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Screening for hypertension in the inpatient environment (SHINE): a prospective diagnostic accuracy study among adult hospital patients

Por: Armitage · L. C. · Roman · C. · Lawson · B. K. · Mahdi · A. · Biggs · C. · Young · L. · Edmundson · H. · Fanshawe · T. · Tarassenko · L. · Farmer · A. · Watkinson · P. J.
Background

Hypertension is the leading risk factor for death globally. Undiagnosed hypertension is common, but the incidence in hospitalised patients is unclear. There are calls for universal facility-based screening for hypertension among all attending patients. The hospital inpatient setting, where blood pressure (BP) is measured routinely and repeatedly, presents an ideal opportunity. However, international hypertension guidelines do not include inpatient BP thresholds for diagnostic or treatment purposes. We investigated the performance of current UK community BP thresholds for diagnosing hypertension in the hospital setting.

Objectives

Investigate the diagnostic performance of the current UK ambulatory BP diagnostic thresholds for systolic and diastolic hypertension in the hospital setting against the reference test of community-based ambulatory BP monitoring (ABPM).

Design

A prospective diagnostic accuracy study.

Setting

Hospital inpatients admitted to three UK centres were approached. Follow-up ABPM was delivered in the community.

Participants

Eligible patients were aged between 18 and 80 years, with no prior diagnosis of, or prescription for hypertension, and whose mean cumulative daytime BP was 120 mm Hg to 179 mm Hg systolic and ≤109 mm Hg diastolic from the 24th hour of their hospital admission.

Interventions

Participants received 24-hour ABPM 4–26 weeks post-discharge, as the reference test for hypertension, with UK diagnostic thresholds of an average daytime BP of ≥135 mm Hg systolic and ≥85 mm Hg diastolic applied. Participants found to be severely hypertensive at the ABPM fitting appointment were also considered reference-test positive but did not proceed with ABPM.

Primary and secondary outcome measures

The diagnostic performance of a mean daytime in-hospital BP of ≥135 mm Hg systolic or ≥85 mm Hg diastolic (index test) for the prediction of hypertension diagnosed on ABPM (reference test) was assessed using sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) as primary outcome measures. Additionally, we explored the accuracy of a range of alternative in-hospital systolic and diastolic BP thresholds against the same reference test.

Results

351 participants were enrolled and 206 completed the study protocol. The average age of the 206 participants was 53 years, 55% were male, and 91 (44%) had daytime community hypertension on ABPM reference testing. Of 107 participants with raised in-hospital daytime BP, 59 (55%) had daytime community hypertension. When assessing the performance of the index test for detecting daytime community hypertension, sensitivity was 65% (59/91, 54% to 75%) and specificity was 58% (67/115, 49% to 67%). The PPV was 55% (59/107, 45% to 65%) and NPV was 68% (67/99, 58% to 77%), respectively. A further 45/206 participants (23%) had night-time community hypertension when assessed using European diagnostic thresholds for nocturnal hypertension (120 mm Hg systolic or 70 mm Hg diastolic), while 25/107 of those with raised in-hospital daytime BP (23%) had night-time community hypertension. When assessing the performance of the index test for detecting either day or night-time community hypertension, sensitivity was 62% (84/135, 53% to 70%) and specificity was 68% (48/71, 55% to 78%). The PPV was 79% (84/107, 70% to 86%) and NPV was 48% (48/99, 38% to 59%).

Conclusions

Undiagnosed hypertension is common in hospitalised patients, particularly those with raised in-hospital BP. While in-hospital BP alone is an imperfect predictor and should not be used as a stand-alone diagnostic test, this could serve as a trigger for further assessment of BP in the community after discharge.

Trial registration number

The study protocol was registered with the ISCTRN Registry (ISRCTN80586284).

Optimisation of oral anticoagulation for stroke prevention: a scoping review of factors influencing implementation

Por: Weldon · J. C. · Bray · E. P. · Gibson · J. · Bangee · M. · Chesworth · B. · Doherty · A. · Hirst · Y. · Lane · D. · Harris · C. · Patel · A. S. · Watkins · C.
Background

For people whose stroke risk would be reduced by taking a long-term oral anticoagulant (OAC), it is important to implement effective strategies to support medication initiation, adherence and persistence. To do this, a better understanding of the factors associated with implementation of interventions to optimise OAC management is needed.

Objectives

This scoping review aimed to summarise the evidence-based characteristics associated with implementing interventions designed to optimise long-term OAC adherence.

Eligibility criteria

Primary research (published post-2000) evaluating any intervention designed to optimise implementation of long-term OAC for stroke prevention by way of change in OAC services, staff or patient behaviour.

Sources of evidence

Five databases (MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo, Cochrane Library) were searched from 1 January 2000 to 4 August 2023 using a combination of terms relating to population, intervention and study design.

Charting methods

Titles/abstracts were screened by at least one reviewer. Data from each full text were abstracted (with 20% double-checked for accuracy) and its implementation content reviewed, guided by the Expert Recommendations for Implementing Change strategies.

Results

216 studies were included, with varying descriptive reporting of implementation strategies, and only 61 (28%) self-identifying as an implementation study. The median number of implementation strategies used was three, with recently published studies (2015 onwards), those including patients receiving either direct OACs (DOACs) or vitamin K antagonists (VKAs) and those including multiple intervention targets (service, staff or patients) associated with using more implementation strategies. ‘Train and educate stakeholders’ strategies were the most commonly used, and ‘Adapt and tailor to the context’ strategies were the least used by included studies. Conversely, self-defined implementation studies were less likely to use ‘Train and educate stakeholders’ strategies, although they were positively associated with use of ‘Adapt and tailor to the context’. ‘Use evaluative & iterative’ strategies were used more frequently in studies where patients used either VKAs or DOACs, or were published more recently.

Conclusions

Studies need to self-define as implementation studies, improve implementation strategy reporting and be transparently registered, alongside conducting process evaluations or more richly describing implementation processes. Future research could explore why some implementation strategies are used more than others and whether aligning strategy clusters with intervention targets results in clinically significant differences in patient care.

A multicentred two-arm parallel single-blind superiority randomised controlled trial comparing psychological and emotional stabilisation with eye movement desensitisation and reprocessing and treatment-as-usual to treatment-as-usual with adults with intel

Por: Willner · P. · Anderson · P. · Bisson · J. I. · Clifford · C. · Cooper · V. · Farrell · D. · Harris · S. · Hiles · S. · Holland · G. · Hutchings · H. A. · Murphy · G. H. · Rose · J. · Stenfert-Kroese · B. · Unwin · G. L. · Watkins · A. · Willott · S. · Langdon · P. E.
Introduction

The primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic stress disorder (PTSD) among adults with intellectual disabilities compared with TAU. Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability.

Methods

This is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ

Analysis

The primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD.

Ethics and dissemination

This clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners.

Trial registration number

ISRCTN35167485.

Neuropsychiatric research databases for people with intellectual disabilities and epilepsy (REFINE): a feasibility study protocol

Por: Musicha · C. · Neilens · H. · Stanyard · E. · Allgar · V. · Lomax · J. · Ashford · R. · Hambly · H. · Aspinall · P. · OShaughnessy · E. · Rollinson · C. · Lennard · S. · Mclean · B. · Simpson · A. · Bowman · P. · Angus-Leppan · H. · Watkins · L. · Laugharne · R. · Allard · J. · Shankar · R.
Introduction

This project explores the feasibility of setting up a neuropsychiatric de-identified database (DiD) and a Research Register (RR) to collect, analyse, monitor and systematically report clinical data for people with intellectual disabilities (PwIDs) and epilepsy.

Methods and analysis

A multicentre project designed to collect de-identified data from clinical records at three adult ID specialist services in England and Wales and to develop an RR of PwID and epilepsy. Patients added to the DiD will be identified from patient clinic lists, clinic letters, in-house databases and electronic systems. Patients to be added to the RR will also be identified through attendance for regular review at clinic appointments. The collected data will be entered into the Research Electronic Data Capture (REDCap) database. Personal details of PwID and their consultees will also be collected from participants who consent to be on the RR. Around 600 PwID and epilepsy (200 per site) will be added to the DiD at the three sites, while around 45–60 participants (15–20 per site) are anticipated to be added to the RR. Data analysis will involve using descriptive statistics to summarise feasibility outcomes, such as screening and recruitment rates, as well as the completeness of the collected data. The characteristics of the participants (demographic, ID classification, clinical, epilepsy history and antiseizure medication) will be summarised descriptively. Progression will be assessed using the Red/Amber/Green stop-go criteria to determine if a national register should be created.

Ethics and dissemination

Ethical approval (24/NW/0210) has been obtained from the Northwest-Haydock Research Ethics Committee and the University of Plymouth Faculty Research Ethics and Integrity Committee (reference no. 5284). The project is funded by Jazz Pharmaceuticals as an independent investigator-initiated support grant and, as such, has received independent peer review.

Trial registration number

NCT06780501.

Cultural stress, family functioning, hazardous alcohol use, and mental health among Latin American parents in the United States: A latent profile analysis

by Andrea Lopez-Soto, Esmeralda Ramírez, Duyen H. Vo, Aigerim Alpysbekova, Seo Woo Lee, Maria Duque, Lawrence Watkins, Cory L. Cobb, Beyhan Ertanir, Alejandra Garcia Isaza, Evelyn Gualdron, Sumeyra Sahbaz, Collette Steed, Neel Devan Youts, Shriya Senapathi, Seth J. Schwartz, Pablo Montero-Zamora

There is a limited understanding of how different subgroups of Latin American immigrant parents experience cultural stressors, as well as its impact on family dynamics, health behaviors, and mental health. The present study aimed to (1) identify latent cultural stress profiles among Latin American immigrant parents in the U.S. and (2) examine differences among these profiles concerning family intimacy, democratic parenting style, family conflict, hazardous alcohol use, and depressive and anxiety symptoms. Participants consisted of a sample of 1,351 parents (61.9% female; M age = 39.83, 62% first-generation; North America [61%], Central America and the Caribbean [21%], and South America [19%]) of children aged 8–16. We used latent profile analysis to identify subgroups of cultural stress, defined by perceived discrimination (PDS) and negative context of reception (NCR). Multinomial logistic regression was conducted to examine key correlates of profile membership. Five latent profiles were identified (1) Low PDS/NCR (22.2%), (2) Low PDS/Elevated NCR (14.8%), (3) Moderate PDS/NCR (18.7%), (4) Elevated PDS/NCR (33.5%), and (5) Highest PDS/NCR (10.8%). Compared with Profile 1 (Low PDS/NCR), parents in Profiles 2–5 generally reported lower family intimacy (RRR = 0.93–0.97). Parents in Profile 5 (Highest PDS/NCR) reported more family conflict (RRR = 1.13), hazardous alcohol use (RRR = 1.20), depressive symptoms (RRR = 1.31), and anxiety symptoms (RRR = 1.29), with markedly elevated depressive (RRR = 22.94) and anxiety symptomatology (RRR = 17.48) compared with Profile 1. Our findings suggest the presence of vulnerable subgroups due to cultural stress among Latin American parents in the United States. A better understanding of cultural stress patterns may improve current and future interventions tailored for Latin American families, addressing health disparities within this population.

Pancreatic, nutritional and clinical outcomes in children 0-5 years with cystic fibrosis during the first 2 years of CFTR modulator therapy (PaNC): a multicentre prospective observational study protocol

Por: Miles · C. · Katz · T. · Grunert · J. · Ford · K. · Hall · C. · Hawthorn · C. · See · D. W. · McMahon · M. · Vass · H. · Watkins · S. · Zanardo · G. · Brookes · I. · Handley · S. · Woodward · T. · Wademan · J. · Cameron · B. · King · S. · Nixon · G. M. · Davidson · Z.
Background

Cystic fibrosis (CF) is a genetic condition of impaired membrane electrolyte transport and is characterised by defects in the production and function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. Ground-breaking CFTR modulator therapy has resulted in a notable shift in the clinical presentation and progressive nature of CF, across both pulmonary and extrapulmonary systems. Access to CFTR modulator therapies in people with CF is occurring in a staged, descending age process, with clinical trials focusing primarily on safety and efficacy. There is a lack of robust, real-world longitudinal data on CFTR modulator therapy in infants and young children where extrapulmonary outcomes such as growth, micronutrient status and pancreatic function are the key focus.

Methods and analysis

Pancreatic, nutritional and clinical outcomes in children 0–5 years with CF during the first 2 years of CFTR modulator therapy (PaNC) is a prospective cohort study involving all eight tertiary paediatric CF centres in Australia. Infants and children 4 months to 5 years of age who are eligible for elexacaftor/tezacaftor/ivacaftor (ETI) or ivacaftor (IVA) meet the inclusion criteria for PaNC, with a total eligible cohort of 303 children at the commencement of recruitment. The primary outcomes are change in weight-for-length/body mass index z score and change in serum micronutrient status, at 6–12 monthly intervals, during the first 2 years of treatment with ETI or IVA. Secondary outcomes include change in exocrine pancreatic function, measured by faecal elastase-1, change in the use and dose of pancreatic enzyme replacement therapy, nutritional and gastrointestinal therapies and change in sweat chloride levels. Linear mixed modelling will be used to analyse primary and secondary endpoints. This protocol is reported in accordance with ‘The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement’ reporting guidelines.

Ethics and dissemination

Overarching governance and ethics approval has been granted by Monash Health Human Research Ethics Committee, in addition to all eight sites receiving site-specific authorisation approvals prior to the commencement of recruitment. Opportunities for CF consumers to be involved in targeted dissemination plans will be initiated via CF Australia at the completion of the study period. Additionally, a summary of non-identifiable results will be provided to CF consumers and CF healthcare providers via scientific and lay conferences and via peer-reviewed journals.

Trial registration number

ACTRN12624001185550; Pre-results.

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