Search

Background: Parents commonly ask about food allergy tests, to find a cause for their child's eczema, yet the value of routine testing is uncertain., Objective: To determine whether a clinical trial comparing test-guided dietary advice versus usual care, for the management of eczema, is feasible., Methods: Children (>3 months and <5 years) with mild-to-severe eczema, recruited via primary care, were individually randomized (1:1) to intervention or usual care. Intervention participants underwent structured allergy history and skin prick tests (SPT) with dietary advice for cow's milk, hen's egg, wheat, peanut, cashew and codfish. All participants were followed up for 24 weeks. A sample of doctors and parents was interviewed. Registration ISRCTN15397185., Results: From 1059 invitation letters sent to carers of potentially eligible children, 84 were randomized (42 per group) with mean age of 32.4 months (SD 13.9) and POEM of 8.7 (4.8). Of the 42, 6 (14%) intervention participants were advised to exclude one or more foods, most commonly egg, peanut or milk. By participant, 1/6 had an oral food challenge (negative); 3/6 were told to exclude until review in allergy clinic; and 6/6 advised a home dietary trial (exclusion and reintroduction of food over 4-6 weeks) - with 1/6 partially completing it. Participant retention (four withdrawals) and data completeness (74%-100%) were acceptable and contamination low (two usual care participants had allergy tests). There were three minor SPT-related adverse events. During follow-up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission., Conclusions: It is possible to recruit, randomize and retain children with eczema from primary care into a trial of food allergy screening and to collect the outcomes of interest. Changes to recruitment and inclusion criteria are needed in a definitive trial, to ensure inclusion of younger children from more diverse backgrounds., (© 2021 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.)

Aim: To explore parent and general practitioner (GP) understanding and beliefs about food allergy testing for children with eczema., Design and Setting: Qualitative interview study in UK primary care within the Trial of Eczema allergy Screening Tests feasibility trial., Participants: Semi-structured interviews with parents of children with eczema taking part in the feasibility study and GPs at practices hosting the study., Results: 21 parents and 11 GPs were interviewed. Parents discussed a range of potential causes for eczema, including a role for food allergy. They believed allergy testing to be beneficial as it could potentially identify a cure or help reduce symptoms and they found negative tests reassuring, suggesting to them that no dietary changes were needed. GPs reported limited experience and uncertainty regarding food allergy in children with eczema. While some GPs believed referral for allergy testing could be appropriate, most were unclear about its utility. They thought it should be reserved for children with severe eczema or complex problems but wanted more information to advise parents and help guide decision making., Conclusions: Parents' motivations for allergy testing are driven by the desire to improve their child's condition and exclude food allergy as a possible cause of symptoms. GPs are uncertain about the role of allergy testing and want more information about its usefulness to support parents and help inform decision making., Trial Registration Number: ISRCTN15397185., Competing Interests: Competing interests: MJR: No financial interests; convenes the NIHR SPCR Allergy working group; and was a member of theNational Institute for Health and Care Excellence (NICE) Quality Standard 44 for Atopic eczema in under 12s and RCPCH ‘Care pathway for children with eczema’ groups. RB has received honoraria for participating in advisory boards for ALK-Abello who manufacture allergy diagnostics and treatments, and DBV technologies and Prota therapeutics who develop food allergy treatments. RB has undertaken expert witness work in legal cases concerning food anaphylaxis or infant formula health claims., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Objectives: During a cluster randomised trial, (the 3D study) of an intervention enacting recommended care for people with multimorbidity, including continuity of care and comprehensive biennial reviews, we examined implementation fidelity to interpret the trial outcome and inform future implementation decisions., Design: Mixed-methods process evaluation using cross-trial data and a sample of practices, clinicians, administrators and patients. Interviews, focus groups and review observations were analysed thematically and integrated with quantitative data about implementation. Analysis was blind to trial outcomes and examined context, intervention adoption, reach and maintenance, and delivery of reviews to patients., Setting: Thirty-three UK general practices in three areas., Participants: The trial included 1546 people with multimorbidity. 11 general practitioners, 14 nurses, 7 administrators and 38 patients from 9 of 16 intervention practices were sampled for an interview., Results: Staff loss, practice size and different administrative strategies influenced implementation fidelity. Practices with whole administrative team involvement and good alignment between the intervention and usual care generally implemented better. Fewer reviews than intended were delivered (49% of patients receiving both intended reviews, 30% partially reviewed). In completed reviews >90% of intended components were delivered, but review observations and interviews with patients and clinicians found variation in style of component delivery, from 'tick-box' to patient-centred approaches. Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns., Conclusions: Implementation failure contributed to lack of impact of the 3D intervention on the trial primary outcome (quality of life), but so did intervention failure since modifiable elements of intervention design were partially responsible. When a decisive distinction between implementation failure and intervention failure cannot be made, identifying potentially modifiable reasons for suboptimal implementation is important to enhance potential for impact and effectiveness of a redesigned intervention., Trial Registration Number: ISRCTN06180958., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Atopic dermatitis/eczema affects around 20% of children and is characterised by inflamed, dry, itchy skin. Guidelines recommend 'leave-on' emollients that are applied directly to the skin to add or trap moisture and used regularly, they can soothe, enhance the skin barrier and may prevent disease 'flares'. However, the suitability of the many different emollients varies between people and there is little evidence to help prescribers and parents and carers decide which type to try first., Methods and Analysis: Design: pragmatic, multicentre, individually randomised, parallel group superiority trial of four types of emollient (lotions, creams, gel or ointments)., Setting: general practitioner surgeries in England., Participants: children aged over 6 months and less than 12 years with mild-to-severe eczema and no known sensitivity to study emollients., Interventions: study-approved lotion, cream, gel or ointment as the only leave-on emollient for 16 weeks, with directions to apply twice daily and as required. Other treatments, such as topical corticosteroids, used as standard care., Follow-Up: 52 weeks., Primary Outcome: validated patient-orientated eczema measure measured weekly for 16 weeks., Secondary Outcomes: eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact)., Sample Size: 520 participants (130 per group)., Analysis: intention-to-treat using linear mixed models for repeated measures.Nested qualitative study: audio-recording of sample of baseline appointments and up to 60 interviews with participants at 4 and 16 weeks, interviews to be transcribed and analysed thematically., Ethics and Dissemination: Ethics approval granted by the NHS REC (South West - Central Bristol Research Ethics Committee 17/SW/0089). Findings will be presented at conferences, published in open-access peer-reviewed journals and the study website; and summaries shared with key stakeholders., Trial Registration Number: ISRCTN84540529., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To explore what factors shape a service user's decision to call an emergency ambulance for a 'primary care sensitive' condition (PCSC), including contextual factors. Additionally, to understand the function and purpose of ambulance care from the perspective of service users, and the role health professionals may play in influencing demand for ambulances in PCSCs., Design: An ethnographic study set in one UK ambulance service. Patient cases were recruited upon receipt of ambulance treatment for a situation potentially manageable in primary care, as determined by a primary care clinician accompanying emergency medical services (EMS) crews. Methods used included: structured observations of treatment episodes; in-depth interviews with patients, relatives and carers and their GPs; purposeful conversations with ambulance clinicians; analysis of routine healthcare records; analysis of the original EMS 'emergency' telephone call recording., Results: We analysed 170 qualitative data items across 50 cases. Three cross-cutting concepts emerged as central to EMS use for a PCSC: (1) There exists a typology of nine 'triggers', which we categorise as either 'internal' or 'external', depending on how much control the caller feels they have of the situation; (2) Calling an ambulance on behalf of someone else creates a specific anxiety about urgency; (3) Healthcare professionals experience conflict around fuelling demand for ambulances., Conclusions: Previous work suggests a range of sociodemographic factors that may be associated with choosing ambulance care in preference to alternatives. Building on established sociological models, this work helps understand how candidacy is displayed during the negotiation of eligibility for ambulance care. Seeking urgent assistance on behalf of another often requires specific support and different strategies. Use of EMS for such problems-although inefficient-is often conceptualised as 'rational' by service users. Public health strategies that seek to advise the public about appropriate use of EMS need to consider how individuals conceptualise an 'emergency' situation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Background: Early onset eczema is associated with food allergy, and allergic reactions to foods can cause acute exacerbations of eczema. Parents often pursue dietary restrictions as a way of managing eczema and seek allergy testing for their children to guide dietary management. However, it is unclear whether test-guided dietary management improves eczema symptoms, and whether the practice causes harm through reduced use of conventional eczema treatment or unnecessary dietary restrictions. The aim of the Trial of Eczema allergy Screening Tests Study is to determine the feasibility of conducting a trial comparing food allergy testing and dietary advice versus usual care, for the management of eczema in children., Methods and Analysis: Design: A single centre, two-group, individually randomised, feasibility randomised controlled trial (RCT) with economic scoping and a nested qualitative study., Setting: General Practioner (GP) surgeries in the west of England., Participants: children aged over 3 months and less than 5 years with mild to severe eczema., Interventions: allergy testing (structured allergy history and skin prick tests) or usual care. Sample size and outcome measures: we aim to recruit 80 participants and follow them up using 4-weekly questionnaires for 24 weeks. Nested qualitative study: We will conduct ~20 interviews with parents of participating children, 5-8 interviews with parents who decline or withdraw from the trial and ~10 interviews with participating GPs. Economic scoping: We will gather data on key costs and outcomes to assess the feasibility of carrying out a cost-effectiveness analysis in a future definitive trial., Ethics and Dissemination: The study has been reviewed by the Health Research Authority and given a favourable opinion by the NHS REC (West Midlands - South Birmingham Research Ethics Committee, Reference Number 18/WM/0124). Findings will be submitted for presentation at conferences and written up for publication in peer-reviewed journals, which may include mixed-method triangulation and integration of the quantitative and qualitative findings., Trial Registration: ISRCTN15397185; Pre-results., Competing Interests: Competing interests: MJR: No financial interests; convenes the NIHR SPCR Allergy working group; and was a member of the NICE Quality Standard 44 for Atopic eczema in under 12s and RCPCH “Care pathway for children with eczema” groups. LW: Direct – financial: write articles, attend round table infant formula company meetings and present at sponsored lectures relating to food allergy; received infant formula company sponsorship to attend national/international allergy related conferences/ meetings. Runs a private practice (Food Allergy Nottingham Service Ltd, 2013-) in addition to NHS role (Feb 2012-). BDA cow’s milk allergy course facilitator (2018-). Direct – non-financial: member of RCPCH faculty for tier 3 paediatric allergy course (2018-); member of Allergy UK health advisory board (2015-); member of iMAP implementation team (2017-); produce food allergy related dietary information for BDA food allergy group (2014-); NICE Expert adviser relating to paediatric food allergy and gastro-oesophageal reflux (2017-2020); previous member of NICE food allergy guidelines GDG and RCPCH food allergy care pathway (2010-2011). RJB has received honoraria for participating in advisory boards for ALK-Abello who manufacture allergy diagnostics and treatments, and DBV technologies who manufacture a food allergy treatment., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To explore common features of conversations occurring in a sample of emergency calls that result in an ambulance dispatch for a 'primary care sensitive' situation, and better understand the challenges of triaging this cohort., Design: A qualitative study, applying conversation analytic methods to routinely recorded telephone calls made through the '999' system for an emergency ambulance. Cases were identified by a primary care clinician, observing front-line UK ambulance service shifts. A sample of 48 '999' recordings were analysed, corresponding to situations potentially amenable to primary care management., Results: The analysis focuses on four recurring ways that speakers use talk in these calls. Progress can be impeded when call-taker's questions appear to require callers to have access to knowledge that is not available to them. Accordingly, callers often provide personal accounts of observed events, which may be troublesome for call-takers to 'code' and triage. Certain question formats-notably 'alternative question' formats-appear particularly problematic. Callers deploy specific lexical, grammatical and prosodic resources to legitimise the contact as 'urgent', and ensure that their perception of risk is conveyed. Difficulties encountered in the triage exchange may be evidence of misalignment between organisational and caller perceptions of the 'purpose' of the questions., Conclusions: Previous work has focused on exploring the presentation and triage of life-threatening medical emergencies. Meaningful insights into the challenges of EMS triage can also be gained by exploring calls for 'primary care sensitive' situations. The highly scripted triage process requires precise, 'codeable' responses to questions, which can create challenges when the exact urgency of the problem is unclear to both caller and call-taker. Calling on behalf of someone else may compound this complexity. The aetiology of some common interactional challenges may offer a useful frame for future comparison between calls for 'primary care sensitive' situations and life-threatening emergencies., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.)

Background: The recruitment and retention of patients are significant methodological challenges for trials. Whilst research has focussed on recruitment, the failure to retain recruited patients and collect outcome data can lead to additional problems and potentially biased results. Research to identify effective retention strategies has focussed on influencing patient behaviour through incentives, reminders and alleviating patient burden, but has not sought to improve patient understanding of the importance of retention. Our aim is to assess how withdrawal, retention and the value of outcome data collection is described within the Patient Information Leaflets (PIL) used during consent., Methods: Fifty adult or parent PIL from a cohort of trials starting between 2009-2012 and funded by the NIHR Health Technology Assessment programme were obtained from protocols, websites or by contacting trialists. A checklist of PIL content based on Health Research Authority (HRA) and ICH GCP Guidelines was supplemented with retention specific questions. Corresponding protocols were also evaluated to cross reference trial specific procedures with information communicated to patients., Results: PIL frequently reiterated the patient's right to withdraw at any time (n = 49, 98%), without having to give a reason and without penalty (n = 45, 90%). However, few informed patients they may be asked to give a withdrawal reason where willing (n = 6, 12%). Statements about the value of retention were infrequent (n = 8, 16%). Consent documents failed to include key content that might mitigate withdrawals, such as the need for treatment equipoise (n = 3, 6%). Nearly half the trials in the cohort (n = 23, 46%) wanted to continue to collect outcome data if patients withdraw. However, in 70% of PIL using prospective consent, withdrawal was described in generic terms leaving patients unaware of the difference between stopping treatment and all trial involvement. Nineteen (38%) trials offered withdrawing patients the option to delete existing data., Conclusions: Withdrawal and retention is poorly described within PIL and addressing this might positively impact levels of patient attrition, reducing missing data. Consent information is unbalanced, focussing on patient's rights to withdraw without accompanying information that promotes robust consent and sustained participation. With many citing altruistic reasons for participation it is essential that PIL include more information on retention and clarify withdrawal terminology so patients are aware of how they can make a valuable contribution to clinical studies. There is a need to determine how retention can be described to patients to avoid concerns of coercion. Future research is needed to explore whether the absence of information about retention at the time of consent is impacting attrition., Competing Interests: The authors have declared that no competing interests exist.

Objectives: Recent evidence has highlighted the high prevalence and impact of multimorbidity, but the evidence base for improving management is limited. We have tested a new complex intervention for multimorbidity (the 3D model). The paper describes the baseline characteristics of practices and patients in order to establish the external validity of trial participants. It also explores current 'usual primary care' for multimorbidity, against which the 3D intervention was tested., Design: Analysis of baseline data from patients in a cluster-randomised controlled trial and additional data from practice staff., Setting: Primary care in the UK., Participants: Patients with multimorbidity (n=5253) and 154 practice staff., Primary and Secondary Outcome Measures: Using surveys and routinely available data, we compared the characteristics of participating and non-participating practices and participating and non-participating eligible patients.Baseline questionnaire data from patient participants was used to examine participant illness burden, treatment burden and perceptions of receiving patient-centred care. We obtained data about usual care preintervention from practice staff using questionnaires and a structured pro forma., Results: Participating practices were slightly larger, in less deprived areas, and with slightly higher scores for patient satisfaction compared with non-participating practices. Patients with dementia or learning difficulties were likely to be excluded by their general practitioners, but comparison of participants with non-participants identified only minor differences in characteristics, suggesting that the sample was otherwise representative. Patients reported substantial illness burden, and an important minority reported high treatment burden. Although patients reported relatively high levels of satisfaction with care, many reported not having received potentially important components of care., Conclusion: This trial achieved good levels of external validity. Although patients were generally satisfied with primary care services, there was significant room for improvement in important aspects of care for multimorbidity that are targeted by the 3D intervention., Trial Registration Number: ISRCTN06180958; Post-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.)

Background: The failure to retain patients or collect primary-outcome data is a common challenge for trials and reduces the statistical power and potentially introduces bias into the analysis. Identifying strategies to minimise missing data was the second highest methodological research priority in a Delphi survey of the Directors of UK Clinical Trial Units (CTUs) and is important to minimise waste in research. Our aim was to assess the current retention practices within the UK and priorities for future research to evaluate the effectiveness of strategies to reduce attrition., Methods: Seventy-five chief investigators of NIHR Health Technology Assessment (HTA)-funded trials starting between 2009 and 2012 were surveyed to elicit their awareness about causes of missing data within their trial and recommended practices for improving retention. Forty-seven CTUs registered within the UKCRC network were surveyed separately to identify approaches and strategies being used to mitigate missing data across trials. Responses from the current practice surveys were used to inform a subsequent two-round Delphi survey with registered CTUs. A consensus list of retention research strategies was produced and ranked by priority., Results: Fifty out of seventy-five (67%) chief investigators and 33/47 (70%) registered CTUs completed the current practice surveys. Seventy-eight percent of trialists were aware of retention challenges and implemented strategies at trial design. Patient-initiated withdrawal was the most common cause of missing data. Registered CTUs routinely used newsletters, timeline of participant visits, and telephone reminders to mitigate missing data. Whilst 36 out of 59 strategies presented had been formally or informally evaluated, some frequently used strategies, such as site initiation training, have had no research to inform practice. Thirty-five registered CTUs (74%) participated in the Delphi survey. Research into the effectiveness of site initiation training, frequency of patient contact during a trial, the use of routinely collected data, the frequency and timing of reminders, triggered site training and the time needed to complete questionnaires was deemed critical. Research into the effectiveness of Christmas cards for site staff was not of critical importance., Conclusion: The surveys of current practices demonstrates that a variety of strategies are being used to mitigate missing data but with little evidence to support their use. Six retention strategies were deemed critically important within the Delphi survey and should be a primary focus of future retention research.

Objectives: To understand the reasons behind, and experience of, seeking and receiving emergency ambulance treatment for a 'primary care sensitive' condition., Design: A comprehensive, qualitative systematic review. Medline, Embase, PsychInfo, Cumulative Index of Nursing and Allied Health, Health Management Information Systems, Healthcare Management Information Consortium, OpenSigle, EThOS and Digital Archive of Research Theses databases were systematically searched for studies exploring patient, carer or healthcare professional interactions with ambulance services for 'primary care sensitive' problems. Studies using wholly qualitative approaches or mixed-methods studies with substantial use of qualitative techniques in both the methods and analysis sections were included. An analytical thematic synthesis was undertaken, using a line-by-line qualitative coding method and a hierarchical inductive approach., Results: Of 1458 initial results, 33 studies met the first level (relevance) inclusion criteria, and six studies met the second level (methodology and quality) criteria. The analysis suggests that patients define situations worthy of 'emergency' ambulance use according to complex socioemotional factors, as well as experienced physical symptoms. There can be a mismatch between how patients and professionals define 'emergency' situations. Deciding to call an ambulance is a process shaped by practical considerations and a strong emotional component, which can be influenced by the views of caregivers. Sometimes the value of a contact with the ambulance service is principally in managing this emotional component. Patients often wish to hand over responsibility for decisions when experiencing a perceived emergency. Feeling empowered to take control of a situation is a highly valued aspect of ambulance care., Conclusions: When responding to a request for 'emergency' help for a low-acuity condition, urgent-care services need to be sensitive to how the patient's emotional and practical perception of the situation may have shaped their decision-making and the influence that carers may have had on the process. There may be novel ways to deliver some of the valued aspects of urgent care, more geared to the resource-limited environment., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background/objectives: There are some older patients who are 'at the decision margin' of admission. This systematic review sought to explore this issue with the following objective: what admission alternatives are there for older patients and are they safe, effective and cost-effective? A secondary objective was to identify the characteristics of those older patients for whom the decision to admit to hospital may be unclear., Design: Systematic review of controlled studies (April 2005-December 2016) with searches in Medline, Embase, Cinahl and CENTRAL databases. The protocol is registered at PROSPERO (CRD42015020371). Studies were assessed using Cochrane risk of bias criteria, and relevant reviews were assessed with the AMSTAR tool. The results are presented narratively and discussed., Setting: Primary and secondary healthcare interface., Participants: People aged over 65 years at risk of an unplanned admission., Interventions: Any community-based intervention offered as an alternative to admission to an acute hospital., Primary and Secondary Outcomes Measures: Reduction in secondary care use, patient-related outcomes, safety and costs., Results: Nineteen studies and seven systematic reviews were identified. These recruited patients with both specific conditions and mixed chronic and acute conditions. The interventions involved paramedic/emergency care practitioners (n=3), emergency department-based interventions (n=3), community hospitals (n=2) and hospital-at-home services (n=11). Data suggest that alternatives to admission appear safe with potential to reduce secondary care use and length of time receiving care. There is a lack of patient-related outcomes and cost data. The important features of older patients for whom the decision to admit is uncertain are: age over 75 years, comorbidities/multi-morbidities, dementia, home situation, social support and individual coping abilities., Conclusions: This systematic review describes and assesses evidence on alternatives to acute care for older patients and shows that many of the options available are safe and appear to reduce resource use. However, cost analyses and patient preference data are lacking., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)