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Introduction Successful implementation and embedding of new health care practices relies on co-ordinated, collective behaviour of individuals working within the constraints of health care settings. Normalization Process Theory (NPT) provides a theory of implementation that emphasises collective action in explaining, and shaping, the embedding of new practices. To extend the practical utility of NPT for improving implementation success, an instrument (NoMAD) was developed and validated. Methods Descriptive analysis and psychometric testing of an instrument developed by the authors, through an iterative process that included item generation, consensus methods, item appraisal, and cognitive testing. A 46 item questionnaire was tested in 6 sites implementing health related interventions, using paper and online completion. Participants were staff directly involved in working with the interventions. Descriptive analysis and consensus methods were used to remove redundancy, reducing the final tool to 23 items. Data were subject to confirmatory factor analysis which sought to confirm the theoretical structure within the sample. Results We obtained 831 completed questionnaires, an average response rate of 39% (range: 22–77%). Full completion of items was 50% ( n  = 413). The confirmatory factor analysis showed the model achieved acceptable fit (CFI = 0.95, TLI = 0.93, RMSEA = 0.08, SRMR = 0.03). Construct validity of the four theoretical constructs of NPT was supported, and internal consistency (Cronbach’s alpha) were as follows: Coherence (4 items, α = 0.71); Collective Action (7 items, α = 0.78); Cognitive Participation (4 items, α = 0.81); Reflexive Monitoring (5 items, α = 0.65). The normalisation scale overall, was highly reliable (20 items, α = 0.89). Conclusions The NoMAD instrument has good face validity, construct validity and internal consistency, for assessing staff perceptions of factors relevant to embedding interventions that change their work practices. Uses in evaluating and guiding implementation are proposed.

To identify and map the existing literature on the conduct of patient and public involvement and engagement (PPIE) for statistical methodology. PPIE refers to the consideration of patient and public perspectives into research development, conduct and dissemination and, while commonly integrated in applied healthcare research, it currently remains underutilised in statistical methodology research. Many statistical methodologists lack confidence in conducting PPIE citing barriers such as insufficient training, unclear tasks, and concerns about impact. This review will examine literature on PPIE in the context of statistical methodology aiming to inform the design or analysis of healthcare research studies and related methodological research domains such as trials methodology and health data science. A three-step search strategy, developed with an information specialist and based on JBI guidelines, will identify published and unpublished PPIE literature. This will include database searches, hand-searching key journals, and grey literature searches via search engines. The authors will contact their professional networks to identify additional material. The literature will be screened, selected and extracted by two independent researchers. Results will be presented in an evidence map and using a qualitative, thematic analysis.

Background Although outcome goals for acute healthcare among older people living with frailty often include Health-Related Quality of Life (HRQoL) and other patient-reported outcome measures (PROMs), current quality metrics usually focus on waiting times and survival. Lay and patient review have identified the EuroQol EQ-5D as a candidate measure for this setting. This research appraised the EQ-5D for feasibility, psychometric performance, and respondents’ outcomes in the acute frailty setting. Methods People aged 65 + with Clinical Frailty Scale (CFS) 5–8 were recruited from eight UK hospitals’ emergency care and acute admissions settings. They completed the five-level EQ-5D and the EQ-VAS. Feasibility was assessed with completion times and completeness. For reliability, response distributions and internal consistency were analysed. Finally, EQ-Index values were compared with demographic characteristics and service outcomes for construct validity. Results The 232 participants were aged 65–102. 38% responded in emergency departments and 62% in admissions wards. Median completion time was 12 (IQR, 11) minutes. 98% responses were complete. EQ-5D had acceptable response distribution (SD 1.1–1.3) and internal consistency (Cronbach’s alpha 0.69). EQ-VAS demonstrated a midpoint response pattern. Median EQ-Index was 0.574 (IQR, 0.410) and was related positively with increasing age ( p  = 0.010) and negatively with CFS ( p  < 0.001). Participants with higher CFS had more frequent problems with mobility, self-care, and usual activities. Conclusions Administration of the EQ-5D was feasible in these emergency and acute frailty care settings. EQ-5D had acceptable properties, while EQ-VAS appeared problematic. Participants with more severe frailty had also poorer HRQoL.

Background Healthcare outcome goals are central to person-centred acute care, however evidence among older people is scarce. Older people who are living with frailty have distinct requirements for healthcare delivery and have distinct risk for adverse outcomes from healthcare. There is insufficient evidence for whether those living with frailty also have distinct healthcare outcome goals. This study explored the nature of acute care outcome goals in people living with frailty. Methods Healthcare outcome goals were explored using semi-structured patient interviews. Participants aged over 65 with Clinical Frailty Score 5-8 (mild to very severe frailty) were recruited during their first 72 hours in a UK hospital. Purposive, maximum variation sampling was guided by lay partners from a Patient and Public Involvement Forum specialising in ageing-related research. Qualitative analysis used a blended approach based on framework and constant comparative methodologies for the identification of themes. Findings were validated through triangulation with participant, lay partner, and technical expert review. Results The 22 participants were aged 71 to 98 and had mild to very severe frailty. One quarter were living with dementia. Most participants had reflected on their situation and considered their outcome goals. Theme categories (and corresponding sub-categories) were ‘Autonomy’ (information, control, and security) and ‘Functioning’ (physical, psychosocial, and relief). A novel ‘security’ theme was identified, whereby participants sought to feel safe in their usual living place and with their health problems. Those living with milder frailty were concerned to maintain ability to support loved ones, while those living with most severe frailty were concerned about burdening others. Conclusions Outcome goals for acute care among older participants living with frailty were influenced by the insecurity of their situation and fear of deterioration. Patients may be supported to feel safe and in control through appropriate information provision and functional support.

Background Women and their relatives can play an important role in early detection and help seeking for acute perinatal events. Recent UK reports indicate that patient-professional partnership in ‘working for safety’ can be difficult to achieve in practice, sometimes with catastrophic consequences. This research explored the experiences of women and relatives who had experienced early warning signs about their condition and sought help in escalating care. Methods Secondary analysis of case study data which included qualitative interviews with 22 women purposively sampled on account of experiencing a step up in care and 4 of their relatives from two NHS Trusts in England during 2010. Analysis focused on the type of safety work participants engaged in, and the opportunities and challenges reported by women and family members when negotiating safety at home and in hospital. Results Women and relatives took on a dual responsibility for self-diagnosis, self-care and seeking triage, whilst trying to avoid overburdening stretched services. Being informed, however, did not necessarily enable engagement from staff and services. The women’s narratives highlighted the work that they engaged in to build a case for clinical attention, the negotiations that took place with health care professionals and the strategies women and partners drew on (such as objective signs and symptoms, use of verbal insistence and repetition) to secure clinical help. For some women, the events left them with a lasting feeling that their concerns had been disregarded. Some described a sense of betrayal and loss of trust in an institution they believed had failed to care for them. Conclusion The notion of ‘safety partnerships’ which suggests a sense of equality and reciprocity was not borne out by our data, especially with regards to the experiences of teenage women. To enable women and families to secure a rapid response in clinical emergencies, strategies need to move beyond the provision of patient information about warning signs. Effective partnerships for safety may be supported by system level change such as improved triage, continuity of care, self-referral pathways and staff training to address asymmetries of power that persist within the health system.

Background Pregnancy is an important life experience that requires uniquely tailored approach to health care. The socio-cultural care practices of indigenous pregnant women (IPW) are passed along the maternal line with respect to identity, worldview and nature. The cultural differences between non-indigenous healthcare professionals (HPs) and IPW could present a great challenge in women’s health care. This article presents an analysis from a human rights and gender perspective of this potential cultural divide that could affect the health of the IPW in an Andean region of Ecuador with the objective of describing the health challenges of IPWs as rights holders through the experiences and perceptions of HP as guarantors of rights. Methods We conducted 15 in-depth interviews with HPs who care for IPW in Chimborazo, Pichincha provinces of Ecuador. We utilized a semi-structured interview guide including questions about the experiences and perceptions of HPs in delivering health care to IPW. The interviews were recorded, transcribed and subjected to thematic analysis in Spanish and translated for reporting. Results We found disagreements and discrepancies in the Ecuadorian health service that led to the ignorance of indigenous cultural values. Common characteristics among the indigenous population such as illiteracy, low income and the age of pregnancy are important challenges for the health system. The gender approach highlights the enormous challenges: machismo, gender stereotypes and communication problems that IPWs face in accessing quality healthcare. Conclusions Understanding the diverse perspectives of IPW, acknowledging their human rights particularly those related to gender, has the potential to lead to more comprehensive and respectful health care delivery in Ecuador. Further, recognizing there is a gender and power differential between the provider and the IPW can lead to improvements in the quality of health care delivery and reproductive, maternal and child health outcomes.

Ethnographic approaches to health and care research are invaluable. They offer rich insight into contextual and cultural factors that influence the health service, as well as the delivery of care within any given community, and recognise the centrality of the researcher in the process. Understanding the unfolding of real-life events, as well as interactions between people, space, technology and other affordances, is crucial to developing impactful and contextually sensitive interventions. Information derived from ethnography may also be unreachable by other, retrospective research approaches. By combining a collection of ten researchers’ diverse first-hand experiences relating to past studies, with collaborative reflections on conceptual, theoretical, methodological, and ethical issues pertaining to ethnographic inquiry in health and care research, this paper offers a unique, accessible and revealing ‘backstage’ introduction to ethnographic approaches. It aims to de-mystify ethnography and prepare researchers planning to adopt ethnographic approaches to health research, by describing how it can look and feel in practice with empirical illustrations. This is perhaps particularly valuable for researchers new to ethnographic approaches across disciplines and expertise levels (e.g., clinical researchers and PhD students), as well as any stakeholder who may wish to be involved, or support such work in health and care settings.

Introduction The current service metrics used to evaluate quality in emergency care do not account for specific healthcare outcome goals for older people living with frailty. These have previously been classified under themes of ‘Autonomy’ and ‘Functioning’. There is no person-reported outcome measure (PROM) for older people with frailty and emergency care needs. This study aimed to identify and co-produce recommendations for instruments potentially suitable for use in this population. Methods In this systematic review, we searched six databases for PROMs used between 2010 and 2021 by older people living with frailty receiving acute hospital care. Studies were reviewed against predefined eligibility criteria and appraised for quality using the COSMIN Risk of Bias checklist. Data were extracted to map instrument constructs against an existing framework of acute healthcare outcome goals. Instrument face and content validity were assessed by lay collaborators. Recommendations for instruments with potential emergency care suitability were formed through co-production. Results Of 9392 unique citations screened, we appraised the full texts of 158 studies. Nine studies were identified, evaluating nine PROMs. Quality of included studies ranged from ‘doubtful’ to ‘very good’. Most instruments had strong evidence for measurement properties. PROMs mainly assessed ‘Functioning’ constructs, with limited coverage of ‘Autonomy’. Five instruments were considered too burdensome for the emergency care setting or too specific for older people living with frailty. Conclusions Four PROMs were recommended as potentially suitable for further validation with older people with frailty and emergency care needs: COOP/WONCA charts, EuroQol, McGill Quality of Life (Expanded), and Palliative care Outcome Scale.

Background Current acute healthcare service metrics are not meaningful for older people living with frailty. Healthcare knowledge, situational security, and physical and psychosocial function are important outcomes typically not collected. The use of patient-reported outcome measures (PROMs) could support these assessments. Existing instruments are not comprehensive as they typically consider function, while older people with frailty also value enablement (self-determination and security in health and healthcare). This study field-tested and validated a PROM for older people with frailty receiving acute care (PROM-OPAC) to measure enablement. Methods People aged 65+ with Clinical Frailty Scale 5–8 were recruited within seventy-two hours of an emergency attendance. Iterations of the novel instrument were administered over three stages: (1) preliminary field-testing for reliability (response distribution and internal consistency) and structure (exploratory factor analysis, EFA); (2) intermediate field-testing of an improved instrument for reliability and structure; (3) final draft validation assessing reliability, structure (confirmatory factor analysis, CFA), and construct validity based on a priori hypotheses. Feasibility was appraised throughout using data completeness and response rates and times. Results 241 people participated. Three items of a preliminary seven-item measure had poor response distribution or loading and were accordingly improved. The intermediate instrument had interpretability issues and three items required further improvement. The final eight-item draft had acceptable reliability (Cronbach’s alpha: 0.71), structure (two factors for self-determination and security; RMSEA: 0.065; TLI: 0.917; CFI: 0.944), and construct validity (lower scores from respondents waiting longer and requiring admission). Feasibility was promising (response rate 39%; 98% responses complete; median completion time 11 (IQR: 12) minutes). Conclusions Administration of the PROM-OPAC appeared feasible and the instrument had acceptable psychometric properties. Further evaluation is required to assess generalisability.

Objective In Latin America, there is an increasing prevalence of pregnancy complications, leading to poor maternal and neonatal outcomes. Although essential antenatal health services are available to diagnose and treat pregnancy-related complications, their uptake is low and results in many Latin American women not receiving adequate antenatal care. This study aimed to understand the challenges experienced by women managing high-risk pregnancies while interacting with antenatal services and the perceived value of digital health in supporting their care practices. Methods This qualitative case study collected data through eight focus group discussions with 43 pregnant women with complications, and 33 semi-structured interviews with healthcare professionals across different levels of the healthcare infrastructure in public and private hospitals and health subcenters in three Ecuadorian cities. Results Our findings uncovered a number of material, spatial, technical, organizational, and everyday life constraints that negatively impacted women's access and experiences with antenatal services during pregnancy complications. Unintended consequences were also discovered in the fragmented Ecuadorian healthcare system, including extra data work, duplication of information, incomplete medical records and delayed diagnosis. Another important finding was the necessity for emotional support for healthcare professionals and pregnant women dealing with complications. Healthcare professionals and pregnant women perceived value in digital health that can support women's self-care practices as well as the communication, coordination and information management within and across healthcare institutions to improve antenatal care. Conclusions This study provides a contextual understanding of the socio-technical challenges and constraints that affect the access and uptake of antenatal services during pregnancy complications in Ecuador. We discuss the potential of digital health to support both women and healthcare professionals’ efforts while caring for pregnancy complications and the need for taking a sociomaterial approach to scope digital health opportunities in antenatal care.