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Background: Following a Mediterranean diet (MedDiet) is associated with a lower risk of cardiovascular disease. He Rourou Whai Painga is a dietary intervention trial with behaviour change support that seeks to determine whether a MedDiet pattern can provide equivalent benefits in Aotearoa New Zealand (NZ), a country where cardiovascular disease is a leading cause of death. To do this, the MedDiet needs to be adapted in an acceptable way for NZ, with consideration of the Maori (indigenous) population. Methods: The MedDiet was defined using existing MedDiet scoring tools and adapted to the NZ context using local guidelines. The resulting NZ MedDiet pattern was used to develop a kai/food basket, including products from industry partners, for participants in He Rourou Whai Painga. Criteria set for the kai/food basket included providing up to 75% of energy requirements and falling within the Australia/NZ Acceptable Macronutrient Distribution Range to reduce risk of chronic disease. Maori researchers on the team provided support to ensure Matauranga Maori (Maori knowledge and values) was upheld through this process. Results: The NZ MedDiet pattern criteria was similar to the identified MedDiet scoring tools, with differences in recommendations for dairy, red meat, alcohol and olive oil. The resulting kai/food baskets were estimated to provide on average 73.5% of energy requirements for households, with 36% from fat, 8.6% from saturated fat, 17% protein, and 42% carbohydrate. Forty-two industry partners, including 3 Maori businesses, agreed to provide 22 types of food products towards the total. Conclusion: Small, feasible changes to the MedDiet can be made to align with the NZ guidelines and food environment. However, this eating pattern still differs from what the population, particularly Maori, are currently consuming. Continued partnership with Maori and additional behavioural support is important to facilitate adherence to this dietary pattern within He Rourou Whai Painga.Trial registration: https://www.anzctr.org.au/Default.aspx, identifier ACTRN12622000906752 and https://www.isrctn.com/, identifier ISRCTN89011056.
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BACKGROUND AND OBJECTIVES: People with parkinsonism who are older, living in a care home, with frailty, multimorbidity or impaired capacity to consent are under-represented in research, limiting its generalisability. We aimed to evaluate more inclusive recruitment strategies. METHODS: From one UK centre, we invited people with parkinsonism to participate in a cross-sectional study. Postal invitations were followed by telephone reminders and additional support to facilitate participation. Personal consultees provided information on the views regarding research participation of adults with impaired capacity. These approaches were evaluated: (i) using external data from the Parkinson's Real World Impact assesSMent (PRISM) study and Clinical Practice Research Datalink (CPRD), a sample of all cases in UK primary care, and (ii) comparing those recruited with or without intensive engagement. RESULTS: We approached 1,032 eligible patients, of whom 542 (53%) consented and 477 (46%) returned questionnaires. The gender ratio in PRIME-UK (65% male) closely matched CPRD (61% male), unlike in the PRISM sample (46%). Mean age of PRIME participants was 75.9 (SD 8.5) years, compared to 75.3 (9.5) and 65.4 (8.9) years for CPRD and PRISM, respectively. More intensive engagement enhanced recruitment of women (13.3%; 95% CI 3.8, 22.9%; P = 0.005), care home residents (6.2%; 1.1, 11.2%; P = 0.004), patients diagnosed with atypical parkinsonism (13.7%; 5.4, 19.9%; P < 0.001), and those with a higher frailty score (mean score 0.2, 0.1, 0.2; P < 0.001). CONCLUSIONS: These recruitment strategies resulted in a less biased and more representative sample, with greater inclusion of older people with more complex parkinsonism.
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Disfunción Cognitiva , Fragilidad , Multimorbilidad , Enfermedad de Parkinson , Selección de Paciente , Humanos , Masculino , Femenino , Anciano , Estudios Transversales , Disfunción Cognitiva/epidemiología , Disfunción Cognitiva/psicología , Disfunción Cognitiva/diagnóstico , Reino Unido/epidemiología , Fragilidad/epidemiología , Fragilidad/psicología , Fragilidad/diagnóstico , Anciano de 80 o más Años , Enfermedad de Parkinson/psicología , Enfermedad de Parkinson/epidemiología , Enfermedad de Parkinson/diagnóstico , Anciano Frágil/psicología , Anciano Frágil/estadística & datos numéricos , Trastornos Parkinsonianos/epidemiología , Trastornos Parkinsonianos/psicología , Trastornos Parkinsonianos/diagnósticoRESUMEN
The current paradigm for the multidisciplinary management of Parkinson's Disease (PD) does not include regular nutritional assessment despite research showing that 90 % of people living with Parkinson's (PwP) lack access to basic dietetic services. Since many non-motor symptoms such as dysphagia, constipation and orthostatic hypotension and PD complications such as weight loss and sarcopenia can be improved through dietary intervention, dietitians are a critical missing piece of the PD management puzzle. This paper serves to review the role of dietitians and medical nutrition therapy in management of PD as well as a call to action for future studies to investigate improvement of nutritional status and quality of life for all PwP.
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Nutricionistas , Enfermedad de Parkinson , Humanos , Enfermedad de Parkinson/complicaciones , Enfermedad de Parkinson/terapia , Calidad de Vida , Atención a la Salud , Estreñimiento/etiologíaRESUMEN
INTRODUCTION: Craniopharyngiomas are rare brain tumours (incidence 1.1-1.7 cases/million/year). Although non-malignant, craniopharyngioma causes major endocrine and visual morbidities including hypothalamic obesity, yet mechanisms leading to obesity are poorly understood. This study investigated the feasibility and acceptability of eating behaviour measures in patients with craniopharyngioma to inform the design of future trials. METHODS: Patients with childhood-onset craniopharyngioma and controls matched for sex, pubertal stage, and age were recruited. After an overnight fast, participants received the following measures: body composition, resting metabolic rate, oral glucose tolerance test including magnetic resonance imaging (patients only), appetite ratings, eating behaviour, and quality of life questionnaires, ad libitum lunch, and an acceptability questionnaire. Data are reported as median ± IQR, with effect size measure (Cliff's delta) and Kendall's tau for correlations, due to the small sample size. RESULTS: Eleven patients (median age = 14 years; 5 F/6 M) and matched controls (median age = 12 years; 5 F/6 M) were recruited. All patients had received surgery, and 9/11 also received radiotherapy. Hypothalamic damage post-surgery was graded (Paris grading): grade 2 n = 6; grade 1 n = 1; grade 0 n = 2. The included measures were deemed highly tolerable by participants and their parent/carers. Preliminary data suggest a difference in hyperphagia between patients and controls (d = 0.5), and a relationship between hyperphagia with body mass index standard deviation score (BMISDS) in patients (τ = 0.46). DISCUSSION: These findings demonstrate that eating behaviour research is feasible and acceptable to craniopharyngioma patients and there is an association between BMISDS and hyperphagia in patients. Thus, food approach and avoidance behaviours may be useful targets for interventions to manage obesity in this patient group.
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Craneofaringioma , Obesidad Infantil , Neoplasias Hipofisarias , Humanos , Adolescente , Niño , Craneofaringioma/complicaciones , Estudios de Factibilidad , Obesidad Infantil/epidemiología , Obesidad Infantil/complicaciones , Calidad de Vida , Neoplasias Hipofisarias/epidemiología , Neoplasias Hipofisarias/complicaciones , Hiperfagia/complicaciones , Conducta Alimentaria , HomeostasisRESUMEN
AIM: To assess the feasibility of a family-based dietary intervention study using a meal kit home delivery service, in people at risk of cardio-metabolic disease. METHODS: A 12-week dietary intervention feasibility study of adults (termed the index participants) at increased risk of metabolic and cardiovascular disease, enriched for Maori who are indigenous New Zealanders. The study sample also included the household/whanau members living with the index participant. All participants received a 12 week intervention using weekly home delivery of meal kits and groceries consistent with a Mediterranean dietary pattern. Outcomes were the metabolic syndrome severity score (MetSSS); feasibility and acceptability of the intervention; dietary intake; and other clinical and anthropometric measures. RESULTS: There were 29 index participants recruited and in addition, 50 household/whanau members took part in the feasibility study. The mean (SD) household/whanau size was 3.45 (1.4) people, and the mean (SD) number of people in each household/whanau who participated in the study was 2.84 (1.2). The feasibility of intervention to households/whanau was proven in this context. The mean (SD) change in MetSSS was 0.03 (0.33), N = 27, P = 0.69 and there was a statistically significant decrease in body weight of 1.37 kg (95% CI 0.11 to 2.62), p = 0.034. The food deliveries were well received, the dinner kits more so than the grocery items. CONCLUSION: It is feasible to recruit individuals and households/whanau to a family-based dietary intervention. Use of a meal kit home delivery service to provide food which is consistent with the intervention dietary pattern was well received. This feasibility study identified improvements to be made such as nutrition behaviour change support, more variety in food provided, more recipes, and better matching of food quantity to family size. TRIAL REGISTRATION: ANZCTR-ACTRN12621000856819p registered 2.JUN.2021 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382021&isReview=true.
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Background: Cardiometabolic diseases are highly prevalent in Aotearoa New Zealand. Dietary intake is a modifiable risk factor for such diseases and certain dietary patterns, specifically the Mediterranean diet (MedDiet), are associated with improved metabolic health. This study aims to test whether an intervention including a Mediterranean dietary pattern incorporating high quality New Zealand foods (NZMedDiet pattern) and behavior change science can improve the metabolic health of participants and their household/whanau. Methods and analysis: This is a multi-center, three-stage trial with two parallel group superiority randomized controlled trials (RCTs), and a longitudinal cohort study embedded within the trial design. The first RCT (RCT 1) is a comparison of the NZMedDiet pattern compared to usual diet for 12 weeks. The Behavior Change Wheel was used to select and implement strategies to support participant adherence to the NZMedDiet, such as web-based nutrition education on healthy shopping and cooking. The second (RCT 2) compares online social support to no online social support for 12 weeks, administered to participants immediately following RCT 1. The third stage is a longitudinal cohort study where all participants are followed from the beginning of their start of the active intervention for 12 months in total. The primary outcome measure for each stage is the metabolic syndrome severity score (MetSSS). The duration of enrolment is 12-15 months. The total recruitment target is 200 index participants and their household/whanau members who participate with them, and the primary analyses will be intention to treat on index participants. Discussion: The trial will test whether the NZMedDiet pattern and behavior change support improves the cardiometabolic health of people in Aotearoa New Zealand. Clinical trial registration: https://www.anzctr.org.au/Default.aspx, identifier ACTRN12622000906752 and https://www.isrctn.com/, identifier ISRCTN89011056 (Spirit 2).
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INTRODUCTION: This paper provides a critical reflection from both the researcher and public contributor (PC) perspective on the benefits and the learnings taken from involving PCs in research related to Parkinson's. APPROACH TO PATIENT AND PUBLIC INVOLVEMENT (PPI): This paper reports on how PCs shaped the design and development of the PRIME-UK research programme study materials through input into information leaflets, consent forms and other patient-facing documents used across three studies within the PRIME-UK research programme. The PRIME-UK research programme is designed to improve the quality of life of people with Parkinson's and this project included three studies: a cross-sectional study, a randomised control trial and a qualitative study. We captured these impacts using Public Involvement Impact Logs, which provide a framework allowing researchers and PCs to report on the learnings, immediate outcomes and impacts from PPI. For this project, the impact logs enabled us to provide reflections from PCs and researchers on the process of involving 'the public' in Parkinson's research. FINDINGS: This paper builds on existing evidence of the range of benefits and challenges that emerge from working with patients and the public in Parkinson's research; this includes reflecting on the changes made to the study materials and benefits for the people involved. Four themes emerged from the reflections that were common to the researchers and PCs; these were the importance of providing a supportive environment; recognition of the benefit of the evaluation of the impact of PPI; acknowledgement that engagement of PPI can make a positive difference to the research process and that timely communication and the use of face-to-face communication, where available, is key. Furthermore, we demonstrate how impact logs provide a useful and straightforward tool for evaluating public involvement practices and supporting the feedback process. CONCLUSION: We offer key recommendations for involving patients and the public in Parkinson's research and suggest approaches that could be implemented to capture the impacts of public involvement. PUBLIC CONTRIBUTION: Public contributors (PCs) were involved in the design and development of the participant information leaflets, consent forms and other patient-facing documents used for studies within the PRIME-UK research programme. In addition, PCs evaluated their involvement using impact logs and co-authored this paper.
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Acute exercise suppresses appetite and alters food-cue reactivity, but the extent exercise-induced changes in cerebral blood flow (CBF) influences the blood-oxygen-level-dependent (BOLD) signal during appetite-related paradigms is not known. This study examined the impact of acute running on visual food-cue reactivity and explored whether such responses are influenced by CBF variability. In a randomised crossover design, 23 men (mean ± SD: 24 ± 4 years, 22.9 ± 2.1 kg/m2 ) completed fMRI scans before and after 60 min of running (68% ± 3% peak oxygen uptake) or rest (control). Five-minute pseudo-continuous arterial spin labelling fMRI scans were conducted for CBF assessment before and at four consecutive repeat acquisitions after exercise/rest. BOLD-fMRI was acquired during a food-cue reactivity task before and 28 min after exercise/rest. Food-cue reactivity analysis was performed with and without CBF adjustment. Subjective appetite ratings were assessed before, during and after exercise/rest. Exercise CBF was higher in grey matter, the posterior insula and in the region of the amygdala/hippocampus, and lower in the medial orbitofrontal cortex and dorsal striatum than control (main effect trial p ≤ .018). No time-by-trial interactions for CBF were identified (p ≥ .087). Exercise induced moderate-to-large reductions in subjective appetite ratings (Cohen's d = 0.53-0.84; p ≤ .024) and increased food-cue reactivity in the paracingulate gyrus, hippocampus, precuneous cortex, frontal pole and posterior cingulate gyrus. Accounting for CBF variability did not markedly alter detection of exercise-induced BOLD signal changes. Acute running evoked overall changes in CBF that were not time dependent and increased food-cue reactivity in regions implicated in attention, anticipation of reward, and episodic memory independent of CBF.
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Señales (Psicología) , Carrera , Humanos , Masculino , Encéfalo/fisiología , Circulación Cerebrovascular/fisiología , Imagen por Resonancia Magnética/métodos , Oxígeno , Estudios CruzadosRESUMEN
BACKGROUND: People living with Parkinson's disease experience progressive motor and non-motor symptoms, which negatively impact on health-related quality of life and can lead to an increased risk of hospitalisation. It is increasingly recognised that the current care models are not suitable for the needs of people with parkinsonism whose care needs evolve and change as the disease progresses. This trial aims to evaluate whether a complex and innovative model of integrated care will increase an individual's ability to achieve their personal goals, have a positive impact on health and symptom burden and be more cost-effective when compared with usual care. METHODS: This is a single-centre, randomised controlled trial where people with parkinsonism and their informal caregivers are randomised into one of two groups: either PRIME Parkinson multi-component model of care or usual care. Adults ≥18 years with a diagnosis of parkinsonism, able to provide informed consent or the availability of a close friend or relative to act as a personal consultee if capacity to do so is absent and living in the trial geographical area are eligible. Up to three caregivers per patient can also take part, must be ≥18 years, provide informal, unpaid care and able to give informed consent. The primary outcome measure is goal attainment, as measured using the Bangor Goal Setting Interview. The duration of enrolment is 24 months. The total recruitment target is n=214, and the main analyses will be intention to treat. DISCUSSION: This trial tests whether a novel model of care improves health and disease-related metrics including goal attainment and decreases hospitalisations whilst being more cost-effective than the current usual care. Subject to successful implementation of this intervention within one centre, the PRIME Parkinson model of care could then be evaluated within a cluster-randomised trial at multiple centres.
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Enfermedad de Parkinson , Adulto , Humanos , Enfermedad de Parkinson/diagnóstico , Enfermedad de Parkinson/terapia , Calidad de Vida , Hospitalización , Consentimiento Informado , Reino Unido , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Dementia is the most common neurodegenerative disorder globally. Disease progression is marked by declining cognitive function accompanied by changes in mobility. Increased sedentary behaviour and, conversely, wandering and becoming lost are common. Global positioning system (GPS) solutions are increasingly used by caregivers to locate missing people with dementia (PwD) but also offer a non-invasive means of monitoring mobility patterns in PwD. We performed a systematic search across five databases to identify papers published since 2000, where wearable or portable GPS was used to monitor mobility in patients with common dementias or mild cognitive impairment (MCI). Disease and GPS-specific vocabulary were searched singly, and then in combination, identifying 3004 papers. Following deduplication, we screened 1972 papers and retained 17 studies after a full-text review. Only 1/17 studies used a wrist-worn GPS solution, while all others were variously located on the patient. We characterised the studies using a conceptual framework, finding marked heterogeneity in the number and complexity of reported GPS-derived mobility outcomes. Duration was the most frequently reported category of mobility reported (15/17), followed by out of home (14/17), and stop and trajectory (both 10/17). Future research would benefit from greater standardisation and harmonisation of reporting which would enable GPS-derived measures of mobility to be incorporated more robustly into clinical trials.
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Disfunción Cognitiva , Demencia , Dispositivos Electrónicos Vestibles , Disfunción Cognitiva/diagnóstico , Progresión de la Enfermedad , Sistemas de Información Geográfica , HumanosRESUMEN
INTRODUCTION: People with parkinsonism are a highly heterogeneous group and the disease encompasses a spectrum of motor and non-motor symptoms which variably emerge and manifest across the disease course, fluctuate over time and negatively impact quality of life. While parkinsonism is not directly the result of ageing, it is a condition that mostly affects older people, who may also be living with frailty and multimorbidity. This study aims to describe the broad range of health needs for people with parkinsonism and their carers in relation to their symptomatology, disability, disease stage, comorbidities and sociodemographic characteristics. METHODS AND ANALYSIS: In this single site cross-sectional study, people with parkinsonism will be sent a study information pack for themselves and their primary informal caregiver, if relevant. Data are collected via questionnaire, with additional support, if required, to maximise participation. A specific strategy has been developed to target and proactively recruit patients lacking capacity to consent, including those in residential care settings, with input from a personal consultee prior to completion of a bespoke questionnaire by a representative. Caregivers are also recruited to look at various health outcomes. Results will be displayed as descriptive statistics and regression models will be used to test simple associations and interactions. ETHICS AND DISSEMINATION: This protocol was approved by the London-Brighton & Sussex Research Ethics Committee (REC reference 20/LO/0890). The results of this protocol will be disseminated through publication in an international peer-reviewed journal; presentation at academic meetings and conferences; and a lay summary uploaded to the PRIME-Parkinson website. TRIAL REGISTRATION NUMBER: ISRCTN11452969; Pre-results.
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Cuidadores , Trastornos Parkinsonianos , Anciano , Estudios Transversales , Humanos , Calidad de Vida , Reino UnidoRESUMEN
Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease and affects about 1% of the population over the age of 60 years in industrialised countries. The aim of this review is to examine nutrition in PD across three domains: dietary intake and the development of PD; whole body metabolism in PD and the effects of PD symptoms and treatment on nutritional status. In most cases, PD is believed to be caused by a combination of genetic and environmental factors and although there has been much research in the area, evidence suggests that poor dietary intake is not a risk factor for the development of PD. The evidence about body weight changes in both the prodromal and symptomatic phases of PD is inconclusive and is confounded by many factors. Malnutrition in PD has been documented as has sarcopaenia, although the prevalence of the latter remains uncertain due to a lack of consensus in the definition of sarcopaenia. PD symptoms, including those which are gastrointestinal and non-gastrointestinal, are known to adversely affect nutritional status. Similarly, PD treatments can cause nausea, vomiting and constipation, all of which can adversely affect nutritional status. Given that the prevalence of PD will increase as the population ages, it is important to understand the interplay between PD, comorbidities and nutritional status. Further research may contribute to the development of interventional strategies to improve symptoms, augment care and importantly, enhance the quality of life for patients living with this complex neurodegenerative disease.
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Desnutrición , Enfermedades Neurodegenerativas , Enfermedad de Parkinson , Humanos , Desnutrición/etiología , Persona de Mediana Edad , Enfermedades Neurodegenerativas/complicaciones , Estado Nutricional , Enfermedad de Parkinson/complicaciones , Calidad de VidaRESUMEN
BACKGROUND: While a number of studies have examined associations between dietary factors and risk of multiple sclerosis (MS), little is known about intakes of inflammation-modulating foods and nutrients and risk of MS. OBJECTIVES: To test associations between the Dietary Inflammatory Index (DII®) and risk of a first clinical diagnosis of central nervous system (CNS) demyelination (FCD) (267 cases, 507 controls) using data from the Ausimmune Study. METHODS: The 2003-2006 Ausimmune Study was a multicentre, matched, case-control study examining environmental risk factors for an FCD, a common precursor to MS. The DII is a well-recognised tool that categorises individuals' diets on a continuum from maximally anti-inflammatory to maximally pro-inflammatory. The DII score was calculated from dietary intake data collected using a food frequency questionnaire. Conditional logistic regression models were used to estimate the association between DII and FCD separately for men and women. RESULTS: In women, a higher DII score was associated with increased likelihood of FCD, with a 17% increase in likelihood of FCD per one-unit increase in DII score (adjusted odds ratio 1.17, 95% confidence interval 1.04-1.33). There was no association between DII and FCD in men (adjusted odds ratio 0.88, 95% confidence interval 0.73-1.07). CONCLUSIONS: These findings suggest that a pro-inflammatory diet is associated with an increased likelihood of FCD in women.
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Dieta , Esclerosis Múltiple , Estudios de Casos y Controles , Sistema Nervioso Central , Femenino , Humanos , Inflamación , Masculino , Factores de RiesgoRESUMEN
Neurodegenerative disorders (NDDs) constitute an increasing global burden and can significantly impair an individual's mobility, physical activity (PA), and independence. Remote monitoring has been difficult without relying on diaries/questionnaires which are more challenging for people with dementia to complete. Wearable global positioning system (GPS) sensors and accelerometers present a cost-effective and noninvasive way to passively monitor mobility and PA. In addition, changes in sensor-derived outcomes (such as walking behaviour, sedentary, and active activity) may serve as potential biomarkers of disease onset, progression, and response to treatment. We performed a systematic search across four databases to identify papers published within the past 5 years, in which wearable GPS or accelerometers were used to monitor mobility or PA in patients with common NDDs (Parkinson's disease, Alzheimer's disease, motor neuron diseases/amyotrophic lateral sclerosis, vascular parkinsonism, and vascular dementia). Disease and technology-specific vocabulary were searched singly, and then in combination, identifying 4985 papers. Following deduplication, we screened 3115 papers and retained 28 studies following a full text review. One study used wearable GPS and accelerometers, while 27 studies used solely accelerometers in NDDs. GPS-derived measures had been validated against current gold standard measures in one Parkinson's cohort, suggesting that the technology may be applicable to other NDDs. In contrast, accelerometers are widely utilised in NDDs and have been operationalised in well-designed clinical trials.
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Enfermedades Neurodegenerativas , Dispositivos Electrónicos Vestibles , Acelerometría , Ejercicio Físico , Sistemas de Información Geográfica , Humanos , TecnologíaRESUMEN
OBJECTIVE: Familial hypercholesterolaemia (FH) elevates low-density lipoprotein cholesterol (LDL-C) and increases cardiovascular disease (CVD) risk. This study aimed to provide evidence for the feasibility of conducting a randomised controlled trial to evaluate the efficacy of an intervention designed to improve diet and physical activity in families with FH. DESIGN: A parallel, randomised, waitlist-controlled, feasibility pilot trial. SETTING: Three outpatient lipid clinics in the UK. PARTICIPANTS: Families that comprised children (aged 10-18 years) and their parent with genetically diagnosed FH. INTERVENTION: Families were randomised to either 12-week usual care or intervention. The behavioural change intervention aimed to improve dietary, physical activity and sedentary behaviours. It was delivered to families by dietitians initially via a single face-to-face session and then by four telephone or email follow-up sessions. OUTCOME MEASURES: Feasibility was assessed via measures related to recruitment, retention and intervention fidelity. Postintervention qualitative interviews were conducted to explore intervention acceptability. Behavioural (dietary intake, physical activity and sedentary time) and clinical (blood pressure, body composition and blood lipids) outcomes were collected at baseline and endpoint assessments to evaluate the intervention's potential benefit. RESULTS: Twenty-one families (38% of those approached) were recruited which comprised 22 children and 17 adults with FH, and 97% of families completed the study. The intervention was implemented with high fidelity and the qualitative data revealed it was well accepted. Between-group differences at the endpoint assessment were indicative of the intervention's potential for improving diet in children and adults. Evidence for potential benefits on physical activity and sedentary behaviours was less apparent. However, the intervention was associated with improvements in several CVD risk factors including LDL-C, with a within-group mean decrease of 8% (children) and 10% (adults). CONCLUSIONS: The study's recruitment, retention, acceptability and potential efficacy support the development of a definitive trial, subject to identified refinements. TRIAL REGISTRATION NUMBER: ISRCTN24880714.
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Enfermedades Cardiovasculares , Hiperlipoproteinemia Tipo II , Adolescente , Adulto , Enfermedades Cardiovasculares/prevención & control , Niño , Dieta , Ejercicio Físico , Estudios de Factibilidad , HumanosRESUMEN
INTRODUCTION: the COVID-19 pandemic poses a high risk to older people. The aim of this article is to provide a rapid overview of the COVID-19 literature, with a specific focus on older adults. We frame our findings within an overview of the disease and have also evaluated the inclusion of older people within forthcoming clinical trials. METHODS: we searched PubMed and bioRxiv/medRxiv to identify English language papers describing the testing, treatment and prognosis of COVID-19. PubMed and bioRxiv/medRxiv searches took place on 20 and 24 March 2020, respectively. RESULTS: screening of over 1,100 peer-reviewed and pre-print papers yielded n = 22 on COVID-19 testing, n = 15 on treatment and n = 13 on prognosis. Viral polymerase chain reaction (PCR) and serology are the mainstays of testing, but a positive diagnosis may be increasingly supported by radiological findings. The current evidence for the effectiveness of antiviral, corticosteroid and immunotherapies is inconclusive, although trial data are largely based on younger people. In addition to age, male gender and comorbidities, specific laboratory and radiology findings are important prognostic factors. Evidence suggests that social distancing policies could have important negative consequences, particularly if in place for an extended period. CONCLUSION: given the established association between increasing age and poor prognosis in COVID-19, we anticipate that this rapid review of the current and emergent evidence might form a basis on which future work can be established. Exclusion of older people, particularly those with comorbidities, from clinical trials is well recognised and is potentially being perpetuated in the field of current COVID-19 research.
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Antivirales/uso terapéutico , Betacoronavirus , Infecciones por Coronavirus/epidemiología , Manejo de la Enfermedad , Pandemias , Neumonía Viral/epidemiología , Factores de Edad , Anciano , COVID-19 , Comorbilidad , Infecciones por Coronavirus/tratamiento farmacológico , Humanos , Neumonía Viral/tratamiento farmacológico , Pronóstico , SARS-CoV-2RESUMEN
BACKGROUND: Untreated heterozygous familial hypercholesterolaemia (FH) causes high low-density lipoprotein cholesterol (LDL-C) levels and increased cardiovascular disease (CVD) risk. Despite pharmacological treatment, many treated individuals remain at higher CVD risk than non-affected individuals. This may be due to LDL-C targets not being met and presence of other CVD risk factors. Adhering to dietary and physical activity (PA) recommendations developed for individuals with FH may further reduce CVD risk. However, there is insufficient research to support the efficacy of adhering to these guidelines on LDL-C and other CVD risk factors. The need for studies to investigate the effectiveness of nutrition and PA interventions in the FH population has been widely recognised and recommended. This paper describes the protocol of a pilot, randomised controlled trial designed to evaluate the feasibility and acceptability of a specifically developed nutrition and PA intervention aimed at improving the dietary intakes and PA levels of families with FH. METHODS: A two-arm randomised waitlist-controlled pilot trial will be conducted across three National Health Service (NHS) sites in England, UK. Twenty-four young people with FH, aged 10-18 years, and their affected parent, will be recruited and randomly assigned to the intervention or waitlist and usual care control. The primary aim is to provide evidence for the feasibility and acceptability of delivering the intervention, explored quantitatively (rates of recruitment, retention and outcome measure completeness) and qualitatively (qualitative interviews). The secondary aim is to provide evidence for the potential efficacy of the intervention on dietary intake, PA, sedentary time, body composition, CVD risk factors and quality of life determined at baseline and endpoint assessments. The intervention will involve an hour-long consultation with a dietitian at baseline and four follow-up contacts across the 12-week intervention. It has been specifically developed for use with individuals with FH and incorporates behavioural change techniques to target identified enablers and barriers to adherence in this population. DISCUSSION: This trial will estimate the feasibility and acceptability of the nutrition and PA intervention delivered to young people and parents with FH. If appropriate, this study can be used to inform the design of an adequately powered definitive trial. TRIAL REGISTRATION: ISRCTN, ISRCTN24880714. Registered 07/06/2018, http://www.isrctn.com/ISRCTN24880714.
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OBJECTIVES: Individuals with heterozygous familial hypercholesterolaemia (FH) are at high risk of developing cardiovascular disease (CVD). This risk can be substantially reduced with lifelong pharmacological and lifestyle treatment; however, research suggests adherence is poor. We synthesised the qualitative research to identify enablers and barriers to treatment adherence. DESIGN: This study conducted a thematic synthesis of qualitative studies. DATA SOURCES: MEDLINE, Embase, PsycINFO via OVID, Cochrane library and CINAHL databases and grey literature sources were searched through September 2018. ELIGIBILITY CRITERIA: We included studies conducted in individuals with FH, and their family members, which reported primary qualitative data regarding their experiences of and beliefs about their condition and its treatment. DATA EXTRACTION AND SYNTHESIS: Quality assessment was undertaken using the Critical Appraisal Skills Programme for qualitative studies. A thematic synthesis was conducted to uncover descriptive and generate analytical themes. These findings were then used to identify enablers and barriers to treatment adherence for application in clinical practice. RESULTS: 24 papers reporting the findings of 15 population samples (264 individuals with FH and 13 of their family members) across 8 countries were included. Data captured within 20 descriptive themes were considered in relation to treatment adherence and 6 analytical themes were generated: risk assessment; perceived personal control of health; disease identity; family influence; informed decision-making; and incorporating treatment into daily life. These findings were used to identify seven enablers (eg, 'commencement of treatment from a young age') and six barriers (eg, 'incorrect and/or inadequate knowledge of treatment advice') to treatment adherence. There were insufficient data to explore if the findings differed between adults and children. CONCLUSIONS: The findings reveal several enablers and barriers to treatment adherence in individuals with FH. These could be used in clinical practice to facilitate optimal adherence to lifelong treatment thereby minimising the risk of CVD in this vulnerable population. PROSPERO REGISTRATION NUMBER: CRD42018085946.