14 research outputs found

    Choosing and evaluating randomisation methods in clinical trials: a qualitative study

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    Background: There exist many different methods of allocating participants to treatment groups during a randomised controlled trial. Although there is research that explores trial characteristics that are associated with the choice of method, there is still a lot of variety in practice not explained. This study used qualitative methods to explore more deeply the motivations behind researchers’ choice of randomisation, and which features of the method they use to evaluate the performance of these methods. Methods: Data was collected from online focus groups with various stakeholders involved in the randomisation process. Focus groups were recorded and then transcribed verbatim. A thematic analysis was used to analyse the transcripts. Results: Twenty-five participants from twenty clinical trials units across the UK were recruited to take part in one of four focus groups. Four main themes were identified: how randomisation methods are selected; researchers’ opinions of the different methods; which features of the method are desirable and ways to measure method features. Most researchers agree that the randomisation method should be selected based on key trial characteristics; however, for many, a unit standard is in place. Opinions of methods were varied with some participants favouring stratified blocks and others favouring minimisation. This was generally due to researchers’ perception of the effect these methods had on balance and predictability. Generally, predictability was considered more important than balance as adjustments cannot be made for it; however, most researchers felt that the importance of these two methods was dependent on the design of the study. Balance is usually evaluated by tabulating variables by treatment arm and looking for perceived imbalances, predictability was generally considered much harder to measure, partly due to differing definitions. Conclusion: There is a wide variety in practice on how randomisation methods are selected and researcher’s opinions on methods. The difference in practice observed when looking at randomisation method selection can be explained by a difference in unit practice, and also by a difference in researchers prioritisation of balance and predictability. The findings of this study show a need for more guidance on randomisation method selection

    Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study

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    Background: Barriers to mental health research participation are well documented including distrust of services and research; and stigma surrounding mental health. They can contribute to a lack of diversity amongst participants in mental health research, which threatens the generalisability of knowledge. Given the recent widespread use of the internet in medical research, this study aimed to explore the perspectives of key partners on the use of online (e.g. social media) and offline (e.g. in-person) recruitment as an approach to improving diversity in mental health randomised controlled trials (RCTs).Methods: Face-to-face and online interviews/focus groups with researchers working in mental health and Patient and Public Involvement partners in the United Kingdom. Recordings were transcribed and analysed using a combination of inductive and deductive thematic analysis.Results: Three focus groups and three interviews were conducted with a total N=23 participants. Four overarching themes were identified: (1) recruitment reach; (2) Demographic factors that affect selection of recruitment method; (3) safety of technology, and; (4) practical challenges. Five main factors were identified that affect the choice of recruitment method: age, complexity of mental health problem and stigma, cultural and ethnicity differences and digital divide. The use of online methods was considered more accessible to people who may feel stigmatised by their mental health condition and with a benefit of reaching a wider population. However, a common view amongst participants was that online methods require closer data monitoring for quality of responders, are not fully secure and less trustworthy compared to offline methods that enable participants to build relationships with health providers. Funding, staff time and experience, organisational support, and technical issues such as spam or phishing emails were highlighted as practical challenges facing online recruitment. All participants agreed that using a hybrid approach tailored to the population under study is paramount.Conclusions: This study highlighted the importance of offering a flexible and multifaceted recruitment approach by integrating online with offline methods to support inclusivity and widening participation in mental health research. The findings will be used to develop considerations for researchers designing RCTs to improve recruitment in mental health research

    Awareness of physicians and clinical pharmacists about ACC/AHA guidelines for dyslipidemia management: A cross sectional study

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    Introduction: Cardiovascular diseases (CVDs) are one of the leading causes of morbidity and mortality worldwide. Although genetics could contribute to the incidence of CVD, they are mostly acquired conditions. Management of precipitating factors such as hyperlipidemia can prevent CVD. Therefore, clinical guidelines have been used as a tool to improve patient outcomes and minimize practice variation. Objective: The objective of this study was to assess health-care providers’ (physicians and clinical pharmacists) awareness about the latest edition of the American College of Cardiology/American Heart Association (ACC/AHA) guidelines of dyslipidemia management. Materials and Methods: To meet the study objective, a self-administered questionnaire was designed based on the recommendations of the latest edition of the ACC/AHA guidelines for dyslipidemia management. After validation, the questionnaire was distributed to physicians and clinical pharmacists in Al-Ahsa province of Saudi Arabia. Results: Validation of the questionnaire was carried on 10 participants (Cronbach’s alpha = 0.816). Seventy-seven participants completed the questionnaire (acceptance rate = 51.33%). The majority of participants knew about the release of the ACC/AHA 2013 guidelines for dyslipidemia (77% of the physicians and 48% of the clinical pharmacist). Inadequate knowledge of the major changes in the dyslipidemia management was observed in both study groups with no significant difference between them (the median score for physicians and pharmacists was 4 out of 10 with a range of 1–9, Z = −0.15, P = 0.88).Conclusion: Inadequate level of knowledge about practice-changing recommendations of the recent ACC/AHA guidelines for dyslipidemia management was observed among the study participants. This level of knowledge could result in clinical malpractice and worsen management outcomes. Thus, efforts should be in place to raise awareness about the evidence-based management of dyslipidemia and monitor compliance to guidelines and their implementation outcomes
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