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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.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.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, p0.001). No effect on subsequent mammography was detectable (p = 0.47).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.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.

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. Findings: Between Jan 28, 2021, and July 22, 2021, 1014 participants were enrolled, of whom 910 were randomly assigned to a treatment group (456 to receive tixagevimab–cilgavimab and 454 to receive placebo). The mean age of participants was 46·1 years (SD 15·2). Severe COVID-19 or death occurred in 18 (4%) of 407 participants in the tixagevimab–cilgavimab group versus 37 (9%) of 415 participants in the placebo group (relative risk reduction 50·5% [95% CI 14·6–71·3]; p=0·0096). The absolute risk reduction was 4·5% (95% CI 1·1–8·0; p Interpretation: A single intramuscular tixagevimab–cilgavimab dose provided statistically and clinically significant protection against progression to severe COVID-19 or death versus placebo in unvaccinated individuals and safety was favourable. Treating mild to moderate COVID-19 earlier in the disease course with tixagevimab–cilgavimab might lead to more favourable outcomes.

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 P P P

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 and to investigate their heterogeneity (due to medical prescription methodology) and their combination in multiseries CT protocols. When weighted computed tomography dose index (CTDIw) was available, we calculated the volumetric computed tomography dose index (CTDIvol) using the pitch value to make the results uniform. Eventually, the correlation between protocol intents and CTDIvol values was obtained using a Kruskal–Wallis one-way ANOVA statistical test. Result Starting from a total of 1440 retrieved records, twenty-four studies were eligible for inclusion in addition to two large multicentric works that we used to compare the results. We analyzed 87 CT protocols. There was a considerable range of variation in the acquisition parameters: tube current–time product revealed to have the most variable range, which was 10–300 mAs for adults and 10–80 mAs for paediatric patients. Seventy percent of datasets presented scans acquired with tube current modulation, 9% used fixed tube current and in 21% of them, this information was not available. Dependence between mean CTDIvol values and protocol intent was statistically significant (p = 0.002). As expected, in diagnostic protocols, there was a statistically significant difference between CTDIvol values of with and without contrast acquisitions (11.68 mGy vs 7.99 mGy, p = 0.009). In 13 out of 87 studies, the optimisation aim was not reported; in 2 papers, a clinical protocol was used; and in 11 works, a dose optimisation protocol was applied. Conclusions According to this review, the dose optimisation in PET/CT exams depends heavily on the correct implementation of the CT protocol. In addition to this, considering the latest technology advances (i.e. iterative algorithms development), we suggest a periodic quality control audit to stay updated on new clinical utility modalities and to achieve a shared standardisation of clinical protocols. In conclusion, this study pointed out the necessity to better identify the specific CT protocol use within PET/CT scans, taking into account the continuous development of new technologies.

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 p Conclusions Further studies are necessary to improve the understanding of these findings; a randomised controlled trial is being set up at our institution.

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.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.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.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.

There is need for improvement in effective pressure ulcers preventive strategies.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.Open-label, parallel group, multi-center randomized controlled trial.709 in-hospital patients at risk for pressure ulcers from 25 medical, surgical, and intensive care units of 12 Italian hospitals.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.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 (p0.001; 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.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.ClinicalTrials.gov NCT03900455. The registration (April 1st, 2019) occurred before the first patient was enrolled (October 21st, 2019).

Sinusoidal obstruction syndrome (SOS) is one of the most serious complications post haematopoietic stem cell transplantation (HSCT). The diagnosis of SOS is clinical, but nurses should be involved in the pre-transplant risk assessment period and play a crucial role in the early detection of signs and symptoms during and after hospitalization. The aim of this work is to achieve a consensus on nurses’ behaviour in caring for SOS. On behalf of the Italian Group for Bone and Marrow Transplantation (GITMO), a promoter committee was established to put in place a consensus conference approach. A multidisciplinary group of GITMO together with four nurses, three haematology physicians and one patient representative acted as jury, who reviewed the reports and wrote recommendations and suggestions. Recommendations gaining 100% of consensus were considered ‘Golden Points of Care’; if a consensus was achieved by ≥ 75% of the jury’s members, those recommendations were defined as ‘Good Practices’. Eighteen papers written by nurses as first authors have been identified. Golden Points of Care and Good Practices were worked out for the following topics: nurses’ role in general, nurses’ role in pre-transplant assessment, pre-transplant risk assessment and risk stratification, baseline monitoring, suspected mild or moderate SOS, suspected severe or very severe SOS and late-onset cases. SOS is relatively rare; therefore, a holistic approach to the patients’ needs considering nursing role as essential may result in better care outcomes.

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 application was shown effective on vaginal dryness related symptoms limitation. Its use as food supplement showed interesting effects preventing upper respiratory illness in sportsmen, modulating immune system response and reducing intestinal permeability in healthy and sick subjects. Conflicting results were provided in pediatric population and little evidence is available on its use with older adults. Further studies are mandatory to better understand all factors influencing its activity.

Background: 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. Aim: Assessing feasibility of early integration of palliative care, and exploring concerns perceived and problems encountered by patients, relatives and oncologists. Design: A phase 2 mixed-methods study ( ClinicalTrials.Gov :NCT02078700). Methods: 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. Results: 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 patients (80.0%). It did not start for three (7.5%) and was interrupted for three patients who refused (7.5%). The Palliative Care Unit performed 274 visits in 38 patients (median per patient 4.5), and 24 family meetings with relatives of 16 patients. All patients and most relatives referred to the usefulness of the intervention, specifically for symptoms management, information and support to strategies for coping. Oncologists highlighted their difficulties in informing patients on palliative intervention, sharing information and coordinating patient’s care with the palliative care team. Conclusion: Early integration of palliative care in oncological setting seems feasible and well accepted by patients, relatives and, to a lesser extent, oncologists. Some difficulties emerged concerning patient information and inter-professional communication.

Surgery is the treatment of choice in most head and neck cancers. Very often, the surgery is radical with high impact on the psychosocial, functional and aesthetic fields. The aim of this study is to gain a deeper understanding of the patient's, clinician's and key informant's point of view when surgery is proposed, to improve the quality of pathways in terms of patients' practical, psychological and relational needs. We followed a Grounded Theory approach with semi-structured interviews. Seventeen participants (six patients, nine healthcare 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 healthcare professionals to rebut 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. The interplay between the organisational 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.

Background Older adult patients with fragility hip fractures constitute a population at high risk for complications, in particular pressure ulcers. The aim was to evaluate the incidence of pressure ulcers and potential predictive factors. Methods and Findings A prospective multicentric prognostic cohort study in orthopedic wards in three Italian public hospitals. Participants were all consecutive patients 65 years of age or older diagnosed with a fragility hip fracture. Outcomes were incidence of pressure ulcers. The exposure variables were grouped into three macro areas in order to facilitate reading: “intrinsic” variables, “extrinsic” variables and variables linked to the organization of patient care. One thousand eighty-three older adult patients with fragility hip fractures were enrolled from October 1st, 2013 to January 31st, 2015, and pressure ulcers developed in 22.7%. At multivariate analysis, the following were found to be risk factors: age> 80 years (odds ratio (OR) 1.03; p = 0.015), the length of time a urinary catheter was used (OR 1.013; p

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.

Summary 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.

e18793Background: Patient blood management (PBM) is an evidence-based, multidisciplinary and multimodal approach aiming to optimize the care of patients (pts) who might need blood transfusions.This...

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 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 how the patient was received on hospital entry and during his stay and the safety of the patient throught hospitalization.

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 (FOCUS+), 2) a web-based intervention (iFOCUS) or 3) a control group (care as usual). The two interventions offer tailored psychoeducational support for patient-family caregiver dyads. The nurse-led face-to-face intervention consists of two home visits and one online video session and the web-based intervention is completed independently by the patient-family caregiver dyad in four online sessions. The interventions are based on the FOCUS intervention, developed in the USA, that addresses five core components: family involvement, optimistic outlook, coping effectiveness, uncertainty reduction, and symptom management. The FOCUS intervention will be adapted to the European context. The primary outcomes are emotional functioning and self-efficacy of the patient and the family caregiver, respectively. The secondary outcomes are quality of life, benefits of illness, coping, dyadic communication, and ways of giving support of the patient and family caregiver. Discussion DIAdIC aims to develop cost-effective interventions that integrate principles of early palliative care into standard care. The cross-country setup in six European countries allows for comparison of effectiveness of the interventions in different healthcare systems across Europe. By focusing on empowerment of the person with cancer and their family caregiver, the results of this RCT can contribute to the search for cost-effective novel interventions that can relieve constraints on professional healthcare. Trial registration Registration on ClinicalTrials.gov on 12/11/2020, identifier NCT04626349. Date and version identifier 20211209_DIAdIC_Protocol_Article.