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Ayer — Junio 14th 2026Tus fuentes RSS

Factors influencing data quality in electronic health records among health professionals in hospital settings: a scoping review protocol

Por: Brinkmann · E. M.-B. · Haahr · A. · Bossen · C. · Aadal · L.
Introduction

Data quality in electronic health records (EHRs) is central to data-informed healthcare. Health professionals play a key role in ensuring data quality yet the complexities of clinical data practices remain poorly understood. Previous reviews have focused on specific documentation domains or professions, leaving a gap in understanding the broader individual, organisational, technological and contextual factors influencing data quality in hospital settings. This scoping review aims to identify and map factors that promote or hinder data quality in EHRs among health professionals in hospital settings.

Methods and analysis

The review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews and be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis for Scoping Reviews (PRISMA-ScR) checklist. Peer-reviewed studies will be identified through comprehensive searches in PubMed, Scopus, Web of Science, CINAHL and Google Scholar. Two independent reviewers will screen titles, abstracts and full texts and extract data using the JBI Extraction Form. Data will be charted and mapped according to the six dimensions of the Digital Health Data Quality Dimension and Outcome (DQ-DO) framework—accuracy, completeness, consistency, contextual validity, currency and accessibility—and analysed across professional groups and hospital contexts.

Ethics and dissemination

Ethical approval is not required for this scoping review as it is based on publicly available data. The findings will be disseminated through peer-reviewed publication and presentations at relevant academic and clinical conferences.

Registration

The protocol has been registered in the Open Science Framework: https://doi.org/10.17605/OSF.IO/YQ2DX

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In their own words: experiences surrounding masculinising chest surgery among transgender and gender-diverse adolescents - a secondary analysis of GENDER-Q data

Por: Armstrong · K. · Quan · I. · Kennedy · S. L. · Kaur · M. N. · Cornacchi · S. D. · Rae · C. · Johnson · N. · Khatchadourian · K. · Marinkovic · M. · Sequeira · G. M. · Bradley · B. · Cheung · K. · Morrison · S. D. · Klassen · A. F.
Objective

Masculinising chest surgery, also known as top surgery, is the most requested gender-affirming procedure among transgender and gender-diverse (TGD) adolescents, yet research on patient experiences remains limited. This study explored the experiences of TGD adolescents who were seeking or had undergone masculinising chest surgery.

Design

Qualitative secondary analysis using existing themes framework and data from the GENDER-Q (GQ) and GENDER-Q Youth (GQY) research programmes, which aim to develop comprehensive patient-reported outcome measures for gender-affirming care.

Setting

Participants were sampled from five high-volume gender-affirming care clinics, three in Canada and two in the United States. Interviews were conducted online.

Participants

35 GQ and GQY participants aged 13–18 years who were assigned female at birth, identified as trans men or non-binary, and were pursuing (n=19) or had undergone (n=16) masculinising chest surgery.

Results

Three major themes emerged: chest appearance, health-related quality of life (HRQL) and gender practices. Most participants expected a flatter chest that aesthetically aligned with their gender identity. Presurgery participants anticipated that surgery would allow them to engage in previously avoided physical activities and would enhance their relationships. Postoperative participants reported increased physical activity, mental resilience, bodily connection and social comfort. Most reported binder use and related reliance or discomfort as motivators for pursuing surgery.

Conclusions

This study highlights the multidimensional experiences surrounding masculinising chest surgery on TGD adolescents with impacts on chest appearance, HRQL and gender practices. Centering adolescents’ perspectives, these findings underscore the importance of accessible, affirming surgical care and provide valuable insights for clinicians, policymakers and future research.

Mortality differences between ICUs that are regarded as 'in control: a longitudinal register-based study in the Netherlands, 2013-2023

Por: Termorshuizen · F. · Brinkman · S. · Arbous · S. M. · Dongelmans · D. A. · de Keizer · N. F. · Bakhshi-Raiez · F.
Objectives

Funnel plots are used to identify intensive care units (ICUs) with a higher than expected risk-adjusted mortality. ICUs with a standardised mortality ratio (SMR) within pre-defined control limits (often the 99.8% CL) are regarded as ‘in control’ and not labelled as a potential outlier for a particular calendar year. However, increased mortality rates not due to random fluctuations within and across the calendar years may be overlooked. We examined whether statistically significant and relevant differences in mortality over time between ICUs regarded as ‘in control’ are present.

Design

A longitudinal register-based study.

Setting and participants

88 ICUs in the Netherlands registering the admissions of all critically ill patients in the National Intensive Care Evaluation registry in the Netherlands from 2013 to 2023.

Primary outcome measure

Hospital death analysed in a multivariable logistic regression analysis with a random intercept for ICU. The random intercept variance was translated to the median OR (MOR).

Results

877 ICU-calendar year combinations were included, covering 759 498 unique admissions. The MOR increased from 1.12 (95% CI 1.10 to 1.15) for ICU-calendar year combinations with an SMR within the narrowest 95% CL (N=677) to 1.20 (1.17 to 1.24) for combinations with an SMR within the expanded 99.8% CL (including adjustment for overdispersion) (N=194) and to 1.21 (1.17 to 1.25) when including all ICU-calendar year combinations. Similar results were found for separate calendar years and separate diagnostic groups.

Conclusions

These results show differences in mortality between ICUs that were not labelled as outliers. Assessment of mortality performance should integrate cross-sectional funnel plots, the MOR and longitudinal trends in the SMR to better capture persistent patterns of excess risk.

Sick leave and engagement as workforce well-being proxies in hospital departments: a cross-sectional study of routinely collected organisational data in a Dutch academic hospital

Por: Bazuin · T. · Oerbekke · M. S. · Bontjer · S. · Reijmerink · I. M. · Dongelmans · D. A. · Franx · A. · Wietasch · J. K. G. · Hooft · L. · van der Laan · M. J.
Objectives

Well-being of healthcare professionals (HCPs) is vital for care quality, staff retention and overall healthcare system effectiveness. This study aims to identify the organisational and workplace variables associated with sick leave and measures of engagement of HCPs on department level within a single Dutch academic hospital.

Design

Cross-sectional study using routinely collected organisational data.

Setting

A tertiary-care academic hospital in the Netherlands.

Participants

25 clinical departments were included. Department level variables were derived from routinely collected hospital databases. Availability of data varied across variables. Analysis included information on patient population, human resources, care processes, quality of care and employee and patient experiences to assess differences, correlations and predictors for sick leave and engagement.

Primary and secondary outcome measures

Primary outcome measures were (1) sick leave (%) and (2) engagement, assessed through two staff-survey items (vitality and connectedness; 0–10 Numeric Rating Scale). Both outcomes were analysed at department level.

Results

Employee population data showed the most consistent patterns across analyses. Departments with higher staffing capacity had higher sick leave and lower engagement in group comparisons (p=0.009, p=0.030, respectively). In multivariable models, higher staffing capacity remained associated with increased sick leave (B=1.38, 95% CI 0.53 to 2.23, p=0.003). Engagement was positively associated with higher inflow (B=0.92, 95% CI 0.06 to 1.77, p=0.037) and negatively associated with outflow (B = –1.36, 95% CI –2.08 to –0.63, p=0.001). No consistent associations were found with patient population and patient experience measures.

Conclusions

Workforce-related factors, particularly staffing capacity and inflow and outflow, are strongly linked to sick leave and engagement. Routinely collected hospital data can be used to identify at-risk departments and inform targeted strategies for improving workforce sustainability. Future studies should explore more granular, team-level data to better support staff well-being and care quality.

Barriers and facilitators to implementing a shared decision-making tool for anticoagulant-related drug-drug interactions: a qualitative study across three academic medical centres in the USA

Por: Becker · R. A. · Bonnet · K. · Shah · M. V. · Dang · E. · Ancker · J. S. · Malone · D. C. · Trinkley · K. E. · Gomez-Lumbreras · A. · Del Fiol · G. · Kawamoto · K. · Tawfik · A. G. · Cornia · R. · Jones · A. E. · Mitchell · J. · Reese · T. J.
Objectives

To identify barriers and facilitators to implementing an electronic shared decision-making tool for managing anticoagulant-related drug-drug interactions that affect bleeding risk in routine clinical care.

Design

Preimplementation qualitative study using semistructured interviews.

Setting

Three academic medical centres in the southeastern and western USA. Interviews were conducted between 27 March and 25 September 2024.

Participants

36 participants, including 19 clinicians involved in prescribing or managing anticoagulants and seventeen patients prescribed anticoagulants, were recruited using purposive and convenience sampling.

Results

Participants identified multiple barriers and facilitators to tool implementation. Common barriers included limited visit time, challenges integrating the tool into existing workflows, role and scope-of-practice constraints, and variation in patient digital literacy. Facilitators included clear visualisation of bleeding risk, access to supporting evidence, familiar interface design and perceived potential to support patient engagement and shared decision-making. Several determinants functioned as both barriers and facilitators, depending on clinical context and user role.

Conclusions

This preimplementation qualitative study identified context-specific determinants that influence the adoption of an electronic shared decision-making tool for anticoagulant-related drug–drug interactions. Findings highlight the importance of early attention to workflow integration, role alignment and usability to support uptake in routine care. Addressing these factors during design and implementation may inform strategies to support adoption and future evaluation in real-world clinical settings.

Identifying facilitators and barriers to implementing the Feverkidstool, a clinical decision tool, in the emergency department: a qualitative study in the Netherlands

Por: Vrijlandt · S. · Ista · E. · Kuiper · R. · van Veen · M. · van Wermeskerken · A.-M. · Ropers · F. · Oostenbrink · R.
Objectives

This study aimed to identify determinants that hinder or facilitate implementation of the Feverkidstool, a clinical decision support tool offering a quantitative, evidence-based approach, to manage children with fever in the emergency department (ED) setting.

Design

Qualitative study using semistructured interviews, analysed through directed content analysis guided by the Consolidated Framework for Implementation Research (CFIR).

Setting

Secondary and tertiary paediatric emergency departments in three hospitals in the Netherlands.

Participants

Eighteen potential end users of the Feverkidstool, including paediatricians and paediatric residents working in the ED and involved in the care of febrile children, participated in the study.

Primary outcome measure

Determinants of Feverkidstool implementation, categorised by CFIR domains: intervention characteristics, outer setting, inner setting, characteristics of individuals and implementation process.

Results

Respondents (n=18) perceived the evidence-based guidance by the Feverkidstool and its potential to reduce antibiotic use as valuable. However, concerns were raised about its applicability to critically ill children and those with comorbidities. User-friendliness was seen as a facilitator, whereas the need for C reactive protein testing and lack of integration with electronic health records were mentioned as barriers. The ability to standardise care for febrile children was considered an important benefit of using the Feverkidstool.

Conclusion

Barriers and facilitators across all CFIR domains are identified. Addressing these will facilitate implementation. When effectively implemented, the Feverkidstool has the potential to improve care for children presenting with fever in the ED. This may potentially lead to a more standardised approach and reduce unnecessary antibiotic prescriptions.

Experiences of Nurses With Power‐Structures in Hospital Care: A Qualitative Study

ABSTRACT

Aim

To explore nurses' experiences with power structures in hospital care and to develop policy recommendations for transforming disempowering structures.

Design

A three-phased critical ethnographic design.

Method

Data were collected in a general teaching hospital in the Netherlands between December 2022 and June 2024 through (1) ethnographic diaries kept by nurses, (2) semi-structured interviews, (3) partial participant observations, (4) one focus group discussion with only nurses and (5) one multistakeholder focus group. Thematic analysis was used to identify themes.

Findings

Twenty-eight nurses of thirteen different departments and nine stakeholders participated. Four themes emerged from the analysis: (1) power in cooperation, (2) hierarchical relationships, (3) aggression and (4) insufficient decision-making power in hospital policies. The first theme was experienced as an empowering structural condition, while the last three were identified as disempowering structures.

Conclusion

Job satisfaction and quality of care among nurses are at risk and elicit feelings of burnout because of nurse–doctor hierarchies, aggression and insufficient decision-making power in hospital policies. Therefore, improving interprofessional cooperation and including nurses in decision-making is crucial to structurally empower nurses.

Implications

Hospital administrators need to create empowering conditions for nurses by furthering inclusion in policy making and setting department goals, implementing interprofessional education for effective collaboration, increasing nurse representation throughout hospital management layers and ensuring strong support systems. These interventions are important in addressing aggression, hierarchies, nurse turnover and burnout.

Reporting Method

COREQ guidelines were used for reporting qualitative studies.

Patient or Public Contribution

None.

Safety and potential efficacy of DM199, a tissue kallikrein-1 analogue, for treating pre-eclampsia and fetal growth restriction: study protocol for a South African, hospital-based phase I/II open-label trial

Por: Cluver · C. A. · Thake · J. · Hassim · T. · van Greunen · A. · Budhram · S. · Knipe · K. · Decloedt · E. · Brink · L. · Langenegger · E. · Bergman · L. · Imberg · H. · Bekker · A. · Walker · S. P. · Tong · S.
Introduction

Pre-eclampsia and fetal growth restriction are leading causes of perinatal morbidity and mortality. A therapy that enhances maternal vascular function and promotes vasodilation to increase placental perfusion could treat both conditions.

Tissue kallikrein-1 is an endogenous enzyme that releases bradykinin to activate the bradykinin 2 receptor on endothelial cells. This induces potent vasodilation and pro-angiogenic, anti-oxidant and anti-inflammatory effects.

DM199 is a recombinant form of tissue kallikrein which can be administered intravenously or subcutaneously. Clinical trials in non-pregnant populations have demonstrated its safety. Being a protein, it is unlikely to cross the placenta. This protocol describes an early-phase trial for DM199 for pre-eclampsia and fetal growth restriction.

Methods and analysis

This phase IB/IIA open-label trial at Tygerberg Hospital, Western Cape Province, South Africa, will determine the safety and effective dose of DM199 for pre-eclampsia and/or fetal growth restriction. The trial consists of two parts. Part 1 will be an ascending dose finding study, treating women with pre-eclampsia and severe hypertension who are for planned birth within 72 hours. This will search for doses that safely lower blood pressure (n=3/dose, recruiting up to 42 participants). Part 2 is a safety and efficacy study of three cohorts of pregnant women (n=30/cohort): (1) with pre-eclampsia and severe hypertension requiring delivery within 72 hours, (2) with preterm pre-eclampsia (

Ethics and dissemination

The trial has ethical approval (Health Research Ethics Committee, Stellenbosch University, Protocol number M24/04/009) and is registered (Pan African Clinical Trial Registry, PACTR202404895013782) and approved by the South African Health Products Regulatory Authority (20240801). Data will be presented at international conferences and published in peer-reviewed journals.

Patterns of symptom deterioration can support multimorbidity management in COPD: Perspectives of patients and healthcare professionals

by Sanne H. B. van Dijk, Marjolein G. J. Brusse-Keizer, Bente Rodenburg, Anke Lenferink

Introduction

Comorbidities significantly complicate COPD management. Remote monitoring could aid real-time disease and symptom management, assisting both patients with multimorbidity and healthcare professionals (HCPs). This study aimed to explore how insight in patterns of symptom deterioration, derived from remote monitoring, could enhance multimorbid COPD management as perceived by patients and HCPs.

Methods

Using daily symptom data collected via a mobile diary in the prospective RE-SAMPLE cohort study, patterns of symptom deterioration of COPD, chronic heart failure, anxiety, and depression were visualized per patient (follow-up duration of ≥4 months). Semi-structured individual interviews were conducted with Dutch patients with COPD and ≥1 comorbidity, and with HCPs from pulmonology, cardiology, and medical psychology who were involved in care for patients with multimorbidity. Interviews addressed current multimorbid COPD management, its challenges, and the way pattern visualizations of symptoms deterioration could support disease management. Transcripts were thematically analyzed using an inductive approach.

Results

7 patients (69–80 years, 4 men) and 7 HCPs were interviewed in the hospital (patients and HCPs), at home (patients) or online (HCPs). Three overarching themes were identified, representing the elements of multimorbid COPD management that could be supported by the pattern visualizations: 1) relationship between diseases, 2) decision-making, and 3) self-management. According to patients and HCPs, pattern visualizations can be an informative source to explain the relation between COPD and comorbidities, function as a conversation starter facilitating communication between patients and HCPs as well as between medical disciplines, and educate patients in adequately recognizing their care needs.

Conclusion

Three elements of personalized multimorbid COPD management were identified through qualitative analysis, which can all be supported by visualizing patterns of symptom deterioration via remote monitoring. The visualizations could enhance patients’ understanding of their diseases, improve shared decision-making, improve in-hospital multidisciplinary collaboration, and support multimorbid COPD (self-)management.

Studying COVID-19 transmission in US state prisons using an agent-based modelling approach: a simulation study

Por: Owens · A. L. · Fliss · M. · Brinkley-Rubinstein · L.
Objectives

We aim to use an agent-based model to accurately predict the spread of COVID-19 within multiple US state prisons.

Design

We developed a semistochastic transmission model of COVID-19.

Setting

Five regional state-owned prisons within North Carolina.

Participants

Several thousand incarcerated individuals.

Primary and secondary outcome measures

We measured (1) the observed and simulated average daily infection rate of COVID-19 for each prison studied in 30-day intervals, (2) the observed and simulated average daily recovery rate from COVID-19 for each prison studied in 30-day intervals, (3) the mean absolute percentage error (MAPE) of each prison’s summary statistics and the simulated results and (4) the parameter estimates of key predictors used in the model.

Introduction

The COVID-19 pandemic disparately affected incarcerated populations in the USA, with severe morbidity and infection rates across the country. In response, many predictive models were developed to help mitigate risk. However, these models did not feature the systemic factors of prisons, such as vaccination rates, populations and capacities (to determine overcrowding) and design and were not generalisable to other prisons.

Methods

An agent-based model that used geospatial contact networks and compartmental transmission dynamics was built to create predictive microsimulations that simulated COVID-19 outbreaks within five North Carolinian regional prisons between July 2020 and June 2021. The model used the characteristics of an outbreak’s initial case size, a given facility’s capacity and its incarcerated vaccination rate as additional parameters alongside traditional susceptible-exposed-infected-recovered transmission dynamics. By fitting the model to each prison’s data using approximate Bayesian computation methods, we derived parameter estimates that reasonably modelled real-world results. These individualised estimates were then averaged to produce generalised parameter estimates for North Carolina state prisons overall.

Results

Our model had a mean average MAPE score of 23.0 across all facilities, meaning that it reasonably forecasted facilities’ average daily positive and recovery rates of COVID-19. Our model estimated an average incarcerated vaccination rate of 54% across all prisons (with a 95% CI of ±0.12). In addition, the prisons of this study were estimated to be operating at 90% of their capacity on average (95% CI ±0.16). Given the high levels of COVID-19 observed in these prisons, which averaged over one-third positive tests on respective 1-day maxima, we conclude that vaccination levels were not sufficient in curbing COVID-19 outbreaks, and high occupancy levels likely exacerbated the spread of COVID-19 within prisons.

In addition, data gaps in facilities without recorded daily testing resulted in poor spread predictions, demonstrating how important consistent data release practices are in incarcerated settings for accurate tracking and prediction of outbreaks.

Conclusion

The findings of this study better quantify how spatial contact networks and facility-level characteristics unique to congregate living facilities can be used to predict infectious disease spread. Our approach also highlights the need for increased vaccination efforts and potential capacity reductions to mitigate COVID-19 transmission in prisons.

Comparison of Vyntus CPX and Vmax Encore 29N for indirect calorimetry: a randomised crossover study in participants of the German Diabetes Study with type 2 diabetes

Por: Trinks · N. · Pützer · J. · Sutkowski · A. · Burkart · V. · Roden · M. · Kuss · O.
Objectives

This study compared the reliability of two metabolic cart systems, Vyntus CPX and Vmax Encore 29N, to measure whole-body energy metabolism by indirect calorimetry (IC) in individuals with type 2 diabetes (T2D).

Design

Randomised, prospective, crossover study.

Setting

Single-centre study conducted in the clinical research centre of the German Diabetes Study (GDS).

Participants

Five participants (3 men, 2 women, mean age 49±6 years, body mass index (BMI) 32.62±4.2 kg/m²) with T2D completed the study protocol. Eligibility requires existing participation in GDS and availability for four consecutive study days.

Interventions

Participants underwent four IC measurements per day on four consecutive days, totalling 16 measurements per device. On each study day, two measurements with both devices, Vyntus CPX and Vmax Encore 29N, were performed in randomised order. Postcalorimetric gas calibration with normalisation was applied after each measurement.

Primary outcome measures

Reliability of respiratory quotient (RQ) and resting energy expenditure (REE), as assessed from the coefficient of variation (CV) and 95% CIs.

Results

Device comparison showed minor differences in CV (95% CI) for carbon dioxide production (VCO2) (3.5% vs 5.3%; 95% CI –8.2% to 8.0%), oxygen consumption (VO2) (3.4% vs 5.7%; 95% CI –9.3% to 8.2%), RQ (3.6% vs 2.3%; 95% CI –3.5% to 3.7%) and REE (3.1% vs 5.6%; 95% CI –8.4% to 7.8%). Postcalorimetric calibration did not consistently affect RQ or REE. 

Conclusions

Vyntus CPX provides reliable IC measurements comparable to Vmax Encore 29N and may serve as a suitable replacement in clinical settings.

Trial registration number

ClinicalTrials.gov identifier: NCT01055093.

Study protocol: MRI-based assessment of cerebral blood flow under pharmacologically elevated blood pressure in patients under general anesthesia, and in sedated ICU patients with aneurysmal subarachnoid hemorrhage

by Jonas Österlind, Johan Birnefeld, Elin Birnefeld, Magnus Hultin, Sara Qvarlander, Anders Wåhlin, Petter Holmlund, Laleh Zarrinkoob

Background

Maintaining cerebral perfusion during anesthesia and intensive care is critical, yet the relationship between mean arterial pressure (MAP) and cerebral blood flow (CBF) remains poorly defined. In patients with aneurysmal subarachnoid hemorrhage (aSAH), pharmacologically induced hypertension is commonly applied to support cerebral perfusion, but its effects are uncertain.

Methods

This protocol describes two parallel clinical studies using identical methodology. The first study population includes adults undergoing elective general anesthesia (MAP-ANE), and the second comprises sedated intensive care patients with aSAH (MAP-SAH). In both study populations, MAP will be increased stepwise with norepinephrine (NE) infusion under continuous invasive blood pressure monitoring, and CBF measured with phase-contrast MRI (PCMRI) and arterial spin labeling (ASL), while near-infrared spectroscopy (NIRS) will be performed in parallel to evaluate its validity as a surrogate marker. The primary outcome is the change in total CBF between baseline and elevated MAP, directly testing whether induced hypertension increases CBF. Secondary outcomes include ASL perfusion changes, the slope of the MAP–CBF relationship, systemic–cerebral hemodynamic correlations, and NIRS responses.

Expected impact

These studies test the hypothesis that pharmacological MAP augmentation does not predictably increase CBF. By combining quantitative MRI with invasive monitoring, it aims to clarify MAP–CBF interactions, define the physiological basis of induced hypertension, and assess whether NIRS can serve as a clinically useful proxy. Findings are expected to inform safer and more individualized blood pressure management in perioperative and neurocritical care. The studies are registered at ClinicalTrials.gov (MAP-ANE: NCT06855407; MAP-SAH: NCT06033378).

Trial registration

ClinicalTrials.gov, MAP-ANE NCT06855407, MAP-SAH NCT06033378

Development of a practical guide for patient participation in value-based healthcare: an action research study

Objectives

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.

Design

An action research study.

Setting

This study was conducted in seven collaborating Dutch hospitals from March 2023 to November 2024.

Participants

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.

Outcomes

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.

Results

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.

Conclusions

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.

Does luteal phase support in MOH-IUI treatment improve cumulative live birth rates in couples with unexplained subfertility? Study protocol of the LUMO study: a centre, randomised, double-blind, controlled trial with cost-effectiveness analysis

Por: Preesman · E. · Drechsel · K. · Crommelin · H. · Broekmans · F. · Verpoest · W. · Broer · S. · On behalf of the LUMO Study Group · LUMO Study Group · Musters · Cantineau · Heusden · Heteren · Koks · Koning · Lashley · Kuijper · Santbrink · Janse · Mol · Tecklenburg · Krom · Verhoe
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

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).

Views of European Union medicine regulators and healthcare professionals on the approved versus prescribed dose of protein kinase inhibitors: an interview study

Por: Brinkhof · M. · de Vries · S. T. · Mol · P. G. M. · Trapani · D. · Marije de Jong · I. · Broekman · K. E.
Objective

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).

Design

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.

Setting

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

Participants

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.

Results

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.

Conclusions

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.

'Harm? I dont think so!: medical overuse from the perspective of allied health professionals in Germany - a qualitative study

Por: Stelzner · B. · Rink · L. · Kühlein · T. · Sebastiao · M.
Objectives

Medical overuse is a well-documented increasing issue, primarily examined in the context of physicians. Previous research has also identified unnecessary services involving allied health professionals (AHPs). The objectives of our study were to explore: (1) To what extent are physiotherapists (PT), occupational therapists (OT) or speech and language therapists (SLT) familiar with the phenomenon of medical overuse?, (2) What drivers do PTs, OTs and SLTs suspect?, (3) What are the consequences of medical overuse? and (4) What measures can be taken to reduce medical overuse?

Design

This study used a qualitative descriptive design and applied qualitative content analysis to explore the AHPs’ point of view. A qualitative content analysis using a deductive–inductive approach was conducted. After coding half of the interviews, no further categories were added, indicating data saturation.

Setting

Bavaria, Germany.

Participants

14 AHPs, mostly female.

Results

AHPs struggled to define overuse. To them, underuse was perceived as a much more pressing issue. AHPs identified structural, economic, physician and patient-driven factors. They did not see themselves as part of the problem of medical overuse and assumed that their treatment, even without indication, has little to no disadvantage for patients. AHPs found it difficult to derive specific solutions; they named terminating unnecessary therapies and healthcare system reforms.

Conclusions

AHPs lacked initial awareness of medical overuse, highlighting the need for education and broader research.

Exploring family health, support, self-efficacy and quality of life during the cancer trajectory: a protocol for a longitudinal mixed methods multi-centre cohort study

Por: Tolstrup · L. K. · Hyldig · N. · Moller · S. · Stie · M. · Kjerholt · M. · Jarden · M. · Piil · K. · Coyne · E. · Garcia-Vivar · C. · Voltelen · B. · Munk-Olsen · T. · Dieperink · K. B.
Introduction

A cancer diagnosis not only profoundly impacts individuals but also the very core of their families, reshaping their lives in many ways. However, there is a lack of focus on the well-being and health of the entire family across adult cancer research. This is concerning given that one-third of the Danish population will get a cancer diagnosis before the age of 75, suggesting that many Danes will become caregivers during their lifetime. In addition, identifying vulnerable families is challenging, and the determinant factors for their vulnerability are unknown.

Aims

The principal aim of this study is to investigate family health during cancer treatment. This will be done by gathering information on various parameters such as perceived support, quality of life and self-efficacy in patients with cancer and families across the cancer trajectory. Additionally, the study seeks to pinpoint particularly vulnerable families and investigate contributing factors to their vulnerability.

Methods and analysis

This mixed-methods study follows a sequential explanatory design, combining patient-reported outcomes in a longitudinal, prospective multicentre survey with interviews conducted with a nested sampling of the participants from the survey. A total of 240 patients diagnosed with prostate-, breast-, gastrointestinal- and lymphoma cancer, and designated adult family caregivers will be recruited from six different sites for the survey. Variables such as family health, needs and perceived support, quality of life, self-efficacy, depression, stress and resilience will be explored. Survey data will be collected at baseline, 3, 6, 12 and 18 months. The interviews (n=12–15) will be conducted twice with patients and caregivers jointly: once during the treatment phase (3 months) and once after completion of treatment (12 months). For the survey part, we estimated a sample size with 90% power and 5% significance to detect a minimal clinically important change in the Family Health Scale. Assuming an SD of 2x22 = 31, based on a cross-sectional SD of 22, 44 patients per group were required; to allow for dropout, 60 per group (240 total) were included. Patient and caregiver characteristics will be summarised descriptively. Longitudinal patient-reported outcomes will be analysed with linear mixed regression, separately for patients and caregivers. Changes will be reported as mean differences with 95% CIs and compared with published minimal clinically important differences or, if unavailable, 0.3xbaseline SD. For the qualitative part, thematic analysis by Braun and Clarke is chosen to extract data, identify patterns and analyse data and themes from the interviews. NVivo will be used for coding interview data.

Ethics and dissemination

The study will be conducted in accordance with the Helsinki Declaration. Measures will be taken to ensure confidentiality, data protection and participant safety throughout the study. The results will be published in peer-reviewed journals and conference presentations.

Trial registration number

ClinicalTrials.gov: NCT06433349. Protocol version 2.0, June 2024.

Implementing a Scalable, personalised, behaviour Change digitAL hEalth programme in primary care for type 2 diabetes treatment: the SCALE cluster-randomised study protocol

Por: Shahidi · M. · deCourten · B. · Glennan · J. · Assange · J. · Seng-Lim · K. · Maberly · G. · Brinkworth · G. · Meyerowitz-Katz · G.
Introduction

Type 2 diabetes mellitus (T2DM) is a fast-growing chronic disease, with at least 1.3 million people diagnosed in Australia. In the Western Sydney Local Health District (WSLHD), an estimated 13.1% of all adults have T2DM. The condition significantly contributes to cardiovascular, heart and kidney diseases and causes a large disease burden. Lifestyle modifications, such as improved nutrition, increased physical activity and stress reduction, are recommended as first-line treatments for T2DM management. However, the current primary care system cannot meet the growing demands for diabetes care, necessitating the development of innovative, scalable, cost-effective solutions. Digital health technologies present a promising approach for promoting self-management in individuals with T2DM.

Methods and analysis

This cluster-randomised controlled trial aims to evaluate the feasibility and effectiveness of Gro-AUS, a localised version of the Gro Health app in Australia, to support T2DM management in Australian primary care settings. The trial will be conducted across multiple general practice clinics within the WSLHD, an area with a high prevalence of T2DM and significant cultural diversity in patient populations. Participants will be randomly assigned by clinic to either the intervention group (digital health programme) or control group (standard care). Primary outcomes include improvements in glycaemic control, cardiovascular risk factors and diabetes remission, with secondary outcomes such as weight loss, physical activity and mental well-being. Data will be collected using electronic and paper methods, with secure storage and de-identification ensuring participant privacy. The study’s mixed-method approach ensures inclusivity for patients with varying levels of digital literacy. Data will be securely stored, de-identified and used to assess the effectiveness of the intervention. Findings are expected to inform future models of diabetes care in Australia, providing evidence for the scalability of digital health technologies in chronic disease management.

Strengths and limitations

This trial is by nature unblinded. The recruitment style for a stepped-wedge trial may also bias participant engagement. However, it has direct implications for clinical practice as an effectiveness implementation trial. The design also allows for a much larger sample and more statistical power to examine outcomes.

Ethics and dissemination

This trial has been prospectively registered with the Australian New Zealand Clinical Trials Registry. Ethical approval has been granted by the WSLHD Human Research Ethics Committee prior to data collection. Results will be disseminated through publication in a peer-reviewed medical journal and shared via the Agency for Clinical Innovation, the Primary Care Health Network and through community engagement initiatives.

Trial registration

ANZCTR388639.

Understanding the human fit of access during initial recovery from the COVID-19 pandemic: a qualitative study in English general practice

Por: Hammond · J. · Goulding · R. · Drinkwater · J. · Kent · L. · Bailey · S. · Checkland · K. · Voorhees · J.
Objectives

Access to general practice in England is a challenging issue of enduring importance. COVID-19 precipitated various abrupt changes, exposing and compounding existing problems. The access as human fit conceptualisation provides a nuanced understanding of access that extends beyond a limited focus on appointment numbers and speed. This qualitative study explored the pandemic’s impact on access to general practice and the experiences of patients and healthcare staff in England using access as human fit as an analytical framework.

Design

A community-based participatory approach underpinned by qualitative semi-structured interviews and focus groups, and observations.

Setting and participants

The following were conducted in Northwest England (December 2021—August 2022): interviews (10 participants) with patients, general practice staff and professionals; seven focus groups (42 participants) with patients from general practice patient groups and underserved groups; and twenty observation sessions of non-clinical access encounters (seven general practice and Primary Care Network premises; 45 hours total).

Analysis

A rapid qualitative analysis methodology facilitated an abductive thematic approach, applying the dimensions of access as human fit to the data.

Results

The access as human fit framework highlighted key areas where there is a lack of fit between patients and staff. Patients expressed that the array of access options and changes made it hard to know how to be a patient; some thought general practice should be ‘back to normal’ and the pandemic was an excuse to restrict access. Providers reported working harder than ever with insufficient resources.

Conclusions

The pandemic created greater distance between staff and patient realities of access. Access as a human fit facilitated in-depth exploration of patient and staff experiences, improving understanding and identifying key issues. Broader adoption and application of this framework, within policy and practice, could focus improvement efforts, optimise access fit and improve patient satisfaction and staff retention.

Health impacts of electronic nicotine delivery systems: an umbrella review of systematic reviews

Por: Kaur · J. · Goel · S. · Shabil · M. · Rana · R. K. · Rinkoo · A. V. · Chauhan · A. · Gupta · S.
Background

The rise of electronic nicotine delivery systems (ENDS) has introduced new challenges to tobacco control and regulation, particularly among young adults, raising questions about their safety. This umbrella review aimed to synthesise existing systematic reviews with or without meta-analyses to evaluate the health impacts of ENDS.

Methods

We conducted a systematic literature search via the PICO strategy across multiple databases, focusing on e-cigarettes, ENDS and e-liquids, while excluding non-nicotine e-cigarette and nicotine replacement therapies (NRTs). Health outcomes include a range of clinical diseases and physiological changes. Quality assessment was performed via assessing the methodoligcal quality of systematic reviews 2 (AMSTAR-2), and the findings were synthesised narratively and in tables, prioritising the highest-rated reviews. The meta-analyses used R software (V.4.3) random effects models, and evidence quality was assessed via the Grading of Recommendations, Assessment, Development and Evaluation criteria.

Results

Of the 5055 records, 69 systematic reviews were included. Systematic reviews have indicated increased risks of cardiovascular and respiratory diseases, mental health issues and substance abuse with ENDS use, especially among adolescents. Cardiovascular risk factors included increased heart rate (mean difference (MD) 1.41, 95% CI 0.81 to 2.01, I2=91%) from 25 studies; increased blood pressure (MD for systolic blood pressure=0.51 mm Hg, 95% CI 0.26 to 0.75, I2=89%; MD for diastolic blood pressure=0.59 mm Hg, 95% CI 0.35 to 0.83, I2=82%) from 23 studies; endothelial dysfunction and increased platelet activity. Respiratory risk factors included reduced lung function and a higher incidence of asthma in nine studies (OR 1.30, 95% CI 1.1 to 1.55; I2=43%) and chronic obstructive pulmonary disease. Mental health concerns, such as depression and suicidality, were also prevalent among adolescent ENDS users. Nine studies reported a negative effect of ENDS on periodontal health. Evidence of carcinogens has been found in the urinary examinations of ENDS users in some studies. The adverse events reported in seven randomised controlled trials with 2611 participants were similar between ENDS and NRT (RR 1.13, 95% CI 0.83 to 1.54, I2=12%).

Conclusions

Exposure to ENDS is harmful to various organ systems, especially cardiovascular and respiratory systems. Comprehensive regulatory measures and public health strategies are necessary to curb the use of ENDS, particularly among young people.

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