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Involvement of vulnerable populations in research is critical to inform the generalisability of evidence-based medicine to all groups of the population.
In this communication, we reflect on our previous research, and that of other authors, to identify and explore key ethical and methodological considerations.
Focus groups are a widely implemented qualitative methodology, but their use, particularly in vulnerable neurodegenerative disease populations, is not straightforward. Although the risk of harm is generally low in focus group research, neurodegenerative disease populations are particularly vulnerable to issues relating to comprehension and their capacity to consent. Physical and cognitive impairments may also affect social interactions among participants and therefore impact data collection and analyses.
We offer a number of ethical and methodological recommendations to facilitate the processes of recruitment and data collection when conducting focus groups with neurodegenerative disease populations.
We offer a number of ethical and methodological recommendations to facilitate the processes of recruitment and data collection when conducting focus groups with neurodegenerative disease populations.
Vitamin D insufficiency is much more common among patients with cancer than the general population. Previous meta-analyses of controlled trials showed an approximately 15% reduction of cancer mortality by vitamin D supplementation compared with placebo or no treatment in the general population.On top of updating the latest systematic review on vitamin D supplementation and cancer mortality in the general population, we aim to conduct the first meta-analyses of trials on vitamin D
supplementation and cancer-specific and overall survival of patients with cancer. Besides, we will conduct for the first time subgroup analyses based on individual patient data collected from randomised controlled trials.
A systematic review and individual patient data meta-analysis will be performed on randomised placebo-controlled trials with a vitamin D
intervention. All databases are searched from inception without time restriction. The addressed outcomes are cancer mortality in the general population as well as cancer-sp20185566.
CRD42020185566.
In 2017, the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) introduced a standardised process to appraise innovativeness of medicines. Innovative medicines are provided speeder market access and dedicated funds. Innovativeness criteria are unmet therapeutic need, added therapeutic value and quality of the evidence (Grading of Recommendations Assessment, Development and Evaluation method). We investigated the role played by these three criteria on the final decision aimed to understand how the new Italian innovativeness appraisal framework was implemented.
A desk research gathered AIFA's appraisal reports on innovativeness and data analyses were conducted. No patients were directly involved in this study.
We scrutinised all 77 appraisal reports available on AIFA's website (2017-2020).
The impact of the three domains on final decision was investigated through a series of univariate analyses.
Among 77 appraisal reports on innovativeness available, 49 (64%) and 28 (36%) were for oncology cess. This has important implications in terms of transparency and accountability in the prioritisation process applied to innovative medicines.
Pilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.
A two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.
Three community-based cohorts in the South-West of England.
Eligible participants with post-stroke aphasia were randomised 11 to SPA or control.
The manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed usidherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified.
The SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.
NCT03076736.
NCT03076736.
This study examined the associations between the Second-Generation Cessation Payment Scheme (SCPS) and the use of smoking cessation treatments. Furthermore, these associations were compared between light and heavy smokers in Taiwan.
This study had a cross-sectional design.
Data were obtained from the Taiwan Adult Smoking Behaviour Surveillance System 2010-2011 and 2013-2014; data for each year consisted of a nationally representative sample of adults aged 18 years and older.
Current smokers who had either quit or made a serious attempt to quit smoking were selected for the analysis.
The primary outcome measure was the use of a smoking cessation clinic or pharmacy in a twice daily to quit smoking.
According to multivariate analysis, the SCPS was positively associated with the combined use of a smoking cessation clinic and a pharmacy (OR=3.947; 95% CI 1.359 to 11.463) when individual-level predictors (gender, age, education level, marital status, monthly household income, daily cigarette consumption, smoking status and self-reported health) were controlled. selleck products Heavy smokers showed a significant increase in the sole use of a pharmacy (OR=1.676; 95% CI 1.094 to 2.569) and combined use of a smoking cessation clinic and pharmacy (OR=8.984; 95% CI 1.914 to 42.173) after the SCPS was introduced. In addition, when related factors were controlled, the use of smoking cessation services was more frequent among heavy smokers than light smokers, including any treatment (OR=1.594; 95% CI 1.308 to 1.942), a smoking cessation clinic (OR=1.539; 95% CI 1.232 to 1.922), a pharmacy (OR=1.632; 95% CI 1.157 to 2.302) and the combination of a smoking cessation clinic and pharmacy (OR=4.608; 95% CI 1.331 to 15.949) .
The SCPS subsidisation policy increased the use of smoking cessation treatments, particularly among heavy smokers.
The SCPS subsidisation policy increased the use of smoking cessation treatments, particularly among heavy smokers.
