ObjectivesInvestigating end-of-life use of anticancer drugs and of palliative care services.Desig... more ObjectivesInvestigating end-of-life use of anticancer drugs and of palliative care services.DesignPopulation based cohort linked to mortality registry and administrative databases.SettingEmilia-Romagna Region (Northern Italy).Participants55 625 residents who died of cancer between 2017 and 2020.Primary and secondary outcome measuresMultivariate analyses were carried out to assess the relationship between cancer drug therapy and palliative care services, and their association with factors related to tumour severity.ResultsIn the last month of life, 15.3% of study population received anticancer drugs (from 12.5% to 16.9% across the eight Local Health Authorities—LHA) and 40.2% received palliative care services (from 36.2% to 43.7%). Drug therapy was inversely associated with receiving palliative care services within the last 30 days (OR 0.92, 95% CI 0.87 to 0.97), surgery within the last 6 months (OR 0.59, 95% CI 0.52 to 0.67), aggressive tumours (OR 0.88, 95% CI 0.84 to 0.93) and inc...
Background Early intramuscular administration of SARS-CoV-2-neutralising monoclonal antibody comb... more Background Early intramuscular administration of SARS-CoV-2-neutralising monoclonal antibody combination, tixagevimab-cilgavimab, to non-hospitalised adults with mild to moderate COVID-19 has potential to prevent disease progression. We aimed to evaluate the safety and efficacy of tixagevimab-cilgavimab in preventing progression to severe COVID-19 or death. Methods TACKLE is an ongoing, phase 3, randomised, double-blind, placebo-controlled study conducted at 95 sites in the USA, Latin America, Europe, and Japan. Eligible participants were non-hospitalised adults aged 18 years or older with a laboratory-confirmed SARS-CoV-2 infection (determined by RT-PCR or an antigen test) from any respiratory tract specimen collected 3 days or less before enrolment and who had not received a COVID-19 vaccination. A WHO Clinical Progression Scale score from more than 1 to less than 4 was required for inclusion and participants had to receive the study drug 7 days or less from self-reported onset of mild to moderate COVID-19 symptoms or measured fever. Participants were randomly assigned (1:1) to receive either a single tixagevimab-cilgavimab 600 mg dose (two consecutive 3 mL intramuscular injections, one each of 300 mg tixagevimab and 300 mg cilgavimab) or placebo. Randomisation was stratified (using central blocked randomisation with randomly varying block sizes) by time from symptom onset, and high-risk versus low-risk of progression to severe COVID-19. Participants, investigators, and sponsor staff involved in the treatment or clinical evaluation and monitoring of the participants were masked to treatment-group assignments. The primary endpoints were severe COVID-19 or death from any cause through to day 29, and safety. This study is registered with ClinicalTrials.gov, NCT04723394.
Oral mucositis is one of the worst effects of the conditioning regimens given to patients undergo... more Oral mucositis is one of the worst effects of the conditioning regimens given to patients undergoing hematopoietic stem cell transplantation. It is characterized by dry mouth, erythema, mucosal soreness, ulcers, and pain, and it may impact patient outcomes. Bovine colostrum and Aloe vera contain a wide variety of biologically active compounds that promote mucosal healing. A non-randomized phase II study was designed to assess the safety and efficacy of a combined bovine colostrum and Aloe vera oral care protocol to prevent and to treat severe oral mucositis in transplant patients. Two commercially available products were given to patients in addition to the standard protocol: Remargin Colostrum OS® mouthwash and Remargin Colostrum Gastro-Gel® taken orally. Forty-six (78.0%) patients experienced oral mucositis, 40 (67.8%) developed mild–moderate forms, and 6 (10.2%) severe ones. Comparing the study group’s outcomes with those of a homogeneous historical control group, severe oral muc...
PURPOSE Health systems are using ever-increasing resources on treating hip fractures. Optimal pos... more PURPOSE Health systems are using ever-increasing resources on treating hip fractures. Optimal post-hospital care needs to be defined to design an effective care pathway. The aim of the present study was to describe the post-hospital care pathway of individuals with hip fracture and to assess its association with the degree of recovery of independence achieved four months after surgery. MATERIALS AND METHODS A prognostic multicentric cohort study was conducted. All patients aged 65 years and over who were admitted with a diagnosis of fragility hip fracture were enrolled. After the hospital discharge, the patients were followed either at an inpatient rehabilitation facility with an intensive or extensive regimen, a nursing home, a long-term care facility or at home. Among the various care pathways, the intensity of rehabilitation differed according to its duration, frequency of sessions, and activities proposed. Primary outcome was the patient's degree of independence achieved four months after surgery, as measured with Activities of Daily Living scale. Several covariates were collected to test the correlation between the different post-hospital care pathways and the recovery of independence. RESULTS A total of 923 patients completed the follow-up. A post- hospital rehabilitation pathway was indicated for 88.2% of the patients. The extensive rehabilitation pathway, indicated for 36.7% of the patients, was the most common. The intensive rehabilitation pathway gave better results in terms of independence at four-month follow up, leading to a median ADL score of 1.4 (95% CI 1.0-2.0). The other care pathways did not show significant difference between each other. CONCLUSIONS High-intensity rehabilitation was associated to better results in terms of recovering of Activities of Daily Living.IMPLICATIONS FOR REHABILITATIONPost-hospital care pathways that include an intensive rehabilitation treatment should be improved/supported to make them available to a larger number of hip fracture patients.Patient selection criteria for post-hospital rehabilitation pathways should be standardized to optimize available healthcare resources.A cost-effectiveness analysis should be performed to analyze the economic sustainability of each post-hospital care pathway.
BackgroundPatients with solid or hematological tumors, neurological and immune-inflammatory disor... more BackgroundPatients with solid or hematological tumors, neurological and immune-inflammatory disorders represent potentially fragile subjects with increased risk to experience severe COVID-19 and inadequate response to SARS-CoV2 vaccination.MethodsWe designed a prospective Italian multicentric study to assess humoral and T-cell response to SARS-CoV2 vaccination in patients (n=378) with solid tumors (ST), hematological malignancies (HM), neurological (ND) and immuno-rheumatological diseases (ID). The immunogenicity of primary vaccination schedule and of the booster dose were analyzed.ResultsOverall, patient seroconversion rate after two doses was 62.1%. A significant lower rate was observed in HM (52.4%) and ID (51.9%) patients compared to ST (95.6%) and ND (70.7%); a lower median level of antibodies was detected in HM and ID versus the others (p<0.0001). A similar rate of patients with a positive SARS-CoV2 T-cell response was observed in all disease groups, with a higher level obs...
BACKGROUND There is need for improvement in effective pressure ulcers preventive strategies. OBJE... more BACKGROUND There is need for improvement in effective pressure ulcers preventive strategies. OBJECTIVE To study whether a multi-layer silicone-adhesive polyurethane foam dressing shaped for the sacrum prevents PUs development in addition to standard PU preventive care for at-risk hospitalized patients. DESIGN Open-label, parallel group, multi-center randomized controlled trial. PARTICIPANTS AND SETTING 709 in-hospital patients at risk for pressure ulcers from 25 medical, surgical, and intensive care units of 12 Italian hospitals. METHODS A multi-layer silicone-adhesive polyurethane foam was applied to the sacrum in addition to standard PUs preventive care in the intervention group. In the control group, standard preventive care alone, including systematic pressure ulcer risk assessment, skin assessment three times per day, routine positioning every 4 h, use of active support surface as appropriate, and incontinence skin care, was guaranteed. Primary outcome was incidence of sacral pressure ulcers of any stage at seven days from hospital admission. Secondary outcomes were incidence of sacral pressure ulcers ≥ II stage, number of days needed to PU development, number of skin adverse events due to the foam dressing, number of dressings used for each patient, number of withdrawing patients due to discomfort caused by the foam dressing. Participants were evaluated at baseline and at seven days. RESULTS In patients admitted to medical units, 15/113 controls and 4/118 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 9.2%; NNT for benefit 11, 95% CI 6 to 44). In patients admitted to surgical units, 21/144 controls and 8/142 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 8.9%; NNT for benefit 11 95% CI 6 to 49). Pressure ulcers incidence was not significantly different between the randomization arms (5.2% experimental vs 10.4% control, p = 0.141) in patients admitted to intensive care units. Overall, 46/358 (12.8%) controls and 17/351 (4.8%) in the intervention group developed sacral pressure ulcers (p<0.001; absolute reduction 8%; number needed to treat (NNT) for benefit 12, 95% CI 8 to 26). Incidence of sacral pressure ulcers ≥ II stage did not differ significantly between the two groups. No adverse skin reactions and discomfort attributable to the foam application were reported. CONCLUSION A sacral multi-layer silicone-adhesive polyurethane foam in addition to standard preventive care is effective for pressure ulcers prevention in at-risk hospitalized patients admitted to medical and surgical units. TRIAL REGISTRATION ClinicalTrials.gov NCT03900455. The registration (April 1st, 2019) occurred before the first patient was enrolled (October 21st, 2019).
Background Worldwide, millions of people with advanced cancer and their family caregivers are exp... more Background Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress. Psychosocial support and education can reduce distress and prevent avoidable healthcare resource use. To date, we lack knowledge from large-scale studies on which interventions generate positive outcomes for people with cancer and their informal caregivers’ quality of life. This protocol describes the DIAdIC study that will evaluate the effectiveness of two psychosocial and educational interventions aimed at improving patient-family caregiver dyads’ emotional functioning and self-efficacy. Methods We will conduct an international multicenter three-arm randomized controlled trial in Belgium, Denmark, Ireland, Italy, The Netherlands, and the United Kingdom. In each country, 156 dyads (936 in total) of people with advanced cancer and their family caregiver will be randomized to one of the study arms: 1) a nurse-led face-to-face intervention (FO...
Colostrum is the first secretion of mammalian glands during the early period after birth giving. ... more Colostrum is the first secretion of mammalian glands during the early period after birth giving. Its components are biologically active and have beneficial effects on new-born growth and well-being. Bovine colostrum has the highest concentration of these substances and its supplementation or application may provide health benefits. This systematic review was conducted to update current knowledge on bovine colostrum effects including all administration routes on healthy and sick subjects. Full texts or abstracts of twenty-eight papers as reports of systematic reviews, randomized controlled trials, observational studies and case series were included after searches in Medline, Embase, Cochrane Library and Cinahl databases. The full texts of selected studies were assessed for quality using validated tools and their results were summarized in different categories. Studies were highly heterogeneous as regards to population, intervention, outcome and risk of bias. Bovine colostrum topical ...
BACKGROUND Within the context of Patient Blood Management (PBM) policy for the peri-operative per... more BACKGROUND Within the context of Patient Blood Management (PBM) policy for the peri-operative period, the transfusion medicine unit of our institution adopted a series of strategies to support and enhance red blood cell (RBC) transfusion best practices. This study aimed to evaluate the appropriateness of RBC transfusion therapy in the post-operative period, before and after starting a multifactorial PBM policy. MATERIALS AND METHODS A 2-phase observational study was conducted on patients who underwent major surgery. The study was designed as follows: 3 months of preliminary audit, followed by multifactorial PBM policy, and a final audit. The policy comprised seminars, teaching lessons, periodic consultations and the insertion of Points of Care. RBC transfusion appropriateness was evaluated in both audits. RESULTS The preliminary audit, performed on 168 patients, showed that 37.7% of the patients were appropriately transfused. The final audit, performed on 205 patients, indicated a s...
Purpose Currently, no consistent guidelines for CT scans used within PET/CT examinations are avai... more Purpose Currently, no consistent guidelines for CT scans used within PET/CT examinations are available. This systematic review provides an up-to-date overview of studies to answer the following questions: What are the specific CT protocols used in PET/CT? What are the possible purposes of requiring a CT study within a PET/CT scan? Is the CT protocol obtained from a dosimetric optimisation study? Materials and method PubMed/MEDLINE, Cochrane Library, Embase and Scopus were systematically searched for relevant studies in accordance with the PRISMA statement. The literature search was conducted from January 2007 until June 2019. Data derived from studies were standardized in order to reduce possible biases, and they were divided into clinically homogeneous subgroups (adult, child or phantom). Subsequently, we divided the CT protocol intents into 3 types (anatomic localization only, attenuation correction only and diagnostic purpose). A narrative approach was used to summarise datasets ...
Objective: Surgery is the treatment of choice in most head and neck cancers. Very often, the surg... more Objective: Surgery is the treatment of choice in most head and neck cancers. Very often, the surgery is demolitive with high impact on the psycho-social, functional and aesthetic fields. Methods: We conducted a grounded theory study with semi-structured interviews to explore the psycho-social process occurring when a patient with head and neck cancer needs to undergo surgery. Results: Seventeen participants (six patients, nine health care professionals, and two volunteers) were interviewed immediately before surgery. The study generated a process of "persuading the patient of an obligation" as the core category. The other principal categories that emerged highlighted the patients' doubts and fears regarding the surgery consequences and, in parallel, strategies employed by the health care professionals to contrast hindering issues impeding surgery. In particular, healthcare professionals involved patients in an affiliation process through simplified communication to sustain the choice of surgery; the family plays a supportive role in this process. Conclusion: The interplay between the organizational process and patients' experience results in "I will let you convince me" at the end of the decision making process, where the main aim was to save and be saved.
There is evidence that early integration of palliative care improves quality of life, lowers spen... more There is evidence that early integration of palliative care improves quality of life, lowers spending and helps clarify preferences and goals for advanced cancer patients. Little is known about the feasibility and acceptability of early integration. Assessing feasibility of early integration of palliative care, and exploring concerns perceived and problems encountered by patients, relatives and oncologists. A phase 2 mixed-methods study ( ClinicalTrials.Gov :NCT02078700). Oncologists of two outpatient clinics offered a specialised palliative care intervention integrated with standard oncological care to all consecutive newly diagnosed metastatic respiratory/gastrointestinal cancer patients. We interviewed samples of patients, relatives and oncologists to explore strengths and weaknesses of the intervention. The intervention was proposed to 44/54 eligible patients (81.5%), 40 (90.1%) accepted, 38 (95.0%) attended the first palliative care visit. The intervention was completed for 32 ...
Background: In patients with head-neck cancer treated with IMRT, immobility of the upper part of ... more Background: In patients with head-neck cancer treated with IMRT, immobility of the upper part of the body during radiation is maintained by means of customised immobilisation devices. The main purpose of this study was to determine how the procedures for preparation of customised immobilisation systems and the patients characteristics influence the extent of setup errors. Methods: A longitudinal, prospective study involving 29 patients treated with IMRT. Data were collected before CT simulation and during all the treatment sessions (528 setup errors analysed overall); the correlation with possible risk factors for setup errors was explored using a linear mixed model. Results: Setup errors were not influenced by the patient's anxiety and pain. Temporary removal of the thermoplastic mask before carrying out the CT simulation shows statistically borderline, clinically relevant, increase of setup errors (+24.7%, 95% CI: −0.5%-55.8%). Moreover, a unit increase of radiation therapists who model the customised thermoplastic mask is associated to a −18% (−29.2%-4.9%) reduction of the errors. The setup error is influenced by the patient's physical features; in particular, it increases both in patients in whom the treatment position is obtained with 'Shoulder down' (+27.9%, 2.2%-59.7%) and in patients with 'Scoliosis/kyphosis' problems (+65.4%, 2.3%-164.2%). Using a 'Small size standard plus customized neck support device' is associated to a −52.3% (−73.7%-11.2%) reduction. The increase in number of radiation therapists encountered during the entire treatment cycle does not show associations. Increase in the body mass index is associated with a slight reduction in setup error by (−2.8%, −5%-0.7%). Conclusion: The position of the patient obtained by forcing the shoulders downwards, clinically significant scoliosis or kyphosis and the reduction of the number of radiation therapists who model the thermoplastic mask are found to be statistically significant risk factors that can cause an increase in setup errors, while the use of 'Small size' neck support device and patient BMI can diminish them.
Questo studio osservazionale prospettico di tipo quantitativo nasce dalla volonta della Direzione... more Questo studio osservazionale prospettico di tipo quantitativo nasce dalla volonta della Direzione delle Professioni Sanitarie dell’Arcispedale Santa Maria Nuova di Reggio Emilia di analizzare la collaborazione tra Infermiere e Operatore Socio Sanitario. Anche se l’argomento e di grande rilevanza per le aziende sanitarie, finora sono pochi nella letteratura nazionale e internazionale studi specifici relativi alla valutazione dell’interazione fra queste due figure professionali. Lo scenario internazionale fornisce un quadro molto variegato delle diverse tipologie di figure deputate a tali mansioni, che trovano solo in Italia una normativa unica nazionale che individua l’operatore socio-sanitario quale figura di supporto alle professioni sanitarie nei contesti sia sociali che sanitari. Lo scopo principale dello studio e quello di individuare aree di miglioramento nell’ambito della collaborazione tra infermiere e operatore socio sanitario ed elevare cosi il livello della qualita assistenziale erogata, attraverso interventi che favoriscano le capacita di negoziazione e di confronto fra le due figure professionali. L’ipotesi che la percezione da parte dell’infermiere della collaborazione con l’operatore socio sanitario sia molto diversa tra le due figure, e stata confermata dal lavoro di un gruppo multi professionale che si e avvalso dell’uso di uno strumento opportunamente tradotto, adattato e validato: la Jefferson Scale of Attitude Toward Pysician Nurse Collaboration, nata negli Stati Uniti per indagare la collaborazione fra medico e infermiere, ma che considera anche altre figure professionali I risultati hanno permesso alla Direzione delle Professioni Sanitarie di identificare alcune aree prioritarie sulle quali intervenire, per migliorare l’accoglienza, la permanenza e la sicurezza del paziente in ospedale. I limiti sono relativi alla scelta di un campione non randomizzato per lo studio. Parole chiave : accoglienza, sicurezza, comunicazione interprofessionale
Background: Nursing research is not well-developed in Italy, and knowledge of the methodologies f... more Background: Nursing research is not well-developed in Italy, and knowledge of the methodologies for conducting research is lacking. In several hospitals, including those in which this study was conducted, a research center has been established to support and educate nurses on how to conduct clinical research. Aims and Objectives: In this observational study, we sought to assess whether establishing a support center for nursing research has resulted in an increase in scientific production in terms of the numbers of protocols approved (primary outcome), articles published and nurse authors involved in the publications (secondary outcomes). Design: Multiple interrupted time series. Methods: Data from 2002 to 2012 were collected in seven hospitals. Research centers have been established at various times in only four of these hospitals. Results: A statistically significant increase in the primary outcome (the number of protocols approved by the Research Ethics Committee in which the principal investigator was a nurse) was observed in two hospitals approximately 2 years after establishing a research center. The number of nursing research articles published in scientific journals with an impact factor increased but was not statistically significant. Finally, the number of nurse authors increased significantly in two hospitals with support units. Definitive conclusions could not be reached for the other two experimental hospitals because notably few post-intervention data were available. In the control hospitals, the scientific production outcomes did not change. Conclusions: This study shows that establishing a support center for nursing research inside hospitals can facilitate the production of research.
Nurse-physician collaboration involves healthcare operators from different professions working to... more Nurse-physician collaboration involves healthcare operators from different professions working together. The dual identity model predicts that nurse-physician interprofessional collaboration could improve if these operators feel they belong to both their professional category and care unit. This study tested this prediction by analyzing the effect of professional and team commitments on interprofessional collaboration between nurses and physicians in a hospital based in Northern Italy. A cross-section questionnaire survey was administered to 270 nurses and 95 physicians. Results indicate that interprofessional collaboration is positively affected by team commitment, while professional commitment had no effect. In accordance with the dual identity model, results indicate that interprofessional collaboration is higher when: (i) both professional and team commitment is high, and (ii) when team commitment is high and professional commitment is low. These results support dual identity model predictions and suggest that interprofessional collaboration can be increased by bolstering both team and professional commitment of nurses and physicians.
The aim of this study was to analyze collaboration between nurses and auxiliary staff and it was ... more The aim of this study was to analyze collaboration between nurses and auxiliary staff and it was implemented at the Santa Maria Nuova Hospital of Reggio Emilia. Although this topic is of great interest for the health structures, so far few studies dealing specifically with the interactions between these two categories have been published. The international scenario offers an extremely varied picture of the staff employed in such tasks : in fact, only Italy has a single national legislation which establishes that auxiliary staff are figures supporting the health professions in both a social and healty context. The study assessed the areas susceptible to improvement in terms of nursing-auxiliary staff collaboration , thus improving the quality of care, by promoting negotiation and confrontation between the two categories. In the literture the Jefferson Scale of Attitude Toward Physician Nurse Collaboration was used. Results identified that the priority areas of intervention regarded h...
Background: Oral mucositis (OM) is one of the most debilitating effects of toxicity due to hemato... more Background: Oral mucositis (OM) is one of the most debilitating effects of toxicity due to hematopoietic stem cell transplantation (HSCT) conditioning regimens. The aim of this secondary analysis of the data of a phase II study designed to assess the efficacy of a novel oral care protocol containing bovine colostrum and aloe vera to prevent oral mucositis was to compare outcomes reported by patients with those collected by healthcare professionals (HCPs). Method: Data on oral mucositis severity, duration, time of onset and related pain were collected from patients using the Oral Mucositis Daily Questionnaire (OMDQ). HCPs assessed the same outcomes using the World Health Organization oral mucositis scale and pain numerical rating scale. Quality of life was assessed with the 3-level EuroQol-5 dimensions.Results: Fifty-nine autologous/ allogeneic graft patients were recruited, 46 of whom (78.0%) experienced OM. Mean onset was 9.1 (SD±3.5) days after conditioning initiation, mean durati...
ObjectivesInvestigating end-of-life use of anticancer drugs and of palliative care services.Desig... more ObjectivesInvestigating end-of-life use of anticancer drugs and of palliative care services.DesignPopulation based cohort linked to mortality registry and administrative databases.SettingEmilia-Romagna Region (Northern Italy).Participants55 625 residents who died of cancer between 2017 and 2020.Primary and secondary outcome measuresMultivariate analyses were carried out to assess the relationship between cancer drug therapy and palliative care services, and their association with factors related to tumour severity.ResultsIn the last month of life, 15.3% of study population received anticancer drugs (from 12.5% to 16.9% across the eight Local Health Authorities—LHA) and 40.2% received palliative care services (from 36.2% to 43.7%). Drug therapy was inversely associated with receiving palliative care services within the last 30 days (OR 0.92, 95% CI 0.87 to 0.97), surgery within the last 6 months (OR 0.59, 95% CI 0.52 to 0.67), aggressive tumours (OR 0.88, 95% CI 0.84 to 0.93) and inc...
Background Early intramuscular administration of SARS-CoV-2-neutralising monoclonal antibody comb... more Background Early intramuscular administration of SARS-CoV-2-neutralising monoclonal antibody combination, tixagevimab-cilgavimab, to non-hospitalised adults with mild to moderate COVID-19 has potential to prevent disease progression. We aimed to evaluate the safety and efficacy of tixagevimab-cilgavimab in preventing progression to severe COVID-19 or death. Methods TACKLE is an ongoing, phase 3, randomised, double-blind, placebo-controlled study conducted at 95 sites in the USA, Latin America, Europe, and Japan. Eligible participants were non-hospitalised adults aged 18 years or older with a laboratory-confirmed SARS-CoV-2 infection (determined by RT-PCR or an antigen test) from any respiratory tract specimen collected 3 days or less before enrolment and who had not received a COVID-19 vaccination. A WHO Clinical Progression Scale score from more than 1 to less than 4 was required for inclusion and participants had to receive the study drug 7 days or less from self-reported onset of mild to moderate COVID-19 symptoms or measured fever. Participants were randomly assigned (1:1) to receive either a single tixagevimab-cilgavimab 600 mg dose (two consecutive 3 mL intramuscular injections, one each of 300 mg tixagevimab and 300 mg cilgavimab) or placebo. Randomisation was stratified (using central blocked randomisation with randomly varying block sizes) by time from symptom onset, and high-risk versus low-risk of progression to severe COVID-19. Participants, investigators, and sponsor staff involved in the treatment or clinical evaluation and monitoring of the participants were masked to treatment-group assignments. The primary endpoints were severe COVID-19 or death from any cause through to day 29, and safety. This study is registered with ClinicalTrials.gov, NCT04723394.
Oral mucositis is one of the worst effects of the conditioning regimens given to patients undergo... more Oral mucositis is one of the worst effects of the conditioning regimens given to patients undergoing hematopoietic stem cell transplantation. It is characterized by dry mouth, erythema, mucosal soreness, ulcers, and pain, and it may impact patient outcomes. Bovine colostrum and Aloe vera contain a wide variety of biologically active compounds that promote mucosal healing. A non-randomized phase II study was designed to assess the safety and efficacy of a combined bovine colostrum and Aloe vera oral care protocol to prevent and to treat severe oral mucositis in transplant patients. Two commercially available products were given to patients in addition to the standard protocol: Remargin Colostrum OS® mouthwash and Remargin Colostrum Gastro-Gel® taken orally. Forty-six (78.0%) patients experienced oral mucositis, 40 (67.8%) developed mild–moderate forms, and 6 (10.2%) severe ones. Comparing the study group’s outcomes with those of a homogeneous historical control group, severe oral muc...
PURPOSE Health systems are using ever-increasing resources on treating hip fractures. Optimal pos... more PURPOSE Health systems are using ever-increasing resources on treating hip fractures. Optimal post-hospital care needs to be defined to design an effective care pathway. The aim of the present study was to describe the post-hospital care pathway of individuals with hip fracture and to assess its association with the degree of recovery of independence achieved four months after surgery. MATERIALS AND METHODS A prognostic multicentric cohort study was conducted. All patients aged 65 years and over who were admitted with a diagnosis of fragility hip fracture were enrolled. After the hospital discharge, the patients were followed either at an inpatient rehabilitation facility with an intensive or extensive regimen, a nursing home, a long-term care facility or at home. Among the various care pathways, the intensity of rehabilitation differed according to its duration, frequency of sessions, and activities proposed. Primary outcome was the patient's degree of independence achieved four months after surgery, as measured with Activities of Daily Living scale. Several covariates were collected to test the correlation between the different post-hospital care pathways and the recovery of independence. RESULTS A total of 923 patients completed the follow-up. A post- hospital rehabilitation pathway was indicated for 88.2% of the patients. The extensive rehabilitation pathway, indicated for 36.7% of the patients, was the most common. The intensive rehabilitation pathway gave better results in terms of independence at four-month follow up, leading to a median ADL score of 1.4 (95% CI 1.0-2.0). The other care pathways did not show significant difference between each other. CONCLUSIONS High-intensity rehabilitation was associated to better results in terms of recovering of Activities of Daily Living.IMPLICATIONS FOR REHABILITATIONPost-hospital care pathways that include an intensive rehabilitation treatment should be improved/supported to make them available to a larger number of hip fracture patients.Patient selection criteria for post-hospital rehabilitation pathways should be standardized to optimize available healthcare resources.A cost-effectiveness analysis should be performed to analyze the economic sustainability of each post-hospital care pathway.
BackgroundPatients with solid or hematological tumors, neurological and immune-inflammatory disor... more BackgroundPatients with solid or hematological tumors, neurological and immune-inflammatory disorders represent potentially fragile subjects with increased risk to experience severe COVID-19 and inadequate response to SARS-CoV2 vaccination.MethodsWe designed a prospective Italian multicentric study to assess humoral and T-cell response to SARS-CoV2 vaccination in patients (n=378) with solid tumors (ST), hematological malignancies (HM), neurological (ND) and immuno-rheumatological diseases (ID). The immunogenicity of primary vaccination schedule and of the booster dose were analyzed.ResultsOverall, patient seroconversion rate after two doses was 62.1%. A significant lower rate was observed in HM (52.4%) and ID (51.9%) patients compared to ST (95.6%) and ND (70.7%); a lower median level of antibodies was detected in HM and ID versus the others (p<0.0001). A similar rate of patients with a positive SARS-CoV2 T-cell response was observed in all disease groups, with a higher level obs...
BACKGROUND There is need for improvement in effective pressure ulcers preventive strategies. OBJE... more BACKGROUND There is need for improvement in effective pressure ulcers preventive strategies. OBJECTIVE To study whether a multi-layer silicone-adhesive polyurethane foam dressing shaped for the sacrum prevents PUs development in addition to standard PU preventive care for at-risk hospitalized patients. DESIGN Open-label, parallel group, multi-center randomized controlled trial. PARTICIPANTS AND SETTING 709 in-hospital patients at risk for pressure ulcers from 25 medical, surgical, and intensive care units of 12 Italian hospitals. METHODS A multi-layer silicone-adhesive polyurethane foam was applied to the sacrum in addition to standard PUs preventive care in the intervention group. In the control group, standard preventive care alone, including systematic pressure ulcer risk assessment, skin assessment three times per day, routine positioning every 4 h, use of active support surface as appropriate, and incontinence skin care, was guaranteed. Primary outcome was incidence of sacral pressure ulcers of any stage at seven days from hospital admission. Secondary outcomes were incidence of sacral pressure ulcers ≥ II stage, number of days needed to PU development, number of skin adverse events due to the foam dressing, number of dressings used for each patient, number of withdrawing patients due to discomfort caused by the foam dressing. Participants were evaluated at baseline and at seven days. RESULTS In patients admitted to medical units, 15/113 controls and 4/118 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 9.2%; NNT for benefit 11, 95% CI 6 to 44). In patients admitted to surgical units, 21/144 controls and 8/142 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 8.9%; NNT for benefit 11 95% CI 6 to 49). Pressure ulcers incidence was not significantly different between the randomization arms (5.2% experimental vs 10.4% control, p = 0.141) in patients admitted to intensive care units. Overall, 46/358 (12.8%) controls and 17/351 (4.8%) in the intervention group developed sacral pressure ulcers (p<0.001; absolute reduction 8%; number needed to treat (NNT) for benefit 12, 95% CI 8 to 26). Incidence of sacral pressure ulcers ≥ II stage did not differ significantly between the two groups. No adverse skin reactions and discomfort attributable to the foam application were reported. CONCLUSION A sacral multi-layer silicone-adhesive polyurethane foam in addition to standard preventive care is effective for pressure ulcers prevention in at-risk hospitalized patients admitted to medical and surgical units. TRIAL REGISTRATION ClinicalTrials.gov NCT03900455. The registration (April 1st, 2019) occurred before the first patient was enrolled (October 21st, 2019).
Background Worldwide, millions of people with advanced cancer and their family caregivers are exp... more Background Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress. Psychosocial support and education can reduce distress and prevent avoidable healthcare resource use. To date, we lack knowledge from large-scale studies on which interventions generate positive outcomes for people with cancer and their informal caregivers’ quality of life. This protocol describes the DIAdIC study that will evaluate the effectiveness of two psychosocial and educational interventions aimed at improving patient-family caregiver dyads’ emotional functioning and self-efficacy. Methods We will conduct an international multicenter three-arm randomized controlled trial in Belgium, Denmark, Ireland, Italy, The Netherlands, and the United Kingdom. In each country, 156 dyads (936 in total) of people with advanced cancer and their family caregiver will be randomized to one of the study arms: 1) a nurse-led face-to-face intervention (FO...
Colostrum is the first secretion of mammalian glands during the early period after birth giving. ... more Colostrum is the first secretion of mammalian glands during the early period after birth giving. Its components are biologically active and have beneficial effects on new-born growth and well-being. Bovine colostrum has the highest concentration of these substances and its supplementation or application may provide health benefits. This systematic review was conducted to update current knowledge on bovine colostrum effects including all administration routes on healthy and sick subjects. Full texts or abstracts of twenty-eight papers as reports of systematic reviews, randomized controlled trials, observational studies and case series were included after searches in Medline, Embase, Cochrane Library and Cinahl databases. The full texts of selected studies were assessed for quality using validated tools and their results were summarized in different categories. Studies were highly heterogeneous as regards to population, intervention, outcome and risk of bias. Bovine colostrum topical ...
BACKGROUND Within the context of Patient Blood Management (PBM) policy for the peri-operative per... more BACKGROUND Within the context of Patient Blood Management (PBM) policy for the peri-operative period, the transfusion medicine unit of our institution adopted a series of strategies to support and enhance red blood cell (RBC) transfusion best practices. This study aimed to evaluate the appropriateness of RBC transfusion therapy in the post-operative period, before and after starting a multifactorial PBM policy. MATERIALS AND METHODS A 2-phase observational study was conducted on patients who underwent major surgery. The study was designed as follows: 3 months of preliminary audit, followed by multifactorial PBM policy, and a final audit. The policy comprised seminars, teaching lessons, periodic consultations and the insertion of Points of Care. RBC transfusion appropriateness was evaluated in both audits. RESULTS The preliminary audit, performed on 168 patients, showed that 37.7% of the patients were appropriately transfused. The final audit, performed on 205 patients, indicated a s...
Purpose Currently, no consistent guidelines for CT scans used within PET/CT examinations are avai... more Purpose Currently, no consistent guidelines for CT scans used within PET/CT examinations are available. This systematic review provides an up-to-date overview of studies to answer the following questions: What are the specific CT protocols used in PET/CT? What are the possible purposes of requiring a CT study within a PET/CT scan? Is the CT protocol obtained from a dosimetric optimisation study? Materials and method PubMed/MEDLINE, Cochrane Library, Embase and Scopus were systematically searched for relevant studies in accordance with the PRISMA statement. The literature search was conducted from January 2007 until June 2019. Data derived from studies were standardized in order to reduce possible biases, and they were divided into clinically homogeneous subgroups (adult, child or phantom). Subsequently, we divided the CT protocol intents into 3 types (anatomic localization only, attenuation correction only and diagnostic purpose). A narrative approach was used to summarise datasets ...
Objective: Surgery is the treatment of choice in most head and neck cancers. Very often, the surg... more Objective: Surgery is the treatment of choice in most head and neck cancers. Very often, the surgery is demolitive with high impact on the psycho-social, functional and aesthetic fields. Methods: We conducted a grounded theory study with semi-structured interviews to explore the psycho-social process occurring when a patient with head and neck cancer needs to undergo surgery. Results: Seventeen participants (six patients, nine health care professionals, and two volunteers) were interviewed immediately before surgery. The study generated a process of "persuading the patient of an obligation" as the core category. The other principal categories that emerged highlighted the patients' doubts and fears regarding the surgery consequences and, in parallel, strategies employed by the health care professionals to contrast hindering issues impeding surgery. In particular, healthcare professionals involved patients in an affiliation process through simplified communication to sustain the choice of surgery; the family plays a supportive role in this process. Conclusion: The interplay between the organizational process and patients' experience results in "I will let you convince me" at the end of the decision making process, where the main aim was to save and be saved.
There is evidence that early integration of palliative care improves quality of life, lowers spen... more There is evidence that early integration of palliative care improves quality of life, lowers spending and helps clarify preferences and goals for advanced cancer patients. Little is known about the feasibility and acceptability of early integration. Assessing feasibility of early integration of palliative care, and exploring concerns perceived and problems encountered by patients, relatives and oncologists. A phase 2 mixed-methods study ( ClinicalTrials.Gov :NCT02078700). Oncologists of two outpatient clinics offered a specialised palliative care intervention integrated with standard oncological care to all consecutive newly diagnosed metastatic respiratory/gastrointestinal cancer patients. We interviewed samples of patients, relatives and oncologists to explore strengths and weaknesses of the intervention. The intervention was proposed to 44/54 eligible patients (81.5%), 40 (90.1%) accepted, 38 (95.0%) attended the first palliative care visit. The intervention was completed for 32 ...
Background: In patients with head-neck cancer treated with IMRT, immobility of the upper part of ... more Background: In patients with head-neck cancer treated with IMRT, immobility of the upper part of the body during radiation is maintained by means of customised immobilisation devices. The main purpose of this study was to determine how the procedures for preparation of customised immobilisation systems and the patients characteristics influence the extent of setup errors. Methods: A longitudinal, prospective study involving 29 patients treated with IMRT. Data were collected before CT simulation and during all the treatment sessions (528 setup errors analysed overall); the correlation with possible risk factors for setup errors was explored using a linear mixed model. Results: Setup errors were not influenced by the patient's anxiety and pain. Temporary removal of the thermoplastic mask before carrying out the CT simulation shows statistically borderline, clinically relevant, increase of setup errors (+24.7%, 95% CI: −0.5%-55.8%). Moreover, a unit increase of radiation therapists who model the customised thermoplastic mask is associated to a −18% (−29.2%-4.9%) reduction of the errors. The setup error is influenced by the patient's physical features; in particular, it increases both in patients in whom the treatment position is obtained with 'Shoulder down' (+27.9%, 2.2%-59.7%) and in patients with 'Scoliosis/kyphosis' problems (+65.4%, 2.3%-164.2%). Using a 'Small size standard plus customized neck support device' is associated to a −52.3% (−73.7%-11.2%) reduction. The increase in number of radiation therapists encountered during the entire treatment cycle does not show associations. Increase in the body mass index is associated with a slight reduction in setup error by (−2.8%, −5%-0.7%). Conclusion: The position of the patient obtained by forcing the shoulders downwards, clinically significant scoliosis or kyphosis and the reduction of the number of radiation therapists who model the thermoplastic mask are found to be statistically significant risk factors that can cause an increase in setup errors, while the use of 'Small size' neck support device and patient BMI can diminish them.
Questo studio osservazionale prospettico di tipo quantitativo nasce dalla volonta della Direzione... more Questo studio osservazionale prospettico di tipo quantitativo nasce dalla volonta della Direzione delle Professioni Sanitarie dell’Arcispedale Santa Maria Nuova di Reggio Emilia di analizzare la collaborazione tra Infermiere e Operatore Socio Sanitario. Anche se l’argomento e di grande rilevanza per le aziende sanitarie, finora sono pochi nella letteratura nazionale e internazionale studi specifici relativi alla valutazione dell’interazione fra queste due figure professionali. Lo scenario internazionale fornisce un quadro molto variegato delle diverse tipologie di figure deputate a tali mansioni, che trovano solo in Italia una normativa unica nazionale che individua l’operatore socio-sanitario quale figura di supporto alle professioni sanitarie nei contesti sia sociali che sanitari. Lo scopo principale dello studio e quello di individuare aree di miglioramento nell’ambito della collaborazione tra infermiere e operatore socio sanitario ed elevare cosi il livello della qualita assistenziale erogata, attraverso interventi che favoriscano le capacita di negoziazione e di confronto fra le due figure professionali. L’ipotesi che la percezione da parte dell’infermiere della collaborazione con l’operatore socio sanitario sia molto diversa tra le due figure, e stata confermata dal lavoro di un gruppo multi professionale che si e avvalso dell’uso di uno strumento opportunamente tradotto, adattato e validato: la Jefferson Scale of Attitude Toward Pysician Nurse Collaboration, nata negli Stati Uniti per indagare la collaborazione fra medico e infermiere, ma che considera anche altre figure professionali I risultati hanno permesso alla Direzione delle Professioni Sanitarie di identificare alcune aree prioritarie sulle quali intervenire, per migliorare l’accoglienza, la permanenza e la sicurezza del paziente in ospedale. I limiti sono relativi alla scelta di un campione non randomizzato per lo studio. Parole chiave : accoglienza, sicurezza, comunicazione interprofessionale
Background: Nursing research is not well-developed in Italy, and knowledge of the methodologies f... more Background: Nursing research is not well-developed in Italy, and knowledge of the methodologies for conducting research is lacking. In several hospitals, including those in which this study was conducted, a research center has been established to support and educate nurses on how to conduct clinical research. Aims and Objectives: In this observational study, we sought to assess whether establishing a support center for nursing research has resulted in an increase in scientific production in terms of the numbers of protocols approved (primary outcome), articles published and nurse authors involved in the publications (secondary outcomes). Design: Multiple interrupted time series. Methods: Data from 2002 to 2012 were collected in seven hospitals. Research centers have been established at various times in only four of these hospitals. Results: A statistically significant increase in the primary outcome (the number of protocols approved by the Research Ethics Committee in which the principal investigator was a nurse) was observed in two hospitals approximately 2 years after establishing a research center. The number of nursing research articles published in scientific journals with an impact factor increased but was not statistically significant. Finally, the number of nurse authors increased significantly in two hospitals with support units. Definitive conclusions could not be reached for the other two experimental hospitals because notably few post-intervention data were available. In the control hospitals, the scientific production outcomes did not change. Conclusions: This study shows that establishing a support center for nursing research inside hospitals can facilitate the production of research.
Nurse-physician collaboration involves healthcare operators from different professions working to... more Nurse-physician collaboration involves healthcare operators from different professions working together. The dual identity model predicts that nurse-physician interprofessional collaboration could improve if these operators feel they belong to both their professional category and care unit. This study tested this prediction by analyzing the effect of professional and team commitments on interprofessional collaboration between nurses and physicians in a hospital based in Northern Italy. A cross-section questionnaire survey was administered to 270 nurses and 95 physicians. Results indicate that interprofessional collaboration is positively affected by team commitment, while professional commitment had no effect. In accordance with the dual identity model, results indicate that interprofessional collaboration is higher when: (i) both professional and team commitment is high, and (ii) when team commitment is high and professional commitment is low. These results support dual identity model predictions and suggest that interprofessional collaboration can be increased by bolstering both team and professional commitment of nurses and physicians.
The aim of this study was to analyze collaboration between nurses and auxiliary staff and it was ... more The aim of this study was to analyze collaboration between nurses and auxiliary staff and it was implemented at the Santa Maria Nuova Hospital of Reggio Emilia. Although this topic is of great interest for the health structures, so far few studies dealing specifically with the interactions between these two categories have been published. The international scenario offers an extremely varied picture of the staff employed in such tasks : in fact, only Italy has a single national legislation which establishes that auxiliary staff are figures supporting the health professions in both a social and healty context. The study assessed the areas susceptible to improvement in terms of nursing-auxiliary staff collaboration , thus improving the quality of care, by promoting negotiation and confrontation between the two categories. In the literture the Jefferson Scale of Attitude Toward Physician Nurse Collaboration was used. Results identified that the priority areas of intervention regarded h...
Background: Oral mucositis (OM) is one of the most debilitating effects of toxicity due to hemato... more Background: Oral mucositis (OM) is one of the most debilitating effects of toxicity due to hematopoietic stem cell transplantation (HSCT) conditioning regimens. The aim of this secondary analysis of the data of a phase II study designed to assess the efficacy of a novel oral care protocol containing bovine colostrum and aloe vera to prevent oral mucositis was to compare outcomes reported by patients with those collected by healthcare professionals (HCPs). Method: Data on oral mucositis severity, duration, time of onset and related pain were collected from patients using the Oral Mucositis Daily Questionnaire (OMDQ). HCPs assessed the same outcomes using the World Health Organization oral mucositis scale and pain numerical rating scale. Quality of life was assessed with the 3-level EuroQol-5 dimensions.Results: Fifty-nine autologous/ allogeneic graft patients were recruited, 46 of whom (78.0%) experienced OM. Mean onset was 9.1 (SD±3.5) days after conditioning initiation, mean durati...
Uploads
Papers by Monica Guberti