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AnteayerBMJ Open

Meeting high-risk patient pain care needs through intensive primary care: a secondary analysis

Por: Giannitrapani · K. F. · Holliday · J. R. · McCaa · M. D. · Stockdale · S. · Bergman · A. A. · Katz · M. L. · Zulman · D. M. · Rubenstein · L. V. · Chang · E. T.
Objective

Chronic pain disproportionately affects medically and psychosocially complex patients, many of whom are at high risk of hospitalisation. Pain prevalence among high-risk patients, however, is unknown, and pain is seldom a focus for improving high-risk patient outcomes. Our objective is to (1) evaluate pain frequency in a high-risk patient population and (2) identify intensive management (IM) programme features that patients and providers perceive as important for promoting patient-centred pain care within primary care (PC)-based IM.

Design

Secondary observational analysis of quantitative and qualitative evaluation data from a multisite randomised PC-based IM programme for high-risk patients.

Setting

Five integrated local Veterans Affairs (VA) healthcare systems within distinct VA administrative regions.

Participants

Staff and high-risk PC patients in the VA.

Intervention

A multisite randomised PC-based IM programme for high-risk patients.

Outcome measures

(a) Pain prevalence based on VA electronic administrative data and (b) transcripts of interviews with IM staff and patients that mentioned pain.

Results

Most (70%, 2593/3723) high-risk patients had at least moderate pain. Over one-third (38%, 40/104) of the interviewees mentioned pain or pain care. There were 89 pain-related comments addressing IM impacts on pain care within the 40 interview transcripts. Patient-identified themes were that IM improved communication and responsiveness to pain. PC provider-identified themes were that IM improved workload and access to expertise. IM team member-identified themes were that IM improved pain care coordination, facilitated non-opioid pain management options and mitigated provider compassion fatigue. No negative IM impacts on pain care were mentioned.

Conclusions

Pain is common among high-risk patients. Future IM evaluations should consider including a focus on pain and pain care, with attention to impacts on patients, PC providers and IM teams.

Use of external control arms in immune-mediated inflammatory diseases: a systematic review

Por: Zayadi · A. · Edge · R. · Parker · C. E. · Macdonald · J. K. · Neustifter · B. · Chang · J. · Zhong · G. · Singh · S. · Feagan · B. G. · Ma · C. · Jairath · V.
Objectives

External control arms (ECAs) provide useful comparisons in clinical trials when randomised control arms are limited or not feasible. We conducted a systematic review to summarise applications of ECAs in trials of immune-mediated inflammatory diseases (IMIDs).

Design

Systematic review with an appraisal of ECA source quality rated across five domains (data collection, study populations, outcome definitions, reliability and comprehensiveness of the dataset, and other potential limitations) as high, low or unclear quality.

Data sources

Embase, Medline and Cochrane Central Register of Controlled Trial were searched through to 12 September 2023.

Eligibility criteria

Eligible studies were single-arm or randomised controlled trials (RCTs) of inflammatory bowel disease, pouchitis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and atopic dermatitis in which an ECA was used as the comparator.

Data extraction and synthesis

Two authors independently screened the search results in duplicate. The characteristics of included studies, external data source(s), outcomes and statistical methods were recorded, and the quality of the ECA data source was assessed by two independent authors.

Results

Forty-three studies met the inclusion criteria (inflammatory bowel disease: 16, pouchitis: 1, rheumatoid arthritis: 12, juvenile idiopathic arthritis: 1, ankylosing spondylitis: 5, psoriasis: 3, multiple indications: 4). The majority of these trials were single-arm (33/43) and enrolled adult patients (34/43). All included studies used a historical control rather than a contemporaneous ECA. In RCTs, ECAs were most often derived from the placebo arm of another RCT (6/10). In single-arm trials, historical case series were the most common ECA source (19/33). Most studies (31/43) did not employ a statistical approach to generate the ECA from historical data.

Conclusions

Standardised ECA methodology and reporting conventions are lacking for IMIDs trials. The establishment of ECA reporting guidelines may enhance the rigour and transparency of future research.

Early monitoring of intravenous thrombolysis in acute ischaemic stroke using wearable intelligent vital sign devices: protocol for a prospective, multicentre, observational registry cohort study

Por: Liu · M. · Zhao · J. · Li · S. · Han · J. · Ma · G. · Wang · Y. · Chang · H.
Introduction

Continuous monitoring of vital signs during and after ischaemic stroke was recommended by the ‘Guidelines for the Early Management of Patients with Acute Ischaemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischaemic Stroke’. Vital sign data can be associated with disease conditions and prognosis, while there is limited evidence regarding continuous monitoring of vital signs during and after acute ischaemic stroke. The wearable intelligent vital sign monitoring device is small and lightweight and constantly monitors the health status during daily activities. However, wearable intelligent vital sign monitoring devices have not been widely used in clinical practice so far. Therefore, we will investigate the effectiveness and safety of wearable intelligent vital sign monitoring devices in early in-hospital management and monitoring programmes for patients with acute ischaemic stroke. This paper presents the study protocol.

Methods and design

This study is a prospective, multicentre, observational registry study starting from 20 March 2023 to 20 March 2025. A total of 5740 patients with acute ischaemic stroke from 10 Chinese hospitals are planned to be enrolled. Continuous vital sign data, demographics, medical history, medication history, treatments, laboratory tests, imaging scans and follow-up data will be collected. Follow-up time points were 30 days after discharge, 30 days after intravenous thrombolysis, 3 months after intravenous thrombolysis and 12 months after intravenous thrombolysis (until March 2026). The primary outcome included the evaluation of the modified Rankin Scale at 3 months, as well as the assessment of the rate of symptomatic and asymptomatic intracranial haemorrhage throughout the hospitalisation period.

Ethics and dissemination

This study has been approved by the Medical Ethics Committee of Xuanwu Hospital, Capital Medical University ([2022] 203). We plan to disseminate the research findings through publication in peer-reviewed scientific journals and presentations at international conferences.

Trial registration number

ChiCTR2300069512.

Chronotypes and their association with sleep quality among Chinese college students of Anhui Province: a cross-sectional study

Por: Tong · X. · Gao · M.-m. · Zhang · L. · Song · J.-g. · Feng · Y. · Tao · Y. · Zhu · L.-j. · Wen · L.-y. · Jin · Y.-l. · Chang · W.-w.
Objectives

To describe the prevalence of chronotype and sleep quality among Chinese college students and explore the relationship between chronotype and sleep quality.

Design

A cross-sectional study.

Setting

Four colleges and universities in Anhui, China, between November and December 2020.

Participants

A total of 4768 college students were recruited using a stratified, multistage, cluster sampling survey.

Outcome measures

Morningness-Eveningness Questionnaire 19 was used to determine the chronotype of the students and the Pittsburgh Sleep Quality Index (PSQI) was used to measure their sleep quality. The multiple logistic regression model was used to explore the potential association between chronotype and sleep quality.

Results

The self-reported proportions of evening-type (E-type), neutral-type and morning-type among college students were 51.17%, 45.14% and 3.69%, respectively. The mean PSQI score was 4.97±2.82 and the prevalence of poor sleep quality was 18.2%. After adjusting the covariates by multiple logistic regression analysis, E-type was positively associated with subjective sleep quality (OR=1.671, 95% CI 1.414 to 1.975), sleep latency (OR=1.436, 95% CI 1.252 to 1.647), sleep duration (OR=2.149, 95% CI 1.506 to 3.067), habitual sleep efficiency (OR=1.702, 95% CI 1.329 to 2.180), daytime dysfunction (OR=1.602, 95% CI 1.412 to 1.818) and overall poor sleep quality (OR=1.866, 95% CI 1.586 to 2.196).

Conclusions

College students mainly exhibited E-type, and an elevated prevalence of poor sleep quality existed among these students. The E-type was positively associated with poor sleep quality.

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