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Intermittent-vigorous intensity physical activity as a strategy for recovery in severe mental illness: study protocol for a pragmatic clinical trial

Por: Caro-Crous · M. · Santos · J. M. · Jabardo-Camprubi · G. · Brown · W. J. · Puig-Ribera · A.
Introduction

Achieving physical activity recommendations for health as part of mental healthcare for adults with severe mental illness (SMI) could enhance clinical, functional and quality of life outcomes. We have co-designed a protocol to evaluate the impact of an intervention which combines High Intensity Interval Training (HIIT) and Vigorous Intermittent Lifestyle Physical Activity (VILPA) on clinical, functional and quality of life outcomes in people who have SMI.

Methods and analysis

Pragmatic clinical trial with an intervention and control arms. Participants will be recruited from two mental health services in two different cities in the same geographical area. Participants who meet the inclusion criteria (>18 years, SMI diagnosis, not at medical risk to practise vigorous physical activity, living in the community) will be included. Those from one service will be assigned to the intervention group and those from the other to the control group. The intervention will take place in the mental healthcare centre and will comprise 16 weeks of group-based HIIT, with transition to an individual lifestyle intervention VILPA over the next 12 weeks—for a total intervention period of 28 weeks. Primary outcome (clinical and functional and quality of life) measures and secondary (self-perception and device-measured fitness, physical activity and sedentary behaviour, and experience) measures will be assessed at baseline and at 16-week, 28-week and 40-week follow-ups. Group differences in change scores will be assessed using linear mixed-effects models with time, group and their interaction as fixed effects, accounting for within-subject correlations.

Ethics and dissemination

The study was approved by the Human Ethics Committee of the Institute for Research and Innovation in Life and Health Sciences in Central Catalonia (Spain, CEIm code: 24/007). Data will be shared following publication of results with no end date. Results will be disseminated in peer-reviewed journals and at national and international conferences and will inform the development of recovery protocols for people with SMI.

Trial registration number

ClinicalTrials.gov NCT06338917.

Attitudes towards addressing environmental sustainability in patient-provider interactions: a qualitative study among Dutch physicians

Por: Cohen · E. S. · Grandiek · F. · Kringos · D. S. · Kouwenberg · L. H. J. A. · Sperna Weiland · N. H. · Richie · C. · Aarts · J. W. M. · Hehenkamp · W. J. K.
Objectives

To investigate the attitudes of physicians towards addressing environmental sustainability in patient conversations, and to identify barriers and facilitators to doing so.

Design

A qualitative, nation-wide study was conducted using semi-structured online focus groups and interviews. Reflexive thematic analysis was used to analyse transcripts, guided by the Theoretical Domains Framework.

Setting

Secondary and tertiary healthcare institutions in the Netherlands.

Participants

Participants were medical specialists and residents in obstetrics and gynaecology (OB-GYN physicians) in the Netherlands. Participants were purposefully identified to capture diverse demographics and practice settings.

Primary and secondary outcome measures

Physicians’ attitudes towards discussing the environmental impact of healthcare and the health effects of environmental pollution with patients. Themes were identified and categorised using the Theoretical Domains Framework.

Results

The study included 28 OB-GYN physicians working across 23 healthcare institutions in the Netherlands. Six themes were developed: (1) strong sense of urgency to reduce healthcare's environmental impact, (2) knowledge gaps impair communication about environmental impact to patients, (3) prioritisation of individual patient health over environmental concerns in decision-making, (4) perceived lack of patient interest in environmental outcomes, (5) system-level support facilitates discussions about environmental sustainability with patients and (6) limited perceived value in discussing the health effects of environmental pollution and climate change with patients.

Conclusions

OB-GYN physicians are supportive of discussing the environmental impact of healthcare services when clinically appropriate. Addressing knowledge gaps, providing evidence-based guidance and embedding sustainability into clinical guidelines and decision aids may facilitate the integration of environmental sustainability into patient-provider interactions.

Development of explainable machine learning models to predict side effects in patients with rheumatoid arthritis taking methotrexate treatment: a nationwide multicentre cohort study

Por: Jang · J. · Kim · W. J. · Park · S. W. · Moon · K. W. W.
Objectives

Methotrexate (MTX) effectively controls rheumatoid arthritis (RA) but often leads to side effects (SE) such as gastrointestinal (GI) issues, liver toxicity and bone marrow suppression. To develop clinically interpretable machine learning (ML) models that accurately predict MTX-related SE in patients with RA taking MTX. The aim was to enhance predictive accuracy and to identify patient-specific risk factors using explainable artificial intelligence (XAI), thereby enabling transparent clinical interpretation. We specifically sought to address the unmet need for individualised risk stratification using real-world, multicentre observational data.

Design

Retrospective case-control study.

Setting

Across 23 rheumatology clinics in South Korea, based on data from a nationwide multicentre cohort.

Participants

A total of 5077 patients with RA were initially enrolled from the Korean Observational Study Network for Arthritis. After excluding those with missing clinical, demographic or prescription data and those not receiving MTX, 2375 patients remained eligible. Among these, 1654 and 1218 patients were included in the overall SE and GI SE analysis groups, respectively, after 1:1 propensity score matching. All patients were aged ≥18 years and met the 1987 American College of Rheumatology classification criteria.

Primary and secondary outcome measures

The primary outcome was the presence of SE in patients with RA taking MTX, categorised into overall SE and GI SE, based on standardised patient questionnaires and clinical assessments. The secondary outcome was the identification of key predictors using SHapley Additive exPlanations (SHAP) to enhance the interpretability of ML predictions.

Results

Among six ML classifiers, extreme gradient boosting demonstrated the highest performance in predicting overall SE (area under the curve (AUC) 0.781, F1 score 0.672, area under the precision-recall curve (AUPRC) 0.757) and GI SE (AUC 0.701, F1 score 0.690, AUPRC 0.670). SHAP analysis identified key predictive features including age, physician visual analogue scale score, alanine aminotransferase, Health Assessment Questionnaire score, celecoxib use and drug adherence. Logistic regression confirmed statistical significance for multiple variables (eg, OR 4.63; 95% CI 1.41 to 20.90 for non-adherence >30 days; OR 1.45; 95% CI 1.14 to 1.85 for celecoxib use). DeLong’s test indicated that boosting models significantly outperformed support vector machine (p

Conclusions

Interpretable ML models using real-world clinical data can accurately predict SE in patients with RA taking MTX. These models may facilitate early identification of high-risk individuals and inform personalised treatment strategies. Integration into clinical decision support systems could improve MTX safety monitoring. Further prospective validation in external cohorts is warranted.

Assessment of validity, reliability, responsiveness and acceptability of seven Dutch-Flemish PROMIS computerised adaptive tests (CATs) in Dutch people with type 2 diabetes: an observational and qualitative study

Por: Groeneveld · L. · Terwee · C. B. · van der Willik · E. M. · van Ittersum · F. J. · Langendoen-Gort · M. · Pals · F. · Blom · M. T. · Beulens · J. W. J. · Elders · P. J. M. · Rutters · F.
Objectives

This study aimed to assess construct validity against commonly used patient-reported outcome measures (PROMs), test–retest reliability and responsiveness of seven Dutch-Flemish Patient-Reported Outcomes Measurement Information System (PROMIS) computerised adaptive testing (CATs) in Dutch adults with type 2 diabetes (T2D), and assess their acceptability in healthcare providers and people with T2D.

Design

A cross-sectional observational study in people with T2D and qualitative study involving both people with T2D and healthcare professionals.

Setting

Participants with T2D were recruited from the ongoing Hoorn Diabetes Care System cohort in the West-Friesland area of the Netherlands. Additionally, people with T2D and advanced chronic kidney disease were recruited at the outpatient clinics of Amsterdam University Medical Centre and ‘Niercentrum aan de Amstel’, both in the Amsterdam area of the Netherlands. The healthcare professionals involved in the qualitative part were recruited at the Amsterdam University Medical Centre.

Participants

314 people with T2D (age 64.0±10.8 years, 63.7% men).

Primary and secondary outcome measures

Participants completed seven PROMIS CATs (assessing (1) Physical Function, (2) Pain Interference, (3) Fatigue, (4) Sleep Disturbance, (5) Anxiety, (6) Depression and (7) Ability to Participate in Social Roles and Activities), and PROMs measuring similar constructs. After 2 weeks and 6 months, participants completed the CATs measures again, together with seven Global Rating Scales (GRS) on perceived change in each domain. Construct validity was assessed using Pearson’s correlations. Test–retest reliability was assessed by the intraclass correlation coefficient (ICC). Measurement error was assessed by the standard error of measurement (SEM) and minimal detectable change (MDC). Responsiveness was assessed by correlations between change scores on the PROMIS CAT and GRS. Acceptability was assessed through focus groups and interviews in healthcare providers and people with T2D.

Results

Except for Fatigue, all PROMIS CAT domains demonstrated sufficient construct validity, since ≥75% of the results was in accordance with a priori hypotheses. All seven PROMIS CATs showed sufficient test–retest reliability (ICCs 0.73–0.91). SEM and MDC ranged from 2.1 to 2.7 and from 5.7 to 7.4, respectively. Responsiveness was rated as insufficient in this study design as there was almost no change in participants’ own rating of their health compared with 6 months ago according to a global rating of change.

During the focus groups and interviews, healthcare providers and people with T2D agreed that CATs could serve as a conversation starter in routine care, but should never replace personal consultations with a doctor. If implemented, participants would be willing to spend 15 min to complete the PROMIS CATs.

Conclusions

The PROMIS CATs showed sufficient construct validity and test–retest reliability in most domains in people with T2D. Responsiveness needs to be evaluated in a population with poorer diabetes control or in a study design with longer follow-up. The CATs are well accepted to be used in care to identify relevant topics, but should not replace personal contact with the doctor.

Retrospective analysis of value-driven outcomes of diabetic foot ulcer in a tertiary hospital in Singapore

Por: Chia · A. C. K. · Tan · I. E.-H. · Tan · Z. N. · Yeo · W. J. · Zhao · Y. · Yap · C. J. Q. · Ang · K. A. · Au · M. K. H. · Chong · T. T.
Objective

This study analysed the clinical outcomes and healthcare costs associated with diabetic foot ulcer (DFU) within a tertiary healthcare centre in Singapore.

Design

This is a retrospective, single-centre study. Patient data were extracted from the hospital’s electronic health system, including demographic, clinical and hospitalisation information. Hospitalisation costs were categorised into DFU-related and other hospitalisation costs. A one-way sensitivity analysis was performed to estimate the total healthcare costs associated with DFU.

Setting

Tertiary centre within a population suffering from a diabetic epidemic.

Participants

All patients aged 18 years or older who received DFU treatment between January 2019 and December 2023 at the Singapore General Hospital were included.

Results

A total of 2857 DFU patients were included in the study. In-hospital mortality remained stable at 5%–6% annually. Among the cohort, 39.1% underwent minor amputations, 19.6% had major amputations and 9.0% experienced both minor and major amputations. The median length of stay for surgical patients ranged from 10 (IQR 4–24) to 13 days (IQR 6–31), compared with 4 (IQR 2–8) to 5 (IQR 3–9.5) days for non-surgical patients. Total costs per admission for patients with DFU-related surgery ranged from US$28 588.96 to US$34 204.77, while for those without surgery, costs ranged from US$6637.59 to US$7955.23. Total hospitalisation costs for DFU during the study period ranged from US$65.87 million to US$72.16 million. All figures were inflation adjusted to 2023 US dollars.

Conclusions

DFU poses a significant clinical and economic burden in Singapore. Understanding the costs associated with DFU is essential for resource allocation and planning in DFU management.

Substitution of surgical care within benign gynaecology during COVID-19: waste of a good crisis? - a quantitative longitudinal study in the Netherlands

Por: Velthuijs · E. L. M. · Ismail · I. · Koolman · X. · de Leeuw · R. A. · Hehenkamp · W. J. K.
Objective

To examine the impact of the COVID-19 pandemic on the substitution of surgical procedures in benign gynaecology in the Netherlands.

Design

Quantitative longitudinal study evaluating the effects of the COVID-19 pandemic.

Setting

Nationwide healthcare delivery was analysed across six benign gynaecological pathways from 2016 to 2022 using Vektis and Dutch Hospital Data (DHD), accessed via Statistics Netherlands (Centraal Bureau voor de Statistiek).

Participants

The study focused on six benign gynaecological pathways classified using Dutch Diagnosis Treatment Combinations (DTCs): heavy menstrual blood loss (G11), uterine fibroids (G15), endometriosis (G17), prolapse (G25), infertility treatment (F11) and first trimester pregnancy complications (Z12). All patients receiving care within these pathways between 1 January 2016 and 31 December 2022 were included. Exclusions applied to all patients under 18 years old and, only within the menstrual disorder pathway, patients over 51 years old to exclude most postmenopausal blood loss cases where no alternative treatment applies.

Interventions

Cohorts from the initial pandemic year (2020) were compared with four prepandemic cohorts (2016–2019) and late-pandemic (2021) and postpandemic (2022) cohorts.

Primary and secondary outcome measures

The primary outcome was the trend in the total number of patients in surgical and non-surgical procedure groups across cohort periods. Secondary outcomes included trends within individual pathways.

Results

The analysis identified a significant reduction in benign gynaecological care during 2020, with an 18.3% (p

Conclusions

The COVID-19 pandemic significantly disrupted both surgical and non-surgical procedures within benign gynaecological pathways. Reduced care uptake during the pandemic waves was not recovered but instead forgone. The reduction in surgical procedures did not correspond with increased use of non-surgical alternatives. Future research should prioritise evaluating the long-term impacts of this disruption on patients and society.

Content validity of self-reports of excess skin after bariatric surgery: protocol for a Dutch cross-sectional study

Por: van Hogezand · L. L. · Dijksman · L. M. · Derksen · W. J. M. · Mink van der Molen · A. B. · Geenen · R.
Introduction

Body contouring surgery (BCS) can be applied to reduce the physical and mental burden of excess skin after massive weight loss. Self-reported outcomes of patients are used to assess this burden and to evaluate the effectiveness of BCS. The aim of this study is to clarify what is reflected in self-reports of excess skin after bariatric surgery. We hypothesise that the self-reported burden of excess skin is associated with both objectively assessed excess skin and the disposition to experience negative emotions.

Methods and analysis

This cross-sectional study will include 68 outpatients presenting at a plastic surgery clinic with a request for BCS. Patients fill out two questionnaires (the BODY-Q and the Sahlgrenska Excess Skin Questionnaire (SESQ)) to measure the size and burden of excess skin as well as the Big Five Inventory (BFI) to measure the disposition towards negative emotionality. Anonymised photographs of excess skin will be rated independently by four plastic surgeons using the Pittsburgh Rating Scale (PRS) Rainbow Classification to establish the objective amount of excess skin. Multiple linear regression analyses will be performed to identify the association of BODY-Q and SESQ scores with objective appraisals of excess skin by plastic surgeons, negative emotionality and demographics. Interobserver agreement for PRS Rainbow Classification will be established by Fleiss’ kappa.

Ethics and dissemination

Ethical approval was obtained from the regional medical ethics committee (METC; W20.258) and the institutional review board (Lokale Toetsing, St. Antonius Hospital in Nieuwegein, no. Z23.035). Informed consent of participants will be obtained. The results of this study will be submitted for publication in a peer-reviewed journal.

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