Environmental diseases, recognition for care: A qualitative study of nurses' perceptions.

OBJECTIVES: This study aims to investigate hospital nurses' perceptions of illness due to environmental exposures. DESIGN: A qualitative exploratory study, designed in accordance with the specified reporting guidelines for qualitative research. SAMPLE: Nurses working in Italian hospitals. METHODS: Semi-structured interviews were used to collect data, then evaluated using the framework analysis methodology. Data collection was from January to June 2022 and analysed from July to September 2022. RESULTS: Forty-two nurses were interviewed. Data analysis revealed three themes: 1) the concept of disease in relation to environmental exposure; 2) the dangers of chemical and physical substances; 3) environmental changes cause concern and a sense of helplessness for the future. CONCLUSIONS: The results suggest the need for specific training on topics related to environmental disease types, environmental exposure, preventive measures, health promotion, and environmental impact to support professional development and support nurses in the management of this important aspect of health care.

Nurses' experiences of caring for nursing care-dependent ICU patients: A qualitative study.

BACKGROUND: Nursing care dependency is a key, yet under-studied, nursing phenomenon. Patients in intensive care units are highly dependent on nursing care. Patients find dependency challenging, experiencing feelings of powerlessness and shame. The nurse-patient care relationship can influence patients' perception of dependency. Understanding how nurses experience their care for dependent patients is crucial, as nurses might not always grasp the impact of their actions on patients' dependency experiences. AIM: To explore and interpret ICU nurses' perceptions of patients' nursing care dependency and their experiences in caring for nursing care-dependent patients. METHODS: A qualitative interpretative phenomenological study inspired by Merleau-Ponty's philosophical stance was conducted using focus groups with nurses who had been caring for adult patients for at least 6 months in ICUs of two hospitals. Data analysis followed Smith et al.'s guidance. Researchers immersed themselves in the transcripts, noted individual's experiences before transitioning to shared insights, coded significant phrases and generated themes and superordinate themes. RESULTS: Four focus groups were conducted with 18 nurses with widely ranging ages and work experience. Four superordinate themes emerged: 'Time and context define dependency', 'Empathetic relationships help nurses understand patients' experience of dependency', 'Trusting nurse-patient relationships change the dependency experience' and 'Nurses' skills help patients to recover independence'. CONCLUSION: This study increases critical care nurses' awareness of the overlooked phenomenon of caring for nursing care dependent patients and offers them an opportunity to reflect on their care for dependent patients and adapt it to patients' experiences. Further studies are needed with nurses and patients in different ICUs, cultures and countries, to gain a broader picture of experiences of nursing care dependency. RELEVANCE TO CLINICAL PRACTICE: ICU nurses need strong relational skills to offer high-quality care for dependent patients, facilitating meaningful nurse-patient relationships based on empathy and trust. These relationships can significantly impact the patient's experience of dependence.

Nurse specialist and ostomy patient: Competence and skills in the care pathway. A scoping review.

AIMS AND OBJECTIVES: To summarise the evidence published to date regarding nursing core competence in stoma care of any type of ostomy throughout the patient's ostomy surgery candidate care pathway from preoperative to follow-up. BACKGROUND: Nurses should play a key role in all ostomy patient care pathways to help them to adapt to the new physics and psychological conditions from the preoperative phases to the prevention of tardive stomal complications. DESIGN: Scoping review. METHODS: This scoping review was conducted following the methodological framework proposed by Arskey and O'Malley, following the Preferred Reporting Item for Systematic Review and Meta-analysis for Scoping Review. PRISMA-ScR Checklist is included in the manuscript. The following databases were queried: PubMed, EMBASE and CINAHL, from August to October 2022. RESULTS: The search strategy in the consulted databases identified 3144 studies. Different types of ostomies were found and investigated: tracheostomy, gastrostomy, jejunostomy, ileostomy, colostomy and urostomy. The results of the included studies helped address the objective that allowed the ostomatherapy skills to be broken down into the different periods of the care pathway. CONCLUSION: Caring for an ostomy patient requires advanced skills and a trusting relationship. The skills outlined in this research suggest how essential the stoma care nurse specialist is in these patients' care.

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.

Becoming a mother during the COVID-19 pandemic: The lived experience as told by birthing mothers: A qualitative study.

AIMS AND OBJECTIVES: The aim of this study is to explore the lived experience of women who gave birth during the COVID-19 pandemic. BACKGROUND: Experiencing pregnancy during the Covid-19 pandemic exacerbates the risk of the onset of psychological problems. DESIGN: This is a descriptive, single-centre, qualitative study. METHODS: The enrolment for data collection included childbearing mothers aged 18 years and over between November 2021 and April 2022. The researchers invited them to write about their personal experiences during the isolation period of the first pandemic wave. The descriptive phenomenological analysis of the data was carried out using the method described by Mortari. RESULTS: A total of 50 mothers were recruited, of whom 28 were primiparous (56.0%) and 22 multiparous (44.0%). From the analysis of the interviews, five main themes emerged that enclose the experience of both primiparous and multiparous mothers: 'The negative feeling: between loneliness, sadness and fear'; 'The comfort of being cared for: between humanity and competence'; 'Family proximity: between comfort and stress'; 'Symbiotic intimacy: bonding; Managing physical pain and consciousness of being resilient women'. CONCLUSIONS: The study showed that the discomfort associated with the absence of family support in the phase of labour and childbirth was compensated by the professionalism of the health staff and allowed new mothers to experience moments of great intimacy with the child. IMPLICATIONS FOR NURSING MANAGEMENT: Such data could help create recommendations based on the assisted person's experiences to ensure that care is increasingly attentive and tailored to the needs of mothers and, thus, of children.

Development and psychometric testing of the care dependence perception questionnaire.

OBJECTIVE: This multicentre study aimed to develop a measure of the perception of care dependence in patients diagnosed with cancer and to test its psychometric properties. METHODS: The questionnaire was developed based on findings emerged from a meta-synthesis and from qualitative studies conducted in three hospitals in Italy. The draft questionnaire was tested for face and content validity and pilot-tested with patients. The questionnaire was completed by care-dependent patients with cancer. Test-retest was conducted to verify stability. Exploratory factor analysis (EFA) was performed using a Maximum Likelihood robust estimator. RESULTS AND CONCLUSION: The Scale-Content Validity Index was 0.92. The final 15-item questionnaire was completed by 208 patients admitted to two hospitals. The EFA yielded a two-factor model including a positive and a negative perception of care dependence. Factor score determinacy coefficients, Cronbach's alpha coefficients, composite reliability coefficients and Intraclass Correlations Coefficients yielded satisfactory results confirming internal consistency and stability. The hedonic balance score is also available as a single indicator of subjective well-being. The study provides initial validation of the Care DEeP Questionnaire that can be used by cancer nurses to assess positive and negative patient experiences with care dependence and to personalise and improve their care.

The efficacy of balneotherapy, mud therapy and spa therapy in patients with osteoarthritis: an overview of reviews.

Osteoarthritis is a degenerative disease considered a leading cause of functional disability. Its treatment is based on a combination of pharmacological and non-pharmacological interventions, but the role of these latter is still debated. This overview of systematic reviews aimed at evaluating the short-term efficacy of different thermal modalities in patients with osteoarthritis. We searched PubMed, Scopus, CINHAL, Web of Science, ProQuest and the Cochrane Database of Systematic Reviews from inception until October 2020, with no language restrictions. We selected the following outcomes a priori: pain, stiffness and quality of life. Seventeen systematic reviews containing 27 unique relevant studies were included. The quality of the reviews ranged from low to critically low. Substantial variations in terms of interventions studied, comparison groups, population, outcomes and follow-up between the included SRs were found. From a re-analysis of primary data, emerged that balneotherapy was effective in reducing pain and improving stiffness and quality of life, mud therapy significantly reduced pain and stiffness, and spa therapy showed pain relief. However, the evidence supporting the efficacy of different thermal modalities could be seriously flawed due to methodological quality and sample size, to the presence of important treatment variations, and to the high level of heterogeneity and the absence of a double-blind design. There is some encouraging evidence that deserves clinicians' consideration, suggesting that thermal modalities are effective on a short-term basis for treating patients with AO.

Nurses' perception of the oncology patient's death: a qualitative study.

BACKGROUND: Death is one of the basic theme with which nurses are faced, and for which it is hard for them to prepare deeply and sincerely. The difficulties in handling the emotional burden can cause them to develop negative feelings towards life and clinical practice, so that it affects their caregiving capacity and the quality of care provided. AIM: To explore nurses' perceptions facing the death of a hospitalized oncology patient. METHODS: Qualitative phenomenological study. The sample of nurses was recruited at IRCCS (Scientific Institute for Research and Healthcare) in Rome, a hospice in Latina and a hospice in Rieti. The data were collected by means of focus groups. The semi-structured interviews featuring three guiding questions constructed for this purpose, were audio-recorded, transcribed, and then analyzed using the analysis framework approach. RESULTS: In total 7 focus groups were conducted with a total participation of 39 nurses. Four themes emerged from the qualitative analysis: "The different meanings of death", "The rupture of death", "The perceptual variables of death", and "Requests for help". CONCLUSION: The study highlighted the need to provide nurses with substantial psychological and emotional support, and give consideration to organizational and environmental factors for better management of the event of death in oncology.

Finding meaning in life: an exploration on the experiences with dependence on care of patients with advanced cancer and nurses caring for them.

PURPOSE: Patients with advanced cancer are likely to face increasing levels of care dependence. Adult patients who become care dependent on others can experience this condition as one of suffering and humiliation. The nurse-patient relationship plays a key role in the experience of dependence. Understanding patients' and nurses' perceptions of care dependence is crucial to addressing the impact it has on the lives of both. The aim of this study is to explore the experiences of patients with cancer and nurses caring for them. METHODS: A multicentre qualitative study was conducted in Italy using semi-structured interviews with patients with advanced cancer admitted to 3 hospitals, and 9 focus groups with nurses working in oncology wards of 2 hospitals. Data were analysed with inductive content analysis. RESULTS: Thirty-two patients and 44 nurses participated in the study. Three common themes were identified: within dependence, the relationship is a lifeline; dependence is influenced by internal and external factors and dependence generates changes. Dependence impacts on patients' and nurses' lives and implies a process of personal maturing for both. Patients learn the humility to ask for help by exposing their vulnerability. Nurses become aware that a trusting relationship helps patients to accept dependence, and they learn to self-transcend in order to build it. CONCLUSIONS: Striving to build positive relationships implies a change in nurses' and patients' lives. In this way, they come to understand important aspects of life and find meaning in difficult situations. Further studies should explore also homecare settings and patients' families.

Mobile Health in Adherence to Oral Anticancer Drugs: A Scoping Review.

In oncology, adherence to oral antineoplastic medication is a key element of treatment, on which the success of any therapeutic intervention depends. Given their widespread use in clinical practice, it is important to identify tools that can facilitate the monitoring and self-management of the patient at home, to avoid the consequences of employing ineffective treatment. One of the tools available today to take action on this phenomenon is mobile health technology. The aim of this review is to describe published studies relating to the use of mobile health to promote adherence to oral antineoplastic medication. This scoping review was conducted using the framework proposed by Arksey and O'Malley, adapted according to Levac et al. Of 1320 articles identified, only seven met the eligibility criteria and therefore were included in the review. All seven articles involved the use of digital means to measure adherence to treatment, patient satisfaction, acceptability and feasibility of the digital means used, and presence of symptoms, but not the effectiveness of the digital instrument used. In conclusion, the use of digital means to assist adherence of cancer patients to oral antineoplastic medication is widely recognized, but its effectiveness in clinical practice is poorly supported by the nature of the published studies.

[Linguistic validation and cultural adaptation of the Nurse Clinical Reasoning Scale]. / Validazione Linguistica e Adattamento Culturale della Scala Infermieristica sul Ragionamento Clinico.

INTRODUCTION: The clinical reasoning is a process in which nurses collect ideas, process information, they come to understand the problem or the patient's situation by planning and implementing interventions, evaluating the results. STUDY DESIGN: The aim of this study is to perform linguistic and cultural validation for the Italian context of the Nurse Clinical Reasoning Scale (NCRS). METHODS: Transcultural adaptation to develop the Italian version of the questionnaire was carried out following the guidelines proposed by Beaton and collaborators in 2000. RESULTS: The results showed that the Italian version of the instrument is reliable both showing a good internal consistency (Cronbach's Alpha = 0.90), and a good stability (ICC = 0.90; CI = 0.87-0.92) and can be proposed as an interesting means of evaluating nursing students in the course of clinical placements and nurses in their daily clinical practice. CONCLUSIONS: Having tools available in Italian promotes the implementation of new research projects in various areas, such as health, in order to ensure the centrality of the patient in the care process.

Risk factors for a difficult intravenous access: A multicentre study comparing nurses' beliefs to evidence.

AIMS AND OBJECTIVES: To summarise the evidence about patient-related risk factors for difficult intravenous access in adults, and at identifying nurses' beliefs and their consistency with evidence. BACKGROUND: Peripheral intravenous cannulation is a common procedure for nurses, but rates of failure at first attempt of peripheral intravenous cannulation range 10%-40%. Nurses' beliefs about difficult intravenous access factors might influence their clinical practice more than current evidence. DESIGN: The study included a literature review of the evidence on patient-related risk factors for difficult intravenous access, the development of an instrument to investigate nurses' beliefs about this topic and a cross-sectional multicentre survey on clinical nurses. METHODS: The quality of the studies included was evaluated through the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. A synthesis of evidence for each risk factor was produced. A survey instrument was developed including 26 risk factors, which were then rated by nurses as perceived predictors of difficult intravenous access. The STROBE guidelines for study reporting were followed. RESULTS: Four hundred and fifty clinical nurses working in four hospitals in Italy were surveyed. Nurses' beliefs were in line with evidence in considering body mass index, drug abuse, lymphadenectomy and chemotherapy as difficult intravenous access factors. Beliefs about difficult intravenous access factors were influenced by nurses' work experience and frequency of peripheral intravenous cannulation. Nurses also identified as risk factors for difficult intravenous access oedema, thrombophlebitis, hypovolaemia, skin lesions and irritant therapies, which have been minimally investigated by research. CONCLUSIONS: An overall congruence between nurses' beliefs and evidence about risk factors for difficult intravenous access was found. With their expertise, nurses may fill the knowledge gap of clinical evidence and open new paths for clinically meaningful research. RELEVANCE TO CLINICAL PRACTICE: Nurses' beliefs about difficult intravenous access factors can be influenced by their work experience and clinical setting. Integrating nurses' beliefs with scientific evidence can increase the quality of care.

Being in protective isolation following autologous haematopoietic stem cell transplantation: A phenomenological study.

AIMS AND OBJECTIVES: To explore the lived experiences of patients with haematological malignancies who had been in protective isolation during their hospital stay for autologous haematopoietic stem cell transplantation. BACKGROUND: Although protective isolation aims to benefit patients' health by preventing infection, it could also imply harmful psycho-social implications for patients, such as loneliness. DESIGN: A descriptive phenomenological study was conducted in an Italian university hospital. METHODS: Nine patients with haematological malignancies who had been in protective isolation for autologous haematopoietic stem cell transplantation were enrolled. They were interviewed during their weekly ambulatory visits, which are usually carried out up to 100 days post-transplant, and asked about their stay in isolation. Giorgi's method of analysis was used to describe the experience of protective isolation from the patient' perspective. RESULTS: Eight themes emerged: isolation is a defence, threats from which patients have to defend themselves, rules for defence, the burden of the defence, external strategies for defence, inner strengths for defence, defending loved ones and outcomes of the defence. The general structure was expressed as a defence from suffering. CONCLUSIONS: While fighting a hard battle against cancer, informants largely accepted the strict isolation measure and represented it as a shield for an effective defence. RELEVANCE TO CLINICAL PRACTICE: Nurses should provide emotional and social support to help patients feel like active fighters and strengthen their strategies for an effective defence from suffering.

[The impact of Reiki on side effects in patients with head-neck neoplasia undergoing radiotherapy: a pilot study]. / L'impatto del Reiki sugli effetti collaterali nei pazienti con neoplasia testa-collo in trattamento radioterapico: uno studio pilota.

BACKGROUND: Cancer patients often report symptoms related to therapeutic treatment, whose management is based on traditional medicine. In recent years, however, there has been growing interest towards adopting some form of complementary medicine, among these, Reiki. The aim of this study is to evaluate how this type of discipline can contribute to managing radiotherapy-related symptoms in patients with head and neck cancer. METHOD: The study was performed in the Radiotherapy Department at the Regina Elena National Cancer Institute in Rome. To assess QoL, the FACT-H N questionnaire was used, while the CTCAE Scale was adopted to evaluate mucositis, cutaneous toxicity and salivation. RESULTS: 10.5% of patients were reported to experience strong pain in the fifth week, compared to 21.1% of patients in the previous week; a degree of mucositis equal to G3 was also found in 15.5% of cases according to the clinical evaluation, as well as in 10.5% of patients according to the functional one. Only one case (5.3%) of grade 3 cutaneous toxicity was registered. CONCLUSION: The study shows how the Reiki treatment benefits patients in most cases, with both psychological support to help deal with the therapeutic process together with integrated support towards pain therapy.

Adherence to hormone therapy in women with breast cancer: a quantitative study.

INTRODUCTION: The majority of patients with hormone receptor-positive breast cancer are treated with oral endocrine therapies, which are administered in periods ranging from 5 to 10 years. Adherence, ie the degree a subject's behavior corresponds to the agreed recommendations, then becomes a significant problem, which can also affect distress levels. The aim of this study is to evaluate the level of adherence to endocrine therapy and distress in a sample of Italian women. METHOD: The study is a descriptive cross sectional survey. Adherence was measured with the Morisky Medication Adherence 8-item Scale and distress was measured by the Distress Thermometer. Socio-demographic and clinical data were also collected and then processed. RESULTS: Adherence measured with MMAS-8 items scored 6.18 corresponding to an average level of adherence in the 151 patients examined. The only factors affecting adherence signi- ficantly were: level of education, marital status and, among the side effects of therapy, poor concentration and memory. The data analysis obtained from the Distress Thermometer showed a degree of discomfort equal to 4.71,For example, in younger patients' levels of distress are greater in relationships, whereas in married/defacto women and workers distress levels are greater in practical areas. CONCLUSIONS: Results from this study can be useful to identify patients at risk for non-adhe- rence and distress, and consequently to help, the oncology team. Despite this, the study of adherence and related-factors needs further investigation.

Psychometric Evaluation of the Nurse Clinical Reasoning Scale (NCRS): A Validation Study Among Italian Nurses.

Background and Purpose: Clinical reasoning for nurses is considered a valuable component of clinical nursing competencies, but there are few tools to ascertain this. This study tested the Italian Nurses Clinical Reasoning Scale (I-NCRS) psychometric properties based on Levett-Jones' theoretical clinical reasoning model. Methods: Content, face, and construct characteristics were ascertained for their validity. The study had a two-phase design: (a) content and face validity and (b) construct validity. Results: Three factors emerged from the factorial analysis of our reference sample: nursing problems of health, nursing information of health, and nursing assessment of health. Conclusions: The scale represents a valuable tool for the self-assessment of the clinical reasoning skills of nurses. I-NCRS showed evidence of validity and reliability, being also useful for assessing clinical reasoning for educational and research purposes among Italian nurses.

Management of the patient with urostomy: Caregiver needs during the three months after discharge. A qualitative study.

OBJECTIVE: To examine caregivers' experiences and training needs after radical cystectomy with urinary diversion for the first three months following the patient's discharge. METHODS: This study applied a phenomenological design approach through open-ended interviews and descriptive analysis. Phenomenology applied to empirical research requires researchers to explore the empirical facts narrated by partici-pants. This study followed the Consolidated Criteria for Reporting Qualitative Research guidelines, a 32 - item checklist for inter-views and focus groups. The study population included caregivers of bladder cancer patients, admitted to three Italian hospitals. Data were collected between March 2020 and March 2022. RESULTS: Fifty-two caregivers of patients who underwent cystecto-my with urinary diversion from three Italian hospitals (41 males and 11 females) participated to the study. The data analysis con-verged in the identification of three themes - with sub-themes -that included various aspects of the caregiver's lived experiences: 1) living with the burden of being indispensable, for the family member, 2) feeling abandoned by institutions, 3) tiredness and less willingness to look after the relative due to work burden. CONCLUSIONS: Our study demonstrates that the caregiver of a patient with bladder cancer and urostomy in the first three months of hospital discharge is very worried and stressed. Despite the training program received in hospital, the caregiver does not recognize the newly acquired skills and has difficulty applying them. Further study would be required.

Moral Distress in Oncology: A Descriptive Study of Healthcare Professionals.

BACKGROUND: The oncology setting is characterized by various complexities, and healthcare professionals may experience stressful conditions associated with ethical decisions during daily clinical practice. Moral distress (MD) is a condition of distress that is generated when an individual would like to take action in line with their ethical beliefs but in conflict with the healthcare facility's customs and/or organization. This study aims to describe the MD of oncology health professionals in different care settings. METHODS: Descriptive quantitative study was conducted in the Operating Units of the Istituti Fisioterapici Ospitalieri in Rome between January and March 2022. The investigated sample consisted of the medical and nursing staff on duty at the facility, who were given a questionnaire through a web survey. Besides a brief sociodemographic form, the MD Scale-Revised questionnaire was used for data collection. RESULTS: The sample consisted of nurses (51%) and physicians (49%), predominantly working in surgeries (48%), and having 20-30 years of service (30%). MD was higher among healthcare professionals, in medicine than that ing in corporate organizations, surgeries, or outpatient clinics (p = 0.007). It was not related to the profession (p = 0.163), gender (p = 0.103), or years of service (p = 0.610). CONCLUSIONS: This paper outlines the prevalence of MD in care settings and describes its relationship with profession, gender, and seniority. There is no patient care without the care of health professionals: knowing and fighting MD improves the safety of the treatments provided and the quality perceived by patients.

Psychometric Properties of the Italian Version of the Leader Member Exchange Scale (LMX-7): A Validation Study.

For decades, scholars have studied leader-member exchange (LMX) relationships to understand and explain the effects of leadership on follower attitudes and performance outcomes within work settings. One available instrument to measure these aspects is the LMX-7 scale. This measurement has been widely used in empirical studies, but its psychometric properties have been poorly explored. The aim of this study was to test the psychometric characteristics (content, structural and construct validity, and reliability) of the Italian version of the LMX-7 scale and to support its cultural adaptation. We used a cross-sectional multi-center design. The forward-backward translation process was used to develop the Italian version of the scale. The scale was administered through an online survey to 837 nurses and nurse managers working in different settings. The factorial structure was tested using both exploratory and confirmatory factor analyses (EFA and CFA), and reliability was evaluated using Cronbach's alpha. For the construct validity, we used hypothesis testing and differentiation by known groups. The Italian version of the LMX-7 scale presented one dimension. All the psychometric tests performed confirmed its validity and suggested its usefulness for future research.

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.