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Impact of omitting annual reviews for COPD on patient reported care quality- outcomes from the Asthma+Lung COPD patient passport

Por: Williams · P. J. · Bachir · L. · Philip · K. E. J. · Cumella · A. · Polkey · M. · Laverty · A. A. · Hopkinson · N. S.
Background

Regular clinical reviews of people with COPD provide an opportunity to optimise management and are recommended in national and international guidelines. However, there are limited data about the relationship between having an annual review and other aspects of care quality, which might influence decision-making by healthcare professionals and commissioners.

Method

Using data from 74 827 people with COPD completing the Asthma+Lung UK COPD Patient Passport, between 2014 and 2022, we conducted adjusted logistic regression (adjusting for year) and compared receipt of key items of care between those reporting that they had had an annual review (65.3%) and those who did not (34.7%). To further capture patient experience, we also analysed 4228 free-text responses to the 2021 Asthma+Lung UK annual COPD survey to the question ‘What is the one thing that could improve your COPD care?’

Results

We found that the absence of an annual review was associated with significantly worse COPD care across all domains studied; in particular, inhaler training (yes: 80.8% vs no: 38.4%, adjusted OR (AOR): 8.18, 95% CI (7.89 to 8.47), having a written care plan (89.6% vs 56.9%, AOR 6.68 (95% CI 6.35 to 7.05) and medication knowledge (72.6% vs 33.6%, AOR 5.73 (95% CI 5.51 to 5.96). Thematic analysis of the 2021 COPD survey responses identified three areas to improve care: (1) access and support from healthcare services, (2) improved treatment effectiveness and (3) interaction between COPD and the social environment.

Discussion

Failure to deliver annual COPD reviews is associated with worse patient-reported experience of care quality. In parallel, people with COPD express a desire for greater support and access to healthcare services.

Global trends in chronic kidney disease-related mortality: a systematic review protocol

Por: Tungsanga · S. · Ghimire · A. · Hariramani · V. K. · Abdulrahman · A. · Khan · A. S. · Ye · F. · Kung · J. Y. · Klarenbach · S. · Thompson · S. · Collister · D. · Srisawat · N. · Okpechi · I. G. · Bello · A. K.
Introduction

In recent decades, all-cause mortality has increased among individuals with chronic kidney disease (CKD), influenced by factors such as aetiology, standards of care and access to kidney replacement therapies (dialysis and transplantation). The recent COVID-19 pandemic also affected mortality over the past few years. Here, we outline the protocol for a systematic review to investigate global temporal trends in all-cause mortality among patients with CKD at any stage from 1990 to current. We also aim to assess temporal trends in the mortality rate associated with the COVID-19 pandemic.

Methods and analysis

We will conduct a systematic review of studies reporting mortality for patients with CKD following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We will search electronic databases, national and multiregional kidney registries and grey literature to identify observational studies that reported on mortality associated with any cause for patients with CKD of all ages with any stage of the disease. We will collect data between April and August 2023 to include all studies published from 1990 to August 2023. There will be no language restriction, and clinical trials will be excluded. Primary outcome will be temporal trends in CKD-related mortality. Secondary outcomes include assessing mortality differences before and during the COVID-19 pandemic, exploring causes of death and examining trends across CKD stages, country classifications, income levels and demographics.

Ethics and dissemination

A systematic review will analyse existing data from previously published studies and have no direct involvement with patient data. Thus, ethical approval is not required. Our findings will be published in an open-access peer-reviewed journal and presented at scientific conferences.

PROSPERO registration number

CRD42023416084.

A standardized wound infection model for antimicrobial testing of wound dressings in vitro

Abstract

To investigate the effectiveness of antimicrobial agents against wound infections, experiments using either 2D cultures with planktonic microorganisms or animal infection models are frequently carried out. However, the transferability of the results to human skin is limited by the lack of complexity of the 2D models or by the poor translation of the results from animal models. Hence, there is a need for wound infection models capable of assessing antimicrobial agents. In this study, an easily standardized wound infection model was established. This model consists of a mechanically wounded human skin model on a collagen matrix infected with various clinically relevant bacteria. Infection of the model led to recognition of the pathogens and induction of an inflammatory response. The untreated infection spread over time, causing significant tissue damage. By applying an antimicrobial-releasing wound dressing, the bacterial load could be reduced and the success of the treatment could be further measured by a decrease in the inflammatory reaction. In conclusion, this wound infection model can be used to evaluate new antimicrobial therapeutics as well as to study host-pathogen interactions.

Evaluations of virtual exercise programmes for adults with mobility limitations: a scoping review protocol incorporating an equity lens to inform the development of strategies to optimise participation of under-represented groups

Por: dos Santos · R. B. · Lin · J. · Badwal · A. · Singh · H. · Jaglal · S. B. · Sperling · C. · Salbach · N. M.
Introduction

For individuals with mobility limitations, virtual exercise programmes can address the challenges of in-person participation in community exercise programmes. A synthesis of studies of virtual exercise programmes targeting mobility limitations provided outside of conventional rehabilitation services and strategies used to optimise equitable access and inclusivity in these programmes is lacking. We aim to characterise evaluations of virtual exercise programmes for adults with mobility limitations, and the nature of and extent to which equity, diversity and inclusion considerations are integrated in the research process.

Methods and analysis

A scoping review following a six-stage methodological framework, including a consultation exercise, is proposed. A comprehensive strategy will be used to search Medline, Embase, PEDro, CINAHL and Scopus to identify peer-reviewed studies evaluating virtual exercise programmes for adults with mobility limitations living in the community. Three trained reviewers will select studies independently. Data (eg, study methodology, programme structure and content, participant characteristics) will be extracted using a standardised form, and collated and summarised using quantitative and qualitative methods. The PROGRESS-Plus and International Classification of Functioning, Disability and Health frameworks will be used to classify participant characteristics and study outcomes, respectively. During the consultation exercise, key knowledge users, including exercise participants, programme providers and coordinators, and members of community organisations for persons living with disabilities and under-represented groups, will be asked to provide insights regarding the applicability of review findings. A directed content analysis of data from the consultation exercise will be performed.

Ethics and dissemination

The research ethics board at the University of Toronto approved the consultation exercise. Findings will be disseminated through peer-reviewed publications and conference presentations. Findings will enhance understanding of current research evaluating virtual exercise programmes and inform future research and strategies for promoting equitable access and outcomes for individuals with mobility limitations.

Registration details

https://doi.org/10.17605/OSF.IO/X5JMA.

Allogeneic limbo-deep anterior lamellar keratoplasty (Limbo-DALK)—A novel surgical technique in corneal stromal disease and limbal stem cell deficiency

by Verena Schöneberger, Volkan Tahmaz, Mario Matthaei, Sigrid Roters, Simona L. Schlereth, Friederike Schaub, Claus Cursiefen, Björn O. Bachmann

Purpose

To describe a novel corneal surgical technique combining Deep Anterior Lamellar Keratoplasty (DALK) with grafting of allogeneic limbus (Limbo-DALK) for the treatment of eyes with corneal stromal pathology and limbal stem cell deficiency (LSCD).

Methods

Clinical records of six Limbo-DALKs performed in five patients diagnosed with LSCD and corneal stromal pathology requiring keratoplasty were retrospectively reviewed. All patients were diagnosed with LSCD due to various pathologies including thermal and chemical burns, congenital aniridia or chronic inflammatory ocular surface disease. Parameters analysed included demographics, diagnoses, clinical history, thickness measurements using anterior segment OCT, visual acuity, and epithelial status. Regular follow-up visits were scheduled at 6 weeks as well as 3, 6, 9, and 12 and 18 months postoperatively. Main outcome measures were time to graft epithelialisation and the occurrence of corneal endothelial decompensation.

Results

Two grafts showed complete epithelial closure at 2 days, two at 14 days. In one eye, complete epithelial closure was not achieved after the first Limbo-DALK, but was achieved one month after the second Limbo-DALK. No endothelial decompensation occurred except in one patient with silicone oil associated keratopathy. Endothelial graft rejection was not observed in any of the grafts.

Conclusion

Based on the data from this pilot series, limbo-DALK appears to be a viable surgical approach for eyes with severe LSCD and corneal stromal pathology, suitable for emergency situations (e.g. corneal ulceration with impending corneal perforation), while minimising the risk of corneal endothelial decompensation.

Energy drink consumption and sleep parameters in college and university students: a national cross-sectional study

Por: Kaldenbach · S. · Hysing · M. · Strand · T. A. · Sivertsen · B.
Objectives

To investigate the frequency of energy drink (ED) consumption, and the association between ED consumption and selected sleep characteristics and parameters in Norwegian college and university students. We also explored whether these associations varied based on sex.

Design

Cross-sectional.

Setting

Data were gathered from the SHOT2022 study (Students’ Health and Well-being Study), a national survey.

Participants

53 266 students, aged 18–35 years, enrolled in higher education in Norway (2022).

Main outcome measures

Estimated marginal means were computed from general linear models investigating the association between ED consumption and continuous sleep outcomes, while log-link binomial regression analysis was used for dichotomous sleep outcomes of sleep measures. All models were adjusted for age.

Results

Among the participants, 4.7% of men and 3.3% of women reported consuming ED daily. The frequency of ED consumption was inversely associated with sleep duration and sleep efficiency, while a direct association was observed with the frequency of ED consumption and sleep patterns such as sleep onset latency and wake after sleep onset across sexes. The strongest association was found between daily ED consumption and short sleep duration where men had a risk ratio (RR) of 2.07; 95% CI 1.77 to 2.42, and women had a RR of 1.87; 95% CI 1.64 to 2.14.

Conclusion

ED consumption was a strong determinant for negative sleep outcomes. Even small amounts of ED were associated with poorer sleep outcomes, which warrant more attention towards the consequences of consuming ED among college and university students.

Individual and environmental variables related to outdoor walking among older adults: Verifying a model to guide the design of interventions targeting outdoor walking

by Yixiu Liu, Nancy M. Salbach, Sandra C. Webber, Ruth Barclay

Objective

To estimate the relationships between individual and environmental variables and outdoor walking (OW) in older adults with OW limitations through verifying a conceptual model.

Methods

Baseline data from 205 older adults participating in a randomized trial of a park-based OW program were analyzed using structural equation modeling. We evaluated a three latent factor model: OW (accelerometry and self-report); individual factors (balance; leg strength; walking self-confidence, speed and endurance; mental health; education; income; car access); and environmental factors (neighbourhood walkability components).

Results

Mean age was 75 years; 73% were women. Individual factors was significantly associated with OW (β = 0.39, p p Conclusions

Better walking capacity and more confidence in the ability to walk outdoors are associated with higher OW in older adults. Better neighbourhood walkability is indirectly associated with more OW. The conceptual model demonstrates an individual and environment association; if the capacity of the individual is increased (potentially through walking interventions), they may be able to better navigate environmental challenges.

Does Health & Her app use improve menopausal symptoms? A longitudinal cohort study

Por: Andrews · R. · Lancastle · D. · Bache · K. · Lacey · A. S.
Objectives

The Health & Her app provides menopausal women with a means of monitoring their symptoms, symptom triggers and menstrual periods, and enables them to engage in a variety of digital activities designed to promote well-being. This study aimed to examine whether sustained weekly engagement with the app is associated with improvements in menopausal symptoms.

Design

A pre–post longitudinal cohort study.

Setting

Analysed data collected from Health & Her app users.

Participants

1900 women who provided symptom data via the app across a 2-month period.

Primary and secondary outcome measures

Symptom changes from baseline to 2 months was the outcome measure. A linear mixed effects model explored whether levels of weekly app engagement influenced symptom changes. Secondary analyses explored whether app-usage factors such as total number of days spent logging symptoms, reporting triggers, reporting menstrual periods and using in-app activities were independently predictive of symptom changes from baseline. Covariates included hormone replacement therapy use, hormonal contraceptive use, present comorbidities, age and dietary supplement use.

Results

Findings demonstrated that greater engagement with the Health & Her app for 2 months was associated with greater reductions in symptoms over time. Daily use of in-app activities and logging symptoms and menstrual periods were each independently associated with symptom reductions.

Conclusions

This study demonstrated that greater weekly engagement with the app was associated with greater reductions in symptoms. It is recommended that women be made aware of menopause-specific apps, such as that provided by Health & Her, to support them to manage their symptoms.

Scheduled and urgent inguinal hernia repair in Ontario, Canada between 2010 and 2022: Population-based cross sectional analysis of trends and outcomes

by Steven Habbous, David Gomez, David Urbach, Erik Hellsten

Introduction

We examine trends in inguinal hernia repairs with respect to the COVID-19 pandemic and secular trends in Ontario, Canada.

Methods

This was a retrospective cohort study. Hernia repairs performed January 1, 2010-December 31, 2022 were captured from health administrative inpatient and outpatient databases. Patients managed in three clinical settings were examined: public hospital in-patient, semi-private hospital in-patient (Shouldice Hospital), and public hospital out-patient. We examined the effect of the COVID-19 pandemic on surgical volumes, clinical setting, patient characteristics by setting, time from diagnosis until surgery, hospital length-of-stay, and patient outcomes (90-day readmissions, 1-year reoperations). We used multivariable logistic regression to examine whether patient outcomes were comparable between the COVID-19 period and the pre-pandemic period, adjusted sociodemographic and clinical factors. Shouldice Hospital is the only semi-private hospital in Ontario specializing in hernia repair (patients pay for the mandated admission, but not for the procedure).

Results

During the pandemic (March 2020-December 2022), there were 8,162 fewer (15%) scheduled inguinal hernia repairs than expected, but the age-sex standardized rate of urgent repairs remained unchanged. Shouldice Hospital performed more surgeries in the COVID-19 era than pre-pandemic and had a shorter average LOS by 24 hours, despite treating more patients with older age, higher ASA score [adjusted odds ratio (aOR) 2.13 (1.93–2.35) III vs I-II] and greater comorbidity [aOR 1.36 (1.08–1.70) for 2 vs none] than pre-pandemic. Patients treated in the COVID-19 era experienced a longer time until surgery, being the longest in 2022 (median 133 days). Ninety-day readmissions and 1-year reoperations were lower in the COVID-19 era and lower for patients receiving surgery at Shouldice Hospital.

Conclusion

During the COVID-19 pandemic, there were 8,162 fewer scheduled hernia repairs than expected, longer wait-times until surgery, shorter length-of-stay, and more patients with comorbidities, but outcomes were not worse compared with the pre-pandemic period.

Analysis of uterine evacuation methods in postabortion care after implementation of a surveillance network (CLAP MUSA-Network) at a university hospital

by Nelio N. Veiga-Junior, Caroline Eugeni, Beatriz D. Kajiura, Priscilla B. F. Dantas, Caroline B. Trabach, Aline A. Junqueira, Carina C. Nunes, Luiz F. Baccaro

Background

Management of uterine evacuation is essential for increasing safe abortion care. Monitoring through surveillance systems tracks changes in clinical practice and provides information to improve equity in abortion care quality.

Objective

This study aimed to evaluate the frequency of manual vacuum aspiration (MVA) and medical abortion (MA), and identify the factors associated with each uterine evacuation method after surveillance network installation at a Brazilian hospital.

Methods

This cross-sectional study included women admitted for abortion or miscarriage to the University of Campinas Women’s Hospital, Brazil, between July 2017 and November 2020. The dependent variables were the use of MVA and MA with misoprostol. The independent variables were the patients’ clinical and sociodemographic data. The Cochran–Armitage, chi-square, and Mann–Whitney U tests, as well as multiple logistic regression analysis, were used to compare uterine evacuation methods.

Results

We enrolled 474 women in the study, 91.35% of whom underwent uterine evacuation via uterine curettage (78.75%), MVA (9.46%), or MA (11.54%). MVA use increased during the study period (Z = 9.85, p Conclusion

MVA use increased following the installation of a surveillance network for good clinical practice. Being part of a network that encourages the use of evidence-based methods provides an opportunity for healthcare facilities to increase access to safe abortions.

A comprehensive examination of research instruments utilized for assessing the attitudes of healthcare professionals towards the use of restraints in mental healthcare: A systematic review

Abstract

Aim

This systematic review aimed to identify, describe and evaluate questionnaires measuring health professionals’ attitudes towards restraints in mental healthcare.

Design

A systematic review was undertaken in accordance with the COSMIN protocol for systematic review and the relevant sections of the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

Data Sources

OVID Medline, OVID nursing, Psychinfo, Embase and Cinahl were systematically searched from databases inception, with an initial search in December 2021 and updated in April 2022.

Review Methods

The inclusion criteria compromised articles reporting on self-reported instruments of attitudes or perceptions, development or validation of instruments and the evaluation of one or more measurement properties. Articles using multiple instruments in one study or not published in English were excluded. Two researchers independently extracted the data and appraised the methodological quality using the COSMIN guidelines and standards (consensus-based standards for the selection of health measurement instrument). A narrative synthesis without meta-analysis was performed. The systematic review was registered in PROSPERO Protocol ID CRD42022308818.

Results

A total of 23 studies reporting ten instruments were included. The findings revealed a broad variation in the content of the questionnaires, the use of terms/constructs and the context in which the various instruments measure attitudes towards coercive measures. Many studies lacked sufficient details on report of psychometric properties. Finally, the results were not summarized and the evidence not GRADED.

Conclusions

There is a need for updated and adapted instruments with origins in theory and clear joint definitions such that attitudes towards coercive measures can be reliably assessed regarding the validity and reliability of instruments, which will be of importance to facilitate the use of instruments in research and clinical settings.

Impact

Reviews addressing surveys, self-reported attitudes towards restraints in mental healthcare and examination of psychometric properties seem limited. We highlight distinct complexity, psychometric limitations and broad variation in the context and content measuring attitudes towards coercive measures, and their various use of terms/constructs in the existing questionnaires. These findings contribute to further research regarding the development of questionnaires and the need of representing the concept well – carefully denoted by the indicators, likewise the importance of applying questionnaires with properly reported measurement properties in terms of validity and reliability to ensure the use in research and clinical settings.

Can welfare states buffer technostress? Income and technostress in the context of various OECD countries

by Ann S. Lauterbach, Tobias Tober, Florian Kunze, Marius R. Busemeyer

Many workers are experiencing the downsides of being exposed to an overload of information and communication technology (ICT), highlighting the need for resources to cope with the resulting technostress. This article offers a novel cross-level perspective on technostress by examining how the context of the welfare state influences the relationship between income and technostress. Showing that individuals with higher income experience less technostress, this study argues that the welfare state represents an additional coping resource, in particular in the form of unemployment benefits. Since unemployment benefits insure income earners in the case of job loss, the negative effect of income on technostress should increase with higher levels of unemployment generosity. In line with these expectations, empirical results based on original survey data collected in collaboration with the OECD show that the impact of income on technostress varies across welfare state contexts. Implications for public health and policymakers are being discussed.

Prediction models of incontinence and sexual function one year after radical prostatectomy based on data from 20 164 prostate cancer patients

by Nora Tabea Sibert, Tobias Kurth, Clara Breidenbach, Simone Wesselmann, Günther Feick, Ernst-Günter Carl, Sebastian Dieng, Mohamad Hatem Albarghouth, Atiqullah Aziz, Stefan Baltes, Elisabeth Bartolf, Jens Bedke, Andreas Blana, Marko Brock, Stefan Conrad, Christopher Darr, Florian Distler, Konstantinos Drosos, Gregor Duwe, Amr Gaber, Markus Giessing, Nina Natascha Harke, Axel Heidenreich, Sameh Hijazi, Andreas Hinkel, Björn Theodor Kaftan, Shatlyk Kheiderov, Thomas Knoll, Gerd Lümmen, Inga Peters, Bülent Polat, Valentin Schrodi, Jens-Uwe Stolzenburg, Zoltan Varga, Julius von Süßkind-Schwendi, Vahudin Zugor, Christoph Kowalski

Background

Incontinence and sexual dysfunction are long-lasting side effects after surgical treatment (radical prostatectomy, RP) of prostate cancer (PC). For an informed treatment decision, physicians and patients should discuss expected impairments. Therefore, this paper firstly aims to develop and validate prognostic models that predict incontinence and sexual function of PC patients one year after RP and secondly to provide an online decision making tool.

Methods

Observational cohorts of PC patients treated between July 2016 and March 2021 in Germany were used. Models to predict functional outcomes one year after RP measured by the EPIC-26 questionnaire were developed using lasso regression, 80–20 splitting of the data set and 10-fold cross validation. To assess performance, R2, RMSE, analysis of residuals and calibration-in-the-large were applied. Final models were externally temporally validated. Additionally, percentages of functional impairment (pad use for incontinence and firmness of erection for sexual score) per score decile were calculated to be used together with the prediction models.

Results

For model development and internal as well as external validation, samples of 11 355 and 8 809 patients were analysed. Results from the internal validation (incontinence: R2 = 0.12, RMSE = 25.40, sexual function: R2 = 0.23, RMSE = 21.44) were comparable with those of the external validation. Residual analysis and calibration-in-the-large showed good results. The prediction tool is freely accessible: https://nora-tabea.shinyapps.io/EPIC-26-Prediction/.

Conclusion

The final models showed appropriate predictive properties and can be used together with the calculated risks for specific functional impairments. Main strengths are the large study sample (> 20 000) and the inclusion of an external validation. The models incorporate meaningful and clinically available predictors ensuring an easy implementation. All predictions are displayed together with risks of frequent impairments such as pad use or erectile dysfunction such that the developed online tool provides a detailed and informative overview for clinicians as well as patients.

Impact of a capacity-building intervention on views and perceptions of healthcare providers towards the provision of adolescent sexual and reproductive health services in southeast Nigeria: a cross-sectional qualitative study

Por: Agu · I. C. · Agu · C. · Mbachu · C. · Onwujekwe · O.
Objectives

Negative views of healthcare providers towards adolescent sexual and reproductive health (SRH) services deter adolescents from seeking vital SRH services. This paper assessed the impact of an intervention on the views and perceptions of healthcare providers towards the provision of adolescent SRH services.

Design and setting

A descriptive, cross-sectional, qualitative study was conducted between 14 October and 19 November 2021 in six local government areas (LGAs) in Ebonyi state, southeast Nigeria, after the implementation of an intervention comprising of training and supportive supervision.

Participants and data collection

Data were collected through: (1) two in-depth interviews (IDIs) with LGA healthcare managers; (2) six IDIs with LGA adolescent health programme managers; (3) two focus group discussions (FGDs) with 15 primary healthcare facility managers; (4) two FGDs with 20 patent medicine vendors and (5) two FGDs with 17 community health volunteers. A total of six FGDs were held with 52 healthcare providers. The interviews were conducted using pretested interview guides. Transcripts were coded in NVivo (V.12) and themes were identified through inductive analysis.

Results

As a result of the intervention, most healthcare providers started recognising the rights of adolescents to obtain contraceptive services and no longer deny them access to contraceptive services. The providers also became friendlier and were no longer harsh in their interactions with adolescents. There were some unique findings relative to whether the providers were formal or informal healthcare providers. It was found that the informal healthcare providers were bolder and more comfortable delivering SRH services to adolescents and reported improved patronage by the adolescents. The formal healthcare providers made their facilities more conducive for adolescents by creating safe spaces and introducing extracurricular activities.

Conclusion

These findings highlight the importance of the constant capacity building of both formal and informal healthcare providers, which can address healthcare providers’ biases, views and perceptions of delivering SRH services to adolescents.

Prevention of psychosocial distress consequences in somatic hospital inpatients via a stepped and collaborative care model: protocol of SomPsyNet, a stepped wedge cluster randomised trial

Por: Meinlschmidt · G. · Frick · A. · Baenteli · I. · Karpf · C. · Studer · A. · Bachmann · M. · Dörner · A. · Tschudin · S. · Trost · S. · Wyss · K. · Fink · G. · Schwenkglenks · M. · Caviezel · S. · Rocco · T. · Schaefert · R. · The SomPsyNet consortium · Aebi · Bachmann · Caviezel · Baen
Introduction

Approximately 30% of somatic hospital inpatients experience psychosocial distress, contributing to increased (re-)hospitalisation rates, treatment resistance, morbidity, and direct and indirect costs. However, such distress often remains unrecognised and unaddressed. We established ‘SomPsyNet’, a ‘stepped and collaborative care model’ (SCCM) for somatic hospital inpatients, aiming at alleviating this issue through early identification of distress and provision of appropriate care, providing problem-focused pathways and strengthening collaborative care. We report the protocol of the ‘SomPsyNet’ study, aiming to evaluate implementation and impact of the SCCM on distressed patients’ health-related quality of life. Secondary objectives include assessing efficacy of the screening procedures, influence of SCCM on other health outcomes and associated costs.

Methods and analysis

Our stepped wedge cluster randomised trial conducted at three tertiary hospitals comprises three conditions: treatment as usual (TAU) without screening for distress (phase 0), TAU with screening but without consequences (phase I, main comparator) and TAU with screening and psychosomatic-psychiatric consultations for those distressed (phase II). The time-of-transition between phases I and II was randomised. Sample size target is N=2200–2500 participants, with 6 month follow-up for distressed (anticipated n=640–700) and a subsample of non-distressed (anticipated n=200) patients. Primary outcome is mental health-related quality of life (SF-36 ‘Mental Health Component Summary score’); secondary outcomes include psychosocial distress, anxiety, depressive and somatic symptoms, symptom burden and distress, resilience, social support and qualitative of life, assessed by internationally accepted instruments, with good psychometric properties. Further, health claims data will be used to assess SCCM’s impact on direct and indirect costs.

Ethics and dissemination

SomPsyNet adheres to the Helsinki Declaration and is approved by the ‘Ethikkommission Nordwest- und Zentralschweiz’ (2019–01724). Findings will be published in peer-reviewed journals and communicated to participants, healthcare professionals and the public.

Trial registration number

Swiss National Clinical Trials Portal; ClinicalTrials.gov (NCT04269005, updated 19.09.2023).

Impact of deintensifying hypoglycaemic drugs in older adults with type 2 diabetes: protocol for an emulation of a target trial

Por: Christiaens · A. · Simon-Tillaux · N. · Thompson · W. · Sinclair · A. J. · Henrard · S. · Boland · B. B. · Slaouti-Jegou · Y. · Lekens · B. · Bonnet-Zamponi · D. · Tubach · F. · Zerah · L.
Introduction

In older adults with type 2 diabetes (T2D), overtreatment with hypoglycaemic drugs (HDs: sulfonylureas, glinides and/or insulins) is frequent and associated with increased 1-year mortality. Deintensification of HD is thus a key issue, for which evidence is though limited. The primary objective of this study will be to estimate the effect of deintensifying HD on clinical outcomes (hospital admission or death) within 3 months in older adults (≥75 years) with T2D.

Methods

We will emulate with real-world data a target trial, within The Health Improvement Network cohort, a large-scale database of data collected from electronic medical records of 2000 general practitioners in France. From 1 January 2010 to 28 February 2019, we will include eligible patients ≥75 years who will have T2D, a stable dose of HDs, glycated haemoglobin A1c (HbA1c) value 75 mmol/mol within 1 year. Participants will be followed from baseline to 12 months after randomisation, administrative censoring, or death, whichever occurs first. A pooled logistic regression will be used to estimate the treatment effect on the incidence of the outcomes.

Dissemination and ethics

No ethical approval is needed for using retrospectively this fully anonymised database. The results will be disseminated during conferences and through publications in scientific journals.

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