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1.
BMC Health Serv Res ; 24(1): 146, 2024 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-38287389

RESUMO

BACKGROUND: A lifelong gluten-free diet is the only treatment for coeliac disease. The cost and availability of gluten-free substitute food (GFSF) remain challenging. Some local areas in England have stopped gluten-free prescriptions for coeliac disease. The aim of this paper is to present the quantitative findings of the financial impact of prescription withdrawal on people with coeliac disease. METHODS: A cross-sectional survey with adults in England who reported having been diagnosed with coeliac disease by a health professional. The postal survey was distributed by Coeliac UK to their members in 13 prescribing and 13 non-prescribing local areas that were matched for geographical location and level of deprivation. Additionally, an advertisement for the survey was placed on social media. The questionnaire contained items on the availability and use of prescriptions; the weekly amount spent on GFSF; amount of specific GFSF bought; affordability of GFSF; demographics and health-related variables. Data were analysed by descriptive statistics, analysis of variance and regression analysis. RESULTS: Of the 1697 participants, 809 resided in areas that provided prescriptions and 888 in non-prescribing areas. Participants self-report of their prescription did not always match the local area prescription policy. There was no statistically significant difference between prescribing and non-prescribing areas in how easy or difficult participants found it to obtain GFSF (p = 0.644) and its availability in various locations. Participants in non-prescribing areas purchased most types of GFSF items in statistically significantly higher quantities and thereby spent an additional £11.32/month on GFSF items than participants in prescribing areas (p < 0.001). While taking into account the self-reported prescription status, the amount increased to £14.09/month (p < 0.001). Although affordability to buy GFSF did not differ based on local area prescription policy or self-reported prescription status, it was dependent on equivalised annual income. However, affordability did not influence spending on GFSF. Regression analysis indicated that males and households with additional members with coeliac disease spent more on GFSF. CONCLUSIONS: The study has highlighted that gluten-free prescription withdrawal can have financial implications for people with coeliac disease. Any future changes to the prescription policy of GFSF should consider the impact on the population, especially lower income households.


Assuntos
Doença Celíaca , Adulto , Masculino , Humanos , Doença Celíaca/diagnóstico , Estudos Transversais , Glutens , Inglaterra , Prescrições
2.
J Hum Nutr Diet ; 37(1): 47-56, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37723662

RESUMO

BACKGROUND: Changes to prescribing policies in England have restricted or stopped access to gluten-free food on prescription for people with coeliac disease in some geographical areas. The present study aimed to explore the impact of these changes on the affordability and obtainability of gluten-free foods for adults with coeliac disease. METHODS: Semi-structured qualitative interviews (n = 24) were conducted with people with coeliac disease living in areas where prescriptions for gluten-free foods were no longer available, were restricted or followed national guidelines. Interviews explored the impact of gluten-free prescribing changes on the affordability and obtainability of gluten-free food, as well as dietary adherence. RESULTS: All participants considered gluten-free substitute foods to be expensive. Participants felt the availability of gluten-free foods has improved over time, also acknowledging some challenges remain, such as limited local availability. For most, the withdrawal of prescriptions had minimal impact requiring small adjustments such as reducing the quantity of foods obtained. However, greater challenges were faced by those less mobile, permanently sick or disabled and/or on lower incomes. CONCLUSIONS: The majority of participants affected by the withdrawal of prescriptions were able to adapt to cope with these changes. However, participants with mobility issues, who are permanently sick or disabled and/or on lower incomes were struggling to afford and obtain gluten-free substitute foods from elsewhere. The withdrawal of prescriptions may further widen health inequalities. Further research should focus on the long-term impacts of prescription withdrawal for the vulnerable groups identified.


Assuntos
Doença Celíaca , Alimentos Especializados , Adulto , Humanos , Dieta Livre de Glúten , Inglaterra , Prescrições , Custos e Análise de Custo , Glutens
3.
Proc Natl Acad Sci U S A ; 118(38)2021 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-34526400

RESUMO

How does the public want a COVID-19 vaccine to be allocated? We conducted a conjoint experiment asking 15,536 adults in 13 countries to evaluate 248,576 profiles of potential vaccine recipients who varied randomly on five attributes. Our sample includes diverse countries from all continents. The results suggest that in addition to giving priority to health workers and to those at high risk, the public favors giving priority to a broad range of key workers and to those with lower income. These preferences are similar across respondents of different education levels, incomes, and political ideologies, as well as across most surveyed countries. The public favored COVID-19 vaccines being allocated solely via government programs but were highly polarized in some developed countries on whether taking a vaccine should be mandatory. There is a consensus among the public on many aspects of COVID-19 vaccination, which needs to be taken into account when developing and communicating rollout strategies.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Saúde Pública , Opinião Pública , Vacinação/psicologia , Adulto , Pessoal de Saúde , Humanos , SARS-CoV-2 , Inquéritos e Questionários
4.
PLoS Med ; 20(4): e1004146, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-37040329

RESUMO

BACKGROUND: Most research on the Coronavirus Disease 2019 (COVID-19) health burden has focused on confirmed cases and deaths, rather than consequences for the general population's health-related quality of life (HRQoL). It is also important to consider HRQoL to better understand the potential multifaceted implications of the COVID-19 pandemic in various international contexts. This study aimed to assess the association between the COVID-19 pandemic and changes in HRQoL in 13 diverse countries. METHODS AND FINDINGS: Adults (18+ years) were surveyed online (24 November to 17 December 2020) in 13 countries spanning 6 continents. Our cross-sectional study used descriptive and regression-based analyses (age adjusted and stratified by gender) to assess the association between the pandemic and changes in the general population's HRQoL, measured by the EQ-5D-5L instrument and its domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and how overall health deterioration was associated with individual-level (socioeconomic, clinical, and experiences of COVID-19) and national-level (pandemic severity, government responsiveness, and effectiveness) factors. We also produced country-level quality-adjusted life years (QALYs) associated to COVID-19 pandemic-related morbidity. We found that overall health deteriorated, on average across countries, for more than one-third of the 15,480 participants, mostly in the anxiety/depression health domain, especially for younger people (<35 years old) and females/other gender. This translated overall into a 0.066 mean "loss" (95% CI: -0.075, -0.057; p-value < 0.001) in the EQ-5D-5L index, representing a reduction of 8% in overall HRQoL. QALYs lost associated with morbidity were 5 to 11 times greater than QALYs lost based on COVID-19 premature mortality. A limitation of the study is that participants were asked to complete the prepandemic health questionnaire retrospectively, meaning responses may be subject to recall bias. CONCLUSIONS: In this study, we observed that the COVID-19 pandemic was associated with a reduction in perceived HRQoL globally, especially with respect to the anxiety/depression health domain and among younger people. The COVID-19 health burden would therefore be substantially underestimated if based only on mortality. HRQoL measures are important to fully capture morbidity from the pandemic in the general population.


Assuntos
COVID-19 , Qualidade de Vida , Adulto , Feminino , Humanos , Estudos Transversais , Nível de Saúde , Pandemias , Países em Desenvolvimento , Estudos Retrospectivos
5.
Stroke ; 52(2): 664-673, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33423511

RESUMO

BACKGROUND AND PURPOSE: Mechanical thrombectomy (MT) has been recommended for the treatment of nonminor ischemic stroke by national and international guidelines, but cost-effectiveness evidence has been generated for only a few countries using heterogeneous evaluation methods. We estimate the cost-effectiveness of MT across 32 European countries. METHODS: A Markov model was developed to estimate the cost-effectiveness of MT compared with standard care over a 5-year time horizon. Patients with ischemic stroke eligible for MT were identified from 2017 country-specific incidence data. A societal perspective was adopted, including health, social, and informal care costs, and productivity losses. Model outcomes were expressed as quality-adjusted life years. Sensitivity analyses were conducted to test the robustness of findings. RESULTS: We identified 267 514 ischemic stroke cases that were eligible for MT treatment across 32 European countries. MT was found to be more effective and cheaper than standard care in two-thirds of the countries (21/32) and cost-effective in all but one country (Bulgaria). Across Europe, the intervention was estimated to produce over 101 327 additional quality-adjusted life years (95% uncertainty interval, 65 180-149 085) and cost savings of $981 million (€868 million, 95% uncertainty interval, -1544 to 2564) and of $1.7 billion (€1.5 billion, 95% uncertainty interval, -1.2 to 3.6) in health and social care and societal costs, respectively. CONCLUSIONS: MT is highly likely to be cost-effective compared with standard care across Europe as a whole and in the vast majority of European countries.


Assuntos
AVC Isquêmico/economia , Trombectomia/economia , Redução de Custos , Análise Custo-Benefício , Bases de Dados Factuais , Eficiência , Europa (Continente)/epidemiologia , Custos de Cuidados de Saúde , Humanos , Incidência , AVC Isquêmico/mortalidade , AVC Isquêmico/terapia , Cadeias de Markov , Anos de Vida Ajustados por Qualidade de Vida , Sensibilidade e Especificidade , Análise de Sobrevida
6.
Int J Eat Disord ; 54(7): 1224-1237, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33998020

RESUMO

OBJECTIVE: Increasing the availability and accessibility of evidence-based treatments for eating disorders is an important goal. This study investigated the effectiveness and cost-effectiveness of guided self-help via face-to-face meetings (fGSH) and a more scalable method, providing support via email (eGSH). METHOD: A pragmatic, randomized controlled trial was conducted at three sites. Adults with binge-eating disorders were randomized to fGSH, eGSH, or a waiting list condition, each lasting 12 weeks. The primary outcome variable for clinical effectiveness was overall severity of eating psychopathology and, for cost-effectiveness, binge-free days, with explorative analyses using symptom abstinence. Costs were estimated from both a partial societal and healthcare provider perspective. RESULTS: Sixty participants were included in each condition. Both forms of GSH were superior to the control condition in reducing eating psychopathology (IRR = -1.32 [95% CI -1.77, -0.87], p < .0001; IRR = -1.62 [95% CI -2.25, -1.00], p < .0001) and binge eating. Attrition was higher in eGSH. Probabilities that fGSH and eGSH were cost-effective compared with WL were 93% (99%) and 51% (79%), respectively, for a willingness to pay of £100 (£150) per additional binge-free day. DISCUSSION: Both forms of GSH were associated with clinical improvement and were likely to be cost-effective compared with a waiting list condition. Provision of support via email is likely to be more convenient for many patients although the risk of non-completion is greater.


Assuntos
Transtorno da Compulsão Alimentar , Terapia Cognitivo-Comportamental , Adulto , Análise Custo-Benefício , Comportamentos Relacionados com a Saúde , Humanos , Resultado do Tratamento
7.
Behav Cogn Psychother ; : 1-13, 2021 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-33645498

RESUMO

BACKGROUND: Cognitive therapy, based on the Clark and Wells (1995) model, is a first-line treatment for adults with social anxiety disorder (SAD), and findings from research settings suggest it has promise for use with adolescents (Cognitive Therapy for Social Anxiety Disorder in Adolescents; CT-SAD-A). However, for the treatment to be suitable for delivery in routine clinical care, two questions need to be addressed. AIMS: Can therapists be trained to achieve good outcomes in routine Child and Adolescent Mental Health Services (CAMHS), and what are the costs associated with training and treatment? METHOD: CAMHS therapists working in two NHS trusts received training in CT-SAD-A. They delivered the treatment to adolescents with SAD during a period of supervised practice. We examined the clinical outcomes for the 12 patients treated during this period, and estimated costs associated with treatment and training. RESULTS: Treatment produced significant improvements in social anxiety symptoms, general anxiety and depression symptoms, and reductions in putative process measures. Seventy-five per cent (9 out of 12) patients showed a reliable and clinically significant improvement in social anxiety symptoms, and 64% (7/11) lost their primary diagnosis of SAD. The total cost to the NHS of the CT-SAD-A treatment was £4047 (SD = £1003) per adolescent treated, of which £1861 (SD = £358) referred to the specific estimated cost of face-to-face delivery; the remaining cost was for training and supervising therapists who were not previously familiar with the treatment. CONCLUSIONS: This study provides preliminary evidence that clinicians can deliver good patient outcomes for adolescents with SAD in routine CAMHS during a period of supervised practice after receiving a 2-day training workshop. Furthermore, the cost of delivering CT-SAD-A with adolescents appeared to be no more than the cost of delivering CT-SAD with adults.

8.
J Child Psychol Psychiatry ; 61(1): 62-76, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31364169

RESUMO

BACKGROUND: This study evaluated whether clinical and economic outcomes from CBT for child anxiety disorders in the context of maternal anxiety disorders are improved by adding treatment focused on (a) maternal anxiety disorders or (b) mother-child interactions. METHODS: Two hundred and eleven children (7-12 years, 85% White British, 52% female) with a primary anxiety disorder, whose mothers also had a current anxiety disorder, were randomised to receive (a) child-focused CBT with nonspecific control interventions (CCBT+Con), (b) CCBT with CBT for the maternal anxiety disorder (CCBT+MCBT), or (c) CCBT with an intervention targeting the mother-child interaction (CCBT+MCI). A cost-utility analysis from a societal perspective was conducted using mother/child combined quality-adjusted life years (QALYs). [Trial registration: https://doi.org/10.1186/isrctn19762288]. RESULTS: MCBT was associated with immediate reductions in maternal anxiety compared to the nonspecific control; however, after children had also received CCBT, maternal outcomes in the CCBT+MCI and CCBT+Con arms improved and CCBT+MCBT was no longer superior. Neither CCBT+MCBT nor CCBT+MCI conferred a benefit over CCBT+Con in terms of child anxiety disorder diagnoses post-treatment [primary outcome] (adj RR: 1.22 (95% CI: 0.88, 1.67), p = .23; adj RR: 1.21 (95% CI: 0.88, 1.65), p = .24, respectively) or global improvement ratings (adj RR: 1.25 (95% CI: 0.99, 1.57), p = .06; adj RR: 1.18 (95% CI: 0.93, 1.50), p = .17) or six and 12 months later. No significant differences between the groups were found on the main economic outcome measures (child/mother combined QALY mean difference: CCBT+MCBT vs. CCBT+Con: -0.04 (95% CI: -0.12, 0.04), p = .29; CCBT+MCI vs. CCBT+Con: 0.02 (95% CI: -0.05, -0.09), p = .54). CCBT+MCI was associated with nonsignificantly higher costs than CCBT (mean difference: £154 (95% CI: -£1,239, £1,547), p = .83) but, when taking into account sampling uncertainty, it may be cost-effective compared with CCBT alone. CONCLUSIONS: Good outcomes were achieved for children and their mothers across treatment arms. There was no evidence of significant clinical benefit from supplementing CCBT with either CBT for the maternal anxiety disorder or treatment focussed on mother-child interactions, but the addition of MCI (and not MCBT) may be cost-effective.


Assuntos
Transtornos de Ansiedade/terapia , Filho de Pais com Deficiência , Terapia Cognitivo-Comportamental , Análise Custo-Benefício , Relações Mãe-Filho , Mães , Avaliação de Resultados em Cuidados de Saúde , Adulto , Criança , Feminino , Humanos , Masculino
10.
BMC Gastroenterol ; 19(1): 68, 2019 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-31046685

RESUMO

BACKGROUND: Before diagnosis, people with coeliac disease suffer reduced quality of life, which improves substantially after the disease has been diagnosed. Delayed diagnosis is common. The aim of this study was to assess changes over time in prevalence of coeliac disease symptoms/associated medical conditions, time to diagnosis, quality of life and its determinants before and after diagnosis in the United Kingdom. METHODS: A postal questionnaire was designed in 2015 and sent to 4000 individuals with diagnosed coeliac disease, requesting information on respondents' socio-demographic and clinical characteristics, and their quality of life pre- and post-diagnosis using the EQ-5D instrument. Data were analysed and compared with results from a survey conducted in 2006 using descriptive analyses, univariate and multivariable regression methods. RESULTS: The survey response rate was 40%. Sixty-five percent of respondents reported at least 4 symptoms pre-diagnosis, a significant reduction by 13 percentage points (95% CI: -16.9, - 9.4; p-value: < 0.001) compared to 2006. Pre-diagnosis mean duration of symptoms was 12.8 years (SD: 15.3), a non-significant reduction of 0.6 years (95% CI: -2, 0.8; p-value: 0.426) compared to 2006. There was a significant improvement of 0.20 (95% CI: 0.18, 0.22; p-value: < 0.001) in quality of life from pre- (0.65) to post-diagnosis (0.85). Pre-diagnosis values were significantly higher by 0.09 (95% CI: 0.06, 0.12; p-value: < 0.001) than in 2006. Number of symptoms and low income were associated with decreased quality of life. CONCLUSIONS: Undiagnosed coeliac disease is associated with a substantial decrement in quality of life. Time to diagnosis has not significantly shortened over the decade 2006-2015, but symptoms are less severe when diagnosis occurs. Harmonising clinical guidelines for intensified active case finding will help improve quality of life of people with coeliac disease.


Assuntos
Doença Celíaca/diagnóstico , Qualidade de Vida , Adolescente , Adulto , Idoso , Doença Celíaca/dietoterapia , Doença Celíaca/epidemiologia , Comorbidade , Diagnóstico Tardio , Dieta Livre de Glúten , Status Econômico , Feminino , Inquéritos Epidemiológicos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Pobreza , Prevalência , Reino Unido/epidemiologia , Adulto Jovem
11.
Eur J Public Health ; 28(1): 134-138, 2018 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-29016791

RESUMO

Background: Infectious intestinal diseases (IID) are common, affecting around 25% of people in UK each year at an estimated annual cost to the economy, individuals and the NHS of £1.5 billion. While there is evidence of higher IID hospital admissions in more disadvantaged groups, the association between socioeconomic status (SES) and risk of IID remains unclear. This study aims to investigate the relationship between SES and IID in a large community cohort. Methods: Longitudinal analysis of a prospective community cohort in the UK following 6836 participants of all ages was undertaken. Hazard ratios for IID by SES were estimated using Cox proportional hazard, adjusting for follow-up time and potential confounding factors. Results: In the fully adjusted analysis, hazard ratio of IID was significantly lower among routine/manual occupations compared with managerial/professional occupations (HR 0.74, 95% CI 0.61-0.90). Conclusion: In this large community cohort, lower SES was associated with lower IID risk. This may be partially explained by the low response rate which varied by SES. However, it may be related to differences in exposure or recognition of IID symptoms by SES. Higher hospital admissions associated with lower SES observed in some studies could relate to more severe consequences, rather than increased infection risk.


Assuntos
Doenças Transmissíveis/epidemiologia , Inquéritos Epidemiológicos/estatística & dados numéricos , Enteropatias/epidemiologia , Classe Social , Adolescente , Adulto , Idoso , Estudos de Coortes , Feminino , Humanos , Incidência , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Prospectivos , Reino Unido/epidemiologia , Adulto Jovem
12.
BMC Infect Dis ; 17(1): 447, 2017 06 23.
Artigo em Inglês | MEDLINE | ID: mdl-28645256

RESUMO

BACKGROUND: The burden of infectious intestinal disease (IID) in the UK is substantial. Negative consequences including sickness absence are common, but little is known about the social patterning of these outcomes, or the extent to which they relate to disease severity. METHODS: We performed a cross-sectional analysis using IID cases identified from a large population-based survey, to explore the association between socioeconomic status (SES) and symptom severity and sickness absence; and to assess the role of symptom severity on the relationship between SES and absence. Regression modelling was used to investigate these associations, whilst controlling for potential confounders such as age, sex and ethnicity. RESULTS: Among 1164 cases, those of lower SES versus high had twice the odds of experiencing severe symptoms (OR 2.2, 95%CI;1.66-2.87). Lower SES was associated with higher odds of sickness absence (OR 1.8, 95%CI;1.26-2.69), however this association was attenuated after adjusting for symptom severity (OR 1.4, 95%CI;0.92-2.07). CONCLUSIONS: In a large sample of IID cases, those of low SES versus high were more likely to report severe symptoms, and sickness absence; with greater severity largely explaining the higher absence. Public health interventions are needed to address the unequal consequences of IID identified.


Assuntos
Enteropatias/microbiologia , Licença Médica/estatística & dados numéricos , Classe Social , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Estudos de Coortes , Estudos Transversais , Feminino , Humanos , Renda , Enteropatias/epidemiologia , Enteropatias/etiologia , Masculino , Pessoa de Meia-Idade , Autorrelato , Inquéritos e Questionários , Reino Unido/epidemiologia , Adulto Jovem
13.
Pharmacoeconomics ; 42(6): 649-661, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38568340

RESUMO

BACKGROUND: Assessing the cost-effectiveness of interventions targeting childhood excess weight requires estimates of the hazards of transitioning between weight status categories. Current estimates are based on studies characterized by insufficient sample sizes, a lack of national representativeness, and untested assumptions. OBJECTIVES: We sought to (1) estimate transition probabilities and hazard ratios for transitioning between childhood weight status categories, (2) test the validity of the underlying assumption in the literature that transitions between childhood bodyweight categories are time-homogeneous, (3) account for complex sampling procedures when deriving nationally representative transition estimates, and (4) explore the impact of child, maternal, and sociodemographic characteristics. METHODS: We applied a multistate transition modeling approach accounting for complex survey design to UK Millennium Cohort Study (MCS) data to predict transition probabilities and hazard ratios for weight status movements for children aged 3-17. Surveys were conducted at ages 3 (wave 2 in 2004), 5 (wave 3 in 2006), 7 (wave 4 in 2008), 11 (wave 5 in 2012), 14 (wave 6 in 2015), and 17 (wave 7 in 2018) years. We derived datasets that included repeated body mass index measurements across waves after excluding multiple births and children with missing or implausible bodyweight records. To account for the stratified cluster sample design of the MCS, we incorporated survey weights and jackknife replicates of survey weights. Using a validation dataset from the MCS, we tested the validity of our models. Finally, we estimated the relationships between state transitions and child, maternal, and sociodemographic factors. RESULTS: The datasets for our primary analysis consisted of 10,399 children for waves 2-3, 10,729 for waves 3-4, 9685 for waves 4-5, 8593 for waves 5-6, and 7085 for waves 6-7. All datasets consisted of roughly equal splits of boys and girls. Under the assumption of time-heterogeneous transition rates (our base-case model), younger children (ages 3-5 and 5-7 years) had significantly higher annual transition probabilities of moving from healthy weight to overweight (0.033, 95% confidence interval [CI] 0.026-0.041, and 0.027, 95% CI 0.021-0.033, respectively) compared to older children (0.015, 95% CI 0.012-0.018, at ages 7-11; 0.018, 95% CI 0.013-0.023, at ages 11-14; and 0.018, 95% CI 0.013-0.025 at ages 14-17 years). However, the resolution of unhealthy weight was more strongly age-dependent than transitions from healthy weight to non-healthy weight states. Transition hazards differed by child, maternal, and sociodemographic factors. CONCLUSIONS: Our models generated estimates of bodyweight status transitions in a representative UK childhood population. Compared to our scenario models (i.e., time-homogeneous transition rates), our base-case model fits the observed data best, indicating a non-time-homogeneous pattern in transitions between bodyweight categories during childhood. Transition hazards varied significantly by age and across subpopulations, suggesting that conducting subgroup-specific cost-effectiveness analyses of childhood weight management interventions will optimize decision-making.


Assuntos
Índice de Massa Corporal , Peso Corporal , Obesidade Infantil , Humanos , Criança , Reino Unido , Feminino , Masculino , Adolescente , Estudos de Coortes , Pré-Escolar , Análise Custo-Benefício
14.
Trials ; 25(1): 62, 2024 Jan 17.
Artigo em Inglês | MEDLINE | ID: mdl-38233861

RESUMO

BACKGROUND: The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether 'screening and intervention', consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only - 'usual school practice', for children aged 8-9 years in the following: (1) the 'target population', who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire - iCATS-2, and (2) the 'total population', comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial. METHODS AND DESIGN: iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses. TRIAL REGISTRATION: ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022.


Assuntos
Ansiedade , Instituições Acadêmicas , Criança , Humanos , Retroalimentação , Ansiedade/terapia , Ansiedade/prevenção & controle , Transtornos de Ansiedade , Pais
15.
Lancet Psychiatry ; 11(3): 193-209, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38335987

RESUMO

BACKGROUND: Anxiety problems are common in children, yet few affected children access evidence-based treatment. Digitally augmented psychological therapies bring potential to increase availability of effective help for children with mental health problems. This study aimed to establish whether therapist-supported, digitally augmented, parent-led cognitive behavioural therapy (CBT) could increase the efficiency of treatment without compromising clinical effectiveness and acceptability. METHODS: We conducted a pragmatic, unblinded, two-arm, multisite, randomised controlled non-inferiority trial to evaluate the clinical effectiveness and cost-effectiveness of therapist-supported, parent-led CBT using the Online Support and Intervention (OSI) for child anxiety platform compared with treatment as usual for child (aged 5-12 years) anxiety problems in 34 Child and Adolescent Mental Health Services in England and Northern Ireland. We examined acceptability of OSI plus therapist support via qualitative interviews. Participants were randomly assigned (1:1) to OSI plus therapist support or treatment as usual, minimised by child age, gender, service type, and baseline child anxiety interference. Outcomes were assessed at week 14 and week 26 after randomisation. The primary clinical outcome was parent-reported interference caused by child anxiety at week 26 assessment, using the Child Anxiety Impact Scale-parent report (CAIS-P). The primary measure of health economic effect was quality-adjusted life-years (QALYs). Outcome analyses were conducted blind in the intention-to-treat (ITT) population with a standardised non-inferiority margin of 0·33 for clinical analyses. The trial was registered with ISRCTN, 12890382. FINDINGS: Between Dec 5, 2020, and Aug 3, 2022, 706 families (706 children and their parents or carers) were referred to the study information. 444 families were enrolled. Parents reported 255 (58%) child participants' gender to be female, 184 (41%) male, three (<1%) other, and one (<1%) preferred not to report their child's gender. 400 (90%) children were White and the mean age was 9·20 years (SD 1·79). 85% of families for whom clinicians provided information in the treatment as usual group received CBT. OSI plus therapist support was non-inferior for parent-reported anxiety interference on the CAIS-P (SMD 0·01, 95% CI -0·15 to 0·17; p<0·0001) and all secondary outcomes. The mean difference in QALYs across trial arms approximated to zero, and OSI plus therapist support was associated with lower costs than treatment as usual. OSI plus therapist support was likely to be cost effective under certain scenarios, but uncertainty was high. OSI plus therapist support acceptability was good. No serious adverse events were reported. INTERPRETATION: Digitally augmented intervention brought promising savings without compromising outcomes and as such presents a valuable tool for increasing access to psychological therapies and meeting the demand for treatment of child anxiety problems. FUNDING: Department for Health and Social Care and United Kingdom Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, Oxford Health NIHR Biomedical Research Centre.


Assuntos
Terapia Cognitivo-Comportamental , Serviços de Saúde Mental , Criança , Feminino , Humanos , Masculino , Ansiedade , Análise Custo-Benefício , Inglaterra , Irlanda do Norte , Resultado do Tratamento
16.
SSM Popul Health ; 24: 101534, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37954013

RESUMO

Background: Children from low income families are likely to have poorer mental health than their more affluent peers. However, it is unclear how this association varies at different developmental stages and what the potential underpinning mechanisms are. This study investigates the relationship between family income and mental health problems from early childhood to adolescence in the UK, and examines the potential mediating role of family-related factors over time. Methods: Data were drawn from the UK Millennium Cohort Study at ages 3, 5, 7, 11, 14 and 17 years. Child mental health was measured by the Strengths and Difficulties Questionnaire Total Difficulties Score, and the Internalising and Externalising subscales. Family income was operationalised as permanent income. Cross-sectional analyses were conducted at each age to examine the association between income and mental health problems, and to examine potential mechanisms based on the Parental Stress and Parental Investment theories. Results: The samples included 8096 children aged up to 14 years, of which 5667 remained in the study at age 17. Results indicated a statistically significant association between lower family income and poorer mental health in all age groups after adjusting for confounding factors. The strength of the association was reduced after adjustment for Parental Stress and Parental Investment factors, with the larger attenuation driven by Parental Stress factors in most cases. Fully adjusted models suggested an increased independent association between maternal psychological distress and children's mental health as children grew older. Conclusions: While lower family income is associated with a child's poorer mental health, much of this association is explained by other factors such as maternal psychological distress, and therefore the direct association is relatively small. This suggests that policies targeting income redistribution may reduce child mental health problems, and also benefit the wider family, reducing the prevalence of other associated risk factors.

17.
Health Policy ; 137: 104895, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37666080

RESUMO

Vaccine hesitancy has the potential to cripple efforts to end the COVID-19 pandemic. Policy makers need to be informed about the scale, nature and drivers of this problem, both domestically and globally, so that effective interventions can be designed. To this end, we conducted a statistical analysis of data from the CANDOUR survey (n = 15,536), which was carried out in 13 countries representing approximately half of the global population. Both pooled and country-level ordered regression models were estimated to identify predictors of vaccine hesitancy and reasons for not getting vaccinated. We found high levels of hesitancy, particularly in high-income countries. Factors driving moderate hesitancy differed from those driving extreme hesitancy. A lack of trust in health care providers was consistently the underlying driver of more extreme hesitancy. Predictors of moderate hesitancy varied across countries, though being younger and female was typically associated with greater hesitancy. While political ideology played a role in vaccine hesitancy in some countries, this effect was often moderated by income level, particularly in the US. Overall, the results suggest that different interventions such as mass-media campaigns and monetary incentives may be needed to target the moderately versus extremely hesitant. The lack of trust in health care professionals that drives extreme hesitancy may reflect deep societal mistrust in science and institutions and be challenging to overcome.

18.
Pilot Feasibility Stud ; 9(1): 122, 2023 Jul 13.
Artigo em Inglês | MEDLINE | ID: mdl-37443045

RESUMO

BACKGROUND: Depression is common and the prevalence increasing worldwide; at least 1 in 10 people will experience depression in their lifetime. It is associated with economic costs at the individual, healthcare and societal level. Recommended treatments include medication and psychological therapies. However, given the long waiting times, and sometimes poor concordance and engagement with these treatments, a greater range of approaches are needed. Evidence for the potential of outdoor swimming as an intervention to support recovery from depression is emerging, but randomised controlled trials (RCTs) evaluating clinical and cost-effectiveness are lacking. This study seeks to investigate the feasibility of conducting a definitive superiority RCT, comparing an 8-session outdoor swimming course offered in addition to usual care compared to usual care only, in adults who are experiencing mild to moderate symptoms of depression. Feasibility questions will examine recruitment and retention rates, acceptability of randomisation and measures, and identify the primary outcome measure that will inform the sample size calculation for a definitive full-scale RCT. This study will also explore potential facilitators and barriers of participation through evaluation questionnaires, focus-group discussions and interviews. METHODS/DESIGN: To address these aims and objectives, a feasibility superiority RCT with 1:1 allocation will be undertaken. We will recruit 88 participants with mild to moderate symptoms of depression through social prescribing organisations and social media in three sites in England. Participants will be randomised to either (1) intervention (8-session outdoor swimming course) plus usual care or (2) usual care only. Both groups will be followed up for a further 8 weeks. DISCUSSION: If findings from this feasibility RCT are favourable, a fully powered RCT will be conducted to investigate the clinical- and cost-effectiveness of the intervention. Findings from the definitive trial will provide evidence about outdoor swimming for depression for policymakers and has the potential to lead to greater choice of interventions for adults experiencing symptoms of depression. TRIAL REGISTRATION: Current controlled trial registration number is ISRCTN 90851983 registered on 19 May 2022.

19.
Nat Med ; 29(12): 3193-3202, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38012315

RESUMO

We implemented a clustered randomized controlled trial with 6,963 residents in six rural Ghana districts to estimate the causal impact of financial incentives on coronavirus disease 2019 (COVID-19) vaccination uptake. Villages randomly received one of four video treatment arms: a placebo, a standard health message, a high cash incentive (60 Ghana cedis) and a low cash incentive (20 Ghana cedis). For the first co-primary outcome-COVID-19 vaccination intentions-non-vaccinated participants assigned to the cash incentive treatments had an average rate of 81% (1,733 of 2,168) compared to 71% (1,895 of 2,669) for those in the placebo treatment arm. For the other co-primary outcome of self-reported vaccinations 2 months after the initial intervention, the average rate for participants in the cash treatment was 3.5% higher than for participants in the placebo treatment (95% confidence interval (CI): 0.001, 6.9; P = 0.045): 40% (602 of 1,486) versus 36.3% (672 of 1,850). We also verified vaccination status of participants: in the cash treatment arm, 36.6% (355 of 1,058) of verified participants had at least one dose of the COVID-19 vaccine compared to 30.3% (439 of 1,544) for those in the placebo-a difference of 6.3% (95% CI: 2.4, 10.2; P = 0.001). For the intention and the vaccination outcomes, the low cash incentive (20 Ghana cedis) had a larger positive effect on COVID-19 vaccine uptake than the high cash incentive (60 Ghana cedis). Trial identifier: AEARCTR-0008775 .


Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , Vacinas contra COVID-19/uso terapêutico , Motivação , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinação
20.
JCPP Adv ; 3(3): e12149, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37720587

RESUMO

Background: Over a quarter of people have an anxiety disorder at some point in their life, with many first experiencing difficulties during childhood or adolescence. Despite this, gaps still exist in the current evidence base of the multiple consequences of childhood anxiety problems and their costs. Methods: A systematic review of Medline, PsycINFO, EconLit and the National Health Service Economic Evaluation Database was conducted for longitudinal and economic studies reporting on the association between childhood anxiety problems and at least one individual-, family- or societal-level outcome or cost. All studies were synthesised narratively. For longitudinal studies, 'effect direction' was used as a common metric, with random effects meta-analysis undertaken where possible. Results: Eighty-three studies met inclusion criteria and were synthesised narratively. We identified 788 separate analyses from the longitudinal studies, which we grouped into 15 overarching outcome domains. Thirteen of the studies were incorporated into 13 meta-analyses, which indicated that childhood anxiety disorders were associated with future anxiety, mood, behaviour and substance disorders. Narrative synthesis also suggested associations between anxiety problems and worse physical health, behaviour, self-harm, eating, relationship, educational, health care, employment, and financial outcomes. 'Effect direction' was conflicting in some domains due to a sparse evidence base. Higher economic costs were identified for the child, their families, healthcare providers and wider society, although evidence was limited and only covered short follow-up periods, up to a maximum of 2 years. Total annual societal costs per anxious child were up to £4040 (2021 GBP). Conclusions: Childhood anxiety problems are associated with impaired outcomes in numerous domains, and considerable economic costs, which highlight the need for cost-effective interventions and policies to tackle them. More economic evidence is needed to inform models of the long-term, economic-related, consequences of childhood anxiety problems.

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