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Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol

Por: PelvEx Collaborative · West · West · Drami · Denys · Glyn · Sutton · Tiernan · Behrenbruch · Guerra · Waters · Woodward · Applin · Charles · Rose · Pape · van Ramshorst · Mirnezami · Aalbers · Abdul Aziz · Abecasis · Abraham-Nordling · Akiyoshi · Alahmadi · Alberda · Albert · And
Introduction

The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. ‘PelvEx—Beating the empty pelvis syndrome’ aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome.

Methods and analysis

A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting.

Ethics and dissemination

The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome.

Trial registration number

NCT05683795.

The impact of the newly developed school-based ‘Digital Health Contact’—Evaluating a health and wellbeing screening tool for adolescents in England

by Alice Porter, Katrina d’Apice, Patricia Albers, Nicholas Woodrow, Hannah Fairbrother, Katie Breheny, Clare Mills, Sarah Tebbett, Frank De Vocht

Introduction

Supporting adolescents with their health and wellbeing is an international public health priority. Schools are well placed to universally detect unmet health needs and support pupils. This study aimed to evaluate the effectiveness of a digital health and wellbeing screening tool, called the ‘Digital Health Contact’ (DHC) implemented in schools in the East Midlands of England. The DHC, delivered by Public Health Nurses (School Nurses) (PHN(SN)), aims to identify pupils with unmet health needs (via a ‘red flag’ system) and provide appropriate support.

Materials and methods

Using data from 22 schools which took part in the DHC and 14 schools which did not take part, across three academic years (2018–2020), we conducted a controlled interrupted timeseries analysis with negative binomial regression to explore the effect of the DHC on the number of annual referrals to PHN(SN). Using DHC data from 164 pupils, we further conducted a Difference-in-Difference analysis to explore the impact of ‘red flag’ and referral via the DHC in Year 9 (age 13–14) on the number of red flags in Year 11 (age 15–16).

Results

Across all schools, the mean annual number of referrals increased over the three year follow-up period. In the adjusted model, the number of referrals was comparable between schools taking part in the DHC and non-participating schools (0.15 referrals [95% CI -0.21, 0.50]). Red flag score was not significantly different among Year 11 pupils, after being referred via the DHC in Year 9 (-0.36 red flags [95% CI -0.97, 0.24]).

Discussion

The DHC, and similar screening tools, have the potential to raise awareness of the health and wellbeing support in schools and provide an additional pathway of referral to this support for pupils with unmet health needs, without replacing the traditional pathway where pupils refer themselves or are referred by teachers.

Impact of different surgical and non-surgical interventions on health-related quality of life after thoracolumbar burst fractures without neurological deficit: protocol for a comprehensive systematic review with network meta-analysis

Por: Lanter · L. · Rutsch · N. · Kreuzer · S. · Albers · C. E. · Obid · P. · Henssler · J. · Torbahn · G. · Müller · M. · Bigdon · S. F.
Introduction

There is no international consensus on how to treat thoracolumbar burst fractures (TLBFs) without neurological deficits. The planned systematic review with network meta-analyses (NMA) aims to compare the effects on treatment outcomes, focusing on midterm health-related quality of life (HRQoL).

Methods and analysis

We will conduct a comprehensive and systematic literature search, identifying studies comparing two or more treatment modalities. We will search MEDLINE, EMBASE, Google Scholar, Scopus and Web of Science from January 2000 until July 2023 for publications. We will include (randomised and non-randomised) controlled clinical trials assessing surgical and non-surgical treatment methods for adults with TLBF. Screening of references, data extraction and risk of bias (RoB) assessment will be done independently by two reviewers. We will extract relevant studies, participants and intervention characteristics. The RoB will be assessed using the revised Cochrane RoB V.2.0 tool for randomised trials and the Newcastle-Ottawa Scale for controlled trials. The OR for dichotomous data and standardised mean differences for continuous data will be presented with their respective 95% CIs. We will conduct a random-effects NMA to assess the treatments and determine the superiority of the therapeutic approaches. Our primary outcomes will be midterm (6 months to 2 years after injury) overall HRQoL and pain. Secondary outcomes will include radiological or clinical findings. We will present network graphs, forest plots and relative rankings on plotted rankograms corresponding to the treatment rank probabilities. The ranking results will be represented by the area under the cumulative ranking curve. Analyses will be performed in Stata V.16.1 and R. The quality of the evidence will be evaluated according to the Grading of Recommendations, Assessment, Development and Evaluations framework.

Ethics and dissemination

Ethical approval is not required. The research will be published in a peer-reviewed journal.

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