Risultati per: Approccio pre-rete e Cure Palliative di base

Introduction
Almonds have prebiotic potential to maintain gut health and regulate glycaemia. Western studies have shown their positive effects on preventing non-communicable diseases like diabetes and cardiovascular diseases. However, there is a lack of research involving Asian Indians, who have a higher predisposition to diabetes due to their unique ‘Asian phenotype’. Therefore, this study aims to evaluate the impact of almond supplementation on glycaemic control and gut health in adults with pre-diabetes in rural India through a randomised clinical trial.

Methods and analysis
A parallel cluster randomised controlled trial with 178 participants with pre-diabetes (assigned 1:1) aged 20–50 years, of both genders, with a body mass index of 18.9–25 kg/m2, will be conducted in rural areas of Chikkaballapur, Kolar and Rural Bangalore districts in India. The intervention group will receive 56 g of almonds as mid-morning snacks for 16 weeks, while the control group will receive cereal/pulse-based traditional isocaloric snacks under the closed supervision of the study investigators. The primary outcome of the study is HbA1c measured at the 16th week. The secondary outcomes—anthropometry, clinical and other biochemical parameters—will be measured at 0th, 8th and 16th weeks, and a subgroup of 120 participants will undergo gut health analysis. Glucagon-like peptide 1 analysis will be conducted on 30 participants at 0th and 16th weeks. Statistical analysis will be performed using SPSS for Windows V.27.0, and both intention-to-treat and per-protocol analyses will be conducted.

Ethics and dissemination
Ethics approval was obtained from the Institutional Ethics Committee at Ramaiah Medical College, Bangalore, Karnataka, India (DRPEFP7672021). We will obtain the informed written consent of the participants prior to screening and enrolling them in the study. Results from this trial will be disseminated through publication in peer-reviewed journals and scientific gatherings.

Trial registration number
Clinical Trial Registry of India (CTRI/2023/03/050421).

Introduction
Obesity has become a worldwide public health problem and is directly linked to loss of quality of life, complications and comorbidities. One of them is chronic pain, especially in the knees, which increases significantly and proportionally with weight gain. In patients with severe obesity, with indication for bariatric surgery, the presence of chronic pain disables and often prevents their participation in a pre-surgical rehabilitation programme. As an analgesic therapy, photobiomodulation (PBM) has been studied with safety, efficacy, well-tolerated used and low costs. Thus, this study aims to evaluate the use of PBM for the treatment of chronic knee pain in obese patients undergoing a pre-surgical rehabilitation programme for bariatric surgery.

Methods and analyses
This is a double-blinded, randomised, placebo-controlled clinical, superiority, trial protocol. The PBM will be applied in bilateral knees and lumbar paraspinal points levels referring to the roots of innervation of the knee. The outcomes evaluated will be pain intensity, functionality, quality of life and clinical signs of neurological sensitization of chronic knee pain pathways.

Ethics and dissemination
This protocol has already been approved by the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH—Ethics Committee and it is following SPIRIT guidelines. The results will be statistically analysed and subsequently published in peer-reviewed journals.

Trial registration number
Clinical Trials Platform (https://clinicaltrials.gov/) with the number NCT05816798.

This cohort study examines the role of comprehensive bridging radiotherapy in the setting of chimeric antigen receptor T-cell therapy for non-Hodgkin lymphoma.

Introduction
Guidelines are important tools for supporting quality management in the care of patients with cancer. However, in clinical practice barriers exist to their implementation. Consequently, Quincie aims at: (1) gaining a comprehensive picture of the implementation of quality indicators from the national guideline on palliative care for patients with incurable cancer in palliative care units and (2) describing the factors that facilitate and hinder their implementation to develop recommendations.

Methods and analysis
The Quincie study follows a mixed-methods approach across two study phases. In phase 1, routinely collected data of 845 patients with incurable cancer from eight palliative care units in the commuting area of the Comprehensive Cancer Centre Lower Saxony will be analysed, regarding the implementation of 10 quality indicators from the national guideline on palliative care. Structural characteristics of the palliative care units will also be collected. In phase 2, recommendations for the practical implementation of the quality indicators, focusing on the achievement of the quality objectives identified in phase 1, will be developed in an implementation workshop. These recommendations will be subsequently agreed on via a Delphi survey.

Ethics and dissemination
Ethical approval has been given by the ethics committee of the Hannover Medical School (first vote, No. 10567_BO_K_2022) and other relevant institutions. The results will provide urgently needed insights on the implementation of the national guideline on palliative care in clinical care and on the factors that facilitate and hinder this implementation. The results are expected to promote better care for patients with incurable cancer. The results will be directly reported to the participating palliative care units and will be published in relevant peer-reviewed journals. They will also be presented at national conferences.

Trial registration number
German Clinical Trials Register (DRKS00029965).

Si punta a fronteggiare l’allerta caldo che in questi giorni è tornata ad allarmare sopratutto in alcune città dove si rischia di raggiungere i 40 gradi

Secondo il Crea Sanità solo il 55% degli italiani vive in Regioni con risultati soddisfacenti per la tutela della salute

Introduction
Preterm pre-eclampsia is a leading cause of maternal morbidity and mortality. The Pre-eclampsia Intervention 2 (PI 2) trial suggested that metformin sustained release (XR) may prolong gestation by a week in pregnant women undergoing expectant management (7.6 days, geometric mean ratio 1.39, 95% CI 0.99 to 1.95; p=0.057). These findings should be confirmed with a larger sample size, and we need to know if such a prolongation improves neonatal outcome. Here, we describe the protocol for such a follow-up trial.

Methods
The PI 3 trial is a phase III, intention-to-treat, double-blind, placebo-controlled randomised clinical trial to assess if metformin XR can prolong gestation and improve neonatal outcomes in women undergoing expectant management for preterm pre-eclampsia. We will recruit women who are between 26+0 and 31+6 weeks pregnant. Women will be randomised to receive either 3 g metformin XR or an identical placebo in divided daily doses. The primary outcome is prolongation of pregnancy. Secondary outcomes are neonatal birth weight and length of neonatal care admission (an indicator of neonatal health at birth). All other outcomes will be exploratory. We will record tolerability and adverse events. We plan a sample size of 500 participants to be powered for the primary and secondary outcomes.

Ethics and dissemination
PI 3 has ethical approval (Health Research Ethics Committee 2, Stellenbosch University, Protocol number M21/03/007, Project ID 21639, Federal Wide Assurance Number 00001372, Institutional Review Board Number IRB0005239), and is registered with the Pan African Clinical Trial Registry (PACTR202104532026017) and the South African Medicine Control Council (20211211). Data will be presented at international conferences and published in peer-reviewed journals.

Trial registration number
PACTR202104532026017)

Objectives
This study aimed to identify factors that shaped working parents (WPs’) experiences of COVID-19-related social restrictions and analyse the relationships between those factors.

Design
A qualitative descriptive design was used to collect five time points of data including two online questionnaires and three telephone or online interviews between March 2021 and August 2021 with some follow-up interviews in December 2022.

Setting
The COVID-19 pandemic led to social restrictions which greatly impacted WPs who had to both work and look after their children within their home space without any formal childcare.

Participants
19 participants living in Scotland who had at least one child of primary school age and who had been working in March 2020.

Results
All parents were affected by social restrictions during the COVID-19 pandemic, with the flexibility of employers, their socioeconomic situation and the amount of space in their home environment being particularly influential. The impact of social restrictions was greater for lone parents (LPs) due to the inability to share childcare with another adult in the home. Parents in low-income households were affected due to pre-existing inequalities of resources.

Conclusions
These findings indicate several policy options that could mitigate negative outcomes for parents in the case of a future pandemic, including options to lessen inequities experienced by LPs. These include priority access to school places (particularly for children with underlying chronic medical conditions), the ability to establish a ‘support bubble’ at the beginning of social restrictions and being given access to safe outside places for children without a garden.

Objective
The objective was to analyse how the pandemic affected primary care access and comprehensiveness in chronic disease management by comparing primary care patterns before and during the early COVID-19 pandemic.

Design
We conducted a quasi-experimental pre–post design cohort study and reported indicators for the 21 months before and after the onset of the COVID-19 pandemic.

Setting
We used electronic medical record data from primary care clinics enrolled in the Canadian Primary Care Sentinel Surveillance Network from 1 January 2018 to 31 December 2021.

Population
The study population included patients (n=919 928) aged 18 years or older with at least one primary care contact from 12 March 2018 to 12 March 2020, in Canada.

Outcome measures
The study indicators included three indicators measuring access to primary care (encounters, blood pressure measurements and lab tests) and three for comprehensiveness (diagnoses, non-COVID-19 vaccines administered and referrals).

Results
67.3% of the cohort was aged ≥40 years, 56.4% were female and 53.5% were from Ontario, Canada. Fewer patients received an encounter during the pandemic (91.5% to 81.5%), while the median (IQR) number of encounters remained the same (5 (2–1)) for those with access. Fewer patients received a blood pressure measurement (47.9% to 31.8%), and patients received fewer measurements during the pandemic (2 (1–4) to 1 (0–2)).

Conclusions
Encounters with primary care remained consistent during the pandemic, but in-person care, such as lab tests and blood pressure measurements, decreased. In-person care indicators followed temporally to national COVID-19 case counts during the pandemic.

Introduction
Healthcare providers usually manage medication for patients during hospitalisation, although patients are expected to self-manage their medication after discharge. A lack of self-management competencies is found to be associated with low adherence levels and medication errors harming patients’ health. Currently, patients seldom receive support or education in medication self-management. When self-management is allowed during hospitalisation, it is rarely provided using a structured, evidence-based format. Therefore, an in-hospital medication self-management intervention (ie, SelfMED) was developed based on current evidence. To date, empirical data demonstrating the effect of SelfMED on medication adherence are lacking. This study primarily aims to evaluate the effect of the SelfMED intervention on medication adherence 2 months postdischarge in polypharmacy patients, as compared with usual care.

Methods and analysis
A multicentre pre–post intervention study will be conducted. The study will start with a control phase investigating usual care (ie, medication management entirely provided by healthcare providers), followed by an intervention period, investigating the effects of the SelfMED intervention. SelfMED consists of multiple components: (1) a stepped assessment evaluating patients’ eligibility for in-hospital medication self-management, (2) a monitoring system allowing healthcare providers to follow up medication management and detect problems and (3) a supportive tool providing healthcare providers with a resource to act on observed problems with medication self-management. Polymedicated patients recruited during the control and intervention periods will be monitored for 2 months postdischarge. A total of 225 participants with polypharmacy should be included in each group. Medication adherence 2 months postdischarge, measured by pill counts, will be the primary outcome. Secondary outcomes include self-management, medication knowledge, patient and staff satisfaction, perceived workload and healthcare service utilisation.

Ethics and dissemination
The ethics committee of the Antwerp University Hospital approved the study (reference no: B3002023000176). Study findings will be disseminated through peer-reviewed publications, conference presentations and summaries in layman’s terms.

Trial registration number
ISRCTN15132085.

Objectives
To evaluate how the codesigned training programme, ‘No conversation too tough’, can help cancer, palliative and wider healthcare professionals support patients to communicate with their dependent children when a parent is dying. We examined perceptions of learning provided by the training, its contribution to confidence in communicating with families when a parent is dying, and subjective experience of, and reactions to, the training. We also explored potential changes in practice behaviours.

Design
Pre–post, convergent, parallel, mixed-methods study. Motivations for practice change were measured quantitatively, and qualitatively through semi-structured interviews. Non-parametric analysis was conducted for self-efficacy and outcome expectancy measures; descriptive statistics examined perceptions of usefulness; intentions to use learning in practice and reactions to the training. Semi-structured interviews examined motivations and perceptions of learning in depth. A 6-week, practice log recorded immediate practice effects and reflections.

Setting
1-day training delivered 3 times, total delegates 36: online December 2021, February 2022, face-to-face March 2022. Questionnaires delivered correspondingly in online or paper formats, semi-structured interviews online.

Participants
Pre–post: palliative care professionals (n=14/12), acute cancer clinical nurse specialists (n=16/11), other healthcare professionals (n=5/5).

Results
Positive changes were observed in self-efficacy (17 of 19 dimensions p

Introduction
Exercise has been used to reverse dysglycaemic states in patients with pre-diabetes. Systematic reviews show that exercise is an effective way to reduce the incidence of diabetes, but there is conflicting evidence for reducing the occurrence of cardiovascular events. Therefore, we present a systematic review and network meta-analysis protocol designed to compare the effectiveness of different forms of exercise in reducing cardiovascular events and their tolerability in different populations.

Methods and analysis
We will include all randomised controlled trials and compare one exercise intervention to another. We will compare the following exercise patterns: standard endurance training, strength training, high-intensity interval training, mind-body exercise, and mixed strength and aerobic training. The primary outcomes are the occurrence of major cardiovascular events and the rate of patient attrition during the intervention. We will search major English and Chinese databases as well as trial registry websites for published and unpublished studies. All reference selection and data extraction will be conducted by at least two independent reviewers. We will conduct a random effects model to combine effect sizes and use the surface under the cumulative ranking curve and the mean ranks to rank the effectiveness of interventions. All data will be fitted at WinBUGS in a Bayesian framework and correlation graphs will be plotted using StataSE 14. We will also use the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework to evaluate the quality of evidence for the study results.

Ethics and dissemination
This study does not involve a population-based intervention, and therefore, does not require ethical approval. We will publish the findings of this systematic review in a peer-reviewed scientific journal, and the dataset will be made available free of charge. The completed review will be disseminated electronically in print and on social media, where appropriate.

PROSPERO registration number
CRD42023422737.

Pochi sanno che da oltre 20 anni c’è una norma che “difende” i pazienti costretti ad attendere oltre ai tempi massimi previsti

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.