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Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multicentre, randomised controlled trial with integrated Qui

Por: Mazuquin · B. · Moffatt · M. · Realpe · A. · Sherman · R. · Ireland · K. · Connan · Z. · Tildsley · J. · Manca · A. · Gc · V. S. · Foster · N. E. · Rees · J. · Drew · S. · Bateman · M. · Fakis · A. · Farnsworth · M. · Littlewood · C.
Introduction

Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation.

Methods and analysis

The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022.

Trial registration number

ISRCTN11499185.

Implementation of integrated maternity care in the southwestern region of the Netherlands: evaluation of its effect on preterm birth, low birthweight infants and number of secondary care consultations

Por: Hermans · A. · Spaan · J. · Hermus · M. · Visser · J. · Annature Research Collaboration · Franx · A. · Kooy · J. v. d.
Objectives

To determine whether integrated maternity care is associated with reduced preterm births (PTB) and fewer small-for-gestational-age infants (SGA), and whether its implementation leads to a reduction of secondary care consultations.

Design

Retrospective study.

Setting

Integrated maternity care organisation in the southwestern region of the Netherlands.

Participants

All singleton pregnancies (≥24 weeks) within integrated maternity care organisation Annature between 2015 and 2020.

Intervention

Implementation of a shared maternity record in primary and secondary care.

Methods

Data of 20 818 women were derived from patient records and from the Netherlands Perinatal Registry. Intervention was the introduction of integrated maternity care in January 2018. Through multivariate logistic regression and segmented regression analysis we assessed the combined prevalence of SGA and PTB (SGA-PTB) before (2015–2017), and after the intervention (2018–2020). Regional rates were contrasted with nationwide rates (n=782 176).

Main outcome measures

SGA-PTB prevalence and mean number of secondary care consultations per pregnancy.

Results

SGA-PTB prevalence declined from 618/3443 (17.9%) in 2015 to 560/3501 (16.0%) in 2017 to 507/3459 (14.7%) in 2020 (p

Conclusion

Our results suggest that implementation of integrated maternity care was associated with reduced PTBs and/or low birth weight, and fewer secondary care consultations. These encouraging findings were observed in a less favourable sociodemographic profile and should be confirmed in other regions with sufficiently large populations, and the possibility to test individual components of integrated maternity care.

Blood pressure and heart rate variability responses following an acute bout of vinyasa yoga and a prolonged seated control: A randomized crossover trial

by Alexis Thrower, Bethany Barone Gibbs, Abdullah Alansare, Sally Sherman, Kelliann Davis

Vinyasa yoga is moderate-intensity physical activity, yet physiological responses are poorly characterized. The purpose of this study was to examine the effect of a vinyasa yoga session on autonomic/cardiovascular functioning in healthy adults. A randomized crossover design took place at the Physical Activity and Weight Management laboratory (Pittsburgh, PA; n = 18), and included two experimental conditions: 60 minutes of vinyasa yoga or a seated control, and measurements were taken at baseline, 5-minutes, and 65-minute post-conditions. The primary cardiovascular-related outcomes of this study included blood pressure (BP), heart rate (HR), and HR variability (HRV) measures [natural log transformed (ln) standard deviation of normal-to-normal R-R intervals (SDNN), root mean square of successive differences (RMSSD), high frequency (HF), and low frequency to high frequency ratio (LF/HF ratio)]. Linear mixed effects models were used for data analyses. Systolic BP was 8.14 mmHg lower at 5 minutes post yoga (p

Assessment of cervical softening and the prediction of preterm birth (STIPP): protocol for a prospective cohort study

Por: Breuking · S. · Oudijk · M. A. · van Eekelen · R. · de Boer · M. A. · Pajkrt · E. · Hermans · F.
Introduction

Preterm birth (PTB) is among the leading causes of perinatal and childhood morbidity and mortality. Therefore, accurate identification of pregnant women at high risk of PTB is key to enable obstetric healthcare professionals to apply interventions that improve perinatal and childhood outcomes. Serial transvaginal cervical length measurement is used to screen asymptomatic pregnant women with a history of PTB and identify those at high risk for a recurrent PTB. Cervical length measurement, fetal fibronectin test or a combination of both can be used to identify women at high risk of PTB presenting with symptoms of threatened PTB. The predictive capacity of these methods can be improved. Cervical softening is a precursor of cervical shortening, effacement and dilatation and could be a new marker to identify women a high risk of PTB. However, the predictive value of cervical softening to predict spontaneous PTB still needs to be determined.

Methods and analysis

This is a single-centre, prospective cohort study, conducted at the Amsterdam University Medical Centers in the Netherlands. Cervical softening will be investigated with a non-invasive CE-marked device called the Pregnolia System. This device has been developed to evaluate consistency of the cervix based on tissue elasticity. Two different cohorts will be investigated. The first cohort includes women with a history of spontaneous PTB

Ethics and dissemination

The study is approved by the Medical Ethics Committee of Amsterdam UMC (METC2022.0226). All patients will give oral and written informed consent prior to study entry. Results will be disseminated via a peer-reviewed journal.

Trial registration number

NCT05477381.

Stigma, social and structural vulnerability, and mental health among transgender women: A partial least square path modeling analysis

Abstract

Introduction

Existing literature suggests that transgender women (TW) may be at high risk for adverse mental health due to stress attributed to combined experiences of stigma and complex social and structural vulnerabilities. Little research has examined how these co-occurring experiences relate to mental health. We aimed to test a theoretically driven conceptual model of relationships between stigma, social and structural vulnerabilities, and mental health to inform future intervention tailoring.

Design/Methods

Partial least square path modeling followed by response-based unit segmentation was used to identify homogenous clusters in a diverse community sample of United States (US)-based TW (N = 1418; 46.2% White non-Hispanic). This approach examined associations between latent constructs of stigma (polyvictimization and discrimination), social and structural vulnerabilities (housing and food insecurity, unemployment, sex work, social support, and substance use), and mental health (post-traumatic stress and psychological distress).

Results

The final conceptual model defined the structural relationship between the variables of interest within stigma, vulnerability, and mental health. Six clusters were identified within this structural framework which suggests that racism, ethnicism, and geography may be related to mental health inequities among TW.

Conclusion

Our findings around the impact of racism, ethnicism, and geography reflect the existing literature, which unfortunately shows us that little change has occurred in the last decade for TW of color in the Southern US; however, the strength of our evidence (related to sampling structure and sample size) and type of analyses (accounting for co-occurring predictors of health, i.e., stigma and complex vulnerabilities, reflecting that of real-world patients) is a novel and necessary addition to the literature. Findings suggest that health interventions designed to offset the negative effects of stigma must include anti-racist approaches with components to reduce or eliminate barriers to resources that contribute to social and structural vulnerabilities among TW. Herein we provide detailed recommendations to guide primary, secondary, and tertiary prevention efforts.

Clinical Relevance

This study demonstrated the importance of considering stigma and complex social and structural vulnerabilities during clinical care and design of mental health interventions for transgender women who are experiencing post-traumatic stress disorder and psychological distress. Specifically, interventions should take an anti-racist approach and would benefit from incorporating social support-building activities.

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