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Ayer — Mayo 14th 2024Tus fuentes RSS

Spatial variations in the osteocyte lacuno-canalicular network density and analysis of the connectomic parameters

by Junning Chen, Marta Aido, Andreas Roschger, Alexander van Tol, Sara Checa, Bettina M. Willie, Richard Weinkamer

Osteocyte lacuno-canalicular network (LCN) is comprised of micrometre-sized pores and submicrometric wide channels in bone. Accumulating evidence suggests multiple functions of this network in material transportation, mechanobiological signalling, mineral homeostasis and bone remodelling. Combining rhodamine staining and confocal laser scanning microscopy, the longitudinal cross-sections of six mouse tibiae were imaged, and the connectome of the network was quantified with a focus on the spatial heterogeneities of network density, connectivity and length of canaliculi. In-vivo loading and double calcein labelling on these tibiae allowed differentiating the newly formed bone from the pre-existing regions. The canalicular density of the murine cortical bone varied between 0.174 and 0.243 μm/μm3, and therefore is three times larger than the corresponding value for human femoral midshaft osteons. The spatial heterogeneity of the network was found distinctly more pronounced across the cortex than along the cortex. We found that in regions with a dense network, the LCN conserves its largely tree-like character, but increases the density by including shorter canaliculi. The current study on healthy mice should serve as a motivating starting point to study the connectome of genetically modified mice, including models of bone diseases and of reduced mechanoresponse.

Documentation of social determinants of health across individuals from different racial and ethnic groups in home healthcare

Abstract

Introduction

Home healthcare (HHC) enables patients to receive healthcare services within their homes to manage chronic conditions and recover from illnesses. Recent research has identified disparities in HHC based on race or ethnicity. Social determinants of health (SDOH) describe the external factors influencing a patient's health, such as access to care and social support. Individuals from racially or ethnically minoritized communities are known to be disproportionately affected by SDOH. Existing evidence suggests that SDOH are documented in clinical notes. However, no prior study has investigated the documentation of SDOH across individuals from different racial or ethnic backgrounds in the HHC setting. This study aimed to (1) describe frequencies of SDOH documented in clinical notes by race or ethnicity and (2) determine associations between race or ethnicity and SDOH documentation.

Design

Retrospective data analysis.

Methods

We conducted a cross-sectional secondary data analysis of 86,866 HHC episodes representing 65,693 unique patients from one large HHC agency in New York collected between January 1, 2015, and December 31, 2017. We reported the frequency of six SDOH (physical environment, social environment, housing and economic circumstances, food insecurity, access to care, and education and literacy) documented in clinical notes across individuals reported as Asian/Pacific Islander, Black, Hispanic, multi-racial, Native American, or White. We analyzed differences in SDOH documentation by race or ethnicity using logistic regression models.

Results

Compared to patients reported as White, patients across other racial or ethnic groups had higher frequencies of SDOH documented in their clinical notes. Our results suggest that race or ethnicity is associated with SDOH documentation in HHC.

Conclusion

As the study of SDOH in HHC continues to evolve, our results provide a foundation to evaluate social information in the HHC setting and understand how it influences the quality of care provided.

Clinical Relevance

The results of this exploratory study can help clinicians understand the differences in SDOH across individuals from different racial and ethnic groups and serve as a foundation for future research aimed at fostering more inclusive HHC documentation practices.

Artificial Intelligence and the National Violent Death Reporting System: A Rapid Review

imageAs the awareness on violent deaths from guns, drugs, and suicides emerges as a public health crisis in the United States, attempts to prevent injury and mortality through nursing research are critical. The National Violent Death Reporting System provides public health surveillance of US violent deaths; however, understanding the National Violent Death Reporting System's research utility is limited. The purpose of our rapid review of the 2019-2023 literature was to understand to what extent artificial intelligence methods are being used with the National Violent Death Reporting System. We identified 16 National Violent Death Reporting System artificial intelligence studies, with more than half published after 2020. The text-rich content of National Violent Death Reporting System enabled researchers to center their artificial intelligence approaches mostly on natural language processing (50%) or natural language processing and machine learning (37%). Significant heterogeneity in approaches, techniques, and processes was noted across the studies, with critical methods information often lacking. The aims and focus of National Violent Death Reporting System studies were homogeneous and mostly examined suicide among nurses and older adults. Our findings suggested that artificial intelligence is a promising approach to the National Violent Death Reporting System data with significant untapped potential in its use. Artificial intelligence may prove to be a powerful tool enabling nursing scholars and practitioners to reduce the number of preventable, violent deaths.

Impact evaluation of a cash-plus programme for children with disabilities in the Xiengkhouang Province in Lao PDR: study protocol for a non-randomised controlled trial

Por: Banks · L. M. · Soukkhaphone · B. · Scherer · N. · Siengsounthone · L. · Carew · M. T. · Shakespeare · T. · Chen · S. · Davey · C. · Goyal · D. · Zinke-Allmang · A. · Kuper · H. · Chanthakoumane · K.
Introduction

More than 170 countries have implemented disability-targeted social protection programmes, although few have been rigorously evaluated. Consequently, a non-randomised controlled trial is being conducted of a pilot ‘cash-plus’ programme implemented by UNICEF Laos and the Laos government for children with disabilities in the Xiengkhouang Province in Laos. The intervention combines a regular cash transfer with provision of assistive devices and access for caregivers to a family support programme.

Methods and analysis

The non-randomised controlled trial will involve 350 children with disabilities across 3 districts identified by programme implementers as eligible for the programme (intervention arm). Implementers have also identified approximately 180 children with disabilities in neighbouring districts, who would otherwise meet eligibility criteria but do not live in the project areas (control arm). The trial will assess the impact of the programme on child well-being (primary outcome), as well as household poverty, caregiver quality of life and time use (secondary outcomes). Baseline data are being collected May–October 2023, with endline 24 months later. Analysis will be intention to treat. A complementary process evaluation will explore the implementation, acceptability of the programme, challenges and enablers to its delivery and mechanisms of impact.

Ethics and dissemination

The study has received ethical approval from the London School of Hygiene and Tropical Medicine and the National Ethics Committee for Health Research in Laos. Informed consent and assent will be taken by trained data collectors. Data will be collected and stored on a secure, encrypted server and its use will follow a detailed data management plan. Findings will be disseminated in academic journals and in short briefs for policy and programmatic actors, and in online and in-person events.

Trial registration number

ISRCTN80603476.

Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies

Por: van Gils · L. · de Boer · M. A. · Bosmans · J. · Duijnhoven · R. · Schoenmakers · S. · Derks · J. B. · Prins · J. R. · Al-Nasiry · S. · Lutke Holzik · M. · Lopriore · E. · van Drongelen · J. · Knol · M. H. · van Laar · J. O. E. H. · Jacquemyn · Y. · van Holsbeke · C. · Dehaene · I. · L
Introduction

Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.

Methods and analysis

We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at

Ethics and dissemination

This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.

Trial registration number

ClinicalTrials.gov, NCT05968794.

Risk and time preferences in individuals with lifestyle-related and non-lifestyle-related cardiovascular diseases: a pilot study

Por: Kairies-Schwarz · N. · Mussio · I. · Bulla-Holthaus · N. · Wankmüller · E. · Wolff · G. · Gontscharuk · V. · Heinen · Y. · Perings · S. · Brockmeyer · M. · Kelm · M. · Icks · A.
Objectives

To (1) pilot a study of behavioural characterisation based on risk and time preferences in clinically well-characterised individuals, (2) assess the distribution of preferences in this population and (3) explore differences in preferences between individuals with ‘lifestyle-related’ (LS) and ‘non-lifestyle-related’ (NLS) cardiovascular diseases.

Design

Cross-sectional study with an economic online experiment to collect risk and time preferences, a detailed clinical characterisation and a sociodemographic and lifestyle survey. A definition of LS and NLS groups was developed.

Setting

Specialist outpatient clinics of the clinic for cardiology and pneumology of the University Hospital Düsseldorf and patients from a cardiology practice in Düsseldorf.

Participants

A total of 74 individuals with cardiovascular diseases.

Outcomes

Risk and time preferences.

Results

The implementation of the study process, including participant recruitment and data collection, ran smoothly. The medical checklist, the survey and the time preference instrument were well received. However, the conceptual understanding of the risk preference instrument resulted in inconsistent choices for many participants (47%). The remaining individuals were more risk averse (27%) than risk seeking (16%) and risk neutral (10%). Individuals in our sample were also more impatient (49%) than patient (42%). The participant classification showed that 65% belonged to the LS group, 19% to the NLS group and 16% could not be assigned (unclear allocation to lifestyle (ULS) group). Excluding the ULS group, we show that individuals in the LS group were more risk seeking, and unexpectedly, more patient than those in the NLS group.

Conclusions

The process of the pilot study and its results can be used as a basis for the design of the main study. The differences in risk and time preferences between the LS and NLS groups provide us with a novel hypothesis for unhealthy behaviours: individuals never give up a bad habit, they simply postpone the latter, which can be tested alongside other additional research questions.

Appropriateness and acceptability of continuous glucose monitoring in people with type 1 diabetes at rural first-level hospitals in Malawi: a qualitative study

Por: Thapa · A. · Chibvunde · S. · Schwartz · L. · Trujillo · C. · Ferrari · G. · Drown · L. · Gomber · A. · Park · P. H. · Matanje · B. · Msekandiana · A. · Kachimanga · C. · Bukhman · G. · Ruderman · T. · Adler · A. J.
Objectives

The purpose of this qualitative study is to describe the acceptability and appropriateness of continuous glucose monitoring (CGM) in people living with type 1 diabetes (PLWT1D) at first-level (district) hospitals in Malawi.

Design

We conducted semistructured qualitative interviews among PLWT1D and healthcare providers participating in the study. Standardised interview guides elicited perspectives on the appropriateness and acceptability of CGM use for PLWT1D and their providers, and provider perspectives on the effectiveness of CGM use in Malawi. Data were coded using Dedoose software and analysed using a thematic approach.

Setting

First-level hospitals in Neno district, Malawi.

Participants

Participants were part of a randomised controlled trial focused on CGM at first-level hospitals in Neno district, Malawi. Pretrial and post-trial interviews were conducted for participants in the CGM and usual care arms, and one set of interviews was conducted with providers.

Results

Eleven PLWT1D recruited for the CGM randomised controlled trial and five healthcare providers who provided care to participants with T1D were included. Nine PLWT1D were interviewed twice, two were interviewed once. Of the 11 participants with T1D, six were from the CGM arm and five were in usual care arm. Key themes emerged regarding the appropriateness and effectiveness of CGM use in lower resource setting. The four main themes were (a) patient provider relationship, (b) stigma and psychosocial support, (c) device usage and (d) clinical management.

Conclusions

Participants and healthcare providers reported that CGM use was appropriate and acceptable in the study setting, although the need to support it with health education sessions was highlighted. This research supports the use of CGM as a component of personalised diabetes treatment for PLWT1D in resource constraint settings.

Trial registration number

PACTR202102832069874; Post-results.

Economic impact of informal caring for a person with arthritis in Australia from 2015 to 2030: a microsimulation approach using national survey data

Por: Schofield · D. J. · Lim · K. · Tanton · R. · Veerman · L. · Kelly · S. J. · Passey · M. · Shrestha · R.
Objectives

To estimate the economic burden of informal caregivers not in the labour force (NILF) due to caring for a person with arthritis in Australia, with projections of these costs from 2015 to 2030.

Design

Static microsimulation modelling using national survey data.

Setting

Australia nationwide survey.

Participants

Participants include respondents to the Survey of Disability, Ageing and Carers who are informal carers of a person who has arthritis as their main chronic condition and non-carers.

Outcome measures

Estimating the economic impact and national aggregated costs of informal carers NILF to care for a person with arthritis and projecting these costs from 2015 to 2030 in 5-year intervals.

Results

On a per-person basis, when adjusted for age, sex and highest education attained, the difference in average weekly total income between informal carers and non-carers employed in the labour force is $A1051 (95% CI: $A927 to $A1204) in 2015 and projected to increase by up to 22% by 2030. When aggregated, the total national annual loss of income to informal carers NILF is estimated at $A388.2 million (95% CI: $A324.3 to $A461.9 million) in 2015, increasing to $A576.9 million (95% CI: $A489.2 to $A681.8 million) by 2030. The national annual tax revenue lost to the government of the informal carers NILF is estimated at $A99 million (95% CI: $A77.9 to $A126.4 million) in 2015 and is projected to increase 49% by 2030.

Conclusion

Informal carers NILF are economically worse off than employed non-carers, and the aggregated national annual costs are substantial. The future economic impact of informal carers NILF to care for a person with arthritis in Australia is projected to increase, with the estimated differences in income between informal carers and employed non-carers increasing by 22% from 2015 to 2030.

Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME) study: protocol for a randomised controlled trial

Por: Little · R. B. · Carter · S. J. · Motl · R. W. · Hunter · G. · Cook · A. · Liu · N. · Krontiras · H. · Lefkowitz · E. J. · Turan · B. · Schleicher · E. · Rogers · L. Q.
Introduction

Breast cancer survivors have an increased risk for chronic fatigue and altered gut microbiota composition, both with negative health and quality of life affects. Exercise modestly improves fatigue and is linked to gut microbial diversity and production of beneficial metabolites. Studies suggest that gut microbiota composition is a potential mechanism underlying fatigue response to exercise. Randomised controlled trials testing the effects of exercise on the gut microbiome are limited and there is a scarcity of findings specific to breast cancer survivors. The objective of this study is to determine if fitness-related modifications to gut microbiota occur and, if so, mediate the effects of aerobic exercise on fatigue response.

Methods and analysis

The research is a randomised controlled trial among breast cancer survivors aged 18–74 with fatigue. The primary aim is to determine the effects of aerobic exercise training compared with an attention control on gut microbiota composition. The secondary study aims are to test if exercise training (1) affects the gut microbiota composition directly and/or indirectly through inflammation (serum cytokines), autonomic nervous system (heart rate variability) or hypothalamic-pituitary-adrenal axis mediators (hair cortisol assays), and (2) effects on fatigue are direct and/or indirect through changes in the gut microbiota composition. All participants receive a standardised controlled diet. Assessments occur at baseline, 5 weeks, 10 weeks and 15 weeks (5 weeks post intervention completion). Faecal samples collect the gut microbiome and 16S gene sequencing will identify the microbiome. Fatigue is measured by a 13-item multidimensional fatigue scale.

Ethics and dissemination

The University of Alabama at Birmingham Institutional Review Board (IRB) approved this study on 15 May 2019, UAB IRB#30000320. A Data and Safety Monitoring Board convenes annually or more often if indicated. Findings will be disseminated in peer-reviewed journals and conference presentations.

Trial registration number

ClinicalTrials.gov, NCT04088708.

Saxon Epidemiological Study in General Practice-6 (SESAM-6): protocol of a cross-sectional study

Por: Gräfe · W. · Liebig · L. · Deutsch · T. · Schübel · J. · Bergmann · A. · Bleckwenn · M. · Frese · T. · Brütting · C. · Riemenschneider · H.
Introduction

General practitioners (GPs) are mostly the first point of contact for patients with health problems in Germany. There is only a limited epidemiological overview data that describe the GP consultation hours based on other than billing data. Therefore, the aim of Saxon Epidemiological Study in General Practice-6 (SESAM-6) is to examine the frequency of reasons for encounter, prevalence of long-term diagnosed diseases and diagnostic and therapeutic decisions in general practice. This knowledge is fundamental to identify the healthcare needs and to develop strategies to improve the GP care. The results of the study will be incorporated into the undergraduate, postgraduate and continuing medical education for GP.

Methods and analysis

This cross-sectional study SESAM-6 is conducted in general practices in the state of Saxony, Germany. The study design is based on previous SESAM studies. Participating physicians are assigned to 1 week per quarter (over a survey period of 12 months) in which every fifth doctor–patient contact is recorded for one-half of the day (morning or afternoon). To facilitate valid statements, a minimum of 50 GP is required to document a total of at least 2500 doctor–patient contacts. Univariable, multivariable and subgroup analyses as well as comparisons to the previous SESAM data sets will be conducted.

Ethics and dissemination

The study was approved by the Ethics Committee of the Technical University of Dresden in March 2023 (SR-EK-7502023). Participation in the study is voluntary and will not be remunerated. The study results will be published in peer-reviewed scientific journals, preferably with open access. They will also be disseminated at scientific and public symposia, congresses and conferences. A final report will be published to summarise the central results and provided to all study participants and the public.

Effects of physiotherapy and home-based training in parkinsonian syndromes: protocol for a randomised controlled trial (MobilityAPP)

Por: Raccagni · C. · Sidoroff · V. · Paraschiv-Ionescu · A. · Roth · N. · Schönherr · G. · Eskofier · B. · Gassner · H. · Kluge · F. · Teatini · F. · Seppi · K. · Goebel · G. · Benninger · D. H. · Aminian · K. · Klucken · J. · Wenning · G.
Introduction

Gait and mobility impairment are pivotal signs of parkinsonism, and they are particularly severe in atypical parkinsonian disorders including multiple system atrophy (MSA) and progressive supranuclear palsy (PSP). A pilot study demonstrated a significant improvement of gait in patients with MSA of parkinsonian type (MSA-P) after physiotherapy and matching home-based exercise, as reflected by sensor-based gait parameters. In this study, we aim to investigate whether a gait-focused physiotherapy (GPT) and matching home-based exercise lead to a greater improvement of gait performance compared with a standard physiotherapy/home-based exercise programme (standard physiotherapy, SPT).

Methods and analysis

This protocol was deployed to evaluate the effects of a GPT versus an active control undergoing SPT and matching home-based exercise with regard to laboratory gait parameters, physical activity measures and clinical scales in patients with Parkinson’s disease (PD), MSA-P and PSP. The primary outcomes of the trial are sensor-based laboratory gait parameters, while the secondary outcome measures comprise real-world derived parameters, clinical rating scales and patient questionnaires. We aim to enrol 48 patients per disease group into this double-blind, randomised-controlled trial. The study starts with a 1 week wearable sensor-based monitoring of physical activity. After randomisation, patients undergo a 2 week daily inpatient physiotherapy, followed by 5 week matching unsupervised home-based training. A 1 week physical activity monitoring is repeated during the last week of intervention.

Ethics and dissemination

This study, registered as ‘Mobility in Atypical Parkinsonism: a Trial of Physiotherapy (Mobility_APP)’ at clinicaltrials.gov (NCT04608604), received ethics approval by local committees of the involved centres. The patient’s recruitment takes place at the Movement Disorders Units of Innsbruck (Austria), Erlangen (Germany), Lausanne (Switzerland), Luxembourg (Luxembourg) and Bolzano (Italy). The data resulting from this project will be submitted to peer-reviewed journals, presented at international congresses and made publicly available at the end of the trial.

Trial registration number

NCT04608604.

Coordination of oral anticoagulant care at hospital discharge (COACHeD): pilot randomised controlled trial

Por: Holbrook · A. · Troyan · S. · Telford · V. · Koubaesh · Y. · Vidug · K. · Yoo · L. · Deng · J. · Lohit · S. · Giilck · S. · Ahmed · A. · Talman · M. · Leonard · B. · Refaei · M. · Tarride · J.-E. · Schulman · S. · Douketis · J. · Thabane · L. · Hyland · S. · Ho · J. M.-W. · Siegal · D.
Objectives

To evaluate whether a focused, expert medication management intervention is feasible and potentially effective in preventing anticoagulation-related adverse events for patients transitioning from hospital to home.

Design

Randomised, parallel design.

Setting

Medical wards at six hospital sites in southern Ontario, Canada.

Participants

Adults 18 years of age or older being discharged to home on an oral anticoagulant (OAC) to be taken for at least 4 weeks.

Interventions

Clinical pharmacologist-led intervention, including a detailed discharge medication management plan, a circle of care handover and early postdischarge virtual check-up visits to 1 month with 3-month follow-up. The control group received the usual care.

Outcomes measures

Primary outcomes were study feasibility outcomes (recruitment, retention and cost per patient). Secondary outcomes included adverse anticoagulant safety events composite, quality of transitional care, quality of life, anticoagulant knowledge, satisfaction with care, problems with medications and health resource utilisation.

Results

Extensive periods of restriction of recruitment plus difficulties accessing patients at the time of discharge negatively impacted feasibility, especially cost per patient recruited. Of 845 patients screened, 167 were eligible and 56 were randomised. The mean age (±SD) was 71.2±12.5 years, 42.9% females, with two lost to follow-up. Intervention patients were more likely to rate their ability to manage their OAC as improved (17/27 (63.0%) vs 7/22 (31.8%), OR 3.6 (95% CI 1.1 to 12.0)) and their continuity of care as improved (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Fewer intervention patients were taking one or more inappropriate medications (7 (22.5%) vs 15 (60%), OR 0.19 (95% CI 0.06 to 0.62)).

Conclusion

This pilot randomised controlled trial suggests that a transitional care intervention at hospital discharge for older adults taking OACs was well received and potentially effective for some surrogate outcomes, but overly costly to proceed to a definitive large trial.

Trial registration number

NCT02777047.

Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance

Por: Ramboarina · S. · Crucitti · T. · Gill · K. · Bekker · L. G. · Harding-Esch · E. M. · van de Wijgert · J. H. H. M. · Huynh · B.-T. · Fortas · C. · Harimanana · A. · Mayouya Gamana · T. · Randremanana · R. V. · Mangahasimbola · R. · Dziva Chikwari · C. · Kranzer · K. · Mackworth-You
Introduction

A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test—called the Genital InFlammation Test (GIFT)—for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care.

Methods and analysis

We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical (‘diagnostic study’) and a qualitative, modelling and economic (‘an integration into care study’) part. The diagnostic study aims to evaluate GIFT’s performance in identifying asymptomatic women with discharge-causing STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms.

Ethics and dissemination

Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.

The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d’Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).

Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484).

Trial registration number

NCT05723484.

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Changes in parenting behavior in the time of COVID—19: A mixed method approach

by Luiza Mesesan-Schmitz, Claudiu Coman, Carmen Stanciu, Venera Bucur, Laurentiu Gabriel Tiru, Maria Cristina Bularca

This study was designed to explore mothers’ perceptions about changes in parenting behavior in the middle of the pandemic COVID 19 period. Based on the convergent mixed-method design and Parental Stress model, we illustrated these changes by taking into account the impact of the pandemic perceived by mothers and the resources they had available. Research on parenting changes was important in the Romanian context because, in that challenging period, there were no regulations to safeguard parents, especially single parents as mothers. Mothers experienced increased levels of stress, some of them having to leave their jobs to stay at home with their children. Other mothers needed to work from home and in the meantime to take care of their children. In this context we wanted to illustrate the possible changes that occurred in their parenting behavior during the pandemic period. Results from the quantitative survey showed that there is a moderate correlation between the negative impact felt by mothers and the negative changes in their parenting behavior, and this correlation was diminished by a series of resources such as: social support, parenting alliance, or high income. Qualitative data provided better understanding of mothers’ parenting behavior by showing that mothers shared both positive and negative experiences during the pandemic, regardless of the general trend mentioned. As shown by the quantitative data, the qualitative data also showed that mothers who felt more strongly the impact of the pandemic reported more negative changes in their parenting behavior. The positive changes most frequently stated involved expressing affection and communicating more often on various topics, carrying out leisure activities or activities meant to help with the personal development of the child, and involving children in domestic activities. Mothers mostly described negative aspects such as too much involvement in school life, increased control and surveillance of children, especially when it comes to school related activities and to the time children were allowed to spend on their digital devices. These changes led to conflicts and sometimes, mothers resorted to discipline practices. In addition to the resources identified in quantitative research, mothers with higher education and medium–high income also turned to specialized resources (psychologists, online courses, support groups) in order to manage conflicts, them being able to see the challenges of the pandemic as an opportunity to develop and improve the relationship with their children.

Evaluation of a manualised neurofeedback training in psychosomatic-psychotherapeutic outpatient treatment (Neuro-pp-out): study protocol for a clinical mixed-methods pilot study

Por: Schmidt · K. L. · Kowalski · A. · Schweda · A. · Dörrie · N. · Skoda · E. M. · Bäuerle · A. · Teufel · M.
Introduction

Electroencephalographic neurofeedback (NFB), as a non-invasive form of brainwave training, has been shown to be effective in the treatment of various mental health disorders. However, only few results regarding manualised and standardised NFB trainings exist. This makes comparison as well as replication of studies difficult. Therefore, we developed a standard manual for NFB training in patients with mental health disorders attending a psychosomatic outpatient clinic. The current study aims at investigating the conduction of a standardised manual for NFB training in patients with mental health disorders. If successful, the study provides new opportunities to investigate NFB in a more controlled and comparable manner in clinical practice.

Methods and analysis

30 patients diagnosed with a mental health disorder will be included. After the educational interview, patients will undergo baseline diagnostics (T0). The subsequent intervention consists of 10 sessions of NFB training aiming at increasing sensorimotor rhythm and alpha-frequency amplitudes and decreasing theta-frequency and high beta-frequency amplitudes to induce relaxation and decrease subjective stress. All patients will undergo a post-treatment diagnostic assessment (T1) and a follow-up assessment 8 weeks following the closing session (T2). Changes in amplitude bands (primary outcome) will be recorded with electroencephalography during pre-assessments, post-assessments and follow-up assessments and during NFB sessions. Physiological (respiratory rate, blood volume pulse, muscle tension) and psychometric parameters (distress, perceived stress, relaxation ability, depressive and anxiety symptoms, insomnia, self-efficacy and quality of life) will be assessed at T0, T1 and T2. Moreover, satisfaction, acceptance and usability will be assessed at T1 after NFB training. Further, qualitative interviews about the experiences with the intervention will be conducted with NFB practitioners 6 months after the study starts. Quantitative data will be analysed using repeated measures analysis of variance as well as mediation analyses on mixed linear models. Qualitative data will be analysed using Mayring’s content analysis.

Ethics and dissemination

The study was approved by the ethics committee of the Medical Faculty of the University of Duisburg-Essen (23–11140-BO) and patient enrolment began in April 2023. Before participation, written informed consent by each participant will be required. Results will be published in peer-reviewed journals and conference presentations.

Trial registration number

Prospectively registered on 28 March 2023 in the German clinical trials register, DRKS00031497.

Cost of SARS-CoV-2 self-test distribution programmes by different modalities: a micro-costing study in five countries (Brazil, Georgia, Malaysia, Ethiopia and the Philippines)

Por: Hansen · M. A. · Lekodeba · N. A. · Chevalier · J. M. · Ockhuisen · T. · del Rey-Puech · P. · Marban-Castro · E. · Martinez-Perez · G. Z. · Shilton · S. · Radzi Abu Hassan · M. · Getia · V. · Weinert-Mizuschima · C. · Tenorio Bezerra · M. I. · Chala · L. · Leong · R. · Peregino · R.
Objective

Diagnostic testing is an important tool to combat the COVID-19 pandemic, yet access to and uptake of testing vary widely 3 years into the pandemic. The WHO recommends the use of COVID-19 self-testing as an option to help expand testing access. We aimed to calculate the cost of providing COVID-19 self-testing across countries and distribution modalities.

Design

We estimated economic costs from the provider perspective to calculate the total cost and the cost per self-test kit distributed for three scenarios that differed by costing period (pilot, annual), the number of tests distributed (actual, planned, scaled assuming an epidemic peak) and self-test kit costs (pilot purchase price, 50% reduction).

Setting

We used data collected between August and December 2022 in Brazil, Georgia, Malaysia, Ethiopia and the Philippines from pilot implementation studies designed to provide COVID-19 self-tests in a variety of settings—namely, workplace and healthcare facilities.

Results

Across all five countries, 173 000 kits were distributed during pilot implementation with the cost/test distributed ranging from $2.44 to $12.78. The cost/self-test kit distributed was lowest in the scenario that assumed implementation over a longer period (year), with higher test demand (peak) and a test kit price reduction of 50% ($1.04–3.07). Across all countries and scenarios, test procurement occupied the greatest proportion of costs: 58–87% for countries with off-site self-testing (outside the workplace, for example, home) and 15–50% for countries with on-site self-testing (at the workplace). Staffing was the next key cost driver, particularly for distribution modalities that had on-site self-testing (29–35%) versus off-site self-testing (7–27%).

Conclusions

Our results indicate that it is likely to cost between $2.44 and $12.78 per test to distribute COVID-19 self-tests across common settings in five heterogeneous countries. Cost-effectiveness analyses using these results will allow policymakers to make informed decisions on optimally scaling up COVID-19 self-test distribution programmes across diverse settings and evolving needs.

Shared decision-making for non-operative management versus operative management of hip fractures in selected frail older adults with a limited life expectancy: a protocol for a nationwide implementation study

Por: Zeelenberg · M. L. · Oosterwijk · P. C. · Willems · H. C. · Gosens · T. · Den Hartog · D. · Joosse · P. · Loggers · S. A. I. · Nijdam · T. M. · Pel-Littel · R. E. · Polinder · S. · Schuijt · H. J. · Wijnen · H. H. · Van der Velde · D. · Van Lieshout · E. M. M. · Verhofstad · M. H. J
Background and purpose

Recent research has highlighted non-operative management (NOM) as a viable alternative for frail older adults with hip fractures in the final phase of life. This study aims to guide Dutch physicians and hospitals nationwide in a standardised implementation of shared decision-making regarding surgery or NOM in selected frail older adults with a hip fracture.

Methods and analysis

The patient population for implementation includes frail older adults aged ≥70 years with an acute proximal femoral fracture, nursing home care or a similar level of care elsewhere and at least one additional criterion (ie, malnutrition, severe mobility impairment or ASA≥4). The 2-year implementation study will be conducted in four phases. In phases 1 and 2, barriers and facilitators for implementation will be identified and an implementation protocol, educational materials and patient information will be developed. Phase 3 will involve an implementation pilot in 14 hospitals across the Netherlands. The protocol and educational material will be improved based on healthcare provider and patient experiences gathered through interviews. Phase 4 will focus on upscaling to nationwide implementation and the effect of the implementation on NOM rate will be measured using data from the Dutch Hip Fracture Audit.

Ethics and dissemination

The study was exempted by the local Medical Research Ethics Committee (MEC-2023-0270, 10 May 2023) and Medical Ethics Committee United (W23.083, 26 April 2023). The study’s results will be submitted to an open access international peer-reviewed journal. Its protocols, tools and results will be presented at several national and international academic conferences of relevant orthogeriatric (scientific) associations.

Trial registration number

NCT06079905 .

Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial

Por: Sonneville · R. · Couffignal · C. · Sigaud · F. · Godard · V. · Audibert · J. · Contou · D. · Celier · A. · Djibre · M. · Schmidt · J. · Jaquet · P. · Mekontso Dessap · A. · Bourel · C. · Bellot · R. · Roy · C. · Lamara · F. · Essardy · F. · Timsit · J.-F. · Cornic · R. · Bouadma · L. · On b
Introduction

Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation.

Methods and analysis

The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation.

Ethics and dissemination

The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III—PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences.

Trial registration number

NCT04273360.

Real-world data evaluating Guys rapid diagnostic clinic as an alternate pathway for patients with FIT levels below 10

Por: Monroy-Iglesias · M. J. · Martin · S. · Cargaleiro · C. · Jones · G. · Steward · L. · Murtagh · C. · Bruno · F. · Millwaters · J. · Schizas · A. · Watson · H. · Haire · A. · Haire · K. · Moss · C. L. · Russell · B. · Srirajaskanthan · R. · Van Hemelrijck · M. · Dolly · S.
Objective

To analyse the effectiveness of rapid diagnostic clinics (RDCs) as an alternative pathway for patients with concerning symptoms and a faecal immunochemical test (FIT) result

Design

A retrospective and prospective cohort study.

Setting

GSTT RDC, one of England’s largest single-centre RDCs. Sociodemographic and clinical characteristics of FIT

Participants

Patients with an FIT result

Results

A total of 1299 patients with an FIT

Conclusion

This study demonstrates the effectiveness of RDCs as an alternate pathway for FIT

Chronic disease prevention and screening outcomes for patients with and without financial difficulty: a secondary analysis of the BETTER WISE cluster randomised controlled trial

Por: Aubrey-Bassler · K. · Patel · D. · Fernandes · C. · Lofters · A. K. · Campbell-Scherer · D. · Meaney · C. · Moineddin · R. · Wong · T. · Pinto · A. D. · Shea-Budgell · M. · McBrien · K. · Grunfeld · E. · Manca · D. P.
Objective

Building on Existing Tools To improvE chronic disease pRevention and screening in primary care Wellness of cancer survIvorS and patiEnts (BETTER WISE) was designed to assess the effectiveness of a cancer and chronic disease prevention and screening (CCDPS) programme. Here, we compare outcomes in participants living with and without financial difficulty.

Design

Secondary analysis of a cluster-randomised controlled trial.

Setting

Patients of 59 physicians from 13 clinics enrolled between September 2018 and August 2019.

Participants

596 of 1005 trial participants who responded to a financial difficulty screening question at enrolment.

Intervention

1-hour CCDPS visit versus usual care.

Outcome measures

Eligibility for a possible 24 CCDPS actions was assessed at baseline and the primary outcome was the percentage of eligible items that were completed at 12-month follow-up. We also compared the change in response to the financial difficulty screening question between baseline and follow-up.

Results

55 of 265 participants (20.7%) in the control group and 69 of 331 participants (20.8%) in the intervention group reported living with financial difficulty. The primary outcome was 29% (95% CI 26% to 33%) for intervention and 23% (95% CI 21% to 26%) for control participants without financial difficulty (p=0.01). Intervention and control participants with financial difficulty scored 28% (95% CI 24% to 32%) and 32% (95% CI 27% to 38%), respectively (p=0.14). In participants who responded to the financial difficulty question at both time points (n=302), there was a net decrease in the percentage of participants who reported financial difficulty between baseline (21%) and follow-up (12%, p

Conclusion

The BETTER intervention improved uptake of CCDPS manoeuvres in participants without financial difficulty, but not in those living with financial difficulty. Improving CCDPS for people living with financial difficulty may require a different clinical approach or that social determinants be addressed concurrently with clinical and lifestyle needs or both.

Trial registration number

ISRCTN21333761.

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