Audit of head injury management in Accident and Emergency at two hospitals: implications for NICE CT guidelines

BACKGROUND: The National Institute for Clinical Excellence (NICE) has produced guidelines on the early management of head injury. This study audits the process of the management of patients with head injury presenting at Accident and Emergency (A&E) departments and examines the impact upon resources of introducing NICE guidelines for eligibility of a CT scan. METHODS: A retrospective audit of consecutive patients of any age, presenting at A&E with a complaint of head injury during one month in two northern District General Hospitals forming part of a single NHS Trust. RESULTS: 419 patients presented with a median age of 15.5 years, and 61% were male. 58% had a Glasgow Coma Score (GCS) recorded and 33 (8%) were admitted. Only four of the ten indicators for a CT scan were routinely assessed, but data were complete for only one (age), and largely absent for another (vomiting). Using just three (incomplete) indicators showed a likely 4 fold increase in the need for a CT scan. CONCLUSIONS: The majority of patients who present with a head injury to Accident and Emergency departments are discharged home. Current assessment processes and associated data collection routines do not provide the information necessary to implement NICE guidelines for CT brain scans. The development of such clinical audit systems in a busy A&E department is likely to require considerable investment in technology and/or staff. The resource implications for radiology are likely to be substantial

The effect of telehealth on quality of life and psychological outcomes over a 12-month period in a diabetic cohort within the Whole Systems Demonstrator cluster randomised trial

Background: Much is written about the promise of telehealth and there is great enthusiasm about its potential. However, many studies of telehealth do not meet orthodox quality standards and there are few studies examining quality of life in diabetes as an outcome. Objective: To assess the impact of home-based telehealth (remote monitoring of physiological, symptom and self-care behavior data for long-term conditions) on generic and disease-specific health-related quality of life, anxiety, and depressive symptoms over 12 months in patients with diabetes. Remote monitoring provides the potential to improve quality of life, through the reassurance it provides patients. Methods: The study focused on participant-reported outcomes of patients with diabetes within the Whole Systems Demonstrator (WSD) Telehealth Questionnaire Study, nested within a pragmatic cluster-randomized trial of telehealth (the WSD Telehealth Trial), held across 3 regions of England. Telehealth was compared with usual-care, with general practice as the unit of randomization. Participant-reported outcome measures (ShortForm 12, EuroQual-5D, Diabetes Health Profile scales, Brief State-Trait Anxiety Inventory, and Centre for Epidemiological Studies Depression Scale) were collected at baseline, short-term (4 months) and long-term (12months) follow-ups. Intention-to-treat analyses testing treatment effectiveness, were conducted using multilevel models controlling for practice clustering and a range of covariates. Analyses assumed participants received their allocated treatment and were conducted for participants who completed the baseline plus at least one follow-up assessment (n=317). Results: Primary analyses showed differences between telehealth and usual care were small and only reached significance for 1 scale [dibetes health profile-disinhibited eating, P=.006). The magnitude of differences between trial arms did not reach the trial-defined minimal clinically important difference of 0.3 standard deviations for any outcome. Effect sizes (Hedge's g) ranged from 0.015 to 0.143 for Generic quality of life (QoL) measures and 0.018 to 0.394 for disease specific measures. Conclusions: Second generation home-based telehealth as implemented in the WSD evaluation was not effective in the subsample of people with diabetes. Overall, telehealth did not improve or have a deleterious effect quality of life or psychological outcomes for patients with diabetes over a 12-month period

An Australian longitudinal pilot study examining health determinants of cardiac outcomes 12 months post percutaneous coronary intervention

Background Percutaneous coronary intervention (PCI) is a very common revascularisation procedure for coronary artery disease (CAD). The purpose of this study was to evaluate cardiac outcomes, health related quality of life (HRQoL), resilience and adherence behaviours in patients who have undergone a PCI at two time points (6 and 12 months) following their procedure. Methods A longitudinal pilot study was conducted to observe the cardiac outcomes across a cohort of patients who had undergone a percutaneous coronary intervention (PCI). Participants who had undergone PCI 6 months prior were invited. Those participants who met the inclusion criteria and provided consent then completed a telephone survey (time point 1). These participants were then contacted 6 months later (i.e. 12 months post-intervention, time point 2) and the measures were repeated. Results All patients (n = 51) were recorded as being alive at time point 1. The multiple model indicated that controlling for other factors, gender was significantly associated with a linear combination of outcome measures (p = 0.004). The effect was moderate in magnitude (partial-η2 = 0.303), where males performed significantly better than females 6 months after the PCI procedure physically and with mood. Follow-up univariate ANOVAs indicated that gender differences were grounded in the scale measuring depression (PHQ9) (p = 0.005) and the physical component score of the short form measuring HRQoL (SF12-PCS) (p = 0.003). Thirteen patients were lost to follow-up between time points 1 and 2. One patient was confirmed to have passed away. The pattern of correlations between outcome measures at time point 2 revealed statistically significant negative correlation between the PHQ instrument and the resilience scale (CD-RISC) (r = -0.611; p < 0.001); and the physical component score of the SF-12 instrument (r = -0.437; p = 0.054). Conclusions Men were performing better than women in the 6 months post-PCI, particularly in the areas of mood (depression) and physical health. This pilot results indicate gender-sensitive practices are recommended particularly up to 6 months post-PCI. Any gender differences observed at 6 month appear to disappear at 12 months post-PCI. Further research into the management of mood particularly for women post-PCI is warranted. A more detailed inquiry related to access/attendance to secondary prevention is also warranted

Tratamiento quirúrgico de las enfermedades de transición cervicotorácica

OBJETIVO: avaliar o resultado do tratamento cirúrgico de pacientes portadores de doenças na transição cervicotorácica da coluna vertebral. MÉTODOS: foram avaliados, retrospectivamente, 20 pacientes: nove (45%) apresentavam lesões traumáticas, sete (35%) lesões neoplásicas e quatro (20%) doenças degenerativas. No grupo de pacientes com lesões traumáticas, foi realizada fixação posterior em cinco deles (55,5%), fixação anterior em um (11,1%) e abordagem combinada (anterior e posterior) em três (33,3%). Dos sete pacientes com lesões tumorais, quatro (57,1%) foram submetidos ao tratamento cirúrgico pela abordagem combinada e três (42,8%) pela abordagem posterior isolada. No grupo de pacientes com doenças degenerativas da coluna vertebral, três (75%) foram tratados pela abordagem posterior e um (25%) de forma combinada. Todos os pacientes foram avaliados por meio de parâmetros clínicos (dor e déficit neurológico), radiológicos (manutenção da redução, soltura ou quebra dos implantes) e funcionais (SF-36, escala de dor e trabalho de Denis). RESULTADOS: os 20 pacientes foram seguidos por um período que variou de seis meses a 11 anos (média de 44,6 meses ± 29,02). Dos 13 pacientes que apresentavam déficit neurológico, oito apresentaram melhora do nível na escala de Frankel (61,5%) e cinco pacientes (38,4%) permaneceram com o quadro inalterado. Como complicações um paciente (5%) apresentou soltura do implante e quatro pacientes evoluíram com infecção pós-operatória (20%). Segundo as escalas de dor e trabalho de Denis, 80% dos pacientes apresentavam pouca ou nenhuma dor (P1 e P2) e 70% dos pacientes tinham retornado ao trabalho (W1, W2 e W3). Os pacientes que não apresentavam déficit neurológico (Frankel E) obtiveram escores mais altos de qualidade de vida pelo questionário SF-36, quando comparados aos escores dos pacientes que mantinham alterações neurológicas (Frankel A-D). CONCLUSÃO: o tratamento das doenças da transição cervicotorácica da coluna vertebral apresenta detalhes adicionais aos demais segmentos da coluna vertebral. Na vigência de tratamento cirúrgico, existem pontos a serem respeitados como a anatomia relacionada ao acesso cirúrgico, as características anatômicas peculiares das vértebras e a biomecânica singular desse segmento da coluna vertebral.OBJECTIVE: to assess the results of the surgical treatment of patients with disease in the cervicothoracic junction of the spine. METHODS: twenty patients were retrospectively evaluated. Nine patients (45%) had traumatic lesions, seven (35%) neoplasic lesions and four (20%) degenerative arthropathies. In the group of patients with traumatic lesions it has been accomplished the posterior fixation in five patients (55.5%), anterior fixation in one patient (11.1%) and the combined approach (anterior and posterior) in three patients (33.3%). In the seven patients with neoplasic lesions, four (57.1%) underwent to the surgical treatment through the combined approach and 3 (42.8%) through the posterior approach. In the group of patients with spinal degenerative disease, three (75%) were treated through the posterior approach and one (25%) in a combined way. The patients were evaluated on the basis of clinical (pain and neurological deficit), radiological (reduction maintenance and implant loosening or break) and functional parameters (SF-36, Denis scale of work and pain). RESULTS: twenty patients were followed-up for a period of time ranging from six months to 11 years (44.6 months ± 29.02). From 13 patients which presented neurological deficit, eight patients presented improvement in Frankel scale level (61.5%) and five patients (38.5%) remained with the same level. As complications, one patient (5%) presented implant loosening and four patients presented postoperative infection (20%). In pain and work assessment, 80% of the patients presented few or no pain (P1 and P2) through Denis scale of pain, and 70% of the patients had returned to work (W1, W2 and W3) through Denis scale of work. The patients without neurological deficit (Frankel E) presented higher scores of life quality through the SF-36 questionnaire compared to the patients who had neurological deficit (Frankel A-D). CONCLUSION: the treatment of the diseases of the cervicothoracic junction of the spine presents additional details compared to the others segments of the spine. The surgical treatment has aspects to be respected as the anatomy related to the surgical access, the peculiar anatomic characteristics of the vertebrae and the unique biomechanics of this spinal segment.OBJETIVO: evaluar el resultado del tratamiento quirúrgico de pacientes portadores de enfermedades de transición cervicotorácica de la columna vertebral. MÉTODOS: fueron retrospectivamente evaluados veinte pacientes. Nueve pacientes (45%) presentaron lesiones traumáticas, 7 (35%) lesiones neoplásicas y 4 enfermedades degenerativas (20%). En el grupo de pacientes con lesiones traumáticas fue realizada una fijación posterior en 5 pacientes (55.5%), una fijación anterior en 1 paciente (11,1%) y abordaje combinado (anterior y posterior) en 3 pacientes (33.3%). De los 7 pacientes con lesiones tumorales, cuatro (57.1%) fueron sometidos al tratamiento quirúrgico por abordaje combinado y 3 (42.8%) por abordaje posterior aislado. En el grupo de pacientes con enfermedades degenerativas de la columna vertebral, tres (75%) fueron tratados por abordaje posterior y uno de forma combinada (25%). Todos los pacientes fueron evaluados por medio de parámetros clínicos (dolor y déficit neurológico), radiológicos (mantenimiento de la reducción, soltura o quiebra de los implantes) y funcionales (SF-36, escala de dolor y trabajo de Denis). RESULTADOS: los veinte pacientes fueron seguidos por um periodo que varió de 6 meses a 11 años (promedio de 44.6 meses ± 29.02). De los 13 pacientes que presentaron déficit neurológico, ocho presentaron una mejora en el nivel de la escala de Frankel (61.5%) y cinco pacientes (38.4%) permanecieron con un cuadro inalterado. Como complicaciones un paciente (5%) presentó soltura del implante y cuatro pacientes evolucionaron con infección postoperatoria (20%). Según las escalas de dolor y el trabajo de Denis, el 80% de los pacientes presentaron poco o nada de dolor (P1 y P2) y el 70% de los pacientes regresaron al trabajo (W1, W2 y W3). Los pacientes que no presentaron déficit neurológico (Frankel E) tuvieron escores mas altos de calidad de vida por el cuestionario SF-36, cuando comparados con los pacientes con alteraciones neurológicas (Frankel A-D). CONCLUSIÓN: el tratamiento de las enfermedades de la transición cervicotorácica de la columna vertebral presenta detalles adicionales a los demás segmentos de la columna vertebral. En la vigencia al acceso quirúrgico existen puntos a ser respetados como la anatomía relacionada al acceso quirúrgico, las características anatómicas peculiares de las vértebras y biomecánica singular de ese segmento de la columna vertebral

Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) protocol : a pragmatic multi-centre randomised controlled trial of cast treatment versus surgical fixation for the treatment of bi-cortical, minimally displaced fractures of the scaphoid waist in adults

BACKGROUND: A scaphoid fracture is the most common type of carpal fracture affecting young active people. The optimal management of this fracture is uncertain. When treated with a cast, 88 to 90 % of these fractures unite; however, for the remaining 10-12 % the non-union almost invariably leads to arthritis. The alternative is surgery to fix the scaphoid with a screw at the outset. METHODS/DESIGN: We will conduct a randomised controlled trial (RCT) of 438 adult patients with a "clear" and "bicortical" scaphoid waist fracture on plain radiographs to evaluate the clinical effectiveness and cost-effectiveness of plaster cast treatment (with fixation of those that fail to unite) versus early surgical fixation. The plaster cast treatment will be immobilisation in a below elbow cast for 6 to 10 weeks followed by mobilisation. If non-union is confirmed on plain radiographs and/or Computerised Tomogram at 6 to 12 weeks, then urgent surgical fixation will be performed. This is being compared with immediate surgical fixation with surgeons using their preferred technique and implant. These treatments will be undertaken in trauma units across the United Kingdom. The primary outcome and end-point will be the Patient Rated Wrist Evaluation (a patient self-reported assessment of wrist pain and function) at 52 weeks and also measured at 6, 12, 26 weeks and 5 years. Secondary outcomes include an assessment of radiological union of the fracture; quality of life; recovery of wrist range and strength; and complications. We will also qualitatively investigate patient experiences of their treatment. DISCUSSION: Scaphoid fractures are an important public health problem as they predominantly affect young active individuals in the more productive working years of their lives. Non-union, if untreated, can lead to arthritis which can disable patients at a very young age. There is a rapidly increasing trend for immediate surgical fixation of these fractures but there is insufficient evidence from existing RCTs to support this. The SWIFFT Trial is a rigorously designed and adequately powered study which aims to contribute to the evidence-base to inform clinical decisions for the treatment of this common fracture in adults. TRIAL REGISTRATION: The trial is registered with the International Standard Randomised Controlled Trial Register ( ISRCTN67901257 ). Date registration assigned was 13/02/2013

Parenting a child with phenylketonuria or galactosemia: implications for health-related quality of life

Parents of children with chronic disorders have an impaired health-related quality of life (HRQoL) compared to parents of healthy children. Remarkably, parents of children with a metabolic disorder reported an even lower HRQoL than parents of children with other chronic disorders. Possibly, the uncertainty about the course of the disease and the limited life expectancy in many metabolic disorders are important factors in the low parental HRQoL. Therefore, we performed a cross-sectional study in parents of children with phenylketonuria (PKU, OMIM #261600) and galactosemia (OMIM #230400), metabolic disorders not affecting life expectancy, in order to investigate their HRQoL compared to parents of healthy children and to parents of children with other metabolic disorders. A total of 185 parents of children with PKU and galactosemia aged 1-19 years completed two questionnaires. Parents of children with PKU or galactosemia reported a HRQoL comparable to parents of healthy children and a significantly better HRQoL than parents of children with other metabolic disorders. Important predictors for parental mental HRQoL were the psychosocial factors emotional support and loss of friendship. As parental mental functioning influences the health, development and adjustment of their children, it is important that treating physicians also pay attention to the wellbeing of the parents. The insight that emotional support and loss of friendship influence the HRQoL of the parents enables treating physicians to provide better support for these parents

Predicting consumer biomass, size-structure, production, catch potential, responses to fishing and associated uncertainties in the world's marine ecosystems

Existing estimates of fish and consumer biomass in the world’s oceans are disparate. This creates uncertainty about the roles of fish and other consumers in biogeochemical cycles and ecosystem processes, the extent of human and environmental impacts and fishery potential. We develop and use a size-based macroecological model to assess the effects of parameter uncertainty on predicted consumer biomass, production and distribution. Resulting uncertainty is large (e.g. median global biomass 4.9 billion tonnes for consumers weighing 1 g to 1000 kg; 50% uncertainty intervals of 2 to 10.4 billion tonnes; 90% uncertainty intervals of 0.3 to 26.1 billion tonnes) and driven primarily by uncertainty in trophic transfer efficiency and its relationship with predator-prey body mass ratios. Even the upper uncertainty intervals for global predictions of consumer biomass demonstrate the remarkable scarcity of marine consumers, with less than one part in 30 million by volume of the global oceans comprising tissue of macroscopic animals. Thus the apparently high densities of marine life seen in surface and coastal waters and frequently visited abundance hotspots will likely give many in society a false impression of the abundance of marine animals. Unexploited baseline biomass predictions from the simple macroecological model were used to calibrate a more complex size- and trait-based model to estimate fisheries yield and impacts. Yields are highly dependent on baseline biomass and fisheries selectivity. Predicted global sustainable fisheries yield increases ≈4 fold when smaller individuals (< 20 cm from species of maximum mass < 1kg) are targeted in all oceans, but the predicted yields would rarely be accessible in practice and this fishing strategy leads to the collapse of larger species if fishing mortality rates on different size classes cannot be decoupled. Our analyses show that models with minimal parameter demands that are based on a few established ecological principles can support equitable analysis and comparison of diverse ecosystems. The analyses provide insights into the effects of parameter uncertainty on global biomass and production estimates, which have yet to be achieved with complex models, and will therefore help to highlight priorities for future research and data collection. However, the focus on simple model structures and global processes means that non-phytoplankton primary production and several groups, structures and processes of ecological and conservation interest are not represented. Consequently, our simple models become increasingly less useful than more complex alternatives when addressing questions about food web structure and function, biodiversity, resilience and human impacts at smaller scales and for areas closer to coasts

Sensitivity Analysis for Not-at-Random Missing Data in Trial-Based Cost-Effectiveness Analysis : A Tutorial

Cost-effectiveness analyses (CEA) of randomised controlled trials are a key source of information for health care decision makers. Missing data are, however, a common issue that can seriously undermine their validity. A major concern is that the chance of data being missing may be directly linked to the unobserved value itself [missing not at random (MNAR)]. For example, patients with poorer health may be less likely to complete quality-of-life questionnaires. However, the extent to which this occurs cannot be ascertained from the data at hand. Guidelines recommend conducting sensitivity analyses to assess the robustness of conclusions to plausible MNAR assumptions, but this is rarely done in practice, possibly because of a lack of practical guidance. This tutorial aims to address this by presenting an accessible framework and practical guidance for conducting sensitivity analysis for MNAR data in trial-based CEA. We review some of the methods for conducting sensitivity analysis, but focus on one particularly accessible approach, where the data are multiply-imputed and then modified to reflect plausible MNAR scenarios. We illustrate the implementation of this approach on a weight-loss trial, providing the software code. We then explore further issues around its use in practice

Development of a Core Outcome Set for effectiveness trials aimed at optimising prescribing in older adults in care homes

Background: Prescribing medicines for older adults in care homes is known to be sub-optimal. Whilst trials testing interventions to optimise prescribing in this setting have been published, heterogeneity in outcome reporting has hindered comparison of interventions, thus limiting evidence synthesis. The aim of this study was to develop a core outcome set (COS), a list of outcomes which should be measured and reported, as a minimum, for all effectiveness trials involving optimising prescribing in care homes. The COS was developed as part of the Care Homes Independent Pharmacist Prescribing Study (CHIPPS). Methods: A long-list of outcomes was identified through a review of published literature and stakeholder input. Outcomes were reviewed and refined prior to entering a two-round online Delphi exercise and then distributed via a web link to the CHIPPS Management Team, a multidisciplinary team including pharmacists, doctors and Patient Public Involvement representatives (amongst others), who comprised the Delphi panel. The Delphi panellists (n = 19) rated the importance of outcomes on a 9-point Likert scale from 1 (not important) to 9 (critically important). Consensus for an outcome being included in the COS was defined as ≥70% participants scoring 7–9 and <15% scoring 1–3. Exclusion was defined as ≥70% scoring 1–3 and <15% 7–9. Individual and group scores were fed back to participants alongside the second questionnaire round, which included outcomes for which no consensus had been achieved. Results: A long-list of 63 potential outcomes was identified. Refinement of this long-list of outcomes resulted in 29 outcomes, which were included in the Delphi questionnaire (round 1). Following both rounds of the Delphi exercise, 13 outcomes (organised into seven overarching domains: medication appropriateness, adverse drug events, prescribing errors, falls, quality of life, all-cause mortality and admissions to hospital (and associated costs)) met the criteria for inclusion in the final COS. Conclusions: We have developed a COS for effectiveness trials aimed at optimising prescribing in older adults in care homes using robust methodology. Widespread adoption of this COS will facilitate evidence synthesis between trials. Future work should focus on evaluating appropriate tools for these key outcomes to further reduce heterogeneity in outcome measurement in this context