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Non-infectious skeletal complications in the lower extremity after treatment with a transfemoral bone-anchored prosthesis: a retrospective observational study

Por: Svensson Malchau · K. · Malchau · H. · Thomsen · P. · Hagberg · K.
Background

The use of bone-anchored prostheses (BAPs) has greatly increased quality of life for lower limb amputees. However, the long-term frequency of skeletal fractures and the need for arthroplasty surgery in the lower extremities following BAP use is scarce.

Objectives

The current study aimed to investigate the frequency of fractures and arthroplasties in the lower limb after BAP surgery with the Osseointegrated Prosthesis for the Rehabilitation of Amputees (OPRA) system.

Design

Retrospective cohort study using the OPRA database and medical record review for data collection.

Setting

A single-centre study at a tertiary hospital.

Participants

All patients with a transfemoral BAP (OPRA system) who underwent surgery between 1999 and 2019, and had completed at least 2 years of follow-up were included in the study. Patients with bilateral transfemoral amputations were excluded. A total of 100 patients were included.

Primary outcome measure

The primary outcome measure was to identify patients who had a fracture or had undergone arthroplasty surgery in the lower extremities after BAP surgery.

Results

Of the 100 patients included, 16 patients (16%) had an event in their lower limb. 11 patients (11%) had a fracture, all of the femur, and six patients (6%) underwent arthroplasty surgery due to osteoarthritis. Long-term prosthetic use was not affected by the occurrence of an event.

Conclusions

Patients with BAP may be at a higher risk for femur fractures and arthroplasty surgery than the general population. Although encouraging that prosthetic usage is not affected after a fracture or arthroplasty surgery, prospective studies on larger cohorts and control groups need to be conducted.

Acceptance, and Impact Mechanisms: Patient and Healthcare Professional Insights From a Self‐Management Intervention for Newly Diagnosed With Inflammatory Arthritis

ABSTRACT

Aim

To evaluate the acceptability, mechanisms of impact, and contextual factors affecting a 9-month, nurse-led self-management intervention specifically designed for newly diagnosed patients with inflammatory arthritis, from both the patient and healthcare professional (HPs) perspectives.

Design

A qualitative longitudinal study.

Methods

Individual baseline and follow-up interviews were conducted with 12 patients (baseline n = 12; follow-up n = 10) and four focus group interviews were conducted with 4 HPs at key intervention stages. Interview guides were drafted with open-ended questions and iteratively refined across interviews to match the evolving stages of the intervention. Data analysis was conducted using template analysis. This study adhered to the Consolidated Criteria for Reporting Qualitative Studies (COREQ): 32-item checklist.

Results

Patients valued the tailored individual sessions, which provided emotional support and improved their understanding of IA. Group sessions received mixed feedback, with some patients suggesting a need for more organisation. The intervention fostered a sense of community, reducing isolation and empowering patients to navigate the healthcare system better. HPs praised the patient-centred approach and emphasised the importance of training and organisational support.

Conclusion

Both patients and HPs highly accepted our nurse-led self-management intervention, though group sessions received mixed feedback. Key impact mechanisms were the proactive management of symptoms and lifestyle, and the intervention's tailored support and emotional guidance. The HPs experienced professional growth but scheduling occasionally conflicted with regular work.

Impact

This study has provided valuable information in understanding intervention mechanisms. Findings from the evaluation will be used to refine the intervention.

Patient or Public Contribution

Two patients contributed to the development of the intervention, and a patient research partner was actively engaged in all phases of this study.

Patients' Experiences of Day Surgery: A Qualitative Systematic Review

ABSTRACT

Aim

To examine how patients experience day surgery.

Design

Systematic review using Thomas and Harden's framework for synthesis and analysed through Ricoeur's theory of interpretation.

Methods and Data Sources

Systematic searches in MEDLINE, CINAHL and EMBASE (September 2023) identified qualitative studies focusing on patients' lived experiences with day surgery (defined as < 24-h hospital stay). Studies were required to provide qualitative data on patient experiences and be published in English or Scandinavian languages. Forward and backward citation searches were also conducted in Scopus.

Results

Thirty-four studies met the inclusion criteria. The analysis revealed four key themes: (1) ‘Perceptions of the day surgery concept shape patient expectations’; (2) ‘Navigating expectation and reality: Surprises and challenges in day surgery’; (3) ‘Navigating through postoperative recovery: Feelings of responsibility and insecurity following day surgery’; and (4) ‘The vital role of support from both family and professionals during recovery after day surgery’.

Conclusion

Patients' expectations of day surgery strongly influence their overall experience, while the complex self-care demands of postoperative recovery underscore the need for robust support systems involving families and healthcare professionals.

Implications for Patient Care

This review highlights the importance of thorough preoperative counselling and ongoing support for patients' complex postoperative self-care. These findings suggest that improved patient-centred care and targeted support could enhance recovery outcomes in day surgery pathways.

Impact

Problem addressed: The study explores the often-overlooked challenges that patients face with postoperative self-care following day surgery. Main findings: Expectations of day surgery as ‘minor’ often conflict with patients' emotional and physical self-care needs, revealing a need for comprehensive support. Research impact: Insights from this review can inform patient-centred care practices in day surgery settings globally, underscoring the critical role of family and professional support.

Patient or Public Contribution

No patient or public contribution.

Trial Registration

Registered with PROSPERO: CRD42023414310

Study protocol for the investigator-initiated Danish pragmatic randomised STENO INTEN-CT trial: does screening and intervention for subclinical coronary artery disease in type 2 diabetes reduce cardiovascular events?

Por: Funck · K. L. · Borregaard · B. · Egstrup · K. · Fredslund · E. K. · Hansen · T. W. · Kallestrup · P. · Olsen · M. H. · Reventlow · S. · Rossing · P. · Sandbaek · A. · Sondergaard · J. · Thomsen · J. L. · Vestergaard · P. · Poulsen · P. L. · Diederichsen · A.
Introduction

Cardiovascular disease (CVD) risk remains high but unevenly distributed in patients with type 2 diabetes mellitus (T2DM). Current risk stratification strategies are far from optimal, leading to both undertreatment and overtreatment of patients. The STENO INTEN-CT trial aims to evaluate a strategy of improved CVD risk management by using cardiac CT (coronary artery calcification (CAC)) for stratification and tailoring of multifactorial cardiovascular treatment based on CAC score. We hypothesise that (1) intensified medical treatment will lower CVD event rates in high-risk patients (CAC≥100), and (2) less intensive multifactorial treatment is safe in very low-risk patients (CAC=0).

Methods and analysis

The Steno INTEN-CT trial is an investigator-initiated, pragmatic, open-label, event-driven randomised controlled trial including patients with T2DM without known CVD. All participants (expected n=7300) will be invited for a non-contrast coronary CT scan. After the scan, participants will be randomised to either standard treatment (blinded for CAC results) or CAC-based treatment. Participants in CAC-based treatment and their general practitioner (GP) will receive information on CAC and a recommendation of multifactorial treatment. High-risk participants in the interventional arm will be invited for one or more initial study visits to intensify treatment with a combination of sodium glucose co-transporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, high-dose lipid-lowering, antihypertensive and antithrombotic treatment. Very low-risk patients in the interventional arm will be recommended less intensive treatment targets. After initial study-related activities, all participants will continue to be taken care of by their GP guided by specific treatment recommendations. The primary outcome in the primary hierarchical analysis (the rate of the combined CVD endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for heart failure) will be monitored through national health registries. The trial is event-driven, but a median follow-up of 5 years is expected. Key secondary outcomes include patient-reported outcomes, quality-adjusted life years and healthcare costs.

Ethics and dissemination

The protocol V.1.9 is approved by the Research Ethics Committee and the Danish Medicines Agency and the Danish Data Protection Agency. The results of the study—positive, negative or neutral—will be published in peer-reviewed journals and through www.clinicaltrials.org.

Trial registration number

NCT05700877.

Missed Nursing Care From the Perspectives of Patients: A Cross‐Sectional Study in Denmark

ABSTRACT

Aim

To identify the prevalence and types of missed nursing care in a Danish hospital context from patients' perspectives and to examine associations between missed nursing care, patient demographics, and patient-reported adverse events.

Design

Cross-sectional study.

Methods

A total of 284 medical and surgical patients from 21 wards at a Danish university hospital completed the Danish version of the MISSCARE Survey–Patient. Descriptive statistics and analyses of associations between missed nursing care and patient demographics and adverse events were conducted.

Results

Patients reported an overall prevalence of missed nursing care of 15%, with most omissions occurring in the physical care domain (22%), followed by psychosocial care (13%) and timeliness (6%). The most frequently missed activities included oral care, clarity about which nurse was responsible for their care, repositioning in bed, and help with eating. Medication errors were significantly associated with higher missed nursing care scores across all domains, while associations with other adverse events and demographics were inconsistent.

Conclusion

Patients generally perceived a low prevalence of missed nursing care, although notable variations were observed across care domains and specific activities. Incorporating patient perspectives alongside nurse perspectives offers a more complete understanding of missed nursing care.

Implication

Continuous assessment of missed nursing care from patients' perspectives could serve as a valuable complement to nurse-reported assessments, helping to identify specific areas for improvement. Targeted interventions addressing activities with higher patient-reported missed nursing care may enhance both care quality and patient outcomes.

Reporting Method

STROBE guidelines were followed.

Patient Contribution

Patients were not involved in the study's design, conduct, or reporting.

Impact

This study highlights missed nursing care from patients' perspectives, revealing key care gaps. The findings can inform hospital administrators, nursing leaders, nursing educators, and policymakers in developing strategies to improve care quality and patient satisfaction.

Cross‐Cultural Adaptation and Validation of the MISSCARE Survey–Patient—Danish Version

ABSTRACT

Aim

To translate, cross-culturally adapt, validate and psychometrically test the MISSCARE Survey–Patient for assessing patients' perspectives on missed nursing care (MNC) in a Danish hospital setting.

Design

A two-phase cross-cultural adaptation and psychometric validation study.

Methods

The study was conducted in two phases. First, the MISSCARE Survey–Patient was cross-culturally adapted to ensure its relevance in a Danish hospital context. This phase involved translation and back-translation, expert committee reviews and cognitive interviews with 18 inpatients to establish content validity. Second, a convenience sample of 284 patients from surgical and medical departments completed the adapted survey. Psychometric properties were evaluated using structural equation modelling to test a second-order formative model.

Results

The cross-cultural adaptation phase led to minor and substantial revisions, including the addition of six new items to enhance content validity. These items addressed aspects of nursing care relevant to patients in the contemporary hospital setting that were not captured by the original survey. Structural equation modelling confirmed the second-order formative model and demonstrated robust psychometric properties.

Conclusion

The MISSCARE Survey–Patient was successfully adapted and validated for use in Danish hospitals, ensuring strong content validity and psychometric robustness.

Implication

The Danish version of the survey provides a valuable tool for assessing MNC from patients' perspectives in hospital settings. Its use can help identify specific areas where nursing care falls short, guiding targeted initiatives to enhance care quality and patient safety. By integrating patients' experiences into quality improvement initiatives, the survey supports the development of more person-centred care practices.

Reporting Method

The study adhered to the COnsensus-based Standards for the selection of health Measurement INstruments reporting guideline for studies on measurement properties of patient-reported outcome measures.

Patient Contribution

Patients were not involved in the study's design, conduct, or reporting.

Impact

The Danish version of the survey facilitates data collection on patients' perspectives of MNC in contemporary hospital settings, providing valuable insights into care quality. By offering a validated tool to assess MNC from patients' perspectives, the survey helps hospitals identify care gaps, prioritise improvement efforts and enhance person-centred care.

Perspectives on the treatment of sequela from cancer: a qualitative interview study of primary care physiotherapists

Por: Toftdahl · A. K. S. · Hjornholm · L. H. · Virgilsen · L. · Stuiver · M. · Thomsen · J. L. · Riis · A.
Objectives

Despite the potential benefits of physiotherapy and physical activity, awareness remains limited among patients with sequela and healthcare professionals. This study aims to explore Danish physiotherapists’ (PTs) perspectives on barriers, facilitators and potential solutions to improve the care of sequelae after cancer in physiotherapy clinics.

Design, setting and participants

This qualitative study used semi-structured interviews with Danish PTs, following a published research protocol and the Criteria for Reporting Qualitative Research checklist. Danish-speaking PTs working in private clinics in Denmark were eligible to participate and were selected via purposive sampling. Online interviews with PTs were conducted in June and July 2022.

Data collection and analysis

A phenomenological approach was employed for data collection and thematic analysis, allowing researchers to set aside preconceptions. Preunderstandings were stated and revisited post-analysis for validation. The interview guide was developed and validated through discussions and pilot testing. A patient panel provided feedback on the interview guide. Interviews were conducted by a trained and experienced PT and transcribed using a standardised key.

Results

Online interviews with 12 PTs were conducted. Five themes were identified: being aware of important physiotherapy competencies, PTs’ basic education and specialisation, patients’ resources, healthcare system and organisation, and sharing knowledge regarding sequelae from cancer and potential treatments. PTs emphasised the need for specialised competencies, emotional resilience and life experience. Patients experienced financial and psychosocial barriers, while systemic issues and poor communication hindered care. PTs suggested public lists of specialised providers and broader dissemination of knowledge to reduce stigma and improve access.

Conclusions

PTs identify clinical and systemic challenges requiring specialisation, improved collaboration and increased awareness to enhance rehabilitation and quality of life for cancer survivors.

Protocol for the SUPPORTED study: a Danish multicentre complex intervention for first-time fathers of preterm infants

Por: Holm · K. G. · Hägi-Pedersen · M.-B. · Haslund-Thomsen · H. · Nilsson · I. · Aagaard · H. · Maastrup · R. · Ejlertsen · C. · Petersen · M. · Feenstra · M. M. · Kristensen · I. · Brodsgaard · A.
Introduction

Fathers of preterm infants wish to be actively involved and attentive in caring for their children. The positive impacts of paternal caregiving on preterm infants’ cognitive and social development have been recognised. Awareness of the need to support fathers during early parenthood is increasing, but fathers may feel excluded when their infants are in the neonatal intensive care unit. Here, we present the protocol for a study involving the development and national implementation of a complex intervention supporting first-time fathers of preterm infants in early parenthood.

Methods and analysis

The study adheres to the Medical Research Council framework for complex interventions. A multicentre, prospective, non-blinded, quasi-experimental design will be applied to evaluate the effect of a clinical and technology-based intervention targeting both nurses and the fathers. Outcomes from participants enrolled during the control (2023–2024) and intervention (2025–2026) periods, comprising 295 fathers and their partners, will be compared. Effects on parental confidence, stress, depression and mood and family and reflective functioning as well as infants’ emotional and social development will be assessed. A comprehensive process evaluation will be applied using both qualitative and quantitative methods.

Ethics and dissemination

The study has been registered at Clinicaltrials.org [no. NCT0 6 116 747 (The SUPPORTED study – First-time Fathers of Preterm Infants), approved on 3 November 2023]. The Danish Data Protection Agency has approved the study (P-2022–792). The findings will be disseminated through peer-reviewed publications.

Trial registration number

NCT06116747.

Longitudinal investigation of psychological outcomes associated with screen use in Danish preschool children: study protocol for The Digital Child

Por: Nygaard · M. · Olsen · M. F. · Thomsen · M. M. W. · Hadi · N. H. A. · Trans · K. L. · Horwood · S. · Flensborg-Madsen · T.
Introduction

Despite an increasing use of screens among preschool children and evidence suggesting potential adverse effects, there is a paucity of longitudinal research that aims to disentangle the multifaceted components of screen use and their unique associations with development. We present a protocol for a large-scale national longitudinal study with repeated measurements in Danish preschool children, with the aim of investigating the cross-sectional and cross-lagged longitudinal associations between screen use and psychological outcomes.

Methods and analysis

The Digital Child Study is a national prospective observational cohort of Danish preschool children. Baseline parent-report data collection commenced in 2024 via online questionnaires, and in total will include three time points over 1 year: baseline (age 4 years), and follow-ups at 6 and 12 months (ages 4.5 and 5 years). Participants were divided into two waves based on birth dates, starting in March and September 2024. Recruitment targeted parents and primary caregivers of all Danish children born between specific dates in 2020. Of 30 235 children whose parents were sent invitations, baseline questionnaire data were available for 11 690 (39%).

Children’s screen use was measured by detailed information of amount, content and timing of children’s screen use, and the broader context, incorporating parental mediation strategies, attitudes, motivations and practices. Cognitive and socioemotional developmental outcomes were measured using validated tools such as the Strengths and Difficulties Questionnaire, the Nordic Five-to-Fifteen parent questionnaire and the Behaviour Rating Inventory of Executive Function—Preschool Version. Questionnaire data will be linked to national social and health registries to enable long-term follow-up. Statistical analyses will include longitudinal modelling to explore associations between screen use and developmental outcomes, with sensitivity analyses for robustness. The study’s large sample size provides high statistical power to detect meaningful effects.

Ethics and dissemination

The study adheres to ethical research guidelines, ensuring voluntary participation, confidentiality and compliance with data protection laws, with approvals from relevant authorities. Findings will be disseminated through peer-reviewed publications, conferences and plain-language summaries to engage stakeholders and the broader community.

Prospective multicentre randomised controlled trial to assess the clinical effectiveness of the novel CirrhoCare digital therapeutic management system: a study protocol

Por: Greenham · O. · Gananandan · K. · Balaji · A. · Kazankov · K. · Thomsen · K. L. · Bamber · J. · Philip · J. · Wadke · A. · Sadique · Z. · Raja · M. · Boddu · R. · Kumar · R. · Jalan · R. · Mookerjee · R. P.
Introduction

Liver cirrhosis accounts for over 10 000 deaths in the UK each year with a total loss of 60 000 quality-adjusted life-years. There is a substantial cost to the NHS of £4.5 billion, with new liver-related decompensation events accounting for the majority of this. Following an acute cirrhosis decompensating event, there is a significant risk of hospital readmission with 90-day readmission rates as high as 53%. Current care in the UK is reactive and patients are often only readmitted when they have presented acutely as an emergency with significant decompensation.

Methods and analysis

CirrhoCare is a prospective, multicentre, randomised controlled trial comparing the CirrhoCare management system with standard-of-care for high-risk cirrhosis patients who have been discharged following an admission with acute decompensation. The CirrhoCare management system comprises a novel digital platform for use in a patient’s home, designed to proactively detect the first signs of new decompensation in patients with established cirrhosis, discharged to the community. This enables a clinician to instigate early community-based care or, if needed, to triage the patient for hospital interventions.

214 patients will be recruited to the CirrhoCare trial from at least 12 UK centres. Patients will be randomised on a 1:1 ratio allocation to the CirrhoCare Management System or standard of care. Participants who are randomised to CirrhoCare will receive a CirrhoCare health kit comprising a smart watch, smart phone with enabled SIM (Subscriber Identity Module) network card, blood pressure monitor, weighing scales and thermometer. Participants will take measurements every morning Monday to Friday and will be followed up for 90 days postdischarge.

The primary objective of this study is to assess the clinical effectiveness of the CirrhoCare digital management system. We hypothesise that its early community-based intervention will reduce the number of unplanned hospital interventions and admissions and prevent liver-related complications when compared with standard-of-care management.

Ethics and dissemination

CirrhoCare is a National Institute for Health and Care Research-funded study (NCT06223893). The study has UK Research Ethics Committee and Health Research Authority (HRA) approvals, with approval granted by the HRA and Health and Care Research Wales committee. The results of this study will be published in peer review journals, disseminated at international conferences as well as established Patient and Public Involvement and Engagement networks.

Trial registration number

ISRCTN11380842.

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