Controversy on the CONVINCE study findings: the PRO take / Controvérsia sobre os achados do estudo CONVINCE: a perspectiva PRO

ABSTRACT The CONVINCE study, recently published in the New England Journal of Medicine, reveals a groundbreaking 23% reduction in the relative risk of all-cause mortality among end-stage kidney patients undergoing high convective volume hemodiafiltration. This significant finding challenges the conventional use of high-flux hemodialysis and offers hope for improving outcomes in chronic kidney disease patients. While some controversies surround the study's findings, including concerns about generalizability and the causes of death, it is essential to acknowledge the study's design and its main outcomes. The CONVINCE study, part of the HORIZON 2020 project, enrolled 1360 patients and demonstrated the superiority of hemodiafiltration in reducing all-cause mortality overall, as well as in specific patient subgroups (elderly, short vintage, non-diabetic, and those without cardiac issues). Interestingly, it was shown that hemodiafiltration had a protective effect against infection, including COVID-19. Future research will address sustainability, dose scaling effects, identification of subgroups especially likely to benefit and cost-effectiveness. However, for now, the findings strongly support a broader adoption of hemodiafiltration in renal replacement therapy, marking a significant advancement in the field.

RESUMO O estudo CONVINCE, publicado recentemente no New England Journal of Medicine, revela uma redução inovadora de 23% no risco relativo de mortalidade por todas as causas entre pacientes renais em estágio terminal submetidos à hemodiafiltração de alto volume de convecção. Esse achado significativo desafia o uso convencional da hemodiálise de alto fluxo e oferece esperança de melhoria dos desfechos em pacientes com doença renal crônica. Embora algumas controvérsias cerquem os achados do estudo, incluindo preocupações sobre a generalização e as causas de óbito, é essencial reconhecer o desenho do estudo e seus principais desfechos. O estudo CONVINCE, parte do projeto HORIZON 2020, inscreveu 1.360 pacientes e demonstrou a superioridade da hemodiafiltração na redução da mortalidade por todas as causas em geral, bem como em subgrupos específicos de pacientes (idosos, HD de curta duração, não diabéticos e aqueles sem problemas cardíacos). Curiosamente, demonstrou-se que a hemodiafiltração teve um efeito protetor contra infecções, incluindo a COVID-19. Pesquisas futuras abordarão sustentabilidade, efeitos de escalonamento da dose, identificação de subgrupos especialmente propensos a se beneficiar e a relação custo-benefício. No entanto, por ora, os achados apoiam fortemente uma adoção mais ampla da hemodiafiltração na terapia renal substitutiva, marcando um avanço significativo na área.

Aetiology and predictors of major bleeding events in patients with heart failure with reduced ejection fraction undergoing percutaneous coronary intervention.

OBJECTIVES: We sought to determine the relationship between the degree of left ventricular ejection fraction (LVEF) impairment and the frequency and type of bleeding events after percutaneous coronary intervention (PCI). DESIGN: This was an observational retrospective cohort analysis. Patients who underwent PCI from 2009 to 2017 were identified from our institutional National Cardiovascular Disease Registry (NCDR) CathPCI database. Patients were stratified by pre-PCI LVEF: preserved (≥50%), mildly reduced (41%-49%) and reduced (≤40%) LVEF. PRIMARY OUTCOME MEASURES: The outcome was major bleeding, defined by NCDR criteria. Events were classified based on bleeding aetiology and analysed by multivariable logistic regression. RESULTS: Among 13 537 PCIs, there were 817 bleeding events (6%). The rate of bleeding due to any cause, blood transfusion, gastrointestinal bleeding and coronary artery perforation or tamponade each increased in a stepwise fashion comparing preserved, mildly reduced and reduced LVEF reduction (p<0.05 for all comparisons). However, there were no differences in bleeding due to asymptomatic drops in haemoglobin, access site haematoma or retroperitoneal bleeding. After multivariable adjustment, mildly reduced and reduced LVEF remained independent predictors of bleeding events (OR 1.36, 95% CI 1.06 to 1.74, p<0.05 and OR 1.73, 95% CI 1.45 to 2.06, p<0.0001). CONCLUSIONS: The degree of LV dysfunction is an independent predictor of post-PCI major bleeding events. Patients with mildly reduced or reduced LVEF are at greatest risk of post-PCI bleeding, driven by an increased need for blood transfusion, major GI bleeding events and coronary artery perforation or tamponade. Pre-PCI LV dysfunction does not predict asymptomatic declines in haemoglobin, access site haematoma or retroperitoneal bleeding.

Identifying prehospital trauma patients from ambulance patient care records; comparing two methods using linked data in New South Wales, Australia.

BACKGROUND: Linked datasets for trauma system monitoring should ideally follow patients from the prehospital scene to hospital admission and post-discharge. Having a well-defined cohort when using administrative datasets is essential because they must capture the representative population. Unlike hospital electronic health records (EHR), ambulance patient-care records lack access to sources beyond immediate clinical notes. Relying on a limited set of variables to define a study population might result in missed patient inclusion. We aimed to compare two methods of identifying prehospital trauma patients: one using only those documented under a trauma protocol and another incorporating additional data elements from ambulance patient care records. METHODS: We analyzed data from six routinely collected administrative datasets from 2015 to 2018, including ambulance patient-care records, aeromedical data, emergency department visits, hospitalizations, rehabilitation outcomes, and death records. Three prehospital trauma cohorts were created: an Extended-T-protocol cohort (patients transported under a trauma protocol and/or patients with prespecified criteria from structured data fields), T-protocol cohort (only patients documented as transported under a trauma protocol) and non-T-protocol (extended-T-protocol population not in the T-protocol cohort). Patient-encounter characteristics, mortality, clinical and post-hospital discharge outcomes were compared. A conservative p-value of 0.01 was considered significant RESULTS: Of 1 038 263 patient-encounters included in the extended-T-population 814 729 (78.5 %) were transported, with 438 893 (53.9 %) documented as a T-protocol patient. Half (49.6 %) of the non-T-protocol sub-cohort had an International Classification of Disease 10th edition injury or external cause code, indicating 79644 missed patients when a T-protocol-only definition was used. The non-T-protocol sub-cohort also identified additional patients with intubation, prehospital blood transfusion and positive eFAST. A higher proportion of non-T protocol patients than T-protocol patients were admitted to the ICU (4.6% vs 3.6 %), ventilated (1.8% vs 1.3 %), received in-hospital transfusion (7.9 vs 6.8 %) or died (1.8% vs 1.3 %). Urgent trauma surgery was similar between groups (1.3% vs 1.4 %). CONCLUSION: The extended-T-population definition identified 50 % more admitted patients with an ICD-10-AM code consistent with an injury, including patients with severe trauma. Developing an EHR phenotype incorporating multiple data fields of ambulance-transported trauma patients for use with linked data may avoid missing these patients.

Qualitative interviews of patients with COPD and muscle weakness enrolled in a clinical trial evaluating a new anabolic treatment: patient perspectives of disease experience, trial participation and outcome assessments.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) and muscle weakness can cause impaired physical function, significantly impacting patients' health-related quality of life (HRQoL). Loss of muscle strength is usually assessed through clinical and performance outcome (PerfO) assessments, which consists of tasks performed in a standardized manner, providing evidence of a patient's functional ability. However, evidence documenting the patient experience of COPD and muscle weakness is limited. METHODS: This two-stage qualitative study used semi-structured interviews in patients aged 45-80 years with COPD (post-bronchodilator forced expiratory volume in 1s [FEV1]/forced vital capacity ratio < 0.70, and FEV1% predicted of 30-80%) and muscle weakness. In Stage 1, 30-minute concept elicitation interviews were conducted with participants recruited across three US sites to explore impacts on physical functioning and activities of daily living. In Stage 2, interviews were performed with participants exiting a Phase IIa trial investigating the efficacy of a selective androgen receptor modulator (GSK2881078) on leg strength, whereby PerfOs were used to evaluate strength and physical functioning endpoints. These participants completed either 60-minute in-depth (n = 32) or 15-minute confirmatory (n = 35) interviews exploring trial experience, completion of outcome measures, disease experience and treatment satisfaction. RESULTS: In Stage 1 (n = 20), most participants described their muscles as weak (83.3%). Difficulties with walking (100%) and lifting heavy objects (90%) were reported. In Stage 2, 60-minute interviews, all participants (n = 32) reported a positive trial experience. Most participants reported that the home exercise program was easy to fit into daily life (77.8%), the PROactive daily diary was easy to complete (100%) and wearable sensors were easy to use (65.6%). However, technical issues were reported (71%), and few participants (19.4%) found physical assessments easy to complete. Improvements in muscle strength and functional limitations were reported by most participants. The shorter 15-minute confirmatory interviews (n = 35) supported the in-depth interview results. CONCLUSION: The qualitative interviews generated in-depth evidence of key concepts relevant to patients with COPD and muscle weakness and support the assessments of patient strength and physical function as outcome measures in this population in future studies. TRIAL NUMBER: GSK Stage 1: 206869; Stage 2: 200182, NCT03359473; Registered December 2, 2017, https://clinicaltrials.gov/ct2/show/NCT03359473 .

Analysis of belimumab prescription and outcomes in a 10-year monocentric cohort: is there an advantage with early use?

OBJECTIVE: The objective is to evaluate perscriptions of belimumab (BEL), how these have changed over the years and their impact on clinical outcomes in patients with systemic lupus erythematosus (SLE). METHODS: This is a retrospective analysis of prospectively collected data. We retrieved demographic and clinical data and concomitant therapies at BEL starting (baseline). Disease activity was assessed at baseline and after 6 and 12 months and organ damage at baseline and at the last visit. RESULTS: From 422 patients followed in the Pisa SLE cohort, 102 patients received BEL and were included and 22 (21.6%) were immunosuppressant (IS)-naïve. Lupus Low Disease Activity State (LLDAS) with a glucocorticoid (GC) dosage ≤5 mg/day (LLDAS5) and remission were achieved by 47% and 38% of patients at 6 months, and by 75% and 66% at 12 months. Comparing IS-naïve patients with those who received BEL after at least one conventional IS, we did not find significant differences in baseline characteristics and in the achievement of LLDAS5 and remission. Despite at baseline we did not observe significant differences in mean GC daily dosage, IS-naïve patients were taking a significantly lower GC daily dose at 6 and 12 months. Interestingly, IS-naïve patients were more common in the most recent years. CONCLUSIONS: Our data confirm that BEL is effective in controlling disease activity, and in recent years BEL has been considered as an earlier treatment option before other IS. Early introduction of BEL can be at least as effective as a step-up approach and can help to reduce the GC dosage.

Validity and reliability of outcome measures to assess dysfunctional breathing: a systematic review.

OBJECTIVE: This study aimed to systematically review the psychometric properties of outcome measures that assess dysfunctional breathing (DB) in adults. METHODS: Studies on developing and evaluating measurement properties to assess DB were included. The study investigated the empirical research published between 1990 and February 2022, with an updated search in May 2023 in the Cochrane Library database of systematic reviews and the Cochrane Central Register of Controlled Trials, the Ovid Medline (full), the Ovid Excerta Medica Database, the Ovid allied and complementary medicines database, the Ebscohost Cumulative Index to Nursing and Allied Health Literature and the Physiotherapy Evidence Database. The included studies' methodological quality was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist. Data analysis and synthesis followed the COSMIN methodology for reviews of outcome measurement instruments. RESULTS: Sixteen studies met the inclusion criteria, and 10 outcome measures were identified. The psychometric properties of these outcome measures were evaluated using COSMIN. The Nijmegen Questionnaire (NQ) is the only outcome measure with 'sufficient' ratings for content validity, internal consistency, reliability and construct validity. All other outcome measures did not report characteristics of content validity in the patients' group. DISCUSSION: The NQ showed high-quality evidence for validity and reliability in assessing DB. Our review suggests that using NQ to evaluate DB in people with bronchial asthma and hyperventilation syndrome is helpful. Further evaluation of the psychometric properties is needed for the remaining outcome measures before considering them for clinical use. PROSPERO REGISTRATION NUMBER: CRD42021274960.

Comparison of cognitive performance measures in individuals with systemic lupus erythematosus.

OBJECTIVE: Cognitive impairment is a common complaint in SLE, but approaches to measuring cognitive performance objectively vary. Leveraging data collected in a population-based cohort of individuals with validated SLE, we compared performance and potential impairment across multiple measures of cognition. METHODS: During a single study visit (October 2019-May 2022), times to complete the Trail Making Test B (TMTB; N=423) were recorded; potential impairment was defined as an age-corrected and education-corrected T-score <35 (>1.5 SD longer than the normative time). A clock drawing assessment (CLOX; N=435) with two parts (free clock draw (CLOX1) and copy (CLOX2)) was also performed (score range: 0-15; higher scores=better performance); potential impairment was defined as CLOX1 <10 or CLOX2 <12. Fluid cognition (N=199; in-person visits only) was measured via the National Institutes of Health (NIH) Toolbox Fluid Cognition Battery and expressed as age-corrected standard scores; potential impairment was defined by a score <77.5 (>1.5 SD lower the normative score). RESULTS: Participants (mean age 46 years; 92% female; 82% black) had a median (IQR) TMTB time of 96 (76-130) s; median (IQR) CLOX1 and CLOX2 scores of 12 (10-13) and 14 (13-15); and a mean (SD) fluid cognition standard score of 87.2 (15.6). TMTB time and fluid cognition score (ρ=-0.53, p<0.001) were the most highly intercorrelated measures. Overall, 65%, 55% and 28% were potentially impaired by the TMTB test, CLOX task and NIH Toolbox Fluid Cognition Battery, respectively. While there was overlap in potential impairment between TMTB and CLOX, more than half (58%) had impairment by only one of these assessments. Few (2%) had impairment in fluid cognition only. CONCLUSION: The TMTB, CLOX and NIH Fluid Cognition Battery each provided unique and potentially important information about cognitive performance in our SLE cohort. Future studies are needed to validate these measures in SLE and explore interventions that maintain or improve cognitive performance in this population.

Impact of pharmaceutical care for asthma patients on health-related outcomes: An umbrella review.

Recent systematic reviews suggest that pharmacists' interventions in asthma patients have a positive impact on health-related outcomes. Nevertheless, the association is not well established, and the role of clinical pharmacists is poorly represented. The aim of this overview of systematic reviews is to identify published systematic reviews assessing the impact of pharmacists' interventions on health-related outcomes measured in asthma patients. PubMed, Embase, Scopus, and Cochrane Library were searched from inception to December 2022. Systematic reviews of all study designs and settings were included. Methodological quality was assessed using AMSTAR 2. Two investigators performed study selection, quality assessment and data collection independently. Nine systematic reviews met the inclusion criteria. Methodological quality was rated as high in one, low in two, and critically low in six. Reviews included 51 primary studies reporting mainly quality of life, asthma control, lung capacity, and therapeutic adherence. Only four studies were carried out in a hospital setting and only two reviews stated the inclusion of severe asthma patients. The quality of the systematic reviews was generally low, and this was the major limitation of this overview of systematic reviews. However, solid evidence supports that pharmaceutical care improves health-related outcomes in asthma patients.

Implementing strategies to improve uptake of patient-reported outcome measures (PROMs) in gender-affirming care: a mixed-methods implementation study.

IMPORTANCE: The Practical Guide to Implementing PROMs in Gender-Affirming Care (PG-PROM-GAC) is an evidence-based resource, which was developed in response to international calls for improved patient-reported outcome measure (PROM) implementation in gender-affirming care. The PG-PROM-GAC has the potential to improve PROM implementation; however, its real-world effectiveness has not yet been investigated. OBJECTIVE: Investigate effectiveness and fidelity of three implementation strategies from the PG-PROM-GAC in a real-world gender clinic setting. DESIGN: Interrupted time series mixed-methods study investigating response rates to a PROM deployed alongside implementation strategies from the PG-PROM-GAC; and open-ended feedback on the fidelity and effectiveness of implementation strategies. SETTING: Participants were recruited from a National Health Service (NHS) gender clinic. PARTICIPANTS: Eligible participants were being seen at an NHS gender clinic for an appointment during the study period, and were invited to participate in this study via email. INTERVENTION: Three implementation strategies from the PG-PROM-GAC deployed alongside a PROM. MAIN OUTCOMES AND MEASURES: Response rates were calculated at 2-week intervals, in line with the deployment of each implementation strategy. Open-ended responses were thematically analysed by two researchers following guidance from implementation science and interpretation from Normalisation Process Theory. RESULTS: A total of 28 participants were included in this study with a mean (SD) age of 39 (17) years. In general, participants rated education material for PROMs as the most important for PROM implementation, and accessibility options for PROMs as the second most important. Response rates to PROM completion dropped as the study progressed, as the burden of reviewing implementation strategies increased. Results were used to construct recommendations for future PROM implementation efforts. CONCLUSIONS AND RELEVANCE: The PG-PROM-GAC and implementation strategy materials developed from this study (ie, educational video on PROMs co-developed with key stakeholders) can be used by clinicians, researchers and policymakers to lead PROM implementation efforts in gender-affirming care.

Prediction of high-risk emergency department revisits from a machine-learning algorithm: a proof-of-concept study.

BACKGROUND: High-risk emergency department (ED) revisit is considered an important quality indicator that may reflect an increase in complications and medical burden. However, because of its multidimensional and highly complex nature, this factor has not been comprehensively investigated. This study aimed to predict high-risk ED revisit with a machine-learning (ML) approach. METHODS: This 3-year retrospective cohort study assessed adult patients between January 2019 and December 2021 from National Taiwan University Hospital Hsin-Chu Branch with high-risk ED revisit, defined as hospital or intensive care unit admission after ED return within 72 hours. A total of 150 features were preliminarily screened, and 79 were used in the prediction model. Deep learning, random forest, extreme gradient boosting (XGBoost) and stacked ensemble algorithm were used. The stacked ensemble model combined multiple ML models and performed model stacking as a meta-level algorithm. Confusion matrix, accuracy, sensitivity, specificity and area under the receiver operating characteristic curve (AUROC) were used to evaluate performance. RESULTS: Analysis was performed for 6282 eligible adult patients: 5025 (80.0%) in the training set and 1257 (20.0%) in the testing set. High-risk ED revisit occurred for 971 (19.3%) of training set patients vs 252 (20.1%) in the testing set. Leading predictors of high-risk ED revisit were age, systolic blood pressure and heart rate. The stacked ensemble model showed more favourable prediction performance (AUROC 0.82) than the other models: deep learning (0.69), random forest (0.78) and XGBoost (0.79). Also, the stacked ensemble model achieved favourable accuracy and specificity. CONCLUSION: The stacked ensemble algorithm exhibited better prediction performance in which the predictions were generated from different ML algorithms to optimally maximise the final set of results. Patients with older age and abnormal systolic blood pressure and heart rate at the index ED visit were vulnerable to high-risk ED revisit. Further studies should be conducted to externally validate the model.

Impacts of an Acute Care Telenursing Program on Discharge, Patient Experience, and Nursing Experience: Retrospective Cohort Comparison Study.

BACKGROUND: Despite widespread growth of televisits and telemedicine, it is unclear how telenursing could be applied to augment nurse labor and support nursing. OBJECTIVE: This study evaluated a large-scale acute care telenurse (ACTN) program to support web-based admission and discharge processes for hospitalized patients. METHODS: A retrospective, observational cohort comparison was performed in a large academic hospital system (approximately 2100 beds) in Houston, Texas, comparing patients in our pilot units for the ACTN program (telenursing cohort) between June 15, 2022, and December 31, 2022, with patients who did not participate (nontelenursing cohort) in the same units and timeframe. We used a case mix index analysis to confirm comparable patient cases between groups. The outcomes investigated were patient experience, measured using the Hospital Consumer Assessment of Health Care Providers and Systems (HCAHCPS) survey; nursing experience, measured by a web-based questionnaire with quantitative multiple-choice and qualitative open-ended questions; time of discharge during the day (from electronic health record data); and duration of discharge education processes. RESULTS: Case mix index analysis found no significant case differences between cohorts (P=.75). For the first 4 units that rolled out in phase 1, all units experienced improvement in at least 4 and up to 7 HCAHCPS domains. Scores for "communication with doctors" and "would recommend hospital" were improved significantly (P=.03 and P=.04, respectively) in 1 unit in phase 1. The impact of telenursing in phases 2 and 3 was mixed. However, "communication with doctors" was significantly improved in 2 units (P=.049 and P=.002), and the overall rating of the hospital and the "would recommend hospital" scores were significantly improved in 1 unit (P=.02 and P=04, respectively). Of 289 nurses who were invited to participate in the survey, 106 completed the nursing experience survey (response rate 106/289, 36.7%). Of the 106 nurses, 101 (95.3%) indicated that the ACTN program was very helpful or somewhat helpful to them as bedside nurses. The only noticeable difference between the telenursing and nontelenursing cohorts for the time of day discharge was a shift in the volume of patients discharged before 2 PM compared to those discharged after 2 PM at a hospital-wide level. The ACTN admissions averaged 12 minutes and 6 seconds (SD 7 min and 29 s), and the discharges averaged 14 minutes and 51 seconds (SD 8 min and 10 s). The average duration for ACTN calls was 13 minutes and 17 seconds (SD 7 min and 52 s). Traditional cohort standard practice (nontelenursing cohort) of a bedside nurse engaging in discharge and admission processes was 45 minutes, consistent with our preimplementation time study. CONCLUSIONS: This study shows that ACTN programs are feasible and associated with improved outcomes for patient and nursing experience and reducing time allocated to admission and discharge education.

Brain Derived Neurotrophic Factor Methylation and Long-term Outcomes after Stroke Interacting with Suicidal Ideation.

Objective: This study aimed to evaluate the unexplored relationship between BDNF methylation, long-term outcomes, and its interaction with suicidal ideation (SI), which is closely associated with both BDNF expression and stroke outcomes. Methods: A total of 278 stroke patients were assessed for BDNF methylation status and SI using suicide-related item in the Montgomery-Åsberg Depression Rating Scale at 2 weeks post-stroke. We investigated the incidence of composite cerebro-cardiovascular events (CCVEs) during an 8-14-year period after the initial stroke as long-term stroke outcome. We conducted Cox regression models adjusted for covariates to evaluate the association between BDNF methylation status and CCVEs, as well as its interaction with post-stroke SI at 2 weeks. Results: Higher methylation status of CpG 1, 3, and 5, but not the average value, predicted a greater number of composite CCVEs during 8-14 years following the stroke. The associations between a higher methylation status of CpGs 1, 3, 5, and 8, as well as the average BDNF methylation value, and a greater number of composite CCVEs, were prominent in patients who had post-stroke SI at 2 weeks. Notably, a significant interaction between methylation status and SI on composite CCVEs was observed only for CpG 8. Conclusion: The significant association between BDNF methylation and poor long-term stroke outcomes, particularly amplified in individuals who had post-stroke SI at 2 weeks, suggested that evaluating the biological marker status of BDNF methylation along with assessing SI during the acute phase of stroke can help predict long-term outcomes.

New consensus definition on defining and measuring care for children with paediatric feeding disorder.

AIM: This study addresses the absence of a definition of care for children with feeding disorders, limited agreement on key performance indicators (KPIs), and the lack of data linked to those KPIs. METHODS: Clinicians, consumers and researchers involved in outpatient feeding care in New South Wales (NSW), Australia were invited to participate in a two-Phase study. In Phase 1, a modified Delphi method was used. Two rounds of voting resulted in a new consensus definition of a multidisciplinary paediatric feeding clinic. Three further rounds voting determined relevant KPIs. In Phase 2, the KPIs were piloted prospectively in 10 clinics. RESULTS: Twenty-six clinicians, consumers and researchers participated in Phase 1. Participation across five voting rounds declined from 92% to 60% and a valid definition and KPI set were created. In Phase 2, the definition and KPIs were piloted in 10 clinics over 6 weeks. Data for 110 patients were collected. The final KPI set of 28 measures proposed covers clinical features, patient demographics and medical issues, parent-child interaction and outcome measures. CONCLUSIONS: A new definition of a multidisciplinary paediatric feeding clinic is now available, linked to a standardised KPI set covering relevant performance measures. These proved viable in baseline data collection for 10 clinics across NSW. This sets a foundation for further data collection, systematic measurement of care provision and outcomes, and research needed to deliver care improvement for children with paediatric feeding disorder.

Healthcare experiences of fibromyalgia patients and their associations with satisfaction and pain relief. A patient survey.

OBJECTIVES: The etiology of fibromyalgia (FM) is disputed, and there is no established cure. Quantitative data on how this may affect patients' healthcare experiences are scarce. The present study aims to investigate FM patients' pain-related healthcare experiences and explore factors associated with high satisfaction and pain relief. METHODS: An anonymous, online, and patient-administered survey was developed and distributed to members of the Norwegian Fibromyalgia Association. It addressed their pain-related healthcare experiences from both primary and specialist care. Odds ratios for healthcare satisfaction and pain relief were estimated by binary logistic regression. Directed acyclic graphs guided the multivariable analyses. RESULTS: The patients (n = 1,626, mean age: 51 years) were primarily women (95%) with a 21.8-year mean pain duration and 12.7 years in pain before diagnosis. One-third did not understand why they had pain, and 56.6% did not know how to get better. More than half had not received satisfactory information on their pain cause from a physician, and guidance on how to improve was reported below medium. Patients regretted a lack of medical specialized competence on muscle pain and reported many unmet needs, including regular follow-up and pain assessment. Physician-mediated pain relief was low, and guideline adherence was deficient. Only 14.8% were satisfied with non-physician health providers evaluating and treating their pain, and 21.5% were satisfied (46.9% dissatisfied) with their global pain-related healthcare. Patients' knowledge of their condition, physicians' pain competence and provision of information and guidance, agreement in explanations and advice, and the absence of unmet needs significantly increased the odds of both healthcare satisfaction and pain relief. CONCLUSIONS: Our survey describes deficiencies in FM patients' pain-related healthcare and suggests areas for improvement to increase healthcare satisfaction and pain relief. (REC# 2019/845, 09.05.19).

Outcomes of Distal Third Femur Fractures in Patients 18 Years and Older: A Pilot Study.

INTRODUCTION: The selection of the most optimal fixation method for fractures of the distal femur, whether intramedullary nail (NL), lateral locking plate (PL), or nail/plate (NP) is not always clear. This study retrospectively evaluates surgical patients with distal femur fractures and introduces a pilot study using cluster analysis to identify the most optimal fracture fixation method for a given fracture type. METHODS: This is a retrospective cohort study of patients 18 years and older with an isolated distal femur fracture who presented to our Level-1 trauma center between January 1, 2012, and December 31, 2022, and obtained NL, PL, or NP implants. Patients with polytrauma and those without at least six months of follow-up were excluded. A chart review was used to obtain demographics, fracture classification, fixation method, and postoperative complications. A cluster analysis was performed. The following factors were used to determine a successful outcome: ambulatory status pre-injury and 6-12 months postoperatively, infection, non-union, mortality, and implant failure. RESULTS: A total of 169 patients met inclusion criteria. No statistically significant association between the fracture classification and fixation type with overall outcome was found. However, patients treated with an NP (n = 14) had a success rate of 92.9% vs only a 68.1% success rate in those treated with a PL (n = 116) (p = 0.106). The most notable findings in the cluster analysis (15 total clusters) included transverse extraarticular fractures demonstrating 100% success if treated with NP (n = 6), 50% success with NL (n=2), and 78.57% success with PL fixation (n=14). NP constructs in complete articular fractures demonstrated success in 100% of patients (n = 5), whereas 77.78% of patients treated with NL (n = 9) and 61.36% of those treated with PL (n = 44). CONCLUSIONS: Plate fixation was the predominant fixation method used for distal third femur fractures regardless of fracture classification. However, NP constructs trended towards improved success rates, especially in complete intraarticular and transverse extraarticular fractures, suggesting the potential benefit of additional fixation with these fractures. Cluster analysis provided a heuristic way of creating patient profiles in patients with distal third femur fractures. However, a larger cohort study is needed to corroborate these findings to ultimately develop a clinical decision-making tool that also accounts for patient specific characteristics.

Characteristics and Hospital Outcomes of 1403 Patients Hospitalized at Community Hospitals With Ankylosing Spondylitis.

Background: In this study, we aimed to assess the hospital course, outcomes after hospitalization, and predictors of outcomes in patients with ankylosing spondylitis (AS). Methods: We included 1403 patients with AS between 2016 and 2021 who were identified using International Classification of Disease (ICD) codes from a large for-profit healthcare system database. Demographics and clinical characteristics were compared between those who had a favorable outcome, defined as being discharged to home without readmission within 3 months of discharge, versus those who had an unfavorable outcome. A stepwise logistic regression was used to identify demographic and clinical characteristics associated with home discharge and readmission. Results: The mean age for all AS patients was 56.06 ± 17.01 years, which was younger in the favorable outcome group, and 82.47% of patients were discharged to home after the average length of stay of 3.72 ± 4.09 days, also shorter in the favorable outcome group. Of 1403 patients, 37.56% were readmitted within 3 months of discharge, at a lower rate in the group with home discharge. Opioids were the most commonly used medication during hospitalization (67.07%), prescribed at a lower rate in the favorable outcome group. Medical coverage by Medicare and Medicaid, fall at admission, hospital-acquired anemia, steroid, acetaminophen, muscle relaxant use, and an increased dose of morphine milligram equivalent at discharge were significantly associated with decreased odds of home discharge. Surgical procedures during admission, gastrointestinal complications, discharge to inpatient rehabilitation units, and use of benzodiazepine were associated with an increased risk of readmission within 3 months. Conclusion: Recognizing factors that put patients with AS at risk of unfavorable outcomes is useful information to improve patient care during hospitalization.

Impact of pulmonary hypertension on outcomes after TEER in patients suffering from mitral regurgitation.

AIM: Data on associations of invasively determined hemodynamic parameters with procedural success and outcomes in patients suffering from mitral regurgitation (MR) undergoing transcatheter edge-to-edge repair of the mitral valve (M-TEER) is limited. METHODS AND RESULTS: We enrolled 239 patients with symptomatic MR of grade 2 + , who received M-TEER. All patients underwent extensive pre-interventional invasive hemodynamic measurements via right heart catheterization (mean pulmonary arterial pressure (mPAP), systolic- (PAPsys) and diastolic pulmonary arterial pressure (PAPdia), pulmonary arterial wedge pressure (PAWP), a-wave, v-wave, pulmonary vascular resistance (PVR), transpulmonary pressure gradient (TPG), cardiac index (CI), stroke volume index (SVI)). mPAP and PAWP at baseline were neither associated with procedural success, immediate reduction of MR, nor residual MR after 6 months of follow-up. The composite outcome (All-cause mortality (ACM) and/or heart failure induced rehospitalization (HFH)) and HFH differed significantly after M-TEER when stratified according to mPAP, PAWP, PAPdia, a-wave and v-wave. ACM was not associated with the afore mentioned parameters. Neither PVR, TPG, CI nor SVI were associated with the composite outcome and HFH, respectively. In multivariable analyses, PAWP was independently associated with the composite outcome and HFH. PVR and SVI were not associated with outcomes. CONCLUSION: PAWP at baseline was significantly and independently associated with HFH and might serve as a valuable parameter for identifying patients at high risk for HFH after M-TEER. ACM and procedural success were not affected by pulmonary arterial pressure before M-TEER. We suggest that the post-capillary component of PH serves as the driving force behind the risk of HFH.

Feasibility of using an automated call service to collect quality of life and functional outcome data in trauma patients.

Objectives: Following up trauma patients after discharge, to evaluate their subsequent quality of life and functional outcomes, is notoriously difficult, time consuming, and expensive. Automated systems are a conceptually attractive solution. We prospectively assessed the feasibility of using a series of automated phone calls administered by Emmi Patient Engagement to survey trauma patients after discharge. Methods: Recruitment into the study was incorporated into the patient discharge process by nursing staff. For this pilot, we included trauma patients discharging home and who were able to answer phone calls. A script was created to evaluate the Extended Glasgow Outcome Scale and the EuroQol EQ-5D to assess functional status and quality of life, respectively. Call attempts were made at 6 weeks, 3 months, 6 months, and 1 year after discharge. Results: A total of 110 patients initially agreed to participate. 368 attempted patient encounters (calls or attempted calls) took place, with 104 (28.3%) patients answering a least one question in the study. 21 unique patients (19.1% of those enrolled) completed 27 surveys. Conclusions: Automated, scripted phone calls to survey patients after discharge are not a feasible way of collecting functional and quality of life data. Level of evidence: Level II/prospective.

Associated Factors of Cardiopulmonary Resuscitation Outcomes; a Cohort Study on an Adult In-hospital Cardiac Arrest Registry.

Introduction: In-hospital cardiac arrest (IHCA) remains a substantial cause of morbidity and mortality for hospitalized patients worldwide. This study aimed to identify associated factors of return of spontaneous circulation (ROSC) and survival with favorable neurological outcomes of IHCA patients. Method: A two-year retrospective cohort study was conducted at a university-based tertiary care hospital in Bangkok, Thailand, studying adult patients aged ≥ 18 years with IHCA from January 2021 to December 2022. The primary endpoint was sustained ROSC, and the secondary endpoint was survival with favorable neurological outcomes defined as Cerebral Performance Categories (CPC) Scale of 1 or 2 at discharge. Pre-arrest and intra-arrest variables were collected and analyzed using multivariable logistic regression to identify independent factors associated with the outcomes. Results: During the study period, 156 patients were included in the study. 105 (67.3%) patients achieved sustained ROSC after the CPR, 28 patients (18.0%) were discharged alive, and 15 patients (9.6%) survived with a favorable neurological outcome at hospital discharge. Overall, sustained ROSC was higher in patients who had IHCA during the day shift (odds ratio (OR): 4.11; 95% confidence interval (CI): 1.05-16.06) and electrocardiogram (ECG) monitoring prior to arrest (OR: 6.38; 95% CI: 1.18-34.54). In contrast, higher adrenaline doses administrated, and increased CPR duration reduced the odds of sustained ROSC (OR: 0.72; 95% CI: 0.54-0.94 and OR: 0.92; 95% CI: 0.85-0.98, respectively). Arrest due to cardiac etiology was associated with increased discharged survival with favorable neurological outcomes (OR: 13.43; 95% CI: 2.00-89.80), while a higher Good Outcome Following Attempted Resuscitation (GO-FAR) score reduced the odds of the secondary outcome (OR: 0.89; 95% CI: 0.81-0.98). Conclusion: The sustained ROSC was higher in IHCA during the daytime shift and under prior ECG monitoring. The administration of higher doses of adrenaline and prolonged CPR durations decreased the likelihood of achieving sustained ROSC. Furthermore, patients with cardiac-related causes of cardiac arrest exhibited a higher rate of survival to hospital discharge with favorable neurological outcomes.