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Hoy — Abril 20th 2024Tus fuentes RSS

Test-retest reliability of Latin American Group for Maturity (GDLAM) protocol in older women

by Álvaro Huerta Ojeda, Emilio Jofré-Saldía, Jimena Arriagada Molina, Patricia Rojas Quinchavil, María Paz Parada Toledo, Sergio Galdames Maliqueo, María-Mercedes Yeomans-Cabrera, Carlos Jorquera-Aguilera, Frano Giakoni-Ramirez, Maximiliano Bravo

Functional autonomy (FA) is a critical factor in determining the quality of life of older adults (OA), especially in the case of older women (OW), as they face a decline in FA in their later years of life. FA should be assessed early, using valid, reliable, and low-cost tests. This study evaluated the test-retest reliability of GDLAM and GDLAM autonomy index (GI) in OW. Thirty-nine OW (71.2 ± 6.50 years) participated in the study. A repeated measures design was used to compare the interday test-retest reliability of the five GDLAM tests (seconds) and the GI (points). The five tests represent activities of daily living, such as dressing or wandering around the house, while the GI provides a weighting of the results of the five tests. The analysis consisted of the intraclass correlation coefficient (ICC), standard error of measurement (SEM), and coefficient of variation (CV). A CV ≤ 10% and an ICC ≥ 0.80 were considered acceptable reliability, whereas a CV ≤ 5% and an ICC ≥ 0.90 were considered high reliability. The outcome of the five tests, represented by the GI, showed high interday test-retest reliability (CV = 6.00% and ICC = 0.91). The results of this study demonstrate that the five tests of the GDLAM protocol and the GI have high interday test-retest reliability and good interday reproducibility. From a practical point of view, the GDLAM protocol allows the assessment of FA of community-dwelling OW, providing background for early diagnosis and, with it, the possibility of developing an individualized physical exercise prescription.
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Study protocol for a type-II hybrid effectiveness-implementation trial to reach teenagers using mobile money shops to reduce unintended pregnancies in Uganda

Por: Komasawa · M. · Sato · M. · Ssekitoleko · R. · Waiswa · P. · Gitta · S. · Nabugoomu · J. · Honda · S. · Saito · K. · Aung · M. N.
Introduction

Unintended teenage pregnancies have become a global public health challenge, particularly in sub-Saharan Africa. There is a notably high prevalence of unintended pregnancies among unmarried teenagers in Uganda. This study will develop an intervention programme using mobile money shops (vendors) as a platform to deliver sexual and reproductive health and rights (SRHR) services to teenagers and assess its effectiveness and scalability in Uganda.

Methods and analyses

This hybrid study comprises two integral components: an intervention study to assess the effectiveness of vendor-mediated intervention and implementation research to evaluate the implementation process. 30 vendors will be recruited for both intervention and control arms in 2 municipalities in Eastern Uganda, which have a high unintended pregnancy prevalence rate among unmarried teens aged 15–19 years. A preintervention and postintervention repeated survey involving 600 participants for each arm will be conducted over 4 months. The primary outcome is the rate of condom users among teenage vendor users. The secondary outcomes include the rate of preference for receiving SRHR services at vendors and knowledge regarding SRHR. A difference-in-differences analysis will be used to determine the effectiveness of the intervention. The Bowen model will be employed to evaluate the implementation design.

Ethics and dissemination

Ethical approval was obtained from the Ethics Review Committee of Uganda Christen University and JICA Ogata Sadako Research Institute for Peace and Development in Japan. The findings will be widely disseminated. This study was registered with the University Hospital Medical Information Network in Japan (UMIN000053332) on 12 January 2024.

Trial registration number

UMIN000053332.

Impact of telehealth on stroke survivor–caregiver dyad in at‐home rehabilitation: A systematic review

Abstract

Aim

To examine studies involving the impact of telerehabilitation (TLR), tele-training and tele-support on the dyad stroke survivor and caregiver in relation to psychological, physical, social and health dimensions.

Design

A systematic review was conducted.

Data Sources

The following electronic databases were consulted until September 2023: PsycInfo, CINAHL, Eric, Ovid, PubMed, Scopus, Cochrane Central and Web of Science.

Review Methods

It was conducted and reported following the checklists for Reviews of PRISMA 2020 Checklist. Critical evaluation of the quality of the studies included in the review was performed with the Joanna Briggs Institute Checklists.

Data Synthesis

A total of 2290 records were identified after removing duplicates, 501 articles were selected by title and abstract and only 21 met the inclusion criteria. It included 4 quasi-experimental studies, 7 RCTs, 1 cohort study and 9 qualitative studies. The total number of participants between caregivers and stroke survivors was 1697, including 858 stroke survivors and 839 caregivers recruited from 2002 to 2022. For a total of 884 participants who carried out TLR activities in the experimental groups,11 impact domains were identified: cognitive/functional, psychological, caregiver burden, social, general health and self-efficacy, family function, quality of life, healthcare utilization, preparedness, quality of care and relationship with technology.

Conclusions

The results support the application of telehealth in the discharge phase of hospitals and rehabilitation centres for stroke survivors and caregivers. TLR could be considered a substitute for traditional rehabilitation only if it is supported by a tele-learning programme for the caregiver and ongoing technical, computer and health support to satisfy the dyad's needs.

Impact

Designing a comprehensive telemedicine programme upon the return home of the dyad involved in the stroke improves the quality of life, functional, psychological, social, family status, self-efficacy, use of health systems and the dyad's preparation for managing the stroke.

Patient or Public Contribution

No patient or public contribution.

Roles of health system leadership under emergency in drought-affected districts in northeast Uganda: a mixed-method study

Por: Njuguna · C. · Tola · H. · Maina · B. N. · Magambo · K. N. · Namukose · S. · Kamau · S. · Tegegn · Y. W.
Objective

Health system leadership plays a critical role in sustaining healthcare delivery during emergencies. Thus, we aimed to assess the contribution of health system leadership in sustaining healthcare delivery under emergency conditions based on adaptive leadership theoretical framework.

Design

We employed a concurrent mixed-methods study approach to assess health system leadership roles during emergency. This involved a quantitative survey administered to 150 health facilities managers/service focal persons selected via multistage sampling method from 15 districts, and qualitative interviews with 48 key informants who purposively selected.

Participants

We interviewed health facility managers, services focal persons, district health officers and residential district commissioners. We also reviewed weekly emergency situation reports and other relevant documents related to the emergency response. We used structured questionnaire, observation checklist and semistructured questionnaire to collect data. We employed descriptive statistics to analyse quantitative data and thematic analysis for qualitative data.

Main outcome

Health system leadership contributions in sustaining healthcare delivery during emergencies.

Results

Health system leadership was effective in leading emergency response and ensuring the continuity of health service during emergencies. Community engagement, partners coordination and intersectoral collaboration were effectively used in the emergency response and ensuring continuity of healthcare delivery. Deployment of experienced personnel and essential medical and non-medical supplies played a critical role in the continuity of health service. Availability of incidence management teams across health system significantly contributed to health system leadership. Participation of village health teams in community engagement and information communication helped in the success of health system leadership under emergency.

Conclusion

Adaptive health system leadership played a crucial role in managing health services delivery under emergency conditions. Effective partnership coordination and collaboration across sectors, frequent information communication, building local actor capacity and implementing scheduled supportive supervisions emerged as key strategies for sustaining health services during emergencies.

Results from a cross-specialty consensus on optimal management of patients with chronic kidney disease (CKD): from screening to complications

Por: Arici · M. · Assaad-Khalil · S. H. · Bertoluci · M. C. · Choo · J. · Lee · Y.-J. · Madero · M. · Rosa Diez · G. J. · Sanchez Polo · V. · Chung · S. · Thanachayanont · T. · Pollock · C.
Background

Chronic kidney disease (CKD) affects around 10% of the global population and has been estimated to affect around 50% of individuals with type 2 diabetes and 50% of those with heart failure. The guideline-recommended approach is to manage with disease-modifying therapies, but real-world data suggest that prescribing rates do not reflect this in practice.

Objective

To develop a cross-specialty consensus on optimal management of the patient with CKD using a modified Delphi method.

Design

An international steering group of experts specialising in internal medicine, endocrinology/diabetology, nephrology and primary care medicine developed 42 statements on aspects of CKD management including identification and screening, risk factors, holistic management, guidelines, cross-specialty alignment and education. Consensus was determined by agreement using an online survey.

Participants

The survey was distributed to cardiologists, nephrologists, endocrinologists and primary care physicians across 11 countries.

Main outcomes and measures

The threshold for consensus agreement was established a priori by the steering group at 75%. Stopping criteria were defined as a target of 25 responses from each country (N=275), and a 4-week survey period.

Results

274 responses were received in December 2022, 25 responses from Argentina, Australia, Brazil, Guatemala, Mexico, Singapore, South Korea, Taiwan, Thailand, Turkey and 24 responses from Egypt. 53 responses were received from cardiologists, 52 from nephrologists, 55 from endocrinologists and 114 from primary care physicians. 37 statements attained very high agreement (≥90%) and 5 attained high agreement (≥75% and

Conclusions

There is a high degree of consensus regarding aspects of CKD management among healthcare professionals from 11 countries. Based on these strong levels of agreement, the steering group derived 12 key recommendations focused on diagnosis and management of CKD.

Assessing the heterogeneity of the impact of COVID-19 incidence on all-cause excess mortality among healthcare districts in Lombardy, Italy, to evaluate the local response to the pandemic: an ecological study

Por: Paganuzzi · M. · Nattino · G. · Ghilardi · G. I. · Costantino · G. · Rossi · C. · Cortellaro · F. · Cosentini · R. · Paglia · S. · Migliori · M. · Mira · A. · Bertolini · G. · On behalf of the Fenice network
Objectives

The fragmentation of the response to the COVID-19 pandemic at national, regional and local levels is a possible source of variability in the impact of the pandemic on society. This study aims to assess how much of this variability affected the burden of COVID-19, measured in terms of all-cause 2020 excess mortality.

Design

Ecological retrospective study.

Setting

Lombardy region of Italy, 2015–2020.

Outcome measures

We evaluated the relationship between the intensity of the epidemics and excess mortality, assessing the heterogeneity of this relationship across the 91 districts after adjusting for relevant confounders.

Results

The epidemic intensity was quantified as the COVID-19 hospitalisations per 1000 inhabitants. Five confounders were identified through a directed acyclic graph: age distribution, population density, pro-capita gross domestic product, restriction policy and population mobility.

Analyses were based on a negative binomial regression model with district-specific random effects. We found a strong, positive association between COVID-19 hospitalisations and 2020 excess mortality (p

Conclusions

The homogeneous effect of the COVID-19 spread on the excess mortality in the Lombardy districts suggests that, despite the unprecedented conditions, the pandemic reactions did not result in health disparities in the region.

Development and psychometric testing of the actualisation of evidence‐based nursing instrument

Abstract

Aim

To describe the development of the Actualisation of Evidence-Based Nursing instrument targeted at nurses working in clinical practice (ActEBN-nurses), meant for evaluating the actualisation of individual and organisational-level support structures for evidence-based nursing within social and healthcare organisations, and to test its validity and reliability.

Design

Cross-sectional survey.

Methods

The FinYHKÄ model was used as the theoretical background of the instrument development and supplemented with the JBI Model of Evidence-Based Healthcare, previous literature and items from a previous instrument, the Evidence-Based Practice Process Assessment Scale, with permission of the copyright holders. After two rounds of expert panel and piloting, a national survey was conducted with the instrument in 2021. The target group consisted of nurses working in clinical practice. Psychometric testing included internal consistency (Omega, item analysis) confirmatory factor analysis and t-test for comparison of two groups' differences (sensitivity).

Results

A new instrument, ActEBN-nurses was developed, comprising two parts: Individual-level (32 items, 5-point Likert-scale) and Organisational-level support structures for evidence-based nursing (37 items, 5-point Likert-scale). In total, 1289 nurses participated in the survey. The ActEBN-nurses proved to have good internal consistency in both parts (Omega ω .931 and .966), structural validity and sensitivity based on the two educational levels within the sample. The structure of both parts was slightly modified, based on the CFA modification indices, considering the impact of the reverse worded items in part Individual and redundant items within both parts.

Conclusion

The ActEBN-nurses has promising psychometrics, and it can be used for evaluating individual and organisational-level support structures for evidence-based nursing within social and healthcare organisations.

Implications for the profession and/or patient care

Evaluation of the support structures within social and healthcare organisations is needed to recognise shortcomings in current structures and advance evidence-based nursing across different contexts.

Reporting Method

The authors state that they have adhered to relevant EQUATOR guidelines: STROBE statement for cross-sectional studies.

Patient or Public Contribution

No patient or public contribution.

Midwives' stress and burnout during the Omicron wave in Italy: An observational survey

Abstract

Aim

To evaluate midwives' level of stress and burnout during the COVID-19 Omicron phase in Italy. Secondary aims were to explore the impact of the pandemic on midwives' personal dimensions and professional activities and potential supporting strategies.

Design

A mixed-methods study was undertaken from July to December 2022.

Methods

Data were collected using a national online observational survey. Descriptive and inferential analyses were performed to evaluate stress, burnout and the impact of the pandemic on personal and professional dimensions. A deductive qualitative approach was used to analyse open-ended responses, that were merged with quantitative data following a convergent mixed-methods approach.

Results

A total of 1944 midwives participated in the survey. The stress summary score mean was 10.34, and 562 midwives (28.91%) experienced burnout. The intention to reduce working hours was reported by 202 midwives (10.39%), with 60.40% (n = 122) of them experiencing burnout. The intention to leave clinical practice within the following 2 years was reported by 239 (12.29%), with 68.20% (n = 163) of them experiencing burnout. All the personal dimensions and professional activities considered were defined by more than half of midwives as being impacted ‘Moderately’ or ‘To a great extent’ by pandemic. Stress and burnout frequencies increased when the midwives' perception of the pandemic effects was higher. Potential supporting strategies described by midwives as the most important in increasing their ability to cope with the pandemic were ‘Women's awareness of the midwives' role’ (n = 1072; 55.14%) and ‘Family and friends' emotional support’ (n = 746; 38.38%).

Conclusion

Our findings suggested strategies to support a positive and safe working environment for midwives during a pandemic emergency, with potential transferability to similar contexts when human resources are lacking. It is recommended that maternity services provide the necessary resources for a safe and supportive working environment to prevent high stress levels and chronic burnout.

Impact

Studies conducted during the first COVID-19 pandemic wave showed an increased level of stress, anxiety, burnout, post-traumatic stress disorder and depression experienced by healthcare professionals; moreover, midwives experienced drastic changes in care pathways and policies with struggles identified when providing high-quality woman-centred care following pandemic restrictions. Although it is recommended, there is lack of knowledge about long-term psychological effects of COVID-19 for midwives. Our study highlights that during the Omicron wave midwives experienced a high level of stress and burnout with an impact on individual dimensions and professional activities. Their stress and burnout were influenced by several factors, including restrictions in place, lack of organizational acknowledgement, work overload and need for extra childcare cover. Maternity services should provide the necessary resources for a safe and supportive working environment to prevent high stress levels and chronic burnout. Recommendations on how to facilitate this are suggested.

Reporting Method

During the writing process, we referred to ‘The Strengthening the Reporting of Observational Studies Epidemiology Statement’, the guidelines for reporting observational studies from the Equator network.

Patient or Public Contribution

No patient or public contribution.

What does this paper contribute to the wider global clinical community?

Work overload conditions negatively impacted on the quality of maternity services. Improving organizational aspects, reducing working hours, promoting family and friends' emotional support and improving women's awareness of midwife's role were the main strategies reported by midwives. These suggestions for ensuring a positive and safe working environment for midwives during a pandemic emergency could potentially be applied to similar situations where human resources are lacking.

Knowledge, attitude, and sources of information towards burn first aid among people referred to a burn centre in the north of Iran

Abstract

Optimal management of burns begins with first aid from the first hours of injury. Adequate knowledge of how to perform first aid for burns can reduce the consequences of injury. Therefore, this study aims to determine the knowledge, attitude, and sources of information assessment towards burn First aid among people referred to a burn centre in the north of Iran. A questionnaire-based survey was conducted to assess knowledge, attitude, and sources of information towards burn first aid among people referred to a burn centre in the north of Iran in 2023. In this survey, a convenience sampling method was adopted. The variables consisted of four items on socio-demographic information, 15 items on knowledge, ten items on attitude, and one item on sources of information related to burn First aid. A total of 371 individuals responded to the survey. The mean age of participants was 31.90 ± 8.49 years old. The mean score of the total knowledge of the participants in the research was 6.04 ± 3.05. There was a statistically significant relationship between the variables of age, sex, marital status, place of residence, level of education, and history of receiving first aid training with the participants' knowledge level. The average score of the total attitude of the participants was 44.08 ± 3.88. Out of 371 participants, 214 people (57.7%) had an average attitude, and 157 people (42.3%) had a good attitude towards burn first aid. There was a statistically significant relationship between place of residence, level of education, and history of receiving first aid training with the participants' attitudes in the research. In addition, the level of knowledge had a statistically significant relationship with the participants' attitude level in the research (p-value <0.001). The majority of participants have limited knowledge of burn first aid. This lack of knowledge could lead to severe consequences. Therefore, healthcare organizations should review and promote consistent guidelines for burn first aid to tackle and minimize the effect of this grave injury.

Evaluation of a codesigned group cognitive-behavioural therapy intervention for trans young people (TAG TEAM): protocol for a feasibility trial and a subsequent pilot RCT

Por: Chinsen · A. · Cronin · T. J. · Pace · C. C. · Tollit · M. A. · Pang · K. C.
Introduction

Trans young people are at a higher risk of mental health difficulties such as depression, anxiety and suicidality than their cisgender peers, due in part to their experiences of minority stress. This protocol describes a feasibility trial and subsequent pilot randomised controlled trial (RCT) of a codesigned group cognitive–behavioural therapy intervention for trans young people, named Trans Adolescent Group ThErapy for Alleviating Minority stress (TAG TEAM).

Methods and analysis

To evaluate TAG TEAM, we will conduct a feasibility trial followed by a pilot RCT with trans young people aged 14–16 years who have been referred to the Royal Children’s Hospital Gender Service in Melbourne, Australia. In the feasibility trial, we aim to enrol 32 participants who will be randomised at a 1:1 ratio to either in-person or online intervention arms. Participants will be assessed at baseline and post-treatment, with a nested qualitative evaluation post-treatment. Primary outcomes are the feasibility and acceptability of the intervention and the study design and associated procedures, including comparison of the in-person and online delivery modes. In the subsequent pilot RCT, we aim to enrol 64 participants who will be randomised at a 1:1 ratio to an intervention or waitlist control arm, with delivery mode determined by the feasibility trial. Participants will complete assessments at baseline, post-treatment and 3-month follow-up. Primary outcomes are the feasibility and acceptability of the RCT study design. In both the feasibility trial and pilot RCT, participants will complete assessments related to mood, anxiety, suicidality, quality of life, minority stress, family support and social transition. Quantitative data will be analysed using descriptive statistics. Qualitative data will be analysed using thematic and interpretive analysis.

Ethics and dissemination

The Royal Children’s Hospital Human Research Ethics Committee has approved this study (#91162). Informed consent will be obtained in writing from all participants and a legal guardian. Findings will inform the development of a full-scale RCT to evaluate the efficacy of TAG TEAM and will be disseminated through conferences and peer-reviewed journals.

Trial registration number

ACTRN12623000302651, ACTRN12623000318684.

Amantadine and/or transcranial magnetic stimulation for fatigue associated with multiple sclerosis (FETEM): study protocol for a phase 3 randomised, double-blind, cross-over, controlled clinical trial

Por: Matias-Guiu · J. A. · Gonzalez-Rosa · J. · Hernandez · M. A. · Martinez-Gines · M. L. · Portoles · A. · Perez-Macias · N. · Benito-Leon · J. · Padron · I. · Prieto · J. · Matias-Guiu · J.
Introduction

Fatigue is one of the most disabling symptoms of multiple sclerosis (MS), and effective treatments are lacking. Amantadine is one of the most used treatments, although its efficacy is under debate. Transcranial magnetic stimulation (TMS) is a promising intervention that has shown positive effects in some preliminary investigations. We aim to investigate the effect of 6 weeks of amantadine and/or TMS in fatigue due to MS.

Methods and analysis

The study is a national, multicentre, phase 3, randomised, double-blind, cross-over, placebo-controlled and sham-controlled clinical trial. Adult patients with relapsing-remitting MS, Expanded Disability Status Scale score of 1.5–4.5 and Fatigue Severity Score>4 are eligible for the trial. Participants will be randomised to one of the sequences of the study. Each sequence consists of four periods of 6 weeks of treatment and three washout periods of 12–18 weeks. All patients will receive all the combinations of therapies. The primary outcome is the Modified Fatigue Impact Scale. The secondary outcomes are the Symbol Digit Modalities Test (cognition), Beck Depression Inventory-II (depressive symptoms) and Short-Survey 12 (quality of life). Safety and cost-effectiveness will also be evaluated. An exploratory substudy including MRI and blood biomarkers will be conducted.

Ethics and dissemination

The study is approved by the Ethics Committee of the Hospital Clinico San Carlos and the Spanish Agency of Medications and Medical Devices. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.

Trial registration number

EudraCT 2021-004868-95; NCT05809414.

THromboprophylaxis In Sickle Cell Disease with central venous catheters (THIS): an internal pilot randomised controlled trial protocol

Por: Abdulrehman · J. · Forte · S. · Tomlinson · G. · Solh · Z. · Bolster · L. · Sun · H. · Bartolucci · P. · Kuo · K. H. M.
Introduction

Individuals with sickle cell disease (SCD) and central venous catheters (CVC) are at high risk for venous thromboembolism (VTE). Minimal data exist regarding the use of anticoagulation as thromboprophylaxis of VTE in this demographic, and as a result, clinical equipoise exists. Prophylactic dose rivaroxaban, a direct oral anticoagulant, is efficacious and safe as thromboprophylaxis in other demographics, and may be an optimal agent in SCD with CVC. Prior to conducting a full clinical trial to assess rivaroxaban as thromboprophylaxis in SCD with CVC, a pilot study is needed to gauge its feasibility.

Methods and analysis

THromboprophylaxis In Sickle Cell Disease pilot trial is an investigator-initiated, multicentre, double-blinded, randomised controlled trial (RCT) assessing if it is feasible and safe to conduct an adequately powered RCT comparing rivaroxaban to matching placebo as thromboprophylaxis in those with SCD and CVC. Fifty adult patients with SCD and CVC will be randomised to receive either rivaroxaban 10 mg daily or matching placebo for the duration of the CVC in situ for up to 1 year. After randomisation, follow-up visits will occur every 3 months. The primary outcomes pertain to the feasibility of a full trial and include numbers of eligible and recruited participants. Exploratory outcomes include overall incidence of VTE and bleeding complications, as well as quality of life. If the full trial is feasible, blinding will be maintained and patients in the pilot study will be included in the full trial.

Ethics and dissemination

The trial was initially approved by the University Health Network Research Ethics Board (REB) in Toronto, Canada. All sites will obtain approval from their respective REB prior to commencement of study activities. Study results will be disseminated through presentations at medical conferences and peer-reviewed publications.

Trial registration number

NCT05033314.

Randomised controlled trial combining vitamin E-functionalised chocolate with physical exercise to reduce the risk of protein-energy malnutrition in predementia aged people: study protocol for Choko-Age

Por: Pedrinolla · A. · Isanejad · M. · Antognelli · C. · Bartolini · D. · Borras · C. · Cavedon · V. · Di Sante · G. · Migni · A. · Mas-Bargues · C. · Milanese · C. · Baschirotto · C. · Modena · R. · Pistilli · A. · Rende · M. · Schena · F. · Stabile · A. M. · Telesa · N. V. · Tortorella · S.
Objective

Protein–energy malnutrition and the subsequent muscle wasting (sarcopenia) are common ageing complications. It is knowing to be also associated with dementia. Our programme will test the cytoprotective functions of vitamin E combined with the cortisol-lowering effect of chocolate polyphenols (PP), in combination with muscle anabolic effect of adequate dietary protein intake and physical exercise to prevent the age-dependent decline of muscle mass and its key underpinning mechanisms including mitochondrial function, and nutrient metabolism in muscle in the elderly.

Methods and analysis

In 2020, a 6-month double-blind randomised controlled trial in 75 predementia older people was launched to prevent muscle mass loss, in respond to the ‘Joint Programming Initiative A healthy diet for a healthy life’. In the run-in phase, participants will be stabilised on a protein-rich diet (0.9–1.0 g protein/kg ideal body weight/day) and physical exercise programme (high-intensity interval training specifically developed for these subjects). Subsequently, they will be randomised into three groups (1:1:1). The study arms will have a similar isocaloric diet and follow a similar physical exercise programme. Control group (n=25) will maintain the baseline diet; intervention groups will consume either 30 g/day of dark chocolate containing 500 mg total PP (corresponding to 60 mg epicatechin) and 100 mg vitamin E (as RRR-alpha-tocopherol) (n=25); or the high polyphenol chocolate without additional vitamin E (n=25). Muscle mass will be the primary endpoint. Other outcomes are neurocognitive status and previously identified biomolecular indices of frailty in predementia patients. Muscle biopsies will be collected to assess myocyte contraction and mitochondrial metabolism. Blood and plasma samples will be analysed for laboratory endpoints including nutrition metabolism and omics.

Ethics and dissemination

All the ethical and regulatory approvals have been obtained by the ethical committees of the Azienda Ospedaliera Universitaria Integrata of Verona with respect to scientific content and compliance with applicable research and human subjects’ regulation. Given the broader interest of the society toward undernutrition in the elderly, we identify four main target audiences for our research activity: national and local health systems, both internal and external to the project; targeted population (the elderly); general public; and academia. These activities include scientific workshops, public health awareness campaigns, project dedicated website and publication is scientific peer-review journals.

Trial registration number

NCT05343611.

Trajectories of self-kindness, common humanity, and mindfulness during the COVID-19 pandemic: A person-oriented multi-trajectory approach

by Robin Wollast, Éric Lacourse, Geneviève A. Mageau, Mathieu Pelletier-Dumas, Anna Dorfman, Véronique Dupéré, Jean-Marc Lina, Dietlind Stolle, Roxane de la Sablonnière

The COVID-19 pandemic has produced unprecedented changes in the lives of many people. Although research has documented associations between concerns related to COVID-19 and poor mental health indicators, fewer studies have focused on positive factors that could help people better cope with this stressful social context. To fill this gap, the present research investigated the trajectories of self-compassion facets in times of dramatic social change. Using a longitudinal research design, we described the trajectories of self-kindness, common humanity, and mindfulness during the first eight months of the COVID-19 pandemic, in a representative sample of Canadian adults (N = 3617). Relying on a multi-trajectory group-based approach, we identified clusters of individuals following persistently low (4.0%), moderate-low (39.3%), moderate-high (46.7%), and high (10.0%) levels of self-kindness, common humanity, and mindfulness. Interestingly, we found that compassionate self-responding trajectories were mainly stable over time with minor fluctuations for some groups of individuals, in line with the epidemiological situation. In terms of covariates, we observed that older women were more likely to follow trajectories of high compassionate self-responding, as compared to the other age and gender groups. In terms of mental health indicators, we demonstrated that trajectory groups with high levels of compassionate self-responding were associated with greater life satisfaction, more happiness, better sleep quality, higher sleep quantity, and fewer negative emotions, as compared to lower trajectory groups. The results supported the idea that self-compassion during the COVID-19 pandemic could have favored better mental health indicators and could possibly be promoted as a psychological intervention in the general population.

Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial

Por: Mandetta · A. R. H. · Bortoletto · C. C. · Sobral · A. P. T. · Goncalves · M. L. L. · Motta · L. J. · Horliana · A. C. R. T. · Ferrari · R. A. M. · Prates · R. A. · Deana · A. M. · Cordeiro · R. d. C. L. · Pinto · L. A. M. d. S. · Fernandes · K. P. S. · Bussadori · S. K.
Introduction

Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control.

Methods and analysis

Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical–mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the 2 test or Fisher’s exact test. Pearson’s correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.

Ethics and dissemination

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal.

Trial registration number

NCT05443035.

Perceptions of academic staff and students of senior high school in implementing game-based exercises in physical education classes--a research protocol for a qualitative descriptive study

Por: Manlapaz · D. · Vergara · J. A. · Alpuerto · K. M. B. · De Los Santos · I. K. S. · Enriquez · M. U. · Manicio · Z. Z. · Mendres · J. E. F. · Tolosa · C. G. S. · Vilela · Z. G. D. · Zabat · Z. E. G. A.
Background

The COVID-19 pandemic has taken a toll on both physical activity and fitness as several pursuits and activities have been restricted. Coupled with this, increased food intake and sedentary lifestyles have produced poor physical health outcomes. Online physical education classes have been more difficult to conduct given the limitations of the setup. As such, exergaming has been identified as a possible educational tool that could improve students’ motivation, participation and fitness levels and reduce negative behaviours in class while contributing to the current curriculum.

Objectives

The study explores the perspectives of both the physical education academic staff and senior high school students from the University of Santo Tomas on the implementation of exergaming to determine the feasibility of exergaming as an educational tool in the Philippines’ physical education curriculum.

Methodology

A descriptive qualitative design will be used and participants will be selected through criterion sampling. The authors will conduct a process of question development and pilot FGDs beforehand to ensure smooth proceedings. Once done, they will undergo FGDs conducted through Google Meet. Data will be coded and analysed via thematic analysis using manual coding and NVivo V.12 software to summarise central themes and perceptions.

Ethics and dissemination

This study will abide by the Nuremberg Code, Declaration of Helsinki, Belmont Report, Data Privacy Act of 2012 and National Ethical Guidelines (for health-related research) of 2017. The study has received approval from the University of Santo Tomas (UST)-College of Rehabilitation Sciences (CRS) Ethics Review Committee. All participant data will be labelled according to random two-digit computer generated codes to preserve anonymity and stored in password-protected laptops and Google Drive folders to preserve confidentiality. Results will be made available to individual UST physical education academic staff and senior high school students prior to publication in peer-reviewed journal.

El tiempo de juego del niño se revela durante una sesión de juego dramático terapéutico

El objetivo de este estudio fue describir las etapas de creación de apego y detención del juego durante las sesiones de juego terapéutico dramático para niños. Estudio fenomenológico a la luz de la referencia filosófica heideggeriana. Participaron 12 niños de entre 3 y 11 años. El análisis de las entrevistas fenomenológicas mediadas por el juego permitió el surgimiento de un eje temático - El tiempo de juego del niño: ser-en-abertura. El juego permite al niño revelar aspectos de su existencia en el tiempo cronológico y favorece la puesta en común de nuevas posibilidades de relacionarse libremente con el mundo. Sin embargo, el tiempo que juega puede ser elástico y negociable según la necesidad individual, de modo que se consideren todas las expresiones del niño que se convierten en su facticidad durante el juego. Por lo tanto, independientemente de la forma y el momento en que jueguen, este estudio destacó la importancia de respetar la existencia del niño en ese momento.

Could <i>Cratylia argentea</i> replace Tifton 85 hay on growing and finishing lamb diets in tropical areas?

by Elaine Cristina Teixeira, Lucas Freires Abreu, Fernando Antônio de Souza, Walter José Rodrigues Matrangolo, Karina Toledo da Silva, Luciano Soares de Lima, Hemilly Cristina Menezes de Sa, Ângela Maria Quintão Lana

Legumes shrubs such as Cratylia argentea have an ability to thrive in environments with low water availability and poor soil. On the other hand, forage grasses such as Tifton 85 have a greater demand for inputs to be productive. The objective of this study was to evaluate the performance of growing and finishing Lacaune lambs fed Cratylia argentea hay as an alternative to Tifton 85 (Cynodon spp). Twenty-four Lacaune lambs aged between five and six months (average body weight [BW] 21.50 ± 3.38 kg) were arranged in a split-plot randomized block design. The plots consisted of different Cratylia to Tifton 85 hay proportions (0, 20%, 40%, or 100%, dry matter [DM] basis) as a roughage replacement in the total diet. The subplots represented two evaluation times, entitled “initial period” and “final period”, which consisted of the early seven days of total feces and urine collection, and the last seven days of the experiment, respectively. The lambs were blocked by weight with six replicates per treatment. The results show that the level of Tifton 85 replacement for Cratylia hay in the roughage portion of the lamb diet did not influence (P > 0.05) weight gain (WG), dry matter intake or dry matter digestibility; feed conversion, feed efficiency; and the evaluated nitrogen balance variables. The digestibility coefficient of neutral detergent fiber decreased linearly as Tifton 85 replacement for Cratylia level was increased, which probably happened due to the presence of highly lignified material within the Cratylia hay. However, the alternative legume maintained animal performance of Tifton 85. In conclusion, Cratylia hay can be recommended as a potential substitute for Tifton 85 hay, which requires greater inputs for the production. Cratylia may be considered a feeding strategy for livestock production, especially for smallholder livestock systems and regions with unfavorable soil and climate.

Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review protocol

Por: De Oliveira Ascef · B. · Gabriel · F. C. · Suzumura · E. A. · Maia · F. H. d. A. · Bortoluzzi · A. F. R. · Farias · N. S. · Jahn · B. · Siebert · U. · De Soarez · P. C.
Background

Benefit–risk assessment (BRA) is used in multiple phases along the health technology’s life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA’s application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA.

Methods and analysis

This scoping review protocol was developed following the framework proposed by Arksey and O’Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts.

Ethics and dissemination

This review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops.

Trial registration number

Open Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).

Designing intervention prototypes to improve infant and young child nutrition in Peru: a participatory design study protocol

Por: Rousham · E. · Pareja · R. G. · Creed-Kanashiro · H. M. · Bartolini · R. · Pradeilles · R. · Ortega-Roman · D. · Holdsworth · M. · Griffiths · P. · Verdezoto · N.
Introduction

Nutrition during the complementary feeding period (6–23 months) is critical to ensure optimal growth and reduce the risk of diet-related disease across the life course. Strategies to reduce multiple forms of malnutrition (stunting, overweight/obesity and anaemia) in infants and young children (IYC) are a key priority in low-income and middle-income countries, including Peru. This study aims to co-design and develop prototypes for interventions to address the multiple forms of malnutrition in IYC in urban Peru, using a participatory design approach.

Methods and analysis

The study will be based within peri-urban communities in two areas of Peru (Lima and Huánuco city). Following the identification of key nutritional challenges for IYC aged 6–23 months through formative research (phase I), we will conduct a series of workshops bringing together healthcare professionals from government health centres and caregivers of IYC aged 6–23 months. Workshops (on idea generation; creating future scenarios; storyboarding and early implementation and feedback) will take place in parallel in the two study areas. Through these workshops, we will engage with community participants to explore, experiment, co-design and iteratively validate new design ideas to address the challenges around IYC complementary feeding from phase I. Workshop outputs and transcripts will be analysed qualitatively using affinity diagramming and thematic analyses. The intervention prototypes will be evaluated qualitatively and piloted with the participating communities.

Ethics and dissemination

Ethical approval for this study was obtained from the Ethical Review Committee of the Instituto de Investigación Nutricional (IIN) Peru (388-2019/CIEI-IIN), Loughborough University (C19-87) and confirmed by Cardiff University. Findings of the participatory design process will be disseminated through a deliberative workshop in Lima, Peru with national and regional government stakeholders, as well as participants and researchers involved in the design process. Further dissemination will take place through policy briefs, conferences and academic publications.

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