Risultati per: Studio REDUCE-IT e appropriatezza prescrittiva degli acidi grassi omega-3

New England Journal of Medicine, Ahead of Print.

Introduction
Approximately one million prostate biopsies are performed annually in the USA, and most are performed using a transrectal approach under local anaesthesia. The risk of postbiopsy infection is increasing due to increasing antibiotic resistance of rectal flora. Single-centre studies suggest that a clean, percutaneous transperineal approach to prostate biopsy may have a lower risk of infection. To date, there is no high-level evidence comparing transperineal versus transrectal prostate biopsy. We hypothesise that transperineal versus transrectal prostate biopsy under local anaesthesia has a significantly lower risk of infection, similar pain/discomfort levels and comparable detection of non-low-grade prostate cancer.

Methods and analysis
We will perform a multicentre, prospective randomised clinical trial to compare transperineal versus transrectal prostate biopsy for elevated prostate-specific antigen in the first biopsy, prior negative biopsy and active surveillance biopsy setting. Prostate MRI will be performed prior to biopsy, and targeted biopsy will be conducted for suspicious MRI lesions in addition to systematic biopsy (12 cores). Approximately 1700 men will be recruited and randomised in a 1:1 ratio to transperineal versus transrectal biopsy. A streamlined design to collect data and to determine trial eligibility along with the two-stage consent process will be used to facilitate subject recruitment and retention. The primary outcome is postbiopsy infection, and secondary outcomes include other adverse events (bleeding, urinary retention), pain/discomfort/anxiety and critically, detection of non-low-grade (grade group ≥2) prostate cancer.

Ethics and dissemination
The Institutional Review Board of the Biomedical Research Alliance of New York approved the research protocol (protocol number #18-02-365, approved 20 April 2020). The results of the trial will be presented at scientific conferences and published in peer-reviewed medical journals.

Trial registration number
NCT04815876.

Introduction
Considering the increasing complexity of care and workload for home care nurses due to the ageing of the population, it is crucial to describe the work environment and the community care setting. The aim of this study protocol is to map the characteristics and identify gaps of home care in the community to design future interventions aimed at ensuring quality and safety.

Methods and analysis
This is a national cross-sectional descriptive observational study using the survey method. Nurses from all participating community care centres will be recruited through convenience sampling by the coordinators of each centre, who will act as facilitators for this study. All community care recipients and their informal carers during the study period will be invited to complete a survey.
To map the characteristics and identify gaps of home care in the community, three sources of data will be collected: (1) organisational characteristics, professional satisfaction, intention to leave and burn-out; (2) experience of care recipients and their informal carers and (3) improper access to the emergency department, readmission to hospital, comorbidities, services offered and users’ level of autonomy, and main and secondary diagnoses.
Considering the total Italian nursing population of approximately 450 000 registered nurses, a sample size of 1% of this population, equal to approximately 4600 nurses, was hypothesised.
This study started in July 2022 and is planned to end in December 2023.
Data will be analysed using descriptive and inferential statistics.

Ethics and dissemination
This study protocol was approved by the Liguria Regional Ethics Committee in November 2022. Informed consent will be obtained from participants and confidentiality will be ensured. Data collected for this study will be kept anonymised in a protected database.
The results of the study will be disseminated mainly through conferences, publications and meetings with government representatives.

Introduction
It is known that only a limited proportion of developed clinical prediction models (CPMs) are implemented and/or used in clinical practice. This may result in a large amount of research waste, even when considering that some CPMs may demonstrate poor performance. Cross-sectional estimates of the numbers of CPMs that have been developed, validated, evaluated for impact or utilized in practice, have been made in specific medical fields, but studies across multiple fields and studies following up the fate of CPMs are lacking.

Methods and analysis
We have conducted a systematic search for prediction model studies published between January 1995 and December 2020 using the Pubmed and Embase databases, applying a validated search strategy. Taking random samples for every calendar year, abstracts and articles were screened until a target of 100 CPM development studies were identified. Next, we will perform a forward citation search of the resulting CPM development article cohort to identify articles on external validation, impact assessment or implementation of those CPMs. We will also invite the authors of the development studies to complete an online survey to track implementation and clinical utilization of the CPMs.
We will conduct a descriptive synthesis of the included studies, using data from the forward citation search and online survey to quantify the proportion of developed models that are validated, assessed for their impact, implemented and/or used in patient care. We will conduct time-to-event analysis using Kaplan-Meier plots.

Ethics and dissemination
No patient data are involved in the research. Most information will be extracted from published articles. We request written informed consent from the survey respondents. Results will be disseminated through publication in a peer-reviewed journal and presented at international conferences.

OSF registration
(https://osf.io/nj8s9).

Annals of Internal Medicine, Ahead of Print.

Stroke, Ahead of Print. Stroke is a disease of disparities, with tremendous racial and ethnic inequities in incidence, prevalence, treatment, and outcomes. The accumulating literature on the relationship between stroke and social determinants of health (ie, the structural conditions of the places where people live, learn, work, and play) contributes to our understanding of stroke inequities. Several interventions have been tested concurrently to reduce racial and ethnic inequities in stroke preparedness, care, recovery, and risk factor control. It is regrettable that no common theoretical framework has been used to facilitate comparison of interventions. In this scientific statement, we summarize, across the stroke continuum of care, trials of interventions addressing racial and ethnic inequities in stroke care and outcomes. We reviewed the literature on interventions to address racial and ethnic inequities to identify gaps and areas for future research. Although numerous trials tested interventions aimed at reducing inequities in prehospital, acute care, transitions in care, and poststroke risk factor control, few addressed inequities in rehabilitation, recovery, and social reintegration. Most studies addressed proximate determinants (eg, medication adherence, health literacy, and health behaviors), but upstream determinants (eg, structural racism, housing, income, food security, access to care) were not addressed. A common theoretical model of social determinants can help researchers understand the heterogeneity of social determinants, inform future directions in stroke inequities research, support research in understudied areas within the continuum of care, catalyze implementation of successful interventions in additional settings, allow for comparison across studies, and provide insight into whether addressing upstream or downstream social determinants has the strongest effect on reducing inequities in stroke care and outcomes.

Objectives
To (1) generate detailed, person-centred data about the experience of finger injury and treatment and (2) understand the patients’ perspectives of research involvement with a view to informing better designed future studies in hand injury.

Design
Qualitative study using semistructured interviews and framework analysis.

Participants
19 participants who were part of the Cohort study of Patients’ Outcomes for Finger Fractures and Joint Injuries study in a single secondary care centre in the UK.

Results
The results of this study showed that although finger injuries are frequently seen as minor by patients and healthcare professionals, their effects on peoples’ lives are possibly greater than first anticipated. The relative importance of hand functioning means that the experience of treatment and recovery varies and is shaped by an individual’s age, job, lifestyle and hobbies. These factors will also inform an individual’s perspective on and willingness to participate in, hand research. Interviewees showed reluctance to accept randomisation in surgical trials. Interviewees would be more likely to participate in a study testing two variants of the same treatment modality (eg, surgery vs surgery), rather than two different modalities, (eg, surgery vs splint). The Patient-Reported Outcome Measure questionnaires that were used in this study were seen as less relevant by these patients. Pain, hand function and cosmetic appearance were considered important, meaningful outcomes.

Conclusions
Patients with finger injuries need more support from healthcare professionals as they may experience more problems than first anticipated. Good communication by clinicians and empathy can help patients engage with the treatment pathway. Perceptions of an ‘insignificant’ injury and/or need for quick functional recovery will influence recruitment to future hand research (both positively and negatively). Accessible information about the functional and clinical consequences of a hand injury will be important in enabling participants to make fully informed decisions about participation.

Circulation, Volume 147, Issue 19, Page 1433-1435, May 9, 2023.

Recent advances in single-cell RNA sequencing and bioinformatics have drastically increased our ability to interrogate the cellular composition of traditionally difficult to study organs, such as the pancreas. With the advent of these technologies and approaches, the field has grown, in just a few years, from profiling pancreas disease states to identifying molecular mechanisms of therapy resistance in pancreatic ductal adenocarcinoma, a particularly deadly cancer. Single-cell transcriptomics and related spatial approaches have identified previously undescribed epithelial and stromal cell types and states, how these populations change with disease progression, and potential mechanisms of action which will serve as the basis for designing new therapeutic strategies. Here, we review the recent literature on how single-cell transcriptomic approaches have changed our understanding of pancreas biology and disease progression.

The incidence of gastro-oesophageal junction (GEJ) cancer, comprising both oesophageal (EAC) and junctional gastric adenocarcinomas, has increased dramatically in Western countries, correlating with a decrease in non-cardia gastric cancer (GC). A better understanding of the origin and pathogenesis of these cancers may allow for improved cancer prevention, detection and treatment. GEJ adenocarcinomas include tumours classified in the past as either oesophageal or gastric in origin. Adenocarcinoma located just above the GEJ (ie, EAC) was for many years viewed as a distinct entity from GC. This view followed the strong association of EAC with Barrett’s Oesophagus (BE), a metaplastic condition of the lower oesophagus which was viewed as a transdifferentiation of normal squamous epithelium to an intestinalised mucosa in the setting of gastric acid reflux. This assumption of a squamous origin of EAC led to (1) an extensive programme of surveillance of BE patients, (2) the inclusion of oesophageal squamous…

Objective
To explore experiences maintaining weight loss 6 months after completing a multicomponent weight loss programme for knee osteoarthritis.

Design
Qualitative study based on an interpretivist paradigm and a phenomenological approach that was embedded within a randomised controlled trial.

Setting
Semistructured interviews were conducted with participants 6 months after completing a 6-month weight loss programme (ACTRN12618000930280) involving a ketogenic very low calorie diet (VLCD), exercise and physical activity programme, videoconferencing consultations with a dietitian and physiotherapist, and provision of educational and behaviour change resources and meal replacement products. Interviews were audio recorded, transcribed verbatim and data were analysed based on the principles of reflexive thematic analysis.

Participants
20 people with knee osteoarthritis.

Results
Three themes were developed: (1) successfully maintained weight loss; (2) empowering self-management of weight (understand importance of exercise; increased knowledge about food and nutrition; resources from programme still useful; knee pain as a motivator; confidence in ability to self-regulate weight) and (3) challenges keeping on track (loss of accountability to dietitian and study; old habits and social situations; stressful life events or changes in health).

Conclusion
Participants had overall positive experiences maintaining their weight loss since completing the weight loss programme and were confident in their ability to self-regulate their weight in the future. Findings suggest a programme incorporating dietitian and physiotherapist consultations, a VLCD, and educational and behaviour change resources supports confidence maintaining weight loss in the medium term. Further research is required to explore strategies to overcome barriers like loss of accountability and returning to old eating habits.

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

Ricerche realizzate da Cnr e università di Bari e Milano

Ricerche realizzate da Cnr e università di Bari e Milano