Research on psychosocial interventions for dementia demonstrates increased rigour and robustness. However, if we are to influence practice, beyond results from randomised controlled trials, a variety of types and sources of evidence is needed. The Medical Research Council (MRC) framework offers a valuable guide for developing, evaluating and implementing complex interventions, to facilitate integration of research into practice. There is limited knowledge of how researchers design, evaluate and implement psychosocial intervention studies in dementia, using the MRC framework. This scoping review aims to: (1) identify the methodological and methods trends, use and gaps in the development, evaluation and implementation of psychosocial interventions for dementia, and (2) determine if and how the MRC six core elements were considered and applied in studies.
Six databases (Ovid MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, Cochrane Library) will be searched for studies published from 2015 (when MRC process guidance was published) to 2025. Identified deduplicated citations will be imported into Covidence software, where up to 40% of title/abstracts will be double screened by independent reviewers. ASReview will be used to rank articles by relevance, with a stopping criterion of 250 consecutive irrelevant articles. Full texts will be reviewed by a single reviewer and those excluded will be checked by a second reviewer. Data extraction will include study aim/objective (ie, to develop/adapt; test feasibility/pilot; evaluate; implement); methodology and methods applied; information on which MRC six core elements were considered (yes/no), and if so, how they were addressed (ie, qualitative details). A narrative synthesis, alongside graphical representations (eg, table/bar charts/histograms), will be used to synthesise findings on methodologies and methods mapped onto the MRC framework.
This secondary analysis scoping review does not require ethics approval. Results will be disseminated through peer-reviewed publication(s), seminars, webinars, conferences, postgraduate dementia programmes, blogs, commissioner briefings and social media. The findings will provide a state-of-the-art overview of current practices; advance methods/methodology such as informing a Delphi consensus study on appropriate research approaches; and guide researchers in application of the MRC framework to widen the scope of dementia care evidence for practice improvements.
Submitted to Open Science Framework https://doi.org/10.17605/OSF.IO/S56NQ.
To evaluate adherence to National Health Service (NHS) patient registration ID guidelines among General Practitioners’ (GP) practices.
A mystery shopper study, including website reviews and phone calls.
Rural and urban parts of the United Kingdom’s West Midlands.
85 randomly selected GP practices.
In January–April 2024, GP’s websites were reviewed before phone calls in which our ‘mystery shopper’ was asked to register without photo ID and proof of address.
Of 85 GP practices, 60 (71%) breached NHS guidance either online or over the phone, with only 25 (29%) consistently following NHS guidance. Phone calls to rural (vs urban) GP practices were more likely to yield refusal of registration without photo ID and proof of address, despite rural (vs urban) GP practices making similar statements online. During some phone calls, practices sought to negotiate a compromise by requesting less robust ‘documentation’, such as an addressed parcel.
GP practices commonly refuse registration to people without photo ID or proof of address, thus creating ‘sludge’ and undermining access to healthcare especially for poor, vulnerable patients, including immigrants. Changing GP practices’ websites would not address this problem if erroneous information is still provided over the phone. GPs and practice managers should ensure that all staff follow NHS guidance to allow registration without these documents.
Atopic dermatitis (AD) is a chronic, relapsing, heterogeneous skin disease affecting 2%–7% of adults, with roughly 30% having moderate-to-severe disease. AD symptoms, like intense itching and skin pain, carry a substantial disease burden that negatively impacts patients’ quality of life (QoL) and psychosocial well-being. Lebrikizumab is a novel, high-affinity monoclonal antibody that selectively binds to and neutralises interleukin-13 with high potency. Three clinical trials with lebrikizumab (ADvocate 1 and 2; ADhere) demonstrated significant clinical benefit in patients with AD, while the 3-year long-term extension study of lebrikizumab (ADjoin) further demonstrated long-term efficacy and safety in patients with AD. The ADTrust study will evaluate patient well-being, their relationship with their skin, long-term effectiveness, and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on different aspects of patients’ lives, including itch, pain, sleep, fatigue, work impairment and overall QoL among adult patients with moderate-to-severe AD in a real-world setting.
This non-interventional, prospective, observational, real-world evidence study will involve approximately 150 sites across Europe and approximately 1200 adults with moderate-to-severe AD treated with lebrikizumab for 2 years. The primary endpoint is patient well-being assessed by the 5-item WHO Well-Being Index (WHO-5) questionnaire. Key secondary endpoints include clinical effectiveness (Eczema Area and Severity Index and Investigator’s Global Assessment Scale), disease symptomatology and control (Patient-Oriented Eczema Measure, 24-hour peak pruritus, skin pain, fatigue and sleep quality Numerical Rating Scale, and safety and tolerability. Other validated endpoints will evaluate physician-reported and patient-reported QoL and treatment satisfaction (Dermatology Life Quality Index, Treatment Satisfaction Questionnaire-9), patients’ work productivity and impairment (Work Productivity and Activity Impairment (WPAI)-AD) and disease control (AD Control Tool). Novel experimental endpoints will also be evaluated with the aim to assess patients’ relationship with their skin (SkinLove questionnaire), disease control (intensity and frequency of flares) and an Effectiveness Diary+© (a brief monthly survey on a voluntary basis with the aim to assess the long-term impact of lebrikizumab on three fundamental aspects of the patients’ life: the well-being (WHO-5), the itch intensity (24 hours peak pruritus) and the frequency and intensity of flares). Statistical analyses will be descriptive and explorative and based on observed cases. Missing data imputation may be used to handle missing data for primary endpoints and secondary effectiveness endpoints.
This study will be conducted according to the protocol, which has ethics committee approval (Hamburg Ethic Committee in Germany: 2024-101358-BO-ff), and all applicable laws and regulatory requirements for each participating country. The results will be disseminated through scientific publications and congress presentations.
NCT06815380 (Pre-results).