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

Via libera dell’Aifa. Sopravvivenza sale anche senza chemio

Mercoledì la proposta, le Big Pharma promettono battaglia

Studio condotto dall’Istituto Pascale di Napoli

Semplificare le procedure prescrittive per i farmaci attualmente sottoposti a registro di monitoraggio e a piano terapeutico. A chiederlo, la Federazione Nazionale degli Ordini dei Medici Chirurghi e degli Odontoiatri (FNOMCeO) e la Federazione Italiana delle Società Medico-Scientifiche (FISM), che hanno siglato oggi a Roma un Documento di posizione condivisa

Introduction
Obtaining level 1 evidence on efficacy of glycosaminoglycan (GAG) therapy is difficult, due to low incidence of bladder pain syndrome/interstitial cystitis (BPS/IC) and heterogeneous symptoms experienced by patients with BPS/IC. Currently, because of a lack of high-grade evidence, the recommendation for applying GAG therapy in most guidelines is ‘low grade’. An aggregated N-of-1 trial is a multicrossover design that yields similar level 1 evidence as a traditional randomised controlled trial (RCT), while requiring far less patients. The goal of this study is to investigate the efficacy of intravesical GAG therapy (Ialuril) for patients with BPS/IC with Hunner lesions using a dual RCT and aggregated N-of-1 trial design to obtain level 1 evidence.

Methods and analysis
The GETSBI study is a double-blind multidesign multicentre randomised placebo-controlled study to assess the short-term and long-term efficacy of hyaluronic acid (1.6%) + chondroitin sulfate (2%) therapy (Ialuril Prefill, IBSA, Goodlife) in patients with symptomatic BPS/IC with Hunner lesions. It starts as a standard RCT (n=80), but continues as an aggregated N-of-1 trial. There are three parallel arms, receiving blinded treatment for three periods (1 x/week for 6 weeks, ratio placebo to intervention in periods of 2:1). Followed by an open prospective part for the long-term efficacy. The primary study outcome is the maximum bladder pain experienced in the last 3 days measured using the visual analogue pain scale (0–10).
This study is a collaboration with the Dutch government and will deliver evidence for the decision to reimburse the therapy. Furthermore, this multidesign study will allow us to compare the two main methods to evaluate applicability for future study designs for BPS/IC research.

Ethics and dissemination
Ethical approval was given by METC Oost-Nederland, file number: 2020-7265, NL-number: NL76290.091.20. Findings from this study will be disseminated via publication, reports and conference presentations.

Trial registration number
ClinicalTrials.gov identifier (NCT number): NCT05518864.

Introduction
Persistent spine pain syndrome type 2 (PSPS2) represents a significant burden to the individual and society. Treatment options include revision surgery, stabilisation surgery of the spine, neuromodulation, analgesics and cognitive behavioural therapy. Nevertheless, structured treatment algorithms are missing as high-level evidence on the various treatments is sparse. The aim of this study is to compare higher frequency neuromodulation with instrumentation surgery in patients suffering from PSPS2.

Methods and analysis
The sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE) trial is a prospective randomised rater blinded multicentre study. Patients suffering from PSPS2 with a functional burden of Oswestry Disability Index (ODI) >20 points are randomised to treatment via spinal cord stimulation or spinal instrumentation. Primary outcome is back-related functional outcome according to the ODI 12 months after treatment. Secondary outcomes include pain perception (visual analogue scale), Short Form-36, EuroQOL5D, the amount of analgesics, the length of periprocedural hospitalisation and adverse events. Follow-up visits are planned at 3 and 12 months after treatment. Patients with previous lumbar instrumentation, symptomatic spinal stenosis, radiographical apparent spinal instability or severe psychiatric or systemic comorbidities are excluded from the study. In order to detect a significant difference of ≥10 points (ODI) with a power of 80%, n=72 patients need to be included. The recruitment period will be 24 months with a subsequent 12 months follow-up. The beginning of enrolment is planned for October 2022.

Ethics and dissemination
The PROMISE trial is the first randomised rater blinded multicentre study comparing the functional effectiveness of spinal instrumentation versus neuromodulation in patients with PSPS2 in order to achieve high-level evidence for these commonly used treatment options in this severely disabling condition. Patient recruitment will be performed at regular outpatient clinic visits. No further (print, social media) publicity is planned. The study is approved by the local ethics committee (LMU Munich, Germany) and will be conducted according to the Declaration of Helsinki.

Trial registration number
NCT05466110.

Autorizzata da Fda 27 marzo ’98, cambiò approccio a disfunzioni

Esperto, utili pure contro stigma che grava su un paziente su 5

Introduction
Cerebral palsy (CP) is the most common childhood physical disability with rates approximately 50% higher in First Nations Australian children. This study aims to evaluate a culturally-adapted parent-delivered early intervention programme for First Nations Australian infants at high risk of CP (Learning through Everyday Activities with Parents for infants with CP; LEAP-CP).

Methods and analysis
This study is a randomised assessor masked controlled trial. Infants with birth/postnatal risk factors will be eligible for screening. Infants at high risk of CP (‘absent fidgety’ on General Movements Assessment, and/or ‘suboptimal score’ on the Hammersmith Infant Neurological Examination) aged 12–52 weeks corrected age will be recruited. Infants and their caregivers will be randomised to receive LEAP-CP (intervention) or health advice (comparator). LEAP-CP is a culturally-adapted programme of 30 home visits delivered by a peer trainer (First Nations Community Health Worker); and includes goal-directed active motor/cognitive strategies, CP learning games and caregiver educational modules. The control arm receives a monthly health advice visit, based on the Key Family Practices, WHO. All infants continue to receive standard (mainstream) Care as Usual. Dual child primary outcomes are Peabody Developmental Motor Scales-2 (PDMS-2) and Bayley Scales of Infant Development-III. The primary caregiver outcome is the Depression, Anxiety and Stress Scale. Secondary outcomes include function, goal attainment, vision, nutritional status and emotional availability. Sample size: total of 86 children (43/group) will enable an effect size of 0.65 on the PDMS-2 to be detected (80% power, α=0.05; 10% attrition).

Ethics and dissemination
Ethics approval through Queensland ethics committees and Aboriginal Controlled Community Health Organisation Research Governance Groups, with families providing written informed consent. Findings will be disseminated with guidance from the Participatory Action Research, in collaboration with First Nations communities; peer-reviewed journal publications and national/international conference presentations.

Trial registration number
ACTRN12619000969167p.

‘Hangar’ di medicinali in crisi per l’aumento dei carburanti ed energia

Riccardi, traguardo per salute cittadini,Asfuc modello in Italia

Riccardi, traguardo per salute cittadini,Asfuc modello in Italia

Sequestrate 16mila tonnellate alimenti e 1,5 milioni medicine

Sequestrate 16mila tonnellate alimenti e 1,5 milioni medicine