Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an oral healthcare intervention after stroke

<p>Abstract</p> <p>Background</p> <p>Many interventions delivered within the stroke rehabilitation setting could be considered complex, though some are more complex than others. The degree of complexity might be based on the number of and interactions between levels, components and actions targeted within the intervention. The number of (and variation within) participant groups and the contexts in which it is delivered might also reflect the extent of complexity. Similarly, designing the evaluation of a complex intervention can be challenging. Considerations include the necessity for intervention standardisation, the multiplicity of outcome measures employed to capture the impact of a multifaceted intervention and the delivery of the intervention across different clinical settings operating within varying healthcare contexts. Our aim was to develop and evaluate the implementation of a complex, multidimensional oral health care (OHC) intervention for people in stroke rehabilitation settings which would inform the development of a randomised controlled trial.</p> <p>Methods</p> <p>After reviewing the evidence for the provision of OHC following stroke, multi-disciplinary experts informed the development of our intervention. Using both quantitative and qualitative methods we evaluated the implementation of the complex OHC intervention across patients, staff and service levels of care. We also adopted a pragmatic approach to patient recruitment, the completion of assessment tools and delivery of OHC, alongside an attention to the context in which it was delivered.</p> <p>Results</p> <p>We demonstrated the feasibility of implementing a complex OHC intervention across three levels of care. The complementary nature of the mixed methods approach to data gathering provided a complete picture of the implementation of the intervention and a detailed understanding of the variations within and interactions between the components of the intervention. Information on the feasibility of the outcome measures used to capture impact across a range of components was also collected, though some process orientated uncertainties including eligibility and recruitment rates remain to be further explored within a Phase II exploratory trial.</p> <p>Conclusions</p> <p>Complex interventions can be captured and described in a manner which facilitates evaluation in the form of exploratory and subsequently definitive clinical trials. If effective, the evidence captured relating to the intervention context will facilitate translation into clinical practice.</p

Development of a European consensus from dentists, dental hygienists and physicians on a standard for oral health care in care-dependent older people: An e-Delphi study

Objectives: This study aimed to obtain a consensus on oral health policy, access to dental care, oral hygiene measures and training levels. Background: Poor oral health is widespread in care-dependent older people, but no consensus for a minimum standard of oral health care exists yet. Methods: The e-Delphi approach was applied to a selected panel of interdisciplinary experts. Data analysis was based on three measurements: (a) ≥70% of experts’ opinion fall into category “agree or strongly agree,” (b) median score on the 5-point Likert scale ≥4, (c) interquartile range ≤1. Results: A total of 31 experts from 17 European countries participated in this survey. Agreement was achieved for a compulsory dental examination when an elder is admitted to a long-term care (LTC) facility. Older people should brush their teeth twice/day and regularly clean interproximal spaces and oral mucosa. Dentures should be rinsed after meals and cleaned twice/day. The use of denture cleansing tablets was considered necessary. Dentures should be removed before sleeping and stored dry. A 5000&nbsp;ppm fluoride toothpaste should be applied daily in elder with high caries risk. A short report on the oral health status of the elder should be included in the geriatric assessment. All experts concluded that the knowledge and the training in oral health care for caregivers and family members of care-dependent older people were imperative. Conclusions: Using the e-Delphi method, multidisciplinary healthcare professionals from different countries agreed on certain cardinal recommendations for a standard oral health care for care-dependent older people. © 2020 Gerodontology Association and John Wiley &amp; Sons Lt