Risultati per: Analisi RCT - quali sono i farmaci migliori per la lombalgia acuta?

4 su 5 hanno buttato medicine da banco oltre la data di scadenza

Sfoltire ‘polifarmacie’. Si apre l’era della ‘de-prescrizione’

Farmacoterapia pilastro, impiego chirurgia solo per casi gravi

Selezionate 23 medicine potenzialmente utili contro il virus

Sfoltire ‘polifarmacie’. Si apre era della ‘de-prescrizione’

Context
Long-term adherence to physical activity (PA) interventions is challenging. The Lifestyle-integrated Functional Exercise programmes were adapted Lifestyle-integrated Functional Exercise (aLiFE) to include more challenging activities and a behavioural change framework, and then enhanced Lifestyle-integrated Functional Exercise (eLiFE) to be delivered using smartphones and smartwatches.

Objectives
To (1) compare adherence measures, (2) identify determinants of adherence and (3) assess the impact on outcome measures of a lifestyle-integrated programme.

Design, setting and participants
A multicentre, feasibility randomised controlled trial including participants aged 61–70 years conducted in three European cities.

Interventions
Six-month trainer-supported aLiFE or eLiFE compared with a control group, which received written PA advice.

Outcome measures
Self-reporting adherence per month using a single question and after 6-month intervention using the Exercise Adherence Rating Scale (EARS, score range 6–24). Treatment outcomes included function and disability scores (measured using the Late-Life Function and Disability Index) and sensor-derived physical behaviour complexity measure. Determinants of adherence (EARS score) were identified using linear multivariate analysis. Linear regression estimated the association of adherence on treatment outcome.

Results
We included 120 participants randomised to the intervention groups (aLiFE/eLiFE) (66.3±2.3 years, 53% women). The 106 participants reassessed after 6 months had a mean EARS score of 16.0±5.1. Better adherence was associated with lower number of medications taken, lower depression and lower risk of functional decline. We estimated adherence to significantly increase basic lower extremity function by 1.3 points (p

Introduction
Alcohol-related cues trigger relapse in patients with alcohol use disorders (AUDs). These cues may automatically activate motivational approach tendencies. Through computerised cognitive bias modification (CBM), the tendencies of patients with AUD to approach alcohol can be reduced. The present protocol describes a training intervention with approach bias modification (ApBM) incorporating religion-related stimuli as an alternative to alcohol to improve the effectiveness of CBM in a religion-based rehabilitation centre. AUD is often related to patients’ religious attitudes in this treatment context. The religion-adapted ApBM, therefore, combines training in avoidance of alcohol-related motivational cues and an approach to religion-based motivational cues. This combination’s effectiveness will be compared with a standard ApBM and to a sham ApBM.

Methods and analysis
Using a double-blind multiarm parallel randomised controlled trial procedure (ratio 1:1:1), 120 patients with AUD will be randomised into 1 of 3 conditions (religion-adapted ApBM, standard ApBM or sham ApBM) with personalised stimuli. The interventions are delivered over 4 consecutive days during an inpatient detoxification programme in addition to treatment as usual. Assessments occur before the start of the training and after the fourth training session, with follow-up assessments after 1 and 4 months. A multivariate analysis of variance will be used with the primary outcomes, the percentage of days abstinent and meaning in life 4-month follow-up. Secondary outcomes include differences in reported training satisfaction and symptoms of AUD.

Ethics and dissemination
This study has been reviewed and approved by the Medical Research Ethics Committee Academic Medical Center Amsterdam (Reference number: 2020_251). Further, study results will be published in peer-reviewed journals and presented at international conferences.

Trial registration number
NL75499.018.20.

Burocrazia, pochi fondi, misure complicate per la privacy e mancato adeguamento alle nuove regole Ue sulle sperimentazioni cliniche

Introduction
Depression is a common mental disorder and the (global) leading cause of all non-fatal burden of disease worldwide. Currently, supported treatment for depression is antidepressant medication and different psychotherapeutic interventions. Many patients experience, however, adverse effects of antidepressant medication, while at the same time the access to psychotherapeutic interventions are limited. Many patients who suffer from depression turn to complementary medicine and among those modalities often spiritual healing. There is some evidence that consulting a spiritual healer can be beneficial for patients who suffer from depression, and that spiritual healing is associated with low risk. The aim of this protocol is to conduct a pilot randomised controlled trial (RCT) (spiritual healing as addition to usual care vs usual care alone) in preparation of a larger trial in adults with moderate depression, to examine feasibility and individuals’ experience of spiritual healing.

Methods and analysis
This study is a pilot RCT with two parallel groups. A total of 28 adult patients with moderate depression, diagnosed by the physician and according to the Montgomery and Åsberg Depression Rating Scale criteria will be randomised to spiritual healing in addition to usual care (n=14) or usual care alone (n=14). To determine if there is a statistical indication of an effect of healing warranting a full-scale study; the separation test will be used. To investigate participants’ experience with spiritual healing, a qualitative study will be included using semistructured interviews. The data will be analysed based on a direct content analysis.

Ethics and dissemination
This protocol was approved by regional committees for medical and health research ethics by the identifier (63692). The results will be disseminated through open-access, peer-reviewed publications, in addition to stakeholders’ reporting and presenting at conferences.

Trial registration
Norwegian Centre for Research Data (845302) and clinicaltrials.gov (ID: NCT04766242)

Stroke, Ahead of Print. BACKGROUND:In patients with coronary artery disease and concomitant asymptomatic severe carotid stenosis, combined simultaneous coronary artery bypass grafting (CABG) and carotid endarterectomy (CEA) has been widely performed despite lack of evidence from randomized trials. We recently showed that the risk of stroke or death within 30 days was higher following CABG+CEA compared with CABG alone. Here, we report long-term outcomes following CABG with versus without CEA.METHODS:The CABACS (Coronary Artery Bypass Graft Surgery in Patients With Asymptomatic Carotid Stenosis Study) is a randomized, controlled, multicenter, open trial. Patients with asymptomatic severe (≥70%) carotid stenosis undergoing CABG were allocated either CABG+CEA or CABG alone, and follow-up was 5 years. Major secondary end points included nonfatal stroke or death, any death and any nonfatal stroke. Due to low recruitment, the study was stopped prematurely after randomization of 127 patients in 17 centers.RESULTS:By 5 years, the rate of stroke or death did not significantly differ between groups (CABG+CEA 40.6% [95% CI, 0.285–0.536], CABG alone 35.0% [95% CI, 0.231–0.484];P=0.58). Higher albeit statistically nonsignificant rates of nonfatal strokes occurred at any time following CABG+CEA versus CABG alone (1 year: 19.3% versus 7.1%,P=0.09; 5 years: 29.4% versus 18.8%,P=0.25). All-cause mortality up to 5 years was similar in both groups (CABG+CEA: 25.4% versus CABG alone: 23.3%, hazard ratio, 1.148 [95% CI, 0.560–2.353];P=0.71). Subgroup analyses did not reveal any significant effect of age, sex, preoperative modified Rankin Scale and center on outcome events.CONCLUSIONS:During 5-years follow-up, combined simultaneous CABG+CEA was associated with a higher albeit statistically nonsignificant rate of stroke or death compared with CABG alone. This was mainly due to a nonsignificantly higher perioperative risk following CABG+CEA. Since the power of our study was not sufficient, no significant effect of either procedure could be observed at any time during follow-up.Registration:http://www.controlled-trials.com; ISRCTN13486906.

Al via le somministrazioni del vaccino bivalente su Omicron 1. Ma a fine mese potrebbe arrivare quello aggiornato sulla sottovariante Omicron 5

Introduction
Acute variceal haemorrhage (AVH) in patients with cirrhosis remains a topic of great interest. Although several guidelines recommend endoscopy within 24 hours after AVH, there is no consensus on the most appropriate time to perform this intervention. The purpose of this study is to identify whether urgent endoscopy (within 6 hours after gastroenterological consultation) is superior to non-urgent endoscopy (between 6 hours and 24 hours after gastroenterological consultation) in reducing the rebleeding rate of these patients.

Methods and analysis
This is a single-centred, prospective, randomised clinical trial. Between March 2021 and December 2023, an estimated 400 patients will be randomised in a 1:1 ratio to receive endoscopic intervention either within 6 hours or between 6 and 24 hours after gastroenterological consultation. Randomisation will be conducted by permuted block randomisation, with stratification by age, systolic blood pressure and pulse rate. The primary efficacy endpoint is rebleeding within 42 days after control of AVH. The secondary efficacy endpoints mainly include all-cause mortality within 42 days after randomisation, persistent bleeding, length of hospitalisation, etc.

Ethics and dissemination
The study protocol was approved by the Ethical Committees of Jinling Hospital (authorised ethics no. DZQH-KYLL-21-01). This trial will provide valuable insights into the timing of endoscopic intervention for AVH in patients with cirrhosis. Furthermore, the trial results and conclusions could provide high-quality evidence to guide clinical research and treatment.

Trial registration number
NCT04786743.

Finanziato con 23 milioni dalla Commissione europea, il progetto ha l’obiettivo di sviluppare un ecosistema di ricerca e innovazione che faciliti lo sviluppo rapido ed economicamente vantaggioso di farmaci attraverso il drug repurposing. L’Italia è in prima fila con 4 organizzazioni