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Evaluating the effect of a mobile-based symptom monitoring system for improving physical function in patients with cancer during chemotherapy: study protocol for a multicentre randomised controlled trial

Por: Lee · M. · Kang · D. · Um · Y. · Jo · B. · Rhue · J. · Park · S. · Lee · Y.-Y. · Noh · J. J. · Lee · Y.-G. · Koo · D.-H. · Park · K.-H. · Lee · S. · Ahn · J. S. · Oh · D. · Cho · J.
Introduction

Symptoms due to chemotherapy are common in patients with cancer. Cancer-related symptoms are closely associated with the deterioration of physical function which can be associated with decreased quality of life and increased mortality. Thus, timely symptom identification is critical for improving cancer prognosis and survival. Recently, remote symptom monitoring system using digital technology has demonstrated its effects on symptom control or survival. However, few studies examined whether remote monitoring would contribute to retaining physical function among patients with cancer. Therefore, this study aimed to evaluate the effectiveness of mobile-based symptom monitoring in improving physical function among patients with cancer under chemotherapy.

Methods and analysis

This study is a multicentre, open-label, parallel-group, randomised controlled trial. We will recruit 372 patients at three tertiary hospitals located in Seoul, South Korea. Study participants will be randomly assigned to either an intervention group receiving the ePRO-CTCAE app and a control group receiving routine clinical practice only. The primary outcome is changes in physical function from commencement to completion of planned chemotherapy. A linear mixed model will be performed under the intention-to-treat principle. The secondary outcomes include physical activity level; changes in pain interference; changes in depressive symptom; unplanned clinical visits; additional medical expenditure for symptom management; completion rate of planned chemotherapy; changes in symptom burden and health-related quality of life; and 1-year overall mortality.

Ethics and dissemination

The study has been approved by the institutional review board and ethics committee at the three university hospitals involved in this trial. Written informed consent will be obtained from all the participants. The results of the trial will be submitted for publication in peer-reviewed academic journals and disseminated through relevant literatures.

Trial registration number

KCT0007220.

Point-of-choice kilocalorie labelling practices in large, out-of-home food businesses: a preobservational versus post observational study of labelling practices following implementation of The Calorie Labelling (Out of Home Sector) (England) Regulations 2

Por: Polden · M. · Jones · A. · Essman · M. · Adams · J. · Bishop · T. · Burgoine · T. · Donohue · A. · Sharp · S. · White · M. · Smith · R. · Robinson · E.
Background and objectives

On 6 April 2022, the UK government implemented mandatory kilocalorie (kcal) labelling regulations for food and drink products sold in the out-of-home food sector (OHFS) in England. Previous assessments of kcal labelling practices in the UK OHFS found a low prevalence of voluntary implementation and poor compliance with labelling recommendations. This study aimed to examine changes in labelling practices preimplementation versus post implementation of mandatory labelling regulations in 2022.

Methods

In August–December 2021 (preimplementation) and August–November 2022 (post implementation), large OHFS businesses (250 or more employees) subject to labelling regulations were visited. At two time points, a researcher visited the same 117 food outlets (belonging to 90 unique businesses) across four local authorities in England. Outlets were rated for compliance with government regulations for whether kcal labelling was provided at any or all point of choice, provided for all eligible food and drink items, provided per portion for sharing items, if labelling was clear and legible and if kcal reference information was displayed.

Results

There was a significant increase (21% preimplementation vs 80% post implementation, OR=40.98 (95% CI 8.08 to 207.74), p

Conclusion

The number of large businesses in the OHFS providing kcal labelling increased following the implementation of mandatory labelling regulations. However, around one-fifth of eligible outlets sampled were not providing kcal labelling 4–8 months after the regulations came into force, and the majority of businesses only partially complied with government guidance. More effective enforcement may be required to further improve kcal labelling practices in the OHFS in England.

Preregistration

Study protocol and analysis strategy preregistered on Open Science Framework (https://osf.io/pfnm6/).

The efficacy of mindfulness‐based programs in reducing anxiety among nurses in hospital settings: A systematic review

Abstract

Background

The increasing pressure of their professional duties has led to a notable concern regarding the mounting anxiety levels among nurses. The ongoing discussion revolves around the efficacy of mindfulness as a means to alleviate anxiety in nurses.

Aim

This systematic review evaluated the effectiveness of mindfulness in reducing anxiety among nurses.

Methods

The evaluation followed the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. An extensive and comprehensive search was conducted across eight databases to identify studies that utilized randomized controlled trials (RCTs) and were published in English between 2011 and 2022. Independently, two reviewers assessed the validity of the randomized controlled trials using the Consolidated Standards of Reporting Trials criteria. Additionally, two authors independently employed the Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-2) method to evaluate the potential bias in the RCTs.

Results

Eight randomized controlled trial studies that were deemed eligible were included in the current analysis. Based on the literature review, it was determined that mindfulness-based training can assist nurses in reducing their anxiety levels. Furthermore, the effectiveness of mindfulness-based programs in enhancing nurses' mindfulness and self-compassion has been firmly established.

Conclusions

Based on existing literature, mindfulness-based interventions have proven to be effective in reducing anxiety levels among nurses. However, in order to enhance the overall quality of research, it is necessary to implement more rigorous controlled designs that include randomization. Additionally, larger sample sizes with a diverse range of participants are needed to establish and validate the effectiveness of mindfulness-based programs in alleviating anxiety among nurses.

Linking Evidence to Action

Implementing mindfulness-based training in healthcare organizations can offer numerous benefits. One such advantage is that it can help nurses in reducing anxiety and enhancing their ability to handle the pressures associated with their profession.

Study Registration

PROSPERO Protocol registration ID: CRD42023475157.

Effectiveness of mHealth interventions to promote physical activity and reduce sedentary behaviours on work-related productivity and performance: a systematic review protocol

Por: Miki · T. · Nohara · M. · Nomura · K.
Introduction

Technologies such as health and fitness applications (apps) and wearable activity trackers have recently gained popularity and may play a key role in promoting physical activity and reducing sedentary behaviours. Although several systematic reviews have investigated their efficacy in physical activity and sedentary behaviours, few studies have focused on their impact on work-related outcomes among workers. Here, to explore the effects of mHealth interventions designed to encourage physical activity and decrease sedentary behaviours on work-related outcomes, including absenteeism, presenteeism, productivity, work performance and workability among workers, we will conduct a systematic review based on recent articles and an extensive literature search.

Methods and analysis

The literature search will be performed using PubMed, Web of Science, the Cochrane Library and the Japan Medical Abstracts Society from inception to 23 September 2023. We will select studies that (1) investigated the impact of mHealth interventions to promote physical activity and reduce sedentary behaviours on work-related outcomes such as absenteeism, presenteeism, productivity, work performance and workability; (2) were designed as a randomised controlled trial (RCT) or non-randomised study of interventions (NRSI); (3) were conducted among workers and (4) were published as full-text original articles in Japanese or English. We will assess the review quality with the AMSTAR 2 tool. The risk of bias will be assessed with the RoB tool 2.0 and ROBINS-I.

Ethics and dissemination

Ethical approval is unnecessary as the study will rely solely on previously published articles. The research results will be submitted for publication in a peer-reviewed scientific journal.

Trial registration number

The study protocol has been registered with the UMIN Clinical Trials Registry (ID=UMIN000052290).

Stakeholders perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study

Por: Deja · E. · Donohue · C. · Semple · M. G. · Woolfall · K. · for the BESS Investigators · Semple · McNamara · Allen · Fowler · Barker · Peak · Miert · Best · Donohue · Jones · Moitt · Price · Williamson · Clark · Madsen · Dawson · Summers · Deja · Woolfall · Osaghae · Turner · Panchal
Objectives

The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct.

Design

A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.

Setting

Fourteen UK paediatric intensive care units.

Participants

Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.

Results

Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child’s participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be ‘streamlined’ to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.

Conclusion

Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.

Trial registration number

ISRCTN11746266.

Multiocular defect in the Old English Sheepdog: A canine form of Stickler syndrome type II associated with a missense variant in the collagen-type gene <i>COL11A1</i>

by Katherine Stanbury, Renata Stavinohova, Louise Pettitt, Chris Dixon, Ellen C. Schofield, Bryan Mclaughlin, Inka Pettinen, Hannes Lohi, Sally L. Ricketts, James A. Oliver, Cathryn S. Mellersh

Multiocular defect has been described in different canine breeds, including the Old English Sheepdog. Affected dogs typically present with multiple and various ocular abnormalities. We carried out whole genome sequencing on an Old English Sheepdog that had been diagnosed with hereditary cataracts at the age of five and then referred to a board-certified veterinary ophthalmologist due to owner-reported visual deterioration. An ophthalmic assessment revealed that there was bilateral vitreal degeneration, macrophthalmos, and spherophakia in addition to cataracts. Follow-up consultations revealed cataract progression, retinal detachment, uveitis and secondary glaucoma. Whole genome sequence filtered variants private to the case, shared with another Old English Sheepdog genome and predicted to be deleterious were genotyped in an initial cohort of six Old English Sheepdogs (three affected by multiocular defect and three control dogs without evidence of inherited eye disease). Only one of the twenty-two variants segregated correctly with multiocular defect. The variant is a single nucleotide substitution, located in the collagen-type gene COL11A1, c.1775T>C, that causes an amino acid change, p.Phe1592Ser. Genotyping of an additional 14 Old English Sheepdogs affected by multiocular defect revealed a dominant mode of inheritance with four cases heterozygous for the variant. Further genotyping of hereditary cataract-affected Old English Sheepdogs revealed segregation of the variant in eight out of nine dogs. In humans, variants in the COL11A1 gene are associated with Stickler syndrome type II, also dominantly inherited.

Early environmental risk factors and coeliac disease in adolescents: a population-based cohort study in Denmark

Por: Crawley · C. · Sander · S. D. · Nohr · E. A. · Nybo Andersen · A.-M. · Husby · S.
Objectives

Our aim was to investigate the association between early environmental factors and the development of coeliac disease (CeD) in adolescents, recruited from a cohort nested in the Danish National Birth Cohort (DNBC).

Design

The study was designed as a prospective cohort study, nested in DNBC

Participants

The Glutenfunen cohort comprises 1266 participants, nested in DNBC. All participants were screened for CeD, and in total, 28 cases of biopsy proven CeD were identified. Data about breastfeeding, timing of introduction to solid food in infancy, use of antibiotics, infections and symptoms were parentally reported prospectively at 6 months and 18 months, respectively. We estimated ORs and 95% CIs of CeD in adolescents using logistic regression analysis.

Results

Viral croup reported at 18 months of age was associated with CeD in adolescents with an OR of 3.2 (95% CI: 1.2 to 8.7). Furthermore, otitis media also reported at 18 months of age was linked with CeD with an OR of 3.2 (95% CI: 1.5 to 7.3). We were not able to find any statistical associations between CeD and breastfeeding, frequency of infections, parentally reported use of antibiotic and timing of solid foods.

Conclusion

In this study, we present an overview of the relationship between early environmental factors and occurrence of CeD in adolescents. Our findings, despite limitations due to a limited number of cases of CeD, suggest a role of viral infections in the pathogenesis of CeD

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