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Association between smoking behaviours during early pregnancy and the severity of gestational diabetes mellitus: a secondary analysis of prospectively collected cohort data in Korea

Por: Lim · J. H. · Joo · E. H. · Han · H.-J. · Ko · J. S. · Chung · B. · Kim · J. W. · Kim · J. Y. · Choi · Y. J. · Yang · S. J. · Han · Y. J. · Kwak · D. W. · Lee · H. J. · Ryu · H. M.
Objective

This study aimed to investigate the association between smoking behaviours during early pregnancy and the risk and severity of gestational diabetes mellitus (GDM), with a particular focus on smoking status, smoking intensity and secondhand smoke exposure.

Design

Secondary analysis of prospectively collected cohort data.

Setting

Multi-centre study conducted in South Korea (Korean Pregnancy Outcome Study) between March 2013 and January 2017.

Participants

From 4537 pregnant women initially enrolled, 3457 singleton pregnancies were included after excluding cases with transfer, loss to follow-up, twin pregnancies, miscarriages and pre-existing diabetes mellitus. All participants were women of Korean ethnicity.

Secondary outcome measures

Primary outcome was GDM and its subtypes (A1GDM: diet-controlled; A2GDM: insulin-requiring). Secondary outcomes were associations with active smoking (before pregnancy and during early pregnancy), smoking intensity dose–response relationships (pack-years) and secondhand smoke exposure among never-smokers.

Results

Among 3457 participants, 231 women (6.7%) were diagnosed with GDM (198 A1GDM, 33 A2GDM). Active smoking before pregnancy (adjusted OR (aOR) 3.98, 95% CI 1.58 to 9.30) and during early pregnancy (aOR 9.90, 95% CI 2.97 to 29.45) were significantly associated with A2GDM, while no significant association was observed with A1GDM. A clear dose-response relationship was observed, with smoking intensity >4 pack-years markedly increasing A2GDM risk (aOR 20.68, 95% CI 6.75 to 59.39). Detailed pack-year analysis showed 4–6 pack-years (aOR 20.57, 95% CI 5.80 to 65.46) and >6 pack-years (aOR 25.98, 95% CI 3.21 to 146.45). Among never-smokers, secondhand smoke exposure showed a borderline association with overall GDM risk (aOR 1.33, 95% CI 0.98 to 1.81).

Conclusions

Maternal active smoking before and during early pregnancy, as well as higher smoking intensity, was associated with an increased risk of pharmacologically treated GDM (A2GDM). Although secondhand smoke exposure did not reach statistical significance, the trend suggested a potential association with GDM risk among never-smokers. These findings provide important evidence for public health strategies for prenatal care, as smoking cessation and environmental smoke avoidance during prenatal and early antenatal care in women reduce the risk of gestational diabetes.

Artificial intelligence to improve the detection and risk stratification of acute pulmonary embolism (AID-PE): protocol for a pragmatic quasi-experimental comparator study

Por: Gunning · S. G. S. · Page · J. · Rossdale · J. · Charters · P. F. P. · Hudson · B. · Lyen · S. · Mackenzie Ross · R. · Seatter · A. · Bartlett · J. W. · Austin · L. · Myring · G. · McLeod · H. · Mitchell · P. · Stimpson · D. · Cookson · A. · Suntharalingam · J. · Rodrigues · J. C. L.
Introduction

Pulmonary embolism (PE) is a potentially fatal condition requiring timely diagnosis and treatment. CT pulmonary angiography (CTPA) is the gold standard for diagnosis and indicates PE severity through radiological markers of right heart strain. However, accurate interpretation and communication of these findings is often suboptimal in real-world practice. Artificial intelligence (AI) could alleviate pressure on radiology services by supporting PE identification, risk stratification and worklist prioritisation. Before widespread adoption, AI tools must be rigorously validated for diagnostic accuracy, safety and clinical impact.

Methods and analysis

This pragmatic single-centre, non-randomised quasi-experimental study will evaluate the diagnostic accuracy, feasibility, and clinical-cost impact of AI-assisted PE detection and risk stratification using AIDOC and IMBIO software. We will recruit two consecutive cohorts of adult patients undergoing CTPAs for suspected PE: a comparator cohort (12 months pre-AI implementation) and an intervention cohort (12 months post-AI implementation). AI will be applied retrospectively to the comparator cohort, while in the intervention cohort, radiologists will have contemporaneous access to the AI’s interpretation of CTPA images.

A subset of retrospective scans, both PE-positive and PE-negative, will undergo expert thoracic radiologist review to establish a reference standard. Data on patient demographics, clinical management and outcomes will be collected. Clinical management pathways and patient outcomes will be compared between cohorts to assess AI’s influence on acute PE management. Health economic modelling will assess the cost-effectiveness of integrating AI technology within the diagnostic workflow of acute PE.

Ethics and dissemination

This study was approved by the UK Healthcare Research authority (IRAS 311735, 10 May 2023). Ethical approval was granted by West of Scotland Research Ethics Service (23/WS/0067, 3 May 2023). Results will be shared with stakeholders, presented at national and international conferences, and published in open-access peer-reviewed journals.

Trial registration number

NCT06093217.

Mapping social determinants of health data in sub-Saharan Africa: a scoping review protocol

Por: Anyiam · F. E. · Gjonaj · J. · Osango · N. A. · Mugo · R. · Aber · P. · Shah · J. · Mangeni · J. · Vedanthan · R. · Hogan · J. W. · Mwangi · A. · Chunara · R.
Introduction

Research has increasingly underscored the impact of factors such as socioeconomic status, education, healthcare access, housing and environmental conditions in shaping population health outcomes. These factors, collectively called social determinants of health (SDOH), provide crucial context for understanding drivers of health outcomes. In sub-Saharan Africa (SSA), the study of SDOH is critical due to the region’s unique sociocultural and economic conditions. Understanding how SDOH interacts with health systems and capturing SDOH in data is crucial for informing modelling efforts and policies improving population health more effectively. This scoping review aims to map the types of data used to capture SDOH in research conducted in SSA, to identify research gaps and to summarise key findings.

Methods

This scoping review will follow the Arksey and O’Malley methodological framework, enhanced by Levac et al, providing best practices for identifying, selecting and analysing eligible studies. Key steps include (1) identifying the research question, (2) identifying relevant studies, (3) selecting eligible studies via a locally curated search, (4) extracting information, (5) collating, summarising and reporting results and (6) consultation with stakeholders.

Ethics and dissemination

Ethical approval is not required, as this review relies solely on published literature. Findings will be disseminated across academic channels (journals, conferences) and through targeted stakeholder engagement efforts, such as policy briefs and public health workshops, to reach policymakers, healthcare practitioners and community health organisations. This dissemination strategy aims to inform health policy and drive programme development in SSA.

Randomised controlled trial of laparoscopic primary crural repair versus additional circular bioabsorbable mesh reinforcement in hiatal hernia (PRIME-II trial): an RCT protocol

Por: de Haas · J. W. A. · Geerts · J. H. · de Boer · E. · Brohet · R. M. · Hazebroek · E. J. · Wassenaar · E. B. · Nieuwenhuijs · V. B.
Introduction

Laparoscopic hiatal hernia (HH) repair is associated with a high recurrence rate. Repair reinforced with mesh lowers short-term recurrence but can cause dysphagia and visceral erosion. Results of the PRIME trial, in which non-absorbable mesh reinforcement of the posterior crural repair was investigated, showed equal recurrence compared with primary suture repair after 6 months. This study investigates the use of circular absorbable mesh reinforcement in primary HH repair.

Methods and analysis

Prospective double-blinded randomised controlled superiority trial comparing two laparoscopic procedures for HH repair (110 vs 110). Adult patients with proven HH Skinner types II–IV (defined by preoperative CT scan) are included. Patients are randomised to undergo a laparoscopic primary crural repair with sutures alone or suture repair augmented with biosynthetic absorbable, circular mesh at the hiatus. Radiologic integrity of the hiatal repair 1 year after surgery is the main endpoint. Secondary objectives are clinical recurrence of the hernia, development of postoperative reflux disease, postoperative side effects and satisfaction with surgical outcome. Outcome assessors are blinded to allocation. Data are collected at baseline, and follow-up includes interviews and digital questionnaires at 3, 12, 24, 36, 48 and 60 months, as well as CT scan at 12 and 60 months. All patients randomised will be analysed according to the intention-to-treat principle.

Ethics and dissemination

Ethics approval has been obtained by the local ethics committee at Isala, Zwolle, the Netherlands (Medical Ethics Review Committee (METc) Isala, study number: 190516). METc Isala is no longer active; all duties have been taken over by METc of the University Medical Center Groningen. The trial’s results will be submitted to a peer-reviewed international journal as well as (inter)national conferences.

Trial registration number

Registered in the Dutch national trial registry: OMON (NL-OMON48062).

Effectiveness of protein supplementation combined with resistance training to counteract disproportional fat-free mass loss following metabolic bariatric surgery: rationale and design of the ENRICHED randomised controlled trial

Por: de Roos · B. M. · Yeh · L.-L. Y. · van den Hooff · P. S. · Nuijten · M. A. H. · Twisk · J. W. R. · Liem · R. S. L. · van Acker · G. J. D. · Severens · J. L. · Kambic · T. · Serlie · M. J. M. · Monpellier · V. M. · Eijsvogels · T. M. H. · Hopman · M. T. E. · Karregat · J. H. M.
Introduction

Metabolic bariatric surgery (MBS) can lead to substantial fat-free mass loss (FFML) due to malnutrition, decreased protein intake and insufficient physical activity. Disproportional FFML has been associated with an increased risk for adverse health outcomes. Resistance training (RT) combined with protein intake contributes to maintenance and increase of fat-free mass (FFM) in healthy individuals. However, it is unclear whether RT and protein supplementation can prevent FFML after MBS.

Methods and analysis

In the EffectiveNess of pRotein supplementatIon Combined witH resistance Exercise training to counteract Disproportional fat-free mass loss following metabolic bariatric surgery (ENRICHED) randomised controlled trial, 400 patients scheduled to undergo MBS will be randomised in a 1:1 ratio to the ENRICHED perioperative care programme (intervention group) or the standard perioperative care programme of the Dutch Obesity Clinic (control group). The study is currently recruiting participants at two centres in the Netherlands: Nieuwegein and Amsterdam. The postoperative standard programme consists of 13 group sessions spread over a period of 18 months. As part of the ENRICHED programme, RT and protein supplementation will be added 3 weeks after MBS. Additional whole-body RT consists of home-based training sessions two to three times a week, and supervised RT sessions of 45–60 min once weekly, performed at 60–75% of one-repetition maximum (1-RM). Protein supplementation will start by adding 20 g of whey protein to the daily intake. The supplementation will be gradually increased with 20 g every 4 weeks until a total of 60 g whey protein a day is reached. After 12 weeks of protein supplementation, the focus shifts towards incorporating protein-rich food products into the daily dietary intake. The primary endpoint is the prevalence of disproportional FFM loss, defined as FFML/total weight loss ≥30%, at 3 months post-MBS. Secondary endpoints are differences in body composition, muscle strength and function, cardiorespiratory fitness, (cardio)metabolic health, health-related quality of life, gastrointestinal discomfort, cost-effectiveness of the intervention and treatment satisfaction. Outcomes will be assessed preoperatively and at 3, 6 and 12 months postoperatively.

Ethics and dissemination

The study protocol V.2.0 was approved by the Medical Research Ethics Committee Oost-Nederland (NL-OMON57119) on 9 April 2025. All participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations. Insights gained in this study will provide evidence for a patient-tailored intervention that could be implemented in clinical practice.

Trial registration number

NCT07156552.

Can we Save the rectum by watchful waiting or transanal microsurgery following shorT-course radiotherapy and Additional local oR systemic Treatment for early-stage REctal Cancer? STARTREC-3 protocol for a non-randomised, multicentre, phase II platform stu

Por: de Vries · S. E. N. · Couwenberg · A. M. · Marijnen · C. A. M. · Beets · G. L. · Burger · J. W. · Chalabi · M. · de Groot · J. W. · Intven · M. · Peulen · H. M. · Roodhart · J. M. L. · de Wilt · J. H. W. · Grotenhuis · B. A.
Introduction

Total mesorectal excision (TME) is highly effective for early-stage rectal cancer, but is associated with considerable morbidity, which can substantially impair the quality of life (QoL) of patients. For very early tumours (low-risk cT1), local excision (LE) offers the possibility of organ preservation (OP) with reduced morbidity; however, its application is limited to a selected group. For early tumours where upfront LE is not feasible, primary OP with (chemo)radiotherapy as an alternative to TME surgery has been evaluated in the STARTREC phase II/III studies, which reported promising 1-year OP rates.

Objective

The STARTREC-3 trial aims to increase the 2-year OP rate from 60% to 80% in early rectal cancer (cT1–3abN0) and from 30% to 60% in early-intermediate rectal cancer (cT1–3abN1, ≤3 mesorectal nodes measuring ≤8 mm) by intensifying neoadjuvant treatment in different study arms.

Methods

STARTREC-3 is embedded in the STARTREC master trial protocol, which uses an adaptive platform study design allowing early termination of inferior treatment arms and the addition of novel arms. The multicentre STARTREC-3 trial investigates three parallel, non-comparative treatment strategies for patients with early and early-intermediate rectal adenocarcinoma who prefer OP over primary TME surgery. All arms start with 5x5 Gy radiotherapy, followed by: an endoluminal boost via contact X-ray brachytherapy (arm 1), an external beam radiotherapy (EBRT) boost by MR-guided EBRT (arm 2) or three cycles of capecitabine oxaliplatin systemic treatment chemotherapy (arm 3). Treatment allocation is predefined and centre-dependent. Response evaluations (MRI and endoscopy) are planned at 14–16 weeks and 26 weeks after onset of radiotherapy. The primary endpoint is the proportion of patients with successful OP at 24 months from onset of therapy. Secondary endpoints include toxicity, QoL, functional and oncological outcomes. Data will be analysed separately for early (cN0) and early-intermediate (cN1) disease. The total planned sample size is 210 patients across the three arms. Interim analyses will be performed for each study arm to determine early failures and discontinue ineffective arms.

Ethics and dissemination

The trial was approved by the medical ethics committee NedMec of the Netherlands and is registered in the EU Clinical Trials Information System (CTIS). The results will be published in an international peer-reviewed journal.

Trial registration number

CTIS EU 2024-514620-17-00

HERNIIA-II trial (Hernia Endoscopic oR opeN repair In chIldren Analysis): a protocol of a multicentre randomised controlled trial to study the (cost-)effectiveness of laparoscopic hernia repair compared to open hernia repair in children 0-16 years

Por: Maat · S. C. · de Vreeze · L. E. · Eurlings · R. · Anema · J. · Van Baren · R. · Been · J. V. · van den Broek · F. · Cakir · H. · van Dongen · J. M. · Ferenschild · F. · de Graaf · J. · Nijveldt · R. · Ottenhof · A. · Ploeg · A. J. · Rippen · H. · Ruiterkamp · J. · Twisk · J. W. R. · Ver
Introduction

Inguinal hernia repair is one of the most frequently performed operations in the paediatric population and can be performed according to two approaches: open or laparoscopic. At present, decisive evidence about the best treatment strategy is lacking and consequently, there is an ongoing debate about the most (cost-)effective treatment for the paediatric inguinal hernia. The aim of the Hernia Endoscopic oR opeN repair In chIldren Analysis—trial (HERNIIA2-trial) is to estimate the (cost-)effectiveness of the laparoscopic percutaneous internal ring suturing (PIRS) technique compared with open repair in children aged 0–16 years with a primary unilateral inguinal hernia.

Methods and analysis

A national multicentre randomised controlled trial will be performed including 464 children aged 0–16 years with a primary unilateral inguinal hernia. Patients will be randomised between the open or PIRS technique. The primary outcome is the number of reoperations within 2 years after primary surgery. Secondary outcome measures are: operative and postoperative complications, total duration of surgery, postoperative pain, length of admission, time to normal daily activities, cosmetic appearance of the scar, social and healthcare costs and health-related quality of life. Furthermore, cost-effectiveness will be assessed from a societal and healthcare perspective.

Ethics and dissemination

The protocol was approved by the ethics committee of the Amsterdam University Medical Hospital. Informed consent will be obtained by parents and, if possible, according to age, by patient. The study will be conducted according to the principles of the Declaration of Helsinki (2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and Good Clinical Practice. Study findings will be disseminated through scientific publications, conferences and patient-friendly materials. The national study network of participating centres will facilitate rapid dissemination and implementation within the Netherlands and potentially abroad.

Trial registration number

ClinicalTrials.gov PRS (ID NCT06451432).

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.

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.

The LoaD study: the association between different types of physical activity and the progression of knee osteoarthritis--a cohort study protocol

Por: van der Voort · J. W. · Voogt · L. · Huisken · S. · Oei · E. · van Oeveren · B. · van Meurs · J. · Pluim · B. M. · Bierma-Zeinstra · S. M. A. · van Middelkoop · M.
Background

The global prevalence of osteoarthritis (OA) is expected to rise as the population ages, leading to increased physical impairments that often reduce physical activity. Knee OA, in particular, is a leading cause of chronic pain and disability in people over 40. OA progression varies among individuals, with factors such as higher age and body mass index contributing to a more rapid progression. However, research suggests that engaging in physical activity such as hiking and running may help alleviate pain and slow OA progression. However, current literature on the relationship between physical activity and knee OA is largely retrospective, lacks comparative analyses across different physical activity types and rarely considers the intensity of physical activity. To address these gaps, the LoaD study was designed as a prospective cohort study aimed at examining how different physical activity types (ie, hiking, running, cycling and tennis) and their intensities relate to knee OA progression over 24 months in physically active individuals with early signs of the condition.

Methods and analysis

This prospective cohort study will include 300 participants (75 per physical activity group), who will be followed for 24 months. Eligible participants are aged 45–65, meet the National Institute for Health and Care Excellence (NICE) criteria for clinical knee OA and engage in a minimum weekly activity level for either running (60 min), cycling (120 min), playing tennis (60 min) or hiking (1 hike of 10 km). Baseline and follow-up assessments will include MRI, physical examination (eg, biometrics, lower extremity strength) and blood sampling for molecular biomarker assessment (eg, genetics, inflammatory biomarkers). Participants will receive monthly online questionnaires (eg, demographics, lifestyle, general health, history of knee injuries) and their physical activities will be tracked continuously by global positioning system data from wearable devices. The study’s primary outcomes focus on knee OA progression and symptom changes. These will be assessed through (1) structural progression of knee OA, measured using the MRI Osteoarthritis Knee Score (MOAKS) and (2) clinical symptom progression evaluated by (a) the Knee Injury and Osteoarthritis Outcome Score sport and recreation function subscale and (b) Visual Analogue Scale for pain during an activity nominated by the participant to be the most aggravating for knee pain in the past month (VASNA, 0–10). Differences between groups on the primary outcomes will be analysed using mixed-effects models to determine the impact of activity type and intensity on knee OA progression.

Ethics and dissemination

The study is approved by the Erasmus MC Medical Research and Ethics Committee (MREC) (MEC-2022-0420). The results of this study will be made publicly available through peer-reviewed international open-access scientific journals and national and international conferences. Participants will be informed about the results as soon as they are published.

Identifying racial inequalities in long-term outcomes among survivors of critical illness with sepsis in a US cohort: a retrospective cohort study

Por: Naiditch · H. · Talisa · V. B. · Magnani · J. W. · Nouraie · S. M. · Yende · S. · Mayr · F. B.
Objectives

Racial disparities in critical illness outcomes are well-described, with social determinants of health as likely contributors. We sought to identify inequalities in readmissions and mortality between black and white patients among survivors of critical illness with sepsis and assess whether these disparities were explained by neighbourhood characteristics, health insurance and hospital quality.

Design

Retrospective cohort study examining 90-day and 9-month readmissions and survival as coprimary outcomes. Models included age, sex, race and area deprivation index (ADI), Medicaid status or hospital Centers for Medicare & Medicaid Star rating. Accelerated failure time and Cox proportional hazards models with subgroup analyses by age and surgical status were employed.

Setting

14 community and tertiary hospitals in Western Pennsylvania.

Participants

48 027 survivors of sepsis with critical illness; 20 952 (50.4%) male; 6489 (13.5%) identified as black.

Results

Black patients were younger (mean age 59.0 years vs 65.8 years), more likely to have higher ADI, Medicaid insurance and receive care at lower-quality hospitals. Black patients had higher readmission risk: (90-day subdistribution HR (SDHR) 1.13 (95% CI 1.04 to 1.23); p=0.003); 9-month SDHR: 1.11 (95% CI 1.03 to 1.20); p=0.005). Adjusting for age and sex, we found no difference in 90-day and 9-month mortality (90-day acceleration factor (AF): 1.04 (95% CI 0.91 to 1.19); p=0.556; 9-month: 1.08 (95% CI 0.96 to 1.22); p=0.196), which remained consistent when including ADI, Medicaid status or hospital quality. Mortality among black patients was increased relative to white patients among patients ≥60 years (9-month AF 1.23 (95% CI 1.07 to 1.42; p=0.004)) and among surgical patients (90-day AF: 1.23 (95% CI 1.01 to 1.50; p=0.04); 9-month AF: 1.28 (95% CI 1.07 to 1.53; p=0.006)). Medicaid status, but not ADI or hospital quality, attenuated racial differences in subgroup mortality.

Conclusions

In a retrospective analysis of intensive care unit (ICU) survivors with sepsis, black patients had higher readmission rates but comparable mortality to white patients, except among older and surgical subgroups. Medicaid status influenced racial inequalities in mortality, highlighting a need for targeted post-ICU interventions.

Clinician experiences in a DBT-informed consultation group embedded within a US academic primary care clinic: a qualitative study

Por: Gier · N. M. · Maurer · R. R. · Tang · J. W.
Objective

Traditional wellness programming focuses on bringing together individual clinicians during personal time for resources and skill building, without a focus on skill building in the contexts and teams they are embedded in daily. We developed a dialectical behaviour therapy (DBT)-informed consultation group, ‘Complex Care Rounds’ (CCR), implemented within the usual workflow of a primary care clinic. The goal of CCR was to facilitate interprofessional team communication and enhance clinician motivation and efficacy, while simultaneously addressing medical and social needs of patients. During the twice-weekly group, team members provided validation and shared feedback while acknowledging the needs of the clinician and patient. The aim of this study was to explore clinician perspectives on participation in CCR and to create a conceptual model to understand CCR’s influence on individual team members as well as team dynamics.

Setting

The research was completed at the Comprehensive Care Programme, a primary care programme for patients with Medicare insurance at high risk of hospitalisation at an academic institution in Chicago, Illinois, USA.

Study design

This was a qualitative research study examining reflective essays written by participants on how participating in CCR has impacted them. Template analysis, a form of thematic analysis, was applied to code and organise themes.

Study participants

Participants included 12 clinical team members (physicians, nurses, social service team members) and 7 trainees (AmeriCorps members, medical students) from the Comprehensive Care Programme.

Results

We found that CCR’s shared team frameworks (theme 1) grounded in DBT promoted a practice of self-compassion (theme 2) as well as a validating team environment (theme 3) within our interprofessional team. Improvements to patient care (theme 4) extended from increased personal capacity, support from team members and a structured approach to team interactions.

Conclusions

DBT-informed consultation groups embedded within a clinical practice have the potential to promote a practice and culture of interprofessional team members tending to self and others, while also building one’s own skills and capacity to care for complex patients.

Trial registration number

Clinical trial: NCT04489693; Pre-results"

Predicting 30-day mortality in emergency department patients with suspected infection: external validation of the RISE UP score in a single tertiary centre

Por: van Baar de Knegt · S. M. E. · Uffen · J. W. · de Hond · T. A. P. · Stassen · P. M. · Zelis · N. · Kaasjager · K. A. H.
Objective

Rapid identification of high-risk and low-risk patients presenting to the emergency department (ED) influences clinical management and can help optimise patient outcomes as well as resource allocation. This study aims to externally validate the Risk Stratification in the Emergency Department in Acutely Ill Older Patients (RISE UP) score in adult patients in the ED with suspected infection. Furthermore, generalisability was assessed by comparing the discriminatory ability of the RISE UP with the quick Sequential Organ Failure Assessment (qSOFA) as well as the Modified Early Warning Score (MEWS) and National Early Warning Score (NEWS).

Design

Retrospective cohort study.

Setting

Single-centre study in the ED of a tertiary, university-affiliated hospital.

Participants

Adult patients with suspected infection presenting at the ED for internal medicine from 2016 to 2022.

Outcomes

The primary outcome was all-cause 30-day mortality. Secondary outcomes were all-cause 14-day mortality, 7-day mortality and intensive care unit (ICU) admission.

Methods

Prognostic performance was evaluated using discrimination (area under the receiver operating characteristic curve (AUC)) and a calibration plot.

Results

Of the included 5038 ED visits, there was a 30-day mortality of 7.1%. Discrimination of RISE UP for 30-day mortality was good (AUC 0.809; 95% CI 0.786 to 0.832) and significantly higher than that for the other risk scores: qSOFA (AUC 0.675; 95% CI 0.644 to 0.707), MEWS (AUC 0.688; 95% CI 0.658 to 0.718) and NEWS (AUC 0.725; 95% CI 0.696 to 0.754) (p

Conclusions

The RISE UP score outperformed the qSOFA, MEWS and NEWS in predicting 30-day mortality. It is generalisable to an adult infection-specific cohort and may facilitate distinction between high-risk and low-risk patients in the ED, particularly to rule out poor outcomes.

Improving reproducibility of data analysis and code in medical research: 5 recommendations to get started

Por: Streiber · A. M. · Hoepel · S. J. W. · Blok · E. · van Rooij · F. J. A. · Neitzel · J. · Labrecque · J. · Ikram · M. K. · Bos · D.

Due to the growing use of high-dimensional data and methodological advances in medical research, reproducibility of research is increasingly dependent on the availability of reproducible code. However, code is rarely made available and too often only partly reproducible. Here, we aim to provide practical and easily implementable recommendations for medical researchers to improve the reproducibility of their code. We reviewed current coding practices in the population-based Rotterdam Study cohort. Based on this review, we formulated the following five recommendations to improve the reproducibility of code used in data analysis: (1) make reproducibility a priority and allocate time and resources; (2) implement systematic code review by peers, as it further strengthens reproducibility. We provide a code review checklist, which serves as a practical tool to facilitate structured code review; (3) write comprehensible code that is well-structured; (4) report decisions transparently, for instance by providing the annotated workflow code for data cleaning, formatting and sample selection; and (5) focus on accessibility of code and data and share both, when possible, via an open repository to foster accessibility. Ideally, this repository should be managed by the institution and should be accessible to everyone. Based on these five recommendations, medical researchers can take actionable steps to improve the reproducibility of their research. Importantly, these recommendations are thought to provide a practical starting point for enhancing reproducibility rather than mandatory guidelines.

Occurrence of advance care planning for persons with dementia, cancer and other chronic-progressive diseases in general practice: longitudinal analysis of data from health records linked with administrative data

Por: Hommel · D. · Azizi · B. · Visser · M. · Bolt · S. R. · Blom · J. W. · Janssen · D. J. A. · van Hout · H. P. J. · Francke · A. L. · Verheij · R. A. · Joling · K. J. · van der Steen · J. T.
Objectives

There are substantial barriers to initiate advance care planning (ACP) for persons with chronic-progressive disease in primary care settings. Some challenges may be disease-specific, such as communicating in case of cognitive impairment. This study assessed and compared the initiation of ACP in primary care with persons with dementia, Parkinson’s disease, cancer, organ failure and stroke.

Design

Longitudinal study linking data from a database of Dutch general practices’ electronic health records with national administrative databases managed by Statistics Netherlands.

Setting and participants

Data from general practice records of 199 034 community-dwelling persons with chronic-progressive disease diagnosed between 2008 and 2016.

Outcome measure

Incidence rate ratio (IRR) of recorded ACP planning conversations per 1000 person-years in persons with a diagnosis of dementia, Parkinson’s disease, organ failure, cancer or stroke, compared with persons without the particular diagnosis. Poisson regression and competing risk analysis were performed, adjusted for age, gender, migration background, living situation, frailty index and income, also for disease subsamples.

Results

In adjusted analyses, the rate of first ACP conversation for persons with organ failure was the lowest (IRR 0.70 (95% CI 0.68 to 0.73)). Persons with cancer had the highest rate (IRR 1.75 (95% CI 1.68 to 1.83)). Within the subsample of persons with organ failure, the subsample of persons with dementia and the subsample of stroke, a comorbid diagnosis of cancer increased the probability of ACP. Further, for those with organ failure or cancer, comorbid dementia decreased the probability of ACP.

Conclusions

Considering the complexity of initiating ACP for persons with organ failure or dementia, general practitioners should prioritise offering it to them and their family caregivers. Policy initiatives should stimulate the implementation of ACP for people with chronic-progressive disease.

Comparison of cardiovascular risk profiles of patients with type A aortic dissection and thoracic aortic aneurysm: a retrospective multicentre study

Por: Tirpan · A. U. · Dolmaci · O. B. · Jansen · E. K. · Twisk · J. W. R. · Klautz · R. J. M. · Grewal · N.
Objective

A thoracic aortic aneurysm (TAA) is often considered a precursor to an acute type A aortic dissection (ATAAD), a life-threatening condition requiring immediate surgical intervention. While both conditions share histopathological similarities, less is known about their overlap in clinical cardiovascular risk factors. This study aimed to map the cardiovascular disease burden in patients with ATAAD and compare it with patients with TAA.

Design

A multicentre retrospective study.

Setting

The data were collected from electronic health records of two academic hospitals located in the Netherlands.

Participants

Patients who were treated surgically for ATAAD or TAA between 2000 and 2022 were eligible. This study included 731 patients with ATAAD and 480 patients with TAA.

Results

Hypertension was equally prevalent in both groups (50.9% vs 50.6%, p=0.921). Diabetes was uncommon (3.3% vs 6.7%, p=0.638). Hyperlipidaemia (9.6% vs 20.0%, p=0.001) and peripheral arterial disease (8.8% vs 22.7%, p

Conclusion

This study suggests distinct cardiovascular risk profiles in patients with ATAAD and patients with TAA, highlighting the importance of tailored treatment strategies for aortic disease. Further research is needed to investigate the pathophysiological mechanisms underlying these differences and their impact on thoracic aortopathy.

How can post-COVID care be improved using patient experiences with received care and perceived health? A qualitative study of focus groups with 30 patients having post-COVID in the Netherlands

Por: Gruiskens · J. · Gidding-Slok · A. H. · van Meulenbroek · T. · Huijnen · I. · Muris · J. W. M. · Verbunt · J. · van Schayck · O. C. · Burgers · J. S.
Objectives

To provide bottom-up guidance on improving post-COVID care using patients’ experiences with received care and their perceived health

Design

Qualitative study design using focus group interviews

Participants

30 patients with post-COVID condition recruited through purposive sampling based on patient complexity and diversity

Results

Three dimensions for potential improvements of post-COVID care were identified: (1) building, supporting and maintaining patient resilience, (2) redesigning healthcare pathways to meet patient needs and (3) embedding post-COVID care in health systems and organisations. A conceptual framework that could guide improvements in post-COVID care was developed.

Conclusion

This study revealed several opportunities for improving and implementing post-COVID care following a person-centred approach in multidisciplinary integrated care pathways with an integrative vision of health.

The prognostic value of a screening tool for psychological risk factors after mild traumatic brain injury: prospective studies in Canada and New Zealand

Por: Mikolic · A. · Snell · D. L. · Theadom · A. · Faulkner · J. W. · Zemek · R. · Silverberg · N. D.
Objective

To investigate the prognostic value of the Subgroups for Targeted Treatment (STarT) Screening Tool adapted for concussion (STarT-C) on persistent symptoms and disability at 6–9 months following mild traumatic brain injury (mTBI).

Design

Secondary analysis of two prospective studies: an observational cohort study in New Zealand and usual care control arm of a clinical trial in Canada (ClinicalTrials.gov Registry (NCT04704037)).

Setting

Participants in the New Zealand cohort were recruited from concussion clinics (five sites) and those in the Canadian cohort were recruited from emergency departments/urgent care centres (eight sites).

Participants

New Zealand participants (n=93, median age 37 years, 60% women) were assessed at median=6 weeks post-injury (T1) and 6 months later (T2). Canadian participants (n=223, median age 38 years, 56% women) were assessed at median=2 weeks (T1) and 6 months later (T2).

Main outcome measures

Symptoms at T2 were assessed using the validated Rivermead Postconcussion Symptoms Questionnaire (RPQ) and disability using the WHO Disability Assessment Schedule 2.0 12-item Interview.

Results

In linear regression analyses, the STarT-C predicted symptom burden (R2=18–36%) and disability (R2=15–18%) at T2 in both cohorts. While the additional prognostic value over and above baseline variables was substantial (delta R2 8–40%), the additional prognostic value over the RPQ at T1 was variable and generally lower (delta R2=1–9%).

Conclusion

The STarT-C—a brief screening tool—predicted persistent symptoms and disability in adults following mTBI. The incremental prognostic value of the STarT-C over the RPQ may be variable, but regardless, the tool may be useful for identifying those at risk of prolonged recovery who may benefit from early psychological intervention.

Establishing a framework of measurement for use in Long COVID research and practice: protocol for a scoping review involving evidence review and consultation

Por: McDuff · K. · Bhereur · A. · Kadakia · Z. · Corrales-Medina · V. F. · Gross · D. P. · Janaudis-Ferreira · T. · Lam · G. · Naik · H. · Paterson · T. S. E. · Sanchez-Ramirez · D. C. · Sasseville · M. · Sekar · A. · Vohra · S. · Bayley · M. · Birch · S. · Busse · J. W. · Cameron · J. I. · K
Introduction

Our aim is to develop a Framework of Measurement for people living with Long COVID and their caregivers for use in Long COVID research and clinical practice. Specifically, we will characterise evidence pertaining to outcome measurement and identify implementation considerations for use of outcome measures among adults and children living with Long COVID and their caregivers.

Methods and analysis

We will conduct a scoping study involving: (1) an evidence review and (2) a two-phased consultation, using methodological steps outlined by the Arksey and O’Malley Framework and Joanna Briggs Institute. We will answer the following question: What is known about outcome measures used to describe, evaluate or predict health outcomes among adults and children living with Long COVID and their caregivers? Evidence review: we will review peer review published and grey literature to identify existing outcome measures and their reported measurement properties with people living with Long COVID and their caregivers. We will search databases including MEDLINE, Embase, CINAHL, PsycINFO and Scopus for articles published since 2020. Two authors will independently review titles and abstracts, followed by full text to select articles that discuss or use outcome measures for Long COVID health outcomes, pertain to adults or children living with Long COVID and/or their caregivers and are based in research or clinical settings. We will extract data including article characteristics, terminology and definition of Long COVID, health outcomes assessed, characteristics of outcome measures, measurement properties and implementation considerations. We will collate and summarise data to establish a preliminary Framework of Measurement. Consultation phase 1: we will conduct an environmental scan involving a cross-sectional web-based questionnaire among individuals with experience using or completing outcome measures for Long COVID, to identify outcome measures not found in the evidence review and explore implementation considerations for outcome measurement in the context of Long COVID. Consultation phase 2: we will conduct focus groups to review the preliminary Framework of Measurement and to highlight implementation considerations for outcome measurement in Long COVID. We will analyse questionnaire and focus group data using descriptive and content analytical approaches. We will refine the Framework of Measurement based on the focus group consultation using community-engaged approaches with the research team.

Ethics and dissemination

Protocol approved by the University of Toronto Health Sciences Research Ethics Board (protocol #46503) for the consultation phases of the study. Outcomes will include a Framework of Measurement, to enhance measurement of health outcomes in Long COVID research and clinical practice. Knowledge translation will also occur in the form of publications and presentations.

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism (PEREGRINE): a protocol for a randomised multiarm surgical pilot trial

Por: Staibano · P. · Au · M. · Pasternak · J. D. · Parpia · S. · Zhang · H. · Busse · J. W. · Nguyen · N.-T. · Monteiro · E. · Gupta · M. K. · Choi · D. L. · Lewis · T. · McKechnie · T. · Thabane · A. · Ham · J. · Young · J. E. · Bhandari · M.
Background

Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.

Methods/design

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;

Ethics and dissemination

Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.

Trial registration number

NCT06542315, registered on 6 August 2024.

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