p<0.05, respectively). INTERPRETATION: Arterial hypoxemia is associated with cerebral and retinal venous distension, whose magnitude correlates with HAH burden. Restriction in cerebral venous outflow is associated with retinal distension and HAH. Limitations in cerebral venous efferent flow may predispose to headache when hypoxia-related increases in cerebral arterial flow occur.

A Lactobacillus casei Shirota probiotic drink reduces antibiotic-associated diarrhoea in patients with spinal cord injuries: a randomised controlled trial.

Certain probiotics may prevent the development of antibiotic-associated diarrhoea (AAD) and Clostridium difficile-associated diarrhoea (CDAD), but their effectiveness depends on both strain and dose. There are few data on nutritional interventions to control AAD/CDAD in the spinal cord injury (SCI) population. The present study aimed to assess (1) the efficacy of consuming a commercially produced probiotic containing at least 6·5 × 109 live Lactobacillus casei Shirota (LcS) in reducing the incidence of AAD/CDAD, and (2) whether undernutrition and proton pump inhibitors (PPI) are risk factors for AAD/CDAD. A total of 164 SCI patients (50·1 (sd 17·8) years) with a requirement for antibiotics (median 21 d, range 5-366) were randomly allocated to receive LcS (n 76) or no probiotic (n 82). LcS was given once daily for the duration of the antibiotic course and continued for 7 days thereafter. Nutritional risk was assessed by the Spinal Nutrition Screening Tool. The LcS group had a significantly lower incidence of AAD (17·1 v. 54·9%, P< 0·001). At baseline, 65% of patients were at undernutrition risk. Undernutrition (64·1 v. 33·3%, P< 0·01) and the use of PPI (38·4 v. 12·1 %, P= 0·022) were found to be associated with AAD. However, no significant difference was observed in nutrient intake between the groups. The multivariate logistic regression analysis identified poor appetite ( < 1/2 meals eaten) (OR 5·04, 95% CI 1·28, 19·84) and no probiotic (OR 8·46, 95% CI 3·22, 22·20) as the independent risk factors for AAD. The present study indicated that LcS could reduce the incidence of AAD in hospitalised SCI patients. A randomised, placebo-controlled study is needed to confirm this apparent therapeutic success in order to translate into improved clinical outcomes.

Cost-effectiveness of telecare for people with social care needs: the Whole Systems Demonstrator cluster randomised trial.

PURPOSE OF THE STUDY: to examine the costs and cost-effectiveness of 'second-generation' telecare, in addition to standard support and care that could include 'first-generation' forms of telecare, compared with standard support and care that could include 'first-generation' forms of telecare. DESIGN AND METHODS: a pragmatic cluster-randomised controlled trial with nested economic evaluation. A total of 2,600 people with social care needs participated in a trial of community-based telecare in three English local authority areas. In the Whole Systems Demonstrator Telecare Questionnaire Study, 550 participants were randomised to intervention and 639 to control. Participants who were offered the telecare intervention received a package of equipment and monitoring services for 12 months, additional to their standard health and social care services. The control group received usual health and social care. PRIMARY OUTCOME MEASURE: incremental cost per quality-adjusted life year (QALY) gained. The analyses took a health and social care perspective. RESULTS: cost per additional QALY was £297,000. Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of £30,000 per QALY gained was only 16%. Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of £161,000 per QALY. IMPLICATIONS: while QALY gain in the intervention group was similar to that for controls, social and health services costs were higher. Second-generation telecare did not appear to be a cost-effective addition to usual care, assuming a commonly accepted willingness to pay for QALYs. TRIAL REGISTRATION NUMBER: ISRCTN 43002091.

Nutritional supplement usage in patients admitted to a spinal cord injury center.

OBJECTIVES: To (1) assess food intake; (2) establish the prevalence of dietary supplement usage and its associated cost (oral nutritional supplements (ONS); vitamin and mineral supplements (VMS)) and; (3) identify the characteristics of nutritional supplement users among patients admitted to a spinal cord injury (SCI) center. STUDY DESIGN: A single center survey. METHODS: Standardized questionnaires were used to collect demographic information, food consumption over a 24-hour period, and the use of nutritional supplements. Multivariate logistic regression was used to determine the characteristics of dietary supplement usage and those using them. RESULTS: Seventy-three patients with SCI completed and returned the questionnaires (69.5% response rate). From 67 questionnaires with food intake data, 21 patients (31.3%) consumed three full meals a day. Nine of the full 73 patients (12.3%) received artificial nutritional support, 14 of 73 (19.1%) received ONS, 34 of 73 (46.5%) received VMS, and 31 of 73 (42.4%) required assistance in order to eat. The three supplements most often prescribed were multivitamins (19.1%), vitamins B (17.8%), and vitamin D (13.6%). VMS use was associated with age (years: >60 vs. ≤ 60: 62.1 vs. 34.1%, P = 0.019), nutrition risk (Spinal Nutrition Screening Tool (≥ 11 vs. <11: 65.7 vs. 28.9%, P = 0.001), and serum albumin concentration (<35 vs. ≥ 35 g/l: 59.6 vs. 16%, P < 0.01). Patients at nutrition risk were found to consume more ONS than the lower risk group (28.5 vs. 10.5%, P = 0.05). The expenditures on ONS and VMS were higher in the group at greater nutritional risk (£1878.3 vs. £914.3, P = 0.005). CONCLUSION: The use of nutritional supplements is common in patients with SCI, particularly in older adults and patients with poor nutritional state. However, the present study identified only small numbers of patients consuming all of their hospital meals, which may well contribute to undernutrition risk. Given that a high proportion of patients with SCI require assistance to eat, we suggest that further efforts focus on the feasibility of providing feeding assistants, and on reviewing the nature of the hospital menu.