To explore the perceived effectiveness, impact and benefits of a work-based cancer survivorship peer support programme for healthcare employees who have experienced or are experiencing cancer.
A qualitative descriptive study.
Purposive sampling was used to recruit 33 participants (10 peers, 12 peer supporters, 4 line managers and 7 members of the governance group). Data were collected between October 2024 and February 2025 through individual interviews and focus groups. Data were analysed using reflexive thematic analysis.
Four themes were generated: Programme Reach and Adoption, Implementing the Programme, Programme Effectiveness and Impact and Programme Maintenance and Growth. Challenges included the pilot status of the programme impacting awareness and uptake, potential reluctance to share diagnoses and the impact of cancer on colleagues. The approach of peer supporters was considered central to the programmes' success. Peer supporters valued training and continuous practice development opportunities.
Demonstrated benefits, including satisfaction and the value of peer support, were evident. To ensure programme maintenance, increased recruitment and training of peer supporters and clear communication regarding the programme and referral pathways are essential. Financial support is required to maintain training and address dissemination challenges.
Work-based peer support programmes can help cancer survivors reintegrate into the workforce more effectively, rebuilding confidence, fostering resilience and navigating workplace expectations. Enhanced staff well-being may also positively influence retention, performance and health-related disruptions.
Findings from this underexplored area of work-based peer support within a healthcare setting have the potential to influence healthcare leaders, policy makers and future research. Improving staff's' quality of life on return to work benefits the individual, the organisation and care delivery by ensuring a healthy, supported workforce.
The Standards for Reporting Qualitative Research (SRQR) checklist and the Template for Intervention Description and Replication (TiDieR) checklist were utilised.
No patient or public contribution.
Over 50% of patients participating in cardiac rehabilitation (CR) experience poor sleep and/or, closely related, psychological stress. Although stress management interventions are generally available, they are typically underutilised in CR, and sleep remains an underaddressed component within CR. This is concerning, as poor sleep and stress not only reinforce each other but are also associated with poorer cardiovascular health and lower quality of life. Therefore, the primary aim of the OPtimising CArdiac REhabilitation by REfining Sleep and STress (RESST) study is to investigate the (cost-)effectiveness of adding a behavioural intervention targeted at improving sleep and managing stress during CR (RESST intervention) on sleep and psychological stress. Furthermore, the study aims to explore the (bidirectional) associations between sleep, stress and lifestyle behaviours.
This parallel-arm multicentre randomised controlled trial will include 200 CR patients across 3 major CR centres in the Netherlands who experience poor sleep and/or stress. Patients will be randomised in a 1:1 ratio to standard CR or standard CR with the RESST intervention. Standard CR is a structured programme combining exercise, lifestyle guidance and risk management. On top of standard CR, the RESST intervention consists of 5 in-person group sessions targeting sleep and stress and is based on Acceptance and Commitment Therapy and Cognitive Behavioural Therapy. Primary outcomes are accelerometer-assessed and self-reported sleep and perceived stress. Secondary outcomes include quality of life, psychosocial well-being, chronic stress biomarkers (hair cortisol and cortisone), momentary fatigue, momentary stress and physical activity. Linear mixed models will be used to assess changes in outcomes at 3-month (after intervention and/or CR completed) and 6-month follow-up. The momentary data collected with ecological momentary assessment and accelerometry will be analysed using multilevel linear mixed models to explore the (bidirectional) relationship between sleep, stress and other lifestyle components such as physical activity.
This study was approved by the ethics committee of Erasmus MC, Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2024-0238). The findings will be disseminated through publications in peer-reviewed journals, presentations at academic conferences and professional and patient publications.
Early-stage mycosis fungoides (MF) is diagnostically challenging due to overlap with inflammatory dermatoses. Age-related immunological and cutaneous changes may modify histopathological presentation. We aimed to compare clinical, histopathological and immunophenotypic features of early-stage MF between geriatric and non-geriatric patients.
Multicentre retrospective cross-sectional study.
Dermatology departments of tertiary centres in Türkiye.
A total of 541 patients diagnosed with early-stage MF were included and stratified into geriatric (≥65 years) and non-geriatric (18–64 years) groups.
The primary outcomes were age-related differences in histopathological and immunohistochemical features. Secondary outcomes included clinical characteristics and quality of life measures. Primary endpoints were prespecified a priori (epidermotropism, basilar lymphocytes, epidermal atrophy, dermal lymphocytic infiltration, papillary dermal fibrosis and CD4-dominant versus CD8(+)/CD4(–) phenotypes); all other comparisons were considered exploratory.
The geriatric group had a higher proportion of males (59.5% vs 47.1%; p=0.004), while lesion type, duration, surface involvement and Dermatology Life Quality Index scores did not differ between groups. Histopathologically, epidermotropism (81.3% vs 63.3%), basilar lymphocytes (57.1% vs 45.7%), epidermal atrophy (26.6% vs 13.8%), dermal lymphocytic infiltration (75.8% vs 58.5%) and papillary dermal fibrosis (55.2% vs 38.4%) were more frequent in geriatric patients (all p
Although clinical characteristics were comparable across age groups, geriatric patients showed differences in reported histopathological and immunophenotypic features; these observations may facilitate clinicopathological recognition of early-stage MF in older individuals. However, some features (particularly epidermal atrophy and superficial/papillary fibrosis) are not MF-specific and may partly reflect background age- and site-related changes.
To better develop and understand the practice of rooming-in in adult care, this study aims to explore the perceptions of the three most important stakeholders: nurses, patients, and family members.
A cross sectional survey study in a university medical centre in the Netherlands.
A convenience sample was drawn from nurses, adult patients, and family members across ten general wards. Data of patients and family members were collected through online questionnaires, developed and validated prior to the study. Their responses were summarised using descriptive statistics. For the nurses, data were obtained by analysing responses to an open-ended question from an existing questionnaire, using thematic analysis.
The sample consisted of 364 nurses, 26 patients, and 35 family members. Thematic analysis of the nursing data revealed four themes: (1) reducing the workload of nurses, (2) optimising patient recovery, (3) unclear policy and inadequate facilities, and (4) complexities for nurses. Regarding the perceptions of patients and family members, more than 75% perceived that rooming-in enhanced patients' sense of safety. Additionally, 54.1% of family members indicated that rooming-in improved their understanding of medical information. For most patients (57.7%) and family members (62.9%), the rules and conditions for rooming-in were not clear. Moreover, 65.7% of family members reported experiencing physical burden. Both patients and family members rated rooming-in with a median of 8 out of 10.
According to nurses, patients, and family members, rooming-in may be beneficial in reducing nurses' workload, enhancing patient safety, and improving family understanding of medical information.
Given the ambiguity surrounding rooming-in policies in adult care, clear guidelines and their implementation are essential for ensuring their success.
Rooming-in can positively contribute to adult care by facilitating family involvement.
STROBE statement.
No patient or public contribution.
To explore how nurses facilitate social connectivity among older adults in virtual age-friendly communities in Al-Ahsa, Saudi Arabia by serving as digital bridges and emotional anchors. Additionally, the study aimed to identify the factors that influence the effectiveness of nurse-led interventions in enhancing digital literacy and reducing social isolation among older adults.
A qualitative study.
Semi-structured interviews were conducted between June and August 2024 with 12 older adult participants and 10 nurse participants involved in virtual age-friendly community initiatives in Al-Ahsa, Saudi Arabia. Data were analysed using a hybrid approach that combined deductive thematic analysis—guided by socio-technical systems theory and relationship-centred care principles—with inductive analysis to identify key themes related to digital facilitation, emotional support and social connectivity.
The findings indicate that nurse-led digital and emotional support significantly enhances older adults' digital literacy and emotional well-being, leading to improved social connectivity. Nurses acting as digital bridges provided essential technical guidance, while their role as emotional anchors offered empathetic support that mitigated feelings of isolation. However, challenges such as technical issues, resource limitations and cultural factors moderated the overall effectiveness of these interventions.
The study underscores the pivotal role of nurse-led interventions in promoting social connectivity among older adults in virtual settings. Future research should explore strategies to overcome technical and resource-related barriers and further integrate culturally sensitive approaches to optimise the benefits of digital health initiatives.
Healthcare practitioners and policymakers should prioritise the implementation of nurse-led digital and emotional support programmes to reduce social isolation and improve the overall quality of life for older adults. Culturally tailored interventions are essential to address the unique needs of ageing populations in the digital era.
The study was reported in accordance with the Consolidated Criteria for Reporting Qualitative Research (COREQ).
The insights obtained from older adult participants and nurses provided critical understanding of the dynamics and impact of digital and emotional support within virtual age-friendly communities.
To conduct a concept analysis of ‘safe mobility’, with specific application in hospitalised older adults, identifying its defining attributes, antecedents and consequences.
The promotion of safe mobility is essential for maintaining the functionality of hospitalised older adults. However, this idea is not yet clearly defined in the scientific literature, requiring a conceptual analysis for better understanding and applicability in nursing practice.
Concept analysis.
The concept analysis methodology of Walker and Avant was employed, consisting of eight steps. Sources from the scientific literature (BDENF/VHL, Scopus, CINAHL/EBSCO, Embase, Web of Science, PEDro, MEDLINE/PubMed and CAPES Thesis and Dissertation Catalogue, as outlined in a scoping review previously published by the authors) and terminologies from dictionaries and nursing practice, such as SNOMED CT, ICNP, NANDA, NIC and NOC, were analysed.
The concept of ‘safe mobility’ does not have a consolidated definition but was identified through three defining attributes: active movement, prevention of fall-related harm and prevention of immobility-related harm. The antecedents include the older adults' conditions, adaptation of the hospital environment, training of the multidisciplinary team, patient behaviour and family involvement. The consequences involve the maintenance of functionality, improvement of quality of life, reduction of hospital length of stay and costs, as well as a decrease in rates of readmission, referrals to long-term care institutions and mortality.
The concept analysis revealed that safe mobility involves promoting active movement and preventing harm related to both immobility and falls.
Strategies based on this concept can improve the quality of life of older adults, reduce complications and optimise hospital costs.
This concept analysis examines existing literature and does not require patient-related data collection. The methodological approach does not necessitate collaboration with the public.
The coexistence of frailty and type 2 diabetes mellitus in the older population heightens the risk of adverse events. However, research on functional and wellness factors associated with frailty in this population is limited.
To investigate the associations of physical performance, functional dependency, physical activity, nutritional status, sleep, self-perceived health and depression with frailty in community-dwelling older adults with coexisting frailty and type 2 diabetes mellitus.
Cross-sectional.
The study included 123 community-dwelling older adults (73.7 ± 6.0 years) with pre-frailty/frailty and type 2 diabetes mellitus. Physical performance (Short Physical Performance Battery), functional dependency (Barthel Index and Lawton & Brody), physical activity and inactivity (GeneActiv wrist-worn accelerometer), malnutrition risk (Mini Nutritional Assessment), sleep (Pittsburgh Sleep Quality Index), self-perceived health (EuroQoL 5-Dimension 3-Level) and depression (Yesavage 15-item-Geriatric-Depression-Scale) were evaluated through personal interviews. Principal component analysis (PCA) was performed to categorize the variables into components, and logistic regressions were used to propose the best-fitted model for each component.
The PCA identified four components: (i) physical performance, with gait speed and leg mean velocity as the main variables associated with frailty; (ii) balance, showing significant associations with monopodal balance; (iii) daily activities, with moderate to vigorous physical activity and the Lawton and Brody score as the main variables associated with frailty within this component; and (iv) wellness factors, with nutritional status, self-perceived health and depression score as the primary variables associated with frailty.
This research underscores the significance of physical function and daily activities as protective factors against frailty in community-dwelling older adults with coexisting frailty and type 2 diabetes mellitus. The health dimension contributes both protective and risk factors, emphasizing the need for comprehensive assessments in managing frailty in this population.
The study adhered to the STROBE checklist.
No patient or public contribution.
To explore the impact of intergenerational relationships on the social resilience of elderly populations in Arab societies. Additionally, the study aimed to identify the factors that influence the quality of these relationships and their role in enhancing or diminishing the resilience of older adults.
A qualitative study.
Semi-structured interviews were conducted between June and July 2024 with 12 elderly participants from urban and semi-urban communities in Al-Ahsa, Saudi Arabia. Data were analysed using both deductive framework analysis, guided by social support theory, and inductive thematic analysis to identify key themes related to intergenerational relationships and social resilience.
The study involved 12 participants aged 61–85 years (average age of 72 years), with a mix of educational backgrounds and living arrangements. Strong intergenerational ties were found to significantly enhance social resilience by providing emotional support and a sense of security. Participants in multi-generational households reported more positive outcomes compared to those with less frequent family contact. However, generational differences and modern-life pressures posed challenges to maintaining these relationships.
The findings underscore the importance of fostering strong intergenerational relationships to support the social resilience of elderly populations in Arab societies. Future research should explore interventions that bridge generational gaps and strengthen family ties, particularly in the context of evolving social structures.
Healthcare practitioners and policymakers should consider the role of intergenerational relationships when designing interventions aimed at improving the well-being and resilience of older adults in a culturally sensitive approaches.
The Consolidated Criteria for Reporting Qualitative Research (COREQ).
The engagement and interview data from elderly participants provided valuable insights into the dynamics of intergenerational relationships and their impact on social resilience.
This study aimed to determine the discharge learning needs of patients undergoing cardiac surgery and to identify sociodemographic and clinical factors associated with these needs.
A descriptive, cross-sectional study.
This study was conducted among 130 adults who had undergone cardiac surgery in a public hospital in western Türkiye between 15 January and 30 August 2025. Data were collected at hospital discharge using a patient information form and the Patient Learning Needs Scale (PLNS), which measures learning needs across seven domains. Descriptive statistics, independent-samples t-tests, and multiple linear regression analysis were used to examine associations between patient characteristics and PLNS scores.
Overall learning needs were moderately high (mean total PLNS score 183.65 ± 25.25). Treatment and complications (35.62 ± 5.04) and activities of daily living (32.92 ± 6.19) were the highest-priority domains. These were followed by enhancing quality of life (31.77 ± 4.71) and medications (31.13 ± 5.09), while the feelings-related-to-condition domain had the lowest importance (15.54 ± 3.99). Female patients reported significantly higher total PLNS scores than males (190.43 ± 25.36 vs. 177.65 ± 23.74, p = 0.002). In multivariable analysis, male gender (B = −15.27, p < 0.001) and lack of health insurance (B = −17.71, p = 0.004) were independently associated with lower total PLNS scores.
Patients undergoing cardiac surgery have important discharge learning needs that vary according to gender, education, employment status and insurance coverage. Systematic assessment of learning needs can help nurses design individualized, patient-centred discharge education to support safer recovery.
This study highlights the importance of systematically assessing discharge learning needs among patients undergoing cardiac surgery. Understanding individual learning priorities enables nurses to tailor discharge education, address potential gaps in self-care knowledge, and enhance continuity of care during the transition from hospital to home. Incorporating structured learning needs assessments into routine discharge planning may support safer recovery, improve adherence to postoperative recommendations, and reduce preventable complications.
This study was reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
Patients were involved in the study by completing study questionnaires at the time of hospital discharge. However, patients or members of the public were not involved in the study design, analysis, interpretation of data, or preparation of the manuscript.
To explore how community-dwelling older adults with multimorbidity experience, enact and navigate daily self-care using the Caring Life-Course Theory to identify opportunities for strengthening self-care and self-management support.
Qualitative descriptive study.
Semi-structured interviews were conducted with community-dwelling older adults aged ≥ 50 years living with two or more chronic conditions across three Australian states and territories. Data were analysed inductively and deductively using qualitative content analysis. Inductive coding was followed by theory-informed analysis to interpret self-care capability, capacity, care networks and system supports.
Eighteen participants (mean age = 70.9 years) described self-care as an adaptive, experience-based process influenced by lived experience, health transitions, informal care networks and system responsiveness. Participants generally demonstrated agency and resourcefulness in managing complex and changing care needs, often learning through trial and error. Psychosocial and relational needs were frequently under-recognised in healthcare encounters, requiring individuals and informal carers to compensate for fragmented, inconsistent support. Self-care capability and capacity were shaped by experiential learning, health and self-care literacy and access to informal and online resources, particularly where formal education was limited or unavailable.
Self-care for older adults with multimorbidity is shaped by dynamic interactions between personal capability, relational support and system-level factors across the life-course. The Caring Life-Course Theory provides a comprehensive approach for understanding these interdependencies and identifying opportunities for intervention.
Findings highlight the need to strengthen coordinated, person-centred and relationally grounded approaches to self-care and self-management in primary and community care, including improved access to evidence-informed resources and anticipatory support.
This study is reported in accordance with the Consolidated Criteria for Reporting Qualitative Studies.
Participants contributed through semi-structured interviews and provided feedback on study findings.
What problem did the study address? Community-dwelling older adults living with multimorbidity are expected to engage in self-care, yet little is known about how they experience, enact and sustain daily self-care, particularly when psychosocial and relational needs are inconsistently recognised within health and social care systems. What were the main findings? Self-care was characterised as an adaptive, experiential process shaped by life experience, informal support networks and system responsiveness. Participants frequently compensated for under-recognised psychosocial and relational needs through informal and online supports and resources. Where and on whom will the research have an impact? Findings can inform clinicians, service providers and policymakers in primary, community and aged care settings by identifying opportunities to strengthen coordinated, person-centred and relational self-care and self-management support for older people with multimorbidity.
To evaluate the association between exposure to occupational biomechanical factors and the incidence of surgically treated osteoarthritis (OA) treated with arthroplasty in the hip and knee among male construction workers.
Longitudinal register-based cohort study.
Male construction workers (n=291 062) who participated in a national Swedish occupational health examination programme between 1971 and 1993, delivered through multiple primary-level nationwide occupational health centres.
Hip and knee arthroplasties performed due to OA from 1987 to 2019 were identified through linkage with the Swedish National Patient Register. Data on age, smoking habits, body mass index, job title and self-reported biomechanical exposures were collected during the health examinations. Occupational biomechanical workload was assessed using eight factors from a job-exposure matrix. Poisson regression was applied to estimate adjusted incidence rate ratios (IRRs) associated with each type of occupational biomechanical exposure.
The study included 10 336 cases of hip arthroplasties and 8926 cases of knee arthroplasties. All studied biomechanical risk factors were associated with an increased risk of knee OA requiring arthroplasty, especially for individuals exposed to static work in non-neutral lumbar postures (IRR 1.38, 95% CI 1.16 to 1.65) and those with a high frequency of kneeling (IRR 1.27, 95% CI 1.12 to 1.45). In contrast, only a few biomechanical factors were associated with an increased risk of hip OA requiring arthroplasty. Similar results were observed when alternative exposure measures, such as occupational group and self-reported exposure assessments, were employed.
Occupational workload was associated with an increased risk of knee arthroplasty due to OA, whereas the association for hip arthroplasty remains unclear.
Polypharmacy, a rising concern in the older adult population, is associated with significant risks, including adverse drug reactions and inappropriate medication use. Deprescribing, which is supported by effective communication between healthcare professionals and patients, has emerged as an important strategy to reduce potentially inappropriate medications. While numerous frameworks, guidelines, and tools exist to support healthcare professionals in deprescribing, many lack explicit integration of communication strategies, despite their critical role in shared decision-making and patient engagement.
The aim of this rapid review was to synthesize and describe the existing deprescribing frameworks, guidelines, and tools used by healthcare professionals, with a focus on how communication is represented within them. The secondary objective was to extract communication elements from each of the deprescribing frameworks, guidelines, and tools.
We used rapid review methodology recommended by the World Health Organization. The protocol was registered with the Open Science Framework and reported according to the PRISMA statement. CINAHL, Ovid Medline, and Scopus were searched from January 2003 to July 2024. Eligible studies focused on deprescribing frameworks, guidelines, or tools used by healthcare professionals caring for older adults (≥ 65 years). A qualitative synthesis of the evidence was conducted.
The search retrieved 5177 articles. After removing 1704 duplicates, 3473 citations were screened for eligibility. Of those, 343 were reviewed in full, and 18 were included in the final synthesis. We identified three frameworks, two guidelines, and seven tools. Frameworks such as A-TAPER, TAPER, and the 10-Step Conceptual Framework emphasized patient-centered care but varied in approach. Communication strategies, shared decision-making, active listening, feedback, communication adaptation, and encouraging participation were present but not explicit. Most frameworks targeted physicians and pharmacists, with minimal involvement of nurses.
Future deprescribing frameworks should explicitly integrate communication strategies and include nurses in their development. Building on these findings, our next step is to engage nurses to identify the most important communication characteristics for effective deprescribing conversations. These insights can guide the development of future frameworks, guidelines, and tools to support structured, patient-centered communication and improve deprescribing outcomes. This has important implications for clinical practice, education, and policy aimed at optimizing care for older adults.
To develop and user-test a patient decision aid for people diagnosed with degenerative cervical myelopathy and who are considering surgery.
Mixed-methods study describing the development of a patient decision aid.
A draft decision aid was developed by a multidisciplinary steering group (including study authors with degenerative cervical myelopathy, health professionals and researchers) informed by the best available evidence, authorship consensus and existing patient decision aids.
Patient-participants and health professional-participants who manage people with degenerative cervical myelopathy were recruited through social media and the steering group’s research and practice network. Quantitative questionnaires were used to gather baseline data, descriptive feedback, refine the decision aid and assess its acceptability. Qualitative semi-structured interviews were conducted online to gather feedback on the decision aid and were analysed using reflexive thematic analysis.
We conducted 32 interviews: 19 patient-participants and 13 health professional-participants who manage people with degenerative cervical myelopathy (neurosurgeons, neurologists, physiotherapists, orthopaedic surgeons, general practitioners, rehabilitation and pain specialists and consultant occupational physicians and chiropractors). Participants were from 10 countries (Australia, Canada, Cyprus, Germany, Ireland, New Zealand, Sweden, Switzerland, United Kingdom and USA). Most participants rated the decision aid’s acceptability as good-to-excellent and agreed with most aspects of the decision aid (eg, defining degenerative cervical myelopathy, management recommendations, potential benefits and harms, questions to consider asking a health professional).
Our patient decision aid was rated as an acceptable tool by both health professional-participants who treat degenerative cervical myelopathy and patient-participants with lived experience of degenerative cervical myelopathy. This decision aid can be used by clinicians and people with degenerative cervical myelopathy to help with shared decision making following a diagnosis of degenerative cervical myelopathy. A study testing the potential benefits of this decision aid in a clinical setting is recommended.
To map and synthesise the main recommendations for arterial blood gas (ABG) collection in intensive care units (ICUs).
A scoping review was conducted according to the PRISMA-ScR Checklist, supported with The PAGER framework and guided by the Joanna Briggs Institute methodology to ensure methodological rigour and analytical comprehensiveness.
Data collection was conducted from February to April 2024. The data sources included: Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library, PubMed Central, Scientific Electronic Library Online (SciELO), Web of Science (WoS), SCOPUS, Science Direct, Virtual Health Library (VHL), Excerpta Medica database (Embase), CAPES Thesis and Dissertation Catalogue, Brazilian Digital Library of Theses and Dissertations (BDTD), Scientific Open Access Repository of Portugal (RCAAP), Theses Canada and the Oswaldo Cruz Foundation (Fiocruz) repository.
Key findings recommend the radial artery as the preferred puncture site, an insertion angle of 30° to 45°, the use of 1 or 3 mL syringes and 20G or 23G gauge needles. Transport and storage at room temperature are advised. Cryoanalgesia and subcutaneous analgesia methods were found to be effective for pain management.
The review highlights the best practices for arterial blood gas collection in critical care. The synthesized evidence strengthens clinical practice, informs guidelines for intensive care nursing and promotes safer, higher-quality care for critically ill patients.
The evidence-based recommendations identified can enhance nursing care related to arterial blood gas collection. Adherence to these practices promotes safer, more humanised and evidence-based care during the procedure.
The report of this study followed the PRISMA-ScR Checklist.
There was no patient or public involvement in this scoping review.
Video-assisted thoracoscopic surgery (VATS) lobectomy is a commonly employed surgical technique for the management of operable early stage non-small cell lung cancer (NSCLC). This procedure, however, is dependent on the patient’s ability to tolerate surgery. In light of this, stereotactic ablative radiotherapy (SABR) has emerged as a viable alternative treatment strategy for patients who are inoperable or who refuse surgery. Considering the lack of randomised controlled trials and the increased risk of bias in observational cohort studies, this study protocol proposes an emulated target trial design to investigate the causal effect of SABR, in comparison to VATS, on overall survival in operable early stage NSCLC patients.
Data on NSCLC patients will be collected from routinely collected university hospital records linked with German cancer registry data. This study protocol was developed using the target trial methodology outlined by Hernan et al. The protocol establishes specific parameters for key trial components in order to mitigate bias in the analysis of observational data and to facilitate the calculation of causal estimands. The target trial design that would be emulated is a multicentre open-label two-parallel arm superiority randomised trial. Mediators and confounding variables were determined through the use of a directed acyclic graph. The statistical analysis aims to measure the per-protocol and intention to treat effect of SABR versus VATS within 3 months of diagnosis, on survival, through the difference in restricted mean survival times, using weighted non-parametric Kaplan-Meier curves.
The Ethics Committee of the Medical Faculty of Martin Luther University Halle-Wittenberg with an approved addendum with Dnr 2023–112 has approved this study. The study uses anonymised routinely collected hospital and cancer registry data in accordance with applicable data protection regulations. Results will be disseminated through peer-reviewed publications and presentations at scientific conferences.
Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.
Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.
Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.
Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p
In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.
by Josefine Lampinen, Håkan Littbrand, Ingeborg Nilsson, Annika Toots, Yngve Gustafson, Jerry Öhlin, Henrik Holmberg, Birgitta Olofsson, Anita Ericsson, Mia Conradsson
BackgroundTo meet the complex needs of adults with dementia, a team-based, individualized rehabilitation approach may be required. This randomized controlled pilot trial evaluated the feasibility of a person-centred multidimensional interdisciplinary rehabilitation program for older adults with dementia, in terms of follow-up and response rates, and potential short- and long-term effects in adults with dementia on social participation, loneliness, and mental health.
MethodsParticipants (mean age (SD) 78.7 (±6.6) years), were randomized to an intervention group (n = 31) or usual care (n = 30). The rehabilitation program consisted of a 20-week rehabilitation period and two follow-ups after 5 and 14 months. An interdisciplinary team performed assessments and interventions based on the individual’s goals. Assessors blinded to group allocation performed structured assessments at baseline and after 5, 12, 24, and 36 months.
ResultsInitially, response rates in participants with dementia were high for all assessments in the areas of social participation, loneliness, and mental health. Response rates after 12 months decreased, particularly for cognitively demanding questions with multiple-choice options in the area of social participation. Overall, there were few statistically significant differences between the groups in the outcomes over 36 months, but some of the findings seemed potentially clinically meaningful in favor of the intervention group: increased frequency of active recreation and organized social activities outside the home, as reported by both participants with dementia and caregivers or staff; as well as experienced more frequent visits to family and friends; and short-term reduction in depressive symptoms.
ConclusionsAssessments made of loneliness and mental health in this study over three years seemed feasible. It seemed cognitively demanding for participants with dementia to answer questions regarding social participation over time; therefore it seemed worthwhile to also ask informal caregivers or staff to avoid data loss. The positive findings noted during assessments and potential effects indicate that it is relevant to proceed further to an adequately powered RCT and conducted in additional geographical regions.
Trial registrationISRCTN – The UK’s Clinical Study Registry: http://www.isrctn.com/ISRCTN59155421