U-PAIN cohort study among patients with chronic pain in specialised pain care: a feasibility study

Objectives
To examine acceptability of study participation and feasibility of (1) recruitment, (2) data collection and (3) outcome measures for the prospective U-PAIN cohort.

Design
Internal feasibility study of a prospective cohort.

Participants and setting
64 patients, >18 years, with chronic pain at a multidisciplinary pain centre at a university hospital in Sweden.

Outcome measures
Acceptability of study participation was measured with a study-specific 10-item Likert scale. A score 3 was feasible. Recruitment was assessed by participation rates at baseline and retention at the 1-year follow-up, with threshold values for feasibility at 75% and 80%, respectively. Data collection and outcome measures were examined by completions rates of study procedures (90% was considered feasible), sample scores, internal consistency (α >0.70 was considered feasible), and agreement between self-reported data and data retrieved from medical records on opioid use (ICC or >0.60 was considered feasible).

Results
Acceptability for study procedures was feasible, but participation rates were low: 25%. The retention rate at 1-year follow-up was 81% for those included in the feasibility study, that is, filling out computerised patient-reported outcome measures, and 65% for those using paper and pencil format. The completion rates for the different data collection methods ranged from 83% to 95%. Agreement between self-reported opioid use and prescribed dose and between opioid use disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and clinical International Classification of Diseases-10 (ICD-10) diagnoses for opioid dependence were almost perfect (=0.91 and =0.90, respectively).

Conclusions
This feasibility study has helped to explore and improve methods for recruitment, data collection and use of outcome measures for the U-PAIN cohort. Low participation rate and high refusal rate at baseline is a challenge that needs to be further addressed.

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Dicembre 2022

Low-grade inflammation in type 2 diabetes: a cross-sectional study from a Danish diabetes outpatient clinic

Objectives
To investigate low-grade inflammation in type 2 diabetes and explore associations to clinical aspects as well as microvascular and macrovascular complications.

Design
Cross-sectional analysis.

Setting
The outpatient diabetes clinic at the Department of Endocrinology at Aalborg University Hospital, Denmark.

Participants
100 participants with type 2 diabetes confirmed by a haemoglobin A1c (HbA1c)≥6.5% for a minimum of 1 year and 21 healthy controls.

Outcome measures
Serum levels of 27 inflammation-related biomarkers measured by immunoassay. Associations with microvascular and macrovascular complications, body weight, glycaemic control, medication and sex were investigated in the diabetes cohort.

Results
Serum levels of tumour necrosis factor (TNF)-α and eotaxin were elevated in type 2 diabetes (p

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Dicembre 2022

Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial

Introduction
Chronic pain is a common symptom significantly affecting the quality of life of breast cancer survivors. Despite the achievement of pharmacological interventions, the barriers associated with this approach such as inaccessibility, misuse and side effects drive research into effective non-pharmacological interventions to improve chronic pain management, quality of life, anxiety and depression. Breathing exercise (BE) can be a promising option, but research evidence is sparse. This pilot study aims to examine the feasibility and preliminary effect of using an evidence-based BE intervention for chronic pain management in breast cancer survivors.

Method and analysis
This study will be a two-parallel-arm, open-labelled, phase II randomised controlled trial with 1:1 allocation. Seventy-two participants will be recruited from a tertiary hospital in China and randomly allocated to either a BE intervention group (n=36) or a control group (n=36). The participants in the intervention group will receive the usual care, a pain information booklet and a 4-week self-administered BE intervention; the participants in the control group will receive the usual care and the pain information booklet only. The assessment will be conducted at three time points: baseline (week 0), immediately after the intervention completion (week 5) and 4 weeks after the intervention completion (week 9). The primary outcomes will be the acceptability and feasibility assessment of the study protocol and methodological procedures. The secondary outcomes will be the effects of BE on pain, quality of life, anxiety and depression in breast cancer survivors. Descriptive statistics will be applied to present the primary outcomes and the Generalised Estimating Equation Model will be utilised to analyse the clinical outcomes.

Ethics and dissemination
This study has received ethical approvals from the Human Research Ethics Committee at Charles Darwin University (H21089) and the Clinical Trial Ethics Committee at the Affiliated Hospital of Southwest Medical University (KY2022107). Findings from this study will be presented at academic conferences and submitted to peer-reviewed journals for publication.

Trial registration number
ClinicalTrials.gov: NCT05257876.

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Dicembre 2022

Estimation and predictors of direct hospitalisation expenses and in-hospital mortality for patients who had a stroke in a low-middle income country: evidence from a nationwide cross-sectional study in Iranian hospitals

Objective
Stroke is the second most prevalent cardiovascular disease in Iran. This study investigates the estimation and predictors of hospitalisation expenses and in-hospital mortality for patients who had a stroke in Iranian hospitals.

Setting
Patients who had a stroke in Iran between 2019 and 2020 were identified through the data collected from the Iran Health Insurance Organization and the Ministry of Health and Medical Education. This study is the first to conduct a pervasive, nationwide investigation.

Design
This is a cross-sectional, prevalence-based study. Generalised linear models and a multiple logistic regression model were used to determine the predictors of hospitalisation expenses and in-hospital mortality for patients who had a stroke.

Participants
A total of 19 150 patients suffering from stroke were studied.

Results
Mean hospitalisation expenses per patient who had a stroke in Iran amounted to US$590.91±974.44 (mean±SD). Mean daily hospitalisation expenses per patient who had a stroke were US$55.18±37.89. The in-hospital mortality for patients who had a stroke was 18.80%. Younger people (aged ≤49 years) had significantly higher expenses than older patients. The OR of in-hospital mortality in haemorrhagic stroke was significantly higher by 1.539 times (95% CI, 1.401 to 1.691) compared with ischaemic and unspecified strokes. Compared with patients covered by the rural fund, patients covered by Iranian health insurance had significantly higher costs by 1.14 times (95% CI, 1.186 to 1.097) and 1.319 times (95% CI, 1.099 to 1.582) higher mortality. There were also significant geographical variations in patients who had a stroke’s expenses and mortality rates.

Conclusion
Applying cost-effective stroke prevention strategies among the younger population (≤49 years old) is strongly recommended. Migration to universal health insurance can effectively reduce the inequality gap among all insured patients.

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Dicembre 2022

Technical evaluation and usability of a quantitative G6PD POC test in cord blood: a mixed-methods study in a low-resource setting

Objectives
New point-of-care (POC) quantitative G6PD testing devices developed to provide safe radical cure for Plasmodium vivax malaria may be used to diagnose G6PD deficiency in newborns at risk of severe neonatal hyperbilirubinaemia, improving clinical care, and preventing related morbidity and mortality.

Methods
We conducted a mixed-methods study analysing technical performance and usability of the ‘STANDARD G6PD’ Biosensor when used by trained midwives on cord blood samples at two rural clinics on the Thailand–Myanmar border.

Results
In 307 cord blood samples, the Biosensor had a sensitivity of 1.000 (95% CI: 0.859 to 1.000) and a specificity of 0.993 (95% CI: 0.971 to 0.999) as compared with gold-standard spectrophotometry to diagnose G6PD-deficient newborns using a receiver operating characteristic (ROC) analysis-derived threshold of ≤4.8 IU/gHb. The Biosensor had a sensitivity of 0.727 (95% CI: 0.498 to 0.893) and specificity of 0.933 (95% CI: 0.876 to 0.969) for 30%–70% activity range in girls using ROC analysis-derived range of 4.9–9.9 IU/gHb. These thresholds allowed identification of all G6PD-deficient neonates and 80% of female neonates with intermediate phenotypes.
Need of phototherapy treatment for neonatal hyperbilirubinaemia was higher in neonates with deficient and intermediate phenotypes as diagnosed by either reference spectrophotometry or Biosensor.
Focus group discussions found high levels of learnability, willingness, satisfaction and suitability for the Biosensor in this setting. The staff valued the capacity of the Biosensor to identify newborns with G6PD deficiency early (‘We can know that early, we can counsel the parents about the chances of their children getting jaundice’) and at the POC, including in more rural settings (‘Because we can know the right result of the G6PD deficiency in a short time, especially for the clinic which does not have a lab’).

Conclusions
The Biosensor is a suitable tool in this resource-constrained setting to identify newborns with abnormal G6PD phenotypes at increased risk of neonatal hyperbilirubinaemia.

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Dicembre 2022

Health professionals implicit bias of adult patients with low socioeconomic status (SES) and its effects on clinical decision-making: a scoping review protocol

Introduction
Despite efforts to improve population health and reduce health inequalities, higher morbidity and mortality rates for people with lower socioeconomic status (SES) persist. People with lower SES are said to receive worse care and have worse outcomes compared with those with higher SES, in part due to bias and prejudice. Implicit biases adversely affect professional patient relationships and influence healthcare-related decision-making. A better understanding of the relationship between SES and healthcare-related decision-making is therefore essential to address socioeconomic inequalities in health.

Aim
To scope the reported impact of health professionals bias about SES on clinical decision-making and its effect on the care of adults with lower SES in wider literature.

Methods
This scoping review will use Joanna Briggs Institute methods and will report its findings in line with Preferred Items for Systematic Reviews and Meta-Analyses for Protocols and Scoping Reviews guidelines. Data analysis, interpretation and reporting will be underpinned by the PAGER (Patterns, Advances, Gaps, Evidence for Practice and Research recommendations) framework and input from a patient and public interest representative. A systematic search for literature will be conducted on various, pertinent databases to identify relevant literature such as peer-reviewed articles, editorials, discussion papers and empirical research papers. Additionally, other sources of relevant literature such as policies, guidelines, reports and conference abstracts, identified through key website searches will be considered for inclusion.

Ethics and dissemination
Ethical approval is not required for this scoping review. The results will be disseminated through an open access peer-reviewed international journal, conference presentations and a plain language summary that will be shared with the public and other relevant stakeholders.

Leggi
Dicembre 2022

Correction: Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy

Harrison LE, Webster SN, Van Orden AR, et al. Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy. BMJ Open 2022;12:e065997. doi: 10.1136/bmjopen-2022-065997
The authors would like to notify that the co-authors Dr. Marianne Bonnert and Dr. Maria Lalouni were not included in the authorship list. Dr Bonnert and Dr. Lalouni are affiliated to Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden and both of them are now re-instated in the revised version of the publication.

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Dicembre 2022

Lung CAncer SCreening in French women using low-dose CT and Artificial intelligence for DEtection: the CASCADE study protocol

Introduction
Lung cancer screening (LCS) using low-dose CT has been demonstrated to reduce lung cancer-related mortality in large randomised controlled trials. Moving from trials to practice requires answering practical questions about the level of expertise of CT readers, the need for double reading as in trials and the potential role of artificial intelligence (AI). In addition, most LCS studies have predominantly included male participants with women being under-represented, even though the benefit of screening is greater for them. Thus, this study aims to compare the performance of a single CT reading by general radiologists trained in LCS using AI as a second reader to that of a double reading by expert thoracic radiologists, in a campaign for low-dose CT screening in high-risk women.

Methods and analysis
This observational cohort study will recruit 2400 asymptomatic women aged between 50 and 74 years, current or former smokers with at least a 20 pack-year smoking history, in 4 different French district areas. Assistance with smoking cessation will be offered to current smokers. An initial low-dose CT scan will be performed, with subsequent follow-ups at 1 year and 2 years. The primary objective is to compare CT scan readings by a single LCS-trained, AI-assisted radiologist to that of an expert double reading. The secondary objectives are: to evaluate the performance of AI as a stand-alone reader; the adherence to screening of female participants; the influence on smoking cessation; the psychological consequences of screening; the detection of chronic obstructive pulmonary disease (COPD), coronary artery disease and osteoporosis on low-dose CT scans and the costs incurred by screening.

Ethics and dissemination
Ethics approval was obtained from the Comité de Protection des Personnes Sud-Est 1 (ethics approval number: 2021-A02265-36 with an amendment on 15 July 2022). Trial results will be disseminated at conferences, through relevant patient groups and published in peer-reviewed journals.

Trial registration number
NCT05195385.

Leggi
Dicembre 2022

Cohort-profile: Household transmission of SARS-CoV-2 in a low-resource community in Rio de Janeiro, Brazil

Purpose
To better understand the household transmission of SARS-COV-2 in a low-resource community in Rio de Janeiro during the COVID-19 pandemic (2020–2022).

Participants
This is an open prospective cohort study of children ≤12 years old and their household contacts. During home visits over 24 months, we collected data on sociodemographic characteristics, behavioural data, clinical manifestations of SARS-CoV-2, vaccination status, SARS-CoV-2 (reverse transcription-polymerase chain reaction) RT-PCR and anti-S antibody tests. Among adults, the majority of participants were women (62%).

Findings to date
We enrolled 845 families from May 2020 to May 2022. The median number of residents per household was four. The median household density, defined as the number of persons per room, was 0.95. The risk of SARS-CoV-2 occurrence was higher in households with a high number of persons per room. Children were not the principal source of SARS-CoV-2 infections in their households during the first wave of the pandemic.

Future plans
Future studies will investigate cellular and humoral immune responses to locally circulating SARS-CoV-2 variants, which is relevant for the design of vaccines, antivirals and monoclonal antibodies. We will also engage in outreach to encourage vaccination as a means of limiting the transmission of novel SARS-CoV-2 variants and other emerging pathogens.

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Dicembre 2022

Interferon regulatory factor 1 (IRF1) controls the metabolic programmes of low-grade pancreatic cancer cells

Objective
Pancreatic ductal adenocarcinomas (PDACs) include heterogeneous mixtures of low-grade cells forming pseudoglandular structures and compact nests of high-grade cells organised in non-glandular patterns. We previously reported that low-grade PDAC cells display high expression of interferon regulatory factor 1 (IRF1), a pivotal transcription factor of the interferon (IFN) system, suggesting grade-specific, cell-intrinsic activation of IFN responses. Here, we set out to determine the molecular bases and the functional impact of the activation of IFN-regulated responses in human PDACs.

Design
We first confirmed the correlation between glandular differentiation and molecular subtypes of PDAC on the one hand, and the expression of IRF1 and IFN-stimulated genes on the other. We next used unbiased omics approaches to systematically analyse basal and IFN-regulated responses in low-grade and high-grade PDAC cells, as well as the impact of IRF1 on gene expression programmes and metabolic profiles of PDAC cells.

Results
High-level expression of IRF1 in low-grade PDAC cells was controlled by endodermal lineage-determining transcription factors. IRF1-regulated gene expression equipped low-grade PDAC cells with distinctive properties related to antigen presentation and processing as well as responsiveness to IFN stimulation. Notably, IRF1 also controlled the characteristic metabolic profile of low-grade PDAC cells, suppressing both mitochondrial respiration and fatty acid synthesis, which may in part explain its growth-inhibiting activity.

Conclusion
IRF1 links endodermal differentiation to the expression of genes controlling antigen presentation and processing as well as to the specification of the metabolic profile characteristic of classical PDAC cells.

Leggi
Dicembre 2022