Risultati per: Standard di cura del diabete

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

Introduction
The current diagnostic pathway for patients with a suspected inherited bleeding disorder is long, costly, resource intensive, emotionally draining for patients and often futile, as half of patients will remain without a diagnosis and be labelled ‘bleeding disorder of unknown cause’. Advances in understanding the genetic basis of the inherited bleeding disorders, coupled with both increasing infrastructure for genetic/genomic testing and decreasing costs, have increased the feasibility of introducing genomic testing into the clinical diagnostic pathway as a potential solution to improve the care of these patients. Yet, there remain evidence gaps on the optimal integration of genomic analysis into the diagnostic pathway.

Methods and analysis
Using a multicentre randomised-controlled trial design, we will evaluate an early genomic testing strategy for the diagnosis of newly referred patients with a suspected inherited bleeding disorder. Eligible participants will be randomised to early genomic testing diagnostic pathway (intervention) or standard diagnostic pathway (control) and will be followed for a 12-month period. Patients in the control group who remain undiagnosed at study end will be offered identical early genomic testing to ensure equitable access to the intervention. The study will follow a parallel fixed design with waitlist control group and a 1:1 allocation ratio. The study will be conducted at three tertiary care centres in Ontario, Canada, with a target sample size of 212 participants. Clinical utility will be evaluated via the primary outcome of diagnostic yield, as well as the secondary outcome of time to diagnosis. Additional secondary outcomes will allow for assessment of patient impact via health-related quality of life and patient burden measures, as well as evaluation of economic impact through a cost-effectiveness analysis and budget impact analysis.

Ethics and dissemination
This investigator-initiated study was approved by the Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board through Clinical Trials Ontario (CTO-4909). Participant informed consent/assent is required. Findings will be disseminated through academic publications.

Trial registration number
ClinicalTrials.gov, NCT06736158.

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Objective
To qualitatively explore Bangladeshi adult males’ perceptions of existing bidi (tobacco-leaf cigarettes hand-rolled in tendu leaf) packs, which are currently sold in various shapes and sizes, often without the required graphic health warning label (HWL) covering 50% of the top of the pack, versus a proposed standard bidi pack, which was designed by advocates and is a cardboard, rectangular box shape with the required 50% HWL coverage.

Design
Focus group study

Setting
Male participants were recruited from predetermined low-income urban and rural areas in three geographic divisions (Dhaka, Khulna, Sylhet) of Bangladesh.

Participants
98 males participated in 14 focus group discussions (FGDs). An equal number of groups were conducted with males who currently used bidis (n=7 groups) and males who never used tobacco (n=7 groups). Each group had 6–8 participants. For FGDs with males who used bidis, participants were eligible if they were at least 18 years old and reported smoking bidis on at least one of the past 30 days. For FGDs with males who never used tobacco, participants were eligible if they were between 18 and 35 years old to capture those at most risk of initiating tobacco and reported never using any tobacco.

Intervention
Participants were shown four existing bidi packs sold in Bangladesh and one standard bidi pack. The groups were asked to first rank and discuss the existing bidi packs in terms of perceived attractiveness, HWL noticeability and perceived harmfulness. Next, the groups discussed how the standard bidi pack compared with the existing bidi packs in terms of the same three outcomes.

Results
All groups, regardless of bidi use status, discussed the limited noticeability of HWLs on existing bidi packs, which reduced perceived product harm. In contrast, most groups discussed how the standard pack HWL was clearly printed, easy to see and increased perceived harm. Overall, most groups across bidi use status found that the standard pack was as attractive or more attractive than the existing bidi packs, particularly noting that the standard pack shape, colour and cardboard material were attractive.

Conclusions
Standardising the size and shape of bidi packs has the potential to improve HWL compliance and increase harm perceptions. Complementing a standard bidi pack policy with a plain packaging policy (eg, packs only sold in a single drab olive colour), as well as efforts to enhance HWL compliance at the point of manufacturer, could further reduce product appeal and enhance harm perceptions.

Annals of Internal Medicine, Ahead of Print.

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