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Herpes zoster incidence rates in adults aged 18 years or older with immunocompromising or chronic conditions in England: a large retrospective cohort study (Clinical Practice Research Datalink, 2012-2019)

Por: Mahmood · A. · Nishimwe · M. · Vekria · Y. · Keapoletswe · K. · Lay-Flurrie · S. · Paparrodopoulos · S. · Stavrev · S. · Hunjan · M. · Oraichi · D. · OReilly · C. · Farrow · S. · Guimicheva · B. · Posiuniene · I. · Parry · H. M. · Marijam · A.
Objectives

To estimate the annual and overall incidence rates (IRs) of herpes zoster (HZ) in adults with selected immunocompromising or chronic conditions by age and condition and to estimate HZ complications and recurrence in adults with immunocompromising or chronic conditions by age.

Design and setting

Retrospective observational cohort study using data from the UK Clinical Practice Research Database Aurum, with linkage to Hospital Episode Statistics and the Office for National Statistics data in England (January 2012–December 2019).

Participants

Adults ≥18 years with no record of HZ or HZ vaccination prior to the index date. Four study populations were identified and included individuals with: selected immunocompromising conditions (immunocompromised (IC) population, N=1 764 900), none of the selected immunocompromising conditions (IC-free population, N=12 867 750), selected chronic conditions (chronic disease (CD) population, N=6 423 633) and none of the selected immunocompromising or chronic conditions (IC-free/CD-free, N=8 235 858).

Primary and secondary measures

HZ IRs estimated per 1000 person-years (PY) with 95% CIs; percentage (with 95% CIs) of individuals with HZ who developed HZ complications; rate of HZ recurrence per 1000 PY with 95% CIs stratified by age group.

Results

HZ IRs were higher in the IC and CD populations than in the IC-free and IC-free/CD-free populations and increased with age in all populations (eg, from 3.34 per 1000 PY (95% CI 3.26 to 3.42) in the 18–49 years group to 12.58 per 1000 PY (12.34 to 12.81) in the ≥80 years group in the IC population and from 2.45 per 1000 PY (2.42 to 2.48) in the 18–49 years group to 11.54 per 1000 PY (11.40 to 11.68) in the ≥80 years group in the CD population). A similar pattern was seen across individual immunocompromising and chronic conditions. The proportion of HZ complications increased with age and was higher in the IC and CD populations versus the IC-free and IC-free/CD-free populations. HZ recurrence rates were higher in the IC than IC-free population.

Conclusions

This very large, up-to-date, real-world study highlights the higher HZ IRs in adults with immunocompromising or chronic conditions in England compared with those without such conditions. This study reinforces the need for the current UK HZ vaccination programme in adults with immunocompromising conditions and can inform further research, clinical guidelines and immunisation policy discussions.

Obstetric Bleeding Study UK (OBS UK): protocol for a stepped wedge cluster randomised trial investigating the clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth

Por: Kotecha · S. J. · Potter · C. · Hope-Bell · J. · Riddell · N. S. · Munnery · K. · Onyimadu · O. · Liberty · C. · Taylor · H. · Dop · C. · De Lloyd · L. · Parry-Smith · W. · Townson · J. · Pallmann · P. · Moody · G. · Moriarty · Y. · Deere · R. · Barlow · C. · Dhadda · A. · Elsmore · A. · Wil
Introduction

Bleeding during and after childbirth (postpartum haemorrhage, PPH) is the leading cause of severe maternal morbidity in the UK. Between 2017 and 2018, a PPH care bundle termed the Obstetric Bleeding Strategy (OBS) was implemented as a quality improvement project across all Welsh maternity units and improvements in maternal outcomes were observed. The OBS PPH care bundle incorporates assessment of bleeding risk, real-time cumulative quantification of blood loss, escalation of multiprofessional care including more senior staff at defined volumes of blood loss and point-of-care testing of coagulation at 1 L blood loss (or earlier if clinical concern) with targeted blood product transfusion in cases of haemostatic impairment. The Obstetric Bleeding Study UK (OBS UK) will evaluate this intervention in a larger number of maternity units across the UK.

Methods and analysis

OBS UK is a stepped wedge cluster randomised trial designed to test the effectiveness of the OBS intervention compared with usual care on clinical and psychological PPH outcomes after childbirth, evaluate its cost-effectiveness and perform a process evaluation. The study will be capturing data from over 270 000 women and birthing people giving birth in the care of 36 participating maternity units during the 30-month study period. All maternity units will undertake a control period (lasting 3–18 months) during which usual PPH care will be provided, followed by a 9-month implementation period during which the OBS PPH care bundle will be introduced using quality improvement methods and then an OBS UK intervention period (lasting 3–18 months) during which OBS PPH care will be delivered.

The primary outcome is the number of women receiving allogeneic red blood cell transfusion for PPH per 1000 maternities. Secondary outcomes are informed by the core PPH outcome set, psychological and cost-effectiveness measures for women and their partners and a mixed methods process evaluation exploring how the intervention was deployed and possible improvements to inform wider implementation.

Ethics and dissemination

OBS UK will establish whether (and how) the OBS UK PPH care bundle improves outcomes and experiences of women and their partners. Published results will provide evidence to inform PPH maternity care across the UK and internationally. Dissemination of the findings will be made available to members of the public and participants.

Trial registration number

ISRCTN17679951.

Implementation and evaluation of an ambulatory care pathway for intra-arterial treatment of primary liver cancer: study protocol for a multicentre randomised controlled hybrid type 1 trial (CHOC)

Por: Gregory · J. · Hammel · J.-F. · Ronot · M. · Roux · C. · Barat · M. · Allaire · M. · Parlati · L. · Moussa · N. · Beunon · P. · Oberti · F. · Chevallier · P. · Anty · R. · Girot · P. · Sutter · O. · Ganne · N. · Papadopoulos · P. · Blanc · J.-F. · Ghelfi · J. · Decaens · T. · Yzet · T. · Nguye
Introduction

Primary liver cancers, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, are one of the leading causes of cancer-related mortality. Transarterial chemoembolisation (TACE) and radioembolisation (TARE) are established palliative treatments yet they are traditionally performed during inpatient hospitalisation. Recent technical and organisational advances allow for safe same-day ambulatory procedures. In particular, the extent to which ambulatory intra-arterial therapy aligns with patients’ expectations, comfort and quality of life remains poorly documented. The Care pathway for Hepatic intra-arterial Oncology in an ambulatory Context study (CHOC) trial aims to evaluate the implementation and effectiveness from both patient-centred and clinical perspectives of an ambulatory care pathway for intra-arterial treatment of primary liver cancer in a multicentre randomised hybrid type 1 trial.

Methods and analysis

CHOC is a pragmatic, multicentre, randomised controlled hybrid type 1 trial comparing ambulatory versus conventional inpatient care for patients undergoing TACE or TARE for primary liver cancer. A total of 206 patients (103 per arm) will be randomised 1:1 and followed for 7 months. The primary outcome is the patient’s global satisfaction score, measured 3 days post-procedure using the EORTC PATSAT-C33 questionnaire. Secondary outcomes include quality of life, safety, clinical outcomes, cost analysis and an embedded qualitative implementation study assessing acceptability, adoption, feasibility and sustainability across centres. Economic analyses will estimate both per-patient costs and the 5-year budget impact for the French national health insurance.

Ethics and dissemination

The study has received ethical approval from the Protection of Persons Committee and adheres to the Declaration of Helsinki, good clinical practice and French regulatory requirements. Findings will be disseminated through peer-reviewed publications, conferences and participating centres to guide broader implementation of ambulatory interventional radiology care.

Trial registration number

NCT06990659.

Menopause age and hypercholesterolemia comorbidities: a region-wide retrospective cohort study in Andalusia, Spain (2016-2022)

Por: Esteban-Medina · A. · de la Oliva · V. · Fernandez del Valle · P. · Sanchez · A. · Susin · M. B. · Loucera · C. · Antinolo · G. · Dopazo · J.
Objectives

To quantify sex- and age-related differences in hypercholesterolaemia diagnosis and associated comorbidities around the menopausal transition, using a population-based real-world dataset.

Design

Retrospective, multicentre, non-interventional observational cohort study.

Setting

Region-wide public healthcare system data (primary and secondary care) from Andalusia (Spain), 2016–2022.

Participants

All adult patients meeting inclusion criteria with a recorded diagnosis of hypercholesterolaemia between 1 January 2016 and 31 December 2022 (n=557 034; 227 834 men and 329 200 women).

Interventions

None.

Primary and secondary outcome measures

Primary outcomes were age- and sex-stratified patterns of hypercholesterolaemia diagnosis and comorbidity burden before and after age 50 years (proxy for post-menopausal age). Secondary outcomes included comorbidity-specific comparisons between sexes across age strata and trajectory-based analyses (OR trajectories and incidence-ratio summaries).

Results

Women were diagnosed later than men (mean age 59.1 vs 56.0 years; mean difference 3.1 years, 95% CI 3.03 to 3.17). Hypercholesterolaemia diagnoses in women rose sharply around ages 50–55 and remained higher than in men at older ages. Comorbidity patterns differed by sex across age strata: compared with men, women aged ≥50 years had higher frequencies of osteoporosis (42 255 vs 2623), anxiety disorder (94 916 vs 31 374) and hypertension (147 538 vs 91 532), with statistically significant differences for these comparisons (p

Conclusions

Menopause age is a pivotal period associated with a shift towards higher hypercholesterolaemia diagnosis rates and a greater burden of specific comorbidities in women. These findings support sex-specific prevention and management strategies, particularly targeting the menopausal transition and early post-menopause.

Inter-examiner repeatability of measuring phorias using three different methods: Neurolens measurement device, the von Graefe method, and prism cover test

by Denise Skiadopoulos, Alaina Bandstra, Valerie Kattouf, Corina van de Pol, Vivek Labhishetty, Sumeer Singh

Objective

Heterophoria is routinely measured during a comprehensive ocular examination. The aim of the current study is to compare the inter-examiner repeatability of the Neurolens measurement device (nMD), a commercially available instrument that objectively assesses phoria, to the inter-examiner repeatability of prism alternating cover test and the von Graefe method.

Methods

91young adults aged between 18–60 years were enrolled. Two experienced optometrists assessed phoria on each subject using three methods: the von Graefe method (VG), prism alternating cover test (PCT) and nMD. VG and PCT were performed at distance (6m) and near (40 cm). The nMD measurements were obtained using virtual distance (6m) and near (50 cm) targets. All the tests were performed in a single session by both the examiners in a randomized order.

Results

All study participants were students, staff, and faculty of the Illinois College of Optometry. Of the 91 participants recruited, 65 were female. All participants completed the study with no missing data. The repeatability analysis showed nMD (distance: 0.69 ± 0.77PD; near: 1.00 ± 0.98PD) to have the smallest mean absolute difference at both distance and near compared to VG (distance: 3.28 ± 3.18PD; near: 4.48 ± 3.99PD) and PCT (distance: 1.50 ± 2.36PD; near: 4.05 ± 3.69PD). Bland Altmann analysis showed that the phoria measurements from nMD exhibited significantly less variability when compared with VG and PCT.

Conclusions

The Neurolens measurement device (nMD) has the highest inter-examiner repeatability when compared to traditional VG and PCT methods. Given that the measurements are objective and repeatable compared to the two traditional methods, this device has the potential to be a useful addition to current methods of clinical practice.

Skeletal muscle index, grip strength, and physical performance as predictors of severe chemotherapy toxicity among older adults with malignancy

by Efthymios Papadopoulos, Dmitry Rozenberg, Andy Kin On Wong, Sharon Hiu Ching Law, Sarah Costa, Angela M. Cheung, Shabbir M. H. Alibhai

Background

Skeletal muscle index (SMI), grip strength, and physical performance have been shown to predict clinically relevant outcomes in geriatric oncology. However, their predictive ability for chemotherapy toxicity is poorly understood. We examined whether SMI, grip strength, or physical performance are independently associated with severe toxicity among older adults receiving chemotherapy.

Methods

Older adults (≥65y) who had received chemotherapy at an academic cancer center between June 2015 and June 2022 were included in the analysis. SMI prior to chemotherapy was determined via computed tomography (CT), using the entire cross-sectional area of the muscle (cm2) at the third lumbar vertebra (L3) divided by the square of patient height in meters. Grip strength and lower extremity physical performance were measured prior to chemotherapy. Multivariable logistic regression was used to examine the independent associations between SMI, low grip strength, and low physical performance with severe (grade≥3) chemotherapy toxicity.

Results

Of the 115 older adults in the study, 71.3% were males. The most common disease site was genitourinary (53.9%) and most participants received chemotherapy with palliative intent (67.8%). A total of 69 (60.0%) participants experienced at least one grade ≥3 toxicity during the study. In multivariable analyses, low grip strength per the Sarcopenia Definitions and Outcomes Consortium (SDOC) definition was significantly associated with grade ≥3 toxicity (adjusted odds ratio (OR): 2.77, 95%CI: 1.03–7.45, p = 0.044). SMI either as a continuous (OR: 1.03, 95%CI: 0.97–1.09, p = 0.40) or categorical variable (OR: 1.17, 95%CI: 0.47–2.89, p = 0.74) was not predictive of grade ≥3 toxicity. Similarly, low physical performance did not have significant associations with grade ≥3 toxicity (OR: 2.06, 95%CI: 0.86–4.95, p = 0.11).

Conclusion

Low grip strength may predict grade ≥3 toxicity among older adults receiving chemotherapy. Integrating grip strength into geriatric assessment may help clinicians identify older adults who might be at greater risk for severe chemotherapy toxicity.

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