Introduction: Most patients with Adrenal insufficiency (AI) require lifelong glucocorticoid repla... more Introduction: Most patients with Adrenal insufficiency (AI) require lifelong glucocorticoid replacement. They need to increase glucocorticoids during physical illness or major stressful situations and require parenteral hydrocortisone in the event of an adrenal crisis. Patients with AI have impaired quality of life and high mortality; approximately 1 in 6-12 patients are hospitalised at least once/year from a potentially preventable adrenal crisis. Adoption of selfmanagement behaviours are crucial; these include adherence to medication, following "sick day rules" and associated behaviours that aid prevention and treatment of adrenal crisis such as symptom monitoring, having extra tablets, carrying a medical-alert ID and injection kit, and self-injecting when necessary. Current patient education is ineffective at supporting self-management behaviour change or reducing adrenal crisis-related hospitalisations. This research study aims to gain an in-depth understanding of the barriers and enablers to self-management for patients with AI and to develop an evidencebased digital self-management behaviour change intervention. The study is conducted in accordance with the MRC Framework for developing complex interventions. Underpinned by the Behaviour Change Wheel (BCW), the Theoretical Domains Framework (TDF), and the Person-Frontiers in Endocrinology frontiersin.org 01
Background: Childhood chronic illness not only affects the child, but can have an impact upon wid... more Background: Childhood chronic illness not only affects the child, but can have an impact upon wider family members, particularly parents. Having a child with Juvenile Idiopathic Arthritis (JIA) presents parents with many challenges. Interventions that offer parents support to help them manage their child's illness are therefore important(1); however attending face-to-face sessions may be difficult to fit into their lives, and staff resources may be scarce. An alternative approach is to provide online interventions which can be readily and easily accessed. Aims: The aim of this trial is to evaluate the benefits to parents of having access to a specifically designed website for parents of children with JIA called ''WebParC'', in combination with standard clinical care when compared to standard care alone. Method: Design: Multi-centred randomised-controlled trial (RCT) Participants: Parents of children aged 12 years with newly diagnosed JIA (within 6 months of diagnosis), attending rheumatology clinics. Measures: Measures include parenting stress (the primary outcome), parent self-efficacy in managing their child's illness, parent mood, and child health-related quality of life. Randomisation: Once baseline questionnaires are received, parents are randomised by household to either the intervention arm (access to website and standard care) or the control arm (standard care alone). Process Evaluation: A process evaluation will be conducted alongside the trial, and will be based on MRC guidance for conducting process evaluations of complex interventions(2). Conclusions: The trial evaluates the effectiveness of the website when compared to standard care alone, and if effective, will be made freely available. Results: Progress: Currently, we are recruiting across 15 NHS sites in England. Baseline recruitment will continue until March 2017, with follow-up data being collected until March 2018. There are currently 52 participants recruited, and 24 randomised.
Objective: Depression is often comorbid with End-Stage Renal Disease, and associated with poor ad... more Objective: Depression is often comorbid with End-Stage Renal Disease, and associated with poor adherence and clinical outcomes but course of symptoms is variable. This study sought to describe the long-term trajectories of anxiety and depression in hemodialysis patients, to identify predictors of these trajectories over 12 months and to evaluate the effectiveness of the HEmoDialysis Self-Management Randomized Trial (HED SMART) against usual care on symptoms of anxiety and depression. Methods: A secondary analysis of data from a randomized controlled trial that contrasted HED SMART (n=101) against usual care (n=134). Depressive and anxious symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline, 1 week and at 3 and 9 months post-intervention. Latent class growth analysis identified trajectories of depression and anxiety, and their sociodemographic and clinical predictors. Results: Symptoms of depression and anxiety over 12 months were characterized by two trajectories: low stable (depression: 55%; anxiety: 59%) with non-clinical levels of distress, and high stable (depression: 45%; anxiety: 41%) with clinical levels of distress. HED SMART predicted significant reductions in depression relative to usual care. A similar trend was noted for anxiety. Younger age, Chinese ethnicity, and more comorbidities were associated with persistent high depression. Younger age and shorter dialysis vintage was associated with persistent high anxiety. A brief self-management intervention designed to support behavioral change can also lead to significant reductions in symptoms of depression and may be of great value for younger HD patients shown to be at greater risk for persistent distress.
Best Practice & Research Clinical Anaesthesiology, Mar 1, 2020
It is common for patients of all ages to experience some degree of cognitive disturbance followin... more It is common for patients of all ages to experience some degree of cognitive disturbance following surgery. In most cases, impairment appears mild and is restricted to the acute post-operative period, resolving steadily and speedily. In a small number of cases, however, deficits may be more pronounced and/or endure for longer periods, significantly delaying recovery and increasing the risk of serious clinical complications. The ability to accurately measure postoperative cognition, and track recovery of function, is an important clinical task. This review explores practical and methodological issues that may confound this process, examining how best to obtain reliable and meaningful measures of cognition before and after surgery. It considers neuropsychological test selection, administration, analysis and interpretation and offers evidence-based practice points for clinicians and researchers.
Case notes were reviewed for disease activity and treatment. Mann-Whitney test was used to compar... more Case notes were reviewed for disease activity and treatment. Mann-Whitney test was used to compare means. Results: There were a total number of 32 JSLE (male 5, female 27) patients in our cohort. 22 patients had their Vit-D levels. There were 16 patients with severe Vit-D deficiency (<30 nmol/l) and 2 patients with Vit-D insufficiency (30-50 nmol/l). The prevalence of Vit-D deficiency/ insufficiency in our cohort was $80%. There was no seasonal variation in Vit-D levels. Dark-skinned patients were found to have lower Vit-D levels (P < 0.05). We did not observe a significant increase in disease activity (BILAG2004 index score) in patients with Vit-D deficiency/ insufficiency. Nine patients received Vit-D supplements during the study period. One patient had confirmed osteopenia and sustained spinal fractures. Conclusion: Vit-D deficiency/insufficiency prevalence JSLE is $80%. We recommend that Vit-D levels are checked regularly particularly in dark-skinned patients. Further study is required to assess the significance of Vit-D in relation to disease activity.
Background Subjective cognitive complaints refer to self-experienced difficulties with everyday c... more Background Subjective cognitive complaints refer to self-experienced difficulties with everyday cognitive tasks. Although there has been a fair amount of research on cognitive impairments and cognitive complaints in end-stage renal disease, the practical implications of these complaints remain unclear. The current study aims to examine the associations of cognitive complaints with sociodemographic and clinical variables, mood, as well as key patient-reported outcomes, i.e., self-efficacy, self-management skills, and treatment adherence. Methods A total of 305 haemodialysis patients (mean age = 53.97 years, 42.6% female) completed the Kidney Disease Quality of Life Cognitive Function subscale, a brief measure of cognitive complaints. The recommended cut-off point of 60 was used to identify probable cognitive impairment. Measures of self-efficacy, self-management skills (i.e., symptom coping, health monitoring, health service navigation), treatment adherence, and mood symptoms were al...
Background: There is variability in the impact of adult congenital heart disease (ACHD) on health... more 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 four diagnostic groups and identified risk factors for poor HRQoL in ACHD from a comprehensive set of sociodemographic, clinical, and psychosocial factors. We conducted a cross-sectional study with 303 participants from four 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 analysed using one-sample t-tests, ANOVA and hierarchical multiple regressions. Results: There was diminished psychosocial HRQoL in the "Simple" group compared with 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. 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.
Publisher Summary This chapter discusses the relationship between a new test of ocular dominance ... more Publisher Summary This chapter discusses the relationship between a new test of ocular dominance and reading and spelling ability in a group of schoolchildren. The test determines whether the child has a fixed reference eye or whether ocular dominance is unfixed. Ocular dominance is assessed by means of a modified form of the Dunlop test. That test determines with which eye the ocular motor and retinal signals are associated and therefore distinguishes the dominant eye. The subjects' reading and spelling abilities are considered in relation to their intellectual performance by dividing them into four groups using a separate analysis for verbal and performance mental age. The analysis of spelling performance in relation to both verbal and performance mental age fails to indicate any association between unfixed ocular dominance and spelling difficulty.
International Journal of Integrated Care, Jun 8, 2012
There is limited evidence for the effectiveness of TH on quality of life (QoL) in patients with C... more There is limited evidence for the effectiveness of TH on quality of life (QoL) in patients with COPD. A systematic review in the area inclusive of all respiratory conditions indicated that there were no UK based studies, or randomised controlled trials (RCTs) evaluating the effectiveness of TH for COPD (Janna et al. 2009). A more recent systematic review found 6 studies, only two of which measured QoL as an outcome (Bolton et al. 2010). One of these studies was a RCT and found improvements in QoL at 3 months (Koff 2009), while the other was a non-controlled before and after study which found no difference in quality of life scores at 6 months (Trappenburg, 2008). Research in this area is plagued by small sample sizes, absence of longer-term follow-ups, insufficient descriptions of the intervention, poor internal validity of whether using the device in the context of a complex healthcare intervention leads to improved outcomes for the patient, and few attempts to measure quality of life in patients with COPD following the introduction of these devices. The current investigation is part of the Whole System Demonstrator (WSD) programme that aims to evaluate the effectiveness of telehealth (TH) for patient reported outcomes with Chronic Obstructive Pulmonary Disease (COPD). The primary objective was to evaluate the effectiveness of telehealth for COPD specific QoL and to examine whether there were improvements in HRQoL and psychological distress at short-term and long-term follow-up in this cohort of patients with COPD. Methods: WSD is one of the largest pragmatic cluster randomised controlled trials evaluating TH in the UK. Patients with COPD from three regions in England (Cornwall, Kent and Newham) were recruited from 179 GP practices randomised balancing for region, practice size, deprivation index, non-white proportion and prevalence of COPD. Over 570 patients with COPD completed a comprehensive battery of questionnaires assessing a range of patient reported outcomes. Measures of generic Health-Related Quality of Life (HRQoL) (Short Form-12), disease specific QoL including perceived control over COPD, fatigue caused by the disease and the emotional impact of the disease (Chronic Respiratory Questionnaire). Psychological distress was measured by depression (CESD-10) and anxiety (STAI).
Assessment (HTA) programme grant was awarded to King's College London, and that study activity at... more Assessment (HTA) programme grant was awarded to King's College London, and that study activity at Cambridgeshire Community Services NHS Trust was funded by this grant. Peter Bentham reports personal fees from TauRx Therapeutics Ltd (Aberdeen, UK) outside the submitted work. Catherine Henderson reports grants from the NIHR HTA programme during the conduct of the study. John O'Brien reports personal fees from TauRx Therapeutics Ltd, AXON Neuroscience SE (Larnaca, Cyprus), GE Healthcare (Chicago, IL, USA) and Eisai Co., Ltd (Tokyo, Japan), grants and personal fees from Avid Radiopharmaceuticals (Eli Lilly and Company, Indianapolis, IN, USA) and grants from Alliance Medical (Warwick, UK) outside the submitted work. Richard Gray reports grants from the NIHR HTA programme during the conduct of the study. Robert Howard reports grants from the NIHR HTA programme during the conduct of the study. He also reports that he was a member of the HTA programme Commissioning Sub-board (Expressions of Interest) (2009-11) and of the HTA Programme Commissioning Committee (2013-18).
Contemporary clinical trials communications, Mar 1, 2021
Background: The generalizability of findings of Randomised Controlled Trials (RCTs) is undermined... more Background: The generalizability of findings of Randomised Controlled Trials (RCTs) is undermined by low or biased recruitment. Reasons for participant refusal are infrequently reported in published literature. Aims: To apply the Theoretical Framework of Acceptability (TFA) to: (1) explore patient-reported reasons for declining to participate in a RCT comparing a new service model (patient-initiated appointments) with standard care (appointments scheduled by clinician) for managing blepharospasm and hemifacial spasm; (2) to explore associations between decliners' perceptions of acceptability and non-participation. Method: Eligible patients (n = 242) were approached to participate in the trial. Phase 1: decliners provided a brief reason for refusal. Reasons were analysed descriptively and reviewed against TFA constructs. Phase 2: Consecutive decliners participated in short semi-structured interviews, to explore their reasons for refusal in more depth. Interviews were transcribed and analysed, with the TFA as a coding framework. Results: Eighty-seven (36%) eligible patients refused trial participation; all provided a reason. From interviews with 15 decliners (17%), four key beliefs about acceptability were identified: happy with standard care (n = 41) (49%), anticipated burden of patient-initiated service, lack of confidence in ability to engage with new service and uncertainties about effectiveness of new service. Two themes reflected non-TFA factors: trial participation a low priority and burden of completing trial documentation. Conclusion: Reasons for refusal trial participation included: (a) reasons directly associated with intervention acceptability, and (b) reasons associated with trial participation more broadly. The TFA facilitated identification of problematic aspects of the new appointment booking system which could be addressed to enhance acceptability.
In table 1⇓ the raw differences for use of "GP (home)", "GP (surgery)", and "GP (telephone)" serv... more In table 1⇓ the raw differences for use of "GP (home)", "GP (surgery)", and "GP (telephone)" services are incorrect. In table 5⇓ there are errors in the QALY value for the primary outcome in the telehealth group; the ICER for CESD-10; and the footnote text. There are also errors scattered throughout table 4⇓. The three corrected tables are here.
BACKGROUND Preoperative anaemia is a risk factor for adverse postoperative outcomes after cardiac... more BACKGROUND Preoperative anaemia is a risk factor for adverse postoperative outcomes after cardiac surgery. Iron deficiency is a frequent cause of low preoperative haemoglobin. An effective treatment for preoperative anaemia associated with iron deficiency has not been determined. METHODS We conducted a single-centre, open-label, pragmatic randomised trial, enrolling 156 elective cardiac surgery patients who had low preoperative haemoglobin (100-130 g L-1) with iron deficiency (serum ferritin <100 μg L-1 or transferrin saturation <30%) to compare intravenous ferric derisomaltose 1000 mg and darbepoetin 200 μg subcutaneously (intervention group) with oral ferrous sulphate 600 mg daily (control group). The primary outcome was transfusion of at least one unit of allogeneic red cells during surgery and within the following 5 days. Secondary outcomes included the change in haemoglobin concentration between randomisation and surgery, red cell transfusion volume, postoperative blood loss, pre-specified postoperative complications, length of hospital stay, and in-hospital death. RESULTS The odds of red cell transfusion were lower in the intervention group compared with the control group (adjusted odds ratio=0.33; 95% confidence interval [CI], 0.15-0.75; P=0.008). Of the secondary outcomes, the only significant difference was the increase in haemoglobin between randomisation and surgery, intervention vs control 9.5 g L-1 (95% CI, 6.8-12.2; P<0.001). CONCLUSIONS In patients with a low preoperative haemoglobin and iron deficiency, preoperative treatment with a single dose of ferric derisomaltose and darbepoetin decreased the proportion of participants who received a perioperative blood transfusion as a consequence of a greater increase in haemoglobin compared with treatment with oral ferrous sulphate. CLINICAL TRIAL REGISTRATION ISRCTN Number: 41421863; EUDRACT number: 2011-003695-36.
Many studies encounter clustering due to multicenter enrollment and nonmortality outcomes, such a... more 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. Howeve...
Introduction: Most patients with Adrenal insufficiency (AI) require lifelong glucocorticoid repla... more Introduction: Most patients with Adrenal insufficiency (AI) require lifelong glucocorticoid replacement. They need to increase glucocorticoids during physical illness or major stressful situations and require parenteral hydrocortisone in the event of an adrenal crisis. Patients with AI have impaired quality of life and high mortality; approximately 1 in 6-12 patients are hospitalised at least once/year from a potentially preventable adrenal crisis. Adoption of selfmanagement behaviours are crucial; these include adherence to medication, following "sick day rules" and associated behaviours that aid prevention and treatment of adrenal crisis such as symptom monitoring, having extra tablets, carrying a medical-alert ID and injection kit, and self-injecting when necessary. Current patient education is ineffective at supporting self-management behaviour change or reducing adrenal crisis-related hospitalisations. This research study aims to gain an in-depth understanding of the barriers and enablers to self-management for patients with AI and to develop an evidencebased digital self-management behaviour change intervention. The study is conducted in accordance with the MRC Framework for developing complex interventions. Underpinned by the Behaviour Change Wheel (BCW), the Theoretical Domains Framework (TDF), and the Person-Frontiers in Endocrinology frontiersin.org 01
Background: Childhood chronic illness not only affects the child, but can have an impact upon wid... more Background: Childhood chronic illness not only affects the child, but can have an impact upon wider family members, particularly parents. Having a child with Juvenile Idiopathic Arthritis (JIA) presents parents with many challenges. Interventions that offer parents support to help them manage their child's illness are therefore important(1); however attending face-to-face sessions may be difficult to fit into their lives, and staff resources may be scarce. An alternative approach is to provide online interventions which can be readily and easily accessed. Aims: The aim of this trial is to evaluate the benefits to parents of having access to a specifically designed website for parents of children with JIA called ''WebParC'', in combination with standard clinical care when compared to standard care alone. Method: Design: Multi-centred randomised-controlled trial (RCT) Participants: Parents of children aged 12 years with newly diagnosed JIA (within 6 months of diagnosis), attending rheumatology clinics. Measures: Measures include parenting stress (the primary outcome), parent self-efficacy in managing their child's illness, parent mood, and child health-related quality of life. Randomisation: Once baseline questionnaires are received, parents are randomised by household to either the intervention arm (access to website and standard care) or the control arm (standard care alone). Process Evaluation: A process evaluation will be conducted alongside the trial, and will be based on MRC guidance for conducting process evaluations of complex interventions(2). Conclusions: The trial evaluates the effectiveness of the website when compared to standard care alone, and if effective, will be made freely available. Results: Progress: Currently, we are recruiting across 15 NHS sites in England. Baseline recruitment will continue until March 2017, with follow-up data being collected until March 2018. There are currently 52 participants recruited, and 24 randomised.
Objective: Depression is often comorbid with End-Stage Renal Disease, and associated with poor ad... more Objective: Depression is often comorbid with End-Stage Renal Disease, and associated with poor adherence and clinical outcomes but course of symptoms is variable. This study sought to describe the long-term trajectories of anxiety and depression in hemodialysis patients, to identify predictors of these trajectories over 12 months and to evaluate the effectiveness of the HEmoDialysis Self-Management Randomized Trial (HED SMART) against usual care on symptoms of anxiety and depression. Methods: A secondary analysis of data from a randomized controlled trial that contrasted HED SMART (n=101) against usual care (n=134). Depressive and anxious symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline, 1 week and at 3 and 9 months post-intervention. Latent class growth analysis identified trajectories of depression and anxiety, and their sociodemographic and clinical predictors. Results: Symptoms of depression and anxiety over 12 months were characterized by two trajectories: low stable (depression: 55%; anxiety: 59%) with non-clinical levels of distress, and high stable (depression: 45%; anxiety: 41%) with clinical levels of distress. HED SMART predicted significant reductions in depression relative to usual care. A similar trend was noted for anxiety. Younger age, Chinese ethnicity, and more comorbidities were associated with persistent high depression. Younger age and shorter dialysis vintage was associated with persistent high anxiety. A brief self-management intervention designed to support behavioral change can also lead to significant reductions in symptoms of depression and may be of great value for younger HD patients shown to be at greater risk for persistent distress.
Best Practice & Research Clinical Anaesthesiology, Mar 1, 2020
It is common for patients of all ages to experience some degree of cognitive disturbance followin... more It is common for patients of all ages to experience some degree of cognitive disturbance following surgery. In most cases, impairment appears mild and is restricted to the acute post-operative period, resolving steadily and speedily. In a small number of cases, however, deficits may be more pronounced and/or endure for longer periods, significantly delaying recovery and increasing the risk of serious clinical complications. The ability to accurately measure postoperative cognition, and track recovery of function, is an important clinical task. This review explores practical and methodological issues that may confound this process, examining how best to obtain reliable and meaningful measures of cognition before and after surgery. It considers neuropsychological test selection, administration, analysis and interpretation and offers evidence-based practice points for clinicians and researchers.
Case notes were reviewed for disease activity and treatment. Mann-Whitney test was used to compar... more Case notes were reviewed for disease activity and treatment. Mann-Whitney test was used to compare means. Results: There were a total number of 32 JSLE (male 5, female 27) patients in our cohort. 22 patients had their Vit-D levels. There were 16 patients with severe Vit-D deficiency (<30 nmol/l) and 2 patients with Vit-D insufficiency (30-50 nmol/l). The prevalence of Vit-D deficiency/ insufficiency in our cohort was $80%. There was no seasonal variation in Vit-D levels. Dark-skinned patients were found to have lower Vit-D levels (P < 0.05). We did not observe a significant increase in disease activity (BILAG2004 index score) in patients with Vit-D deficiency/ insufficiency. Nine patients received Vit-D supplements during the study period. One patient had confirmed osteopenia and sustained spinal fractures. Conclusion: Vit-D deficiency/insufficiency prevalence JSLE is $80%. We recommend that Vit-D levels are checked regularly particularly in dark-skinned patients. Further study is required to assess the significance of Vit-D in relation to disease activity.
Background Subjective cognitive complaints refer to self-experienced difficulties with everyday c... more Background Subjective cognitive complaints refer to self-experienced difficulties with everyday cognitive tasks. Although there has been a fair amount of research on cognitive impairments and cognitive complaints in end-stage renal disease, the practical implications of these complaints remain unclear. The current study aims to examine the associations of cognitive complaints with sociodemographic and clinical variables, mood, as well as key patient-reported outcomes, i.e., self-efficacy, self-management skills, and treatment adherence. Methods A total of 305 haemodialysis patients (mean age = 53.97 years, 42.6% female) completed the Kidney Disease Quality of Life Cognitive Function subscale, a brief measure of cognitive complaints. The recommended cut-off point of 60 was used to identify probable cognitive impairment. Measures of self-efficacy, self-management skills (i.e., symptom coping, health monitoring, health service navigation), treatment adherence, and mood symptoms were al...
Background: There is variability in the impact of adult congenital heart disease (ACHD) on health... more 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 four diagnostic groups and identified risk factors for poor HRQoL in ACHD from a comprehensive set of sociodemographic, clinical, and psychosocial factors. We conducted a cross-sectional study with 303 participants from four 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 analysed using one-sample t-tests, ANOVA and hierarchical multiple regressions. Results: There was diminished psychosocial HRQoL in the "Simple" group compared with 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. 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.
Publisher Summary This chapter discusses the relationship between a new test of ocular dominance ... more Publisher Summary This chapter discusses the relationship between a new test of ocular dominance and reading and spelling ability in a group of schoolchildren. The test determines whether the child has a fixed reference eye or whether ocular dominance is unfixed. Ocular dominance is assessed by means of a modified form of the Dunlop test. That test determines with which eye the ocular motor and retinal signals are associated and therefore distinguishes the dominant eye. The subjects' reading and spelling abilities are considered in relation to their intellectual performance by dividing them into four groups using a separate analysis for verbal and performance mental age. The analysis of spelling performance in relation to both verbal and performance mental age fails to indicate any association between unfixed ocular dominance and spelling difficulty.
International Journal of Integrated Care, Jun 8, 2012
There is limited evidence for the effectiveness of TH on quality of life (QoL) in patients with C... more There is limited evidence for the effectiveness of TH on quality of life (QoL) in patients with COPD. A systematic review in the area inclusive of all respiratory conditions indicated that there were no UK based studies, or randomised controlled trials (RCTs) evaluating the effectiveness of TH for COPD (Janna et al. 2009). A more recent systematic review found 6 studies, only two of which measured QoL as an outcome (Bolton et al. 2010). One of these studies was a RCT and found improvements in QoL at 3 months (Koff 2009), while the other was a non-controlled before and after study which found no difference in quality of life scores at 6 months (Trappenburg, 2008). Research in this area is plagued by small sample sizes, absence of longer-term follow-ups, insufficient descriptions of the intervention, poor internal validity of whether using the device in the context of a complex healthcare intervention leads to improved outcomes for the patient, and few attempts to measure quality of life in patients with COPD following the introduction of these devices. The current investigation is part of the Whole System Demonstrator (WSD) programme that aims to evaluate the effectiveness of telehealth (TH) for patient reported outcomes with Chronic Obstructive Pulmonary Disease (COPD). The primary objective was to evaluate the effectiveness of telehealth for COPD specific QoL and to examine whether there were improvements in HRQoL and psychological distress at short-term and long-term follow-up in this cohort of patients with COPD. Methods: WSD is one of the largest pragmatic cluster randomised controlled trials evaluating TH in the UK. Patients with COPD from three regions in England (Cornwall, Kent and Newham) were recruited from 179 GP practices randomised balancing for region, practice size, deprivation index, non-white proportion and prevalence of COPD. Over 570 patients with COPD completed a comprehensive battery of questionnaires assessing a range of patient reported outcomes. Measures of generic Health-Related Quality of Life (HRQoL) (Short Form-12), disease specific QoL including perceived control over COPD, fatigue caused by the disease and the emotional impact of the disease (Chronic Respiratory Questionnaire). Psychological distress was measured by depression (CESD-10) and anxiety (STAI).
Assessment (HTA) programme grant was awarded to King's College London, and that study activity at... more Assessment (HTA) programme grant was awarded to King's College London, and that study activity at Cambridgeshire Community Services NHS Trust was funded by this grant. Peter Bentham reports personal fees from TauRx Therapeutics Ltd (Aberdeen, UK) outside the submitted work. Catherine Henderson reports grants from the NIHR HTA programme during the conduct of the study. John O'Brien reports personal fees from TauRx Therapeutics Ltd, AXON Neuroscience SE (Larnaca, Cyprus), GE Healthcare (Chicago, IL, USA) and Eisai Co., Ltd (Tokyo, Japan), grants and personal fees from Avid Radiopharmaceuticals (Eli Lilly and Company, Indianapolis, IN, USA) and grants from Alliance Medical (Warwick, UK) outside the submitted work. Richard Gray reports grants from the NIHR HTA programme during the conduct of the study. Robert Howard reports grants from the NIHR HTA programme during the conduct of the study. He also reports that he was a member of the HTA programme Commissioning Sub-board (Expressions of Interest) (2009-11) and of the HTA Programme Commissioning Committee (2013-18).
Contemporary clinical trials communications, Mar 1, 2021
Background: The generalizability of findings of Randomised Controlled Trials (RCTs) is undermined... more Background: The generalizability of findings of Randomised Controlled Trials (RCTs) is undermined by low or biased recruitment. Reasons for participant refusal are infrequently reported in published literature. Aims: To apply the Theoretical Framework of Acceptability (TFA) to: (1) explore patient-reported reasons for declining to participate in a RCT comparing a new service model (patient-initiated appointments) with standard care (appointments scheduled by clinician) for managing blepharospasm and hemifacial spasm; (2) to explore associations between decliners' perceptions of acceptability and non-participation. Method: Eligible patients (n = 242) were approached to participate in the trial. Phase 1: decliners provided a brief reason for refusal. Reasons were analysed descriptively and reviewed against TFA constructs. Phase 2: Consecutive decliners participated in short semi-structured interviews, to explore their reasons for refusal in more depth. Interviews were transcribed and analysed, with the TFA as a coding framework. Results: Eighty-seven (36%) eligible patients refused trial participation; all provided a reason. From interviews with 15 decliners (17%), four key beliefs about acceptability were identified: happy with standard care (n = 41) (49%), anticipated burden of patient-initiated service, lack of confidence in ability to engage with new service and uncertainties about effectiveness of new service. Two themes reflected non-TFA factors: trial participation a low priority and burden of completing trial documentation. Conclusion: Reasons for refusal trial participation included: (a) reasons directly associated with intervention acceptability, and (b) reasons associated with trial participation more broadly. The TFA facilitated identification of problematic aspects of the new appointment booking system which could be addressed to enhance acceptability.
In table 1⇓ the raw differences for use of "GP (home)", "GP (surgery)", and "GP (telephone)" serv... more In table 1⇓ the raw differences for use of "GP (home)", "GP (surgery)", and "GP (telephone)" services are incorrect. In table 5⇓ there are errors in the QALY value for the primary outcome in the telehealth group; the ICER for CESD-10; and the footnote text. There are also errors scattered throughout table 4⇓. The three corrected tables are here.
BACKGROUND Preoperative anaemia is a risk factor for adverse postoperative outcomes after cardiac... more BACKGROUND Preoperative anaemia is a risk factor for adverse postoperative outcomes after cardiac surgery. Iron deficiency is a frequent cause of low preoperative haemoglobin. An effective treatment for preoperative anaemia associated with iron deficiency has not been determined. METHODS We conducted a single-centre, open-label, pragmatic randomised trial, enrolling 156 elective cardiac surgery patients who had low preoperative haemoglobin (100-130 g L-1) with iron deficiency (serum ferritin <100 μg L-1 or transferrin saturation <30%) to compare intravenous ferric derisomaltose 1000 mg and darbepoetin 200 μg subcutaneously (intervention group) with oral ferrous sulphate 600 mg daily (control group). The primary outcome was transfusion of at least one unit of allogeneic red cells during surgery and within the following 5 days. Secondary outcomes included the change in haemoglobin concentration between randomisation and surgery, red cell transfusion volume, postoperative blood loss, pre-specified postoperative complications, length of hospital stay, and in-hospital death. RESULTS The odds of red cell transfusion were lower in the intervention group compared with the control group (adjusted odds ratio=0.33; 95% confidence interval [CI], 0.15-0.75; P=0.008). Of the secondary outcomes, the only significant difference was the increase in haemoglobin between randomisation and surgery, intervention vs control 9.5 g L-1 (95% CI, 6.8-12.2; P<0.001). CONCLUSIONS In patients with a low preoperative haemoglobin and iron deficiency, preoperative treatment with a single dose of ferric derisomaltose and darbepoetin decreased the proportion of participants who received a perioperative blood transfusion as a consequence of a greater increase in haemoglobin compared with treatment with oral ferrous sulphate. CLINICAL TRIAL REGISTRATION ISRCTN Number: 41421863; EUDRACT number: 2011-003695-36.
Many studies encounter clustering due to multicenter enrollment and nonmortality outcomes, such a... more 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. Howeve...
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Papers by Stanton Newman