Nurses experience with body care among palliative care patients: a phenomenological study.

BACKGROUND: Palliative care is defined as active and global care that provides holistic care integrating the body, mind and spirit of the dying person. A person's health deteriorates at the end of life and nurses facilitate patients to manage their personal body care. Knowing and considering the impact of disease on individuals' lives, how they adapt to cope with it, and the meaning they give to it, can help nurses. This is because of the embodiment concept of living in and through our bodies. The aim of the study is to explore palliative care patients' experiences with nurses during body care. METHODS: A descriptive phenomenological approach based on Husserl's philosophical perspective was used. A purposive sample of eight palliative care patients were enrolled in the study. Semi-structured interviews were conducted between November 2018 and January 2019, in an Italian hospice. The interviews were about patients' feelings during nursing body care. The transcripts were analysed using Giorgi's phenomenological method. Several strategies were used to ensure the study's reliability. RESULTS: The qualitative analysis revealed six categories that converged in three themes: 1) body care requires a specific competence; 2) patients experience difficulties during care by nurses; 3) compassionate care relationships help patients to find wellbeing and balance. CONCLUSIONS: People at the end of life find the deterioration of their body distressing and a reminder that they are about to die. These considerations give us an understanding of patient embodiment and the significance of a patient's lived experiences at the end of their life. This phenomenon in nursing should be explored further in future research, to help inform more targeted care strategies.

Volume replacement in the resuscitation of trauma patients with acute hemorrhage: an umbrella review.

BACKGROUND: The use of intravenous fluid therapy in patients with major trauma in prehospital settings is still controversial. We conducted an umbrella review to evaluate which is the best volume expansion in the resuscitation of a hemorrhagic shock to support the development of major trauma guideline recommendations. METHODS: We searched PubMed, Embase, and CENTRAL up to September 2022 for systematic reviews (SRs) investigating the use of volume expansion fluid on mortality and/or survival. Quality assessment was performed using AMSTAR 2 and the Certainty of the evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. RESULTS: We included 14 SRs investigating the effects on mortality with the comparisons: use of crystalloids, blood components, and whole blood. Most SRs were judged as critically low with slight overlapping of primary studies and high consistency of results. For crystalloids, inconsistent evidence of effectiveness in 28- to 30-day survival (primary endpoint) was found for the hypertonic saline/dextran group compared with isotonic fluid solutions with moderate certainty of evidence. Pre-hospital blood component infusion seems to reduce mortality, however, as the certainty of evidence ranges from very low to moderate, we are unable to provide evidence to support or reject its use. The blood component ratio was in favor of higher ratios among all comparisons considered with moderate to very low certainty of evidence. Results about the effects of whole blood are very uncertain due to limited and heterogeneous interventions in studies included in SRs. CONCLUSION: Hypertonic crystalloid use did not result in superior 28- to 30-day survival. Increasing evidence supports the scientific rationale for early use of high-ratio blood components, but their use requires careful consideration. Preliminary evidence is very uncertain about the effects of whole blood and further high-quality studies are required.

Correction: Sepe et al. The Long Non-Coding RNA RP5-1024C24.1 and Its Associated-Gene MPPED2 Are Down-Regulated in Human Thyroid Neoplasias and Act as Tumour Suppressors. Cancers 2018, 10, 146.

In the original publication [...].

Exploring the definition and methodology of "best practice" in the health care literature: a scoping review protocol.

OBJECTIVE: This review will map and define the terminology used in health care literature for "best practice" as well as its underpinning framework/methodology. INTRODUCTION: Numerous international organizations and institutions have sought to develop models or frameworks to guide health care providers to integrate the best evidence into clinical practice. However, different concepts related to best practice have been used, both in the biomedical literature and by public institutions, leading to a lack of consistency in definitions of the term. This poses a potential difficulty for clinical professionals in applying evidence effectively to achieve desired patient outcomes. INCLUSION CRITERIA: This review will adopt the following inclusion criteria: i) the study must contain a definition of the term "best practice" or its related concepts; ii) the concept of best practice must refer to clinical activities and not have organizational features; and iii) any study design can be included. Studies will be excluded if they describe a definition of best practice that is not directly related to clinical practice (eg, business). METHODS: The review will follow the JBI methodology for scoping reviews. An initial search of MEDLINE identified keywords and MeSH terms. MEDLINE (PubMed), Embase, CINAHL (EBSCOhost), and Google Scholar will be searched from 2001 until the present, the year in which the first definition of best practice appeared in the literature. Four pairs of reviewers will independently select studies and perform data extraction and data synthesis. Data will be presented in figures or tables, accompanied by a narrative summary. Searches will be limited to articles in English, Italian, German, French, and Spanish. REVIEW REGISTRATION: Open Science Framework: https://osf.io/52vxe/.

An example of evaluation of tuning nursing competences in the licensure exam: An observational study.

Introduction The licensure exam in nursing has always focused on the curricula used in universities. 'Tuning' was the first project that sought to harmonize training purposes regarding competences and learning outcomes in Europe. The Tuning educational structures have been offered in various disciplines, including nursing with the development of the Tuning Nursing Project. The study describes which of 47 Tuning Nursing Competences were evaluated during the licensure exam in nursing degree courses, and what types of trials were used for their assessment. Methods A multicentric observational study was conducted in 4 universities in Italy. Data were collected in academic years 2017-2019, using two grids: one for cognitive and one for psychomotor tests. Results The Tuning competences were requested 7522 times. The most frequently demanded were those associated with domain number two, "Nursing practice and clinical decision making". The level of performance most required in cognitive tests was the autonomy of judgement, and both tests concerned the fields of non-communicable diseases and the hospitalized adult patient. Conclusions The competences most often assessed coincided with those deemed core for the first cycle of studies at the European level. Unfortunately, it has been detected a high degree of discrepancy in the types of tests used in different schools.

Structured approach with primary and secondary survey for major trauma care: an overview of reviews.

BACKGROUND: A structured approach involves systematic management of trauma patients. We aim to conduct an overview of reviews about the clinical efficacy and safety of structured approach (i.e., primary and secondary survey) by guideline checklist compared to non-structured approach (i.e. clinical examination); moreover, routine screening whole-body computer tomography (WBCT) was compared to non-routine WBCT in patients with suspected major trauma. METHODS: We systematically searched MEDLINE (PubMed), EMBASE and Cochrane Database of Systematic Reviews up to 3 May 2022. Systematic reviews (SRs) that investigated the use of a structured approach compared to a non-structured approach were eligible. Two authors independently extracted data, managed the overlapping of primary studies belonging to the included SRs and calculated the corrected covered area (CCA). The certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. RESULTS: We included nine SRs investigating two comparisons in stable trauma patients: structured approach vs non-structured approach (n = 1) and routine WBCT vs non-routine WBCT (n = 8). The overlap of included primary studies was generally high across outcomes (CCA ranged between 20.85 and 42.86%) with some discrepancies in the directions of effects across reviews. The application of a structured approach by checklist may improve adherence to guidelines (e.g. Advanced Trauma Life Support) during resuscitation and might lead to a reduction in mortality among severely injured patients as compared to clinical examination (Adjusted OR 0.51; 95% CI 0.30-0.89; p = 0.018; low certainty of evidence). The use of routine WBCT seems to offer little to no effects in reducing mortality and time spent in emergency room or department, whereas non-routine WBCT seems to offer little to no effects in reducing radiation dose, intensive care unit length of stay (LOS) and hospital LOS (low-to-moderate certainty of evidence). CONCLUSIONS: The application of structured approach by checklist during trauma resuscitation may improve patient- and process-related outcomes. Including non-routine WBCT seems to offer the best trade-offs between benefits and harm. Clinicians should consider these findings in the light of their clinical context, the volume of patients in their facilities, the need for time management, and costs.

Systemic hemostatic agents initiated in trauma patients in the pre-hospital setting: a systematic review.

PURPOSE: The effect of systemic hemostatic agents initiated during pre-hospital care of severely injured patients with ongoing bleeding or traumatic brain injury (TBI) remains controversial. A systematic review and meta-analysis was therefore conducted to assess the effectiveness and safety of systemic hemostatic agents as an adjunctive therapy in people with major trauma and hemorrhage or TBI in the context of developing the Italian National Institute of Health guidelines on major trauma integrated management. METHODS: PubMed, Embase, and Cochrane Library databases were searched up to October 2021 for studies that investigated pre-hospital initiated treatment with systemic hemostatic agents. The certainty of evidence was evaluated with the Grading of Recommendations Assessment, Development, and Evaluation approach, and the quality of each study was determined with the Cochrane risk-of-bias tool. The primary outcome was overall mortality, and secondary outcomes included cause-specific mortality, health-related quality of life, any adverse effects and blood product use, hemorrhage expansion, and patient-reported outcomes. RESULTS: Five trials of tranexamic acid (TXA) met the inclusion criteria for this meta-analysis. With a high certainty of evidence, when compared to placebo TXA reduced mortality at 24 h (relative risk = 0.83, 95% confidence interval = 0.73-0.94) and at 1 month among trauma patients (0.91, 0.85-0.97). These results depend on the subgroup of patients with significant hemorrhage because in the subgroup of TBI there are no difference between TXA and placebo. TXA also reduced bleeding death and multiple organ failure whereas no difference in health-related quality of life. CONCLUSION: Balancing benefits and harms, TXA initiated in the pre-hospital setting can be used for patients experiencing major trauma with significant hemorrhage since it reduces the risk of mortality at 24 h and one month with no difference in terms of adverse effects when compared to placebo. Considering the subgroup of severe TBI, no difference in mortality rate was found at 24 h and one month. These results highlight the need to conduct future studies to investigate the role of other systemic hemostatic agents in the pre-hospital settings.

Effectiveness of transitional care interventions in patients with serious illness and their caregivers: a systematic review protocol.

OBJECTIVE: The objective of this review is to evaluate the effectiveness of transitional care interventions for seriously ill patients and their caregivers. INTRODUCTION: Seriously ill patients and their caregivers may have complex health and social care needs that require services from numerous providers across multiple sectors. Transitional care interventions have been designed to enhance a collaborative approach among providers to facilitate the care transition process. However, the effectiveness of transitional care interventions for seriously ill patients and their caregivers, and the effects of such interventions on their outcomes, remain unclear. INCLUSION CRITERIA: Randomized controlled trials with adult patients (≥18 years old) with serious illness and their caregivers involved in transitional care programs will be considered for inclusion. The patients' outcomes will include mortality and/or survival, symptoms (eg, pain, nausea), and health-related quality of life. The caregivers' outcomes will include caregiver burden, preparedness, and well-being. METHODS: The JBI methodology for systematic reviews of effectiveness will be followed. The search strategy will aim to locate published and unpublished studies. Electronic databases, including PubMed, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials, will be systematically searched from 2003 to the present. Studies in English, Italian, Spanish, French, and German will be included. Critical appraisal and data extraction will be conducted using standardized tools. Quantitative data will be pooled in statistical meta-analysis or, if statistical pooling is not possible, the findings will be reported narratively. Certainty of the evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42022319848.

Chronic Non-cancer Pain Management in a Tertiary Pain Clinic Network: a Retrospective Study.

INTRODUCTION: Chronic pain is a distressing condition that should be treated in specialized pain clinics. Pain clinics offer a holistic, evidence-based approach, including pharmacological, complementary, and invasive treatments. This study aimed to provide preliminary information regarding chronic pain treatments and identify reasons for accessing an important hub-spoke pain clinic network. METHODS: A retrospective multicenter cross-sectional study was carried out. A total of 1606 patients' records were included. Patients were selected from the 26 pain clinics of a single region in Italy. Univariate and multivariate logistic regression models were used. RESULTS: Multivariate models showed that the use of opioids were considered effective for severe or moderate pain [odds ratio (OR) 0.41; 95% 0.33-0.51], while the use of invasive treatments (OR 2.45; 95% 1.95-3.06) and the use of complementary therapy (OR 1.87; 95% 1.38-2.51) were associated with severe or moderate pain. Overall, age, sex, nonsteroidal anti-inflammatory drugs (NSAID) use, a combination of NSAIDs, complementary therapies, and a combination of opioids and invasive treatments did not seem to be significantly associated with the nature of pain. Multivariate models confirmed that clinical parameters such as the nature of pain, multi-diagnosis, more than one site of pain, treatments, and general practitioner, but not the severity of pain and use of invasive treatments, had an impact on the choice of a pain clinic. CONCLUSION: Opioids are useful in managing moderate or severe chronic pain. Multimodal approaches are used for the management of chronic pain. Moreover, it is not clear how patients are addressed to access different pain clinics (spoke versus hub) networks. More widespread adoption is needed for an interdisciplinary approach to managing chronic pain and adopting guideline recommendations, and rigorous research is required to provide more substantial evidence and support clinical practice.

Knowledge, attitude and barriers of the Italian National Guidelines System for the development of clinical practice guidelines: a cross-sectional survey of registered scientific-technical societies.

BACKGROUND: To explore knowledge, attitude, and barriers of the Italian National Guidelines System (SNLG) for the development of clinical practice guidelines (CPG) among scientific-technical societies (STS) of health care professional. METHODS: A cross-sectional survey was distributed to the STS registered in the Italian Ministry of Health (n = 336). The questionnaire consisted of three sections: Respondent characteristics; Perception, knowledge, attitude, and use of CPGs; Knowledge of the SNLG. RESULTS: The survey sample was 194 (57.7%) STS: 69% STS members stated they "often consulted CPGs". Two out of three STS perceived scientific activities as extremely important. Additionally, 20.6% STS had submitted at least one CPG to the SNLG platform after the Gelli-Bianco Law went into effect (median 1 CPG; interquartile range, IQR, 1-4). The most often cited barrier (62.7%) to CPG submission was limited economic resources. CONCLUSIONS: STS members hold a positive attitude towards CPGs despite barriers to CPG development.

Job Satisfaction: Knowledge, Attitudes, and Practices Analysis in a Well-Educated Population.

Job satisfaction has a huge impact on overall life quality involving social relationships, family connection and perceived health status, affecting job performances, work absenteeism and job turnover. Over the past decades, the attention towards it has grown constantly. The aim of this study is to analyze simultaneously knowledge, attitudes, and practices toward job satisfaction in a general population in a large metropolitan area. The data acquired from 1043 questionnaires-administered to subjects with an average age of 35.24 years-revealed that only 30% is satisfied by his job. Moreover, among all the tested sample, 12% receive, or often receive intimidation by their superior, and 23% wake up unhappy to go to work. Marital status and having children seem to be an important factor that negatively influences job satisfaction through worst behaviours. The multiple linear regression analysis shows how knowledge is negatively correlated to practices; although this correlation is not present in a simple linear regression showing a mediation role of attitudes in forming practices. On the contrary, attitudes, correlated both to knowledge and practices, greatly affect perceived satisfaction, leading us to target our proposed intervention toward mindfulness and to improve welfare regulation towards couples with children.

Factors influencing self-care in postmenopausal women with osteoporosis: The Guardian Angel® multicentric longitudinal study.

OBJECTIVES: To investigate the factors influencing self-care in a consecutive sample of postmenopausal osteoporotic Italian women. STUDY DESIGN: This was a multicentric, longitudinal study (Guardian Angel) conducted across several osteoporosis centres throughout Italy. MAIN OUTCOME MEASURES: Sociodemographic and clinical data (age, education, employment status, body mass index (BMI), fracture history) were collected at baseline, while self-care behaviours were assessed at baseline, and at one, three and six months from enrolment with the Self-Care of Osteoporosis Scale (SCOS). The SCOS has a total score ranging from 15 to 75 for women who take osteoporosis drugs, while for those who do not take any osteoporosis drug the score is between 13 and 65. Higher scores indicate better self-care. A three-level general linear mixed model with a random intercept for participants and regions was implemented to investigate the possible associations of the sociodemographic and clinical factors with longitudinal SCOS scores. RESULTS: The sample (n= 1525) had a mean age of 72.1 years (standard deviation [SD] = ±10.07), with a high proportion retired (64.2%) and with a low education level (45.8%). Approximately half of the women declared taking multiple medications (70.14%) and osteoporosis pharmacotherapy (69.7%). Average longitudinal SCOS scores ranged between 53.17 and 56.68, indicating a satisfactory level of self-care. There were significant and positive relationships between SCOS scores and time (p < 0.001) and number of medications taken (p < 0.001). Negative relationships were found between SCOS and BMI scores (p= 0.013), smoking status (p < 0.001) and presence of recent fractures (p < 0.001). CONCLUSIONS: Several modifiable characteristics were associated with self-care behaviours in our sample of women with postmenopausal osteoporosis. Psychoeducational interventions are promising in this population to counteract unhealthy behaviours and, ultimately, to promote self-care.

Factors influencing place of death and disenrollment among patients receiving specialist palliative care.

BACKGROUND AND AIM OF THE WORK: Place of death and disenrollment from specialized palliative care services (SPCSs) are two aspects that determine service utilization. These aspects should be determined by patient needs and preferences, but they are often associated to patient sociodemographic or contextual characteristics. The aim of this study was to describe which factors are associated with utilizing SPCSs in terms of place of death and disenrollment. METHODS: Retrospective cohort study. Patients (>18 years) who died or were disenrolled during SPCSs utilization. Two hierarchical regression models were performed, and variables were categorized in predisposing, enabling, and need factors according to the Andersen behavioral model of health services use. RESULTS: We included 35,869 patients (52,5% male, mean age 74,6 ± 12,3 SD), where 17,225 patients died in hospice and 16,953 at home, while 1,691 patients were disenrolled. Dying at home was associated with older age, oncological diagnosis, painful symptoms and longer survival time. Instead, service disenrollment was associated with less education, longer wait time and longer length of stay. CONCLUSIONS: SPCS utilization was not influenced only by patient need, but also by other factors, such as social and contextual factors. These factors need to be considered by health care providers and efforts are needed for 1) identifying barriers and implementing effective interventions to support patients and caregivers in their preferred place of care and death and 2) for avoiding SPCS disenrollment with an increased probability of aggressive treatments and worse quality of life for patients.

Correction: Analysis of miRNA profiles identified miR-196a as a crucial mediator of aberrant PI3K/AKT signaling in lung cancer cells.

[This corrects the article DOI: 10.18632/oncotarget.13432.].

The International Guideline Evaluation Screening Tool (IGEST): development and validation.

BACKGROUND: Guideline adaptation provides an important alternative to de novo guideline development by making the process more efficient and reducing unnecessary duplication. The quality evaluation of international guidelines is an essential part of the adaptation process. The study aims at describing the development and validation of a new tool to screen trustworthy Clinical Practice Guidelines (CPGs) for their adoption/adaption: the International Guideline Evaluation Screening Tool (IGEST). METHODS: The process of developing the IGEST involved two main phases: 1) tool development and 2) content validation. The tool development phase comprised three stages, where the scope of the IGEST was defined and the item pool was generated and refined. The content validation was performed through the computation of a content validity index (CVI) based on the opinions of an expert panel. RESULTS: All the items obtained a CVI >0.78, which resulted in the validation of the instrument. The final instrument comprised four preliminary conditions and 12 criteria organised into three dimensions: (i) the management of conflict of interest; (ii) the quality of evidence and the coherence between evidence and recommendations; and (iii) the panel composition. CONCLUSION: The IGEST showed good content validity for assessing the quality of international guidelines. Using the new tool to select trustworthy guidelines might increase the likelihood that international clinical practice guidelines will be adopted/adapted to the local context by allowing a quick screening of existing guidelines trustworthiness and providing an acceptability threshold that supports the decision-making process.

Accuracy of risk tools to predict critical bleeding in major trauma: A systematic review with meta-analysis.

BACKGROUND: Early detection of critical bleeding by accurate tools can help ensure rapid delivery of blood products to improve outcomes in major trauma patients. We conducted a systematic review to evaluate the accuracy of risk tools to predict critical bleeding in patients with major trauma. METHODS: PubMed, Embase, and CENTRAL were searched up to February 2021 for studies investigating risk tools to predict critical bleeding for major trauma people in prehospital and emergency department. We followed the Preferred Reporting Items for Systematic Review and Meta-Analysis of Diagnostic Test Accuracy study guidelines. Two independent authors included studies, extracted data, appraised the quality using the Quality Assessment of Diagnostic Accuracy Studies 2 and assessed the certainty of evidence (CoE) using the Grading of Recommendations Assessment, Development and Evaluation methodology. Sensitivity, specificity, and the receiver operating characteristics curve for all selected triage tools. RESULTS: Eighty-nine observational studies for adults and 12 observational studies for children met our inclusion criteria. In adults, we found 23 externally validated and 28 unvalidated tools; in children, 3 externally validated tools and 5 unvalidated. In the externally validated tools, we identified those including clinical, laboratory, and ultrasound assessments. Among tools including only a clinical assessment, the Shock Index showed high sensitivity and specificity with the CoE ranging from very low to moderate in adults, as well as Shock Index Pediatric Age adjusted with a moderate CoE. We found that tools using clinical, laboratory, and ultrasound assessments were overall more accurate than those tools without all three components. CONCLUSION: Clinicians should consider risk tools to predict critical bleeding in a time-sensitive setting like major life-threatening trauma. The Shock Index and Shock Index Pediatric Age adjusted are easy and handy tools to predict critical bleeding in the prehospital setting. In the emergency department, however, many other tools can be used, which include laboratory and ultrasound assessments, depending on staff experience and resources. LEVEL OF EVIDENCE: Systematic Review and Meta-Analysis; Level III.

Palliative care organization and staffing models in residential hospices: Which makes the difference?

BACKGROUND: The number of patients using palliative care services, particularly residential hospices, is increasing. Policymakers are urging these services to reflect on the most effective organizational strategies for meeting patients' complex care needs. AIM: To analyze the predictive power of staffing, structure and process indicators towards optimal control of patients' clinically significant symptoms over time. DESIGN: Secondary analysis of data from a multicentre prospective longitudinal observational study (PRELUdiHO) collected between November 2017 and September 2018. SETTING/PARTICIPANTS: Adult patients (n = 992) enrolled in 13 Italian residential hospices. METHODS: Two generalized estimating equations logistic models were built, both with number of hospice beds and length of stay as independent variables as well as, in one case, patient-to-healthcare worker ratios, and, in the other, health professionals' qualification levels. Dependent variables were six not clinically significant (score<4) symptoms: pain, nausea, shortness of breath, feeling sad, feeling nervous, and 'how you feel overall', according to the Edmonton Symptom Assessment System revised (ESAS-r) scale. RESULTS: The generalized estimating equations indicators on staff revealed the following 'optimal' model: Patient-to-Physician ratio (5.5:1-6.5:1); Patient-to-Nurse ratio (1.5:1-2.7:1); Patient-to-Nurse-Assistant ratio (4.1:1-6.3:1); with the most balanced staff composition including 19% physicians, 23% nurse assistants, and 58% registered nurses; hospice beds (12-25); length of stay (median = 12 days). This model predicted an up to four times greater likelihood of controlling all six ESAS-r symptoms over time. The generalized estimating equations model on the educational level of physicians and registered nurses showed that it was significantly associated with optimal patients' symptom control during the entire hospice stay. CONCLUSIONS: This study showed the exact skill-mix composition and proportions of palliative care team able to ensure optimal control of patients' symptoms. The added value of physicians and nurses with a qualification in palliative care in terms of better patient outcomes reaffirmed the importance of education in guaranteeing quality care. Hospices with 12-25 beds, and recruitment methods guaranteeing at least 12-day stay ensured the most propitious organizational environment for optimal management of clinically significant symptoms. The transferability of these results mainly depends on whether the skills of health professionals in our `ideal' model are present in other contexts. Our results provide policymakers and hospice managers with specific, evidence-based information to support decision-making processes regarding hospice staffing and organization. Further prospective studies are needed to confirm the positive impact of this 'optimal' organizational framework on patient outcomes.

Effectiveness of Pre-Hospital Tourniquet in Emergency Patients with Major Trauma and Uncontrolled Haemorrhage: A Systematic Review and Meta-Analysis.

Trauma is one of the leading causes of uncontrolled haemorrhage, death, and disability. Use of a tourniquet can be considered an optimal anti-haemorrhagic resource, in pre-hospital and emergency settings, and its lifesaving effect is clinically contradictory. This review aims to assess the clinical efficacy of the tourniquet in the emergency pre-hospital care setting for the management of haemorrhage. We conducted the systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, the PRISMA statement. We searched the following electronic databases: EMBASE, MEDLINE, and Cochrane-CENTRAL. All studies included were appraised for risk of bias. Prevalent primary outcomes were mortality and use of blood products. Secondary outcomes were related to adverse effects. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE). Four studies were involved (1762 trauma patients). The adjusted odds ratio (aOR) of 0.47 (95% confidence Interval (CI) 0.19-1.16; three studies; 377 patients) for overall mortality estimates did not give a clear indication of the benefits of emergency pre-hospital tourniquets (PH-TQ) versus no pre-hospital tourniquet (NO PH-TQ) placement. The adjusted mean difference for blood product use was -3.28 (95% CI -11.22, 4.66) for packed red blood cells (pRBC) and -4.80 (95% CI -5.61, -3.99) for plasma, respectively. The certainty of evidence was downgraded to very low for all outcomes. Our results suggest an unclear effect of emergency pre-hospital tourniquet placement on overall mortality and blood product use. However, this systematic review highlights the availability of only observational studies and the absence of high quality RCTs assessing the efficacy of PH-TQs. Randomized controlled trials are needed.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) in patients with major trauma and uncontrolled haemorrhagic shock: a systematic review with meta-analysis.

BACKGROUND: Multiple studies regarding the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in patients with non-compressible torso injuries and uncontrolled haemorrhagic shock were recently published. To date, the clinical evidence of the efficacy of REBOA is still debated. We aimed to conduct a systematic review assessing the clinical efficacy and safety of REBOA in patients with major trauma and uncontrolled haemorrhagic shock. METHODS: We systematically searched MEDLINE (PubMed), EMBASE and CENTRAL up to June 2020. All randomized controlled trials and observational studies that investigated the use of REBOA compared to resuscitative thoracotomy (RT) with/without REBOA or no-REBOA were eligible. We followed the PRISMA and MOOSE guidelines. Two authors independently extracted data and appraised the risk of bias of included studies. Effect sizes were pooled in a meta-analysis using random-effects models. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Primary outcomes were mortality, volume of infused blood components, health-related quality of life, time to haemorrhage control and any adverse effects. Secondary outcomes were improvement in haemodynamic status and failure/success of REBOA technique. RESULTS: We included 11 studies (5866 participants) ranging from fair to good quality. REBOA was associated with lower mortality when compared to RT (aOR 0.38; 95% CI 0.20-0.74), whereas no difference was observed when REBOA was compared to no-REBOA (aOR 1.40; 95% CI 0.79-2.46). No significant difference in health-related quality of life between REBOA and RT (p = 0.766). The most commonly reported complications were amputation, haematoma and pseudoaneurysm. Sparse data and heterogeneity of reporting for all other outcomes prevented any estimate. CONCLUSIONS: Our findings on overall mortality suggest a positive effect of REBOA among non-compressible torso injuries when compared to RT but no differences compared to no-REBOA. Variability in indications and patient characteristics prevents any conclusion deserving further investigation. REBOA should be promoted in specific training programs in an experimental setting in order to test its effectiveness and a randomized trial should be planned.