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Critical appraisal and comparison of clinical practice guideline recommendations for the treatment of anaemia in chronic kidney disease: a systematic review protocol

Por: Agnelli · J. C. M. · Costa · W. R. d. · Iwami · R. S. · Franques · R. T. · Lopes · L. C. · Barberato-Filho · S. · Bergamaschi · C. d. C.
Introduction

In chronic kidney disease (CKD), anaemia develops and evolves as kidney dysfunction progresses. The treatment of anaemia is described in clinical practice guidelines (CPGs), which are designed to report the most relevant evidence for clinical practice in disease management. This study will analyse CPGs for transparency, methodological quality and quality of recommendations for their implementation over time, and also compare recommendations for the treatment of anaemia outlined in these documents.

Methods and analysis

CPGs will be identified by conducting a systematic search of the data sources CINAHL, Embase, MEDLINE, Scielo, Scopus, ProQuest, Trip Database, Virtual Health Library, Web of Science, and guidelines on websites, published between January 2009 and December 2025. Three reviewers will, independently, evaluate the methodological quality of the guidelines using the Appraisal of Guidelines for REsearch and Evaluation II (AGREE-II) tool and the quality of recommendations using the AGREE – Recommendations Excellence tool. The treatment recommendations for anaemia in CKD will be summarised and compared. Results will be presented in tables and descriptive statistics will be compiled for all domains of the tools.

Ethics and dissemination

This is a literature-based study and, therefore, no ethical approval will be required. Results of the study can be submitted for publication in high-impact, peer-reviewed scientific journals, and also presented at national and international conferences.

Prospero registration number

CRD42024629656.

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.

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).

Prevalence, incidence and risk factors of chronic kidney disease in people with diabetes and hypertension, and the prognosis and kidney function decline in Indonesia: a multicentre cross-sectional study in primary care centres

Por: Hustrini · N. M. · Susalit · E. · Harimurti · K. · Haryoso · I. S. · Legrans · A. E. · Damarjati · K. · Minangsih · S. · Nurhisan · L. · Zaini · M. · Oktavianti · S. · Pratiwi · S. · Pradesa · M. G. · Anthony · G. · Sari · D. W. R. · Purnama · R. C. · Puspitasari · W. R. M. · Rajagukgu
Objectives

To examine chronic kidney disease (CKD) prevalence, incidence, prognosis, kidney function decline and associated risk factors among people with diabetes and/or hypertension.

Design

Cross-sectional multicentre study.

Setting

14 primary care centres across Jakarta.

Participants

Adults (≥18 years) with diabetes and/or hypertension were included. Exclusion criteria were receiving kidney replacement therapy, language barrier, cognitive impairments, refusal to consent and pregnancy. Participants were grouped into three categories: hypertension only, diabetes only and both.

Interventions

None.

Primary and secondary outcomes

Primary outcomes included CKD prevalence, incidence, number-needed-to-screen, KDIGO-based prognosis and annual kidney function decline. Secondary outcomes were risk factors for CKD, uncontrolled blood glucose, blood pressure and albuminuria.

Results

A total of 1263 participants were enrolled: 51% had hypertension, 17.6% diabetes and 31.4% both. Mean age: 57.1±10.2 years, 72.2% female and 76% obese. Renin angiotensin aldosterone system inhibitors were prescribed in 32.3%, and only 1.2% used insulin despite a median glycated haemoglobin of 7.5% (IQR: 6.5–9.1). CKD prevalence was 14.8%, with an incidence rate of 9.1 per 100 person-years; number-needed-to-screen was 7. Based on KDIGO criteria, 48.9% were at moderate-to-very high risk of adverse outcomes. Baseline estimated glomerular filtration rate was 80.9 (SE=10.1), declining by 4.7 (SE=9.9) mL/min/1.73 m2 annually. CKD incidence was higher with albuminuria (OR 3.6, p=0.007) in the combined group; older age (OR 4.5, p

Conclusions

CKD burden is high among people with diabetes and hypertension. Nearly half were at elevated risk despite preserved kidney function, highlighting the need for targeted early screening.

PLAN-psoriasis: protocol for a randomised controlled feasibility trial comparing patient-led 'as-needed treatment and therapeutic drug monitoring-guided treatment to continuous treatment for adults with clear or almost clear skin on risankizumab monothera

Por: Ye · W. · Powell · K. · Dooley · N. · Thomas · C. M. · Coker · B. · McAteer · H. · Wei · J. R. · Tan · W. R. · Baudry · D. · Dasandi · T. · Pizzato · J. · Sach · T. H. · Gregory · J. · Yang · Z. · Pink · A. E. · Woolf · R. T. · Warren · R. B. · Weinman · J. · Barker · J. N. · Chapman · S. · St
Introduction

Targeted biologic therapies have transformed outcomes for individuals with psoriasis, a common immune-mediated inflammatory skin disease. The widespread use of these highly effective treatments has led to a growing number of individuals with clear or nearly clear skin remaining on continuous, long-term treatment. Personalised strategies to minimise drug exposure may sustain long-term disease control while reducing treatment burden, associated risks and healthcare costs. This study aims to evaluate the feasibility of a definitive pragmatic effectiveness trial of two personalised dose minimisation strategies compared with continuous treatment (standard care) in adults with well-controlled psoriasis receiving the exemplar biologic risankizumab.

Methods and analysis

This is a multicentre, assessor-blind, parallel group, open-label randomised controlled feasibility trial in the UK, evaluating two personalised biologic dose minimisation strategies for psoriasis. 90 adults with both physician-assessed and patient-assessed clear or nearly clear skin on risankizumab monotherapy for ≥12 months will be randomised in a 1:1:1 ratio to (1) patient-led ‘as-needed’ treatment, where risankizumab is administered at the first sign of self-assessed psoriasis recurrence, (2) therapeutic drug monitoring-guided treatment, with personalised dosing intervals determined using a pharmacokinetic model or (3) continuous treatment as per standard care, for 12 months. Participants will be invited to submit self-reported outcomes and self-taken photographs every 3 months using a bespoke remote monitoring system (mySkin app) and will attend an in-person assessment at 12 months. They may also request additional patient-initiated follow-up appointments during the trial if needed. The primary outcome is the practicality and acceptability of the two personalised biologic dose minimisation strategies, assessed as a composite measure including recruitment and retention rates, adherence to the assigned strategies and acceptability to both patients and clinicians. The feasibility of collecting healthcare cost and resource utilisation data will also be evaluated to inform a future cost-effectiveness analysis. A nested qualitative study, involving semistructured interviews with patients and clinicians, will explore perspectives on the personalised biologic dose minimisation strategies. These findings will inform the design of a future definitive trial.

Ethics and dissemination

This study received ethical approval from the Seasonal Research Ethics Committee (reference 24/LO/0089). Results will be disseminated through scientific conferences, peer-reviewed publications and patient/public engagement events. Lay summaries and infographics will be codeveloped with patient partners to ensure the findings are accessible for the wider public.

Trial registration number

ISRCTN17922845.

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 We Improve Personal Care Interactions to Reduce Care Refusals From People With Dementia? A Realist Synthesis

ABSTRACT

Aim

To identify strategies and mechanisms of interventions between caregivers and people with dementia that contribute to reducing refusals of care and determine how they work, in which contexts, why and for whom.

Design

Realist synthesis.

Methods

There were three stages: (1) initial programme theory development and prioritisation through assessing video-recorded personal care interactions and interview transcripts; scoping the literature and team discussions, (2) literature search, review and synthesis and (3) realist interviews with stakeholders and refinement of evidence-based programme theories.

Data Sources

Searches were conducted in MEDLINE, EMBASE, PsycINFO, CINAHL Ultimate, Cochrane CENTRAL Register of Controlled Trials and Web of Science; date range: 2000–2024.

Results

A total of 71 sources were included in the synthesis, and interviews with 15 stakeholders. Eight programme theories were generated, evidenced and refined, each incorporating multiple caregiver strategies. The overarching mechanism which made people with dementia more likely to accept assistance with personal care was trusting the caregiver and feeling safe. Seven mechanisms fed into this: a sense of control, positive connection, care feeling manageable, working together, engaging with the care activity (or something non-care related), comfort and needs being known and addressed.

Conclusion

Refusals of care from people with dementia can be reduced by multiple caregiver strategies related to communication, approach, the type of care offered and the care interaction process. Mechanisms reflect relational aspects: the quality of the caregiver/person partnership and making the person with dementia feel safe.

Practice Implications

Our findings provide programme theories and practical care strategies which could be helpful for those, such as nurses, working to improve personal care practices for people with dementia.

Patient Contributions

Public representatives advised the study throughout, providing advice on initial programme theories, evidence-based programme theories and synthesised stakeholder evidence.

Reporting Method

This synthesis uses the publication standards for realist synthesis (RAMESES 1).

Trial Registration

PROSPERO: 2024 CRD42024496072

Bringing together conceptualisations of the health advocacy competence across the continuum of medical education: a scoping review protocol

Por: Oosthoek · W. R. W. · Cecilio-Fernandes · D. · Engel · M. F. M. · van Prooijen · L. T. · Otto · S. J. · Woltman · A. M.
Introduction

Health advocacy (HA) is acknowledged as a core competence in medical education. However, varying and sometimes conflicting conceptualisations of HA exist, making it challenging to integrate the competence consistently. While this diversity highlights the need for a deeper understanding of HA conceptualisations, a comprehensive analysis across the continuum of medical education is absent in the literature. This protocol has been developed to clarify the conceptual dimensions of the HA competence in literature as applied to medical education.

Methods and analysis

The review will be conducted in line with the JBI (formerly Joanna Briggs Institute) methodology for scoping reviews. A comprehensive literature search was developed and already carried out in eight academic databases and Google Scholar, without restrictions on publication date, geography or language. Articles that describe the HA role among students and physicians who receive or provide medical education will be eligible for inclusion. Two independent reviewers will independently complete title and abstract screening prior to full-text review of selected articles and data extraction on the final set. A descriptive-analytical approach will be applied for summarising the data.

Ethics and dissemination

This scoping review does not involve human participants, as all evidence is sourced from publicly available databases. Therefore, ethical approval is not required for this study. The findings from this scoping review will be disseminated through submission to a high-quality peer-reviewed journal and presented at academic conferences. By clarifying the conceptualisations of HA, this review aims to contribute to a shared narrative that will strengthen the foundation for integrating the HA role into medical education.

Trial registration number

A preliminary version of this protocol was registered on the Open Science Framework on 9 December 2024, and can be accessed at the following link: https://osf.io/ed2br. We have also registered our scoping review protocol as a preprint at medRxiv: https://doi.org/10.1101/2024.12.09.24318699.

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