Abstract Background The scope of medical conditions addressed in Emergency Departments (ED) increases with growing numbers of older patients among the ED patient population. More information on their chief complaints and related treatment outcomes is essential to ensure high-quality ED care. The objective of this study was to describe the pattern of chief complaints of older ED patients and evaluate the associations between these complaints and outcomes such as mortality and hospital admission. Methods This secondary analysis is based on the observational ‘Epidemiology of Geriatric patients in Europe’ (EGERS) study. This prospective, routine data cross-sectional study was conducted in 36 EDs across 9 European countries. Data collection from routine clinical records of all patients aged 65 and older over a 7-day period from October 19 to November 30, 2020 during the Covid-19 pandemic. Patients with one documented non-traumatic chief complaint were analyzed. Descriptive statistics, logistic regression, and general linear mixed models were used to assess factors associated with hospital admission and in-hospital mortality. Odds ratios (OR) and 95% confidence intervals (CI) were reported. Results The study population consisted of 2,794 patients with one specified chief complaint. The mean age was 77.4 (± 8.2) years. The most frequent chief complaints were shortness of breath, abdominal pain, chest pain, weakness and fatigue, and extremity pain and numbness, representing 59% of the cohort. Highest age (≥ 85), geriatric risks (i.e. presence of dementia/Alzheimer’s disease (AD), home help service or previous falls), polypharmacy, and shortness of breath increased the odds of being admitted to hospital (OR 1.4 [1.2–1.9]; OR 1.6 [1.3–1.9]; OR 1.3 [1.1–1.6]; OR 3.0 [2.4–3.8]), while female sex was negatively associated with admission (OR 0.7 [0.6–0.8]). Shortness of breath was positively associated with in-hospital mortality (OR 2.2 [1.4–4.3]). Conclusion Older patients frequently require hospital admission. As chief complaints do not reflect underlying condition or severity, structured evaluation, staff training and geriatric specific care pathways may improve care and reduce adverse clinical outcomes.
Abstract Background Dementia places substantial physical, psychological, and social demands on informal caregivers, and caregiving needs may change across the dementia trajectory as cognitive, behavioral, and functional changes alter day-to-day care demands. Digital interventions may not fully address caregivers’ evolving and heterogeneous needs and preferences. This study aimed to develop a user-centered mobile application informed by caregiver-identified needs and preferences across the dementia trajectory and to evaluate its effectiveness. Methods A randomized controlled trial was conducted following a qualitative intervention-development phase. The intervention was developed in accordance with the Medical Research Council framework for complex interventions and informed by principles of person-centered dementia care and qualitative interviews with informal caregivers. The application provided dementia education; communication and daily-care guidance organized to reflect changing caregiving needs; guidance for behavioral and psychological symptoms; caregiver self-care and stress-management resources; information on formal and informal support services; and customizable reminders. Caregivers were randomized to receive usual care with access to the mobile application for 8 weeks or usual care alone. Outcomes included caregiver burden (Zarit Burden Interview), quality of life (WHOQOL-BREF), neuropsychiatric symptoms (Neuropsychiatric Inventory), and caregiver distress related to these symptoms. System usability was assessed post-intervention in the intervention group. Outcomes were assessed at baseline and week 8 using repeated-measures analysis of variance. Results A total of 86 caregivers were randomized, of whom 75 were included in the analysis (intervention, n = 37; control, n = 38). Significant group-by-time interactions were observed for overall quality of life ( p < 0.001) and the psychological domain ( p < 0.001), with greater improvements in the intervention group than in the control group. No significant group-by-time interactions were observed for caregiver burden, neuropsychiatric symptom severity, or caregiver distress. The application demonstrated good usability at week 8. Conclusions The user-centered mobile application was associated with improvements in overall and psychological quality of life among participants included in the 8-week analysis, while no significant intervention effects were observed for caregiver burden, neuropsychiatric symptoms, or caregiver distress. Larger studies with longer follow-up and more detailed assessment of application engagement are needed to evaluate the durability and broader effects of the intervention. Trial registration This trial was registered at ClinicalTrials.gov (Registration number: NCT06179667 , Date of registration: 27 November 2023).
Background Sickle β-thalassemia (Sβ-thal) is a compound hemoglobinopathy resulting in marked clinical and hematologic heterogeneity. Despite a substantial disease burden in India, large-cohort data integrating molecular, hematologic, and clinical characteristics remain limited, particularly from regions with evolving screening programs. Objectives The study aimed to characterise the clinical, hematological, and molecular features of a large cohort of individuals diagnosed with sickle β-thal. Methods A retrospective analysis of 206 molecularly confirmed Sβ-thal patients enrolled (2016 and 2024) at ICMR-CRMCH, Chandrapur. The demographic, clinical, and hematological parameters were analysed, including HPLC, along with molecular characterisation of β-globin mutations, α-globin gene deletions, and XmnI polymorphism using polymerase chain reaction–based methods. Results The mean age was 16.5 ± 13.2 years; 52.9% were female, and 77.7% were non-tribal. On molecular analysis, IVS I-5 (G > C) was the most common variant (98.0%), followed by Codon 15 (G > A) (1.5%) and Codon 8/9 (+G) (0.5%). The genotype αα/αα was predominant in the cohort (90.9%), and 86% were heterozygous for the Xmn1 polymorphism (+/−). HPLC longitudinal follow-up of children (newborn screening to 36 months) revealed that HbA2 (3.0–4.0%) stabilized after 18–24 months. In the clinical history of hospitalisation (58.5%), blood transfusions (51.8%), acute chest syndrome (27.4%), and splenomegaly (8.6%) were observed. Conclusion These findings delineate the genotypic and phenotypic spectrum of Sβ-thal and underscore the need for cautious interpretation of HbA₂ in early childhood diagnosis and follow-up.
To evaluate the efficacy, safety, and certainty of evidence for telmisartan-based antihypertensive regimens in adults with hypertension. This systematic review and meta-analysis followed PRISMA 2020. PubMed/MEDLINE, Scopus, Web of Science, and Cochrane CENTRAL were searched from inception to 2026. Eligible studies enrolled adults with hypertension and compared telmisartan monotherapy or telmisartan-containing combinations with placebo, usual care, non-telmisartan antihypertensive agents, or alternative telmisartan-based regimens. Continuous outcomes were pooled as mean differences (MDs) and dichotomous outcomes as risk ratios (RRs), both with 95
Abstract Objectives Diet is a recognised risk factor for inflammatory bowel disease (IBD) and a management strategy. Concerns persist regarding the adverse effects of restrictive diets, including nutritional deficiencies and selective eating. The impact of IBD on patients’ beliefs and dietary choices remains poorly characterised, especially in different geographic contexts. Aim To investigate dietary practices and beliefs in patients with IBD in Sweden, including variations by disease phenotype. Methods A 42-item questionnaire on food choices and beliefs was distributed to all adult members of Sweden’s largest IBD-patient organization. Results Of the 2,193 individuals invited, 738 (34%) responded, (Crohn’s disease (CD) 361 (49%); Ulcerative colitis (UC) 377 (51%)). IBD impacted thoughts about food in 71% ( n = 521). A higher proportion of those with CD (254, 70%) than UC (231, 61%), reported changing their diet due to IBD ( p = 0.009). A higher proportion of patients with CD (187, 52%), compared with UC (164, 43%), avoid certain foods in the belief that this can prevent flare-ups ( p = 0.024). 42% ( n = 311) of patients had not received dietary advice from health care providers, which was more common in UC (209, 55%) than CD (102, 28%), ( p < 0.001). Conclusions Beliefs about food and diet appear to influence dietary choices in IBD, many of whom report modifying their diet. This appears to be more pronounced among people with CD than UC, although the latter are less likely to receive dietary advice, highlighting potential disparities in access to dietary guidance.
Sodium–glucose co-transporter 2 inhibitors (SGLT2i) have become essential in the management of heart failure. Their prognostic benefits are consistent across older adults, frail, and underweight patients, but there may be potential adverse effects on the skeletal muscle. In this prospective single-centre observational study, 117 patients with stable congestive heart failure received 10 mg of empagliflozin daily between February 2023 and October 2024. At baseline and again after 6 months, we measured the following nutritional, frailty, and quality-of-life indices (GNRI, CONUT, mini nutritional assessment (MNA), KCCQ-12, Barthel index, clinical frailty scale) and urinary titin N-fragment (U-titin), a biomarker of skeletal muscle degradation. After exclusion, 93 patients (median age 79 years; 40
Proximal femur fractures (PFFs) are associated with high mortality. Both early surgical treatment and early mobilization strategies, including verticalization, are considered key components of patient management. However, the combined association of surgical timing and early verticalization with mortality has not been fully explored. To evaluate the association between the timing of surgery and early verticalization, considered in combination, and 12-month mortality in patients undergoing surgery for proximal femur fracture. In this prospective cohort study, 641 patients aged ≥ 65 years underwent surgery for PFF at a Level I Trauma Center between July 2021 and December 2022. Patients were assessed for nutritional status, cognitive status, and comorbidities and categorized by surgical and verticalization timing. Early verticalization was defined as assisted upright positioning within 72 h after surgery. The primary outcome was 12-month mortality. Associations were analyzed using univariate and multivariable logistic regression. Surgery within 48 h and verticalization within 72 h were associated with lower 12-month mortality (p = 0.007 and p = 0.048). Patients undergoing both early surgery and early verticalization had a lower mortality rate (11.1
Abstract Background Animal-assisted therapy (AAT) is a promising complementary approach in geriatric rehabilitation, but evidence on feasibility and patient experiences remains limited. Methods This exploratory, mixed-methods, two-arm randomized controlled parallel-group design (RCT) compared dog-assisted exercise therapy (intervention) to standard exercise therapy (active control) in geriatric inpatients during a two-week rehabilitation program. Quantitative data on mobility (TUG), depression (HADS-D) symptoms, motivation (VAS), and satisfaction (VAS)were collected and analysed using descriptive statistics, cross-tabulations, group comparisons (unpaired t-test or Mann–Whitney U test), and correlation (Spearman’s ρ). Semi-structured interviews explored patientsexperiences. Data were analyzed separately and integrated using a joint display approach. Results 27 patients participated in the RCT, and 11 in the embedded qualitative study. Quantitative measures showed no clinically meaningful between-group differences in mobility or depressive symptoms: mobility (TUG) (control: Mdn = 16.00, IQR [14.25, 22.50]; intervention: Mdn = 18.00, IQR [13.00, 20.50]); depression (HADS-D) = 0.2 points (95% CI [–3.2, 3.6], SD = 3.05). Motivation and satisfaction were consistently high across conditions. A strong positive correlation was observed between motivation and satisfaction (ρ = 0.65, p < .001). Qualitative results indicated high acceptance and feasibility, enhanced emotional well-being, motivation, social interaction, and engagement, particularly associated with the presence of the therapy dog. Mixed-methods integration indicated high feasibility and acceptability of the intervention. Qualitative findings complemented the quantitative results by demonstrating that the therapy dog enhanced the ward atmosphere and patient engagement, despite the absence of measurable short-term clinical changes. Limitations Key limitations include novelty effects, the dog’s visibility across conditions, the influence of prior pet ownership, COVID-19, dropouts, small sample size, the awareness of the presence of the dog at ward for the control group, and a heterogeneity group of conditions. These factors may have impacted the overall outcomes. Conclusion Animal-assisted exercise therapy is feasible and well accepted in geriatric inpatient care. Its primary benefits appear to be experiential and psychosocial, supporting engagement and rehabilitation participation rather than immediate clinical improvement. Further research should investigate long-term effects and underlying mechanisms. Trial registration This study has been registered in the German Clinical Trial Registry with trial ID DRKS00024955 on 22 April 2021 and was approved by the ethics committee (EA4/071/21).
Mental health problems in older adults are often underrecognized despite their substantial impact on health and well-being. Brief, valid screening tools with age-specific normative data are needed for this growing population. This study examined the psychometric properties of the Patient Health Questionnaire-4 (PHQ-4) and established age- and gender-specific normative values for adults aged 60 years and older in Germany. Data were drawn from four nationally representative face-to-face household surveys conducted in Germany between 2021 and 2024. Four of the total 3,212 participants were excluded due to missing PHQ-4 responses, resulting in a final sample of N = 3,208. The psychometric properties of the Generalized Anxiety Disorder-2 (GAD-2), the Patient Health Questionnaire-2 (PHQ-2), and the Patient Health Questionnaire-4 (PHQ-4) were evaluated. The PHQ-4 showed excellent internal consistency. The correlated two-factor model, distinguishing depression and anxiety symptoms, demonstrated excellent fit. Measurement invariance was supported across gender and age groups. Women reported higher overall psychological distress than men, mainly due to higher anxiety symptoms, and PHQ-4 scores were highest in the oldest age group. Convergent validity was supported by moderate to strong negative correlations with quality of life, resilience, sense of coherence, and well-being. Age- and gender-specific normative values were provided for the PHQ-2, GAD-2, and PHQ-4. The PHQ-4 is a reliable and valid ultra-brief screening instrument for psychological distress. The age- and gender-specific normative values provided here may improve score interpretation for community-dwelling older adults in Germany and help identify individuals who may require further clinical assessment.
Frailty, sarcopenia, and malnutrition are common in older adults; however, simple biomarkers reflecting both inflammatory and nutritional status remain limited. We aimed to evaluate the relationship between the uric acid-to-prealbumin ratio (UPR) and frailty, muscle strength, and the risk of malnutrition. In this retrospective study, 435 patients aged ≥ 65 years who were admitted to the geriatric outpatient clinic between August 2023 and January 2026 were included. Patients were divided into tertiles according to UPR levels. Within the scope of comprehensive geriatric assessment, the Mini Nutritional Assessment-Short Form (MNA-SF), Clinical Frailty Scale (CFS), handgrip strength (HGS), SARC-F, and physical performance tests were evaluated. The relationships between UPR and geriatric syndromes were analyzed using correlation, logistic regression, and ROC analyses. Sarcopenia assessment, based on both muscle strength and fat-free mass index (FFMI), was restricted to patients with valid DXA measurements (n = 187, 43.0
Abstract Background Aortic stiffness (AS) parameters as pulse wave velocity (PWV), aortic distensibility of the ascending and descending aorta (AD AoAsc, AD AoDesc) and pulse pressure (PP) are marker for vascular ageing, whereas data concerning obstructive sleep apnea (OSA) in population-based cohorts are sparse. Thus, we aimed to identify possible associations of AS with OSA in the Hamburg City Health Study (HCHS) cardiovascular magnetic resonance (CMR) cohort. Methods HCHS is a population-based cohort-study quantifying PWV and AD by 2D-phase-contrast-CMR-measuring-methods and PP by blood pressure. OSA was defined as self-reported OSA by HCHS-study-interviews and/or a combination of snoring, respiratory arrest and Epworth-Sleepiness-Scale (ESS) > 10. Logistic regression analyses with adjustments were performed. Results In the cohort of 1,498 participants (median age 66 years, 39.0% female), 143 (9.5%) participants were identified as symptomatic high risk OSA cohort with significantly higher rates of males ( p < 0.001), hypertension ( p < 0.001), and coronary artery disease ( p = 0.037). Median PWV and AD ( p = 0.741, p = 0.145, p = 0.191) were not significantly different, but median PP was significantly higher in this OSA cohort ( p = 0.003). In male OSA participants, median AD AoAsc and AD AoDesc were significantly lower and median PP significantly higher ( p = 0.006, p = 0.015, p < 0.001). After adjustment for age, sex, cardiovascular risk factors (CVRF), diseases (CVD) and antihypertensive medication, OSA remained significantly associated with PP ( p = 0.045), but not with PWV, AD AoAsc and AD AoDesc ( p = 0.633, p = 0.503, p = 0.171). Conclusions Higher PP was associated with OSA after adjustment for age, sex, CVRF, CVD and medication. Therefore, PP might be used to identify individuals at risk for OSA. Trial registration The study has been registered at ClinicalTrial.gov (NCT03934957), retrospectively registered at 01/04/2019.
Behavioural risk factors (BRFs) negatively impact health and well-being across life course, including older age. Data on their prevalence among older adults in Germany are scarce. This study examines prevalence of single BRFs — alcohol use, smoking, insufficient vegetable and fruit consumption, physical inactivity, and obesity — and identifies BRF combinations with a focus on sociodemographic disparities in adults aged 65 years and older. The nationwide Gesundheit 65 + study (06/2021–04/2022) used a two-stage, stratified random sample from residents’ registration offices, and a design tailored to older adults. Data from 3,139 participants with complete information on all BRFs were analysed. Weighted prevalence estimates and 95
Age-friendly environments are increasingly recognised as essential for supporting participation, autonomy, and healthy ageing. In residential care facilities (RCFs) for older adults, the built environment interacts with organisational practices to shape opportunities for person-centred care and rehabilitation. However, limited knowledge exists regarding how architectural configurations influence access to immediate outdoor environments. To examine how storey configuration (single- versus multi-storey) and number of transition points were associated with opportunities for immediate access to outdoor environments within and adjacent to RCFs. A multi-methods design was used, comprising national mapping of storey configuration of 1,603 Swedish RCFs, mapping of transition points at three RCFs, and walking interviews with twelve older adults and eleven care workers. Single-storey RCFs involved fewer transition points between indoor and outdoor environments, shaping opportunities for immediate outdoor access. In contrast, multi-storey RCFs required additional transitions, including corridors, elevators, and stairs, which increased dependence on care workers and constrained opportunities for outdoor engagement. Architectural conditions interacted with organisational routines, shaping older adults' opportunities for outdoor access and the practical possibilities for outdoor person-centred care and rehabilitation. Storey configuration and number of transition points constitute structural conditions that shape outdoor access in RCFs. These findings have implications for age-friendly design and planning of RCFs as well as for person-centred care and rehabilitation.
Metabolic dysfunction–associated steatotic liver disease (MASLD) is a major cause of chronic liver disease. N-acetylcysteine (NAC) has demonstrated antioxidant and hepatoprotective effects in non-alcoholic steatohepatitis. This study evaluated the impact of high-dose NAC on oxidative stress, insulin resistance, and liver-related outcomes in non-diabetic MASLD patients. This prospective, randomized, open-label controlled trial included 60 non-diabetic adults with MASLD. Participants were randomly assigned to receive either oral NAC (2400 mg/day) combined with lifestyle intervention (n = 30) or lifestyle intervention alone (n = 30) for 12 weeks. The primary outcome was change in serum malondialdehyde (MDA). Secondary outcomes included markers of insulin resistance (leptin, fasting insulin, and HOMA-IR), lipid profile, liver steatosis and fibrosis assessed by FibroScan® and non-invasive scores, and quality of life (QOL). No significant differences in serum MDA, leptin, fasting insulin, or HOMA-IR (all p > 0.05) between groups. Similarly, FibroScan® parameters, non-invasive steatosis and fibrosis scores did not differ significantly between groups. A significant reduction in liver steatosis scores in the control group (p = 0.004) while the Hepatic steatosis index improved in both groups (p = 0.008).Triglyceride levels decreased significantly in the control group, whereas HDL-cholesterol increased significantly in the NAC group. QOL scores remained unchanged overall, except for a significant increase in the emotional domain scores in the NAC group. High-dose NAC for three months did not significantly improve oxidative stress, insulin resistance, or hepatic steatosis or fibrosis in non-diabetic MASLD patients. NAC was safe and well tolerated during the study period. This study was registered on clinicaltrials.gov under the identifier number NCT05589584 in October 2022.
The neutrophil-to-high-density lipoprotein cholesterol ratio (NHR), a composite surrogate marker derived from neutrophil count and HDL-C, has been reported to be associated with various metabolic and cardiovascular diseases. This study aimed to investigate the association between NHR and cardiometabolic multimorbidity (CMM) in older adults and to explore whether insulin resistance and uric acid metabolism may statistically account for part of this association. This study was based on data from the National Health and Nutrition Examination Survey (NHANES) and included a total of 5,987 older adults. CMM was defined as the coexistence of at least two cardiometabolic diseases within the same individual, including diabetes mellitus, coronary heart disease, and stroke. Weighted logistic regression, restricted cubic splines (RCS), subgroup analyses, and exploratory mediation analyses were performed to assess the association between NHR and CMM. Receiver operating characteristic (ROC) curves were used to evaluate the discriminatory ability of NHR for CMM. Multivariable weighted logistic regression analysis demonstrated that, compared with older adults in the lowest quartile (Q1) of NHR, those in the highest quartile (Q4) had 2.33-fold higher odds of CMM (95
The COVID-19 pandemic has had significant health and psychosocial consequences in the older adults. However, there is little community-based evidence that clearly distinguishes the effect attributable to SARS-CoV-2 infection to be differentiated from the contextual impact of the pandemic itself. The objective of this study was to describe the 18-month evolution of multidimensional domains of comprehensive geriatric assessment and to compare trajectories according to the presence or absence of confirmed infection at the start of follow-up. Methods A prospective, multicenter cohort study was conducted in primary care across 11 Spanish regions. Non-institutionalized individuals aged 75 years and over recruited by trained nurses were included. Comprehensive geriatric assessments were performed at baseline and at 6, 12, and 18 months, including functional status, emotional state, nutritional risk, social support, and health-related quality of life. Exposure: confirmed SARS-CoV-2 infection documented by RT-PCR and/or rapid antigen testing recorded in the electronic health record from May 2020 until the time of inclusion in the study. Longitudinal trajectories and exposure time interactions were analyzed using linear mixed-effects models adjusted for relevant covariates, with sensitivity analyses based on complete-case analyses restricted to participants with complete follow-up. Results A total of 1,072 participants were included at baseline. In the overall cohort, there were significant time effects indicating gradual worsening in most domains (functional capacity, nutritional status, social support, and quality of life). Trajectories were generally parallel between infected and uninfected individuals, with no consistent exposure time interactions, except for anxiety (p = 0.043), which showed a differential pattern over time. Sensitivity analyses confirmed the robustness of the findings. Conclusions In non-institutionalized adults aged 75 years or older, we observed a slight, progressive decline in overall health during the post-pandemic period, generally unrelated to prior COVID-19. Trajectories were similar between exposed and unexposed individuals, with the exception of anxiety, which showed a differential course by exposure status, underscoring the need for targeted monitoring of emotional health after infection. Public health responses to health or social crises should prioritize functional autonomy, social support, and mental health to preserve quality of life in this population.
Total Knee Arthroplasty (TKA) is a common procedure for knee osteoarthritis, but the Minimal Clinically Important Difference (MCID) for the EQ-5D-5L scale in TKA patients is not established. This study aims to determine the MCID for EQ-5D-5L in TKA patients. A prospective study with 573 TKA patients was conducted. EQ-5D-5L were completed preoperatively and 1-year postoperatively. The MCID was calculated using anchor-based, distribution-based, and ROC curve methods. The MCID for the EQ-5D-5L index was 0.103 (anchor-based), 0.099 (distribution-based), and 0.09 (ROC). For EQ-VAS, the MCID values were 8.55 (anchor-based), 7.315 (distribution-based), and 6.912 (ROC). Significant improvements in both scores were observed postoperatively (p < 0.001). The MCID values for EQ-5D-5L, determined by calculation method, offer complementary insights into recovery. These findings provide benchmarks to optimize postoperative care and enhance patient outcomes.
Population ageing is associated with increasing rates of osteoporosis, frailty, and functional decline. Vitamin D deficiency and disturbances in calcium–parathyroid hormone (PTH) homeostasis are common in older adults and may contribute to bone loss. However, real-world data describing the frequency and skeletal relevance of these endocrine abnormalities in very old hospitalized populations remain limited. We conducted a retrospective cross-sectional study including 1,202 hospitalized patients aged ≥70 years (mean age 85.0 ± 7.1 years) who underwent dual-energy X-ray absorptiometry at a tertiary endocrine and geriatric centre in Germany. Serum 25-hydroxyvitamin D, calcium, parathyroid hormone (PTH), thyroid-stimulating hormone (TSH), and renal function parameters were extracted from electronic medical records. Hip bone mineral density (BMD) served as the primary skeletal outcome. Multivariable linear regression models were used to assess associations between endocrine parameters and BMD after adjustment for age, sex, body mass index, and living setting. Vitamin D deficiency was highly prevalent in this very old cohort. Vitamin D levels <20 ng/mL were present in 68.6
Abstract Background Adults with major lower limb amputation (LLA) due to dysvascular etiology often experience diverse health outcomes. However, the absence of standardized outcome reporting limits the ability to synthesize evidence, evaluate care models, and develop consistent clinical pathways. This review updates a systematic review on outcome measures and indicators reported in this population. Methods A systematic review update was conducted across six databases (MEDLINE, EMBASE, EBM Reviews, PsycINFO, Web of Science, and CINAHL) from 20 April 2017 to 1 December 2022. All study designs were eligible; however, the articles needed to report outcome measures and indicators on at least 50% of the adult population with major dysvascular LLAs. The extracted outcome measures and indicators were organized according to Dodd’s framework and then reclassified alongside those reported in the study by Ambler and colleagues. The pilot phase of data extraction was carried out independently by multiple reviewers, after which a single reviewer completed the data extraction. Results Of the 12,557 articles, 160 studies reporting data on 228,116 individuals with major dysvascular LLA met the inclusion criteria. Combining these with the 440 studies from the previous review, 2,466 outcome measures and indicators were categorized in five core areas: life impact (25.7%), physiological/clinical (23.4%), death (18.7%), resource use (17.6%), and adverse events (14.6%). In terms of the outcome domains, mortality/survival was the most commonly reported domain, followed by physical functioning (e.g. prosthesis fit, use), skin (e.g., stump wound healing), nervous system outcomes (e.g., residual limb pain), need for further interventions (e.g., prescription of medications), hospital outcomes (e.g., duration of stay, discharge), and adverse events. Conclusion This study builds on a previous review by identifying and categorizing outcome measures and indicators in adults with major dysvascular LLA, highlighting inconsistencies in outcome reporting across studies. The absence of a standardized set of outcome measures and indicators limits the ability to conduct meta-analyses or systematic reviews, evaluate the effectiveness of care models, and establish clinical pathways. Developing a core outcome set tailored to the needs of individuals with dysvascular LLA could help address these challenges by promoting consistency in outcome reporting and enabling meaningful comparisons across studies. Ultimately, this could contribute to improving the quality, efficiency, and person-centeredness of care. Trial registration PROSPERO (CRD42023388570).
