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Study protocol for a pilot study for Remote ADHD Monitoring Program (RAMP) for children in rural areas

by Claire A. MacGeorge, Matthew Henry, Hannah A. Ford, Lacy Malloch, Emily Fratesi, Shannon Cabaniss, Jaime Baldner, Melody Greer, Kristin Gaffney, Milan Bimali, Preetha Abraham, Linda Y. Fu, P. Songthip Ounpraseuth, Christine B. Turley

Background

Attention-deficit/hyperactivity Disorder (ADHD) is the most common neurobehavioral condition of childhood and can be controlled with stimulant medication. Evidence-based guidelines endorse use of standardized ADHD symptom reports to facilitate medication titration to therapeutic dosage. Children living in under-resourced areas experience barriers to receiving this recommended evidence-based care. The Remote ADHD Monitoring Program (RAMP) uses a text-based platform to relay symptom reports from caregivers and teachers to healthcare providers. This pilot study is a feasibility study examining intervention uptake. It compares the submission of structured symptom reports in those children enrolled in RAMP compared to usual care as well as utilization of the RAMP platform by providers.

Methods

This paper describes the protocol to evaluate the feasibility of deploying RAMP in practices serving rural or underserved children. We will recruit 36 dyads from 4 practices in 2 separate states. Each dyad will include a caregiver and their child aged 5–11 years with a diagnosis of ADHD who is starting or reinitiating stimulants. Dyads will be randomized 1:1 to receive the RAMP intervention or usual care with attention controls. Our primary outcome is number of symptom reports (paper assessments in control arm and RAMP reports in intervention arm) per participant that are completed by caregivers and teachers and returned to providers. Our secondary outcome is proportion of submitted RAMP reports that are reviewed by providers.

Discussion

As telehealth use increases, it is critical that we improve access to high quality care for children with chronic conditions. Leveraging technology may be a meaningful approach to improve efficiency in optimizing medication management. This pilot study tests a text-based platform designed to improve communication between the caregivers and teachers of children with ADHD and health care providers. If successful, a future trial will examine the effectiveness of the RAMP intervention on improvement in symptoms.

Trial registration

ClinicalTrials.gov NCT06743425.

Telerehabilitation for people with Parkinsons disease: protocol of a randomised clinical trial of mixed methods

Por: Taveira · R. S. · Vasconcellos · L. S. d. · Bezerra · C. F. · Aires · D. N. · Dias de Oliveira · A. K. · da Silva · K. d. O. C. · Melo · L. P. d. · Ribeiro · T. S.
Introduction

Telerehabilitation (TR) programmes are increasingly recognised for their feasibility and potential benefits, such as eliminating travel time, reducing costs and providing a more comfortable rehabilitation experience at home. However, the comparative efficacy of remote physiotherapy compared with traditional in-person sessions for individuals with Parkinson’s disease (PD) remains uncertain. This study aims to evaluate the effects of TR compared with in-person physiotherapy in individuals with PD, focusing on both motor and non-motor outcomes.

Methods and analysis

This is a randomised, single-blind clinical trial with a mixed-methods approach. A total of 22 individuals diagnosed with PD will be randomly assigned to one of two groups. The experimental group will receive TR, consisting of remote physiotherapy sessions conducted once a week for 1 hour over a 4-month period. The control group will receive the same interventions in person. Interventions will include global muscle strengthening exercises, balance training, gait and motor coordination exercises, and cognitive training. The primary outcome will be motor function, measured using part III of the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale. Secondary outcomes will include cognition (Montreal Cognitive Assessment), gait (Functional Gait Assessment), mobility (Timed Up and Go Test) and quality of life (Parkinson’s Disease Questionnaire). Data will be analysed using repeated measures analysis of variance to compare outcomes between groups across four assessment points (baseline, midpoint, postintervention and 2 months follow-up). Additionally, a qualitative phase will explore participants’ perceptions and experiences regarding TR and in-person interventions, with assessments carried out 2 months after the completion of the 24-week interventions, through semistructured interviews that will be analysed using Bardin’s Content Analysis technique.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte (approval number: 5.553.701). All participants will provide written informed consent before inclusion. Results will be disseminated through peer-reviewed publications, scientific conferences and communication with participants and healthcare professionals.

Trial registration number

RBR-6h5knrj.

Public health assistance for people with haemophilia in Brazil (PATCH study): a cross-sectional study protocol

Por: Roberti · M. d. R. F. · Gea · Y. R. e. A. · Marinho · I. A. · Inacio · P. P. · Camelo · R. M. · de Castro · T. F. · Batista · S. R. R.
Introduction

Haemophilia is a rare inherited bleeding disorder with complex support and costly treatment. Comprehensive care for people with haemophilia (PwH) must take place in structured and continuously evaluated treatment centres. The aim of the Public Assistance for People with Haemophilia in Brazil Project (PATCH Project) is to assess the infrastructure, human resources and healthcare delivery processes of Brazilian Blood Centres (BC) involved in the provision of haemophilia care.

Methods and analysis

This is a nationwide cross-sectional study involving 98 BC across Brazil’s 26 states and the Federal District, focusing on the care provided to PwH. A self-administered structured questionnaire was prepared, based on national and international recommendations for management, treatment and outcomes assessment in PwH. The criteria of the World Federation of Haemophilia and the European Association for Haemophilia and Allied Disorders will be used to define standards of quality.

Ethics and dissemination

Ethical approval for this study was granted by the Human Research Ethics Committee of the Federal University of Goiás, the coordinating centre (protocol CAAE 53863221.8.0000.5078), and subsequently by all participating institutions. Written informed consent is obtained from all participants prior to enrolment. Study findings will be disseminated through publication in peer-reviewed journals and presentation at international scientific conferences. Research data will be managed in accordance with ethical and legal standards and will be made available on reasonable request to support future investigations.

Protocol registration

Not applicable

What is the access to NHS fertility treatments for women with Mayer-Rokitansky-Küster-Hauser syndrome across England? A freedom of information study

Por: Milford · K. · Melo · P. · Suleman · M. · Crouch · N. · Mair · I. · Armstrong · S. C.
Objectives

The aims of this study were (1) To investigate the availability of NHS funded in vitro fertilisation (IVF) treatment for individuals affected by Mayer-Rokitansky-Küster-Hauser syndrome (MRKH) from all Integrated Care Boards (ICBs) across England and (2) To assess the ethical implications of piecemeal funding for those with MRKH.

Design

This was a mixed-methods study containing both quantitative and qualitative data. We filed freedom of information (FOI) act requests on 01/06/2023 for all 42 ICBs across England via secure email.

Setting

The study focused on England.

Participants

All 42 ICBs across England were contacted.

Outcome measures

The FOI requests asked for information concerning the provision of funded IVF for uterine factor infertility, and if this included individuals with MRKH. Where assistance was available, we recorded what it comprised along the IVF cycle. If IVF was not offered, we recorded the rationale provided by the ICB.

Results

Responses were received from all 42 ICBs across England. Seven stated that they would fund IVF and cryopreservation of embryos to women with MRKH and other absolute uterine factor infertility diagnoses (NHS Humber and North Yorkshire, NHS Dorset, NHS Devon, NHS Cornwall and Isles of Scilly, NHS Buckinghamshire, Oxford and Berkshire, NHS South Yorkshire and NHS West Yorkshire). However, the number of cycles, the length of cryopreservation and whether they would fund embryo transfer into a surrogate differed between ICBs.

Of the remainder, three (NHS Leicester, Leicestershire and Rutland, NHS Greater Manchester and NHS Hampshire and Isle of Wight) described some provision of fertility preservation (cryopreservation of oocytes or embryos) for women with uterine factor infertility, two of whom suggested their policy may include women with MRKH (NHS Greater Manchester and NHS Hampshire and Isle of Wight). Two ICBs (NHS Gloucester and NHS Bedford, Luton and Milton Keynes) explained that individual funding applications would be considered when made by clinicians on the patient’s behalf, but no information was provided on how many times requests had been made and granted. The remaining 30 ICBs explained that no part of a surrogacy pregnancy would be funded, owing to concerns around commercial surrogacy, which is illegal in the UK.

Conclusions

This work has revealed that only a small proportion of ICBs (7/42, 17%) treat women with MRKH like any other woman applying for NHS fertility treatment. The study revealed that decisions by ICBs not to fund IVF treatments based on concerns about commercial surrogacy create significant inequities. It unfairly penalises individuals with MRKH who require surrogacy as part of their fertility treatment. These individuals face a unique set of reproductive challenges, and denying them access to NHS-funded IVF treatments exacerbates existing inequalities. Furthermore, if individuals with MRKH accept that the expenses of the surrogate will be met by them rather than the ICB, it is unjustifiable to deny them the IVF component of the treatment if they meet all the other criteria for eligibility. Moreover, the fact that some ICBs do fund IVF for individuals with MRKH indicates that legal concerns regarding surrogacy are unfounded and inconsistently applied. This discrepancy highlights the need for a standardised approach that ensures equitable access to fertility treatments across all regions.

Social Representations of Bedside Milk Expression Among Mothers of Preterm Newborns in Neonatal Intensive Care Units

ABSTRACT

Aim

To understand the social representations of bedside milk expression (BME) among mothers of preterm newborns in neonatal intensive care units (NICUs).

Design

Qualitative descriptive study.

Methods

The study was conducted from July to August 2024 in two NICUs of a referral maternity hospital in Fortaleza, Brazil. Nineteen mothers of hospitalised premature newborns participated. Semi-structured interviews were conducted and subjected to thematic content analysis.

Results

Mothers perceived BME as a meaningful act of protection and bonding, though some were unfamiliar with the practice. Emotional ambivalence was common, shaped by prior breastfeeding experiences and the context of prematurity. Discomfort related to privacy and shared spaces was noted. Support from healthcare professionals was essential to promote understanding and adherence.

Conclusion

Social representations of BME are shaped by emotional, social and institutional experiences. Anchored in prior breastfeeding experiences and cultural meanings of maternal care, the practice is objectified through both gestures of affection and tangible barriers.

Implications for the Profession and/or Patient Care

Healthcare professionals, particularly nurses, should receive training to support mothers in BME. Structural improvements, privacy and emotional support are essential for fostering maternal autonomy and confidence.

Impact

This study highlights the barriers to BME, emphasising the role of healthcare support and the need for better infrastructure, privacy and training to enhance maternal confidence and breastfeeding.

Reporting Method

The study followed the Consolidated Criteria for Reporting Qualitative Research checklist.

Patient or Public Contribution

None.

What Does This Paper Contribute to the Wider Global Clinical Community?

This paper highlights the pivotal role of healthcare professional support in overcoming barriers to BME and promoting breastfeeding practices.

What Already Is Known?

Fresh breast milk is considered the gold standard for reducing complications and improving survival in preterm infants. BME is recommended as an effective strategy to ensure the availability of fresh breast milk. Mothers' social representations of this practice remain underexplored within the neonatal intensive care context.

What This Paper Adds?

Explores mothers' social representations of BME in NICUs, addressing a significant gap in qualitative research. Reveals how emotional, social and institutional factors shape mothers' perceptions, motivations and challenges related to BME. Highlights the need for targeted professional support, improved infrastructure and privacy to enhance maternal autonomy and adherence to milk expression practices.

Implications for Practice

Healthcare professionals, particularly nurses, should receive specialised training to provide technical guidance and emotional support, enhancing mothers' confidence and autonomy in BME. Improving infrastructure and ensuring privacy in NICUs are crucial to creating supportive environments that facilitate milk expression and strengthen maternal–infant bonding. Institutional policies should integrate maternal-centred strategies to support breastfeeding continuity and promote humanised neonatal care.

LDL-C achievement in patients with coronary artery disease: a study protocol for the EDHIPO-MARCA retrospective registry

Por: Cordoba-Melo · B. D. · Arango-Ibanez · J. P. · Posso-Marin · S. · Ruiz · A. J. · Molina · D. I. · Gomez-Mesa · J. E.
Introduction

Elevated lipid profiles increase the risk of atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality worldwide. Despite the availability of lipid-lowering therapy (LLT), adherence to therapy and achievement of Low-Density Lipoprotein Cholesterol (LDL-C) target levels remain suboptimal. Coronary artery disease (CAD) presents substantial public health challenges, with LDL-C goal attainment rates reported to be between 30.0% and 54.0%. The EDHIPO MARCA (Evaluación De adherencia a la terapia HIPOlipemiante en pacientes de Muy Alto Riesgo CArdiovascular) study aims to evaluate LDL-C target achievement among Colombian patients with CAD.

Methods and analysis

This is a retrospective and multicentre study aiming to evaluate LDL-C target achievement within 12 months of coronary angiography across multiple Colombian institutions. Data will be retrospectively extracted from medical records corresponding to the years 2011, 2012, 2016, 2017, 2021 and 2022, which were selected to correspond with the European Society of Cardiology/European Atherosclerosis Society guideline updates. Inclusion criteria included patients ≥18 years old with confirmed CAD and LDL-C reports recorded during outpatient follow-up. The study will evaluate a minimum sample size of 5000 patients, with data collected through medical records and managed using the REDCap platform. Statistical analyses will be conducted to assess LDL-C target achievement, associated factors and temporal trends using mixed-effects models. Uncertainty will also be explored through sensitivity analysis. The EDHIPO MARCA study will provide key insights into LDL-C target achievement in Colombia, contributing to both regional and global CAD management. Its findings will be used to help shape public health policies and serve as a foundation for future prospective research and interventions aimed at mitigating the burden of cardiovascular disease.

Ethics and dissemination

This study was approved by the Comité de Ética en Investigación Biomédica of Fundación Valle del Lili, the coordinating institution and creator of the study protocol. Each participating centre will obtain approval from its local ethics committee prior to data collection. Data will be collected in a de-identified manner, ensuring confidentiality. In accordance with Colombian Resolution 8430, this study is classified as 'no-risk', and informed consent was not required. The findings will be disseminated through scientific events and published in international peer-reviewed journals to contribute to cardiovascular disease management and public health policies.

Understanding readmission after hip fracture: a mixed methods study protocol

Por: Sutton · E. · Rahman · U. · Reilly · H. · Miller · C. · Vedutla · T. · Melody · T. · Gudivada · R. · Topping · A. E.
Introduction

Around 75 000 people suffer from hip fractures yearly in the United Kingdom (UK) leading to significant mortality and morbidity. Although mortality has dropped from 8% to 5% between 2013 and 2023 after hip fractures, those undergoing surgery for hip fractures have a 30-day readmission rate which has remained stagnant at around 11% over the same decade in the UK.

This study protocol describes a mixed-methods investigation (The ARTHUR Study—avoiding readmission after hip fracture) which aims to understand and offer solutions to prevent avoidable 30-day readmission after hip fracture surgery. The study will focus on two hospitals in acute and community settings in a large urban and ethnically diverse city in the UK.

Methods and analysis

We describe two work packages.

Work Package One (WP1) involves analysis of 5 year’s worth of routinely collected health data provided by PIONEER, a Health Data Research UK data hub in Acute Care for our local population. Work Package Two (WP2) will involve semistructured interviews with patients, carers or family members as well as non-participant observations of hospital processes to understand systems-based issues related to readmissions after hip fracture surgery. Although recruitment may be an issue, our timeline for recruitment reflects this. We also aim to recruit a diverse population, which has often been under-represented in studies into hip fractures and aim to explore relevant interventions which can be widely generalisable.

Ethics and dissemination

This protocol was submitted via IRAS: 330074 and obtained UK NHS REC approval via the West Midlands Coventry and Warwickshire Research Ethics Committee (REC 23/WM/0242) on 25 January 2024. The results of this study will be published in relevant scientific journals and presented at orthopaedic, fragility fracture and geriatric specialty conferences and scientific meetings. A lay summary of the findings will be publicly available on the HRA website.

Capacity and Capability for Nursing, Midwifery and Allied Health Professional Principal Investigator Roles in Healthcare Research: A National Survey

ABSTRACT

Aims

To understand the current capacity and capability for nursing, midwifery and allied health professional (NMAHP) principal investigator roles in England.

Design

Quantitative online survey.

Methods

Online national quantitative survey across England analysed using descriptive statistics.

Results

The number of NMAHP PIs in an organisation was unrelated to the size of the NMAHP workforce. NMAHP PIs were more common in non-CTIMP studies. A quarter of organisations had no specific education or support for NMAHP PIs. Most respondents indicated that a national approach to support and training would be helpful.

Conclusions

Having more research-active NMAHPs provides career progression, improved staff retention and improves the evidence base for practice. Having a broader range of CI/PIs allows for more targeted and specialty-specific oversight of research studies and streamlines the acceptance process to allow research to be delivered in a more timely manner.

Implications for Practice

This will require more collaboration between NMAHP, medical and industry communities to promote a multidisciplinary approach to healthcare research delivery and to ensure that CI/PI roles are fulfilled by the most appropriate person, regardless of their profession.

Impact

To ascertain NMAHP capacity and capability for PI research roles. Shows where national and organisational effort should be focused to increase this nationally.

Reporting Method

Cross reporting guidance for survey studies was utilised.

Patient Contribution

No patient or patient contribution.

Escuela de Enfermería de la Universidad de São Paulo: 80 años desde la fundación hasta la construcción de puentes con la sociedad

La Escuela de Enfermería de la Universidad de São Paulo celebró su 80 aniversario en octubre de 2022 y consolida una trayectoria histórica de construcción de puentes con la sociedad. Pionera fue su marca registrada, comenzando con el edificio que alberga la Escuela en un estilo contemporáneo, al aceptar hombres y mujeres negras en el curso de enfermería en la década de 1940. La Escuela experimentó profundas transformaciones que elevaron a la institución al nivel de excelencia tanto a nivel nacional como internacional.

Instrumentos para la identificación temprana del deterioro clínico en pacientes hospitalizados: revisión integrativa

Objetivo: recopilar evidencia científica sobre la implementación y evaluación del uso de instrumentos para la identificación temprana del deterioro clínico en pacientes no infectados por SARS-COV-2 en unidades de hospitalización de adultos. Método: revisión integradora realizada en las bases de datos Latin American and Caribbean Literature on Health Sciences, Medical Literature Analysis and Retrieval System Online, Web Of Science y SCOPUS, utilizando la siguiente estrategia de búsqueda: (“Early Medical Intervention” OR “Early Warning Systems” O “Puntuación de alerta temprana”) Y (“Deterioro clínico”). Resultados: se seleccionaron ocho artículos que abordaron la implementación de herramientas para la identificación temprana de deterioro clínico en unidades de hospitalización y evaluaron sus resultados a través de indicadores de incidencia de paro cardiorrespiratorio, incidencia de ingreso no planificado en UTI, incidencia de cirugía de emergencia, mortalidad e incidencia de enfermedad renal. lesión. Conclusión: la implementación de herramientas que permiten la identificación temprana del deterioro clínico en las unidades de hospitalización tuvo un impacto positivo en los indicadores institucionales.

Eficacia del tratamiento para las personas agitadas en situaciones de emergencia en comparación con los servicios comunitarios: revisión sistemática

Objetivo: Conocer la eficacia del tratamiento de personas con conducta hetero agresiva en los servicios de urgencias en comparación con los servicios de salud comunitarios. Método: Revisión sistemática de estudios en bases de datos: LILACS, Psychinfo, Scopus, Web de Ciencia, PUBMED y literatura gris en Google Scholar y en la lista de referencias. La búsqueda se realizó en junio de 2016. Dos mil ciento sesenta estudios fueron encontrados y seis de estos estudios fueron seleccionados para su análisis después de la aplicación de los criterios de exclusión. Resultados: El acercamiento a individuos con comportamiento agitado, agresivo o violento ocurre con mayor frecuencia en servicios de emergencia general y psiquiátrica con intervención médica. Los medicamentos utilizados para controlar la agitación y la sedación fueron benzodiazepina (midazolam, lorazepam), antihistamínico (prometazina), antipsicóticos típicos (haloperidol y droperidol) y antipsicóticos atípicos (olanzapina, ziprasidona, risperidona y quetiapina). Conclusión: Todos los fármacos evaluados promueven la sedación, pero esta revisión muestra ventajas en el uso de la combinación de haloperidol más prometazina.

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