A nurse-led multidisciplinary service for Nipple-Areola complex tattooing after breast cancer: reporting on a complex intervention with TIDieR analysis.

BACKGROUND: The Nipple-Areola Complex (NAC) tattooing can restore physical and mental integrity after breast cancer, but it is not always easily accessible for women. This paper aims to report on the development of a multidisciplinary nurse-led service for NAC tattooing for women who underwent breast cancer surgery with NAC removal to allow its thorough review and replication. METHODS: The Medical Research Council's framework for developing complex healthcare interventions was followed. According to the results of a literature review, and the context analysis, an initial intervention was planned. The Template for Intervention Description and Replication checklist was chosen to ensure the quality and completeness of the intervention description. RESULTS: The Breast Unit and the Research departments were engaged; three nurse-tattooists were selected; the informative material was created and shared with patients, families and local associations, involving them actively. Finally, the setting and the materials were defined. A monthly schedule of activities was set: patients with the indication for NAC tattooing were contacted by the nurse case manager. Each treatment involves 3-4 sessions, 30-40 days apart, in an ambulatory setting. It consists of NAC shaping and tattooing with a dermographer and sterile needles. CONCLUSION: Implementing freely and equally multidisciplinary nurse-led clinics might provide this treatment ensuring the patient's quality of life and nurse competence. The NAC tattooing is a complex intervention that represents the final part of the breast cancer surgical care pathway.

Shaping the future research agenda of Cancer Nursing in Italy: Insights and strategic directions.

This report analyzes the evolution of cancer nursing research in Italy, focusing on 207 publications from nursing journals indexed in MEDLINE. Using Latent Dirichlet Allocation, we identified four primary research topics from the included abstracts: Patient-Centered Care, Clinical Nursing Practice, Healthcare Institutions and Systems, and Research and Data Analysis. The temporal trends reveal a shift from foundational studies on healthcare systems in the late 1990s to more recent emphases on patient-centered care and clinical practice. This progression underscores the growing importance of personalized healthcare approaches. Our findings highlight the need for continued investment in innovative nursing interventions and advanced technologies, such as telehealth, to enhance patient outcomes. Research priorities need to investigate how to tailor nursing interventions to individual patient characteristics, such as their cultural background, lifestyle, and personal values, in the area of clinical nursing practice, which is less represented in the literature thus far. The limited publications regarding clinical nursing practice in the Italian context might reflect the need to strengthen cancer nursing as a specialization in Italy to trigger research and practice that address unmet patient needs. The current analysis provides a foundation for future comprehensive studies and strategic development of a research agenda for cancer nursing research in Italy, led by the Italian Association of Cancer Nursing.

Assessment of Nursing Workload and Complexity Associated with Oncology Clinical Trials: A Scoping Review.

OBJECTIVES: Clinical trials (CTs) play a crucial role in advancing medical knowledge and patient care but are increasingly complex and resource-intensive. This scoping review aims to explore the current approaches for evaluating workload (WL) in oncology CTs and identify tools for measuring clinical research nurses' WL. METHODS: The search was conducted through MEDLINE, Scopus, CINAHL, and COCHRANE databases and carried out through the framework developed by Arksey and O'Malley and revised by the Joanna Briggs Institute. Data extraction and synthesis were performed to analyze instruments used for WL assessment and their dimensions. RESULTS: Of the 1,005 records identified, 12 meet the inclusion criteria. The complexity and WL associated with CTs can be attributed to five main domains: (1) protocol, (2) single case, (3) data management, (4) regulatory, and (5) worker-related. These instruments varied in their approaches, scoring systems, and domains assessed. Notably, the protocol-related domain was prevalent across most instruments, highlighting its importance in WL evaluation. Furthermore, findings revealed a wide range of WL scores across different studies, emphasizing the complexity and variability in WL management within CTs. CONCLUSIONS: This scoping review underscores the importance of evaluating WL in CTs and provides insights into existing tools and approaches. Nurses, as integral members of clinical research teams, bear significant responsibilities in trial management, necessitating a balanced approach to WL allocation. Future research should focus on validating and standardizing assessment tools to optimize resource allocation and enhance research efficiency in CT centers. IMPLICATIONS FOR NURSING PRACTICE: Understanding WL dynamics in CTs is essential for nurses involved in research delivery. By utilizing validated WL assessment tools, nurses can advocate for appropriate staffing levels and promote efficient trial management, ultimately improving patient outcomes and research quality in CT settings.

Telehealth vs in-person education for enhancing self-care of ostomy patients (Self-Stoma): Protocol for a noninferiority, randomized, open-label, controlled trial.

INTRODUCTION: Postoperative patients with ostomies experience significant changes in their lives as a result of the device implantation. Self-care is important to improve their health outcomes. Telehealth provides an opportunity to expand access to self-care education. AIM: This is a multicenter, non-inferiority randomized, open-label, controlled trial to evaluate the non-inferiority of a telehealth intervention to the standard in-person approach in improving self-care behaviors. METHODS AND ANALYSIS: Three hundred and eighty-four patients aged ≥ 18 years, with a recently placed ostomy, no stomal/peristomal complications, and documented cognitive integrity will be randomly assigned (1:1) to receive either a telehealth intervention (four remote educational sessions) or a standard educational approach (four in-person sessions) delivered in outpatient settings. Every session (remote and in-person) will occur on Days 25, 32, 40, and 60 after discharge. Follow-ups will occur 1, 3, and 6 months after the last intervention session. Primary outcome is self-care maintenance measured using the Ostomy Self-care Index (OSCI). Secondary outcomes include self-care monitoring, self-care management, self-efficacy (OSCI), quality of life (Stoma specific quality of Life), depression (Patient Health Questionnaire-9), adjustment (Ostomy Adjustment Inventory-23), stomal and peristomal complication rates, healthcare services utilization, mobility, and number of working days lost. Analyses will be performed per intention-to-treat and per protocol. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board of the main center (registration number: 119/22). Following completion of the trial, dissemination meetings will be held to share the results of the study with the participants and the health-care team. Adoption of telehealth technologies for ostomy patients can improve service organization by ensuring better integration and continuity of care. If the remote intervention produces comparable effects to the in-person intervention, it would be wise to make telehealth education an alternative treatment for addressing the educational needs of uncomplicated postoperative ostomy patients. TRIAL REGISTRATION: ClinicalTrials.gov (identifier number: NCT05796544).

Sexual satisfaction and its predictors in patients with advanced cancer and their family caregivers in six European countries: Baseline data from the DIAdIC study.

OBJECTIVE: To identify predictors of sexual satisfaction in patients with advanced cancer and their family caregivers. METHODS: Cross-sectional study using baseline survey data from a randomized controlled trial in six European countries. Patients with advanced cancer and their family caregiver completed measures on sexual satisfaction (one item from Functional Assessment of Cancer Therapy - General questionnaire for patients and Caregiver Quality of Life Index-Cancer scale for family caregivers) and health-related characteristics. Multivariable linear regressions were performed for all predictors (identified based on literature) with sexual satisfaction as dependent variable. RESULTS: The sample comprised 431 patient-family caregiver dyads. Patients with prostate or gynecological cancer reported lower sexual satisfaction (respectively B = -0.267 95% CI: -1.674, -0.594 and B = -0.196, 95% CI -2.103, -0.452). Higher emotional (B = 0.278, 95% CI 0.024, 0.057) physical (B = 0.305, 95% CI 0.012, 0.025) and social functioning (B = 0.151, 95% CI 0.001, 0.013), global health (B = 0.356, 95% CI 0.007, 0.013) and social wellbeing (B = 0.161, 95% CI 0.013, 0.082) among patients were associated with higher sexual satisfaction. Among family caregivers, sexual satisfaction was lower with increased age (B = -0.142, 95% CI -0.022, -0.004). Higher emotional functioning (B = 0.027, 95% CI 0.011, 0.043) and quality of life (B = 0.165, 95% CI -0.165, 0.716) were associated with higher sexual satisfaction in family caregivers. CONCLUSIONS: The results underscore that sexual wellbeing of patients and family caregivers is related to health related factors in physical, emotional, and social domains. Patients and family caregivers could benefit from a dyadic approach to address sexual wellbeing.

Acceptability and usefulness of the EORTC 'Write In three Symptoms/Problems' (WISP): a brief open-ended instrument for symptom assessment in cancer patients.

BACKGROUND: The use of open-ended questions supplementing static questionnaires with closed questions may facilitate the recognition of symptoms and toxicities. The open-ended 'Write In three Symptoms/Problems (WISP)' instrument permits patients to report additional symptoms/problems not covered by selected EORTC questionnaires. We evaluated the acceptability and usefulness of WISP with cancer patients receiving active and palliative care/treatment in Austria, Chile, France, Jordan, the Netherlands, Norway, Spain and the United Kingdom. METHODS: We conducted a literature search on validated instruments for cancer patients including open-ended questions and analyzing their responses. WISP was translated into eight languages and pilot tested. WISP translations were pre-tested together with EORTC QLQ-C30, QLQ-C15-PAL and relevant modules, followed by patient interviews to evaluate their understanding about WISP. Proportions were used to summarize patient responses obtained from interviews and WISP. RESULTS: From the seven instruments identified in the literature, only the free text collected from the PRO-CTAE has been analyzed previously. In our study, 161 cancer patients participated in the pre-testing and interviews (50% in active treatment). Qualitative interviews showed high acceptability of WISP. Among the 295 symptoms/problems reported using WISP, skin problems, sore mouth and bleeding were more prevalent in patients in active treatment, whereas numbness/tingling, dry mouth and existential problems were more prevalent in patients in palliative care/treatment. CONCLUSIONS: The EORTC WISP instrument was found to be acceptable and useful for symptom assessment in cancer patients. WISP improves the identification of symptoms/problems not assessed by cancer-generic questionnaires and therefore, we recommend its use alongside the EORTC questionnaires.

Tattooing to reconstruct Nipple-Areola Complex after oncological breast surgery: a scoping review.

PURPOSE: The dermopigmentation of the Nipple-Areola Complex (NAC) is a safe non-surgical reconstruction technique that can restore psychophysical integrity, representing the final step after oncological surgery. This scoping review aims to identify and synthesize the literature focused on medical tattooing for NAC reconstruction in women who underwent breast reconstruction after cancer surgery. Competence and training, outcomes and organizational aspects were assessed as specific outcomes. METHODS: The Joanna Briggs Institute (JBI) methodology for scoping reviews was followed. MEDLINE, Embase, Cochrane Library, Clinical Key, Scopus and Cinahl databases were consulted. After title (N = 54) and abstract (N = 39) screening and full-text review (N = 18), articles that met eligibility criteria were analyzed, critically apprised and narratively synthesized. RESULTS: 13 articles were analysed, with full texts (N = 11) and only abstract (N = 2). The overall quality of the literature (N observational studies = 11; N pilot experimental studies = 2) is weak. Nurses were the professionals mostly involved (N = 6), then medical staff (N = 4) and tattoo artists (N = 2). The professional training is poorly described in 6 papers. The most frequently assessed outcome was the satisfaction rate (N = 8). One study explored aspects of quality of life with a validated questionnaire. The management of these services resulted variable. Nurse-led services were implemented in 2 studies. CONCLUSION: Despite methodological weaknesses, NAC tattooing research is relevant because it helps women redefine their identity after demolitive cancer treatments. Further research on processes and outcomes is needed.

Models of Care in Providing Comprehensive Healthcare on Cancer Survivors: A Scoping Review with a TIDieR Checklist Analysis.

BACKGROUND: The study's aim is to identify the models of care used to provide survivorship care plans (SCPs) to cancer survivors in healthcare services, describing what kind of professionals are involved, in which settings and timings, and their feasibility. METHODS: The Joanna Briggs Institute methodology for scoping reviews is followed. Studies that considered the SCPs applying different models of care, in any healthcare setting on any adult cancer survivors who completed oncological treatments, have been included. Pubmed, Embase, Cochrane Library, Scopus, and Cinahal were searched from 2013 to 2023 with these keywords: "Survivorship Care Plan", "Oncology", and "Program". The study selection process was reported with the PRISMA-ScR. A total of 325 records were identified, 42 were screened, and, ultimately, 23 articles were included. RESULTS: The models of care include: SCP standardization in hospitals; self-support oriented; consultation-based; primary or specialist direct referral; shared care; a multimodal approach. Multidisciplinary teams were involved in the SCP models of care. The settings were private clinics or cancer centers. One-hour SCP interventions were most frequently delivered through in-person visits, by telephone, or online. CONCLUSIONS: Implementing SCPs is feasible in healthcare contexts, but with challenges, like time and resource management. Patient-centered programs promoting coordinated care are promising models of care.

Role of emotions in the clinical decision-making process of the hospital nurse: A multicentre qualitative study.

While for a long-time emotional reaction and moral distress, have been primarily investigated for the possible outcomes of the nursing decision-making process rather than in terms of their role as antecedents of the final decision taken. The primary study's aim is to explore how inpatient nurses' decision-making takes place in different care settings, with a special focus on the role played by emotions during decision-making. The secondary aim is to explore the subjective experience of hospital nurses in relation to successful and unsuccessful decision-making situations. Multicentre qualitative study, consisting of three phases with different designs: participatory study, grounded theory study, and phenomenological study. Participants will be nurses and may be doctors with various levels of professional experience working in hospital, outpatient, or ward settings. Participants will be recruited through different sampling (purposive and convenience). Data will be collected through focus groups and in-depth interviews with nurses working in different hospital care settings. The researchers expect to find themes that will contribute to a better understanding of the role of emotions in decision-making. The results of this study have the potential of providing important implications to support nurses in the recognition and management of their emotions during the decision-making process.

Moral injury in a global health emergency: a validation study of the Italian version of the Moral Injury Events Scale adjusted to the healthcare setting.

Background: When exposed to events that transgress one's moral beliefs, a plethora of negative consequences may follow, which are captured by the concept of moral injury (MI). Despite its relevance to experiences of healthcare workers during a global health emergency, there is lack of validated MI instruments adapted to the healthcare setting.Objective: The present study aims to provide a validation of the Italian version of the Moral Injury Events Scale (MIES) adjusted to the healthcare setting by assessing its factor structure, internal consistency and construct validity.Methods: A sample of 794 healthcare workers (46% nurses, 51% female) engaged in hospital facilities during the COVID-19 pandemic in Italy completed measures of MI, PTSD, anxiety, depression, burnout, meaning in life and positive affect.Results: Using an exploratory structural equation modelling (ESEM) we assessed the scale factor structure for the entire sample and separately for nurse professional and female healthcare worker groups. Findings support a three-factor solution: Factor 1 'perceived transgressions by others'; Factor 2 'perceived transgressions by self'; and Factor 3 'perceived betrayals by others'. Findings also indicate some level of convergence with measures of PTSD, anxiety, depression and burnout.Conclusion: Results suggest that the MIES may be useful in capturing unique experiences of moral injury amongst healthcare workers engaged in a global health emergency. The low range correlations with measures of psychological distress might potentially indicate that MI, which captures cognitive value judgements rather than manifest symptomatology, may uniquely explain a certain amount of variance. Implications for the development of new empirically derived and theoretical guided tools are discussed, highlighting the need for future research to examine the role of individualising and social binding moral principles in gaining a more nuanced understanding of moral injury experiences amongst healthcare professionals across different socio-cultural settings.

The Italian validation of the MIES adapted to the healthcare setting yielded a three-factor structure: (a) 'perceived transgressions by self'; (b) 'perceived transgressions by others'; (c) 'perceived betrayals by others'.Findings suggest that the MIES may be useful in capturing unique experiences of moral injury amongst healthcare workers engaged in a global health emergency.Future research should consider the role of individualising and social binding moral principles in shaping moral injury experiences among healthcare professionals across different socio-cultural settings.

Homologous platelet gel on radiation-induced dermatitis in a patient receiving head and neck radiotherapy plus cetuximab: A case report.

INTRODUCTION: Acute radiodermatitis is a significant complication of cancer radiotherapy, and platelet-based therapies are emerging as potential new treatments. MAIN SYMPTOMS AND IMPORTANT CLINICAL FINDINGS: In this report, we present the case of a patient with head and neck cancer undergoing radiotherapy combined with the monoclonal antibody cetuximab. After 4 weeks of this treatment, the patient developed cutaneous radiation dermatitis. Despite receiving standard treatment with corticosteroids and emollient cream, the lesion did not improve. MAIN DIAGNOSIS: cutaneous radiation dermatitis on head and neck cancer patient. THERAPEUTIC INTERVENTIONS: Topical application of platelet gel was initiated on the wound. From the second week of radiotherapy to the 4th week, homologous platelet-rich plasma was applied on the dermatitis using a bandage, 4 times a day. OUTCOMES: The topical treatment with homologous platelet gel resulted in complete healing of the radiodermatitis, including restoration of the epidermis, reepithelialization, and reduction in associated pain. CONCLUSION: homologous platelet gel might be an alternative to standard treatment of radiation dermatitis.

Workload, Job Satisfaction and Quality of Nursing Care in Italy: A Systematic Review of Native Language Articles.

Nursing research is rapidly increasing, yet contributions from numerous countries that may interest the international nursing community are impeded because many research articles are published in authors' native language and not in English. The objectives of this work were to systematically review papers published in Italian related to job satisfaction and the quality of nursing care, and to discuss their findings in light of the international literature. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) method was used. The Directory of Open Access Journals (DOAJ) and Indice della Letteretura Italiana di Scienze Infermieristiche (ILISI) databases were consulted for eligible studies published from January 2015 to November 2022. Two hundred sixteen papers were identified, 11 of which were selected for review: 8 on job satisfaction, two on workload issues, and 1 on quality of nursing care. The quality of included studies was assessed through the Effective Public Health Practice Project quality assessment tool (EPHPP). The results of our review were in line with those of international literature, and they can help to fill the knowledge gap on the quality of nursing performance in Italian care settings. In addition, the proposed method can provide further elements of discussion among literature providers and reviewers.

Patient-reported outcome measure to implement routine assessment of cancer survivors' unmet needs: An overview of reviews and COSMIN analysis.

As the number of cancer survivors (CSs) is increasing worldwide, providing services relevant to the specific, unmet needs of these individuals is crucial. There are currently various patient-reported outcome measures (PROMs) whose aim is to identify the unmet needs of CSs. Still, limited guidance supports healthcare providers in choosing the most valid and reliable PROMs for this purpose. We conducted this overview of systematic reviews (SRs) on the psychometric properties of PROMs addressing the unmet needs of adult CSs suffering from non-cutaneous cancers. We searched databases for SRs published between 2012 and January 2023. Two SRs were included, covering 14 PROMs tested on 19,151 CSs. These were assessed according to the COSMIN methodology for SRs of PROMs for the quality of their measurement properties and risk of bias, thus providing guidance in selecting PROMs that appropriately reflect the unmet needs of CSs.

Integrated Short-term Palliative Rehabilitation to improve quality of life and equitable care access in incurable cancer (INSPIRE): a multinational European research project.

Background: Disability related to incurable cancer affects over a million Europeans each year and people with cancer rank loss of function among the most common unmet supportive care needs. Objectives: To test the clinical and cost-effectiveness of an integrated short-term palliative rehabilitation intervention, to optimise function and quality of life in people affected by incurable cancer. Design: This is a multinational, parallel group, randomised, controlled, assessor blind, superiority trial. Methods: The INSPIRE consortium brings together leaders in palliative care, oncology and rehabilitation from partner organisations across Europe, with complementary expertise in health service research, trials of complex interventions, mixed-method evaluations, statistics and economics. Partnership with leading European civil society organisations ensures citizen engagement and dissemination at the highest level. We will conduct a multinational randomised controlled trial across five European countries, recruiting participants to assess the effectiveness of palliative rehabilitation for people with incurable cancer on the primary outcome - quality of life - and secondary outcomes including disability, symptom burden and goal attainment. To support trial conduct and enhance analysis of trial data, we will also conduct: comparative analysis of current integration of rehabilitation across oncology and palliative care services; mixed-method evaluations of equity and inclusivity, processes and implementation for the intervention, at patient, health service and health system levels. Finally, we will conduct an evidence synthesis, incorporating INSPIRE findings, and a Delphi consensus to develop an international framework for palliative rehabilitation practice and policy, incorporating indicators, core interventions, outcomes and integration methods. Scientific contribution: If positive, the trial could produce a scalable and equitable intervention to improve function and quality of life in people with incurable cancer and reduce the burden of care for their families. It could also upskill the practitioners involved and motivate future research questions. The intervention could be adapted and integrated into different health systems using existing staff and services, with little or no additional cost.

Impact of COVID-19 on cancer care pathways in a comprehensive cancer center in northern Italy.

The COVID-19 pandemic burdened health care systems worldwide. Health services were reorganized with the dual purpose of ensuring the most adequate continuity of care and, simultaneously, the safety of patients and health professionals. The provision of care to patients within cancer care pathways (cCPs) was not touched by such reorganization. We investigated whether the quality of care provided by a local comprehensive cancer center has been maintained using cCP indicators. A retrospective single-cancer center study was conducted on eleven cCPs from 2019 to 2021 by comparing three timeliness indicators, five care indicators and three outcome indicators yearly calculated on incident cases. Comparisons of indicators between 2019 and 2020, and 2019 and 2021, were performed to assess the performance of cCP function during the pandemic. Indicators displayed heterogeneous significant changes attributed to all cCPs over the study period, affecting eight (72%), seven (63%) and ten (91%) out of eleven cCPs in the comparison between 2019 and 2020, 2020 and 2021, and 2019 and 2021, respectively. The most relevant changes were attributed to a negative increase in time-to-treatment surgery-related indicators and to a positive increase in the number of cases discussed by cCP team members. No variations were found attributed to outcome indicators. Significant changes did not account for clinical relevance once discussed by cCP managers and team members. Our experience demonstrated that the CP model constitutes an appropriate tool for providing high levels of quality care, even in the most critical health situations.

Patient-centred care with self-compression mammography in clinical practice: a randomized trial compared to standard compression.

OBJECTIVE: To test the efficacy of self- compared to radiographer-led compression to reduce the average glandular dose without affecting image quality and compliance to follow-up mammography. MATERIALS AND METHODS: Women presenting for mammography for breast cancer follow-up, symptoms, opportunistic screening, or familial risk were asked to participate and, if willing, were randomized to self-compression or radiographer-led compression. Image quality was assessed blindly by two independent radiologists and two radiographers. Pain and discomfort were measured immediately after mammography and their recall was asked when the women participated in the follow-up mammogram, 1 or 2 years later. RESULTS: In total, 495 women (mean age 57 years +/-14) were enrolled, 245 in the self-compression and 250 radiographer-compression arms. Image quality was similar in the two arms (radiologists' judgement p = 0.90; radiographers' judgement p = 0.32). A stronger compression force was reached in the self- than in the radiographer-arm (114.5 vs. 10.25 daN, p < .001), with a 1.7-mm reduction in thickness (p = .14), and almost no impact on dose per exam (1.90 vs. 1.93 mGy, p = .47). Moderate/severe discomfort was reported by 7.8% vs 9.6% (p = .77) and median pain score was 4.0 in both arms (p = .55). Median execution time was 1 min longer with self-compression (10.0 vs. 9.1 min, p < 0.001). No effect on subsequent mammography was detectable (p = 0.47). CONCLUSION: Self-compression achieved stronger compression of the breast, with comparable image quality, but did not substantially reduce glandular dose. The proportion of women who attended follow-up mammography was also similar in the two groups. TRIAL REGISTRATION: clinicaltrials.gov NCT04009278 KEY POINTS: • In mammography, appropriate compression is essential to obtain high image quality and reduce dose. Compression causes pain and discomfort. • Self-compression has been proposed to reach better compression and possibly increase participation in mammography. • In a randomized trial, self-compression reached stronger compression of the breast, with comparable image quality but with no glandular dose reduction or impact on participation in follow-up mammography.

Efficacy and safety of a colostrum- and Aloe vera-based oral care protocol to prevent and treat severe oral mucositis in patients undergoing hematopoietic stem cell transplantation: a single-arm phase II study.

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 mucositis decreased significantly (10.2% vs. 28.4%; P < 0.01), as did its duration (0.5 ± 1.9 vs. 1.5 ± 3.0 days; P < 0.01). Febrile neutropenia episodes (69.5% vs. 95.1%; P < 0.01) and duration (4.0 ± 4.7 vs. 6.2 ± 4.5 days; P < 0.01) also decreased. These findings show that the experimental protocol seems effective in preventing severe forms of oral mucositis. However, a randomized controlled trial is necessary to confirm this.

End-of-life care in cancer patients: how much drug therapy and how much palliative care? Record linkage study in Northern Italy.

OBJECTIVES: Investigating end-of-life use of anticancer drugs and of palliative care services. DESIGN: Population based cohort linked to mortality registry and administrative databases. SETTING: Emilia-Romagna Region (Northern Italy). PARTICIPANTS: 55 625 residents who died of cancer between 2017 and 2020. PRIMARY AND SECONDARY OUTCOME MEASURES: Multivariate 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. RESULTS: In 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 increasing age (OR 0.95, 95% CI 0.95 to 0.95). Drug therapy was more likely among those with haematologic tumours (OR 2.15, 95% CI 2.00 to 2.30) and in case of hospital admissions within the last 6 months (OR 1.63, 95% CI 1.55 to 1.72). Palliative care was less likely among those with haematologic compared with other tumours (OR 0.52, 95% CI 0.49 to 0.56), in case of surgery (OR 0.44, 95% CI 0.39 to 0.49) or hospital admissions (OR 0.70, 95% CI 0.67 to 0.72) within the last 6 months, if receiving anticancer drugs during the last 30 days (OR 0.90, 95% CI 0.85 to 0.94) and for each year of increasing age (OR 0.99, 95% CI 0.99 to 0.99). Palliative care was more likely in the presence of aggressive tumours (OR 1.12, 95% CI 1.08 to 1.16). CONCLUSION: Use of anticancer drugs and palliative care in the last month of life were inversely associated, showing variability across different LHAs. While administrative data have limits, our findings are in line with conclusions of other studies.

Stem cell transplantation patients receiving a novel oral care protocol for oral mucositis prevention and treatment: patient-reported outcomes and quality of life.

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 duration was 10.4 (SD ± 4.3) days, and the average maximum pain score was 3.7 (SD ± 2.7). Self-administration of the OMDQ detected oral symptoms at least 1 day sooner compared to objective assessments (p = 0.025). Significant differences were observed between the patient-reported and the HCP-assessment data on oral mucositis severity grading distribution (p < 0.0001) and highest pain score (p < 0.0001). Quality of life score variations were correlated with changes in oral mucositis severity during patients' hospital stay. CONCLUSIONS: Further studies are necessary to improve the understanding of these findings; a randomised controlled trial is being set up at our institution.

Effectiveness of a multi-layer silicone-adhesive polyurethane foam dressing as prevention for sacral pressure ulcers in at-risk in-patients: Randomized controlled trial.

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).