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INTRODUCTION: Although behavioural interventions have been found to help control type 2 diabetes (T2D), it is important to understand how the delivery context can influence implementation and outcomes. The NHS committed to testing a low-calorie diet (LCD) programme designed to support people living with excess weight and T2D to lose weight and improve diabetes outcomes. Understanding what influenced implementation during the programme pilot is important in optimising rollout. This study explored the transferability of the NHS LCD Programme prior to wider adoption. METHODS: Twenty-five interviews were undertaken with stakeholders involved in implementing the LCD programme in pilot sites (health service leads, referring health professionals and programme deliverers). Interviews with programme participants (people living with T2D) were undertaken within a larger programme of work, exploring what worked, for whom and why, which is reported separately. The conceptual Population-Intervention-Environment-Transfer Model of Transferability (PIET-T) guided study design and data collection. Constructs of the model were also used as a deductive coding frame during data analysis. Key themes were identified which informed recommendations to optimise programme transfer. RESULTS: Population: Referral strategies in some areas lacked consideration of population characteristics. Many believed that offering a choice of delivery model would promote acceptability and accessibility of the eligible population. INTERVENTION: Overall, stakeholders had confidence in the LCD programme due to the robust evidence base along with anecdotal evidence, but some felt the complex referral process hindered engagement from GP practices. ENVIRONMENT: Stakeholders described barriers to accessing the programme, including language and learning difficulties. Transferability: Multidisciplinary working and effective communication supported successful implementation. CONCLUSION: Referral strategies to reach underrepresented groups should be considered during programme transfer, along with timely data from service providers on access and programme benefits. A choice of delivery models may optimise uptake. Knowledge sharing between sites on good working practices is encouraged, including increasing engagement with key stakeholders.
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BACKGROUND: Previous research has illustrated a drift in the fidelity of behaviour change techniques (BCTs) during the design of the pilot NHS England Low-Calorie Diet (NHS-LCD) Programme. This study evaluated a subsequent domain of fidelity, intervention delivery. Two research questions were addressed: (1) To what extent were BCTs delivered with fidelity to providers programme plans? (2) What were the observed barriers and facilitators to delivery? METHODS: A mixed-methods sequential explanatory design was employed. Remote delivery of one-to-one and group-based programmes were observed. A BCT checklist was developed using the BCT Taxonomy v1; BCTs were coded as present, partially delivered, or absent during live sessions. Relational content analysis of field notes identified observed barriers and facilitators to fidelity. RESULTS: Observations of 122 sessions across eight samples and two service providers were completed. Delivery of the complete NHS-LCD was observed for five samples. Fidelity ranged from 33% to 70% across samples and was higher for group-based delivery models (64%) compared with one-to-one models (46%). Barriers and facilitators included alignment with the programme's target behaviours and outcomes, session content, time availability and management, group-based remote delivery, and deviation from the session plan. CONCLUSIONS: Overall, BCTs were delivered with low-to-moderate fidelity. Findings indicate a dilution in fidelity during the delivery of the NHS-LCD and variation in the fidelity of programmes delivered across England. Staff training could provide opportunities to practice the delivery of BCTs. Programme-level changes such as structured activities supported by participant materials and with sufficient allocated time, might improve the delivery of BCTs targeting self-regulation.
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Restrição Calórica , Medicina Estatal , Humanos , Terapia Comportamental/métodos , InglaterraRESUMO
BACKGROUND: NHS England commissioned four independent service providers to pilot low-calorie diet programmes to drive weight loss, improve glycaemia and potentially achieve remission of Type 2 Diabetes across 10 localities. Intervention fidelity might contribute to programme success. Previous research has illustrated a drift in fidelity in the design and delivery of other national diabetes programmes. AIMS: (1) To describe and compare the programme designs across the four service providers; (2) To assess the fidelity of programme designs to the NHS England service specification. METHODS: The NHS England service specification documents and each provider's programme design documents were double-coded for key intervention content using the Template for Intervention Description and Replication Framework and the Behaviour Change Technique (BCT) Taxonomy. RESULTS: The four providers demonstrated fidelity to most but not all of the service parameters stipulated in the NHS England service specification. Providers included between 74% and 87% of the 23 BCTs identified in the NHS specification. Twelve of these BCTs were included by all four providers; two BCTs were consistently absent. An additional seven to 24 BCTs were included across providers. CONCLUSIONS: A loss of fidelity for some service parameters and BCTs was identified across the provider's designs; this may have important consequences for programme delivery and thus programme outcomes. Furthermore, there was a large degree of variation between providers in the presence and dosage of additional BCTs. How these findings relate to the fidelity of programme delivery and variation in programme outcomes and experiences across providers will be examined.
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Diabetes Mellitus Tipo 2 , Humanos , Terapia Comportamental/métodos , Restrição Calórica , Inglaterra , Medicina EstatalRESUMO
BACKGROUND: Prevalence of both obesity and type 2 diabetes can be higher in patients from certain ethnic groups, yet uptake and adherence to current support within these groups is lower, leading to widening health inequalities in high-income countries. OBJECTIVES: The main objective of this study is to understand the views, perceptions, and experiences of and barriers and facilitators in relation to the uptake and adherence to weight management and type 2 diabetes programs in minoritized ethnic groups in high-income countries. METHODS: CINAHL, MEDLINE, PsycINFO, Scopus, Academic Search Complete, and PubMed were searched for English language studies undertaken in community-dwelling adults residing in high-income countries, who are from a minoritized ethnic group within the country of study. RESULTS: Seventeen studies were synthesized using the JBI System for the Unified Management of the Assessment and Review of Information. From these studies, 115 findings were retrieved, and seven key themes were identified: (1) family health status and program education, (2) social support, (3) challenges, (4) cultural beliefs, (5) increased awareness and dietary changes, (6) impact of psychological evaluations, and (7) considerations for future. CONCLUSIONS: Nutritional considerations for type 2 diabetes mellitus and weight management programs in high-income countries should include social, habitual, economic, and conceptual components, which should include consideration of local ethnic and cultural norms and building community relationships while creating culturally tailored programs.
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Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/etnologia , Diabetes Mellitus Tipo 2/psicologia , Países Desenvolvidos , Etnicidade/psicologia , Programas de Redução de Peso , Conhecimentos, Atitudes e Prática em Saúde , Obesidade/etnologia , Obesidade/psicologia , Pesquisa Qualitativa , Apoio SocialRESUMO
BACKGROUND: The management of type 2 diabetes (T2D) within diverse ethnic populations requires a culturally tailored approach. However, little is known about the experiences of coaches delivering interventions for T2D, such as the National Health Service (NHS) Low Calorie Diet (LCD) programme, to people from diverse ethnic backgrounds. OBJECTIVE: To explore the experiences of coaches delivering an NHS programme using total diet replacement approaches to individuals from diverse ethnic backgrounds, to inform the effective tailoring and equitable delivery of future interventions. DESIGN: Qualitative study. SETTING: Individuals delivering the NHS LCD programme. PARTICIPANTS: One-to-one semistructured interviews were conducted with seven health coaches delivering the NHS LCD programme. Inclusion criteria included participants delivering the NHS LCD programme either from a minoritised ethnic background or delivering the programme to those from ethnic minority and white British backgrounds. MAIN OUTCOME MEASURES: Qualitative semistructured interviews conducted through different stages of the programme. Reflexive thematic analysis was used to analyse the transcripts. RESULTS: Key themes highlighted the following experiences of delivering the LCD programme: (1) training and support needs; (2) needing to understand culture and ethnicity; (3) the impact of language; (4) the use of resources in providing dietary advice and (5) experiences of cultural tailoring. The themes highlight the need to prioritise person-centred care, to integrate culturally tailored approaches and for provision of education and training to those delivering health programmes. CONCLUSION: These findings describe the experiences of health coaches in tailoring delivery and emphasise the role of cultural competence in ensuring equitable and effective healthcare interventions for diverse populations. This learning can inform future programmes and policies aimed at promoting inclusive healthcare practices.
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Diabetes Mellitus Tipo 2 , Etnicidade , Pesquisa Qualitativa , Medicina Estatal , Humanos , Inglaterra , Diabetes Mellitus Tipo 2/dietoterapia , Diabetes Mellitus Tipo 2/etnologia , Diabetes Mellitus Tipo 2/terapia , Masculino , Feminino , Restrição Calórica , Projetos Piloto , Entrevistas como Assunto , Pessoa de Meia-Idade , Adulto , TutoriaRESUMO
Obesity and Type 2 Diabetes Mellitus (T2DM) are chronic conditions with significant personal, societal, and economic impacts. Expanding on existing trial evidence, the NHS piloted a 52-week low-calorie diet programme for T2DM, delivered by private providers using total diet replacement products and behaviour change support. This study aimed to determine the extent to which providers and coaches adhered to the service specification outlined by NHS England. An observational qualitative study was conducted to examine the delivery of both one-to-one and group-based delivery of programme sessions. Observations of 122 sessions across eight programme delivery samples and two service providers were completed. Adherence to the service specification was stronger for those outcomes that were easily measurable, such as weight and blood glucose, while less tangible elements of the specification, such as empowering service users, and person-centred delivery were less consistently observed. One-to-one sessions were more successful in their person-centred delivery, and the skills of the coaches delivering the sessions had a strong impact on adherence to the specification. Overall, the results show that there was variability by provider and delivery mode in the extent to which sessions of the NHS Low-Calorie Diet Programme reflected the intended service specification. In subsequent programmes it is recommended that one-to-one sessions are used, with accompanying peer support, and that providers improve standardised training and quality assurance to ensure specification adherence.
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Restrição Calórica , Diabetes Mellitus Tipo 2 , Medicina Estatal , Humanos , Diabetes Mellitus Tipo 2/dietoterapia , Obesidade/dietoterapia , Feminino , Masculino , Inglaterra , Pessoa de Meia-Idade , Pesquisa QualitativaRESUMO
BACKGROUND: To achieve the goal of improving the quality of life for persons with epilepsy within the framework of the WHO's Intersectoral Global Action Plan (IGAP), our study aimed to assess the societal financial burden linked to infantile epileptic spasms syndrome (IESS), ensuring that children afflicted with IESS receive high-quality healthcare without enduring substantial financial constraints. METHODS: Between August 2022 and March 2023, 92 children with IESS (male: female: 2:1), recently diagnosed or previously followed-up, were recruited. We gathered costs for drugs, tests, and medical services, along with legal guardians' monthly income. Total expenditure was determined by multiplying unit costs by the yearly service usage commencing from the onset. Time series analysis was utilised to forecast the financial burden from 2022 to 2032. RESULTS: Clinicians' first choice of treatment was ACTH (n = 60, 65·2%), prednisolone (n = 25, 27·2%), and vigabatrin (n = 7, 7·6%) and the median cost of treatment during the initial year was INR 39,010 [USD 479·2]. The median direct medical, direct non-medical, and indirect cost were INR 31,650 [USD 388·4], INR 6581 [USD 80·8], and INR 10,100 [USD 124·07], respectively. Families lost a median of 12 days of work annually. Drug costs and loss of wages were the key factors in the financial burden. The projected and adjusted figures exhibited an incremental growth rate of 2·6% tri-annually. INTERPRETATION: This pioneering study in developing countries, the first of its kind, evaluates the societal cost, financial hardship, and trajectory of incremental cost in IESS. The primary drivers of the financial burden were pharmacological treatment and family work adjustments. The government shoulders 62% of the financial burden, and projected a triannual growth of 2·6% from 2022 to 2032. Our results rationalize policymakers' focus on incorporating IESS into social security programs, particularly in developing countries.
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Epilepsia , Espasmos Infantis , Criança , Humanos , Masculino , Feminino , Qualidade de Vida , Vigabatrina/uso terapêutico , Epilepsia/tratamento farmacológico , Síndrome , Espasmo , Organização Mundial da Saúde , Espasmos Infantis/tratamento farmacológico , Espasmos Infantis/diagnóstico , Efeitos Psicossociais da DoençaRESUMO
BACKGROUND: Existing literature examines barriers to the provision of ethnically diverse dietary advice, however, is not specific to total diet replacement (TDR). There is a lack of literature from the UK, limiting the potential applicability of existing findings and themes to the UK context. This study addresses this gap in research by interviewing participants of South Asian ethnicity who have undertaken the National Health Service (NHS) low-calorie diet programme (LCD) for people with type 2 diabetes living with overweight or obesity. This study explores factors that may affect the uptake and acceptability of its TDR, food reintroduction and weight maintenance stages. This aims to provide rich data that can inform effective tailoring of future programmes with South Asian participants. OBJECTIVE: To explore the perspectives of individuals of South Asian ethnicity on an NHS programme using TDR approaches for the management of type 2 diabetes (T2D). DESIGN: Qualitative study. SETTING: Individuals in the community undertaking the NHS LCD programme. PARTICIPANTS: Twelve one-to-one interviews were conducted with individuals from a South Asian ethnicity participating in the NHS LCD. MAIN OUTCOME MEASURES: Qualitative semistructured interviews conducted through different stages of the programme. Reflexive thematic analysis was used to analyse the transcripts. RESULTS: Key themes highlighted positive and negative experiences of the programme: (1) more work is needed in the programme for person centeredness; (2) it is not the same taste; (3) needing motivation to make changes and feel better; (4) a mixed relationship with the coach; (5) social experiences; (6) culture-related experiences. CONCLUSION: This study provides important experience-based evidence of the need for culturally tailored T2D programmes. Action to address these findings and improve the tailoring of the NHS LCD may improve experience, retention and outcomes on the programme for people of South Asian ethnicity and thereby reduce inequalities.
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Diabetes Mellitus Tipo 2 , Medicina Estatal , Humanos , Restrição Calórica , Diabetes Mellitus Tipo 2/terapia , Inglaterra , ObesidadeRESUMO
OBJECTIVES: To study the course of West syndrome (WS) and coronavirus disease-19 (COVID-19) in children with WS who contracted SARS-CoV-2 infection. METHODS: This ambispective study was conducted at a tertiary-care center in North India between December 2020 and August 2021 after approval from the Institute Ethics Committee. Five children with WS, positive for COVID-19 based on RT-PCR, fulfilled the inclusion criteria. RESULTS: One child with COVID-19 during the first wave was retrospectively included while four children (of the 70 children screened) were prospectively enrolled. The median age at onset of epileptic spasms was 7 mo (2 boys), and that at presentation with COVID-19 was 18.5 mo. Three had underlying acquired structural etiology. Three were in remission following standard therapy, while two had ongoing spasms at the time of COVID-19 illness. During the illness, two of those in remission continued to be in remission while one child had a relapse. The children with ongoing epileptic spasms had variable course [one had persistent spasms and other had transient cessation lasting 3 wk from day 2 of COVID-19 illness, but electroencephalography (on day 8 of COVID-19 illness) continued to show hypsarrhythmia]. Fever was the most typical symptom (and sometimes the only symptom) of COVID-19, with a duration ranging from 1-8 d. Two children had moderate COVID-19 illness requiring hospitalization, while the rest had a mild illness. All the affected children had complete recovery from COVID-19. CONCLUSION: The severity of COVID-19 illness in children with WS is often mild, while the subsequent course of WS is variable.
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COVID-19 , Espasmos Infantis , Masculino , Humanos , Criança , Espasmos Infantis/diagnóstico , COVID-19/complicações , Estudos Retrospectivos , SARS-CoV-2 , EspasmoRESUMO
This ambispective, observational study evaluated the impact of the COVID-19 pandemic on managing children with Infantile epileptic spasms syndrome (IESS) and the feasibility of telemedicine-based management for IESS. Caregivers of children with IESS were telephonically interviewed using a structured questionnaire and various relevant indices were compared between the study population and a pre-pandemic cohort from the same center. There was a significant increase in diagnostic lag during the pandemic (p = 0.04). Adrenocorticotropic hormone was the first-line antiseizure medication of choice in both cohorts and the response to treatment was also similar. Telemedicine was utilized by around 80% of caregivers and satisfaction rates with telemedicine were high. However, caregivers continued to rate physical consultations higher in preference.
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COVID-19 , Espasmos Infantis , Telemedicina , Humanos , Criança , Lactente , COVID-19/epidemiologia , Espasmos Infantis/tratamento farmacológico , Pandemias , Anticonvulsivantes/uso terapêutico , Síndrome , Espasmo/tratamento farmacológico , Espasmo/epidemiologiaRESUMO
Till today, we are still not clear about the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on reproductive tissues and its vertical transmission through the gametes and embryos. There are few case reports that aim to detect the presence or absence of SARS-CoV-2 viral ribonucleic acid (RNA) in the follicular fluid of the infected females. We hereby present the case report of a 33-year-old woman who was undergoing intracytoplasmic sperm injection with testicular sperm aspiration and was found to be positive for SARS-CoV-2 infection. The follicular fluid analysis failed to detect the presence of viral RNA in the sample. Ours is the first case report from India trying to detect the viral RNA from the follicular fluid of a female with SARS-CoV-2 positive status.
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OBJECTIVES: Considering the dearth of literature on West syndrome (WS) from South Asian countries, this study aimed to evaluate the management practices in South Asia by an online survey and meta-analysis. METHODS: An online questionnaire was sent to 223 pediatric neurologists/pediatricians in India, Pakistan, Myanmar, Sri Lanka, Bhutan, Nepal, and Bangladesh. Their responses were evaluated and supplemented by a meta-analysis. RESULTS: Of 125 responses received (response rate: 56%), around 60% of responders observed male preponderance and an approximate lead-time-to-treatment (LTTT) of 4-12 weeks. The commonest etiology observed was a static structural insult (88.6% of responders). Most commonly used first-line drug (country-wise) was as follows: India-adrenocorticotropin hormone (ACTH, 50%); Pakistan-oral steroids (45.5%); Myanmar, Sri Lanka, and Nepal-oral steroids (94.4%); Bangladesh-ACTH (2/2); Bhutan-vigabatrin (3/5). ACTH and vigabatrin are not available in Myanmar and Nepal. The most commonly used regime for ACTH was maximal-dose-at-initiation-regime in India, Sri Lanka, and Bangladesh and gradually escalating-regime in Pakistan. Maximum dose of prednisolone was variable-most common response from India: 3-4 mg/kg/d; Pakistan, Bhutan, and Bangladesh: 2 mg/kg/d; Sri Lanka, Nepal, and Myanmar: 5-8 mg/kg/d or 60 mg/d. The total duration of hormonal therapy (including tapering) ranged from 4 to 12 weeks (67/91). Most responders considered cessation of spasms for four weeks as complete response (54/111) and advised electroencephalography (EEG; 104/123) to check for hypsarrhythmia resolution. Difficult access to pediatric EEG in Bhutan and Nepal is concerning. More than 95% of responders felt a need for more awareness. The meta-analysis supported the preponderance of male gender (68%; confidence interval [CI]: 64%-73%), structural etiology(80%; CI 73%-86%), longer LTTT (2.4 months; CI 2.1-2.6 months), and low response rate to hormonal therapy(18% and 28% for ACTH and oral steroids respectively) in WS in South Asia. SIGNIFICANCE: This study highlights the practices and challenges in the management of WS in South Asia. These include a preponderance of male gender and structural etiology, a longer LTTT, difficult access to pediatric EEG, nonavailability of ACTH and vigabatrin in some countries, and low effectiveness of hormonal therapy in this region.