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Hoy — Mayo 14th 2024Tus fuentes RSS

SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema

Por: Devoogdt · N. · De Vrieze · T. · Heroes · A.-K. · Bechter-Hugl · B. · Fieuws · S. · Godderis · L. · Segers · K. · Maleux · G. · Deltombe · T. · Frippiat · J. · Servaes · M. · Berners · A. · Fosseprez · P. · Krug · B. · Kayser · F. · Falticeanu · A. · Randon · C. · Monten · C. · Van Landuyt
Introduction

Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema.

Methods and analysis

A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient’s own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased.

Ethics and dissemination

The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations.

Trial registration number

NCT05064176

COS-PPA: protocol to develop a core outcome set for primary progressive aphasia

Por: Volkmer · A. · Copland · D. A. · Henry · M. L. · Warren · J. D. · Varley · R. · Wallace · S. J. · Hardy · C. J.
Introduction

The term primary progressive aphasia (PPA) describes a group of language-led dementias. Disease-modifying treatments that delay, slow or reverse progression of PPA are currently lacking, though a number of interventions to manage the symptoms of PPA have been developed in recent years. Unfortunately, studies exploring the effectiveness of these interventions have used a variety of different outcome measures, limiting comparability. There are more constructs, apart from word retrieval, that are important for people with PPA that have not received much attention in the research literature. Existing core outcome sets (COS) for dementia and non-progressive aphasia do not meet the needs of people with PPA, highlighting a need to develop a specific COS for PPA.

Methods and analysis

This protocol describes a three-stage study to identify a COS for PPA interventions in research and clinical practice. The stage 1 systematic review will identify existing speech, language and communication measures used to examine the effectiveness of interventions for PPA in the research literature. Employing a nominal group technique, stage 2 will identify the most important outcomes for people with PPA and their families. The data collected in stages 1 and 2 will be jointly analysed with the project PPI group and will inform the stage 2 modified Delphi consensus study to identify a core outcome measurement set for PPA among a range of research disciplines undertaking intervention studies for people with PPA.

Ethics and dissemination

Ethical approval for stage 2 of the study has been sought individually in each country at collaborating institutions and is stated in detail in the manuscript. Stage 3 has been granted ethical approval by the Chairs of UCL Language and Cognition Department Ethics, Project ID LCD-2023-06. Work undertaken at stages 1, 2 and 3 will be published in open-access peer-reviewed journal articles and presented at international scientific conferences.

PROSPERO registration number

CRD42022367565.

Bacterial growth in patients with low back pain and Modic changes: protocol of a multicentre, case-control biopsy study

Por: Rolfsen · M. P. · Gammelsrud · K. W. · Espeland · A. · Braten · L. C. · Mjones · S. B. · Austevoll · I. · Dolatowski · F. C. · Arrestad · M. B. · Toppe · M. K. · Orlien · I. E. · Holberg-Petersen · M. · Fagerland · M. · Zwart · J.-A. · Storheim · K. · Hellum · C.
Introduction

Bacterial infection and Modic changes (MCs) as causes of low back pain (LBP) are debated. Results diverged between two randomised controlled trials examining the effect of amoxicillin with and without clavulanic acid versus placebo on patients with chronic LBP (cLBP) and MCs. Previous biopsy studies have been criticised with regard to methods, few patients and controls, and insufficient measures to minimise perioperative contamination. In this study, we minimise contamination risk, include a control group and optimise statistical power. The main aim is to compare bacterial growth between patients with and without MCs.

Methods and analysis

This multicentre, case–control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses.

Ethics and dissemination

The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.

Trial registration number

NCT03406624.

Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial

Por: Ben · A. J. · van der Vaart · L. R. · E. Bosmans · J. · Roovers · J.-P. W. R. · Lagro-Janssen · A. L. M. · van der Vaart · C. H. · Vollebregt · A. · PEOPLE group · Milani · Bon · Bongers · Bos · Broekman · Dietz · van Eijndhoven · Hakvoort · Janszen · Kluivers · Link · Massop-Hel
Objective

To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.

Design

Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.

Setting

21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.

Participants

1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.

Interventions

Pessary therapy and surgery.

Primary and secondary outcome measures

The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of –10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.

Results

For the PGI-I, the mean difference between pessary therapy and surgery was –0.05 (95% CI –0.14; 0.03) and –0.03 (95% CI –0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=–1807, 95% CI –2172; –1446 and mean difference=–1850, 95% CI –2349; –1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between 0 and 20 000/QALY gained from both perspectives.

Conclusions

Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.

Trial registration number

NTR4883.

Characterization of a full‐thickness decellularized and lyophilized human placental membrane for clinical applications

Abstract

Allografts derived from live-birth tissue obtained with donor consent have emerged as an important treatment option for wound and soft tissue repairs. Placental membrane derived from the amniotic sac consists of the amnion and chorion, the latter of which contains the trophoblast layer. For ease of cleaning and processing, these layers are often separated with or without re-lamination and the trophoblast layer is typically discarded, both of which can negatively affect the abundance of native biological factors and make the grafts difficult to handle. Thus, a full-thickness placental membrane that includes a fully-intact decellularized trophoblast layer was developed for homologous clinical use as a protective barrier and scaffold in soft tissue repairs. Here, we demonstrate that this full-thickness placental membrane is effectively decellularized while retaining native extracellular matrix (ECM) scaffold and biological factors, including the full trophoblast layer. Following processing, it is porous, biocompatible, supports cell proliferation in vitro, and retains its biomechanical strength and the ability to pass through a cannula without visible evidence of movement or damage. Finally, it was accepted as a natural scaffold in vivo with evidence of host-cell infiltration, angiogenesis, tissue remodelling, and structural layer retention for up to 10 weeks in a murine subcutaneous implant model.

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Test-retest reliability of Latin American Group for Maturity (GDLAM) protocol in older women

by Álvaro Huerta Ojeda, Emilio Jofré-Saldía, Jimena Arriagada Molina, Patricia Rojas Quinchavil, María Paz Parada Toledo, Sergio Galdames Maliqueo, María-Mercedes Yeomans-Cabrera, Carlos Jorquera-Aguilera, Frano Giakoni-Ramirez, Maximiliano Bravo

Functional autonomy (FA) is a critical factor in determining the quality of life of older adults (OA), especially in the case of older women (OW), as they face a decline in FA in their later years of life. FA should be assessed early, using valid, reliable, and low-cost tests. This study evaluated the test-retest reliability of GDLAM and GDLAM autonomy index (GI) in OW. Thirty-nine OW (71.2 ± 6.50 years) participated in the study. A repeated measures design was used to compare the interday test-retest reliability of the five GDLAM tests (seconds) and the GI (points). The five tests represent activities of daily living, such as dressing or wandering around the house, while the GI provides a weighting of the results of the five tests. The analysis consisted of the intraclass correlation coefficient (ICC), standard error of measurement (SEM), and coefficient of variation (CV). A CV ≤ 10% and an ICC ≥ 0.80 were considered acceptable reliability, whereas a CV ≤ 5% and an ICC ≥ 0.90 were considered high reliability. The outcome of the five tests, represented by the GI, showed high interday test-retest reliability (CV = 6.00% and ICC = 0.91). The results of this study demonstrate that the five tests of the GDLAM protocol and the GI have high interday test-retest reliability and good interday reproducibility. From a practical point of view, the GDLAM protocol allows the assessment of FA of community-dwelling OW, providing background for early diagnosis and, with it, the possibility of developing an individualized physical exercise prescription.

Skin closUre in carPal tunnEl Release (SUPER): protocol for a blinded randomised controlled trial comparing absorbable and non-absorbable sutures in carpal tunnel release

Por: Savolainen · A. · Nietosvaara · Y. · Sirola · J. · Hytönen · M. · Reito · A. · Heikkinen · N. · Räisänen · M. P.
Introduction

Carpal tunnel syndrome is a common disorder affecting a substantial portion of the general population. Surgical intervention is often deemed necessary, with the median nerve release being one of the most frequent operations. Optimising all the aspects of this procedure can enhance patient satisfaction with the treatment.

Methods and analysis

We aim to determine the differences in the aesthetic outcome of the scar as well as the pain experienced during the healing process between the use of absorbable and non-absorbable sutures. The primary outcome measure will be the patients’ subjective satisfaction with the aesthetic appearance of the scar 1 year after the operation. Secondary outcomes will include a similar evaluation of the aesthetics performed by a blinded outcome assessor, as well as pain experienced by the patients during the 2 weeks postoperatively. The severity and improvement of the patients’ symptoms will also be measured by a Finnish version of the Boston Carpal Tunnel Questionnaire. Costs will be evaluated for both groups. Safety of the wound closure will be followed and reported.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Northern Savo Hospital District (2319/2021). The trial will be conducted in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki. The results will be disseminated through publication in peer-reviewed journals.

Trial registration number

NCT05503719.

Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA)

Por: van den Berg · R. · den Hartog · F. P. J. · Bali · C. · Matsagkas · M. · Bevis · P. M. · Earnshaw · J. J. · Debus · E. S. · Honig · S. · Berrevoet · F. · Detry · O. · Stabilini · C. · Muysoms · F. · Tanis · P. J. · European Hernia Society Prophylactic mesh study group collaborato
Introduction

Incisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated that prophylactic mesh reinforcement after abdominal surgery, in general, is effective and safe. In patients with abdominal aortic aneurysm (AAA), prophylactic mesh reinforcement after open repair has not yet been recommended in official guidelines, because of relatively small sample sizes in individual trials. Furthermore, the identification of subgroups that benefit most from prophylactic mesh placement requires larger patient numbers. Our primary aim is to evaluate the efficacy and effectiveness of the use of a prophylactic mesh after open AAA surgery to prevent IH by performing an individual patient data meta-analysis (IPDMA). Secondary aims include the evaluation of postoperative complications, pain and quality of life, and the identification of potential subgroups that benefit most from prophylactic mesh reinforcement.

Methods and analysis

We will conduct a systematic review to identify RCTs that study prophylactic mesh placement after open AAA surgery. Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase, Web of Science Core Collection and Google Scholar will be searched from the date of inception onwards. RCTs must directly compare primary sutured closure with mesh closure in adult patients who undergo open AAA surgery. Lead authors of eligible studies will be asked to share individual participant data (IPD). The risk of bias (ROB) for each included study will be assessed using the Cochrane ROB tool. An IPDMA will be performed to evaluate the efficacy, with the IH rate as the primary outcome. Any signs of heterogeneity will be evaluated by Forest plots. Time-to-event analyses are performed using Cox regression analysis to evaluate risk factors.

Ethics and dissemination

No new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publications in peer-reviewed journals and summaries posted online.

PROSPERO registration number

CRD42022347881.

The impact of delayed diagnosis and treatment due to COVID-19 on Australian thyroid cancer patients: a qualitative interview study

Por: D'souza · B. · Glover · A. · Bavor · C. · Brown · B. · Dodd · R. H. · Lee · J. C. · Millar · J. · Miller · J. A. · Zalcberg · J. R. · Serpell · J. · Ioannou · L. J. · Nickel · B.
Objectives

The study aims to investigate the perceptions of patients with thyroid cancer on the potential impact of diagnosis and treatment delays during the COVID-19 pandemic.

Design

This study involved qualitative semi-structured telephone interviews. The interviews were transcribed verbatim, analysed using the thematic framework analysis method and reported using the Consolidated Criteria for Reporting Qualitative Research.

Setting

Participants in the study were treated and/or managed at hospital sites across New South Wales and Victoria, Australia.

Participants

17 patients with thyroid cancer were interviewed and included in the analysis (14 females and 3 males).

Results

The delays experienced by patients ranged from 12 months. The patients reported about delays to diagnostic tests, delays to surgery and radioactive iodine treatment, perceived disease progression and, for some, the financial burden of choosing to go through private treatment to minimise the delay. Most patients also reported not wanting to experience delays any longer than they did, due to unease and anxiety.

Conclusions

This study highlights an increased psychological burden in patients with thyroid cancer who experienced delayed diagnosis and/or treatment during COVID-19. The impacts experienced by patients during this time may be similar in the case of other unexpected delays and highlight the need for regular clinical review during delays to diagnosis or treatment.

The role of orthobiologics in chronic wound healing

Abstract

Chronic wounds, characterized by prolonged healing processes, pose a significant medical challenge with multifaceted aetiologies, including local and systemic factors. Here, it explores the complex pathogenesis of chronic wounds, emphasizing the disruption in the normal phases of wound healing, particularly the inflammatory phase, leading to an imbalance in extracellular matrix (ECM) dynamics and persistent inflammation. Senescent cell populations further contribute to impaired wound healing in chronic lesions. Traditional medical management focuses on addressing underlying causes, but many chronic wounds resist to conventional treatments, necessitating innovative approaches. Recent attention has turned to autologous orthobiologics, such as platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and mesenchymal stem cells (MSCs), as potential regenerative interventions. These biologically derived materials, including bone marrow aspirate/concentrate (BMA/BMAC) and adipose tissue-derived stem cells (ADSCs), exhibit promising cytokine content and regenerative potential. MSCs, in particular, have emerged as key players in wound healing, influencing inflammation and promoting tissue regeneration. This paper reviews relevant scientific literature regarding basic science and brings real-world evidence regarding the use of orthobiologics in the treatment of chronic wounds, irrespective of aetiology. The discussion highlights the regenerative properties of PRP, PRF, BMA, BMAC and SVF, showcasing their potential to enhance wound healing. Despite advancements, further research is essential to elucidate the specific roles of each orthobiologic and determine optimal applications for different wound types. The conclusion underscores the evolving landscape in chronic wound management, with a call for more comprehensive studies to refine treatment strategies and maximize the benefits of regenerative medicine.

Predicting pressure injury risk in hospitalised patients using machine learning with electronic health records: a US multilevel cohort study

Por: Padula · W. V. · Armstrong · D. G. · Pronovost · P. J. · Saria · S.
Objective

To predict the risk of hospital-acquired pressure injury using machine learning compared with standard care.

Design

We obtained electronic health records (EHRs) to structure a multilevel cohort of hospitalised patients at risk for pressure injury and then calibrate a machine learning model to predict future pressure injury risk. Optimisation methods combined with multilevel logistic regression were used to develop a predictive algorithm of patient-specific shifts in risk over time. Machine learning methods were tested, including random forests, to identify predictive features for the algorithm. We reported the results of the regression approach as well as the area under the receiver operating characteristics (ROC) curve for predictive models.

Setting

Hospitalised inpatients.

Participants

EHRs of 35 001 hospitalisations over 5 years across 2 academic hospitals.

Main outcome measure

Longitudinal shifts in pressure injury risk.

Results

The predictive algorithm with features generated by machine learning achieved significantly improved prediction of pressure injury risk (p

Conclusions

These data could help hospitals conserve resources within a critical period of patient vulnerability of hospital-acquired pressure injury which is not reimbursed by US Medicare; thus, conserving between 30 000 and 90 000 labour-hours per year in an average 500-bed hospital. Hospitals can use this predictive algorithm to initiate a quality improvement programme for pressure injury prevention and further customise the algorithm to patient-specific variation by facility.

Inter-facility transfers for emergency obstetrical and neonatal care in rural Madagascar: a cost-effectiveness analysis

Por: Franke · M. A. · Nordmann · K. · Frühauf · A. · Ranaivoson · R. M. · Rebaliha · M. · Rapanjato · Z. · Bärnighausen · T. · Muller · N. · Knauss · S. · Emmrich · J. V.
Context

There is a substantial lack of inter-facility referral systems for emergency obstetrical and neonatal care in rural areas of sub-Saharan Africa. Data on the costs and cost-effectiveness of such systems that reduce preventable maternal and neonatal deaths are scarce.

Setting

We aimed to determine the cost-effectiveness of a non-governmental organisation (NGO)-run inter-facility referral system for emergency obstetrical and neonatal care in rural Southern Madagascar by analysing the characteristics of cases referred through the intervention as well as its costs.

Design

We used secondary NGO data, drawn from an NGO’s monitoring and financial administration database, including medical and financial records.

Outcome measures

We performed a descriptive and a cost-effectiveness analysis, including a one-way deterministic sensitivity analysis.

Results

1172 cases were referred over a period of 4 years. The most common referral reasons were obstructed labour, ineffective labour and eclampsia. In total, 48 neonates were referred through the referral system over the study period. Estimated cost per referral was US$336 and the incremental cost-effectiveness ratio (ICER) was US$70 per additional life-year saved (undiscounted, discounted US$137). The sensitivity analysis showed that the intervention was cost-effective for all scenarios with the lowest ICER at US$99 and the highest ICER at US$205 per additional life-year saved. When extrapolated to the population living in the study area, the investment costs of the programme were US$0.13 per person and annual running costs US$0.06 per person.

Conclusions

In our study, the inter-facility referral system was a very cost-effective intervention. Our findings may inform policies, decision-making and implementation strategies for emergency obstetrical and neonatal care referral systems in similar resource-constrained settings.

Association between breast feeding and food consumption according to the degree of processing in Brazil: a cohort study

Background

The benefits of breast feeding may be associated with better formation of eating habits beyond childhood. This study was designed to verify the association between breast feeding and food consumption according to the degree of processing in four Brazilian birth cohorts.

Methods

The duration of exclusive, predominant and total breast feeding was evaluated. The analysis of the energy contribution of fresh or minimally processed foods (FMPF) and ultra-processed foods (UPF) in the diet was evaluated during childhood (13–36 months), adolescence (11–18 years) and adulthood (22, 23 and 30 years).

Results

Those who were predominantly breastfed for less than 4 months had a higher UPF consumption (β 3.14, 95% CI 0.82 to 5.47) and a lower FMPF consumption (β –3.47, 95% CI –5.91 to –1.02) at age 22 years in the 1993 cohort. Exclusive breast feeding (EBF) for less than 6 months was associated with increased UPF consumption (β 1.75, 95% CI 0.25 to 3.24) and reduced FMPF consumption (β –1.49, 95% CI –2.93 to –0.04) at age 11 years in the 2004 cohort. In this same cohort, total breast feeding for less than 12 months was associated with increased UPF consumption (β 1.12, 95% CI 0.24 to 2.19) and decreased FMPF consumption (β –1.13, 95% CI –2 .07 to –0.19). Children who did not receive EBF for 6 months showed an increase in the energy contribution of UPF (β 2.36, 95% CI 0.53 to 4.18) and a decrease in FMPF (β –2.33, 95% CI –4 .19 to –0.48) in the diet at 13–36 months in the 2010 cohort. In this cohort, children who were breastfed for less than 12 months in total had higher UPF consumption (β 2.16, 95% CI 0.81 to 3.51) and lower FMPF consumption (β –1.79, 95% CI –3.09 to –0.48).

Conclusion

Exposure to breast feeding is associated with lower UPF consumption and higher FMPF consumption in childhood, adolescence and adulthood.

Electrophysiological correlates of symbolic numerical order processing

by Clemens Brunner, Philip Schadenbauer, Nele Schröder, Roland H. Grabner, Stephan E. Vogel

Determining if a sequence of numbers is ordered or not is one of the fundamental aspects of numerical processing linked to concurrent and future arithmetic skills. While some studies have explored the neural underpinnings of order processing using functional magnetic resonance imaging, our understanding of electrophysiological correlates is comparatively limited. To address this gap, we used a three-item symbolic numerical order verification task (with Arabic numerals from 1 to 9) to study event-related potentials (ERPs) in 73 adult participants in an exploratory approach. We presented three-item sequences and manipulated their order (ordered vs. unordered) as well as their inter-item numerical distance (one vs. two). Participants had to determine if a presented sequence was ordered or not. They also completed a speeded arithmetic fluency test, which measured their arithmetic skills. Our results revealed a significant mean amplitude difference in the grand average ERP waveform between ordered and unordered sequences in a time window of 500–750 ms at left anterior-frontal, left parietal, and central electrodes. We also identified distance-related amplitude differences for both ordered and unordered sequences. While unordered sequences showed an effect in the time window of 500–750 ms at electrode clusters around anterior-frontal and right-frontal regions, ordered sequences differed in an earlier time window (190–275 ms) in frontal and right parieto-occipital regions. Only the mean amplitude difference between ordered and unordered sequences showed an association with arithmetic fluency at the left anterior-frontal electrode. While the earlier time window for ordered sequences is consistent with a more automated and efficient processing of ordered sequential items, distance-related differences in unordered sequences occur later in time.

Investigating patient engagement associations between a postdischarge texting programme and patient experience, readmission and revisit rates outcomes

Por: Bruce · C. · Pinn-Kirkland · T. · Meyers · A. · Javaluyas · E. · Osborn · J. · Kelkar · S. · Bruchhaus · L. · McLaury · K. · Sauceda · K. · Carr · K. · Garcia · C. · Arabie · L. A. · Williams · T. · Vozzella · G. · Nisar · T. · Schwartz · R. L. · Sasangohar · F.
Objectives

This study aimed (1) to examine the association between patient engagement with a bidirectional, semiautomated postdischarge texting programme and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey outcomes, readmissions and revisit rates in a large health system and (2) to describe operational and clinical flow considerations for implementing a postdischarge texting programme.

Setting

The study involved 1 main academic hospital (beds: 2500+) and 6 community hospitals (beds: 190–400, averaging 300 beds per hospital) in Houston, Texas.

Methods

Retrospective, observational cohort study between non-engaged patients (responded with 0–2 incoming text messages) and engaged patients (responded with 3+ incoming, patient-initiated text messages) between December 2022 and May 2023. We used the two-tailed t-test for continuous variables and 2 test for categorical variables to compare the baseline characteristics between the two cohorts. For the binary outcomes, such as the revisit (1=yes, vs 0=no) and readmissions (1=yes vs 0=no), we constructed mixed effect logistic regression models with the random effects to account for repeated measurements from the hospitals. For the continuous outcome, such as the case mix index (CMI), a generalised linear quantile mixed effect model was built. All tests for significance were two tailed, using an alpha level of 0.05, and 95% CIs were provided. Significance tests were performed to evaluate the CMI and readmissions and revisit rates.

Results

From 78 883 patients who were contacted over the course of this pilot implementation, 49 222 (62.4%) responded, with 39 442 (50%) responded with 3+ incoming text messages. The engaged cohort had higher HCAHPS scores in all domains compared with the non-engaged cohort. The engaged cohort used significantly fewer 30-day acute care resources, experiencing 29% fewer overall readmissions and 20% fewer revisit rates (23% less likely to revisit) and were 27% less likely to be readmitted. The results were statistically significant for all but two hospitals.

Conclusions

This study builds on the few postdischarge texting studies, and also builds on the patient engagement literature, finding that patient engagement with postdischarge texting can be associated with fewer acute care resources. To our knowledge, this is the only study that documented an association between a text-based postdischarge programme and HCAHPS scores, perhaps owing to the bidirectionality and ease with which patients could interact with nurses. Future research should explore the texting paradigms to evaluate their associated outcomes in a variety of postdischarge applications.

Comparative effectiveness of baricitinib and alternative biological DMARDs in a Swiss cohort study of patients with RA

Por: Gilbert · B. T. P. · Mongin · D. · Aymon · R. · Lauper · K. · Laedermann · C. · Perrier · C. · Mueller · R. · Courvoisier · D. S. · Finckh · A.
Objectives

This observational study compares the effectiveness of baricitinib (BARI), a targeted synthetic disease-modifying antirheumatic drug (tsDMARD), with alternative biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA), from a prospective, longitudinal cohort.

Methods

We compared patients initiating a treatment course (TC) of BARI, tumour necrosis factor inhibitors (TNFi) or bDMARDs with other modes of action (OMA), during a period when all these DMARDs were available in Switzerland. The primary outcome was drug maintenance; secondary outcomes included discontinuation rates related specifically to ineffectiveness and adverse events. We further analysed rates of low disease activity (LDA) and remission (REM) at 12 months and drug maintenance in bDMARD-naïve and tsDMARD-naïve population.

Results

A total of 1053 TCs were included: 273 on BARI, 473 on TNFi and 307 on OMA. BARI was prescribed to older patients with longer disease duration and more previous treatment failures than TNFi. Compared with BARI, the adjusted drug maintenance was significantly shorter for TNFi (HR for discontinuation: 1.76; 95% CI, 1.32 to 2.35) but not compared with OMA (HR 1.27; 95% CI, 0.93 to 1.72). These results were similar in the b/tsDMARD-naïve population. The higher discontinuation of TNFi was mostly due to increased discontinuation for ineffectiveness (HR 1.49; 95% CI, 1.03 to 2.15), with no significant differences in drug discontinuation for adverse events (HR 1.46; 95% CI, 0.83 to 2.57). The LDA and REM rates at 12 months did not differ significantly between the three groups.

Conclusions

BARI demonstrated a significantly higher drug maintenance compared with TNFi, mainly due to lower drug discontinuations for ineffectiveness. We found no difference in drug maintenance between BARI and OMA. Clinical outcomes did not differ between the three groups. Our results suggest that BARI is an appropriate therapeutic alternative to bDMARDs in the management of RA.

Interprofessional teams with and without nurse practitioners and the level of adherence to best practice guidelines in cardiac surgery: A retrospective study

Abstract

Aim

To examine the level of adherence to best-practice guidelines of interprofessional teams with acute care nurse practitioners (ACNPs) compared to interprofessional teams without ACNPs.

Design

A retrospective observational study was conducted in 2023.

Method

A retrospective cohort was created including 280 patients who underwent a coronary artery bypass graft and/or a valve repair and hospitalised in a cardiac surgery unit of a university affiliated hospital in Québec (Canada) between 1 January 2019 to 31 January 2020.

The level of adherence to best-practice guidelines was measured from a composite score in percentage. The composite score was created from a newly developed tool including 99 items across six categories (patient information, pharmacotherapy, laboratory tests, post-operative assessment, patient and interprofessional teams' characteristics). Multivariate linear and logistic regression models were computed to examine the effect of interprofessional teams with ACNPs on the level of adherence to best-practice guidelines.

Results

Most of the patients of the cohort were male and underwent a coronary artery bypass graft procedure. Patients under the care of interprofessional teams with ACNP were 1.72 times more likely to reach a level of adherence higher than 80% compared to interprofessional teams without ACNPs and were 2.29 times more likely to be within the highest quartile of the scores for the level of adherence to best-practice guidelines of the cohort.

Impact

This study provides empirical data supporting the benefits of ACNP practice for patients, interprofessional teams and healthcare organisations.

Relevance for Practice

Our findings identify the important contributions of interprofessional teams that include ACNPs using a validated instrument, as well as their contribution to the delivery of high quality patient care.

Reporting Method

This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for reporting observational studies guidelines.

Patient or Public Contribution

No patient or public contribution.

Prevalence, risk factors and impact of delirium in adult inpatients in a tertiary care hospital: A point prevalence study

Abstract

Aims

To describe the point prevalence, risk factors and possible outcomes of delirium in inpatients.

Design

A cross-sectional point prevalence study.

Background

Delirium is an acute brain syndrome that negatively affects patients, healthcare professionals and institutions alike; it is common in inpatient settings and is preventable in about one third of cases. Although guidelines recommend systematic screening and assessment, delirium is often unrecognised, undiagnosed and uncoded. There is a lack of valid data on this patient safety indicator in German-speaking countries.

Methods

The study was conducted in a tertiary care hospital in Switzerland on 5 July 2022. Specially trained registered nurses collected data from all patients meeting the inclusion criteria using CAM, ICDSC or mCAM-ED. Data were analysed descriptively with stratification by delirium status, setting and surgery.

Results

The point prevalence across all settings was 6.9% (27/390), with large variation between settings: ICU 28.6% (4/14), IMC 28.0% (7/25), wards 4.6% (15/326) and ED 4% (1/25). Surgical patients were almost twice as likely to be affected as medical patients (8.9% vs. 4.8%). Patients with delirium differed most clearly from those without by having a larger number of ICD-10 F-diagnoses, a larger number of medications and higher age, which are known risk factors. Moreover, those with delirium had more missed diagnoses, increased mortality, more adverse events and higher costs.

Conclusions

A significant number of patients experienced delirium and adverse clinical outcomes. Missed delirium diagnoses may further jeopardise patient safety and result in lost revenue. It remains unclear to what extent the risk factors and effects of delirium are causal and what determinants underlie missed diagnoses.

Relevance to Clinical Practice

Consistent identification of high-risk patients and treatment settings with elevated risk, accompanied by the implementation of effective preventive and management strategies, is critical to addressing delirium.

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