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Cognitive behavioural therapy (CBT) and interpersonal psychotherapy (IPT) are both efficacious treatments for depression, but it is less clear how both compare on outcome domains other than depression and in the longer term. Moreover, it is unclear which of these two psychotherapies works better for whom. This article describes the protocol for a systematic review and individual participant data (IPD) meta-analysis that aims to compare the efficacy of CBT and IPT for adults with depression on a range of outcomes in both the short and long term, and to explore moderators of the treatment effect. This study can enhance our understanding of treatments for depression and inform treatment personalisation.
Systematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library from inception to 1 January 2026, to identify randomised clinical trials (RCTs) comparing CBT and IPT for adult depression. Researchers of eligible studies will be invited to contribute their participant-level data. One-stage IPD meta-analyses will be conducted with mixed-effects models to examine (a) treatment efficacy on all outcome measures that are assessed at post-treatment or follow-up in at least two studies, and (b) various baseline participant characteristics as potential moderators of depressive symptom level at treatment completion.
Ethical approval is not required for this study since it will be based on anonymised data from RCTs that have already been completed. The findings of the present study will be disseminated through a peer-reviewed journal or conference presentation.
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.
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.
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.
ClinicalTrials.gov PRS (ID NCT06451432).
Cisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.
The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m2. Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.
The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.
CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.
Value-based healthcare (VBHC) strives to improve the healthcare system by focusing on value of care, that is, patient relevant outcomes relative to the costs for achieving these outcomes. Within VBHC, patient participation is crucial to identify patient relevant outcomes and value improvement potential. However, patient participation in VBHC initiatives remains limited. Therefore, we aimed to improve patient participation within VBHC teams with the ultimate aim to develop a practical guide for patient participation in VBHC.
An action research study.
This study was conducted in seven collaborating Dutch hospitals from March 2023 to November 2024.
Seven VBHC teams were selected to participate in the cyclical action research steps, that is, orientation, planning, implementation, and evaluation, in which patient participation was implemented or improved. These included the following patient groups: prostate cancer, vulnerable elderly, breast cancer, diabetes, maternity care, colorectal cancer and chronic kidney disease.
Both qualitative and quantitative data were collected. Qualitative data included observations and minutes of meetings with the intervention teams. Quantitative data included responses to the Public and Patient Engagement Evaluation Tool (PPEET) by multiple members of the intervention (n=7) and control teams (n=94) at three time points (T1=6 months, T2=12 months, T3=end of study). Qualitative data were thematically analysed and quantitative data were analysed descriptively. Finally, the data were triangulated to create an overview of lessons learnt in improving patient participation.
Patient participation goals varied across teams, leading to diverse actions, such as establishing a diabetes patient panel and distributing questionnaires to patients with colorectal cancer. PPEET results show that 71% of intervention team members reported that patient participation had an impact on the team’s outcomes compared with 44% in control teams (T3). Furthermore, 80% of the intervention team members initially wanted training in patient participation (T1), which dropped to 29% at T3. Overall, 22 lessons in improving patient participation in multidisciplinary project teams were identified and compiled into a practical guide.
The action research process improved the process and impact of patient participation in the intervention teams. Furthermore, the results indicate that the action research process enhanced the team members’ knowledge and skills on patient participation. The practical guide developed in this study can be used to support implementation of patient participation in VBHC.
Radioembolisation (RE) is gaining traction as a robust treatment option for patients with hepatocellular cancer (HCC) across all cancer stages. RE allows the delivery of targeted high-dose radiation directly to tumours, with relative sparing of the surrounding liver tissue. Traditionally, radiation has been delivered using 90Yttrium ([90Y]Y)-labelled microspheres, either glass or resin. The success of RE is dependent on the dose delivered to the tumour. When using [90Y]Y microspheres, dose prediction is calculated through a 99mTechnitium ([99mTc]Tc)-macroaggregated albumin (MAA) scan, which allows the calculation of the dose to be administered to the tumour. However, [99mTc]Tc-MAA is not a true surrogate of [90Y]Y microspheres, and this will impact on the final dose delivered. [166Ho]Ho, like [90Y]Y, is a beta emitter but unlike [90Y]Y also emits gamma-radiation, allowing for quantitative nuclear imaging. The primary aim of this pilot study was to investigate the safety and efficacy of dosimetry-based individualised 166Holmium ([166Ho]Ho-RE) in patients with HCC.
15 eligible participants will be recruited to receive [166Ho]Ho-RE. The primary objective is to establish the toxicity profile of dosimetry-based individualised [166Ho]Ho-RE. The secondary objective is to assess efficacy as measured by modified Response Evaluation Criteria in Solid Tumours (mRECIST) and Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria. Additional exploratory objectives include quality of life assessment and identification of a radiomic signature of response. The results from this study will be combined with the prospective iHEPAR study to form a larger analysis.
The study has received approval from the East Midlands—Nottingham 1 Research Ethics Committee—approval number 23/EM/0239. The study will be performed in compliance with the Declaration of Helsinki and the principles of Good Clinical Practice. Signed informed consent will be obtained from each patient before study entry. The results will be disseminated through publication in a peer-reviewed scientific journal.
Clinicaltrials.gov NCT06302400.
Chronic pelvic pain, defined as persistent pain in the structures of the pelvis, is a condition that significantly impacts the health-related quality of life (HRQoL) of up to one-third of people worldwide, with substantial associated costs to both the individual and healthcare system/s. The present trial aims to establish the efficacy of e-hypnotherapy over relaxation and waitlist controls on pain, HRQoL and biopsychosocial outcomes, and evaluate cost-effectiveness.
A parallel-group, investigator-blinded, randomised controlled trial will be conducted. Eligible participants will be randomly allocated to either a 7-week online personalised e-hypnotherapy programme (n=44), a 7-week online personalised relaxation control (n=44) or waitlist control (n=44). The primary outcome will be self-reported pain level, and secondary outcomes will include psychological distress, QoL, pain catastrophising, self-efficacy, central sensitisation, somatic symptoms, fatigue and sleep. Cost-effectiveness will also be examined. Longitudinal qualitative interviews will be conducted with participants in the e-hypnotherapy (n=20) and relaxation (n=20) groups to understand meaningful change and barriers/facilitators for ongoing use.
This protocol has received ethics approval in Australia from the Deakin University Research Ethics Committee (DUREC ref. 2024-080). Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences related to chronic pelvic pain and mind–body interventions.
Australian New Zealand Clinical Trials Registry ACTRN12623000368639p.
With the acceleration of globalisation and the increasing frequency of international exchanges, the risk of cross-border transmission of emerging respiratory infectious diseases (ERIDs) has significantly increased. Since the year 2002, epidemics of SARS, Middle East respiratory syndrome (MERS) and COVID-19 have exemplified this trend. These epidemics have impacted the prevalence and transmission of traditional respiratory infectious diseases (RIDs), such as influenza, which share similar transmission routes and control measures. To better explore the impact of ERIDs epidemics on influenza, our study quantitatively evaluates the epidemiological changes in influenza during three representative emerging respiratory coronavirus epidemics: SARS, MERS and COVID-19.
Using Global Influenza Surveillance and Response System data, we examined influenza trends across different periods and regions affected by the three coronavirus epidemics. The impact of the epidemic on influenza was revealed by comparing and analysing the reported positive cases (RPCs) of influenza during the pre-epidemic and epidemics, and during the three postpandemic periods. Based on the Susceptible-Exposed-Infected-Asymptomatic-Recovered (SEIAR) compartmental model, the time-varying effective reproduction number (
There was a significant decline in the RPCs of influenza and transmissibility. The suppressive effect of the COVID-19 epidemic on influenza prevalence was the most pronounced. During the COVID-19 epidemic, the RPCs of the three major influenza subtypes showed the largest decrease compared with historical predictions, with reduction rates of –53.30% for A(H1N1), –57.50% for A(H3N2) and –48.56% for influenza B (p0.05). During the MERS epidemic, the RPCs of A(H1N1) and A(H3N2) decreased by 28.75% and 17.62%, respectively, although influenza B partially rebounded in the later stages, resulting in a relatively smaller overall impact.
The COVID-19 epidemic demonstrated the most pronounced suppressive effect on influenza prevalence. The impact of SARS was secondary, while MERS had the least effect. Among different influenza subtypes, A(H3N2) and influenza B exhibited greater declines compared with A(H1N1). The decrease in RPCs during coronavirus epidemics highlighted the importance of non-pharmaceutical interventions (NPIs), demonstrating the broad applicability and high efficacy of comprehensive control strategies for RIDs. Furthermore, when NPIs are lifted during the later stages of coronavirus epidemics, attention should be paid to the potential rebound of traditional respiratory diseases such as influenza.
To evaluate adherence to National Health Service (NHS) patient registration ID guidelines among General Practitioners’ (GP) practices.
A mystery shopper study, including website reviews and phone calls.
Rural and urban parts of the United Kingdom’s West Midlands.
85 randomly selected GP practices.
In January–April 2024, GP’s websites were reviewed before phone calls in which our ‘mystery shopper’ was asked to register without photo ID and proof of address.
Of 85 GP practices, 60 (71%) breached NHS guidance either online or over the phone, with only 25 (29%) consistently following NHS guidance. Phone calls to rural (vs urban) GP practices were more likely to yield refusal of registration without photo ID and proof of address, despite rural (vs urban) GP practices making similar statements online. During some phone calls, practices sought to negotiate a compromise by requesting less robust ‘documentation’, such as an addressed parcel.
GP practices commonly refuse registration to people without photo ID or proof of address, thus creating ‘sludge’ and undermining access to healthcare especially for poor, vulnerable patients, including immigrants. Changing GP practices’ websites would not address this problem if erroneous information is still provided over the phone. GPs and practice managers should ensure that all staff follow NHS guidance to allow registration without these documents.
In the Netherlands, approximately 2200 major amputations of the lower extremities are performed each year, the majority in vascular patients. Around 61% of these patients will develop postamputation pain (PAP). PAP is a severe, lifelong, disabling condition profoundly affecting quality of life. During amputations, the common practice is to cut the nerves without employing nerve-surgical techniques to prevent chronic pain due to neuroma formation. In recent years, targeted muscle reinnervation (TMR) has been the most frequently studied technique for treating PAP, inhibiting neuroma formation by rerouting the cut mixed nerve to a functional motor nerve. We hypothesise that a primary TMR procedure during major lower limb amputations will result in a lower prevalence of PAP.
We propose a national, multicentre, randomised, sham-controlled trial comparing TMR with traction neurectomy in major amputations of the lower extremities in patients with vascular disease. 203 patients will be recruited with an indication for a transfemoral to transtibial amputation as a primary or secondary sequela of vascular disease. The subjects are randomly assigned to the TMR group or the traction neurectomy group. PAP will be evaluated 1 year postoperatively as the primary endpoint. Secondary outcomes include quality of life, mobility, neuropathic pain, hospital anxiety and depression, cost-effectiveness and complications.
This study has been reviewed and approved by the local ethical review body, ‘The Medical Ethics Committee Leiden The Hague Delft’, under the reference: P24.073 on 28 November 2024. Results will be published in peer-reviewed journals.
NCT06719245. Dutch trial registry: NL87196.058.24
Despite a lack of evidence relating to effectiveness and safety, the use of apps in the field of mental health is increasing due to their ease of use and accessibility. The aim of the EvalDepApps project is to develop and validate an assessment tool for evaluating depression management apps based on scientific evidence, expert judgement and end-user needs.
The purpose of this study was to determine the most relevant criteria for evaluating apps intended to manage depression through consensus-based assessment.
A total of 43 individuals were invited to participate in an online modified Delphi study of 51 criteria identified from the literature. In Round 1, participants rated criteria according to relevance and three levels of consensus were defined: high level when ≥80% of respondents scored the criterion at 5 or 6; medium when 60%–79% of respondents scored the criterion at 5 or 6 and low when
The response rate was 59.0% (26/43) in Round 1 and 53.4% (23/43) in Round 2. In Round 1, 24 criteria (47.1%) attained the maximum level of consensus, 20 (39.2%) the medium level and 7 (13.7%) the lowest level. In Round 2, 4 out of 20 criteria (20.0%) attained the maximum consensus. Participant comments reinforced the relevance of the selected criteria. The final list consisted of 28 criteria, the majority relating to Safety and Privacy and Clinical Effectiveness (25.0% each), followed by Usability and Functionality (17.9%).
By prioritising criteria relating to data safety and clinical effectiveness, participants in this study emphasised that the assessment of apps for depression management must take both these aspects into full consideration. Despite some limitations of the study (eg, lack of participant sociodemographic data and its implications for generalisation, not face-to-face inter-round), the results of this study will enable the EvalDepApps project to develop an assessment tool for depression management apps that incorporates the most relevant criteria.
EvalDepApps will support healthcare professionals and users in identifying safe, effective and user-friendly depression management apps.
Patients with fragility fractures are two times as likely to suffer future fractures as their peers who have not suffered a fracture. In addition, 40% of those who suffer fragility fractures do not recover their level of functioning in terms of activities of daily living after 1 year. The present study aims to verify the hypothesis that a semipersonalised home-based exercise intervention may improve patients’ independence and reduce the number of hospital admissions compared with usual care for a population that suffers fragility fractures.
This parallel-arm single-blinded randomised-controlled trial will take place at the University of Cordoba (Spain) between September 2022 and September 2024. Patients aged >50 years old who have undergone surgery for a fragility hip fracture and who were prefracture independent (Barthel index (BI)>60) will be invited to participate. Patients will be excluded if they present a different type of fracture, mild or greater cognitive impairment or contraindication to exercise training. Patients will then be randomised into exercise or usual care group. The former will receive a daily walking appointment (number of steps to be completed inside home, interspersed with sit-to-stand movements) with the total volume increasing weekly. The latter will receive the usual care. The outcomes, collected at baseline, at the end of training (3 months) and at follow-up (6 months) by blinded operators will include the BI and number of readmissions (primary outcomes) and quality of life, exercise capacity, strength, cognitive status, bone mineral density and laboratory biomarkers (secondary outcomes). Variables related to quality of life, cognitive status, laboratory markers and densitometry will also be analysed.
The research ethics committee of the province of Cordoba approved the project (number 326; date 28 July 2021). Patients who meet the eligibility criteria will receive a patient information document and the consent form and will be encouraged to ask any questions. The proposed research respects the fundamental principles of the Declaration of Helsinki, the Council of Europe Declaration on Human Rights and Biomedicine, the UNESCO Universal Declaration on the Human Genome and Human Rights, and the Oviedo Council on Human Rights and Biomedicine. The data obtained in this study will be confidential. They will be treated by the Organic Law 3/2018, of 5 December, on the Protection of Personal Data and Guarantee of Digital Rights, keeping it strictly confidential and not accessible to unauthorised third parties, and the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on Data Protection (RGPD). Written informed consent will be obtained from all the participants. The study’s results will be published in peer-reviewed journals and presented at scientific congresses worldwide. The results will also be disseminated through patient advocacy group newsletters and social media platforms. Patient partners will help select the appropriate channels and develop plain-language summaries tailored to their communities’ needs.
ClinicalTrials.gov ID: NCT04934358 (registration date: 14 June 2021).
To provide population-level insights into COVID-19 testing behaviour and test results among all pregnant women in the Netherlands and to assess the effects of SARS-CoV-2 infection during pregnancy on maternal and neonatal health outcomes.
Retrospective population-based cohort study.
Dutch registry data on maternal and neonatal health outcomes linked with COVID-19 testing and sociodemographic data for the study period 2020 and 2021.
To study testing behaviour, all pregnant women who gave birth in the Netherlands during 2020 and 2021 were included (N=322 720). To study the effects of maternal infection, women who gave birth between June 2020 and September 2021 and who were tested for COVID-19 were included (N=68 059).
For testing behaviour: number of COVID-19 tests performed and COVID-19 test results. For neonatal health outcomes: preterm birth, low birth weight for gestational age (small for gestational age (SGA)), BIG2 (preterm birth and/or SGA), Apgar score at 5 min below seven (low Apgar), Apgar score at 5 min below four (very low Apgar), neonatal intensive care unit admission, congenital anomalies and mortality. For maternal health outcomes: major postpartum haemorrhage (>1000 mL), severe ruptures (third or fourth degree), type of delivery and episiotomy.
Compared with the reference group (women aged 30–34), women under 20 had the lowest probability of being tested (16.5% vs 31.3%; OR 0.43, 95% CI 0.38 to 0.49), but when tested, they had significantly higher odds of testing positive (19.3% vs 12.9%; OR 1.62, 95% CI 1.21 to 2.14). Women originating from ‘other African’ countries were least likely to be tested (15.1%; OR 0.37, 95% CI 0.35 to 0.39), while women whose country of origin was ‘Morocco’ were most likely to test positive when tested (33.4%; OR 3.63, 95% CI 3.35 to 3.93). While over all trimesters a SARS-CoV-2 infection during pregnancy did not show significant effects, an infection during the first trimester was associated with an increased risk of preterm birth (5.2% vs 6.4%; OR 1.25, 95% CI 1.03 to 1.52) and a low 5-min Apgar score (1.9% vs 2.9%; OR 1.50, 95% CI 1.12 to 2.02). No significant adverse maternal health effects were observed.
There were significant differences in testing behaviour and the probability of testing positive for COVID-19 among pregnant women from different age groups, countries of origin and socioeconomic backgrounds. SARS-CoV-2 infection during pregnancy was not associated with significant effects on maternal health outcomes, and only limited effects on neonatal health were observed. Only infections occurring in the first trimester were linked to an increased risk of preterm births and low 5-min Apgar scores.
The number of people living with dementia is increasing worldwide. Alzheimer’s disease (AD) is the most common type of dementia. It typically manifests itself initially with cognitive impairment in the memory domain and gradually progresses towards affecting all activities of daily living. Active music interventions, particularly singing, may improve mood, social behaviour and quality of life. However, little is known about their effects on cognition, although some studies have provided promising results. The Memory for Music (M4M) project aims to fill this gap in research by measuring the effects of learning new songs on cognitive functioning. Specifically, M4M will examine memory for new songs in non-musician adults with AD after undergoing intensive versus minimal individual musical training based on singing novel songs.
Home-dwelling adults with AD, 65 years or older, will receive 5 months of intensive intervention (2x/week) and 5 months of minimal intervention (1x/month). In a crossover design, participants will be randomised to receive either the intensive or minimal intervention first, with 2 months between the intervention periods. Participants will receive individual music lessons to learn new songs, provided by a music instructor with adequate training. The main outcomes will be measured at the beginning and end of each intervention period. General cognition will be measured with the AD Assessment Scale – Cognitive by an assessor blinded to the randomisation. Participants’ memory for music will be measured using the N400 component of electroencephalographic (EEG) event-related potentials in response to music stimuli. Additional outcomes evaluated during intervention sessions include mood and musical performance observations. With 113 participants randomised, the trial will have 80% power to detect clinically meaningful effects. Relations between mood, memory for music and cognitive abilities will be examined, with sex, age, AD stage, previous musical training and education as covariates. M4M will be conducted in close collaboration between academic researchers, service providers and service users to ensure relevance and applicability.
Dissemination of findings will apply to local, national and international levels. The study has been approved by the Regional Committees for Medical and Health Research Ethics in Norway (reference number 759936) and by Mautalén Salud e Investigación, CECOM in Argentina (register code 14412).
Clinicaltrials.gov, NCT06611878.
Cytomegalovirus (CMV) infection is a common complication in patients undergoing haematopoietic stem cell transplantation (SCT). Letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific immune reconstitution. Hence, a study is needed to evaluate whether the absence of CMV-specific immune reconstitution at the end of LTV prophylaxis is associated with the development of late infection. This could facilitate the individualisation of CMV prophylaxis duration in these patients.
INMUNOEND is a multicentre, prospective, observational, non-interventional study including CMV seropositive patients undergoing allo-SCT who receive LTV prophylaxis during the first 100 days post SCT. Immunological and virological monitoring will be conducted until day+200 post-SCT. The primary outcome is the percentage of patients who develop clinically significant CMV infection up to day+200 post-SCT after completing LTV prophylaxis. Data collected will include baseline characteristics of the haematological diseases and comorbidities, variables related to SCT (ie, engrafment, graft-versus-host disease, use of LTV and CMV replication) and variables related to CMV-specific immune reconstitution.
Ethical approval has been obtained from the institutional review board (Comité de Ética de la Investigación de Córdoba; SICEIA-2024–0 01 762). The results of this study will be published in peer-reviewed journals and disseminated at national and international conferences.
To evaluate the cost-effectiveness of anti-vascular endothelial growth factor (VEGF) treatments for neovascular age-related macular degeneration (nAMD) using a value-based model that considers drug durability, dosing regimens and real-world administration strategies, including safe vial fractionation.
Model-based pharmacoeconomic analysis using data from randomised clinical trials and network meta-analyses. Analysis conducted from the payer perspective using cost data from the Spanish National Health System.
A model-based analysis compared five anti-VEGF agents—innovator and biosimilar ranibizumab, aflibercept 2 mg, brolucizumab and faricimab—across three dosing regimens: fixed, Pro Re Nata and Treat-and-Extend (TAE). Administration formats included single-use vials, prefilled syringes and vial fractionation (VF), with or without dead-space-free (DSF) syringes to minimise waste. The primary outcome was cost per optimal responder, defined as a patient gaining ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, with and without adverse events. Cost-effectiveness was evaluated using Number Needed to Treat (NNT), Net Efficacy Adjusted for Risk-NNT (adjusted for safety) and incremental cost-effectiveness ratios. Secondary outcomes included the number of treated patients and optimal responders achievable within a fixed 1 000 000 budget.
The most cost-effective strategy was aflibercept 2 mg under a TAE regimen using DSF VF, with a total cost of 6214 per patient and a cost per optimal responder of 27 155. Under a fixed budget of 1 000 000, this approach allowed treatment of 160 patients, yielding 36 optimal responders. Faricimab with DSF VF ranked second, with a total cost of 5847 and a cost per optimal responder of 28 652, treating 171 patients and achieving 34 responders. In contrast, single-use vials without VF led to substantially higher total costs (eg, 11 305 for aflibercept TAE) and lower treatment capacity (eg, 88 patients treated).
This model demonstrates that combining durable agents, extended dosing intervals and optimised delivery strategies (eg, prefilled syringes and DSF VF) can substantially improve the cost-effectiveness and sustainability of anti-VEGF therapy in public health systems.
To provide bottom-up guidance on improving post-COVID care using patients’ experiences with received care and their perceived health
Qualitative study design using focus group interviews
30 patients with post-COVID condition recruited through purposive sampling based on patient complexity and diversity
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.
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.
Elevated lipid profiles increase the risk of atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality worldwide. Despite the availability of lipid-lowering therapy (LLT), adherence to therapy and achievement of Low-Density Lipoprotein Cholesterol (LDL-C) target levels remain suboptimal. Coronary artery disease (CAD) presents substantial public health challenges, with LDL-C goal attainment rates reported to be between 30.0% and 54.0%. The EDHIPO MARCA (Evaluación De adherencia a la terapia HIPOlipemiante en pacientes de Muy Alto Riesgo CArdiovascular) study aims to evaluate LDL-C target achievement among Colombian patients with CAD.
This is a retrospective and multicentre study aiming to evaluate LDL-C target achievement within 12 months of coronary angiography across multiple Colombian institutions. Data will be retrospectively extracted from medical records corresponding to the years 2011, 2012, 2016, 2017, 2021 and 2022, which were selected to correspond with the European Society of Cardiology/European Atherosclerosis Society guideline updates. Inclusion criteria included patients ≥18 years old with confirmed CAD and LDL-C reports recorded during outpatient follow-up. The study will evaluate a minimum sample size of 5000 patients, with data collected through medical records and managed using the REDCap platform. Statistical analyses will be conducted to assess LDL-C target achievement, associated factors and temporal trends using mixed-effects models. Uncertainty will also be explored through sensitivity analysis. The EDHIPO MARCA study will provide key insights into LDL-C target achievement in Colombia, contributing to both regional and global CAD management. Its findings will be used to help shape public health policies and serve as a foundation for future prospective research and interventions aimed at mitigating the burden of cardiovascular disease.
This study was approved by the Comité de Ética en Investigación Biomédica of Fundación Valle del Lili, the coordinating institution and creator of the study protocol. Each participating centre will obtain approval from its local ethics committee prior to data collection. Data will be collected in a de-identified manner, ensuring confidentiality. In accordance with Colombian Resolution 8430, this study is classified as 'no-risk', and informed consent was not required. The findings will be disseminated through scientific events and published in international peer-reviewed journals to contribute to cardiovascular disease management and public health policies.
The development of mental disorders is multifactorial across the lifespan. The introduction of the exposome concept has enhanced the understanding of life-course environmental factors by encompassing the totality of environmental exposures. While most studies on chronic diseases have applied a single-exposure approach, the exposome approach remains underutilised in mental disorder research. There is a need to better recognise the environmental factors considered in exposome analysis of mental disorders, the methodologies used and the gaps reported. This scoping review aims to map the evidence on the relationship between the exposome and mental disorders across the lifespan, identifying and describing the methodologies used and highlighting the gaps reported.
This scoping review will follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and the Population-Concept-Context approach. It will include observational and interventional studies involving populations of all ages in the community or healthcare settings. The search strategy will contain indexed terms in MEDLINE and will be adapted for CINAHL (EBSCO), Scopus, Embase and PsycINFO without restrictions on language or date of publication. For the selection of articles, two independent researchers will screen articles by title and abstract, followed by a full-text assessment. Afterwards, the extracted data will be summarised using a narrative and descriptive analysis.
Ethics approval is not required for this scoping review. Dissemination activities will include peer-reviewed publications and academic presentations.
Despite advancements in biomedical and healthcare research, the translation of evidence into routine practice within healthcare systems often lags, perpetuating inefficiencies and disparities in care delivery. Learning health systems (LHS), which integrate internal data and external evidence for continuous improvement, hold promise for addressing these gaps. Implementation science (IS), focused on promoting the systematic uptake of evidence-based practices, offers a robust framework to drive sustainable improvements within LHS. However, the practical application of IS principles in LHS remains underexplored. This scoping review aims to systematically map the literature on the application of IS in LHS, highlighting themes, gaps and opportunities for advancing future practices.
This review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews, supported by the Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews (PRISMA-ScR) checklist. The review employs a population-concept-context framework, focusing on studies engaged in LHS activities and the application of IS principles in various healthcare settings. Relevant literature will be searched across multiple databases, including OVID/Medline, Embase, Web of Science Core Collection and Health Policy Reference Center. Eligible studies will be screened, and data will be extracted and synthesised using both quantitative and qualitative methods. Key outcomes include characterising IS applications in LHS, evaluating barriers and facilitators, exploring equity integration, and identifying knowledge gaps.
As this study does not involve primary data collection, ethical approval is not required. Findings will be disseminated through peer-reviewed publications and conference presentations to inform future research and practice.
This protocol has been registered on the Open Science Framework (DOI: 10.17605/OSF.IO/BMQ6J).
‘Hotspotters’ are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. As reliable data on effective interventions for this population are scarce, the goal of this study is to assess the cost-effectiveness of proactive, personalised, integrated care for this group.
The Hotspotters Project is planned as a stepped wedge cluster randomised controlled trial in 20 primary care practices in the Netherlands. All practices and participants will begin with standard care during the control period (2–8 months), followed by an intervention (12 months) consisting of a positive health intake with goal setting, multidisciplinary meetings, a personalised care plan and proactive care management. The study will conclude with a follow-up (2–8 months), resulting in a total study duration of 22 months. We plan to include 200 patients with (a) problems on two or more life domains and (b) at least two acute care encounters in the previous year. Possible Hotspotters are identified using an Adjusted Clinical Groups-based algorithm or via a local primary healthcare team.
Questionnaires and routine care data will be used to gather data on cost-effectiveness, which will then be assessed using multilevel analysis, with levels for the individual, cluster and duration of control period. Secondary outcomes will include psychological outcomes on self-regulation (proactive coping, patient activation, self-efficacy and intention), experience of care (satisfaction, perceived autonomy support and qualitative data from focus groups) and quality of life, qualitative analysis of the Positive Health approach, implementation outcomes and process evaluation including integration of care.
The Ethics Committee of Leiden University Medical Centre granted approval (METC-LDD, P21.123). Results will be shared through peer-reviewed publication and (inter)national conference presentations.
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