High- vs Low-Dose Tranexamic Acid Infusion and Need for Red Blood Cell Transfusion and Adverse Events in Cardiac Surgery—Reply

In Reply In response to the comments by Dr Koster and colleagues, the OPTIMAL trial enrolled patients aged 18 to 70 years, which is the age range of most patients undergoing adult cardiac bypass surgery in China. We agree that our study results, especially regarding seizures, should be interpreted with caution for patients older than 70 years.

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Gennaio 2023

Association of Hormone Receptors With Clinical Outcomes in Patients With ERBB2-Low Breast Cancer

To the Editor In their cohort study recently reported in JAMA Oncology, Tarantino and colleagues, at variance with others, provide data suggesting that ERBB2-low breast cancer is not a biologically distinct disease. We congratulate the authors for their effort and take this opportunity to highlight a few issues. The study included patients with stage I (72%) and lobular tumors (13%). Consistently, neoadjuvant or adjuvant therapy use was reported in 28% of patients. Such baseline features make the results hardly comparable with those from patients with advanced-stage disease receiving neoadjuvant chemotherapy. Among 675 patients (320 ERBB2-low, 355 ERBB2-0), the authors report that ERBB2 expression was not an independent predictive factor, and the low pathologic complete response rate of ERBB2-low cases was due to hormone receptor (HR) coexpression. However, the odds ratio (OR) and adjusted OR of ERBB2-0 vs ERBB2-low are not dissimilar in HR-positive patients, whereas the adjusted OR in HR-negative patients was not provided. As the study reports that ERBB2-0 tumors are less differentiated than ERBB2-low tumors, we wonder whether the predictive value of ERBB2-low is lost in the multivariable analysis, or rather that ERBB2-0 is underestimated in univariate analysis, which disregarded histological grade. Furthermore, the predictive value of ERBB2-low was tested in HR subgroups, whereas it would be interesting to use HR as a continuous variable. The median follow-up time of 10 months may be insufficient for assessing the potential association of ERBB2 with prognosis. However, disease-free survival tends to be inferior in ERBB2-low tumors compared with ERBB2-0 tumors if HR is low or completely absent, whereas the opposite occurs in HR-positive cases.

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Gennaio 2023

Understanding how patients pain beliefs influence chronic low back pain management in Ghana: a grounded theory approach

Introduction
Chronic low back pain (CLBP) is associated with negative consequences in high and low/middle-income countries. Pain beliefs are important psychosocial factors that affect the occurrence and progression of CLBP and may be influenced by the sociocultural context and interactions with healthcare professionals (HCPs). The pain beliefs of Ghanaian patients with CLBP are unknown and the factors influencing pain beliefs in African contexts are unclear.

Objectives
To explore the pain beliefs of Ghanaian patients with CLBP, how they influence CLBP management/coping and to identify the mechanisms influencing them.

Design
Qualitative study using individual semistructured face-to-face interviews, situated within Straussian grounded theory principles and critical realist philosophy.

Participants
Thirty patients with CLBP accessing physiotherapy at two teaching hospitals in Ghana.

Results
Participants suggested dominant biomedical/mechanical beliefs (related to CLBP causes, posture and activity, and the belief of an endpoint/cure for CLBP). Maladaptive beliefs and practices, in particular fear-avoidance beliefs, and dependence on passive management and coping, were common among participants. These beliefs and practices were mostly influenced by HCPs and sociocultural expectations/norms. Although spirituality, pacing activity and prescribed exercises were commonly mentioned by participants, other active strategies and positive beliefs were expressed by a few participants and influenced by patients’ themselves. Limited physiotherapy involvement, knowledge and awareness were also reported by participants, and this appeared to be influenced by the limited physiotherapy visibility in Ghana.

Conclusion
Participants’ narratives suggested the dominant influence of HCPs and the sociocultural environment on their biomedical/mechanical beliefs. These facilitated maladaptive beliefs and adoption of passive coping and management practices. Therefore, incorporation of more positive beliefs and holistic/active strategies by Ghanaian patients and HCPs may be beneficial. Furthermore, patient empowerment and health literacy opportunities to address unhelpful CLBP/sociocultural beliefs and equip patients with management options for CLBP could be beneficial.

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Dicembre 2022

Protocol for a scoping review of measures and definitions of gender-based discrimination linked to health outcomes in low and middle-income countries

Introduction
Gender-based discrimination (GBD) is generally defined as unequal or disadvantageous treatment based on one’s gender. Emerging evidence suggests that exposure to GBD in its various forms can yield negative consequences for women’s health, including delaying access to healthcare services and lowering the quality of nutrition. Although consensus exists around the theoretical definitions of GBD, current studies are limited on how to measure GBD empirically in order to assess its true impact on women’s health. Our mixed-methods scoping review aims at synthesising existing evidence by answering the question How is gender-based discrimination defined and measured in the health literature, with specific reference to Low and Middle-Income Countries (LMICs)?. Our ambition is to identify commonalities across definitions and measures to generate a dialogue towards reaching consensus around the development of a single standardised tool to be applied in health studies.

Methods and analysis
Our mixed-method scoping review includes quantitative, qualitative and mixed-methods studies and unfolds according to the six stages proposed by Levac et al. Eligibility criteria for studies were defined in order to reflect the three core elements of the search, namely (1) the discrimination based on the gender, (2) the link to health outcomes and (3) the developing countries context. Four databases (PubMed, Web of Science, Cinahl and Econlit) were searched. We will extract and synthesise information from quantitative and qualitative studies following the framework proposed by Hong and use the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping review tool as a guide.

Ethics and dissemination
Since our scoping review relies exclusively on information extracted from published articles, its conduct is not subjected to ethical clearance. Results will be described and discussed in a peer-reviewed article and presented at relevant workshops and conferences.

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Dicembre 2022

Exploring biomarkers in routine diagnostics for the risk stratification of older patients in the Chest Pain Unit: a prospective cohort study

Objectives
This study aims to estimate the association of the often, in daily clinical practice, used biological age-related biomarkers high-sensitivity troponin-T (hs-TnT), C reactive protein (CRP) and haemoglobin (Hb) with all-cause mortality for the purpose of older patient’s risk stratification in the emergency department (ED).

Design
Exploratory, prospective cohort study with a follow-up at 2.5 years after recruitment started. For the predictors, data from the hospital files including the routinely applied biological age-related biomarkers hs-TnT, CRP and Hb were supplemented by a questionnaire.

Setting
A cardiological ED, Chest Pain Unit, University Hospital Heidelberg, Germany.

Participants
N=256 cardiological ED patients with a minimum age of 70 years and the capability to informed consent.

Primary outcome measures
The primary outcome of this study was all-cause mortality which was assessed by requesting registry office information.

Results
Among N=256 patients 63 died over the follow-up period. Positive results in each of the three biomarkers alone as well as the combination were associated with increased all-cause mortality at follow-up. The number of positive age-related biomarkers appeared to be strongly indicative of the risk of mortality, even when controlled for major confounders (age, sex, body mass index, creatinine clearance and comorbidity).

Conclusions
In older ED patients, biomarkers explicitly related to biological ageing processes such as hs-TnT, CRP and Hb were to a certain degree independently of each other as well as combined associated with an increased risk of all-cause mortality. Thus, they may have the potential to be used to supplement the general risk stratification of older patients in the ED. Validation of the results in a large dataset is needed.

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Dicembre 2022

Role of central obesity on pain onset and its association with cardiovascular disease: a retrospective study of a hospital cohort of patients with osteoarthritis

Objectives
To determine the role of central obesity (CO) in the onset and severity of joint pain and in predicting cardiovascular disease (CVD) in subjects affected with osteoarthritis (OA).

Design
Retrospective analysis on the onset of OA joint pain and CO. Waist circumference (WC), Waist-to-height ratio andwaist-to-hip ratio (WHR) were measured at the interview and defined according to the WHO criteria. Cross-sectional analyses on the association of comorbidities, including CVD, pain severity (number of joints and pain score) and CO.

Settings and participants
Medical records and interviews of a hospital cohort study of 609 patients with OA. Analyses included analysis of variance, mean differences (MDs), SE and logistic regression. Areas under the receiver operating characteristic curve (AUROC) compared the predictive value of the sex-specific CVD models.

Outcome measures
Onset of OA joint pain (years) and severity according to body mass index (BMI) and WC categories. Predictive value of WC for CVD by sex. Education level, disability, smoking and alcohol use were used to adjust the analysis.

Results
Subjects with OA and CO by WHR started 2 years earlier with pain symptoms and had more joints affected than those without CO (MD=1.96 years, SE=0.95, p=0.04 and MD=0.32, SE=0.15 and p=0.04, respectively). Age and hypertension were associated with CVD in both genders, and NSAIDs use only in males. In addition, respiratory disease, hypercholesterolaemia, stairs difficulty, a wider WC and obesity were significant risk factors in females, improving 12.7% in the prediction of CVD cases, compared with only age and BMI (AUROCC=0.793 and 0.666, respectively, p=0.03 for the difference between AUROCs).

Conclusion
CO is associated with the onset of joint pain, and all pain analysed variables. CO has a role in CVD in women affected with OA and might help predict CVD cases.

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Dicembre 2022