Optimising post-operative pain management is crucial for recovery in orthopaedic surgery. Methadone has attracted interest due to its long half-life, N-methyl-D-aspartate -receptor antagonism and potential to reduce post-operative opioid consumption. Existing reviews combine multiple surgical populations, limiting applicability to orthopaedic settings. This protocol outlines a systematic review assessing the analgesic efficacy and safety of peri-operative methadone in adult and adolescent orthopaedic patients.

This review will include randomised controlled trials evaluating intravenous peri-operative methadone vs placebo or standard analgesic regimens in orthopaedic surgery. Primary outcomes are post-operative rescue opioid consumption and pain intensity within 72 hours. Secondary outcomes include adverse events, mobility scores and the length of hospital stay. If available data permit, a methadone dose–response pattern may be investigated. Searches will be conducted in MEDLINE (Ovid), Embase (Ovid), CINAHL, CENTRAL, Web of Science and ClinicalTrials.gov without date restrictions. Two reviewers will independently screen studies, extract data and assess risk of bias using the Cochrane risk-of-bias tool for randomised trials. When appropriate, random-effects meta-analysis methods will be performed. Certainty of evidence will be assessed using Grading of recommendations assesment, development and Evaluation (GRADE).

As this study uses previously published data, ethical approval is not required. Findings will be disseminated through a peer-reviewed publication and conference presentations.

CRD42025616291.

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

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

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

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

The functional resonance analysis method (FRAM) is increasingly used to analyse healthcare processes. FRAM uses four steps to analyse a process and its potential variability. We systematically reviewed studies using FRAM in healthcare on how the four steps in FRAM are reported, defined and supported by data.

Systematic review following the preferred reporting items for systematic reviews and meta-analyses 2020 guidelines.

Web of Science, PubMed, Embase, Scopus, PsycINFO, Dimensions and Lens were searched up to December 2025.

All peer-reviewed studies using FRAM in a healthcare context that presented a FRAM visualisation were included. The papers had to be written in English.

Two independent reviewers screened titles and abstracts, and subsequently the full text of selected papers. Data was extracted reporting on the steps of FRAM, how functions were supported by data, and the functions and couplings of the visualisations.

Sixty-eight papers were included, of which 20 (29%) reported at least one aspect of all four steps in FRAM. While most studies (85%) described how functions were supported by data, the methods used varied widely. Terminology was interpreted differently concerning variability, the output of variability and the effect of combined variability.

Most FRAM studies in healthcare do not report all steps of FRAM, and interpretations of key terms differ. FRAM studies should more clearly describe which steps of the method are conducted, and how data is collected and analysed. Refinement of FRAM guidelines, particularly on data use and terminology, would enhance consistency and comparability across studies.

CRD42024592858.

The primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic stress disorder (PTSD) among adults with intellectual disabilities compared with TAU. Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability.

This is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ

The primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD.

This clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners.

ISRCTN35167485.

This study investigates how lean management (LM) practices align with and contribute to strategic objectives in healthcare using the congruence model as a conceptual framework.

This study employed a qualitative research design, integrating both inductive and deductive approaches. Data were collected from multiple hospital departments using primary and secondary sources. Primary data included semi-structured interviews, guided by a standardised interview protocol. Secondary data consisted of reports on courses of action, annual reports, policy documents and findings from exploratory meetings. The analysis involved iterative cycles of open coding, axial coding and selective coding to systematically identify and refine themes, supporting thematic analysis.

Six departments: Kidney and vascular surgery, Care core movement, Clinical department, Systemic diseases, Oncology, Care core Hepato-Pancreato-Biliary disease (HPB), which were part of one business unit within a tertiary care institution, a University Medical Centre in the Netherlands.

22 respondents aged 18 years or older were purposefully selected based on their organisational roles and LM experience. Respondents had to be involved in LM practices, which meant they had to understand LM and have passed at least one LM training programme, or they should be enrolled in a training course during the research.

Interviewees identified several barriers to LM implementation, including insufficient management support for a culture of continuous improvement, limited time for LM projects, inadequate recognition from management and poor communication of strategic objectives. Despite positive individual experiences with LM projects, their contribution to strategic objectives was deemed limited due to these barriers. Specific challenges included an experienced lack of leadership commitment, inadequate follow-up on projects, insufficient resource allocation, limited access to training and leaders failing to acknowledge employee value. Facilitators of success were fostering a culture of continuous improvement, committed managers and providing training.

LM practices have the potential to contribute to strategic objectives in healthcare organisations by reducing waste, improving patient care quality and optimising processes. However, their impact is constrained by organisational barriers and misalignments. Challenges such as insufficient resources, poor project follow-up, lack of management support and the absence of a continuous improvement culture minimise LM’s effectiveness.

Postictal agitation (PIA) is a common adverse effect following electroconvulsive therapy (ECT). Current pharmacological treatments for PIA have undesirable side effects, and interventions to prevent PIA are unsatisfactory. The aim of this study is to assess the effect of peri-interventional music on PIA for patients undergoing ECT. Additionally, the study will assess the impact of music on pretreatment anxiety and post-treatment cognitive impairment.

This multicentre, open-label, parallel randomised controlled trial (RCT) aims to include 92 patients from two centres in Rotterdam, the Netherlands. Participants will be randomised into two groups: a music intervention group and a control group. The music group listens to recorded music 30 min before and 12 min after each of the first six ECT sessions of the full ECT course, while the control group will receive standard care. The primary outcome is the presence of PIA, measured using the Richmond Agitation-Sedation Scale (RASS). Secondary outcomes include the severity and duration of PIA, pretreatment anxiety, recovery duration, peri-treatment medication requirements, cognitive impairment and depression severity. Data will be analysed according to an intention-to-treat principle.

This study protocol has been approved by the Medical Ethical Review Committee of the Erasmus Medical Centre on 28 January 2025 (MEC-2024–0467) and subsequently received local approval at Antes Parnassia group. The trial will be carried out following the Declaration of Helsinki principles. Study results will be reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.

NCT06817330.

To analyse demographic trends and decision-making patterns regarding prenatal diagnosis (PND) in couples at risk for hereditary haemoglobinopathies at the Thalassemia and Rare Haematological Disease Centre in Turin over a 40-year period.

Retrospective observational study analysing demographic and clinical data from 1983 to 2023.

Tertiary care genetic service Centre in Orbassano (TO), Northern Italy.

Couples seeking genetic counselling and PND for hereditary haemoglobinopathies. Selection criteria included couples at risk of having children affected by β-thalassaemia major or Sickle Cell Disease (SCD).

Primary outcomes included acceptance rates of PND and pregnancy termination (TOP). Variables analysed included couples’ age at first consultation, age at first PND, birthplace, employment status, specific haemoglobinopathy risk and number of pregnancies.

The analysis identified three main factors influencing PND and TOP decisions: nationality, type of haemoglobinopathy risk and number of previous pregnancies. Age showed no significant correlation with decision-making patterns. The impact of education level and employment status could not be definitively determined due to unavailable or unfit data.

The 40-year analysis of prenatal diagnosis for haemoglobinopathies in Turin shows evolving trends influenced by immigration patterns, improved medical treatments and cultural factors, leading to increased acceptance of affected pregnancies in recent years, particularly after 2015, due to better disease management and comprehensive healthcare support. This comprehensive analysis of our centre’s experience provides valuable insights that can serve as a model for similar institutions worldwide in supporting couples through carrier screening and PND processes.

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).

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

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

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

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

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

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

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

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

Dysphagia, or difficulty in swallowing, significantly impacts the quality of life of the affected individuals. Diagnostic approaches, including video fluoroscopic swallowing studies and flexible endoscopic evaluation of swallowing, are the most commonly used methods for assessing swallowing function. Recent advancements have led to the development of artificial intelligence (AI), including machine learning (ML) and deep learning (DL), which will provide innovative approaches to dysphagia diagnosis and treatment planning. There is a limited synthesis of literature on AI tools in dysphagia. There is an urgent need for a more rigorous and structured scoping review that can address the existing gaps, provide a more comprehensive evidence synthesis, and establish clearer guidelines for the clinical implementation of AI in assessments and management of dysphagia. This review will include studies focusing on AI tools such as ML, DL and computer vision for assessing and managing dysphagia. The context will be clinical or therapeutic settings, and all language articles will be considered for the review. Studies not involving AI technologies, those without clinical outcomes and ethical approval, and those focusing solely on the paediatric population will be excluded. This scoping review will systematically map and synthesise the existing literature on the use of AI tools for the assessment and management of dysphagia.

This scoping review will follow JBI methodology and PRISMA ScR guidelines. Information to be searched from January 2000 to May 2025 will include MEDLINE (via Ovid), Scopus, CINAHL (via EBSCOhost), Cochrane Library, JBI Evidence Synthesis, ProQuest and Google Scholar. The titles, abstracts and full texts will be screened by two independent reviewers. Data extraction will use a study-specific customised form, with descriptive analysis employed to categorise studies by AI tools and outcomes.

Ethical approval is not mandatory for this scoping review as it does not entail the collection of any individual patient data. Secondary data from publicly accessible research papers will be used. All the data sources will be appropriately cited. The findings will be propagated through peer-reviewed publications and scientific presentations.

Open Science Framework: DOI 10.17605/OSF.IO/DYCE9.

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.

Couples diagnosed with unexplained subfertility are advised to start mild ovarian hyperstimulation and intrauterine insemination (MOH-IUI) as a primary treatment. Natural feedback mechanisms and hormone release are affected by artificially stimulated cycles and induced ovulation. Additional luteal support could positively affect progesterone patterns in the luteal phase. The LUMO study evaluates whether the addition of exogenous progesterone in the luteal phase following MOH-IUI treatment cycle will improve pregnancy and live birth rates.

A multicentre randomised, double-blind, controlled trial will be conducted in Dutch fertility clinics, academic and non-academic hospitals. There are two treatment arms: group A progesterone luteal phase support; group B placebo, without crossover. All initiated MOH-IUI cycles within 6 months after randomisation are included (study period). Participants will start study medication, applying a daily dosage of 2dd 300 mg progesterone (Utrogestan) or 2dd 300 mg placebo in vaginal capsules on the second day after the IUI procedure. Treatment is continued until the onset of menstruation, a negative pregnancy test (IUI+14 days), a miscarriage or until 7 weeks of gestation in case of a viable pregnancy. Follow-up ends at 12 months after the end of study period (18 months after study randomisation). The primary outcome is cumulative pregnancy rate, achieved within 6 months after randomisation, leading to live birth. A total of 1008 patients (504 patients in each group) will be included.

The study was approved by the Central Committee on Research Involving Human Subjects on 30 January 2023. All participating sites have the approval of the local Board of Directors to participate in the LUMO study. An informed consent form will be signed by all participants. Study results will be presented at (inter)national conferences and published in peer-reviewed journals. It is expected that the results of this trial will be used to draft national guidelines on this issue.

The study is registered in the EU CTIS trial register (2022-501534-33-00), the Dutch trial registry (registration number: LTR 24508), ClinicalTrials.gov (NCT05080569) and the WHO registry (universal trial number: U1111-1280-9461).

To explore perceptions regarding the approved and actual prescribed doses of protein kinase inhibitors (PKIs) in clinical practice in the European Union among medicine regulators and healthcare professionals (HCPs).

A qualitative descriptive study was conducted using semistructured interviews, continuing until thematic saturation was reached. Thematic analysis was undertaken using a combined deductive-inductive approach. Deductive main analytical themes were derived from the theoretical framework of questioning-based policy design, namely problem sensing, problem categorisation and problem decomposition. Subthemes were generated inductively and could coherently be situated within these main analytical themes.

Interviews were held online or in person at a location convenient for the interviewee, depending on the participant’s preference.

Seven medicine regulators involved in the regulation of cancer medicines—including PKIs—and 10 HCPs prescribing PKIs in clinical practice, from various countries within Europe, were included.

Regulators highlighted insufficient attention to optimal dose finding, yielding approved doses often based on outdated maximum tolerated dose concepts, leading to uncertainties in efficacy and safety. HCPs reported using alternative dosing strategies in clinical practice to improve tolerability and quality of life (QoL) but noted a lack of robust evidence to guide such adjustments and faced legal constraints to deviate from the approved dose. Participants emphasised the need for improved pre-approval and post-approval dose optimisation to improve safety, enhance QoL and bridge gaps between trial data and real-world patient diversity.

Collaborative efforts involving multistakeholders including HCPs, regulators, pharmaceutical companies, insurers, governments and patient representatives are essential to advance dose optimisation and improve patient-centric outcomes, with further research needed to understand these stakeholders’ perspectives.

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

Heart failure (HF) is a prevalent cardiovascular disease worldwide, affecting 1–2% of adults. According to the WHO 2022 report, Pakistan ranks 18th globally for HF-related deaths. The exact prevalence of HF is not well documented. Additionally, knowledge and self-care behaviour among patients with HF are suboptimal. Therefore, this study aims to assess the knowledge and self-care behaviours of patients with HF before being discharged from the hospital and tracks the time to 30-day readmissions.

A prospective cohort research design will be used. Patients will be recruited from three tertiary care hospitals through consecutive sampling based on specific inclusion criteria. A structured tool will be used to collect demographic and clinical variables from 227 patients with HF. The Urdu version of the knowledge and self-care behaviour questionnaires will be used to collect the data. Kaplan-Meier product limit method and Cox proportional hazards model will be employed to obtain estimates with 95% CIs.

The study has been approved by the Institutional Review Board (IRB) of Shifa Tameer-e-Millat University, Pakistan (IRB 103-24), and written permission was obtained from the administration of the understudy hospitals. Before obtaining a written consent, all patients will receive detailed information about the study. Patients will have the freedom to withdraw from the study at any point. Patients’ confidentiality will be ensured. The study findings will be disseminated to essential stakeholders and published in scientific papers and conference proceedings.