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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.

Efficacy of biological agents combined with oral immunotherapy (OIT) for food allergy: a protocol for a systematic review and meta-analysis

Por: Honda · A. · Okada · Y. · Matsushita · T. · Hasegawa · T. · Ota · E. · Noma · H. · Imai · T. · Kwong · J.
Introduction

Food allergy affects a large population throughout the world. Recently, oral immunotherapy (OIT) has been reported as an effective treatment for severe food allergy. Although OIT was successful in numerous trials in desensitisation, adverse events including anaphylaxis during OIT frequently occur. Additionally, some patients fail to be desensitised after OIT and the response to treatment is often not sustained. As a further adjunctive therapy to facilitate OIT, the role of biological agents has been identified. For example, efficacy and safety of omalizumab as an adjuvant therapy of OIT has become apparent through some RCTs and observational studies. Interest towards this topic is growing worldwide, and ongoing trials will provide additional data on the biologics in food allergy.

We aim to systematically analyse the efficacy and safety of OIT combined with biological agents for food allergy.

Methods and analysis

This paper provides a protocol for a systematic review of the relevant published analytical studies using an aggregate approach following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. Two authors will perform a comprehensive search for studies on MEDLINE/PubMed, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) databases. Subsequently, two independent authors will perform abstract screening, full-text screening and data extraction. A meta-analysis will be conducted as appropriate.

Ethics and dissemination

The protocol of this systematic review will be provided in a peer-reviewed journal. As the researchers will not identify the individual patients included in the studies, they do not need to acquire ethics approval.

PROSPERO registration number

CRD42022373015.

Relationship between vitreous interleukin-6 levels and vitreous particles findings on widefield optical coherence tomography in posterior uveitis

by Mami Tomita, Mizuki Tagami, Norihiko Misawa, Atsushi Sakai, Yusuke Haruna, Shigeru Honda

Purpose

To investigate relationship between vitreous interleukin-6 levels and vitreous particles findings on widefield optical coherence tomography in posterior uveitis.

Methods

This retrospective study examined vitreous inflammatory cells (hyperreflective particles) of posterior uveitis on widefield optical coherence tomography (WOCT). We examined the number of hyperreflective particles (possibility of vitreous inflammatory cells) observed on WOCT and the correlations with interleukin-6 (IL-6) levels. The relationship between vitreous IL-6 levels and image findings from WOCT from 37 eyes (34 patients) with posterior uveitis were analyzed. Mean patient age was 63.4±15.7 years. (Mean± standard deviation) IL-6 concentration in vitreous humor was 79.9±7380.9 pg/mL Uveitis was infectious in 9 cases and non-infectious in 28 cases with multiplex polymerase chain reaction system. We measured the number and size of vitreous cells in the posterior vitreous, defined as the space between the upper vitreous and the internal limiting membrane on WOCT at the macular, upper, and lower regions. Image analysis software was also used for cell counting.

Results

A strong correlation was seen between human and software counts. Pearson’s correlation coefficient (PCC) was performed to compare categorial variables (on macular +0.866; upper cavity +0.713; lower cavity +0.568; total vitreous cavity +0.834; P.001 each). IL-6 levels correlated with both vitreous cell counts and cell counts observed on macular WOCT (human-counted group +0.339, P = 0.04; software-counted group +0.349, P = 0.03). Infectious uveitis showed higher IL-6 levels (P = 0.016) and high cell counts compared with non-infectious uveitis (P = 0.04).

Conclusions

Vitreous number of hyperreflective particles (cells) findings on WOCTcorrelated well with human and software cell counts. Vitreous cells findings on WOCT also correlated with IL-6 concentrations on macular.

Association between physical performance and bone mass in community-dwelling postmenopausal Japanese women: The Unzen study

by Masahiro Suiko, Satoshi Mizukami, Kazuhiko Arima, Hiroki Nakashima, Takayuki Nishimura, Yoshihito Tomita, Yasuyo Abe, Natsumi Tanaka, Yuzo Honda, Michiko Kojima, Tetsuji Okawachi, Maiko Hasegawa, Youko Sou, Ritsu Tsujimoto, Mitsuo Kanagae, Makoto Osaki, Kiyoshi Aoyagi

Background

Low bone mass is an independent risk factor for osteoporotic fractures. We examined the association between physical performance and bone mass using quantitative ultrasound in community-dwelling postmenopausal Japanese women.

Methods

We conducted a cross-sectional study on 524 community-dwelling postmenopausal Japanese women who were not being administered osteoporosis medications. Physical performance was assessed on the basis of grip strength, chair stand time, and functional reach. The stiffness index was measured as a quantitative ultrasound parameter for heel bone mass.

Results

Physical performance, assessed by grip strength, chair stand time, and functional reach, and the stiffness index significantly decreased with age (both p Conclusions

Physical performance was significantly associated with heel bone mass in community-dwelling postmenopausal Japanese women.

Impact of visitation restrictions on the mental health of family caregivers during the COVID‐19 pandemic: A mixed methods study

Abstract

Aim

To examine the mental health conditions of family caregivers residing away from their loved ones who experienced visitation restrictions during the coronavirus disease 2019 pandemic.

Design

A mixed-methods design applying the Kessler Scale-10 for the quantitative measurement of psychological distress and an open-ended question for qualitative analysis.

Methods

The participants were recruited from care facilities between February and September 2021. This cross-sectional study included 197 family caregivers who were utilizing formal residential care services for their loved ones. Using thematic analyses, open-ended responses regarding the impact of visitation restrictions were coded. These themes were then examined to determine thematic patterns across caregiver characteristics.

Results

Thirteen themes were identified regarding the impact of visitation restrictions. Many participants reported primary harmful effects as follows: ‘inability to confirm the type of care and lifestyle assistance provided to an older relative’ and ‘difficulty communicating with an older relative because of the inability to converse face-to-face’. Younger age, being employed, poor sleep, poor relationship quality with the care recipient and experiencing harmful effects from the visitation restrictions were associated with psychological distress.

Conclusion

Our findings suggest that to maintain positive mental health after a care transition, it is important for family caregivers to take part in the care of their loved ones and ensure information sharing between the care recipient's family and institution.

Impact

These findings suggest that both residents and family caregivers living outside facilities may feel distressed due to separation. Therefore, institutional care staff needs to consider how to adjust facility procedures or communication with family caregivers.

Patient or Public Contribution

The comments obtained from the participants in this survey helped to shape the study design and are expected to contribute to the further development of quality facility care.

Evidence and guidelines for trauma-informed doula care

Although trauma and trauma-related health conditions are increasingly common among childbearing people (Sperlich et al., 2017; Vignato et al., 2017), there is a dearth of published evidence and guidance on trauma-informed doula care. Trauma refers to an event(s) or circumstances that are experienced as physically or emotionally harmful or life threatening and that have lasting adverse effects on wellbeing (Substance Abuse and Mental Health Services Administration (SAMHSA, 2014)). This can include post-traumatic stress disorder (PTSD) and negative pregnancy-related outcomes such as substance use, prematurity, low birth weight, postpartum depression, difficulty bonding with the baby, children with PTSD, or even maternal and infant death (Sperlich et al., 2017; Kilpatrick 2017; Kendig et al., 2017).
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