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Association between continuity of care and detection of hypertension in Dutch general practice: a 10-year cohort study

Por: van der Velde · N. R. · te Winkel · M. T. · Kanning · J. P. · Lissenberg-Witte · B. I. · Harskamp · R. · Maarsingh · O. R.
Objectives

Hypertension is a major modifiable risk factor for cardiovascular disease, and timely detection enables interventions that can substantially reduce this risk. General practice, with continuity of care (COC) as one of its core values, plays a pivotal role in hypertension detection. This study aimed to investigate the association between COC and the detection of hypertension in general practice.

Design

Longitudinal dynamic cohort study.

Setting

This study used routine care data from 48 Dutch general practices between 2013 and 2022.

Participants

106 755 adults without known cardiovascular diseases or risk factors at baseline.

Outcome measures

The Herfindahl-Hirschman Index, an established measure for COC, was used to calculate both general practitioner (GP)- and team-COC. A multivariable Cox proportional hazard regression model was used to assess the association between COC level (low, intermediate, high) and the incidence of hypertension detection.

Results

We included 106 755 patients (59.5% female, median age 35 years) in our analysis. The overall incidence rate was 9.42 hypertension diagnoses per 1000 person-years (95% CI 9.20 to 9.64). Compared with low COC, patients receiving intermediate or high GP-COC had a 1.9 (95% CI 1.7 to 2.1) to 4.9 (95% CI 4.4 to 5.4) higher HR of hypertension detection; patients receiving intermediate or high team-COC had a 2.3 (95% CI 2.2 to 2.5) to 7.3 (95% CI 6.8 to 7.8) higher HR of hypertension detection. High personal continuity was associated with up to 8.3 months (95% CI 8.6 to 7.9) earlier detection of hypertension. The association between COC and hypertension detection was dose-dependent.

Conclusions

This study shows that both GP-COC and team-COC are dose-dependently associated with increased HRs and earlier detection of hypertension in adults without preregistered cardiovascular conditions. Promoting COC contributes to cardiovascular preventive care.

Leadership of Nurses' Interprofessional Collaboration: A Mixed‐Methods Systematic Review

ABSTRACT

Aim

To identify and synthesise qualitative and quantitative evidence of nurse managers' qualities, practices and styles related to leading nurses' interprofessional collaboration.

Design

Mixed-methods systematic review.

Methods

Two authors independently selected studies based on predefined inclusion criteria, assessed quality and extracted data. A thematic synthesis with a convergent qualitative design was used.

Data Sources

CINAHL, PubMed and Scopus were searched from January 1, 2010, to September 7, 2025. Citations of relevant articles were screened.

Results

A total of 32 articles were included. The analysis revealed two leadership core qualities, five core practices, and three core styles of nurse managers that promote nurses' interprofessional collaboration. Core qualities were proficiency and mindset. Core practices comprised empowering, communicating and informing, commitment to interprofessional collaboration, creating possibilities, and establishing an enhancing atmosphere. Core styles included authentic, transformational, and transactional leadership styles.

Conclusion

The results reflect the situational nature of nursing leadership related to interprofessional collaboration. Successful leadership requires managers to adopt primarily a transformational leadership style, yet more traditional leadership is required occasionally. Results indicate that nursing leadership is foremost a process that evolves within its context.

Implications for the Profession and/or Patient Care

Greater clarity on how leadership influences nurses' interprofessional collaboration supports leaders, organisations, and educational institutions in developing and sustaining effective leadership.

Impact

This review demonstrates that the quality of nursing leadership is a central factor for successful interprofessional collaboration.

Reporting Method

The PRISMA guidelines for Systematic Reviews and Meta-Analysis were used.

Patient or Public Contribution

This study did not include patient or public involvement in its design, conduct or reporting.

Introducing an integrated maternity care pathway for women with a history of small-for-gestational-age: Evaluation of its effect on care process and clinical outcomes

by Anne C. M. Hermans, Julia Spaan, Marieke A.A. Hermus, Amber M. Hietkamp, Jantien Visser, Arie Franx, Jacoba van der Kooy

Introduction

This study focusses on the implementation of an integrated care pathway for women with SGA in their obstetric history that pursues value-based healthcare. This study aims to 1) Determine whether the integrated care pathway led to a reduction in the number of antenatal secondary care consultations, as an indicator of care efficacy, and 2) compare clinical outcomes for women with a history of SGA before and after implementation of the integrated care pathway.

Methods

Retrospective cohort study including data from pregnant women with a history of SGA within integrated maternity care organisation Annature, 2017–2020. Intervention was an integrated care pathway (2018). Pre- and post-intervention periods were compared assessing prenatal secondary care consultations, place and mode of delivery, and perinatal outcomes.

Results

The implementation of the care pathway for pregnant women with a history of SGA led to a reduction in mean number of prenatal secondary care consultations per pregnancy from 11 in 2017–5 in 2020, and fewer inductions of labour (78 (34.2%) vs 127 (26.8%), p = 0.045). Additionally, the number of births in primary care increased (35 (15.4%) vs 136 (28.8%), p  Conclusion

The implementation of the care pathway for pregnant women with a history of SGA resulted in a reduction in prenatal secondary care consultations and fewer inductions of labour. Additionally, the number of births in primary care increased, with no significant adverse impact on neonatal outcomes in the post-intervention period compared to the pre-intervention period.

Decisional needs among patients and physicians in the treatment of chronic myeloid leukaemia: a qualitative analysis in the Netherlands

Por: Mingels · S. · Cloots · M. J. J. · Smit · Y. · Blijlevens · N. M. A. · Posthuma · E. F. M. · Dekker · A. L. A. J. · Fijten · R. R. R. · Wener · E. · Kromkamp · C. C. G.
Objective

Treatment advancements in chronic myeloid leukaemia (CML) have made the disease manageable but carry significant risk of side effects. Bridging information gaps between patients and physicians through shared decision-making (SDM) is increasingly favoured, yet understanding treatment complexities remains a challenge. This study sought to identify decisional and informational needs of both patients and physicians in CML care.

Design

A qualitative study using semi-structured interviews was conducted to investigate the opinions, attitudes and preferences of both patients with chronic myeloid leukaemia and physicians.

Setting

Patients and physicians were recruited through the Dutch CMyLife platform, an initiative of haematologists, patients and patient organisations. They were provided with the participant information and invited to participate if interested.

Participants

A total of 15 interviews (n=10 patients, n=5 physicians) were conducted between April and October 2023.

Primary and secondary outcome measures

A pre-defined interview guide was developed based on the Decisional Needs Assessment questionnaire. Interview transcripts were thematically analysed.

Results

Eight themes and 28 sub-themes were observed, highlighting patient needs, treatment choices and informational preferences. Patients emphasised the importance of understanding medication options and side effects, while physicians stressed the necessity of delivering up-to-date and comprehensible information. Almost all participants had experienced professionals making the treatment decision, without patient involvement, especially when initiating treatment. Some patients expressed too little information and missed partnership with professionals at treatment onset. Peer support, decision-making dynamics and the role of caregivers were also significant considerations.

Conclusions

Both shared and distinct perspectives on CML treatment decision-making between patients and physicians were revealed, underscoring the complexity of decisional needs in CML management. The findings emphasise the importance of patient-centred care, SDM and tailored communication strategies to optimise patient outcomes and satisfaction. Improved communication and evidence-based decision-making tools can significantly impact patient well-being. Further research and interventions are necessary to address the challenges in decision-making processes in CML care.

Psychometric validation of the Internalised Stigma Scale for Gestational Diabetes Mellitus (ISS-GDM): a cross-sectional study

Por: Davidsen · E. · Maindal · H. T. · Christensen · K. B. · Damm · P. · Byrne · M. · Dahl-Petersen · I. K. · Mathiesen · E. R. · Jensen · D. M. · Vinter · C. · Kampmann · U. · Ovesen · P. G. · Kragelund Nielsen · K.
Objectives

To develop and validate the Internalised Stigma Scale for Gestational Diabetes Mellitus (ISS-GDM), a questionnaire measuring self-reported internalised stigma among women with prior gestational diabetes mellitus (GDM). We hypothesised that internalised GDM stigma could be reliably and validly assessed through a short psychometric instrument.

Design

Cross-sectional validation study.

Setting

Follow-up data from the Danish, multicentre Face-it trial for women with prior GDM and their families.

Participants

In total, 248 women completed the ISS-GDM approximately 1 year after their GDM affected pregnancy.

Primary and secondary outcome measures

The primary outcome was psychometric properties of the ISS-GDM, assessed using Cronbach’s alpha, confirmatory factor analysis (CFA) and Rasch analysis (RA). Secondary outcomes included identification of item anomalies (local response dependence, differential item functioning).

Results

A large proportion of respondents endorsed statements reflecting self-disappointment, self-blame and an altered self-perception. Less endorsed statements included feeling inferior to other mothers or guilt towards family members due to GDM. The ISS-GDM demonstrated satisfactory psychometric properties. CFA indicated that item 2 assessing self-perceived capabilities as a mother did not load onto the main factor, while CFA and RA identified local response dependence and differential item functioning by body mass index. After adjustments, a two-factor solution supported calculating a sum score of items 1 and 3–11, with item 2 retained as a stand-alone indicator of perceived parenting capabilities. The 10-item scale demonstrated acceptable reliability (Cronbach’s alpha=0.78).

Conclusions

The ISS-GDM is a reliable and valid tool for assessing internalised stigma among women with prior GDM. Our findings further suggest that a substantial proportion of women with prior GDM experience self-blame and an altered self-perception due to their diagnosis. The ISS-GDM scale enables research into its prevalence, severity and consequences.

Methodological considerations and cost to measure coverage of multisectoral nutrition interventions: protocol for the One Nutrition Coverage Survey in Bangladesh

Por: Manohar · S. · Nguyen · P. H. · Neupane · S. · Munos · M. K. · Heidkamp · R. · Banerjee · A. · Pandya · N. · Kim · S. S.
Introduction

Despite global commitments to eliminate malnutrition, over half the world’s population remains affected. Multisectoral nutrition interventions targeting both proximate and distal causes of malnutrition are essential across the lifespan. Yet, current data collection lacks comprehensive nutrition intervention coverage measures, risking inaccuracies in tracking progress. The One Nutrition Coverage Survey (ONCS) aims to test new and refined coverage measurement methods, assess coverage equity and guide integration into large-scale household surveys.

Methods and analysis

The ONCS will be a cross-sectional, population-representative household survey conducted in four districts of Bangladesh (Rangpur, Sylhet, Dhaka and Khulna), selected for their geographic spread and urban–rural balance. A stratified multistage sampling approach will be used to select enumeration areas, and a total of approximately 3280 households randomly selected within each EA will be included in the survey. The survey will interview women of reproductive age (15–49 years), caregivers of children (0–9 years), adolescents (10–19 years) and pregnant women, collecting data on multisectoral nutrition interventions relevant to these groups. It will use both existing and new measures, while also capturing monetary and non-monetary costs for survey design to implementation. Data will be analysed to assess coverage, co-coverage and equity by sociodemographic characteristics, as well as the feasibility, accuracy and costs of the survey approach.

Ethics and dissemination

The study protocol and instruments were reviewed and approved by the International Centre for Diarrhoeal Disease Research, Bangladesh’s (icddr,b) Ethical Review Board in Bangladesh and the International Food Policy Research Institute’s Institutional Review Board in Washington, DC, USA. Adults provided signed informed consent and adolescents their assent. Findings will be shared through peer-reviewed publications, conferences and presentations in Bangladesh with key stakeholders. This study will yield new tools, methods and evidence for measuring multisectoral nutrition intervention coverage, applicable to other low-income and middle-income countries. Learnings from ONCS will enhance data collection aligned with national strategies, helping governments improve coverage assessments, inform decisions and strengthen programme monitoring.

Exploring what works, for whom, under what circumstances to transform systems: realist synthesis protocol of four ongoing studies and literature addressing health inequalities

Por: Horck · S. S. · Crone · M. · Kamphuis · C. B. M. · Stevens · G. W. J. M. · Dedding · C. · Bussemaker · J. · van der Pas · S. · van Berkel · J.
Introduction

Health inequalities remain resistant to interventions that primarily target individual behaviour. Although systems approaches are increasingly promoted, their application in practice is often not well grounded in real-world settings. In this protocol paper, we present the approach we will take in an overarching project that synthesises the combined insights of four ongoing systems-based research projects on system-based approaches for reducing health inequalities in the Netherlands. By bringing together and comparing findings across diverse contexts, populations and interventions, we aim to generate an empirically grounded understanding of what works, for whom, in what contexts and why, and to derive actionable strategies for systemic change to reduce health inequalities.

Methods and analysis

We use a realist approach to synthesise insights from the four ongoing projects. The design involves four iterative steps: (1) Identifying cross-cutting themes from project proposals and literature, (2) Developing and refining context–mechanism–outcome (CMO) configurations through literature review and Slow Science meetings, (3) Engaging Critical Friends to co-develop actionable strategies and (4) Assessing and validating these strategies across diverse contexts. Iterative feedback loops ensure continuous refinement, integration of stakeholder perspectives and exploration of emergent challenges. This design enables theory-informed, practice-based strategies to support sustainable system change in reducing health inequalities.

Ethics and dissemination

Ethical approval for the four underlying projects has been obtained from the relevant institutional review boards, and the way their data is used for this overarching project falls within their approved scope. Dissemination will be ongoing and co-created with stakeholders, including policy briefs, factsheets, educational tools and academic publications, to support uptake of strategies for systems change.

Effects of glucagon-like peptide-1 analogues on hard binary outcomes for patients at increased risk of cardiovascular events: a protocol for a systematic review with network meta-analysis and Trial Sequential Analysis

Por: Sillassen · C. D. B. · Faltermeier · P. · Petersen · J. J. · Kamp · C. B. · Grand · J. · Dominguez · H. · Frolich · A. · Gaede · P. H. · Gluud · C. · Mathiesen · O. · Jakobsen · J. C.
Background

Cardiovascular diseases, overweight, type 2 diabetes and chronic kidney disease increase the risk of cardiovascular events.

Glucagon-like peptide-1 analogues are recommended by the European Society of Cardiology and the American College of Cardiology to lower the risk of death and progression of cardiovascular disease in patients with cardiovascular disease and type 2 diabetes. Semaglutide, tirzepatide and liraglutide are approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of type 2 diabetes mellitus and overweight. CagriSema is currently not approved, but several phase III trials are ongoing.

No previous systematic review has investigated the effects of semaglutide, tirzepatide, CagriSema and liraglutide, which may not be disease-specific, on hard binary outcomes for all trial populations at increased risk of cardiovascular events.

Methods and analyses

We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, Conference Proceedings Citation Index—Science) and clinical trial registries from their inception and onwards to identify relevant randomised trials. We expect to perform the literature search in December 2025. Two review authors will independently extract data and assess the risk of bias. We will include randomised trials assessing the effects of semaglutide, tirzepatide, CagriSema and/or liraglutide in participants with an increased risk of cardiovascular events. The primary outcome will be all-cause mortality. Secondary outcomes will be myocardial infarction, stroke and all-cause hospitalisation. Data will be synthesised by aggregate data meta-analyses, Trial Sequential Analyses and network meta-analysis, risk of bias will be assessed with Cochrane Risk of Bias tool V. 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations and the Confidence in Network Meta-Analysis approach.

Ethics and dissemination

This protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals.

PROSPERO registration number

CRD42024623312.

Patient experiences with a smartwatch 1L-ECG versus traditional Holter monitoring for ambulatory cardiac rhythm monitoring: a qualitative study

Por: Karregat · E. P. M. · Vooijs · P. · Wierda · E. · Harskamp · R. · Lucassen · W. · Himmelreich · J. C. L. · Moll van Charante · E. P.
Objective

To explore patients’ experiences and perspectives on using a direct-to-consumer smartwatch with single-lead electrocardiography (1L-ECG) for ambulatory rhythm diagnostics in primary care.

Design

Qualitative study using semi-structured interviews and thematic analysis.

Setting

Primary care patients referred for ambulatory rhythm monitoring in a diagnostic centre.

Participant

Eighteen adults with paroxysmal palpitations, of whom nine were female patients (50%), aged 32–85 (median 66) years.

Intervention

Participants simultaneously wore a smartwatch with 1L-ECG capability (Withings ScanWatch) and a conventional Holter monitor for 7 days.

Outcome measures

Patient experiences and perceived barriers and facilitators to smartwatch use for rhythm monitoring, reported after the monitoring period.

Results

Patients found the smartwatch more user-friendly and feasible than the Holter monitor. Difficulties included uncertainty about when to initiate recordings, challenges capturing brief episodes and anxiety triggered by automated algorithm outputs. Participants emphasised the importance of accessible healthcare support for interpretation and reassurance.

Conclusions

This study shows that smartwatch-based 1L-ECG monitoring is feasible and acceptable for ambulatory rhythm diagnostics in primary care. Prior to routine implementation, it is crucial to address the identified challenges: particularly anxiety related to algorithm results, uncertainty about when to record and accessible clinician support.

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.

Evaluation of the acute flaccid paralysis surveillance system performance in the Upper West Region of Ghana from 2021 to 2023: a retrospective descriptive study

Por: Simon · A. · Punguyire · D. · Bangniyel · J. · Baatiema · L. · Naawa · A. · Alhassan · I. K. · Akampege · C. · Bessing · B.
Objectives

To evaluate the performance of the acute flaccid paralysis (AFP) surveillance system in Ghana’s Upper West Region between 2021 and 2023 against WHO benchmarks in order to identify strengths and weaknesses and sustain Ghana’s progress towards a polio-free future.

Design

Retrospective analysis of routinely collected AFP surveillance data.

Setting

The Upper West Region of Ghana, a remote and resource-limited border region with high vulnerability to poliovirus importation and circulation.

Participants

All 213 AFP cases reported in the Upper West Region between January 2021 and December 2023.

Main outcome measures

WHO-recommended AFP surveillance indicators, including non-polio AFP (NP-AFP) rate, stool adequacy rate, timeliness of case notification and investigation, stool specimen transport and condition and non-polio enterovirus (NPENT) isolation rate.

Results

A total of 213 AFP cases were reported in the Upper West region between 2021 and 2023, with an average age of 24 months. The NP-AFP rate was consistently above the WHO target, averaging 26.7 per 100 000 population under 15 years. However, stool adequacy rates varied, averaging 73%, with a notable increase from 51% in 2021 to 97% in 2022 and a decline to 70% in 2023. The proportion of districts meeting both NP-AFP and stool adequacy targets fluctuated, with 64% in 2022 but dropping to 27% in 2023. Timeliness of case reporting remained high (≥94%), while investigations within 48 hours declined to 74% in 2023. Stool specimen transport was weak, with only 6% reaching the laboratory within 3 days of collection in 2023. NPENT isolation exceeded the WHO benchmark of ≥10% throughout the study period, with rates of 12% in 2021, 31% in 2022 and 11% in 2023, confirming specimen integrity and laboratory sensitivity despite transport challenges.

Conclusion

The AFP surveillance system in the region demonstrated high sensitivity, as reflected by the NP-AFP rate, but challenges remain in maintaining stool adequacy and sample transportation standards. Strengthening sample transportation and logistics, as well as addressing district-level disparities in surveillance performance, will be essential to improving the overall quality of AFP surveillance in the region.

Side effect profile and comparative tolerability of newer generation antidepressants in the acute treatment of major depressive disorder in children and adolescents: protocol for a systematic review and network meta-analysis

Por: Türkmen · C. · Sacu · S. · Furukawa · Y. · de Cates · A. N. · Schoevers · R. A. · Kamphuis · J. · Chevance · A. · Weisz · J. R. · Emslie · G. J. · Strawn · J. R. · Hetrick · S. E. · Efthimiou · O. · Salanti · G. · van Dalfsen · J. H. · Furukawa · T. A. · Cipriani · A.
Introduction

Major depressive disorder (MDD) is among the most common psychiatric disorders in children and adolescents. While previous meta-analyses have synthesised evidence on the efficacy and acceptability of newer-generation antidepressants in this population, specific adverse events (AEs) remain poorly characterised. This is of high clinical importance, as AEs are burdensome for patients, can reduce treatment adherence and lead to discontinuation. Here, we present a protocol for a network meta-analysis designed to evaluate the specific AE profile and comparative tolerability of newer-generation antidepressants in children and adolescents with MDD.

Methods and analysis

The planned study will include double-blind randomised controlled trials that compared one active drug with another and/or placebo for the acute treatment of MDD in children and adolescents. The following antidepressants will be considered: agomelatine, alaproclate, bupropion, citalopram, desvenlafaxine, duloxetine, edivoxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, vilazodone and vortioxetine. The primary outcomes will include the number of patients experiencing at least one AE, specific non-serious AEs, serious AEs (eg, suicidal ideation) and AEs leading to treatment discontinuation. Published and unpublished studies will be retrieved through a systematic search in the following databases: PubMed, Embase, Cochrane Library (including the Cochrane Central Register of Controlled Trials), Web of Science Core Collection, PsycInfo and regulatory agencies’ registries. Study selection and data extraction will be performed independently by two reviewers. For each outcome, a network meta-analysis will be performed to synthesise all evidence. Consistency will be assessed through local and global methods, and the confidence in the evidence will be evaluated using the Confidence in Network Meta-Analysis web application. All analyses will be conducted in the R software.

Ethics and dissemination

The planned review does not require ethical approval. The findings will be published in a peer-reviewed journal and may be presented at international conferences.

PROSPERO registration number

CRD420251011399.

Antipsychotics for Parkinsons disease: a protocol for a systematic review with network meta-analysis and trial sequential analysis

Por: Petersen · J. J. · Kamp · C. B. · Juul · S. · Bjerg · J. L. · Sillassen · C. D. B. · Faltermeier · P. · Salvesen · L. · Hejl · A.-M. · Bech · S. · Lokkegaard · A. · Jakobsen · J. C.
Introduction

Parkinson’s disease is a neurological disease with a rising incidence and prevalence. Patients with Parkinson’s disease may receive antipsychotics, for example, due to Parkinson’s disease psychosis. Parkinson’s disease psychosis is characterised by visual hallucinations and other psychotic symptoms. To date, no systematic review has evaluated the effects of antipsychotics in patients with Parkinson’s disease. Therefore, this review aims to assess the beneficial and harmful effects of antipsychotics for Parkinson’s disease.

Methods and analysis

This is a protocol for a systematic review. A search specialist will perform a search in major medical databases (eg, MEDLINE (Medical Literature Analysis and Retrieval System Online), EMBASE (Excerpta Medica database), CENTRAL (Cochrane Central Register of Controlled Trials)) and clinical trial registries. Published and unpublished randomised clinical trials comparing antipsychotics to any control (placebo, standard care or other antipsychotics) in patients with Parkinson’s disease will be included. Two review authors will independently extract data and conduct risk of bias assessments with the Cochrane Risk of Bias tool—V.2. Primary outcomes will be all-cause mortality, serious adverse events and significant falls. Secondary outcomes will be hospitalisations, non-serious adverse events, Unified Parkinson’s Disease Rating Scale total score and psychotic symptoms using any valid symptom scale. Data will be synthesised by aggregate meta-analysis, trial sequential analysis and network meta-analysis. Several subgroup analyses are planned. An eight-step procedure will be used to assess if the thresholds for clinical significance are crossed, and the certainty of the evidence will be assessed by GRADE (Grading of Recommendations Assessment, Development and Evaluations) and CiNeMA (Confidence in Network Meta-Analysis) approach.

Ethics and dissemination

This protocol does not include results, and ethics approval is not required for the project. The findings from the systematic review will be published in international peer-reviewed scientific journals.

PROSPERO registration number

PROSPERO ID: CRD42025633985. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD42025633985.

Reporting of environmental outcomes in randomised clinical trials: a protocol for a scoping review

Por: Petersen · J. J. · Hemberg · L. · Thabane · L. · Hopewell · S. · Chan · A.-W. · Hrobjartsson · A. · Mathiesen · O. · Kandasamy · S. · Siegfried · N. · Williamson · P. R. · Fox · L. · Kamp · C. B. · Hoffmann · J.-M. · Brorson · S. · Jakobsen · J. C. · Bentzer · P.
Introduction

To increase the sustainability of healthcare, clinical trials must assess the environmental impact of interventions alongside clinical outcomes. This should be guided by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) extensions, which will be developed by The Implementing Climate and Environmental Outcomes in Trials Group. The objective of the scoping review is to describe the existing methods for reporting and measuring environmental outcomes in randomised trials. The results will be used to inform the future development of the SPIRIT and CONSORT extensions on environmental outcomes (SPIRIT-ICE and CONSORT-ICE).

Methods and analysis

This protocol outlines the methodology for a scoping review, which will be conducted in two distinct sections: (1) identifying any existing guidelines, reviews or methodological studies describing environmental impacts of interventions and (2) identifying how environmental outcomes are reported in randomised trial protocols and trial results. A search specialist will search major medical databases, reference lists of trial publications and clinical trial registries to identify relevant publications. Data from the included studies will be extracted independently by two review authors. Based on the results, a preliminary list of items for the SPIRIT and CONSORT extensions will be developed.

Ethics and dissemination

This study does not include any human participants, and ethics approval is not required according to the Declaration of Helsinki. The findings from the scoping review will be published in international peer-reviewed journals, and the findings will be used to inform the design of a Delphi survey of relevant stakeholders.

Open science

Registered with Open Science 28 of February 2025.

Harnessing digital phenotyping to advance university student mental health (Brightline) in Singapore: study protocol for a prospective observational study

Por: Ito · S. · Ang · C.-S. · Kampman · O. P. · Rokde · K. · Buddhika · T. · Heaukulani · C. · Tan · Z.-W. · Dewanti · F. A. · Au · E. W. M. · Huan · V. S. · Morris · R. J. · Khong · A. W. H. · Ho · A. H. Y.
Introduction

Mental health issues such as depression and anxiety are highly and disproportionally prevalent among university students. Beyond the academic rigour, stressors imposed by a new environment result in them being vulnerable to the onset and manifestation of mental health symptomatology. Leveraging smartphones and wearables for digital phenotyping capabilities is an innovative approach for monitoring and intervening in the mental health conditions of university students. This provides a unique opportunity to collect and identify digital and behavioural biomarkers, subsequently enabling the development of predictive models to identify university students at risk.

Methods and analysis

This study—Brightline—will employ an observational study design over a 6-month period, recruiting 500 students from a major public university in Singapore. Passive data collection will occur continuously throughout the monitoring period through a wearable device (Fitbit Charge 6) and smartphone sensors via the Brightline app, which uses a digital phenotyping data collection platform. Active data collection will consist of self-report questionnaires to be completed at the beginning of the study and follow-up assessments at 1, 3 and 6 months after. The passive and active data collected will be analysed to identify the digital biomarkers associated with depression, anxiety, stress, loneliness and affect among university students. Predictive models of these mental health issues will also be developed.

Ethics and dissemination

This study was approved by the Nanyang Technological University Institutional Review Board (IRB-2023-894). Findings from this study will be published in peer-reviewed journals and presented at academic conferences.

Trial registration number

NCT06770075.

Protocol for development of SPIRIT and CONSORT extensions for reporting climate and environmental outcomes in randomised trials (SPIRIT-ICE and CONSORT-ICE)

Por: Petersen · J. J. · Hemberg · L. · Thabane · L. · Hopewell · S. · Chan · A.-W. · Hrobjartsson · A. · Mathiesen · O. · Kandasamy · S. · Siegfried · N. · Williamson · P. R. · Fox · L. · Kamp · C. B. · Hoffmann · J.-M. · Brorson · S. · Boutron · I. · McGain · F. · McAlister · S. · Mutengu · L
Introduction

The WHO has declared climate change the defining public health challenge of the 21st century. Incorporating climate and environmental outcomes in randomised trials is essential for enhancing healthcare treatments’ sustainability and safeguarding global health. To implement such outcomes, it is necessary to establish a framework for unbiased and transparent planning and reporting. We aim to develop extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025) and Consolidated Standards of Reporting Trials (CONSORT 2025) statements by introducing guidelines for reporting climate and environmental outcomes.

Methods and analysis

This is a protocol for SPIRIT and CONSORT extensions on reporting climate and environmental outcomes in randomised trials termed SPIRIT-Implementing Climate and Environmental (ICE) and CONSORT-ICE. The development of the extensions will consist of five phases: phase 1—project launch, phase 2—review of the literature, phase 3—Delphi survey, phase 4—consensus meeting and phase 5—dissemination and implementation. The phases are expected to overlap. The SPIRIT-ICE and CONSORT-ICE extensions will be developed in parallel. The extensions will guide researchers on how and what to report when assessing climate and environmental outcomes.

Ethics and dissemination

The protocol was submitted to the Danish Research Ethics Committees, Denmark in June 2025. Ethics approval is expected in September 2025. The SPIRIT and CONSORT extensions will be published in international peer-reviewed journals.

Two years and counting: a prospective cohort study on the scope and severity of post-COVID symptoms across diverse patient groups in the Netherlands--insights from the CORFU study

Por: Klein · D. O. · Waardenburg · S. F. · Janssen · E. B. N. J. · Wintjens · M. S. J. N. · Imkamp · M. · Heemskerk · S. C. M. · Birnie · E. · Bonsel · G. J. · Warle · M. C. · Jacobs · L. M. C. · Hemmen · B. · Verbunt · J. · van Bussel · B. C. T. · van Santen · S. · Kietelaer · B. L. J.
Importance

Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).

Objective

We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.

Design

The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).

Setting

In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.

Participants

Former COVID-19 patients and controls participated in this cohort study.

Main outcomes and measures

Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Results

A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p

Conclusions

Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.

Trial registration number

The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).

Short-term versus long-term psychotherapy for borderline personality disorder: a protocol for an individual patient data pooled analysis of two randomised clinical trials

Por: Juul · S. · McMain · S. · Olsen · M. H. · Chapman · A. · Pereira Ribeiro · J. · Storebo · O. J. · Kuo · J. · Hestbaek · E. · Kamp · C. B. · Rishede · M. · Frandsen · F. W. · Bo · S. · Poulsen · S. · Sorensen · P. · Bateman · A. · Simonsen · S. · Jakobsen · J. C.
Background

The evidence for the optimal duration of psychotherapy for borderline personality disorder (BPD) is scarce. Two previous trials have compared different durations of psychotherapy. The first compared 6 months versus 12 months of dialectical behaviour therapy for BPD (the FASTER trial). The second compared 5 months versus 14 months of mentalisation-based therapy for BPD (the MBT-RCT trial). The primary objective of the present study will be to provide an individual patient data pooled analysis of two randomised clinical trials by combining the two short-term groups and the two long-term groups from the FASTER and MBT-RCT trials, thereby providing greater statistical power than the individual trials. Accordingly, we will evaluate the overall evidence on the effects of short-term versus long-term psychotherapy for BPD and investigate whether certain subgroups might benefit from short-term versus long-term psychotherapy.

Methods

An individual patient data pooled analysis of the FASTER trial and the MBT-RCT trial will be conducted. The primary outcome will be a composite of the proportion of participants with a suicide, a suicide attempt or a psychiatric hospitalisation. The secondary outcome will be the proportion of participants with self-harm. Exploratory outcomes will be BPD symptoms, symptom distress, level of functioning and quality of life. We will primarily assess outcomes at 15 months after randomisation for the FASTER trial and at 16 months after randomisation for the MBT-RCT trial. Predefined subgroups based on the design variables in the original trials will be tested for interaction with the intervention as follows: trial, sex (male compared with female), age (below or at 30 years compared with above 30 years) and baseline level of functioning (Global Assessment of Functioning baseline score at 0–49 compared with 50–100).

Ethics and dissemination

The statistical analyses will be performed on anonymised trial data that have already been approved by the respective ethical committees that originally assessed the included trials. The final analysis will be published in a peer-reviewed scientific journal and the results will be presented at national seminars and international conferences.

PROSPERO registration number

CRD42024612840.

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.

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