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BACKGROUND: Different dementia support roles exist but evidence is lacking on which aspects are best, for whom, and in what circumstances, and on their associated costs and benefits. Phase 1 of the Dementia PersonAlised Care Team programme (D-PACT) developed a post-diagnostic primary care-based intervention for people with dementia and their carers and assessed the feasibility of a trial. AIM: Phase 2 of the programme aims to 1) refine the programme theory on how, when, and for whom the intervention works; and 2) evaluate its value and impact. DESIGN & SETTING: A realist longitudinal mixed-methods evaluation will be conducted in urban, rural, and coastal areas across South West and North West England where low-income or ethnic minority populations (for example, South Asian) are represented. Design was informed by patient, public, and professional stakeholder input and phase 1 findings. METHOD: High-volume qualitative and quantitative data will be collected longitudinally from people with dementia, carers, and practitioners. Analyses will comprise the following: 1) realist longitudinal case studies; 2) conversation analysis of recorded interactions; 3) statistical analyses of outcome and experience questionnaires; 4a) health economic analysis examining costs of delivery; and 4b) realist economic analysis of high-cost events and 'near misses'. All findings will be synthesised using a joint display table, evidence appraisal tool, triangulation, and stakeholder co-analysis. CONCLUSION: The realist evaluation will describe how, why, and for whom the intervention does or does not lead to change over time. It will also demonstrate how a non-randomised design can be more appropriate for complex interventions with similar questions or populations.
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OBJECTIVES: Penicillin allergy records are often incorrect and may result in harm. We aimed to systematically review the effectiveness and safety of nonallergist health care worker delivery of penicillin allergy delabeling. METHODS: We searched EMBASE/MEDLINE/CINAHL (Ovid), PsycInfo, Web of Science, and Cochrane CENTRAL from inception to January 21, 2022 and unpublished studies and gray literature. The proportion of patients allergic to penicillin delabeled and harmed was calculated using random-effects models. RESULTS: Overall, 5019 patients were delabeled. Using allergy history alone, 14% (95% confidence interval [CI], 9-21%) of 4350 assessed patients were delabeled without reported harm. Direct drug provocation testing resulted in delabeling in 27% (95% CI, 18-37%) of 4207 assessed patients. Of the 1373 patients tested, 98% were delabeled (95% CI, 97-99%), and nonserious harm was reported in 1% (95% CI, 0-2%). Using skin testing, followed by drug provocation testing, 41% (95% CI, 24-59%) of 2890 assessed patients were delabeled. Of the 1294 tested patients, 95.0% (95% CI, 90-99%) were delabeled, and the reported harm was low (0%; (95% CI 0-1%). CONCLUSION: Penicillin allergy delabeling by nonallergists is efficacious and safe. The proportion of assessed patients who can be delabeled increases with the complexity of testing method, but substantial numbers can be delabeled without skin testing.