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BACKGROUND: sarcopenia and frailty are associated with increased risk of falls and fractures. This study evaluated the feasibility of assessing sarcopenia and frailty among older people attending fracture clinics. METHODS: patients aged 65+ years with an arm fracture attending fracture clinics in one UK city were recruited. Sarcopenia was assessed using gait speed, grip strength, skeletal muscle mass index SMI, SARC-F questionnaire and the European Working Group on Sarcopenia in Older People (EWGSOP) I and II criteria. Frailty was assessed using Fried Frailty Phenotype (FFP), FRAIL scale, PRISMA-7, electronic Frailty Index (e-FI), Clinical Frailty Score (CFS) and Study of Osteoporotic Fracture. The sensitivity and specificity of each tool was calculated against the EWGSOP II criteria (sarcopenia) and FFP (frailty). Patients identified to have either condition were referred for Comprehensive Geriatric Assessment (CGA). Interviews with 13 patients and nine staff explored the acceptability of this process. RESULTS: hundred patients (Mean age 75 years) were recruited. Most sarcopenia and frailty assessments were quick with complete data collection and were acceptable to patients and staff. Sarcopenia was identified among 4-39% participants depending on the tool and frailty among 9-25%. Both conditions were more common among men than women with all tools. The SARC-F and PRISMA-7 had the best sensitivity (100 and 93%, respectively) and specificity (96 and 87%). CGA among 80% of referred participants led to three interventions per participant (e.g. medication changes and investigations). CONCLUSION: SARC-F and PRISMA-7 are recommended for use in fracture clinics to screen for sarcopenia and frailty.
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Fragilidad , Sarcopenia , Anciano , Estudios Transversales , Estudios de Factibilidad , Femenino , Fragilidad/diagnóstico , Fragilidad/epidemiología , Fragilidad/terapia , Evaluación Geriátrica , Humanos , Masculino , Sarcopenia/diagnóstico , Sarcopenia/epidemiología , Sarcopenia/terapia , Extremidad SuperiorRESUMEN
The objective of this study is to compare the efficacy and cost of specialised individually delivered parent training (PT) for preschool children with attention-deficit/hyperactivity disorder (ADHD) against generic group-based PT and treatment as usual (TAU). This is a multi-centre three-arm, parallel group randomised controlled trial conducted in National Health Service Trusts. The participants included in this study were preschool children (33-54 months) fulfilling ADHD research diagnostic criteria. New Forest Parenting Programme (NFPP)-12-week individual, home-delivered ADHD PT programme; Incredible Years (IY)-12-week group-based, PT programme initially designed for children with behaviour problems were the interventions. Primary outcome-Parent ratings of child's ADHD symptoms (Swanson, Nolan & Pelham Questionnaire-SNAP-IV). Secondary outcomes-teacher ratings (SNAP-IV) and direct observations of ADHD symptoms and parent/teacher ratings of conduct problems. NFPP, IY and TAU outcomes were measured at baseline (T1) and post treatment (T2). NFPP and IY outcomes only were measured 6 months post treatment (T3). Researchers, but not therapists or parents, were blind to treatment allocation. Analysis employed mixed effect regression models (multiple imputations). Intervention and other costs were estimated using standardized approaches. NFPP and IY did not differ on parent-rated SNAP-IV, ADHD combined symptoms [mean difference - 0.009 95% CI (- 0.191, 0.173), p = 0.921] or any other measure. Small, non-significant, benefits of NFPP over TAU were seen for parent-rated SNAP-IV, ADHD combined symptoms [- 0.189 95% CI (- 0.380, 0.003), p = 0.053]. NFPP significantly reduced parent-rated conduct problems compared to TAU across scales (p values < 0.05). No significant benefits of IY over TAU were seen for parent-rated SNAP, ADHD symptoms [- 0.16 95% CI (- 0.37, 0.04), p = 0.121] or parent-rated conduct problems (p > 0.05). The cost per family of providing NFPP in the trial was significantly lower than IY (£1591 versus £2103). Although, there were no differences between NFPP and IY with regards clinical effectiveness, individually delivered NFPP cost less. However, this difference may be reduced when implemented in routine clinical practice. Clinical decisions should take into account parental preferences between delivery approaches.
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Trastorno por Déficit de Atención con Hiperactividad/terapia , Terapia Familiar/métodos , Responsabilidad Parental , Padres/educación , Trastorno por Déficit de Atención con Hiperactividad/diagnóstico , Niño , Preescolar , Femenino , Humanos , Masculino , Padres/psicología , Problema de Conducta , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
BACKGROUND: Outcome monitoring of depression treatment is recommended but there is a lack of evidence on patient benefit in primary care. AIM: To test monitoring depression using the Patient Health Questionnaire (PHQ-9) with patient feedback. DESIGN AND SETTING: An open cluster-randomised controlled trial was undertaken in 141 group practices. METHOD: Adults with new depressive episodes were recruited through record searches and opportunistically. The exclusion criteria were as follows: dementia; psychosis; substance misuse; and suicide risk. The PHQ-9 was administered soon after diagnosis, and 10-35 days later. The primary outcome was the Beck Depression Inventory (BDI-II) score at 12 weeks. The secondary outcomes were as follows: BDI-II at 26 weeks; Work and Social Adjustment Scale (WSAS) and EuroQol EQ-5D-5L quality of life at 12 and 26 weeks; antidepressant treatment; mental health and social service contacts; adverse events, and Medical Interview Satisfaction Scale (MISS) over 26 weeks. RESULTS: In total, 302 patients were recruited to the intervention arm and 227 to the controls. At 12 weeks, 254 (84.1%) and 199 (87.7%) were followed-up, respectively. Only 40.9% of patients in the intervention had a GP follow-up PHQ-9 recorded. There was no significant difference in BDI-II score at 12 weeks (mean difference -0.46; 95% confidence interval [CI] = -2.16 to 1.26; adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering by practice). EQ-5D-5L quality-of-life scores were higher in the intervention arm at 26 weeks (adjusted mean difference 0.053; 95% CI = 0.013 to 0.093. A clinically significant difference in depression at 26 weeks could not be ruled out. No significant differences were found in social functioning, adverse events, or satisfaction. In a per-protocol analysis, antidepressant use and mental health contacts were significantly greater in patients in the intervention arm with a recorded follow-up PHQ-9 (P = 0.025 and P = 0.010, respectively). CONCLUSION: No evidence was found of improved depression outcome at 12 weeks from monitoring. The findings of possible benefits over 26 weeks warrant replication, investigating possible mechanisms, preferably with automated delivery of monitoring and more instructive feedback.
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Calidad de Vida , Humanos , Masculino , Femenino , Persona de Mediana Edad , Adulto , Estudios de Seguimiento , Antidepresivos/uso terapéutico , Atención Primaria de Salud , Cuestionario de Salud del Paciente , Depresión/diagnóstico , Escalas de Valoración PsiquiátricaRESUMEN
Background: Guidelines on the management of depression recommend that practitioners use patient-reported outcome measures for the follow-up monitoring of symptoms, but there is a lack of evidence of benefit in terms of patient outcomes. Objective: To test using the Patient Health Questionnaire-9 questionnaire as a patient-reported outcome measure for monitoring depression, training practitioners in interpreting scores and giving patients feedback. Design: Parallel-group, cluster-randomised superiority trial; 1 : 1 allocation to intervention and control. Setting: UK primary care (141 group general practices in England and Wales). Inclusion criteria: Patients aged ≥ 18 years with a new episode of depressive disorder or symptoms, recruited mainly through medical record searches, plus opportunistically in consultations. Exclusions: Current depression treatment, dementia, psychosis, substance misuse and risk of suicide. Intervention: Administration of the Patient Health Questionnaire-9 questionnaire with patient feedback soon after diagnosis, and at follow-up 10-35 days later, compared with usual care. Primary outcome: Beck Depression Inventory, 2nd edition, symptom scores at 12 weeks. Secondary outcomes: Beck Depression Inventory, 2nd edition, scores at 26 weeks; antidepressant drug treatment and mental health service contacts; social functioning (Work and Social Adjustment Scale) and quality of life (EuroQol 5-Dimension, five-level) at 12 and 26 weeks; service use over 26 weeks to calculate NHS costs; patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale); and adverse events. Sample size: The original target sample of 676 patients recruited was reduced to 554 due to finding a significant correlation between baseline and follow-up values for the primary outcome measure. Randomisation: Remote computerised randomisation with minimisation by recruiting university, small/large practice and urban/rural location. Blinding: Blinding of participants was impossible given the open cluster design, but self-report outcome measures prevented observer bias. Analysis was blind to allocation. Analysis: Linear mixed models were used, adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering including practice as random effect. Quality of life and costs were analysed over 26 weeks. Qualitative interviews: Practitioner and patient interviews were conducted to reflect on trial processes and use of the Patient Health Questionnaire-9 using the Normalization Process Theory framework. Results: Three hundred and two patients were recruited in intervention arm practices and 227 patients were recruited in control practices. Primary outcome data were collected for 252 (83.4%) and 195 (85.9%), respectively. No significant difference in Beck Depression Inventory, 2nd edition, score was found at 12 weeks (adjusted mean difference -0.46, 95% confidence interval -2.16 to 1.26). Nor were significant differences found in Beck Depression Inventory, 2nd Edition, score at 26 weeks, social functioning, patient satisfaction or adverse events. EuroQol-5 Dimensions, five-level version, quality-of-life scores favoured the intervention arm at 26 weeks (adjusted mean difference 0.053, 95% confidence interval 0.013 to 0.093). However, quality-adjusted life-years over 26 weeks were not significantly greater (difference 0.0013, 95% confidence interval -0.0157 to 0.0182). Costs were lower in the intervention arm but, again, not significantly (-£163, 95% confidence interval -£349 to £28). Cost-effectiveness and cost-utility analyses, therefore, suggested that the intervention was dominant over usual care, but with considerable uncertainty around the point estimates. Patients valued using the Patient Health Questionnaire-9 to compare scores at baseline and follow-up, whereas practitioner views were more mixed, with some considering it too time-consuming. Conclusions: We found no evidence of improved depression management or outcome at 12 weeks from using the Patient Health Questionnaire-9, but patients' quality of life was better at 26 weeks, perhaps because feedback of Patient Health Questionnaire-9 scores increased their awareness of improvement in their depression and reduced their anxiety. Further research in primary care should evaluate patient-reported outcome measures including anxiety symptoms, administered remotely, with algorithms delivering clear recommendations for changes in treatment. Study registration: This study is registered as IRAS250225 and ISRCTN17299295. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/42/02) and is published in full in Health Technology Assessment; Vol. 28, No. 17. See the NIHR Funding and Awards website for further award information.
Depression is common, can be disabling and costs the nation billions. The National Health Service recommends general practitioners who treat people with depression use symptom questionnaires to help assess whether those people are getting better over time. A symptom questionnaire is one type of patient-reported outcome measure. Patient-reported outcome measures appear to benefit people having therapy and mental health care, but this approach has not been tested thoroughly in general practice. Most people with depression are treated in general practice, so it is important to test patient-reported outcome measures there, too. In this study, we tested whether using a patient-reported outcome measure helps people with depression get better more quickly. The study was a 'randomised controlled trial' in general practices, split into two groups. In one group, people with depression completed the Patient Health Questionnaire, or 'PHQ-9', patient-reported outcome measure, which measures nine symptoms of depression. In the other group, people with depression were treated as usual without the Patient Health Questionnaire-9. We fed the results of the Patient Health Questionnaire-9 back to the people with depression themselves to show them how severe their depression was and asked them to discuss the results with the practitioners looking after them. We found no differences between the patient-reported outcome measure group and the control group in their level of depression; their work or social life; their satisfaction with care from their practice; or their use of medicines, therapy or specialist care for depression. However, we did find that their quality of life was improved at 6 months, and the costs of the National Health Service services they used were lower. Using the Patient Health Questionnaire-9 can improve patients' quality of life, perhaps by making them more aware of improvement in their depression symptoms, and less anxious as a result. Future research should test using a patient-reported outcome measure that includes anxiety and processing the answers through a computer to give practitioners clearer advice on possible changes to treatment for depression.
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Depresión , Calidad de Vida , Humanos , Análisis Costo-Beneficio , Depresión/terapia , Medición de Resultados Informados por el Paciente , Atención Primaria de Salud , Adulto Joven , AdultoRESUMEN
Importance: There is significant concern regarding increasing long-term antidepressant treatment for depression beyond an evidence-based duration. Objective: To determine whether adding internet and telephone support to a family practitioner review to consider discontinuing long-term antidepressant treatment is safe and more effective than a practitioner review alone. Design, Setting, and Participants: In this cluster randomized clinical trial, 131 UK family practices were randomized between December 1, 2018, and March 31, 2022, with remote computerized allocation and 12 months of follow-up. Participants and researchers were aware of allocation, but analysis was blind. Participants were adults who were receiving antidepressants for more than 1 year for a first episode of depression or more than 2 years for recurrent depression who were currently well enough to consider discontinuation and wished to do so and who were at low risk of relapse. Of 6725 patients mailed invitations, 330 (4.9%) were eligible and consented. Interventions: Internet and telephone self-management support, codesigned and coproduced with patients and practitioners. Main Outcomes and Measures: The primary (safety) outcome was depression at 6 months (prespecified complete-case analysis), testing for noninferiority of the intervention to under 2 points on the 9-item Patient Health Questionnaire (PHQ-9). Secondary outcomes (testing for superiority) were antidepressant discontinuation, anxiety, quality of life, antidepressant withdrawal symptoms, mental well-being, enablement, satisfaction, use of health care services, and adverse events. Analyses for the main outcomes were performed on a complete-case basis, and multiple imputation sensitivity analysis was performed on an intention-to-treat basis. Results: Of 330 participants recruited (325 eligible for inclusion; 178 in intervention practices and 147 in control practices; mean [SD] age at baseline, 54.0 [14.9] years; 223 women [68.6%]), 276 (83.6%) were followed up at 6 months, and 240 (72.7%) at 12 months. The intervention proved noninferior; mean (SD) PHQ-9 scores at 6 months were slightly lower in the intervention arm than in the control arm in the complete-case analysis (4.0 [4.3] vs 5.0 [4.7]; adjusted difference, -1.1; 95% CI, -2.1 to -0.1; P = .03) but not significantly different in an intention-to-treat multiple imputation sensitivity analysis (adjusted difference, -0.9 (95% CI, -1.9 to 0.1; P = .08). By 6 months, antidepressants had been discontinued by 66 of 145 intervention arm participants (45.5%) who provided discontinuation data and 54 of 129 control arm participants (41.9%) (adjusted odds ratio, 1.02; 95% CI, 0.52-1.99; P = .96). In the intervention arm, antidepressant withdrawal symptoms were less severe, and mental well-being was better compared with the control arm; differences were small but significant. There were no significant differences in the other outcomes; 28 of 179 intervention arm participants (15.6%) and 22 of 151 control arm participants (14.6%) experienced adverse events. Conclusions and Relevance: In this cluster randomized clinical trial of adding internet and telephone support to a practitioner review for possible antidepressant discontinuation, depression was slightly better with support, but the rate of discontinuation of antidepressants did not significantly increase. Improvements in antidepressant withdrawal symptoms and mental well-being were also small. There were no significant harms. Family practitioner review for possible discontinuation of antidepressants appeared safe and effective for more than 40% of patients willing and well enough to discontinue. Trial Registration: ISRCTN registry Identifiers: ISRCTN15036829 (internal pilot trial) and ISRCTN12417565 (main trial).
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Antidepresivos , Internet , Teléfono , Humanos , Femenino , Masculino , Antidepresivos/uso terapéutico , Persona de Mediana Edad , Adulto , Depresión/tratamiento farmacológico , Reino UnidoRESUMEN
INTRODUCTION: Up to 80% of patients with respiratory tract infections (RTI) attending healthcare facilities in rural areas of China are prescribed antibiotics, many of which are unnecessary. Since 2009, China has implemented several policies to try to reduce inappropriate antibiotic use; however, antibiotic prescribing remains high in rural health facilities. METHODS AND ANALYSIS: A cluster randomised controlled trial will be carried out to estimate the effectiveness and cost effectiveness of a complex intervention in reducing antibiotic prescribing at township health centres in Anhui Province, China. 40 Township health centres will be randomised at a 1:1 ratio to the intervention or usual care arms. In the intervention group, practitioners will receive an intervention comprising: (1) training to support appropriate antibiotic prescribing for RTI, (2) a computer-based treatment decision support system, (3) virtual peer support, (4) a leaflet for patients and (5) a letter of commitment to optimise antibiotic use to display in their clinic. The primary outcome is the percentage of antibiotics (intravenous and oral) prescribed for RTI patients. Secondary outcomes include patient symptom severity and duration, recovery status, satisfaction, antibiotic consumption. A full economic evaluation will be conducted within the trial period. Costs and savings for both clinics and patients will be considered and quality of life will be measured by EuroQoL (EQ-5D-5L). A qualitative process evaluation will explore practitioner and patient views and experiences of trial processes, intervention fidelity and acceptability, and barriers and facilitators to implementation. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Biomedical Research Ethics Committee of Anhui Medical University (Ref: 20180259); the study has undergone due diligence checks and is registered at the University of Bristol (Ref: 2020-3137). Research findings will be disseminated to stakeholders through conferences and peer-reviewed journals in China, the UK and internationally. TRIAL REGISTRATION NUMBER: ISRCTN30652037.
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Antibacterianos , Infecciones del Sistema Respiratorio , Antibacterianos/uso terapéutico , China , Humanos , Prescripción Inadecuada/prevención & control , Atención Primaria de Salud , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Infecciones del Sistema Respiratorio/tratamiento farmacológicoRESUMEN
INTRODUCTION: Coronavirus disease (Covid-19) has led to a global pandemic since its emergence in December 2019. The majority of research into Covid-19 has focused on transmission, and mortality and morbidity associated with the virus. However, less attention has been given to its impact on health-related quality of life (HRQoL) of patients with Covid-19. METHODS: We searched for original studies published between December 2019 and Jan 2021 in PubMed, Scopus and Medline databases using a specific search strategy. We also explored literature on websites of distinguished public health organisations and hand-searched reference lists of eligible studies. The studies were screened by two reviewers according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) flowchart using pre-determined eligibility criteria. Data were synthesised, analysed descriptively and reported in line with PRISMA guidelines. RESULTS: In total, 1276 studies were identified through the search strategy. Of these, 77 studies were selected for full-text reading after screening the studies. After reading full-text, 12 eligible studies were included in this review. The majority of the studies used a generic HRQoL assessment tool; five studies used SF-36, five studies used EQ-5D-5L, and three used pulmonary disease-specific HRQoL tools (two studies used two tools each). The impact of Covid-19 on HRQoL was found to be considerable in both Acute Covid and Long Covid patients. Higher impact on HRQoL was reported in Acute Covid, females, older ages, patients with more severe disease and patients from low-income countries. CONCLUSION: The impact of Covid-19 on HRQoL of Acute and Long Covid patients is substantial. There was disproportional impact on patients by gender, age, severity of illness and study country. The long-term impact of Covid-19 is still in its initial stage. The findings of the review may be useful to researchers, policymakers, and clinicians caring for people following Covid-19 infection.
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COVID-19/psicología , Calidad de Vida/psicología , Adulto , Anciano , Anciano de 80 o más Años , COVID-19/complicaciones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pandemias/prevención & control , SARS-CoV-2/patogenicidad , Síndrome Post Agudo de COVID-19RESUMEN
BACKGROUND: Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. OBJECTIVE: In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. METHODS: In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). RESULTS: Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. CONCLUSIONS: The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18929.
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INTRODUCTION: Autism spectrum disorders (ASDs) are associated with difficulties in social interaction, communication and restricted, repetitive behaviours. Much is known about their community prevalence among adults, data on adult inpatients within an acute mental health setting is lacking.This pilot study aimed to estimate the prevalence of ASDs among adults admitted to acute mental health wards and to examine the association between ASDs and psychiatric and physical comorbidities within this group. METHODS AND ANALYSIS: A multiple-phase approach will be used. Phase I will involve testing of 200 patients and corresponding informants, using the autism quotient (AQ), the informant version of the Social Responsiveness Scale, second edition-Adult, the self and informant versions of the Adult Social Behaviour Questionnaire and the EuroQol-5D-5L. Patients with intellectual disability (ID) will bypass Phase I.Phase II will involve diagnostic testing of a subgroup of 40 patients with the Diagnostic Interview for Social and Communication Disorders, the Autism Diagnostic Observation Schedule version 2 and the ASD interview within the Schedules for Clinical Assessment in Neuropsychiatry version 3. 25±5 patients will not have ID and be selected via stratified random sampling according to AQ score; 15±5 patients will have ID. Phase II patients will be interviewed with the Physical Health Conditions and Mental Illness Diagnoses and Treatment sections of the 2014 Adult Psychiatric Morbidity Survey.Prevalence estimates will be based on the proportion of Phase II participants who satisfy the 10th revision of the International Statistical Classification of Diseases and Related Health Problems Diagnostic Criteria for Research (ICD-10-DCR) and the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for ASD, adjusting for selection and non-response. Univariate analysis will be conducted for comorbidities to identify the level of their association with an ASD diagnosis. ETHICS AND DISSEMINATION: Study oversight is provided by the University of Leicester. The National Health Service Health Research Authority have provided written approval. Study results will be disseminated via conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: ISRCTN27739943.
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Trastorno del Espectro Autista/epidemiología , Servicio de Psiquiatría en Hospital/estadística & datos numéricos , Adulto , Trastorno del Espectro Autista/diagnóstico , Estudios Transversales , Humanos , Trastornos Mentales/diagnóstico , Trastornos Mentales/epidemiología , Estudios Multicéntricos como Asunto , Proyectos Piloto , Prevalencia , Encuestas y CuestionariosRESUMEN
INTRODUCTION: Falls are a major health problem for older people; 35% of people aged 65+ years fall every year, leading to fractures in 10%-15%. Upper limb fractures are often the first sign of osteoporosis and routine screening for osteoporosis is recommended by the National Institute for Health and Care Excellence to prevent subsequent hip fractures. However, both frailty and sarcopenia (muscle weakness) are associated with increased risk of falling and fracture but are not routinely identified in this group. The aim of this study is to evaluate the feasibility of assessing and managing frailty and sarcopenia among people aged 65+ years with an upper limb fracture. METHODS AND ANALYSIS: This study will be conducted in three fracture clinics in one acute trust in England. 100 people aged 65+ years with an upper arm fracture will be recruited and assessed using six validated frailty measures and two sarcopenia tools. The prevalence of the two conditions and the best tools to use will be determined. Those with either condition will be referred to geriatric clinical teams for comprehensive geriatric assessment (CGA). We will document the proportion who are referred for CGA and those who receive CGA. Other outcome measures including falls, fractures and healthcare resource use over 6 months will be collected. In-depth interviews with a purposive sample of patients who undergo the frailty and sarcopenia assessments and healthcare professionals in fracture clinics and geriatric services will be carried out to their acceptability of assessing frailty and sarcopenia in a busy environment. ETHICS AND DISSEMINATION: The study was given the relevant ethical approvals from NHS Research Ethics Committee (REC No: 18/NE/0377), the University Hospital Southampton NHS Foundation Trust, and the University of Southampton, Faculty of Medicine Ethics Committee and Research Governance Office. Findings will be published in scientific journals and presented to local, national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN13848445.
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Accidentes por Caídas/estadística & datos numéricos , Fracturas Óseas/complicaciones , Fragilidad/diagnóstico , Evaluación Geriátrica , Sarcopenia/diagnóstico , Anciano , Traumatismos del Brazo/complicaciones , Inglaterra , Estudios de Factibilidad , Anciano Frágil , Fragilidad/complicaciones , Humanos , Calidad de Vida , Proyectos de Investigación , Sarcopenia/complicacionesRESUMEN
INTRODUCTION: Low quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management. METHODS AND ANALYSIS: A randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support. ETHICS AND DISSEMINATION: The trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN96374224; Pre-results.
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Supervivientes de Cáncer/psicología , Dietoterapia/métodos , Ejercicio Físico , Intervención basada en la Internet , Neoplasias , Calidad de Vida , Telerrehabilitación/métodos , Aumento de Peso , Femenino , Humanos , Masculino , Neoplasias/psicología , Neoplasias/rehabilitación , Autocontrol/psicologíaRESUMEN
INTRODUCTION: Self-management of hypertension, including self-monitoring and antihypertensive medication titration, lowers blood pressure (BP) at 1â year compared to usual care. The aim of the current trial is to assess the effectiveness of the Home and Online Management and Evaluation of Blood Pressure (HOME BP) intervention for the self-management of hypertension in primary care. METHODS AND ANALYSIS: The HOME BP trial will be a randomised controlled trial comparing BP self-management-consisting of the HOME BP online digital intervention with self-monitoring, lifestyle advice and antihypertensive drug titration-with usual care for people with uncontrolled essential hypertension. Eligible patients will be recruited from primary care and randomised to usual care or to self-management using HOME BP. The primary outcome will be the difference in mean systolic BP (mmâ Hg) at 12-month follow-up between the intervention and control groups adjusting for baseline BP and covariates. Secondary outcomes (also adjusted for baseline and covariates where appropriate) will be differences in mean BP at 6â months and diastolic BP at 12â months; patient enablement; quality of life, and economic analyses including all key resources associated with the intervention and related services, adopting a broad societal perspective to include NHS, social care and patient costs, considered within trial and modelled with a lifetime horizon. Medication beliefs, adherence and changes; self-efficacy; perceived side effects and lifestyle changes will be measured for process analyses. Qualitative analyses will explore patient and healthcare professional experiences of HOME BP to gain insights into the factors affecting acceptability, feasibility and adherence. ETHICS AND DISSEMINATION: This study has received NHS ethical approval (REC reference 15/SC/0082). The findings from HOME BP will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, HOME BP will be directly applicable to UK primary care management of hypertension. TRIAL REGISTRATION NUMBER: ISRCTN13790648; pre-results.
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Monitoreo Ambulatorio de la Presión Arterial/métodos , Presión Sanguínea/fisiología , Hipertensión Esencial/tratamiento farmacológico , Autocuidado/métodos , Telemedicina/métodos , Anciano , Anciano de 80 o más Años , Antihipertensivos/uso terapéutico , Hipertensión Esencial/fisiopatología , Femenino , Humanos , Internet , Masculino , Persona de Mediana Edad , Atención Primaria de Salud/métodos , Calidad de VidaRESUMEN
OBJECTIVES: CT colonography (CTC) may be an acceptable test for colorectal cancer screening but bowel preparation can be a barrier to uptake. This study tested the hypothesis that prospective screening invitees would prefer full-laxative preparation with higher sensitivity and specificity for polyps, despite greater burden, over less burdensome reduced-laxative or non-laxative alternatives with lower sensitivity and specificity. DESIGN: Discrete choice experiment. SETTING: Online, web-based survey. PARTICIPANTS: 2819 adults (45-54 years) from the UK responded to an online invitation to take part in a cancer screening study. Quota sampling ensured that the sample reflected key demographics of the target population and had no relevant bowel disease or medical qualifications. The analysis comprised 607 participants. INTERVENTIONS: After receiving information about screening and CTC, participants completed 3-4 choice scenarios. Scenarios showed two hypothetical forms of CTC with different permutations of three attributes: preparation, sensitivity and specificity for polyps. PRIMARY OUTCOME MEASURES: Participants considered the trade-offs in each scenario and stated their preferred test (or chose neither). RESULTS: Preparation and sensitivity for polyps were both significant predictors of preferences (coefficients: -3.834 to -6.346 for preparation, 0.207-0.257 for sensitivity; p<0.0005). These attributes predicted preferences to a similar extent. Realistic specificity values were non-significant (-0.002 to 0.025; p=0.953). Contrary to our hypothesis, probabilities of selecting tests were similar for realistic forms of full-laxative, reduced-laxative and non-laxative preparations (0.362-0.421). However, they were substantially higher for hypothetical improved forms of reduced-laxative or non-laxative preparations with better sensitivity for polyps (0.584-0.837). CONCLUSIONS: Uptake of CTC following non-laxative or reduced-laxative preparations is unlikely to be greater than following full-laxative preparation as perceived gains from reduced burden may be diminished by reduced sensitivity. However, both attributes are important so a more sensitive form of reduced-laxative or non-laxative preparation might improve uptake substantially.
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Colonografía Tomográfica Computarizada/métodos , Laxativos/uso terapéutico , Prioridad del Paciente/estadística & datos numéricos , Conducta de Elección , Pólipos del Colon/diagnóstico por imagen , Neoplasias Colorrectales/diagnóstico por imagen , Detección Precoz del Cáncer/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sensibilidad y Especificidad , Encuestas y CuestionariosRESUMEN
AIMS: We wish to assess the clinical and cost-effectiveness of remote monitoring of heart failure patients with cardiac implanted electronic devices. METHODS: REM-HF is a multicentre, randomized, non-blinded, parallel trial designed to compare weekly remote monitoring-driven management with usual care for patients with cardiac implanted electronic devices (ICD, CRT-D, or CRT-P). The trial is event driven, and the final analysis will be performed when 546 events have been observed or the study is terminated at the interim analysis. We have randomized 1650 patients to be followed up for a minimum of 2 years. Patients will remain in the trial up to study termination. The first patient was randomized in September 2011 and the study is expected to complete in early 2016. The primary combined endpoint is time to first event of all-cause death or unplanned hospitalization for cardiovascular reasons. An economic evaluation will be performed, estimating the cost per quality-adjusted life year, with direct costs estimated from the National Health Service perspective and quality of life assessed by the EQ-5D, Short-Form 12, and Kansas City Cardiomyopathy Questionnaires. The study design has been informed by a feasibility study. CONCLUSION: REM-HF is a multicentre randomized study that will provide important data on the effect of remote monitoring-driven management of implanted cardiac devices on morbidity and mortality, as well as the cost-effectiveness of this approach.
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Desfibriladores Implantables , Insuficiencia Cardíaca/terapia , Monitoreo Fisiológico/métodos , Calidad de Vida , Telemedicina/métodos , Anciano , Causas de Muerte/tendencias , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/psicología , Humanos , Masculino , Años de Vida Ajustados por Calidad de Vida , Estudios Retrospectivos , Resultado del Tratamiento , Reino Unido/epidemiologíaRESUMEN
BACKGROUND: Guidelines indicate eligibility for lipid lowering drugs, but it is not known to what extent GPs' follow guidelines in routine clinical practice or whether additional clinical factors systematically influence their prescribing decisions. METHODS: A retrospective cohort analysis was undertaken using electronic primary care records from 421 UK general practices. At baseline (May 2008) patients were aged 30 to 74 years, free from cardiovascular disease and not taking lipid lowering drugs. The outcome was prescription of a lipid lowering drug within the next two years. The proportions of eligible and ineligible patients prescribed lipid lowering drugs were reported and multivariable logistic regression models were used to investigate associations between age, sex, cardiovascular risk factors and prescribing. RESULTS: Of 365,718 patients with complete data, 13.8% (50,558) were prescribed lipid lowering drugs: 28.5% (21,101/74,137) of those eligible and 10.1% (29,457/291,581) of those ineligible. Only 41.7% (21,101/50,558) of those prescribed lipid lowering drugs were eligible. In multivariable analysis prescribing was most strongly associated with increasing age (OR for age ≥ 65 years 4.21; 95% CI 4.05-4.39); diabetes (OR 4.49; 95% CI 4.35-4.64); total cholesterol level ≥ 7 mmol/L (OR 2.20; 95% CI 2.12-2.29); and ≥ 4 blood pressure measurements in the past year (OR 4.24; 95% CI 4.06-4.42). The predictors were similar in eligible and ineligible patients. CONCLUSIONS: Most lipid lowering drugs for primary prevention are prescribed to ineligible patients. There is underuse of lipid lowering drugs in eligible patients.
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Enfermedades Cardiovasculares/tratamiento farmacológico , Enfermedades Cardiovasculares/prevención & control , Prescripciones de Medicamentos/estadística & datos numéricos , Medicina General/estadística & datos numéricos , Hipolipemiantes/uso terapéutico , Pautas de la Práctica en Medicina/estadística & datos numéricos , Prevención Primaria/estadística & datos numéricos , Adulto , Anciano , Enfermedades Cardiovasculares/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Oportunidad Relativa , Estudios Retrospectivos , Factores de Riesgo , Reino Unido/epidemiologíaRESUMEN
A wide range of screening technologies is available for colorectal cancer screening. There is demand to discover public preferences for these tests on the rationale that tailoring screening to preferences may improve uptake. This review describes a type of study (conjoint analysis) used to assess people's preferences for colorectal cancer screening tests and critically evaluates research quality using a recently published set of guidelines. Most primary studies assessed preferences for colonoscopy and fecal occult blood testing but newer technologies (e.g., capsule endoscopy) have not yet been evaluated. Although studies often adhered to guidelines, there was limited correspondence between stated preferences and actual screening behavior. Future research should investigate how studies can go beyond the guidelines in order to improve this and also explore how test preferences may differ by important population subgroups.
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Colonoscopía , Neoplasias Colorrectales/diagnóstico , Colonoscopía/métodos , Colonoscopía/normas , Colonoscopía/tendencias , Adhesión a Directriz , Guías como Asunto , HumanosRESUMEN
PURPOSE: To establish the relative weighting given by patients and healthcare professionals to gains in diagnostic sensitivity versus loss of specificity when using CT colonography (CTC) for colorectal cancer screening. MATERIALS AND METHODS: Following ethical approval and informed consent, 75 patients and 50 healthcare professionals undertook a discrete choice experiment in which they chose between "standard" CTC and "enhanced" CTC that raised diagnostic sensitivity 10% for either cancer or polyps in exchange for varying levels of specificity. We established the relative increase in false-positive diagnoses participants traded for an increase in true-positive diagnoses. RESULTS: Data from 122 participants were analysed. There were 30 (25%) non-traders for the cancer scenario and 20 (16%) for the polyp scenario. For cancer, the 10% gain in sensitivity was traded up to a median 45% (IQR 25 to >85) drop in specificity, equating to 2250 (IQR 1250 to >4250) additional false-positives per additional true-positive cancer, at 0.2% prevalence. For polyps, the figure was 15% (IQR 7.5 to 55), equating to 6 (IQR 3 to 22) additional false-positives per additional true-positive polyp, at 25% prevalence. Tipping points were significantly higher for patients than professionals for both cancer (85 vs 25, p<0.001) and polyps (55 vs 15, p<0.001). Patients were willing to pay significantly more for increased sensitivity for cancer (pâ=â0.021). CONCLUSION: When screening for colorectal cancer, patients and professionals believe gains in true-positive diagnoses are worth much more than the negative consequences of a corresponding rise in false-positives. Evaluation of screening tests should account for this.
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Colonografía Tomográfica Computarizada/psicología , Neoplasias Colorrectales/diagnóstico , Pólipos del Colon/diagnóstico , Detección Precoz del Cáncer/psicología , Humanos , Pacientes/psicología , Sensibilidad y EspecificidadRESUMEN
BACKGROUND: We developed a method to estimate the expected cost-effectiveness of a service intervention at the design stage and 'road-tested' the method on an intervention to improve patient handover of care between hospital and community. METHOD: The development of a nine-step evaluation framework: 1. Identification of multiple endpoints and arranging them into manageable groups; 2. Estimation of baseline overall and preventable risk; 3. Bayesian elicitation of expected effectiveness of the planned intervention; 4. Assigning utilities to groups of endpoints; 5. Costing the intervention; 6. Estimating health service costs associated with preventable adverse events; 7. Calculating health benefits; 8. Cost-effectiveness calculation; 9. Sensitivity and headroom analysis. RESULTS: Literature review suggested that adverse events follow 19% of patient discharges, and that one-third are preventable by improved handover (ie, 6.3% of all discharges). The intervention to improve handover would reduce the incidence of adverse events by 21% (ie, from 6.3% to 4.7%) according to the elicitation exercise. Potentially preventable adverse events were classified by severity and duration. Utilities were assigned to each category of adverse event. The costs associated with each category of event were obtained from the literature. The unit cost of the intervention was 16.6, which would yield a Quality Adjusted Life Year (QALY) gain per discharge of 0.010. The resulting cost saving was 14.3 per discharge. The intervention is cost-effective at approximately 214 per QALY under the base case, and remains cost-effective while the effectiveness is greater than 1.6%. CONCLUSIONS: We offer a usable framework to assist in ex ante health economic evaluations of health service interventions.