The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area.Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1978-4) contains supplementary material, which is available to authorized users.
Plain Language Summary Funders of research are increasingly requiring researchers to involve patients and the public in their research. Patient and public involvement (PPI) in research can potentially help researchers make sure that the design of their research is relevant, that it is participant friendly and ethically sound. Using and sharing PPI resources can benefit those involved in undertaking PPI, but existing PPI resources are not used consistently and this can lead to duplication of effort. This paper describes how we are developing a toolkit to support clinical trials teams in a clinical trials unit. The toolkit will provide a key ‘off the shelf’ resource to support trial teams with limited resources, in undertaking PPI. Key activities in further developing and maintaining the toolkit are to:● listen to the views and experience of both research teams and patient and public contributors who use the tools;● modify the tools based on our experience of using them;● identify the need for future tools;● update the toolkit based on any newly identified resources that come to light;● raise awareness of the toolkit and● work in collaboration with others to either develop or test out PPI resources in order to reduce duplication of work in PPI.Abstract Background Patient and public involvement (PPI) in research is increasingly a funder requirement due to the potential benefits in the design of relevant, participant friendly, ethically sound research. The use and sharing of resources can benefit PPI, but available resources are not consistently used leading to duplication of effort. This paper describes a developing toolkit to support clinical trials teams to undertake effective and meaningful PPI. Methods The first phase in developing the toolkit was to describe which PPI activities should be considered in the pathway of a clinical trial and at what stage these activities should take place. This pathway was informed through review of the type and timing of PPI activities within trials coordinated by the Clinical Trials Research Centre and previously described areas of potential PPI impact in trials.In the second phase, key websites around PPI and identification of resources opportunistically, e.g. in conversation with other trialists or social media, were used to identify resources. Tools were developed where gaps existed. Results A flowchart was developed describing PPI activities that should be considered in the clinical trial pathway and the point at which these activities should happen. Three toolkit domains were identified: planning PPI; supporting PPI; recording and evaluating PPI. Four main activities and corresponding tools were identified under the planning for PPI: developing a plan; identifying patient and public contributors; allocating appropriate costs; and managing expectations. In supporting PPI, tools were developed to review participant information sheets. These tools, which require a summary of potential trial participant characteristics and circumstances help to clarify requirements and expectat...
Plain English summaryPlain English summaryThis commentary article describes three interactive workshops that explored how patients can contribute to decisions about what outcomes are measured in clinical trials across the world. Outcomes like quality of life, side-effects and pain are used in trials to measure whether a treatment is effective. Here, we outline how research groups are increasingly coming together to develop ‘core outcomes sets’ for particular conditions. Core outcome sets are lists of agreed outcomes. Their use will help in identifying which treatments are effective by enabling people to compare the findings of different clinical trials in the same condition. Currently, it is often very difficult to make these comparisons because different studies often measure different outcomes. Delegates attending the workshops included patients, clinicians and researchers. They discussed ways of making core outcome set development more meaningful and accessible for patients, and ensuring that they have a genuine say in the development process. This article summarises these discussions and concludes by identifying three distinctive challenges in securing patient input to core outcome set development: the process and objectives can seem far removed from the immediate concerns of patients, difficulties can arise in securing patient input on an international scale, and difficulties can also arise in bringing multiple stakeholder groups together to achieve consensus. While patient participation, involvement and engagement in core outcome set development can draw on lessons from other research areas, these distinctive challenges point to the need for distinctive solutions to enable meaningful patient input to core outcome set development.AbstractBackground This article describes three workshops that explored how patients can contribute to decisions about what outcomes are measured in clinical trials. People need evidence about what treatments are best for particular health conditions. The strongest evidence comes from systematic reviews comparing outcomes across different studies of treatments for a particular condition. However, it is often difficult to do these comparisons because the different studies—even though they have all investigated the same condition—often measure different outcomes. To tackle this problem, research teams are increasingly coming together to develop core outcome sets (COS) for particular conditions or treatments. The goal is that across the world, all the research teams working on the same condition or treatment will then use the COS in their research.Main body We report on three interactive workshops that explored how patients and the public can contribute to decision making about what outcomes should be included in a COS. About 100 international delegates, including researchers, clinicians and patients, attended the workshops. The workshops were held in the United Kingdom, Italy and Canada as part of the COMET (Core Outcome Measures in Effectiveness Trials) Initiative annual meetings. Pa...
The complexity and diversity of the needs of older people in care homes presents challenges to those responsible for caring for residents, in particular nursing and care assistant staff providing the majority of direct care. This study examines the degree of knowledge and confidence of these staff in caring for people with dementia and seeks to identify factors which can contribute to greater confidence. It reveals that although staff knowledge of dementia is reasonable, confidence in dealing with related situations is lower. Results also suggest that training can positively influence staff confidence in dealing with behaviour associated with the condition, recognizing that it is one of many factors influencing performance as a paid carer. These findings are discussed in terms of the quality of care provided to residents with dementia, the forms such training might take and the importance of a work environment which facilitates on-the-job training.Keywords dementia; care homes; long-term care; staff training, training needs analysis d e m e n t i a http://dem.sagepub.com vol 7(2) 227-238
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