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Abstract In the evolving landscape of older person care, the imperative to explore holistic approaches persists, especially in regions with distinct societal norms around informal caregiving. The deeply ingrained tradition of familial caregiving, often led by female family members, has historically compensated for healthcare system gaps in less integrated systems. Hence, societal expectations may affect registered nurses’ experiences and impact the quality of care for older persons. This study aims to describe the meaning of caring for older persons in care settings in Greece. Ten in-depth interviews with registered nurses in older person care settings underwent qualitative thematic analysis. Four themes emerged from the analysis: (i) Living and bonding with older people as a basis for caring, (ii) Caring as a double-faced fulfillment, (iii) A sense of insufficiency in the caring relationship, and (iv) The encounter of existential issues creating loneliness. This research provides insights into the meaning of caring for older persons, highlighting the experiences of the closest professional caregivers of older individuals. A specific capture of the entanglement of cultural norms, societal expectations, and their impact on professional caregivers’ experiences may contribute to quality care provision in systems rooted in familial caregiving traditions.

Objective To codesign a theoretically underpinned, healthcare practitioner-mediated, tailored intervention to support housebound older patients and their lay carers to adopt pressure ulcer prevention behaviours.Design Theoretical domains framework informed codesign.Setting One geographical area in the UK, spanning several community National Health Service Trusts.Participants Community-dwelling older patients at risk of pressure ulcer development and their lay carers (n=4) and health practitioners (n=6) providing related care.Results Codesigners addressed five identified barriers to pressure ulcer prevention, knowledge and beliefs about consequences, social or professional role and influence, motivation and priorities, emotion and environment. Prioritised intervention components were (1) making every contact count, all health and social care workers to be conversant with basic prevention behaviours and to support and reiterate these at every visit (9.1/10), (2) signposting of existing support groups and sitting services (8.4/10), (3) accessible, timely, trustable and relatable written information including the role of patients, carers and staff in prevention and links to other resources (7.7/10) and (4) supporting close family involvement in some of the practical elements of care (5.6/10).Conclusions Our study sought to codesign a practitioner-mediated, tailored intervention to support housebound older patients and their lay carers to adopt pressure ulcer prevention behaviours. The process of barrier identification and selection of behaviour change techniques for intervention components was theoretically informed. However, further development will be needed to refine the prototype intervention to take into account the complexity of multiple health needs and priorities of patients. The principles of this study are likely to be transferable to similar national and international contexts.

Abstract Background Cellulitis is a painful infection of the skin and underlying tissues, commonly affecting the lower leg. Approximately one‐third of people experience recurrence. Nurses who work in general practice (practice nurses) and see people at home (community or district nurses) could have an important role in managing risk factors for cellulitis, such as long‐term leg swelling, wound care and skin care. Objective To explore practice and community nurses' views and experiences of helping people to manage risk factors for recurrent lower limb cellulitis. Methods Semi‐structured, telephone interviews with 21 practice and community nurses in England from October 2020 to March 2021. Interviews were transcribed verbatim and analysed using reflexive thematic analysis. Results Nurses face multiple challenges when supporting people to manage risk factors for recurrent lower limb cellulitis. Key challenges include limited time and access to resources such as Doppler equipment, and the physical and psychosocial capabilities of patients to self‐manage. Nurses identified potential strategies to overcome these challenges, such as placing greater emphasis on prevention and supporting self‐management by providing resources for patients and support networks (paid and unpaid carers) to reinforce knowledge post‐consultation and develop skills to self‐care. Conclusions We identified a need to develop and evaluate resources, such as support materials, for nurses to use to help patients reduce their risk of recurrent cellulitis.

Background Hand eczema is common and a cause of morbidity and occupational disability. When education, irritant/contact allergen avoidance, moisturisation and topical corticosteroids are insufficient to control chronic hand eczema, ultraviolet therapy or systemic immune-modifying drugs are used. There is no treatment pathway generally accepted by UK dermatologists. Primary objective Compare alitretinoin and ultraviolet therapy as first-line therapy in terms of disease activity at 12 weeks post planned start of treatment. Design Prospective, multicentre, open-label, two-arm parallel group, adaptive randomised controlled trial with one planned interim analysis, and an economic evaluation. Setting UK secondary care dermatology outpatient clinics. Participants Patients with severe chronic hand eczema unresponsive to at least 4 weeks of treatment with potent topical corticosteroids. Primary end point Natural logarithm of the Hand Eczema Severity Index + 1, 12 weeks post planned start of treatment. Randomisation Participants randomised 1 : 1 by minimisation to alitretinoin or ultraviolet therapy for 12 to 24 weeks. Blinding Blinded primary end-point assessor. Results Intention-to-treat population: 441 (100.0%) participants; 220 (49.9%) alitretinoin and 221 (50.1%) ultraviolet therapy. At least one dose was received by 212 (96.4%) alitretinoin and 196 (88.7%) ultraviolet therapy participants. Primary outcome The unadjusted median (interquartile range) relative change in hand eczema severity index at 12 weeks was 30% (10–70%) of that at baseline for alitretinoin compared with 50% (20–100%) for ultraviolet therapy. There was a statistically significant benefit of alitretinoin compared with ultraviolet therapy at 12 weeks, with an estimated fold change or relative difference (95% confidence interval) = 0.66 (0.52 to 0.82), p = 0.0003 at 12 weeks. There was no evidence of a difference at 24 or 52 weeks, with the estimated fold change (95% confidence interval) equal to 0.92 (0.798 to 1.08) and 1.27 (0.97 to 1.67), respectively. Primary analysis results were consistent for secondary end points Fifty-nine per cent allocated to alitretinoin and 61% allocated to ultraviolet therapy achieved a clear/almost clear assessment during the trial period. Differential treatment compliance observed: 145 (65.9%) alitretinoin and 53 (24.0%) ultraviolet therapy participants confirmed compliance (≥ 80% received, no treatment breaks > 7 days during first 12 weeks). High levels of missing data were observed. Safety One hundred and thirty-five reportable adverse events across 79 participants, 55 (25.0%) alitretinoin and 24 (10.9%) ultraviolet therapy. Four serious adverse events (two alitretinoin, two ultraviolet therapy). Four pregnancies reported (three alitretinoin, one ultraviolet therapy). No new safety signals were detected. Conclusion As a first-line therapy, alitretinoin showed more rapid improvement and superiority to ultraviolet therapy at week 12. This difference was not observed at later time points. Alitretinoin is cost-effective at weeks 12 and 52. Ultraviolet therapy is cost-effective after 10 years, with a high degree of uncertainty. Hand eczema severity index may be a useful primary outcome measure for hand eczema trials; ALPHA results will inform future trials. Limitations Treatment compliance was poor for ultraviolet therapy. Regular twice weekly treatment was not received by most patients. Assessment of long-term effects of randomised treatments was complicated by use of second-line treatments post treatment phase. Further work Further analysis of substudies and pilot data will provide valuable information for future studies. A clear need for better therapeutic approaches for severe chronic hand eczema remains. Future studies will need to further address long-term benefits of treatments given. Trial registration This trial is registered as ISRCTN80206075. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/186/01) and is published in full in Health Technology Assessment; Vol. 28, No. 59. See the NIHR Funding and Awards website for further award information. Plain language summary What was the question? The main question was which treatment was better at easing symptoms of severe hand eczema after 12 weeks. The two treatments compared were ones used most often by UK dermatologists. The first is a tablet called alitretinoin, which is taken once a day. The second is called ultraviolet therapy, where hands are soaked in a special liquid and placed under ultraviolet light twice a week at a hospital. What did we do? We treated 220 patients with alitretinoin and 221 patients with ultraviolet therapy. Patients received treatment for 12 to 24 weeks depending on how well their hand eczema responded. Patients could have different treatments afterwards, and we collected information on their hand eczema symptoms for up to 1 year. What did we find? After 12 weeks, severe hand eczema symptoms improved for both groups of patients but improved most for patients who took alitretinoin. However, 1 year after joining the trial, there was no evidence of a difference between alitretinoin and ultraviolet therapy as a first-line treatment. More patients stopped ultraviolet therapy early compared with patients who received alitretinoin. Different treatments may have been prescribed after the first treatment. What does this mean? Alitretinoin provides a convenient, instant relief or a ‘quick fix’ for patients with severe hand eczema. Alitretinoin is more convenient for lots of people, but it is important to have other options available for people who would prefer not to, or are unable to, take alitretinoin. For example, people who take alitretinoin can experience unwanted side effects, and people who are able to become pregnant must also use contraception. Long-term control of severe hand eczema is important. Individual discussions on the pros and cons of each treatment for hand eczema symptoms is needed. Providing flexible options to attend ultraviolet therapy appointments could be helpful (e.g. weekend/evenings). Scientific summary Background Hand eczema (HE) is common and an important cause of morbidity and occupational disability. One-year prevalence of HE is up to 10% in the general population, with 5–7% developing chronic hand eczema (CHE). Current evidence is not compelling enough to guide clinical practice. When patient education, irritant/contact allergen avoidance, moisturisation and topical corticosteroids are insufficient to control CHE, ultraviolet therapy (PUVA) or systemic immune-modifying drugs are used. There is no treatment pathway generally accepted among UK dermatologists. Most UK dermatology centres use phototherapy (mostly Immersion PUVA) or alitretinoin as first-line treatment for uncontrolled CHE. ALPHA is the first trial comparing alitretinoin with Immersion PUVA as a first-line therapy for patients with uncontrolled severe CHE. Objectives Primary objective Compare alitretinoin and Immersion PUVA as first-line therapy in terms of disease activity at 12 weeks post planned start of treatment. Secondary objectives Compare alitretinoin and Immersion PUVA in terms of disease activity over time (focusing on 24 and 52 weeks post planned start of treatment). Compare alitretinoin and Immersion PUVA in terms of time to relapse. Compare alitretinoin and Immersion PUVA in terms of quality of life (QoL) and patient benefit over 52 weeks post planned start of treatment. Determine cost-effectiveness of alitretinoin compared with Immersion PUVA over the short and longer term. Determine the educational need for patients. Compare alitretinoin and Immersion PUVA in terms of safety. Exploratory objectives included subgroup analyses to assess whether treatment response is affected by pre-specified baseline characteristics. Methods Design Prospective, multicentre, open-label, two-arm parallel group, adaptive randomised controlled trial with one planned interim analysis and an economic evaluation. Participants Patients with severe CHE unresponsive to at least 4 weeks of treatment with potent topical corticosteroids. Primary end point Natural logarithm of the Hand Eczema Severity Index (HECSI) + 1 at 12 weeks post planned start of treatment. Secondary end points Disease activity, measured by HECSI, modified Total Lesion Scoring System (mTLSS) and Physician’s Global Assessment (PGA) at 12, 24, 52 weeks post planned start of treatment. Time to relapse, defined as time between achieving clear/almost clear overall on the blinded assessor PGA and scoring 75% of their baseline HECSI, with sensitivity assessed by redefining relapse as 50% of their baseline HECSI. Dermatology Life Quality Index (DLQI) and Patient Benefit Index for Hand Eczema (PBI-HE) at 12, 24 and 52 weeks post planned start of treatment. Person-Centred Dermatology Self-Care Index (PeDeSi) at 12 and 52 (or 24) weeks post planned start of treatment. Reported adverse events (AEs) and serious adverse events (SAEs) over 52 weeks post planned start of treatment. Cost-effectiveness of alitretinoin compared with Immersion PUVA at week 12, 52 (short term) and over 10 years (long term). Randomisation Participants were randomised using minimisation 1 : 1 to alitretinoin 30 mg/day or Immersion PUVA for 12 weeks to 24 weeks. Randomisation factors were: randomising site, disease duration, clinical phenotype, atopy status, DLQI and skin type. Analysis Linear mixed models accounting for the longitudinal data structure were fitted to primary (HECSI) and secondary end points (mTLSS, DLQI) on the intention-to-treat (ITT) population, with adjustment for: smoking history, body mass index (BMI), foot involvement, baseline score, time since planned start of treatment and treatment group. Participant and participant–time interaction were fitted as random effects. An ordinal logistic mixed model was fitted to the PGA, and an ordinal logistic model without random effects was fitted to the PeDeSI at 12 weeks. Exploratory analyses explored differential treatment effects in pre-planned subgroups, correlation of scoring systems and second-line therapies, and safety data were summarised. Total cost and quality-adjusted life-years (QALYs) were estimated at weeks 12, 52, and 10 years after treatment initiation. The latter were combined to estimate short- and long-term cost-effectiveness. Short-term cost-effectiveness was estimated via a within-trial analysis at weeks 12 and 52 and via Markov model to estimate 10-year cost-effectiveness of both interventions. A resource use questionnaire was used to estimate short- and long-term cost of interventions and standard care, while EuroQol-5 Dimensions, three-level version (EQ-5D-3L) responses were used to estimate utility values and generate QALYs. This analysis followed the NHS and personal and social perspective (PSS). Cost-effectiveness was determined using National Institute for Health and Care Excellence (NICE) guidelines. Secondary analysis included societal perspective and QALYs determined by the DLQI. Data collection Data were collected at baseline, 4-weekly to week 36 and 8-weekly to week 52. Sample size A minimum of 500 and maximum of 780 participants were required to detect a relative difference, or fold change, of 1.3 in HECSI score between treatment arms at 12 weeks post planned start of treatment (80% power; two-sided 5% significance level) assuming a coefficient of variation (CV) between 1.175 and 1.7 and 20% attrition. Note that a fold change of 1.3 is equivalent to a fold change of 0.77 if there was a benefit in the opposite direction. A sample size review was planned after 364 participants reached 12 weeks post planned start of treatment but was conducted early in August 2017. Following Data Monitoring and Ethics Committee (DMEC) review, a sample size of 514 participants was recommended based on a CV of 1.2. Results Screening and recruitment Thirty-one NHS hospitals in England, Scotland and Wales assessed 1557 patients for eligibility, registered 582 (37.4%) and randomised 441 (75.8%) participants between October 2015 and June 2021. Of 1557 patients screened, 642 (41.2%) were ineligible, with 347 (54.0%) not having a severe CHE diagnosis. Of 915 eligible patients, 582 (63.6%) were consented and registered. Of 333 patients who did not consent, 74 (22.2%) thought the Immersion PUVA schedule or travel was inconvenient, and 28 (8.4%) did not want alitretinoin. Of 141 patients not randomised, the main reasons were not meeting the eligibility criteria [n = 69 (48.9%)] or patient choice [n = 29 (20.6%)]. Of patients randomised, 220 (49.9%) were allocated to alitretinoin and 221 (50.1%) to Immersion PUVA. Of those allocated to alitretinoin, 201 (91.4%) started treatment within 7 days post randomisation compared with 165 (74.7%) of those allocated to Immersion PUVA. In total, 132 (29.9%) participants withdrew from, or were lost to, follow-up. The ITT population included 441 (100.0%) participants. Primary outcome Hand eczema severity index at 12 weeks In terms of relative change, the median [interquartile range (IQR)] score at 12 weeks was equal to 30% (10–70%) of that at baseline for the alitretinoin group compared with 50% (20–100%) in the Immersion PUVA group. There was a statistically significant benefit of alitretinoin compared with Immersion PUVA at 12 weeks, with an estimated fold change of 0.66 (0.52, 0.82), p = 0.0003 at 12 weeks. Secondary end points Hand eczema severity index over 52 weeks There was no evidence of a difference between alitretinoin and Immersion PUVA at 24 weeks or 52 weeks, with the estimated fold change [95% confidence interval (CI)] equal to 0.92 (0.798 to 1.08) and 1.27 (0.97 to 1.67), respectively. Modified total lesion symptom score over 52 weeks There was no evidence of a difference between treatment groups over 52 weeks, with the estimated difference (95% CI) equal to −0.37 (−1.23 to 0.48) at 12 weeks, −0.14 (−0.84 to 0.56) at 24 weeks and 0.41 (−0.59 to 1.40) at 52 weeks. Physician’s Global Assessment over 52 weeks At 12 weeks, the proportion of participants with available data achieving clear or almost clear (via blinded assessment) was 27.6% (47/170) for alitretinoin and 23.6% (35/148) for Immersion PUVA. Over 52 weeks, 59.4% (123/207) of alitretinoin participants with available data achieved at least one clear/almost clear assessment compared with 61.5% (118/192) of Immersion PUVA participants. There was no evidence of a difference between treatment groups over 52 weeks, with the estimated odds ratios (alitretinoin vs. Immersion PUVA) for achieving lower PGA scores and 95% CI equal to 1.22 (0.90 to 1.64) at 12 weeks, 1.18 (0.89 to 1.56) at 24 weeks and 1.10 (0.64 to 1.89) at 52 weeks. Dermatology quality of life index over 52 weeks There was a statistically significant benefit of alitretinoin compared with Immersion PUVA, with mean scores (95% CI) estimated to be 0.95 (0.09 to 1.82) lower at 12 weeks for the alitretinoin group compared with Immersion PUVA. There was no statistically significant treatment effect at 24 weeks [estimated difference in mean scores = −0.18 (−0.92 to 0.56)], but at 52 weeks, there was a statistically significant treatment effect with increased scores in the alitretinoin group compared with the Immersion PUVA group [estimated difference in mean scores = −1.62 (−2.62 to −0.62)]. The differences observed in the DLQI were not clinically significant. Person-Centred Dermatology Self-Care Index at 12 weeks At baseline, 16.1% (n = 71) were assessed as having sufficient knowledge, ability and confidence to self-manage their condition, with a similar distribution of education needs across treatment groups. At 12 weeks, the proportion of participants with available data who had sufficient knowledge and education was 26.2% (117/324), 28.0% (49/175) in the alitretinoin group and 24.2% (36/149) in the Immersion PUVA group. There was no evidence of a difference in terms of educational need between treatment groups, with an estimated odds ratio (alitretinoin vs. Immersion PUVA) of 0.65 (0.39 to 1.08). Patient Benefit Index – hand eczema over 52 weeks At 12 weeks, the median (IQR) score was equal to 2.3 (1.4–3.2) in the alitretinoin group and 1.9 (0.9–2.8) in the Immersion PUVA group. At 24 weeks, the median (IQR) score was unchanged at 2.3 (1.2–3.5) in the alitretinoin group but had increased to 2.8 (1.4–3.5) in the Immersion PUVA group. At 52 weeks, the median (IQR) score was 2.6 (1.6–3.3) in the alitretinoin group and 3.0 (1.7–3.6) in the Immersion PUVA group. Time to relapse At treatment phase completion, 34.1% (N = 75) of participants allocated to alitretinoin achieved a clear or almost clear response, compared with 25.8% (N = 57) allocated to Immersion PUVA. When relapse was defined as 75% of the baseline HECSI score, 20% (n = 15) of alitretinoin responders relapsed compared with 15.8% (n = 9) of Immersion PUVA responders. When relapse was defined as 50% of the baseline HECSI score, 37.3% (n = 28) of alitretinoin responders and 36.8% (n = 21) of Immersion PUVA responders relapsed. Health economic analysis Within-trial estimated costs indicate that Immersion PUVA is more costly than alitretinoin at weeks 12 and 52 (week 12: £3236 vs. £1904; week 52: £4424 vs. £3336, respectively). Treatment costs are the main drivers of Immersion PUVA costs (including therapy cost, medication and follow-up). Out-of-pocket expenditures are also higher for patients assigned to Immersion PUVA. These increase the cost difference at weeks 12 and 52 (from £1333 to £1650 at week 12 and from £1081 to £1841 at week 52). Immersion PUVA’s QALYs are higher at both time points (week 12: 0.165 vs. 0.159 and week 52: 0.798 vs. 0.761). When using DLQI, the estimated QALYs were slightly higher for alitretinoin compared with Immersion PUVA (week 12: 0.158 vs. 0.154; week 52: 0.784 vs. 0.782, respectively). When combined, the incremental cost-effectiveness ratios (ICERs) indicate alitretinoin is cost-effective at weeks 12 and 52 in all scenarios (primary analysis, societal perspective, and QALYs derived from DLQI). These results are robust, as the probability of cost-effectiveness is between 96% and 100%. Long-term cost-effectiveness The 10-year cost estimates indicate that patients allocated to alitretinoin are slightly more costly than Immersion PUVA (£5432 vs. £5361, respectively). In terms of QALYs, Immersion PUVA is slightly more effective (6.535 vs. 6.530, respectively). The latter suggests Immersion PUVA is the cost-effective strategy; however, results are uncertain, as only 50% of the probabilistic analysis iterations indicate this is the case. Safety data Seventy-nine participants had 135 reportable AEs, 25.0% (n = 55) participants allocated to alitretinoin and 10.9% (n = 24) participants allocated to Immersion PUVA. There were four serious AEs (SAEs; two alitretinoin, two Immersion PUVA); one suspected/expected to be related to treatment, and three related to underlying CHE. There were four pregnancies (three alitretinoin, one Immersion PUVA), including one alitretinoin patient in active treatment, who stopped treatment immediately. Treatment compliance In total, 212 (96.4%) participants randomised to alitretinoin and 196 (88.7%) randomised to Immersion PUVA received treatment. Full ‘trial’ compliance (≥ 80% received and no treatment breaks > 7 days during the first 12 weeks) was observed in 65.9% (N = 145) participants allocated to alitretinoin and 24.0% (N = 53) allocated to Immersion PUVA. Subgroup analysis No differential treatment effects were observed within subgroups defined by disease duration, clinical phenotype, disease severity, presence of atopy, filaggrin loss of function mutation, smoking history, BMI, foot involvement or biomarkers identified through tape stripping. Conclusion Alitretinoin and Immersion PUVA both led to reductions in symptoms. As a first-line therapy, alitretinoin showed a more rapid improvement and was superior to Immersion PUVA in terms of primary end point at 12 weeks. This difference was not observed at later time points. Alitretinoin was more cost-effective over the short term (12 and 52 weeks) with robust results. Long-term analysis indicates that Immersion PUVA is cost-effective in the long term; these results, however, are uncertain. These findings will inform clinical management of patients with severe CHE. Alitretinoin may be considered as the recommended first-line therapy; however, Immersion PUVA may also be considered for longer-term outcomes, particularly in patients where alitretinoin is not an appropriate treatment. Recruitment was difficult, with perceived treatment pathway challenges. The trial implemented a self-referral service, through which 13.8% of randomised participants were recruited. The Immersion PUVA schedule was problematic, with more than 20% of participants declining participation citing this as their main reason. Immersion PUVA treatment compliance was poor, and regular twice-weekly treatment was not achieved by most patients. Hand eczema severity index (HECSI) was the chosen primary outcome measure because it incorporated more details about the condition compared with PGA, which had been used previously. Furthermore, HECSI is continuous rather than discrete, which meant a smaller sample size was required for a desired level of power. The results from ALPHA will help inform future CHE trial designs. Most participants had some educational need for how to manage their condition, and overall, there remains a need for better therapeutic approaches for severe CHE. Just 59% and 61% of patients allocated to alitretinoin and Immersion PUVA, respectively, were known to achieve a clear/almost clear assessment at any time point during the trial period. Further work includes deeper analysis of substudies and pilot data to inform future research, which is needed to understand the long-term effects of treatments. Trial registration This trial is registered as ISRCTN80206075. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/186/01) and is published in full in Health Technology Assessment; Vol. 28, No. 59. See the NIHR Funding and Awards website for further award information.

Objective To identify barriers and facilitators to pressure ulcer prevention behaviours in community-dwelling older people and their lay carers.Design Theoretically informed qualitative interviews with two-phase, deductive then inductive, thematic analysis.Setting The study was conducted in one geographical region in the UK, spanning several community National Health Service Trusts.Participants Community-dwelling older patients at risk of pressure ulcer development (n=10) and their lay carers (n=10).Results Six themes and subthemes were identified: (1) knowledge and beliefs about consequences (nature, source, timing and taboo); (2) social and professional role and influences (who does what, conflicting advice and disagreements); (3) motivation and priorities (competing self-care needs and carer physical ability); (4) memory; (5) emotion (carer exhaustion and isolation, carergiver role conflict and patient feelings) and (6) environment (human resource shortage and equipment).Conclusions There is minimal research in pressure ulcer prevention in community-dwelling older people. This study has robustly applied the theoretical domains framework to understanding barriers and facilitators to pressure ulcer prevention behaviours. Our findings will support co-design of strategies to promote preventative behaviours and are likely to be transferable to comparable healthcare systems nationally and internationally.

Aim The aim of this meta-ethnography was to identify and synthesize qualitative studies focusing on older people’s and registered nurses’ interpretations of competence in home care. Methods The meta-ethnography followed the six phases developed by Noblit and Hare (1988). Results In Phase 6, the translation process of the included studies, three themes were identified: i) temporality—the feeling of being of value; ii) dignity—a person, not just a patient; and iii) mutuality of being—togetherness. A synthesis was developed, and the phrase “a becoming in the meeting” emerged. Conclusion The sense of becoming includes progress, which means becoming something other than before in relation with others and refers to what constitutes the meeting between the older person and the registered nurse working in home care. Competence originates from becoming in the meeting, and registered nurses should therefore value what they do and hold on to this aspect of caring competence that centres on a caring relationship. It is important for registered nurses working in home care to be able to cultivate a caring relationship.

Abstract Background Cancer and dementia are common in older people and management of the conditions as comorbidities can be challenging, yet little is known about the size or characteristics of this group. We aimed to estimate the prevalence, characteristics and general practice resource usage of people living with both conditions in England. Methods Anonymised electronic healthcare records from 391 National Health Service general practices across England using the TPP SystmOne general practice system were obtained from ResearchOne. Data included demographic and clinical characteristics, and general practice healthcare useage (appointments, prescriptions, referrals and secondary care contacts) for people aged 50 and over with a cancer and/or dementia diagnosis consistent with the Quality and Outcomes Framework between 2005 and 2016. Multi-level negative binomial regression was used to analyse the association between having cancer and/or dementia and the number of general practice appointments. Results Data from 162,371 people with cancer and/or dementia were analysed; 3616 (2.2%) people were identified as having comorbid cancer and dementia. Of people with cancer, 3.1% also had dementia, rising to 7.5% (1 in 13 people) in those aged 75 and over. Fewer people with both conditions were female (50.7%) compared to those with dementia alone (65.6%) and those with comorbid cancer and dementia were older than those with cancer alone [mean ages 83 (sd = 7), 69 (sd = 12) respectively]. Those with both conditions were less likely to have lung cancer than those with cancer alone (7.5% vs. 10.3%) but more likely to have prostate cancer (20.9% vs. 15.8%). Additional comorbidities were more prevalent for those with both conditions than those with cancer or dementia alone (68.4% vs. 50.2% vs. 54.0%). In the year following the first record of either condition, people with cancer and dementia had 9% more general practice appointments (IRR:1.09, 95% CI:1.01–1.17) than those with cancer alone and 37% more appointments than those with dementia alone (IRR: 1.37, 95% CI: 1.28–1.47). Conclusions A significant number of people are living with comorbid cancer and dementia in England. This group have additional comorbidity and higher general practice usage than those with cancer/dementia alone. The needs of this group should be considered in future general practice care planning and research.

Abstract Background and purpose The caregiving’s impact on informal carers’ quality of life and gender-based stereotypes make older individuals’ informal care a complex process for which our knowledge is still limited. The purpose of this review is to identify how gender relates to informal carers’ experiences of providing care for people aged 60 years and over with mental and physical health needs by synthesising the available empirical data published between 2000 to 2020. Design and methods The systematic method for reviewing and synthesising qualitative data was performed using the PRISMA checklist and ENTREQ statement. The CASP tool was used to examine the quality of the included papers. Thematic synthesis was used as the methodological framework. Results This review produced two analytical themes, the impact of gender on the caregivers’ labour and negotiating gender identity with self, society, and cultural norms. While informal caregivers share motivators, a linkage between traditional gender stereotypes impacts caregiving burden and coping strategies. Informal carers’ experiences entail a constant pursuit of self-agency after acquiring the caregiver role. Cultural values and their intersection with gender appear to influence caregivers’ healthy adjustment into their new caregiving identities. The flexibility to move beyond gender boundaries could mediate caregivers’ negotiations between self and society on developing their new caregiving identity. Providing intensive informal primary care to older people affects both men’s and women’s mental and physical health. Gender ideals of the feminine nurturing role further disadvantage women as they determine the caregiving arrangements, the strategies and resources to sustain the caring burden, and the adaptability to experience their new caregiving role positively. Men appear more flexible to debate their hegemonic masculinity and defend their existence in the caregiving role. Conclusion and implications Transgressing gender lines and expanding gender possibilities can ease the caregiving burden and strengthen caregivers coping potentials. Health professionals can empower informal careers to challenge gender binaries and expand gender possibilities by intentionally injecting the language of diversity in caring information and caring processes. The review findings outline a path for research on gender identity development in older people’s care.

Objectives To describe the development of Eczema Care Online (ECO), an online behaviour change intervention for young people with eczema (phase I); and explore and optimise the acceptability of ECO among this target group using think-aloud interviews (phase II).Methods Theory-based, evidence-based and person-based approaches to intervention development were used. In phase I, a qualitative systematic review and qualitative interviews developed an in-depth understanding of the needs and challenges of young people with eczema. Guiding principles highlighted key intervention design objectives and features to address the needs of this target group to maximise user engagement. Behavioural analysis and logic modelling developed ECO’s hypothesised programme theory. In phase II, qualitative think-aloud interviews were carried out with 28 young people with eczema and the intervention was optimised based on their feedback.Results The final intervention aimed to reduce eczema severity by supporting treatment use (emollients, topical corticosteroids/topical calcineurin inhibitors), management of irritants/triggers, emotional management and reducing scratching. Generally, young people expressed positive views of intervention content and design in think-aloud interviews. Quotes and stories from other young people with eczema and ECO’s focus on living with eczema (not just topical treatments) were valuable for normalising eczema. Young people believed ECO addressed knowledge gaps they had from childhood and the safety information about topical corticosteroids was reassuring. Negative feedback was used to modify ECO.Conclusions A prototype of the ECO intervention was developed using rigorous and complementary intervention development approaches. Subsequent think-aloud interviews helped optimise the intervention, demonstrated ECO is likely to be acceptable to this target group, and provided support for our guiding principles including key design objectives and features to consider when developing interventions for this population. A randomised controlled trial and process evaluation of the intervention is underway to assess effectiveness and explore user engagement with the intervention’s behavioural goals.

Abstract Aim The aims of this study were (a) to translate the MOLES index from English to Italian and (ii) to compare the two versions using non‐parametric item response theory. Design An online survey was used to gather data. Methods Forward and back translation was used to prepare the Italian version of the MOLES which was then analysed using the non‐parametric item response theory of Mokken scaling. Results Mokken scales were found in both the English and the Italian versions of the MOLES index. However, the two scales—while the total scale score was not significantly different—showed different properties, and Mokken scaling selected different items from each scale.

Objective To devise strategies to amend lay and practitioner atopic eczema mindlines ‘collectively reinforced, internalised tacit guidelines’, to improve consultation experiences and self-management practices in primary care.Design Co-creation workshops informed by the Co:Create Coproduction Matrix.Setting Conference centre in central England and via remote communication.Participants Lay people with, and parents of children with, atopic eczema, practitioners, a researcher and a facilitator (n=22).Results Eczema mindline amendment needs to address people and parents of children with the condition, practitioners and wider society in parallel. For lay people trust and ‘realness’ of amendment activity was vital and practitioners wanted practical, locally relevant, hints and tips, tailored, ‘no faff’ approaches. To improve consultation experiences and self-management practices, five key, consistent, evidence-based messages need to be instilled into eczema mindlines: (1) eczema is more than just dry skin, (2) eczema does not just go away, (3) moisturisers are for every day, (4) steroid creams are okay when you need them and (5) you know your child’s eczema best.Conclusion This co-creation study provides original insights into what eczema knowledge should be mobilised, who needs to have this knowledge, how this should be achieved to amend existing mindlines to improve consultation experiences and self-management practices in primary care.The remaining challenge is to refine, implement and evaluate the effectiveness of strategies developed to instil the five core messages and erase outdated or inaccurate information.

Purpose: Using a theory-led action research process test applicability of humanizing care theory to better understand what matters to people and assess how the process can improve human dimensions of health care services. Consideration of the value of this process to guide enhancements in humanly sensitive care and investigate transferable benefits of the participatory strategy for improving human dimensions of health care services. Methods: Action research with service users, practitioners and academics, with participatory processes led through the application of theory via a novel Humanizing Care Framework in two diverse clinical settings. Results: Participants engaged in a theory-led participatory process, understood and valued the framework seeing how it relates to own experiences. Comparative analysis of settings identified transferable processes with potential to enhance human dimensions of care more generally. We offer transferable strategy with contextualized practical details of humanizing processes and outcomes that can contribute to portable pathways to enhance dignity in care through application of humanizing care theory in practice. Conclusion: The theoretical framework is a feasible and effective guide to enhance human dimensions of care. Our rigorous participative process facilitates sharing of patient and staff experience, sensitizing practitioners’ understandings and helping develop new ways of providing theoretically robust person-centred care based on lifeworld approaches.

ObjectivesTo investigate whether initial eczema mindlines, ‘collectively reinforced, internalised, tacit guidelines’, are an accurate representation of the experiences of lay people and practitioners in primary care and to explore how these mindlines may best be revised to improve eczema care.DesignExploratory qualitative interviews with constant comparative analysis and data mining.SettingUK, primary care.ParticipantsPeople with eczema or parents of children with eczema (n=19) and primary care practitioners (n=13).ResultsInterview data were analysed using constant comparison of new data with existing initial eczema mindlines to identify areas of agreement and disagreement. Data were mined for participant’s thoughts about whose mindlines should be modified, how this may be achieved and what core content is essential. Eczema mindlines and the spiral of knowledge creation, from which they evolved, intuitively made sense. Participants offered examples of how their eczema knowledge is continually produced and transformed as they interact with others. They reported diverse and wide-ranging influences on their thinking and recognised the critical relationship between lay and practitioner mindlines. For this reason they advocated modifying lay and practitioner mindlines in parallel. Participants advised amendment based on consistent information directed to all who influence eczema care. Information should come from trusted sources and be easy to access, distilled, practical, contextually relevant and amenable to assimilation.ConclusionsThe purpose here is to improve primary care consultation experiences and self-management in eczema. The remaining challenge is to find novel, simple and pragmatic methods of modifying eczema mindlines to instil shared and consistent understanding. Given the prevalence of eczema and the scope of people who influence self-care, interventions should transcend patient-practitioner boundaries and address the wider community. One conceptually congruent approach is to create a Ba, which in this case would be a virtual space for generating and sharing eczema knowledge.

Background: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood. Objectives: To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease. Design: Parallel-group, observer-blind, randomised controlled trial of 6 months’ duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE. Setting: Secondary care and the community in five UK centres. Participants: Children aged 1–15 years with moderate or severe AE. Interventions: Participants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100% silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilkTM (AlPreTec Srl, San Donà di Piave, Italy) or DreamSkinTM (DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period. Main outcome measures: Primary outcome – AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes – patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility – 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes – number of skin infections and hospitalisations for AE. Results: A total of 300 children were randomised (26 November 2013 to 5 May 2015): 42% female, 79% white, mean age 5 years. The primary analysis included 282 out of 300 (94%) children (n = 141 in each group). Garments were worn for at least 50% of the time by 82% of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95% confidence interval 0.85 to 1.07; p = 0.43). This confidence interval is equivalent to a difference of –1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28%) and 36 out of 142 (25%) participants for standard care and silk clothing groups, respectively. The incremental cost per QALY of silk garments for children with moderate to severe eczema was £56,811 from a NHS perspective in the base case. Sensitivity analyses supported the finding that silk garments do not appear to be cost-effective within currently accepted thresholds. Limitations: Knowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes. Conclusions: The addition of silk garments to standard AE care is unlikely to improve AE severity, or to be cost-effective compared with standard care alone, for children with moderate or severe AE. This trial adds to the evidence base to guide clinical decision-making. Future work: Non-pharmacological interventions for the management of AE remain a research priority among patients. Trial registration: Current Controlled Trials ISRCTN77261365. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 16. See the NIHR Journals Library website for further project information.

Background A priority setting partnership for eczema (syn atopic eczema, atopic dermatitis) has identified that bathing frequency is a key area of patient interest. However, there are nolarge, high-quality randomised controlled trials (RCTs) investigating this. The Rapid Eczema Trials project is a novel programme of research that aims to deliver multiple online RCTs, using a citizen science approach. This project involves working with members of the public to co-design and conduct studies that answer questions of importance to them. The first trial to be conducted through this project is assessing the impact of bathing frequency on eczema. Methods This is an online, two-arm, parallel-group superiority RCT with internal pilot phase. People aged ≥1 year with eczemaliving in the United Kingdom are eligible. Exclusion criteria are: people with other types of eczema such as venous eczema, hand eczema and contact eczema; recently started a new eczema treatment; taking part in another eczema trial; Patient Oriented Eczema Measure (POEM) ≤2; planning to swim more than twice a week; unable/unwilling to change bathing practices. Participants are allocated 1:1 to either the weekly bathing group (bathe 1 or 2 times a week) or the daily bathing group (bathe 6 or more times a week) for 4 weeks. The primary outcome is POEM, assessed weekly over 4 weeks. Secondary outcomes include skin specific quality of life, eczema control, itch severity, use of usual eczema treatments, proportion who achieve an improvement in POEM of ≥3 points, global change in eczema and safety outcomes. A sample of participants will also be invited to a semi-structured interview to discuss their experience. The primary comparative analysis will be according to randomised allocation regardless of actual frequency of bathing. The trial will be reported in accordance with CONSORT guidelines. The study has received ethical approval by the London - Surrey Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom) on 11/10/2023 ( approval number: 23/PR/0899). Trial registration ISRCTN12016473, 22/11/2023, https://doi.org/10.1186/ISRCTN12016473

Background A priority setting partnership for eczema (syn atopic eczema, atopic dermatitis) has identified that bathing frequency is a key area of patient interest. However, there are nolarge, high-quality randomised controlled trials (RCTs) investigating this. The Rapid Eczema Trials project is a novel programme of research that aims to deliver multiple online RCTs, using a citizen science approach. This project involves working with members of the public to co-design and conduct studies that answer questions of importance to them. The first trial to be conducted through this project is assessing the impact of bathing frequency on eczema. Methods This is an online, two-arm, parallel-group superiority RCT with internal pilot phase. People aged ≥1 year with eczemaliving in the United Kingdom are eligible. Exclusion criteria are: people with other types of eczema such as venous eczema, hand eczema and contact eczema; recently started a new eczema treatment; taking part in another eczema trial; Patient Oriented Eczema Measure (POEM) ≤2; planning to swim more than twice a week; unable/unwilling to change bathing practices. Participants are allocated 1:1 to either the weekly bathing group (bathe 1 or 2 times a week) or the daily bathing group (bathe 6 or more times a week) for 4 weeks. The primary outcome is POEM, assessed weekly over 4 weeks. Secondary outcomes include skin specific quality of life, eczema control, itch severity, use of usual eczema treatments, proportion who achieve an improvement in POEM of ≥3 points, global change in eczema and safety outcomes. A sample of participants will also be invited to a semi-structured interview to discuss their experience. The primary comparative analysis will be according to randomised allocation regardless of actual frequency of bathing. The trial will be reported in accordance with CONSORT guidelines. The study has received ethical approval by the London - Surrey Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom) on 11/10/2023 ( approval number: 23/PR/0899). Trial registration ISRCTN12016473, 22/11/2023, https://doi.org/10.1186/ISRCTN12016473

Objective To evaluate the impact of using knowledge mobilisation interventions to alter and enhance mindlines and improve childhood eczema care.Design The eczema mindlines study involved three stages: (1) mapping and confirming eczema mindlines, (2) intervention development and delivery and (3) analysis of intervention impact. The focus of this paper is on stage 3. Data analysis was guided by the Social Impact Framework to address the questions: (1) what is the impact of this study on individuals and groups? (2) what changes in behaviour and practice have occurred due to their involvement? (3) what mechanisms have enabled these impacts or changes to occur? and (4) what are the recommendations and questions arising from this research?Settings A deprived inner-city neighbourhood in central England and national/international settings.Participants Patients, practitioners and wider community members exposed to the interventions locally, nationally and internationally.Results Data revealed tangible multi-level, relational and intellectual impacts. Mechanisms supporting impact included: simplicity and consistency of messages adapted to audience, flexibility, opportunism and perseverance, personal interconnectivity and acknowledgement of emotion. Co-created knowledge mobilisation strategies to alter and enhance mindlines mediated through knowledge brokering were effective in producing tangible changes in eczema care practice and self-management and in ‘mainstreaming’ childhood eczema in positive way across communities. These changes cannot be directly attributed to the knowledge mobilisation interventions, however, the evidence points to the significant contribution made.Conclusion Co-created knowledge mobilisation interventions offer a valuable method of altering and enhancing eczema mindlines across lay-practitioner-wider society boundaries. The Social Impact Framework provides comprehensive method of understanding and documenting the complex web of impact occurring as a result of knowledge mobilisation. This approach is transferable to managing other long-term conditions.

Abstract Background Enabling behaviour change in health care is a complex process. Although the use of theory to inform behaviour change interventions is advocated, there is limited information about how this might best be achieved. There are multiple models of behaviour change, however, due to their complexity they can be inaccessible to both researchers and healthcare practitioners. To support health care practitioner behaviour change, this was addressed by the development of the Theoretical Domains Framework (TDF) in 2005. Citations of the TDF and associated papers have increased exponentially. Although not predicted or intended by the authors, the TDF has also been used to investigate health behaviour change interventions. Therefore our aim was to narratively synthesize empirical evidence on how the TDF and subsequent iterations have been applied in health behaviour change to inform future intervention development. Methods Systematic search of four online databases, combined with searches for citations of key papers and key author searches, resulted in 3551 articles eligible for screening. Of these 10 met the pre-determined inclusion criteria. Screening of full-texts, data extraction and quality appraisal were independently performed by both authors. Disagreements regarding eligibility were resolved through discussion. Results Of the 10 included studies three used the TDF and seven used subsequent iterations, the Capability, Opportunity, Motivation to Behaviour / Behaviour Change Wheel to assess and /or categorise behavioural determinants to identify relevant behaviour change techniques. Two studies reported feasibility testing. Most interventions were targeted at diet and exercise. Eight reported an explicit and systematic process in applying the framework. Conclusion There is limited evidence of how the framework has been used to support health behaviour change interventions. In the included studies the process of using the framework is not always reported in detail or with clarity. More recent studies use a systematic and judicious process of framework application. From the limited evidence available we tentatively suggest that the steps proposed in the BCW appear to be sufficient for development of interventions that target health behaviour change interventions. Further research is needed to provide evidence in how the framework may be most effectively applied to intervention development. Protocol registration PROSPERO CRD42018086896.

While temperatures in the noxious range are well-known to inhibit acute itch, the impact of temperature in the innocuous temperature range is less well understood. We investigated the effect of alternating short-term temperature changes in the innocuous range on histamine and cowhage-induced acute itch, taking into account individual differences in baseline skin temperature and sensory thresholds. Results indicate that cooling the skin to the cold threshold causes a temporary increase in the intensity of histamine-induced itch, in line with previous findings. Skin warming increased cowhage-induced itch intensity. Potential mecha­nisms of this interaction between thermosensation and pruritoception could involve cold-sensitive channels such as TRPM8, TREK-1 or TRPC5 in the case of histamine. The rapid modulation of cowhage induced itch – but not histamine-induced itch – by transient skin warming could be related to the lower temperature threshold of pruriceptive polymodal C-fibres (cowhage) as compared to the higher temperature threshold of the mechanoinsensitive C-fibres conveying histaminergic itch.

Objective To explore how atopic eczema specific mindlines are developed by primary care practitioners.Design Ethnographic study.Setting One large, urban general practice in central England.Participants In observation, all practitioners and support staff in the practice and in interviews a diverse group of practitioners (n=16).Results Observation of over 250 hours and interview data were combined and analysed using an ethnographic approach through the lenses of mindlines and self-management. Three themes were identified: beliefs about eczema, eczema knowledge and approaches to self-management. Eczema mindlines are set against a backdrop of it being a low priority and not managed as a long-term condition. Practitioners believed that eczema is simple to manage with little change in treatments available and prescribing limited by local formularies. Practice is largely based on tacit knowledge and experience. Self-management is expected but not often explicitly facilitated. Clinical decisions are made from knowledge accumulated over time. Societal and technological developments have altered the way in which practitioner mindlines are developed; in eczema, for most, they are relatively static.Conclusions The outstanding challenge is to find novel, profession and context-specific, simple, pragmatic strategies to revise or modify practitioner mindlines by adding reliable and useful knowledge and by erasing outdated or inaccurate information thus potentially improve quality of eczema care.

BackgroundThe role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease.Methods and findingsThis was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects.ConclusionsSilk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema.Trial registrationCurrent Controlled Trials ISRCTN77261365.