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OBJECTIVE: To evaluate the uptake of universal vitamin D supplementation during pregnancy, its effectiveness in preventing vitamin D deficiency and the factors associated with these. DESIGN: The regional public health organisation in Ayrshire, Scotland has a policy of universal provision of vitamin D supplements (10 µg/d) to all pregnant women for the duration of their pregnancy. Pregnant women in this area were recruited at their 12-week antenatal appointment. Blood samples were collected at the 12-week and 34-week appointments. To account for the seasonal variation, women were recruited in two cohorts: summer and winter. Telephone interviews were conducted at 34 weeks to assess the uptake of vitamin D supplements during pregnancy. Other variables were obtained from medical records. SETTING: The study was conducted in the NHS Ayrshire and Arran Health Board in Scotland. PARTICIPANTS: 612 pregnant women (aged 15-44 years) living in Ayrshire (latitude 55°), Scotland. RESULTS: Sixty-six percentage took supplementation as recommended. Consumption of supplementation was significantly associated with a higher median serum 25-hydroxyvitamin D concentrations at 34 weeks. Despite this at 34 weeks, 33 % of the summer cohort had insufficient or deficient vitamin D status, while 15 % of the winter cohort had insufficient or deficient status. In multivariable analysis, only adherence and season were independent predictors of vitamin D status. CONCLUSIONS: While supplementation improved and maintained vitamin D status during pregnancy, it was not adequate to ensure all those insufficient at 12 weeks achieved sufficient status at the end of pregnancy.
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Complicaciones del Embarazo , Deficiencia de Vitamina D , Femenino , Embarazo , Humanos , Deficiencia de Vitamina D/epidemiología , Deficiencia de Vitamina D/prevención & control , Vitamina D , Vitaminas , Suplementos Dietéticos , Estaciones del Año , Escocia/epidemiología , Complicaciones del Embarazo/epidemiología , Complicaciones del Embarazo/prevención & control , Política de SaludRESUMEN
OBJECTIVE: Neural tube defects (NTD) are potentially preventable by periconceptual folic acid supplementation. Women with obesity are at higher risk of NTD, therefore, are recommended a higher dose of 5 mg folic acid to mitigate this risk. The aim of this study was to evaluate maternal practice of folic acid supplementation amongst the antenatal population in relation to maternal obesity status. DESIGN: Prospective observational study. SETTING: Women ≤18 weeks' gestation at their first antenatal appointment attending University Maternity Hospital Limerick (Ireland) were recruited. Maternal height and weight were measured. Obesity was defined at a threshold of ≥30·0 kg/m2 and ≥27·5 kg/m2 when adjusting for ethnicity. A two-part questionnaire captured maternal characteristics and assessed supplementation compliance, commencement and dosage. Fisher's exact test for independence analysed differences in variables. A P value of <0·05 was considered significant. PARTICIPANTS: A total of 328 women participated over a duration of 6 weeks. RESULTS: Mean gestational age was 12·4 ± 1·4 weeks and mean BMI 26·7 kg/m2 ± 5·2 kg/m2. 23·8 % (n 78) were classified as obese. 96·5 % (n 315) were taking folic acid and 95·7 % (n 314) supplemented daily. 30·2 % (n 99) commenced supplementation 12 weeks prior to conception. Overall, 57·9 % (n 190) of women met folic acid supplementation dose requirements. 89·1 % (n 55) of women with obesity did not. Women with obesity were less likely to meet the higher folic acid supplementation dose requirements (P =< 0·001). CONCLUSION: Folic acid supplementation practices within this cohort were suboptimal to prevent their risk of NTD. This study showed inadequate compliance of folic acid supplementation, and inadequate dosage for women with obesity. Increased patient education and awareness are needed within the antenatal period of pregnancy to bring folic acid supplementation practices in line with best practice guidelines.
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Defectos del Tubo Neural , Mujeres Embarazadas , Suplementos Dietéticos , Femenino , Ácido Fólico/uso terapéutico , Humanos , Lactante , Defectos del Tubo Neural/prevención & control , Obesidad/epidemiología , Obesidad/prevención & control , Embarazo , Atención PrenatalRESUMEN
Poverty, poor housing and poor health are complexly interconnected in a cycle that has proven resistant to intervention by housing providers or policy makers. Research often focuses on the impacts of the physical housing defects, particularly upon rates of (physical) illness and disease. There has been comparatively little research into the ways in which housing services can underpin the generation of positive health and, especially, wellbeing. Drawing on qualitative data from 75 tenants in the social and private rented sectors, this paper describes the findings of a research project that tracked tenants' experiences across their first year in a new tenancy in Greater Glasgow, Scotland. The project collected data on tenants' perceptions of housing and housing service quality, financial coping and health and wellbeing, which was analysed using the principles of Realist Evaluation to elucidate impacts and causal pathways. Being able to establish a sense of home was key to tenants' wellbeing. The home provided many tenants with a recuperative space in which to shelter from daily stressors and was a source of autonomy and social status. A sense of home was underpinned by aspects of the housing service, property quality and affordability which are potentially amenable to intervention by housing providers. These findings raise questions about the extent to which social housing providers and the private rental market in the UK are able to meet the needs of vulnerable tenants. They suggest that approaches to housing provision that go beyond providing a basic dwelling are needed to successfully intervene in the cycle of poverty, poor housing and poor health.
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OBJECTIVES: Underpowered trials risk inaccurate results. Recruitment to stroke rehabilitation randomised controlled trials (RCTs) is often a challenge. Statistical simulations offer an important opportunity to explore the adequacy of sample sizes in the context of specific outcome measures. We aimed to examine and compare the adequacy of stroke rehabilitation RCT sample sizes using the Barthel Index (BI) or modified Rankin Scale (mRS) as primary outcomes. METHODS: We conducted computer simulations using typical experimental event rates (EER) and control event rates (CER) based on individual participant data (IPD) from stroke rehabilitation RCTs. Event rates are the proportion of participants who experienced clinically relevant improvements in the RCT experimental and control groups. We examined minimum sample size requirements and estimated the number of participants required to achieve a number needed to treat within clinically acceptable boundaries for the BI and mRS. RESULTS: We secured 2350 IPD (18 RCTs). For a 90% chance of statistical accuracy on the BI a rehabilitation RCT would require 273 participants per randomised group. Accurate interpretation of effect sizes would require 1000s of participants per group. Simulations for the mRS were not possible as a clinically relevant improvement was not detected when using this outcome measure. CONCLUSIONS: Stroke rehabilitation RCTs with large sample sizes are required for accurate interpretation of effect sizes based on the BI. The mRS lacked sensitivity to detect change and thus may be unsuitable as a primary outcome in stroke rehabilitation trials.
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Ensayos Clínicos Controlados Aleatorios como Asunto , Rehabilitación de Accidente Cerebrovascular , Humanos , Evaluación de Resultado en la Atención de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Proyectos de Investigación , Tamaño de la Muestra , Índice de Severidad de la EnfermedadRESUMEN
AIM: Provisional research on the faecal immunohistochemical test (FIT) for symptomatic colorectal patients has shown a high negative predictive value but has lacked long-term patient follow-up, raising the possibility of missed diagnoses of colorectal cancer (CRC). The aim of this work is to describe the long-term diagnostic accuracy of the FIT for CRC and significant bowel disease (SBD) in a symptomatic population in NHS Lanarkshire. METHOD: From October 2016 to February 2019, all primary care referrals of symptomatic colorectal patients in NHS Lanarkshire were asked to provide a FIT. The baseline demographics, investigations and diagnoses for each patient were prospectively completed until February 2021. A FIT result of ≥10 µg haemoglobin (Hb)/g faeces was considered to be positive. RESULTS: A total of 5250 patients were identified (median age 62 years; 46% male; median follow-up 31 months) with 65.1% (3418) being FIT negative. The SBD rate was 6.2% and the CRC rate was 2.9% (151). The SBD rate was significantly higher in the FIT-positive group (13.8% vs. 2.2%; p < 0.001) and 32.9% of patients with FIT ≥ 400 µg Hb/g had SBD. The sensitivity of FIT ≥ 10 µg Hb/g for CRC was 87.4% and for SBD it was 76.9%. Specificity was 66.6% and 66.7%, and the negative-predictive value was 99.4% and 97.7%, respectively. Sensitivity for CRC could theoretically be increased to 94.8% if FIT-negative patients were to undergo flexible sigmoidoscopy. CONCLUSION: A FIT-only referral pathway for symptomatic colorectal patients will miss over 12% of cancers and over 23% of SBD. Theoretically, combining FIT-negative patients with flexible sigmoidoscopy increases the sensitivity for CRC. The FIT offers a mechanism for prioritizing patient access to investigations, particularly in resource-limited areas; however, further work to identify FIT-negative patients diagnosed with CRC is required.
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Neoplasias Colorrectales , Enfermedades Intestinales , Colonoscopía , Neoplasias Colorrectales/diagnóstico , Detección Precoz del Cáncer , Heces/química , Femenino , Hemoglobinas/análisis , Humanos , Masculino , Persona de Mediana Edad , Sangre Oculta , Sensibilidad y EspecificidadRESUMEN
Introduction: Understanding of how SARS-CoV-2 manifests itself in older adults was unknown at the outset of the pandemic. We undertook a retrospective observational analysis of all patients admitted to older people's services with confirmed COVID-19 in one of the largest hospitals in Europe. We detail presenting symptoms, prognostic features and vulnerability to nosocomial spread. Methods: We retrospectively collected data for each patient with a positive SARSCoV-2 RT PCR between 18th March and the 20th April 2020 in a department of medicine for the elderly in Glasgow. Results: 222 patients were included in our analysis. Age ranged from 56 to 99 years (mean = 82) and 148 were female (67%). 119 patients had a positive swab for SARS-CoV-2 within the first 14 days of admission, only 32% of these patients presented with primarily a respiratory type illness. 103 patients (46%) tested positive after 14 days of admission - this was felt to represent likely nosocomial infection. 95 patients (43%) died by day 30 after diagnosis. Discussion: This data indicates that older people were more likely to present with non-respiratory symptoms. High clinical frailty scores, severe lymphopenia and cumulative comorbidities were associated with higher mortality rates. Several contributing factors will have led to nosocomial transmission.
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Prueba de COVID-19 , COVID-19/diagnóstico , Factores de Edad , Anciano , Anciano de 80 o más Años , COVID-19/complicaciones , COVID-19/mortalidad , Infección Hospitalaria/complicaciones , Infección Hospitalaria/diagnóstico , Infección Hospitalaria/mortalidad , Femenino , Anciano Frágil , Fragilidad/complicaciones , Fragilidad/diagnóstico , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Escocia/epidemiologíaRESUMEN
BACKGROUND: The role of housing as a social determinant of health is well-established, but the causal pathways are poorly understood beyond the direct effects of physical housing defects. For low-income, vulnerable households there are particular challenges in creating a sense of home in a new tenancy which may have substantial effects on health and wellbeing. This study examines the role of these less tangible aspects of the housing experience for tenants in the social and private rented sectors in west central Scotland. METHODS: The paper analyses quantitative data from a mixed methods, longitudinal study of tenants from three housing organisations, collected across the first year of their tenancy. The paper postulates causal hypotheses on the basis of staff interviews and then uses a Realist Research approach to test and refine these into a theoretical framework for the connections between tenants' broader experience of housing and their health and wellbeing. RESULTS: Housing service provision, tenants' experience of property quality and aspects of neighbourhood are all demonstrated to be significantly correlated with measures of of health and wellbeing. Analysis of contextual factors provides additional detail within the theoretical framework, offering a basis for further empirical work. CONCLUSIONS: The findings provide an empirically-informed realist theoretical framework for causal pathways connecting less tangible aspects of the housing experience to health and wellbeing. Applying this within housing policy and practice would facilitate a focus on housing as a public health intervention, with potential for significant impacts on the lives of low-income and vulnerable tenants. The framework also offers a basis for further research to refine our understanding of housing as a social determinant of health.
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Vivienda , Determinantes Sociales de la Salud , Adulto , Composición Familiar , Femenino , Humanos , Entrevistas como Asunto , Estudios Longitudinales , Masculino , Características de la Residencia , EscociaRESUMEN
Housing Associations in many countries exhibit increasing levels of 'hybridity', as reductions in state financing for social housing, exacerbated by austerity policies since the 2008 crash, have instigated 'enterprising' approaches to maintaining income. Alongside this, hybrid organisations have emerged in the Private Rented Sector (PRS), responding to sectoral growth and consequent increases in vulnerable households entering private renting. These developing hybridities have been considered at a strategic level, but there has been little exploration of the impacts on tenants. This paper examines two organisations, operating across the social and private rented sectors, to elucidate potential implications for tenants. The research suggests that different forms of hybridity can affect tenant outcomes and, moreover, that examining such impacts is important in understanding hybridity itself. Furthermore, the study suggests that emerging forms of hybridity, particularly in the PRS, may be blurring the boundaries between housing sectors, with implications for policy and research.
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OBJECTIVE: To explore the underlying reasons for recruitment difficulties to stroke rehabilitation randomized controlled trials from the perspective of trialists. DESIGN: A qualitative study using semi-structured interviews and Framework analysis. PARTICIPANTS: Twenty multidisciplinary stroke rehabilitation trialists across 13 countries with a range of clinical and research experience. METHODS: Twenty semi-structured telephone interviews were carried out. Purposeful sampling ensured a range of opinions were gathered from across the international stroke rehabilitation research community. Using Framework analysis, the analytical framework was formed by three researchers and tested before being applied to the total dataset. RESULTS: Three themes described the trialists' perception of the underlying reasons for recruitment difficulties: (i) decision making, (ii) importance of recruiters and (iii) a broken system. Trialists described frequently disregarding evidence in favour of prior research experiences when planning randomized controlled trial recruitment. All felt that the relationship between the research and clinical teams was vital to ensure recruiters prioritized and found value in recruitment to the trial. Experienced trialists were frustrated by the lack of reporting of the reality of running trials, research governance demands and the feeling that they had to deliberately underestimate recruitment timeframes to secure funding. CONCLUSION: Stroke rehabilitation trialists described recruitment difficulties which may be related to their experiential based recruitment decision making, a lack of understanding of how best to incentivize and maintain relationships with recruiters and unrealistic bureaucratic expectations both in terms of gaining funding and research governance.
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Selección de Paciente , Rehabilitación de Accidente Cerebrovascular , Ensayos Clínicos como Asunto , Humanos , Investigación CualitativaRESUMEN
INTRODUCTION: Randomised controlled trials (RCTs) that fail to meet their recruitment target risk increasing research waste. Acute stroke RCTs experience notable recruitment issues. The efficiency of recruitment to stroke rehabilitation RCTs has not been explored. AIMS AND OBJECTIVES: To explore recruitment efficiency and the trial features associated with efficient recruitment to stroke rehabilitation RCTs. METHODS: A systematic review of stroke rehabilitation RCTs published between 2005 and 2015 identified in a search of the Cochrane Stroke Group (CSG) Trials Register from 35 electronic databases (e.g. Medline, CINAHL; EMBASE), clinical trial registers, and hand-searching. Inclusion criteria are stroke rehabilitation intervention, delivered by a member of the rehabilitation team, and clinically relevant environment. We extracted data on recruitment efficiency and trial features. RESULTS: We screened 12,939 titles, 1270 abstracts and 788 full texts, before extracting data from 512 included RCTs (n = 28,804 stroke survivor participants). This is the largest systematic review of recruitment to date. A third of stroke survivors screened consented to participate (median 34% (IQR 14-61), on average sites recruited 1.5 participants per site per month (IQR 0.71-3.22), and one in twenty (6% (IQR 0-13) dropped out during the RCT. Almost half (48%) of those screened in the community were recruited compared to hospital settings (27%). Similarly, almost half (47%) those screened at least 6 months after stroke participated, compared to 23% of stroke survivors screened within a month of stroke. When one recruiter screened multiple sites, a median of one stroke survivor was recruited every 2 months compared to more than two per month when there was a dedicated recruiter per site. RCT recruitment was significantly faster per site, with fewer dropouts, for trials conducted in Asia (almost three stroke survivors monthly; 2% dropout) compared to European trials (approximately one stroke survivor monthly; 7% dropout). CONCLUSIONS: One third of stroke survivors screened were randomised to rehabilitation RCTs at a rate of between one and two per month, per site. One in twenty did not complete the trial. Our findings will inform recruitment plans of future stroke rehabilitation RCTs. Limited reporting of recruitment details restricted the subgroup analysis performed. TRIAL REGISTRATION: Prospective Register of Systematic Reviews, registration number CRD42016033067.
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Selección de Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular/terapia , Humanos , Tamaño de la Muestra , Resultado del TratamientoRESUMEN
BACKGROUND: Physical activity (PA) improves functional capacity and quality of life and provides secondary prevention benefits in individuals with peripheral arterial disease (PAD) and intermittent claudication (IC). However, pain and patient lack of knowledge are key barriers to the uptake of, and adherence to, PA recommendations. This trial will test the efficacy and feasibility of a non-invasive pain management intervention with and without patient education to improve PA in individuals with PAD and IC. METHODS: This is a randomised, controlled assessor-blinded feasibility trial with four parallel groups. Eighty adults with PAD and IC will be randomly assigned 1:1:1:1 to Active TENS (transcutaneous electrical nerve stimulation), Placebo TENS, Active TENS + Patient education or Placebo TENS + Patient education groups. All groups will continue to receive usual care over the intervention period. Participants randomised to Active TENS will receive a TENS device (preset at 120 Hz, 200 µs) and will be instructed to use the device daily at home or elsewhere for 6 weeks with a patient-determined intensity of "strong but comfortable". Placebo TENS group participants will receive the same model of TENS device and instructions for use as those in the active group, except that the stimulation dose will be safely altered to produce non-therapeutic, ineffective stimulation. Participants randomised to patient education will receive a one-off 3-h workshop of structured group education (four to five persons in each group) and three sets of twice-weekly phone calls. Efficacy outcomes will be assessed at baseline, after 6 weeks of intervention and at 3 months follow-up. Absolute claudication distance using the Gardner treadmill protocol will be assessed as the primary outcome. Secondary outcomes will assess initial claudication distance, daily PA and patient-reported outcomes including quality of life, pain self-efficacy, depression, disease perception and walking impairment pain intensity and quality. Feasibility outcomes will assess rates of recruitment, retention and adherence. Focus groups with participants at the end of the trial will explore the acceptability of the interventions. DISCUSSION: This trial will determine the efficacy and feasibility of using a low-cost, CE-marked non-invasive pain management modality delivered with or without a patient-centred education intervention to improve PA in individuals with PAD and IC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03204825 . Registered on 2 July 2017.
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Ejercicio Físico , Claudicación Intermitente/fisiopatología , Manejo del Dolor , Educación del Paciente como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Factibilidad , Humanos , Claudicación Intermitente/terapia , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Tamaño de la Muestra , Estimulación Eléctrica Transcutánea del NervioRESUMEN
BACKGROUND: People with intellectual disabilities are a high risk population for developing osteoporosis and fragility fractures, yet they experience barriers to accessing dual-energy x-ray absorptiometry (DXA) bone mineral density (BMD) screening and fracture assessment. Reasonable adjustments are a statutory requirement in the UK, but there is a paucity of evidence-based examples to assist their identification, implementation and evaluation. METHOD: Thirty adults with intellectual disabilities underwent DXA BMD screening and fracture risk assessment. Reasonable adjustments were identified and implemented. RESULTS: The presence of osteopenia or osteoporosis was detected in 23 out of 29 (79%) participants. Osteoporosis professionals report that 17 of 18 reasonable adjustments identified and implemented are both important and easy to implement. CONCLUSION: Adults across all levels of intellectual disabilities can complete DXA BMD screening with reasonable adjustments. Widely implementing these reasonable adjustments would contribute to reducing inequalities in health care for adults with intellectual disabilities.
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Absorciometría de Fotón/normas , Densidad Ósea , Fracturas Óseas/diagnóstico por imagen , Accesibilidad a los Servicios de Salud/normas , Disparidades en Atención de Salud/normas , Discapacidad Intelectual , Osteoporosis/diagnóstico por imagen , Medición de Riesgo/normas , Adulto , Anciano , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
The aim of the current study was to report findings about delirium detection when ward nurses screened for delirium in patients with cognitive impairment using the Delirium Observation Screening Scale (DOSS) in comparison to the Confusion Assessment Method (CAM). A secondary analysis was performed of research data collected in 2010 at a Swiss tertiary university hospital. During the first 5 days after admission, patients 70 and older with cognitive impairment were screened for delirium using the DOSS. Throughout patients' hospital stay, research assistants also completed the CAM on a daily basis. A total of 138 patients who did not have delirium initially participated in the study. Of these patients, 44 (32%) developed delirium with a median duration of 3 days (Q1 = 1.25; Q3 = 5.00). Ward nurses correctly identified delirium using the DOSS in 56% of cases (sensitivity) and no delirium in 92% of cases (specificity). Although the DOSS was 100% correct in detecting patients with hyperactive delirium, the identification rate decreased to 60% for patients with mixed delirium subtype and 38% for patients with hypoactive delirium. Delirium screening using observational methods may be insufficiently sensitive and should be supplemented with a formal attention test. [Journal of Gerontological Nursing, 44(12), 35-43.].
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Disfunción Cognitiva/diagnóstico , Disfunción Cognitiva/enfermería , Delirio/diagnóstico , Delirio/enfermería , Evaluación Geriátrica/métodos , Enfermería Geriátrica/métodos , Pruebas de Estado Mental y Demencia , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Tamizaje Masivo/métodos , Rol de la Enfermera , Estudios Prospectivos , SuizaRESUMEN
OBJECTIVE: Attention control comparisons in trials of stroke rehabilitation require care to minimize the risk of comparison choice bias. We compared the similarities and differences in SLT and social support control interventions for people with aphasia. DATA SOURCES: Trial data from the 2016 Cochrane systematic review of SLT for aphasia after stroke Methods: Direct and indirect comparisons between SLT, social support and no therapy controls. We double-data extracted intervention details using the template for intervention description and replication. Standardized mean differences and risk ratios (95% confidence intervals (CIs)) were calculated. RESULTS: Seven trials compared SLT with social support ( n = 447). Interventions were matched in format, frequency, intensity, duration and dose. Procedures and materials were often shared across interventions. Social support providers received specialist training and support. Targeted language rehabilitation was only described in therapy interventions. Higher drop-out ( P = 0.005, odds ratio (OR) 0.51, 95% CI 0.32-0.81) and non-adherence to social support interventions ( P < 0.00001, OR 0.18, 95% CI 0.09-0.37) indicated an imbalance in completion rates increasing the risk of control comparison bias. CONCLUSION: Distinctions between social support and therapy interventions were eroded. Theoretically based language rehabilitation was the remaining difference in therapy interventions. Social support is an important adjunct to formal language rehabilitation. Therapists should continue to enable those close to the person with aphasia to provide tailored communication support, functional language stimulation and opportunities to apply rehabilitation gains. Systematic group differences in completion rates is a design-related risk of bias in outcomes observed.
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Afasia/fisiopatología , Afasia/rehabilitación , Atención/fisiología , Terapia del Lenguaje/métodos , Logopedia/métodos , Rehabilitación de Accidente Cerebrovascular/métodos , Accidente Cerebrovascular/fisiopatología , Adulto , Anciano , Anciano de 80 o más Años , Comunicación , Femenino , Humanos , Masculino , Metaanálisis como Asunto , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Apoyo Social , Revisiones Sistemáticas como AsuntoRESUMEN
BACKGROUND: Foot pain is common in rheumatoid arthritis and appears to persist despite modern day medical management. Several clinical practice guidelines currently recommend the use of foot orthoses for the treatment of foot pain in people with rheumatoid arthritis. However, an evidence gap currently exists concerning the comparative clinical- and cost-effectiveness of prefabricated and customised foot orthoses in people with early rheumatoid arthritis. Early intervention with orthotics may offer the best opportunity for positive therapeutic outcomes. The primary aim of this study is to evaluate the comparative clinical- and cost-effectiveness of prefabricated versus customised orthoses for reducing foot pain over 12 months. METHODS/DESIGN: This is a multi-centre two-arm parallel randomised controlled trial comparing prefabricated versus customised orthoses in participants with early rheumatoid arthritis (< 2 years disease duration). A total of 160 (a minimum of 80 randomised to each arm) eligible participants will be recruited from United Kingdom National Health Service Rheumatology Outpatient Clinics. The primary outcome will be foot pain measured via the Foot Function Index pain subscale at 12 months. Secondary outcomes will include foot related impairments and disability via the Foot Impact Scale for rheumatoid arthritis, global functional status via the Stanford Health Assessment Questionnaire, foot disease activity via the Rheumatoid Arthritis Foot Disease Activity Index, and health-related quality of life at baseline, 6 and 12 months. Process outcomes will include recruitment/retention rates, data completion rates, intervention adherence rates, and participant intervention and trial participation satisfaction. Cost-utility and cost-effectiveness analyses will be undertaken. DISCUSSION: Outcome measures collected at baseline, 6 and 12 months will be used to evaluate the comparative clinical- and cost- effectiveness of customised versus prefabricated orthoses for this treatment of early rheumatoid arthritis foot conditions. This trial will help to guide orthotic prescription recommendations for the management of foot pain for people with early rheumatoid arthritis in future. TRIAL REGISTRATION: ISRCTN13654421. Registered 09 February 2016.
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Artritis Reumatoide/rehabilitación , Enfermedades del Pie/rehabilitación , Ortesis del Pié , Artritis Reumatoide/complicaciones , Artritis Reumatoide/economía , Protocolos Clínicos , Análisis Costo-Beneficio , Evaluación de la Discapacidad , Diseño de Equipo , Enfermedades del Pie/economía , Ortesis del Pié/economía , Humanos , Dolor/etiología , Dolor/prevención & control , Dimensión del Dolor/métodos , Calidad de Vida , Proyectos de Investigación , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Preference elicitation studies reporting societal views on the relative value of end-of-life treatments have produced equivocal results. This paper presents an alternative method, combining Q methodology and survey techniques (Q2S) to determine the distribution of 3 viewpoints on the relative value of end-of-life treatments identified in a previous, published, phase of this work. These were Viewpoint 1, "A population perspective: value for money, no special cases"; Viewpoint 2, "Life is precious: valuing life-extension and patient choice"; and Viewpoint 3, "Valuing wider benefits and opportunity cost: the quality of life and death." A Q2S survey of 4,902 respondents across the United Kingdom measured agreement with these viewpoints; 37% most agreed with Viewpoint 1, 49% with Viewpoint 2, and 9% with Viewpoint 3. Regression analysis showed associations of viewpoints with gender, level of education, religion, voting preferences, and satisfaction with the NHS. The Q2S approach provides a promising means to investigate how in-depth views and opinions are represented in the wider population. As demonstrated in this study, there is often more than 1 viewpoint on a topic and methods that seek to estimate that averages may not provide the best guidance for societal decision-making.
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Esperanza de Vida/tendencias , Asignación de Recursos/economía , Cuidado Terminal/estadística & datos numéricos , Valor de la Vida/economía , Adulto , Anciano , Actitud Frente a la Salud , Femenino , Humanos , Masculino , Persona de Mediana Edad , Opinión Pública , Q-Sort , Calidad de Vida/psicología , Encuestas y Cuestionarios , Reino Unido , Adulto JovenRESUMEN
Criteria used by the National Institute for Health and Care Excellence (NICE) to assess life-extending, end-of-life (EoL) treatments imply that health gains from such treatments are valued more than other health gains. Despite claims that the policy is supported by societal values, evidence from preference elicitation studies is mixed and in-depth research has shown there are different societal viewpoints. Few studies elicit preferences for policies directly or combine different approaches to understand preferences. Survey questions were designed to investigate support for NICE EoL guidance at national and regional levels. These 'Decision Rule' and 'Treatment Choice' questions were administered to an online sample of 1496 UK respondents in May 2014. The same respondents answered questions designed to elicit their agreement with three viewpoints (previously identified and described) in relation to provision of EoL treatments for terminally ill patients. We report the findings of these choice questions and examine how they relate to each other and respondents' viewpoints. The Decision Rule questions described three policies: DA - a standard 'value for money' test, applied to all health technologies; DB - giving special consideration to all treatments for terminal illnesses; and DC - giving special consideration to specific categories of treatments for terminal illnesses e.g. life extension (as in NICE EoL guidance) or those that improve quality-of-life (QoL). Three Treatment Choices were presented: TA - improving QoL for patients with a non-terminal illness; TB - extending life for EoL patients; and TC - improving QoL at the EoL. DC received most support (45%) with most respondents giving special consideration to EoL only when treatments improved QoL. The most commonly preferred treatment choices were TA (51%) and TC (43%). Overall, this study challenges claims about public support for NICE's EoL guidance and the focus on life extension at EoL and substantiates existing evidence of plurality in societal values.
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Conducta de Elección , Esperanza de Vida , Valores Sociales , Cuidado Terminal , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto , Medicina Estatal , Encuestas y Cuestionarios , Reino Unido , Adulto JovenRESUMEN
INTRODUCTION AND AIMS: Scotland has a particular problem with alcohol, and the links between intimate partner abuse (IPA) and alcohol appear stronger here than elsewhere across Europe. This study explored differences in alcohol use, related aggression and relationship conflict across a number of groups: men convicted for intimate partner abuse, men convicted of general offences and men recruited from community sports teams. DESIGN AND METHODS: Participants (n = 64) completed three questionnaires exploring their experiences of alcohol use (Alcohol Use Disorders Identification Test, AUDIT); alcohol and aggression (Alcohol Related Aggression Questionnaire, ARAQ-28), and relationship conflict (Revised Conflict Tactics Scale, CTS-2). RESULTS: There were significant differences across the groups in terms of AUDIT and ARAQ-28 scores, IPA and general offenders scored higher than the community sample. CTS-2 scores showed significant differences: both offender groups reported more use of negotiation and psychological abuse, than the community men, and IPA offenders reported causing more physical harm than either general offenders or the community sample. ARAQ-28 scores correlated with psychological abuse for general offenders. Alcohol use was very high across all groups, but the community group did not endorse an aggression-precipitating view of alcohol and did not report high IPA. DISCUSSION AND CONCLUSIONS: Discussed is the need for cross-cultural research to explore putative mediators and moderators in the relationship between alcohol, aggressiveness and IPA. [Gilchrist EA, Ireland L, Forsyth A, Godwin J, Laxton T. Alcohol use, alcohol-related aggression and intimate partner abuse: A cross-sectional survey of convicted versus general population men in Scotland. Drug Alcohol Rev 2017;36:20-23].
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Agresión , Consumo de Bebidas Alcohólicas/epidemiología , Criminales/estadística & datos numéricos , Violencia de Pareja/estadística & datos numéricos , Adulto , Consumo de Bebidas Alcohólicas/efectos adversos , Estudios Transversales , Conflicto Familiar , Humanos , Masculino , Factores de Riesgo , Escocia , Encuestas y CuestionariosRESUMEN
BACKGROUND: Providers of supported living services to adults with intellectual disabilities (IDs) in the United Kingdom have procedures in place to monitor injuries; this provides opportunity to learn about the injuries being reported and recorded. The aim was to determine the incidence, causes and types of injuries experienced by 593 adults with intellectual disabilities who live with paid support in a 12-month period. METHOD: Injury data, collected via a standard electronic injury monitoring system, were compared with data collected for a matched sample of the general population in the same year. RESULTS: The adults with intellectual disabilities experienced a higher rate of injury. Falls were the commonest cause of injury for both samples, but significantly more so for the adults with intellectual disabilities. CONCLUSIONS: The higher rate of injuries, particularly minor injuries, being reported suggests a culture of injury reporting and recording within these supported living services. Electronic injury monitoring is recommended for organizations providing supported living services for adults with intellectual disabilities.
RESUMEN
AIMS/INTRODUCTION: Gestational diabetes mellitus (GDM) is defined as 'carbohydrate intolerance of varying degrees of severity with onset or first recognition during pregnancy,' and is associated with increased fetal and maternal risks. The aims of the present study were to investigate the prevalence of GDM in Scotland over 32 years (1981-2012), and using the data from 2012, to assess how GDM related to maternal body mass index, maternal age, parity, smoking, Scottish Index of Multiple Deprivation, infant gender and macrosomia status. MATERIALS AND METHODS: GDM prevalence along with anthropometric, obstetric and demographic data were collected on a total of 1,891,097 women with a delivery episode between 1 January 1981 and 31 December 2012 using data extracted from the Scottish Morbidity Record 02. Univariate and multivariate logistic regression analysis was undertaken to investigate their association with GDM. RESULTS: A ninefold increase in GDM prevalence was observed from 1981 to 2012 (P < 0.001). GDM prevalence in 2012 was 1.9%. Maternal body mass index, age, parity status, Scottish index of multiple deprivation and fetal macrosomia were positively associated with GDM. Reported smoking status at booking was inversely associated with GDM. Multivariable analysis showed that fetal macrosomia was not associated with GDM status. CONCLUSIONS: The present study confirmed that the reporting of GDM is low in Scotland, and that GDM is associated with maternal body mass index, maternal age, multiparity and social deprivation. GDM was negatively associated with smoking and requires further investigation. The lack of association between GDM and macrosomia (following multivariate analysis) might reflect the screening processes undertaken in Scotland.