Category: Nevin Manimala

Clin Ther. 2024 Nov 1:S0149-2918(24)00287-X. doi: 10.1016/j.clinthera.2024.09.024. Online ahead of print.

ABSTRACT

PURPOSE: Patients with transfusion-dependent β-thalassemia (TDT) have reduced levels of β-globin, leading to ineffective erythropoiesis and iron overload. Patients with TDT depend on regular red blood cell transfusions (RBCTs) and iron chelation therapy for survival and management of disease- and treatment-related clinical complications. This study describes the clinical and economic burden in patients with TDT in England.

METHODS: This longitudinal, retrospective study linked the Clinical Practice Research Datalink (CPRD) database with secondary care data from the Hospital Episode Statistics database to identify patients with a diagnosis of β-thalassemia between July 1, 2008, and June 30, 2018. Included patients had a diagnosis of β-thalassemia prior to the index date, ≥8 RBCTs per year for ≥2 consecutive years, and ≥1 year of follow-up data available from the index date. Each eligible patient was exact matched with up to 5 controls in the CPRD. Proportions of deaths and rates of mortality, acute and chronic complications, and healthcare resource utilization (HCRU) were calculated during the follow-up period.

FINDINGS: Of 11,359 identified patients with β-thalassemia, 237 patients with TDT met the eligibility criteria and were matched with 1184 controls. The mean age at the index date was approximately 25 years in the patient and control groups. The proportion of deaths (7.17% vs 1.18%; P < 0.05) and mortality rate (1.19 deaths per 100 person-years vs 0.20 deaths per 100 person-years) were higher among patients with TDT compared to controls. Endocrine complications and bone disorders were the most prevalent complications among patients with TDT (58.23%) and included osteoporosis (29.11%), diabetes mellitus (28.27%), and hypopituitarism (28.27%). Patients with TDT had a mean of 13.62 RBCTs per patient per year (PPPY). HCRU was substantially higher among patients with TDT, wherein patients with TDT had higher rates of prescriptions recorded in primary care (24.09 vs 8.61 PPPY), outpatient visits (16.69 vs 1.31 PPPY), and inpatient hospitalizations (17.41 vs 0.24 PPPY) than controls. Inpatient hospitalizations were primarily <1 day, with 16.62 events PPPY lasting <1 day and 0.79 events PPPY lasting ≥1 day. Patients with TDT aged ≥18 years had increased rates of mortality, clinical complications, and HCRU than those aged <18 years.

IMPLICATIONS: Patients with TDT in England have higher mortality than matched controls, substantial disease-related clinical complications, and substantial HCRU. High mortality and clinical complications highlight the need for additional innovative therapies for TDT.

PMID:39488494 | DOI:10.1016/j.clinthera.2024.09.024

An Pediatr (Engl Ed). 2024 Nov 1:S2341-2879(24)00265-5. doi: 10.1016/j.anpede.2024.10.006. Online ahead of print.

ABSTRACT

INTRODUCTION: The management of congenital heart disease (CHD) has evolved, improving patient outcomes; however, challenges persist for patients, emphasizing the importance of assessing health-related quality of life (HRQoL). The widely used Pediatric Quality of Life Inventory underscores the relevance of HRQoL assessment, especially in children subject to medical procedures.

OBJECTIVE: To evaluate HRQoL in children with congenital heart disease undergoing cardiac catheterization, analysing its association with clinical and sociodemographic variables in a tertiary care hospital.

MATERIALS AND METHODS: We conducted a cross-sectional study in paediatric patients aged 2-18 years undergoing haemodynamic procedures for congenital heart diseases. We used the Pediatric Quality of Life Inventory (PedsQL) to assess HRQoL. The statistical analysis included descriptive statistics, χ² tests, Kruskal-Wallis tests and multivariate linear regression analysis with the aim of identifying factors associated with HRQoL.

RESULTS: The sample included 164 patients, among whom pulmonary atresia and patent ductus arteriosus were frequent diagnoses. Physical functioning and school functioning were significantly impaired, with median scores of 32.14 (IQR, 17.14-62.87) and 56 (IQR, 28-88), respectively. The results were more favourable for emotional functioning and social functioning, with median scores of 62 (IQR, 32-74) and 68 (IQR, 44-100), respectively. Single ventricle defects and pulmonary atresia were associated with lower quality of life scores in emotional functioning (P = .035) and physical functioning (P = .048), respectively.

CONCLUSION: This study highlights the current challenges in evaluating HRQoL for children with CHD. It identified significant associations between specific diagnoses and decreased HRQoL scores, emphasizing the need for comprehensive care strategies.

PMID:39488488 | DOI:10.1016/j.anpede.2024.10.006

Cardiovasc Revasc Med. 2024 Oct 28:S1553-8389(24)00705-X. doi: 10.1016/j.carrev.2024.10.007. Online ahead of print.

ABSTRACT

BACKGROUND: The J-CTO investigators recently developed angiographic difficulty scores for each of the three major coronary arteries in patients undergoing first-attempt chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in de novo occlusions.

METHODS: We examined the performance of the individual J-CTO scores in a large multicenter registry.

RESULTS: The CTO lesion location was as follows: right coronary artery (RCA) 3,805 (54%), left anterior descending artery (LAD) 2,303 (33%), and left circumflex (LCX) 935 (13%). Patients in the PROGRESS-CTO registry were younger, more likely to be female, and had higher J-CTO scores compared with the J-CTO registry. Increasing difficulty scores were associated with lower technical success in the PROGRESS-CTO registry (score 0: 94.4 % – score ≥3: 82.6% for the RCA difficulty score; score 0: 96.4% – score ≥3: 86.1 for the LAD difficulty score; and score 0: 95.4% – score ≥3: 81.2% for the LCX difficulty score). The C-statistic of the coronary artery specific J-CTO scores in the PROGRESS-CTO registry were: LAD 0.69 (95% confidence intervals [CI], 0.64-0.73), LCX 0.63 (95% CI, 0.57-0.69), and RCA 0.61 (95-% CI, 0.58-0.64) with good calibration (Hosmer-Lemeshow p-value >0.05 for all). The AUC of the classic J-CTO score for LAD lesions was similar with the LAD J-CTO score (p-for-difference = 0.26), but worse for LCX (p-for-difference = 0.04) and RCA lesions (p-for-difference = 0.04).

CONCLUSION: In the PROGRESS-CTO registry, the coronary artery specific J-CTO scores did not improve prediction of the technical success of CTO-PCI compared with the classic J-CTO score.

PMID:39488482 | DOI:10.1016/j.carrev.2024.10.007

J Pediatr Surg. 2024 Oct 20:162020. doi: 10.1016/j.jpedsurg.2024.162020. Online ahead of print.

ABSTRACT

AIM: To evaluate factors associated with excellent correction in pectus excavatum patients undergoing vacuum bell therapy (VBT).

METHODS: A single-institution retrospective chart review was performed November 2012-April 2023 to assess corrections of patients who underwent VBT. Patient demographics, presentation, and results were collected. Excellent correction was defined as complete correction or >100 % improved from an average standard chest depth of 0.51 cm. Data are reported using odds ratio & confidence intervals; and paired t-test comparison. A p-value of <0.05 was regarded as significant.

RESULTS: VBT was utilized in 431 patients with 278 patients included and 153 excluded due to loss of follow-up or incomplete data. Of those included, 89 % were male. There were 31 patients with excellent corrections (11 %) and 247 non-excellent corrections. Initial chest depth < 1.5 cm and chest wall flexibility remain important predictors of positive outcome (p=0.008 and < 0.001, respectively). Excellent correction was statistically more likely in patients aged 8 to 12.9 (OR = 2.2, p = 0.039). Surgical correction following VBT was performed in only 15.5 % (42 of 278) of our patients, none of which were in the group with an excellent correction.

CONCLUSION: Excellent correction for pectus excavatum via VBT was achieved in a small proportion of patients, with improved outcomes in those initiating therapy at a younger age, with a mild defect, and with increased chest wall flexibility. These data may be used to help determine those more likely to achieve complete correction from a nonsurgical approach and guide decisions towards treatment methods.

PMID:39488480 | DOI:10.1016/j.jpedsurg.2024.162020

Dent Mater. 2024 Nov 1:S0109-5641(24)00309-9. doi: 10.1016/j.dental.2024.10.019. Online ahead of print.

ABSTRACT

OBJECTIVES: To proof the feasibility of direct colour printing on 3Y-TZP using 222 nm UV-C through investigating the degree and durability of the colour changes, and testifying whether surface, mechanical and biological properties are influenced by the treatment.

METHODS: 222 nm UV-C light (Irradiance: 1.870 mW/cm²) was used to treat 3Y-TZP for durations from 15 min to 24 h. ΔE*, TP, crystalline structure, surface morphology, S_a, BFS and biological activities were investigated before and after irradiation. SPSS 28.0 was used for statistical analysis (α = 0.05).

RESULTS: 222 nm UV-C irradiation was capable to shade white 3Y-TZP into tooth colours. With the increase of ΔE*, TP decreased, such that the longer the irradiation time, the higher the ΔE* (logarithmic relationship) and lower the TP. Despite the induced optical changes being prone to fade, the process can be predicted by inversely proportional relationships between ΔE*, TP and the testing points. The treated surface exhibited enhanced hydrophilicity, while the recovery phenomenon was observed. Other properties were not altered by the treatment.

SIGNIFICANCE: This is the seminal study demonstrating the feasibility of direct colour printing on 3Y-TZP using 222 nm UV-C. The new relationship between the colour centre and E_g of 3Y-TZP was established, whereas the induced optical changes were stabilised after a certain period and were highly predictable by controlling the irradiation periods. The irradiation was only correlated to the electron excitation and oxygen vacancies, and would not lead to any changes of other properties. A simple, safe and promising approach to achieve satisfactory colours on 3Y-TZP in clinical practice can be developed.

PMID:39488475 | DOI:10.1016/j.dental.2024.10.019

BMJ Open Qual. 2024 Nov 2;13(4):e002727. doi: 10.1136/bmjoq-2023-002727.

ABSTRACT

BACKGROUND: An advance care plan outlines a patient’s wishes regarding medical treatment or goals of care in the case that they become unable to communicate or to make decisions. An advance care directive (ACD) is an advance care plan that has been formally recorded and has legal status. Despite ACDs playing an important role in person-centred end-of-life care, an earlier retrospective medical records audit demonstrated that only 11% (58/531) of people who died due to a terminal illness had an ACD.The aim of this project was to increase the proportion of patients with a terminal illness completing an ACD. A secondary outcome was to measure the impact of ACDs on hospital and intensive care unit (ICU) admissions in the last 6 months of life.This multifaceted project comprised (1) education for health professionals and the public; (2) individual support for patients on request; (3) development of online resources for health professionals and the general public; and (4) monthly team meetings.

METHOD: The proportion of ACDs completed and hospital and ICU admissions during the last 6 months of life, were extracted via medical record audits.Written consent was required for patients to participate, including being contacted by the project team and accessing their medical records.

RESULTS: 112 patients consented to participate in the project and 109 (97%) completed an ACD. There was no reduction in the average number of hospital admissions, while ICU admissions reduced from 14% (n=74) to 0%.

CONCLUSION: The targeted, multifaceted approach to education and support for completion of ACDs, resulted in a significant increase in ACD completion and a major reduction in ICU admissions.

PMID:39488435 | DOI:10.1136/bmjoq-2023-002727

BMJ Open. 2024 Nov 2;14(11):e084938. doi: 10.1136/bmjopen-2024-084938.

ABSTRACT

OBJECTIVE: The objective of this study is to explore whether offering an integrated self-management strategy and exercise referral scheme intervention (ERS+SMS) or a stand-alone ERS intervention is more effective in reducing healthcare service utilisation among community-dwelling older adults over time compared with a stand-alone SMS/control intervention.

DESIGN: Secondary analyses of two randomised controlled trials (RCTs) with linkage to Danish national health registries.

SETTING: Three Danish municipalities: Esbjerg, Slagelse and Odense.

PARTICIPANTS: Danish community-dwelling older adults, aged 65 years or older, were included in the study. Participants originated from two completed RCTs: the Welfare Innovation in Primary Prevention (WIPP, n=115) and the SITLESS project (SITLESS, n=333).

INTERVENTION: Participants in the two trials were randomly assigned to one of three intervention groups: ERS in combination with SMS (ERS+SMS), ERS alone or an SMS/control intervention.

MAIN OUTCOME MEASURE: Annual number of days with contact to general practice (GP) and days hospitalised for all causes.

RESULTS: No statistically significant between-group difference was observed in the annual number of days with contact with GP between participants randomised to ERS+SMS (p=0.759) or ERS only (p=0.156) compared with those randomised to the SMS/control group. In addition, no statistically significant between-group differences in days hospitalised were observed when comparing the ERS+SMS (p=0.222) or ERS only (p=0.060) group to the SMS/control group.

CONCLUSION: Neither the integrated intervention (ERS+SMS) nor the ERS alone intervention was more effective in reducing healthcare service utilisation during a 2-year follow-up period compared with a stand-alone SMS/control intervention. A potential stabilising effect of ERS and/or SMS interventions on the general age-related increase in healthcare service utilisation cannot be ruled out but needs further exploration in future studies along with the exploration of the effects of long-term interventions.

TRIAL REGISTRATION NUMBERS: NCT04531852 : and : NCT02629666 : .

PMID:39488430 | DOI:10.1136/bmjopen-2024-084938

BMJ Open. 2024 Nov 2;14(11):e083620. doi: 10.1136/bmjopen-2023-083620.

ABSTRACT

OBJECTIVE: Performance visualisation tools are increasingly being applied in healthcare to enhance decision-making and improve quality of care. However, there is a lack of comprehensive synthesis of their overall effectiveness and the contextual factors that influence their success in different clinical settings. This study aims to provide a broad synthesis of visualisation interventions not limited to a specific department.

DESIGN: Systematic review.

DATA SOURCES: MEDLINE and Embase were searched until December 2022.

ELIGIBILITY CRITERIA: Randomised controlled trials (RCTs) and observational studies in English involving a visualisation intervention, either alone or as a core intervention, that reported quantitative outcomes including process and outcome indicators.

DATA EXTRACTION AND SYNTHESIS: Data on study characteristics, intervention characteristics, outcome measures and results were extracted. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach, and risk of bias was evaluated with Risk of Bias 2 for RCTs and Risk of Bias in Non-randomised Studies – of Interventions for non-randomised studies. RESULTS : Of the 12 studies included, 2 were RCTs and 10 were observational studies, including 1 before-after study and 1 interrupted time series study. Five studies (42%) were conducted in teaching hospital settings. Compared with the control group or baseline, 10 studies reported a statistically significant change in at least one of their outcome measures. A majority of the studies reported a positive impact, including prescription adherence (6/10), screening tests (3/10) and monitoring (3/10). Visualisation tool factors like type, clinical setting, workflow integration and clinician engagement, may have some influence on the effectiveness of the intervention, but no reliable evidence was identified.

CONCLUSION: Performance visualisation tools have the potential to improve clinical performance indicators. More studies with standardised outcome measures and integrating qualitative methods are needed to understand the contextual factors that influence the effectiveness of these interventions.

PMID:39488428 | DOI:10.1136/bmjopen-2023-083620

BMJ Open. 2024 Nov 2;14(11):e092165. doi: 10.1136/bmjopen-2024-092165.

ABSTRACT

INTRODUCTION: Delirium, a clinical manifestation of acute encephalopathy, is associated with extended hospitalisation, long-term cognitive dysfunction, increased mortality and high healthcare costs. Despite intensive research, there is still no targeted treatment. Delirium is characterised by electroencephalography (EEG) slowing, increased relative delta power and decreased functional connectivity. Recent studies suggest that transcranial alternating current stimulation (tACS) can entrain EEG activity, strengthen connectivity and improve cognitive functioning. Hence, tACS offers a potential treatment for augmenting EEG activity and reducing the duration of delirium. This study aims to evaluate the feasibility and assess the efficacy of tACS in reducing relative delta power.

METHODS AND ANALYSIS: A randomised, double-blind, sham-controlled trial will be conducted across three medical centres in the Netherlands. The study comprises two phases: a pilot phase (n=30) and a main study phase (n=129). Participants are patients aged 50 years and older who are diagnosed with delirium using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria (DSM-5-TR), that persists despite treatment of underlying causes. During the pilot phase, participants will be randomised (1:1) to receive either standardised (10 Hz) tACS or sham tACS. In the main study phase, participants will be randomised to standardised tACS, sham tACS or personalised tACS, in which tACS settings are tailored to the participant. All participants will undergo daily 30 min of (sham) stimulation for up to 14 days or until delirium resolution or hospital discharge. Sixty-four-channel resting-state EEG will be recorded pre- and post the first tACS session, and following the final tACS session. Daily delirium assessments will be acquired using the Intensive Care Delirium Screening Checklist and Delirium Observation Screening Scale. The pilot phase will assess the percentage of completed tACS sessions and increased care requirements post-tACS. The primary outcome variable is change in relative delta EEG power. Secondary outcomes include (1) delirium duration and severity, (2) quantitative EEG measurements, (3) length of hospital stay, (4) cognitive functioning at 3 months post-tACS and (5) tACS treatment burden. Study recruitment started in April 2024 and is ongoing.

ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethics Committee of the Utrecht University Medical Center and the Institutional Review Boards of all participating centres. Trial results will be disseminated via peer-reviewed publications and conference presentations.

TRIAL REGISTRATION NUMBER: NCT06285721.

PMID:39488424 | DOI:10.1136/bmjopen-2024-092165

BMJ Open. 2024 Nov 2;14(11):e082625. doi: 10.1136/bmjopen-2023-082625.

ABSTRACT

OBJECTIVES: (1) To examine if a more accessible built environment (BE) is significantly associated with better knee function outcomes in knee osteoarthritis (OA) patients. (2) To assess if the relationship between BE and knee function is mediated by fear of movement and self-efficacy.

DESIGN: Cross-sectional study.

SETTING: Two tertiary hospitals in Singapore.

PARTICIPANTS: 212 knee OA patients (mean: 63.81±8.27 years old), majority female (69.8%).

INCLUSION CRITERIA: (i) meets National Institute for Health and Care Excellence criteria for knee OA, (ii) independent community ambulant.

EXCLUSION CRITERIA: (i) alternative diagnosis to knee OA, (ii) secondary osteoarthritis, (iii) severe medical and/or cognitive comorbidity impairing activities of daily living, (iv) previous knee arthroplasty, (v) wheelchair bound, or (vi) pregnant. PRIMARY AND SECONDARY OUTCOME MEASURES; STATISTICS: How self-efficacy (Arthritis Self-Efficacy Scale-8 (ASES-8)) and fear of movement (Brief Fear of Movement (BFOM)) mediates impact of overall BE (IPAQ-Environment module: Access to Destinations) and five item-specific domains of BE accessibility on knee function (Knee Injury and Osteoarthritis Outcome Score-12 (KOOS-12)). For variables significantly correlated with BE and KOOS-12 in bivariate Pearson correlation tests, mediation analysis was performed with confounders adjusted.

RESULTS: Total BE (r=0.142, p=0.038) and accessibility to transit station (r=0.161, p=0.019) were positively correlated with KOOS-12. Structural barriers (r=-0.138, p=0.045) were negatively correlated with KOOS-12. ASES-8 was a significant mediator in the relationship between accessibility to transit station and KOOS-12 (coeff=0.87, 95% CI=(0.24, 1.69), p=0.005) and between total BE and KOOS-12 (coeff=0.25, 95% CI=(0.10, 0.45), p=0.004). BFOM was a marginally significant mediator between structural barriers and KOOS-12 (coeff=-0.36, 95% CI=(-0.86, -0.02); p=0.054).

CONCLUSION: More accessible BE and lesser structural barriers in the BE are associated with better knee function. Self-efficacy mediates the relationship between overall BE accessibility and knee function. Fear of movement mediates the negative association between barriers in the BE and knee function.Applications include assessing BE barriers and psychosocial mediators in clinician consultations, developing multidisciplinary integrated care models and urban designers planning mobility friendly BEs.

TRIAL REGISTRATION NUMBER: The study has been registered under clinicaltrials.gov registry (Identifier: NCT04942236).

PMID:39488423 | DOI:10.1136/bmjopen-2023-082625