Efficacy of perioperative pain management in paediatric cardiac surgery: a protocol for a network meta-analysis

Introduction
Congenital heart disease is a common birth defect, but advancements in diagnosis and treatment have improved survival rates. Enhanced recovery after surgery (ERAS) programmes have emerged in paediatric cardiac surgery. Multimodal pain management, as a vital part of ERAS programmes, has been found to be effective in reducing pain and improving outcomes in cardiac surgery patients. Traditional methods of pain control using high-dose opioids can lead to complications, so nonopioid analgesics and regional anaesthesia techniques are being used to reduce the consumption. However, there is a significant variability in pain management practices in paediatric cardiac surgery. A network meta-analysis (NMA) is needed to comprehensively compare the effects of different analgesic interventions in this population.

Methods and analysis
A comprehensive electronic literature database search will be performed using electronic databases, mainly including PubMed, EMBASE, Web of Science and Cochrane Central Register of Controlled Trials. All randomised controlled trials associated with perioperative pain management for paediatric cardiac surgery will be included. The primary outcome will be visual analogue score or numeric rating scale of pain and total opioid consumption (or equivalent) 24 hours after postoperative tracheal extubation. The Revised Cochrane Risk of Bias Tool will be employed to assess the quality of included articles. A random-effects pairwise meta-analysis will be performed to report the head-to-head comparison. Following the assessment of individual articles, an NMA will be conducted using a Bayesian framework with random-effects’ models.

Ethics and dissemination
Ethics approval is not necessary because this study will be based on publications. The results of this study will be published in a peer-reviewed journal.

PROSPERO registration number
CRD42023477520.

Leggi
Settembre 2024

Regional wall motion abnormalities on focused transthoracic echocardiography in patients presenting with acute chest pain: a predefined post hoc analysis of the prospective single-centre observational EPIC-ACS study

Objectives
We evaluated the ability of the assessment of regional wall motion abnormalities (RWMA) detected via transthoracic echocardiography to predict the presence of obstructive coronary artery disease (CAD) in patients presenting with acute chest pain to the emergency department.

Design
Prospective single-centre observational study.

Setting
Tertiary care university hospital emergency unit.

Participants
Patients presenting to the emergency department with acute chest pain suggestive of obstructive CAD.

Primary outcome measure
The primary endpoint was defined as the presence of obstructive CAD, requiring revascularisation therapy.

Results
Overall, 657 patients (age 58.1±18.0 years, 53% men) were included in our study. RWMA were detected in 76 patients (11.6%). RWMA were significantly more frequent in patients reaching the primary endpoint (26.2% vs 7.6%, p

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Settembre 2024

Mobil Monitoring Doppler Ultrasound (MoMDUS) study: protocol for a prospective, observational study investigating the use of artificial intelligence and low-cost Doppler ultrasound for the automated quantification of hypertension, pre-eclampsia and fetal growth restriction in rural Guatemala

Introduction
Undetected high-risk conditions in pregnancy are a leading cause of perinatal mortality in low-income and middle-income countries. A key contributor to adverse perinatal outcomes in these settings is limited access to high-quality screening and timely referral to care. Recently, a low-cost one-dimensional Doppler ultrasound (1-D DUS) device was developed that front-line workers in rural Guatemala used to collect quality maternal and fetal data. Further, we demonstrated with retrospective preliminary data that 1-D DUS signal could be processed using artificial intelligence and deep-learning algorithms to accurately estimate fetal gestational age, intrauterine growth and maternal blood pressure. This protocol describes a prospective observational pregnancy cohort study designed to prospectively evaluate these preliminary findings.

Methods and analysis
This is a prospective observational cohort study conducted in rural Guatemala. In this study, we will follow pregnant women (N =700) recruited prior to 18 6/7 weeks gestation until their delivery and early postpartum period. During pregnancy, trained nurses will collect data on prenatal risk factors and obstetrical care. Every 4 weeks, the research team will collect maternal weight, blood pressure and 1-D DUS recordings of fetal heart tones. Additionally, we will conduct three serial obstetric ultrasounds to evaluate for fetal growth restriction (FGR), and one postpartum visit to record maternal blood pressure and neonatal weight and length. We will compare the test characteristics (receiver operator curves) of 1-D DUS algorithms developed by deep-learning methods to two-dimensional fetal ultrasound survey and published clinical pre-eclampsia risk prediction algorithms for predicting FGR and pre-eclampsia, respectively.

Ethics and dissemination
Results of this study will be disseminated at scientific conferences and through peer-reviewed articles. Deidentified data sets will be made available through public repositories. The study has been approved by the institutional ethics committees of Maya Health Alliance and Emory University.

Leggi
Settembre 2024

Investigating combined acupuncture and transcranial direct current stimulation in patients with poststroke shoulder pain from China: protocol for a randomised controlled trial

Introduction
Poststroke shoulder pain is a common complication that severely affects the recovery of upper limb motor function. Acupuncture has positive analgesic effects in treating poststroke shoulder pain, and studies have demonstrated the efficacy of transcranial direct current stimulation (tDCS) in treating patients with this pain. However, whether acupuncture combined with tDCS has a superior rehabilitation effect on poststroke shoulder pain is currently unknown. We aimed to observe the effect of the combined intervention on poststroke shoulder pain and explore its possible central analgesic mechanism.

Methods and analysis
This study describes a randomised controlled trial using assessor blinding. A total of 135 poststroke patients with shoulder pain will be randomly assigned in a 1:1:1 ratio to the tDCS group, acupuncture group and combined group (acupuncture plus tDCS). All three groups will undergo conventional rehabilitation treatment. Participants in the tDCS group will receive tDCS stimulation on the M1 area for 20 min, while the acupuncture group will receive 20 min of acupuncture. The combined treatment group will receive both. All treatments will be performed five times per week for 4 weeks. The primary outcome indicator in this study is the Visual Analogue Scale pain score. Secondary outcome indicators include shoulder mobility, Shoulder Pain and Disability Index, Fugl–Meyer Motor Function Scale, Modified Barthel Index Scale, Self-Rating Anxiety and Depression Scale and functional MRI. All scale results will be assessed at baseline and at 2 weeks and 4 weeks, and during follow-up at 1 month, 3 months and 6 months postdischarge. A repeated analysis of variance will be conducted to observe the groupxtime interaction effects of the combined intervention. Moreover, functional MRI will be applied to explore the central analgesic mechanism.

Ethics and dissemination
Ethics approval was obtained from the Ethics Committee of the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine (2023KY-039–001). The results of the study will be published in a peer-reviewed journal and presented at scientific conferences.

Trial registration number
ChiCTR2300078270.

Leggi
Settembre 2024

Discomfort or pain: whats in a name?

Some years ago a symposium about non-invasive diagnostics attended by engineers and gastroenterologists was opened by the chairman with the following comment about his experience of colonoscopy: ‘you doctors call it discomfort, we patients call it pain’. As recognised by the Newcastle Endoprem, there are other elements which contribute to the apparent dichotomous views of patients, who regard colonoscopy with considerable anxiety, and gastroenterologists, who feel that most procedures are relatively straightforward and offer significant benefit at the cost of relatively little distress. Therefore, the valuable insights into patient-reported experience provided by the study of Fuccio et al are absolutely crucial to understanding how to maximise patient compliance with investigation.1 The Endoprem asks patients to rate the level of discomfort they experienced as well as the level of pain. According to the Collins Dictionary, however, discomfort and pain are synonyms2 and therefore using scales for…

Leggi
Settembre 2024

Cost-effectiveness analysis of app-delivered self-management support (selfBACK) in addition to usual care for people with low back pain in Denmark

Objectives
This study aims to investigate the cost-effectiveness of individually tailored self-management support, delivered via the artificial intelligence-based selfBACK app, as an add-on to usual care for people with low back pain (LBP).

Design
Secondary health-economic analysis of the selfBACK randomised controlled trial (RCT) with a 9-month follow-up conducted from a Danish national healthcare perspective (primary scenario) and a societal perspective limited to long-term productivity in the form of long-term absenteeism (secondary scenario).

Setting
Primary care and an outpatient spine clinic in Denmark.

Participants
A subset of Danish participants in the selfBACK RCT, including 297 adults with LBP randomised to the intervention (n=148) or the control group (n=149).

Interventions
App-delivered evidence-based, individually tailored self-management support as an add-on to usual care compared with usual care alone among people with LBP.

Outcome measures
Costs of healthcare usage and productivity loss, quality-adjusted life-years (QALYs) based on the EuroQol-5L Dimension Questionnaire, meaningful changes in LBP-related disability measured by the Roland-Morris Disability Questionnaire (RMDQ) and the Pain Self-Efficacy Questionnaire (PSEQ), costs (healthcare and productivity loss measured in Euro) and incremental cost-effectiveness ratios (ICERs).

Results
The incremental costs were higher for the selfBACK intervention (mean difference 230 (95% CI –136 to 595)), where ICERs showed an increase in costs of 7336 per QALY gained in the intervention group, and 1302 and 1634 for an additional person with minimal important change on the PSEQ and RMDQ score, respectively. At a cost-effectiveness threshold value of 23250, the selfBACK intervention has a 98% probability of being cost-effective. Analysis of productivity loss was very sensitive, which creates uncertainty about the results from a societal perspective limited to long-term productivity.

Conclusions
From a healthcare perspective, the selfBACK intervention is likely to represent a cost-effective treatment for people with LBP. However, including productivity loss introduces uncertainty to the results.

Trial registration number
NCT03798288.

Leggi
Settembre 2024

Quantitative sensory testing and chronic pain syndromes: a cross-sectional study from TwinsUK

Objective
The chronic pain syndromes (CPS) include syndromes such as chronic widespread pain (CWP), dry eye disease (DED) and irritable bowel syndrome (IBS). Highly prevalent and lacking pathognomonic biomarkers, the CPS are known to cluster in individuals in part due to their genetic overlap, but patient diagnosis can be difficult. The success of quantitative sensory testing (QST) and inflammatory biomarkers as phenotyping tools in conditions such as painful neuropathies warrant their investigation in CPS. We aimed to examine whether individual QST modalities and candidate inflammatory markers were associated with CWP, DED or IBS in a large, highly phenotyped population sample.

Design
Cross-sectional study.

Setting
Community-dwelling cohort.

Participants
Twins from the TwinsUK cohort

Primary and secondary outcome measures
We compared 10 QST modalities, measured in participants with and without a CWP diagnosis between 2007 and 2012. We investigated whether inflammatory markers measured by Olink were associated with CWP, including interleukin-6 (IL-6), IL-8, IL-10, monocyte chemoattractant protein-1 and tumour necrosis factor. All analyses were repeated in DED and IBS with correction for multiple testing.

Results
In N=3022 twins (95.8% women), no association was identified between individual QST modalities and CPS diagnoses (CWP, DED and IBS). Analyses of candidate inflammatory marker levels and CPS diagnoses in n=1368 twins also failed to meet statistical significance.

Conclusion
Our findings in a large population cohort suggest a lack of true association between singular QST modalities or candidate inflammatory markers and CPS.

Leggi
Settembre 2024

Exploring the perceptions of senior medical students on gender and pain: a qualitative study of the interplay between formal and hidden curricula

Objective
Explore the perceptions of senior medical students on the relationship between gender and pain and examine how formal and hidden curricula in medical education shape their experiences.

Design
We conducted a cross-sectional qualitative interview study, using individual semistructured interviews and adhering to interpretative description methodology. We used Braun and Clarke’s reflexive approach to thematic analysis to analyse our data.

Setting
Six medical schools across the UK. Data collection occurred between the autumn of 2022 and the spring of 2023.

Participants
14 senior (penultimate or final year) medical students.

Results
We created three themes, which describe key educational forces shaping students’ experiences of the relationship between gender and pain. These are (1) the sociocultural influencer, (2) the pedagogical influencer and (3) the professorial influencer. Our findings highlight the influence of both wider societal norms and students’ own identities on their experiences. Further, we explore the nature and detrimental role of formal curricular gaps, and negative role modelling as a key mechanism by which a hidden curriculum relating to gender and pain exerts its influence.

Conclusions
These findings have several educational implications, including the need for a more holistic, person-centred approach to pain management within medical school curricula. Additionally, we recommend the creation of reflective spaces to engage students in critical thinking around bias and advocacy from the early stages of their training. We present actionable insights for medical educators to address issues of gender bias and pain management.

Leggi
Agosto 2024

Family-centred interventions for people with substance use disorders in low-income and middle-income country settings: a scoping review protocol

Introduction
Substance use disorder (SUD) and problematic substance use are global public health concerns with significant multifaceted implications for physical health and psychosocial well-being. The impact of SUD extends beyond the individual to their family while imposing financial and social burdens on the community. Though family-centred interventions have shown promise in addressing SUD, their implementation and impact in low-income and middle-income countries (LMICs) remain underexplored.

Methods and analysis
Per Joanna Briggs Institute’s scoping review protocol, a systematic search strategy was employed across OVID Medline, Embase, PsycINFO, Web of Science–Core Collection, Global Health and CINAHL from 22 February 2024 to 26 February 2024, to identify relevant studies focused on family-centred interventions for SUD in LMIC, devoid of publication time and language constraints. Two independent reviewers will screen the titles, abstracts and full texts, with discrepancies resolved through discussion or third-party reviews. The extracted data charted in a structured form will be visualised by diagrams or tables, focusing on the feasibility and impact of family-centred interventions for SUD in LMIC. For qualitative studies, the findings will be synthesised and presented in thematic clusters, and for studies that report quantitative outcomes, specific health, including SUD and psychosocial, outcomes will be synthesised, aligning with the Population, Concept and Context framework.

Ethics and dissemination
These data on substance use, psychosocial outcomes and perspectives of individuals with SUD and their families will be presented in narrative format, highlighting patterns and identifying research gaps. This review aims to synthesise the existing evidence on family-centred interventions for improving substance use and/or psychosocial outcomes in individuals with SUD in LMIC and seeks to inform future policy and practice. Ethics approval is not required for this scoping review, and modifications to the review protocol will be disclosed. Findings will be disseminated through conference proceedings and peer-reviewed publication.

Leggi
Agosto 2024

Effect of probiotic administration to breastfeeding mothers with very low birthweight neonates on some neonatal and maternal outcomes: study protocol for a randomised, double-blind, placebo-controlled trial

Introduction
Premature birth and very low birth weight (VLBW) are leading causes of neonatal mortality. Almost all premature infants experience hyperbilirubinaemia. Administering probiotics to breastfeeding mothers may positively affect infant outcomes. This trial aims to investigate whether probiotic supplementation for mothers with VLBW infants affects total serum bilirubin levels and postpartum depression scores (primary outcomes), as well as some other neonatal and maternal outcomes (secondary outcomes).

Methods and analysis
This is a randomised, double-blind, placebo-controlled superiority trial with two parallel arms. Participants, caregivers and outcome assessors will be blinded. A total of 122 breastfeeding mothers of neonates with a birth weight of 1000–1500 g, along with their infants within 48 hours of birth, will be assigned to either the probiotic or placebo group in a 1:1 ratio through block randomisation, stratified by singleton and twin births. The intervention will involve oral administration of probiotics containing Lactobacillus paracasei 431 and Bifidobacterium lactis BB-12, or an indistinguishable placebo, for 42–45 days. Outcomes will be assessed through daily observations, laboratory assessments and the Edinburgh Postpartum Depression Scale. Adverse events will also be documented. Modified intention-to-treat analyses will be employed for the primary and secondary outcomes, excluding participants lost to follow-up from all postintervention assessments.

Ethics and dissemination
This study protocol has been approved by the Medical University of Tabriz Ethics Committee (IR.TBZMED.REC.1401.735). Findings will be disseminated through publication in a peer-reviewed journal and presentations at relevant conferences.

Trial registration number
IRCT20100414003706N42.

Leggi
Agosto 2024