What are the implications for patient safety and experience of a major healthcare IT breakdown? A qualitative study

Introduction: To explore the impact of a three-week downtime to an electronic pathology system on patient safety and experience. Methods: Qualitative study consisting of semi-structured interviews and a focus group at a large NHS teaching hospital in England. Participants included NHS staff (n=16) who represented a variety of staff groups (doctors, nurses, healthcare assistants) and board members. Data were collected 2-5 months after the outage and were analysed thematically. Results: We present the implications which the IT breakdown had for both patient safety and patient experience. Whilst there was no actual recorded harm to patients during the crisis, there was strong and divided opinion regarding the potential for a major safety incident to have occurred. Formal guidance existed to assist staff to navigate the outage but there was predominantly a reliance on informal workarounds. Junior clinicians seemed to struggle without access to routine blood test results whilst senior clinicians seemed largely unperturbed. Patient experience was negatively affected due to the extensive wait time for manually processed diagnostic tests, increasing logistical problems for patients. Conclusion: The potential negative consequences on patient safety and experience relating to IT failures cannot be underestimated. To minimise risks during times of crisis, clear communication involving all relevant stakeholders, and guidance and management strategies that are agreed upon and communicated to all staff are recommended. To improve patient experience flexible approaches to patient management are suggested. Key words: Patient safety, patient experience, quality, qualitative, secondary care, NHS, crisis, technolog

Remote and technology-mediated working during the COVID-19 pandemic : A qualitative exploration of the experiences of nurses working in general practice (the GenCo Study)

Aim To explore how nurses working in general practice experienced remote and technology-mediated working during the COVID-19 pandemic. Design Exploratory qualitative study with nursing team members working in general practices in England and national nurse leaders. Methods Data were collected between April and August 2022. Forty participants took part in either semi-structured interviews or focus groups. Data were analysed using Framework Analysis informed by the PERCS (Planning and Evaluating Remote Consultation Services) Framework. University of York ethics approval [HSRGC/2021/458/I] and Health Research Authority approval were obtained [IRAS:30353. Protocol number: R23982. Ref 21/HRA/5132. CPMS: 51834]. The study was funded by The General Nursing Council for England and Wales Trust. Results Participants continued to deliver a significant proportion of patient care in-person. However, remote and technology-mediated care could meet patients' needs and broaden access in some circumstances. When remote and technology-mediated working were used this was often part of a blended model which was expected to continue. This could support some workforce issues, but also increase workload. Participants did not always have access to remote technology and were not involved in decision-making about what was used and how this was implemented. They rarely used video consultations, which were not seen to add value in comparison to telephone consultations. Some participants expressed concern that care had become more transactional than therapeutic and there were potential safety risks. Conclusion The study explored how nurses working in general practice during the COVID-19 pandemic engaged with remote and technology-mediated working. It identifies specific issues of access to technology, workload, hybrid working, disruption to therapeutic relationships, safety risks and lack of involvement in decision-making. Changes were implemented quickly with little strategic input from nurses. There is now an opportunity to reflect and build on what has been learned in relation to remote and technology-mediated working to ensure the future development of safe and effective nursing care in general practice. Impact The paper contributes to understanding of remote and technology-mediated working by nurses working in general practice during the COVID-19 pandemic and indicates to employers and policy makers how this can be supported moving forward. Reporting method Standards for Reporting Qualitative Research (O'Brien et al., 2014). Patient or public contribution This was a workforce study so there was no patient or public contribution. Implications for the profession and patient care The paper highlights specific issues which have implications for the development of remote, technology-mediated and blended working for nurses in general practice, care quality and patient safety. These require full attention to ensure the future development of safe and effective nursing care in general practice moving forward

The well-being of nurses working in general practice during the COVID-19 pandemic : A qualitative study (The GenCo Study)

Aim Exploration of experiences of nurses working in general practice during the COVID-19 pandemic to evaluate the impact on nurses' professional well-being. Design An exploratory qualitative study comprised of case studies of three general practice sites in England and a nationwide interview study of nurses working in general practice and nurse leaders. The study was funded by The General Nursing Council for England and Wales Trust. University of York ethics approval (HSRGC/2021/458/I) and Health Research Authority approval was obtained (IRAS: 30353, Protocol number: R23982, Ref 21/HRA/5132, CPMS: 51834). Methods Forty participants took part. Case site data consisted of interviews/focus groups and national data consisted of semi-structured interviews. Data collection took place between April and August 2022. Analysis was underpinned by West et al.'s (The courage of compassion. Supporting nurses and midwives to deliver high-quality care, The King's fund, 2020) ABC framework of nurses' core work well-being needs. Findings The majority of participants experienced challenges to their professional well-being contributed to by lack of recognition, feeling undervalued and lack of involvement in higher-level decision-making. Some participants displayed burnout and stress. Structural and cultural issues contributed to this and many experiences pre-dated, but were exacerbated by, the COVID-19 pandemic. Conclusions By mapping findings to the ABC framework, we highlight the impact of the COVID-19 pandemic on the well-being of nurses working in general practice and contributing workplace factors. The issues identified have implications for retention and for the future of nursing in general practice. The study highlights how this professional group can be supported in the future. Impact The study contributes to our understanding of the experiences of nurses working in general practice during the COVID-19 pandemic and beyond. Findings have implications for this skilled and experienced workforce, for retention of nurses in general practice, the sustainability of the profession more broadly and care quality and patient safety. Reporting Method Standards for Reporting Qualitative Research (O'Brien et al. in Journal of the Association of American Medical Colleges, 89(9), 1245–1251, 2014). Patient or Public Contribution As this was a workforce study there was no patient or public contribution

Evidence based spinal surgery or the “journal of anecdotal medicine?” Using qualitative interviews with spinal surgeons to understand how the drivers of orthopaedic decision making can influence the creation and adoption of surgical trial evidence

Background: There is uncertainty regarding the best available treatment for stable thoracolumbar fractures without spinal cord injury. We explore what influences surgical decision making for the treatment of stable thoracolumbar fractures in the UK and discuss the implications of variation in spinal surgical work on the creation and adoption of future evidence. Methods: Qualitative semi-structured interviews with 19 spinal surgeons from 13 UK hospitals. Data were collected as part of a mixed methods randomised pilot study (PRESTO). A conceptual framework of drivers of variation in orthopaedic surgical work informed how we analysed and reported our findings. Results: We identified various patient, surgeon, organisational and cultural factors to influence surgical decision making and variation in the treatment of stable thoracolumbar fractures. We then use our findings to present the ‘cycle of uncertainty,’ to illustrate how a lack of evidence is a justification for a Randomised Controlled Trial (RCT) and the reason why a trial is not deemed feasible. Conclusion: Surgical decision-making is complex, particularly in the absence of robust evidence. The reliance on informal sources to inform decision making and the limited role of evidence, have implications for the likelihood that RCT evidence will be created and/or adopted. To break this cycle of uncertainty we suggest focussing earlier in the research cycle to develop context-specific strategies, designed to avoid equipoise from deeming future surgical trials unfeasible and encourage evidence based surgical decision-making. This could include targeted qualitative research conducted prior to RCTs to explore drivers of surgical decision making

What is important to adults after lower limb reconstruction surgery: a conceptual framework

Purpose Patient-reported outcome measures (PROMs) are used to understand the impact of lower limb reconstruction on patient’s Health-Related Quality of Life (HRQL). Existing measures have not involved this group of patients and their experiences during development. This study aimed to develop a conceptual framework to reflect what is important to patients requiring, undergoing or after undergoing reconstructive surgery. Methods Our population of interest was people requiring, undergoing or after undergoing reconstructive surgery due to trauma, malunion, nonunion, infection or congenital issues treated by internal or external fixation. We undertook semi-structured interviews with patients and orthopaedic healthcare professionals (surgeons, methodologists and patient contributors) in England. Results Thirty-two patients and 22 orthopaedic healthcare professionals (surgeons, methodologists and patient contributors) were interviewed between November 2020 and June 2021. Eight domains from a previously developed preliminary conceptual framework were used as a framework around which to code the interviews using thematic analysis. Six domains important to patients (from the perspective of patients and orthopaedic healthcare professionals) were included in the final conceptual framework: pain, perception-of-self, work and finances, daily lifestyle and functioning, emotional well-being, and support. These findings, plus meetings with our advisory panel led to the refinement of the conceptual framework. Conclusion The first five domains relate to important outcomes for patients; they are all inter-related and their importance to patients changed throughout recovery. The final domain—support (from work, the hospital, physiotherapists and family/friends)—was vital to patients and lessened the negative impact of the other domains on their HRQL. These new data strengthen our original findings and our understanding of the domains we identified in the QES. The next step in this research is to ascertain whether current PROMs used with this group of patients adequately capture these areas of importance

Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials : lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention

Background: Ensuring fidelity to complex interventions is a challenge when conducting pragmatic randomised controlled trials. We explore fidelity through a qualitative process evaluation, which was conducted alongside a pragmatic, multicentre, two-arm cohort randomised controlled trial: the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the delivery of the REFORM intervention and highlight how project-specific fidelity can be assessed using a truly mixed-methods approach when informed by qualitative insights. Design: Semi-structured qualitative interviews carried out as part of a process evaluation. Interviews were analysed thematically. Setting: Seven NHS trusts in the UK and a University podiatry school in Ireland. Interviews were undertaken face-toface or over the telephone. Participants: Twenty-one REFORM trial participants and 14 podiatrists who delivered the REFORM intervention. Results: Factors affecting fidelity included: how similar the intervention was to routine practice; the challenges of delivering a multifaceted intervention to a heterogeneous older population; and practical issues with delivery such as time and training. Trial participants’ views of the intervention, whether falls prevention is a personal priority, their experience of being part of a trial and individual factors such as medical conditions may also have affected intervention fidelity. Conclusions: Our process evaluation highlighted factors that were perceived to have affected the fidelity of the REFORM intervention and in doing so demonstrates the importance of considering fidelity when designing and evaluating pragmatic trials. We propose a number of recommendations of how important project-specific insights from qualitative work can be incorporated into the design of fidelity measurement of future trials, which build on existing conceptual fidelity frameworks. In particular, we encourage adopting a mixed-methods approach whereby qualitative insights can be used to suggest ways to enhance quantitative data collection facilitating integration through hypothesis generation, hypothesis testing and seeking explanation for trial findings. This will provide a framework of enabling measures of fidelity to be incorporated into the understanding of trial results which has been relatively neglected by existing literature. Trial registration: ISRCTN Registry: ISRCTN68240461. Registered on 01/07/2011. Keywords: Process evaluation, Randomised controlled trials, Fidelity, Mixed methods, Falls, Elderly, Ageing, Qualitativ

Models of Mental Health Triage for Individuals coming to the Attention of the Police who may be Experiencing Mental Health Crisis : A Scoping Review

Background Police routinely encounter individuals experiencing mental distress, despite being ill-equipped to do so. Mental health triage aims to address these concerns. A range of approaches to triage have been introduced, however no overview exists. Methods We conducted a systematic scoping review of mental health triage co-responding schemes. Eleven databases were searched to identify the literature; each scheme was charted and described. Results Thirty-three studies describing 47 schemes were included. Intervention details were generally poorly reported, however, differences in personnel, training and information sharing were identified. Conclusions There are multiple schemes in practice based on the co-responding model. Robust research into the cost and effectiveness of mental health triage is needed

Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

Background: Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries, or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development ofstrategies to improve recruitment in future research. Design: Two qualitative process evaluations of a United Kingdom-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. Setting: NHS secondary care organisations throughout the United Kingdom. Interviewswere undertaken via telephone. Participants: 37 health professionals including UK based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). 22 patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed. Results: We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. Conclusions: A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. Trial registries: ACTIVE: (ISRCTN98152560) PRESTO: (ISRCTN12094890

Outcome domains and outcome measures used in studies assessing the effectiveness of interventions to manage non-respiratory sleep disturbances in children with neurodisabilities: a systematic review

Objectives: To assess whether a core outcome set is required for studies evaluating the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities. Design: Survey of outcome measures used in primary studies identified by a systematic review. Data sources: ASSIA; CENTRAL; Cochrane Database of Systematic Reviews; Conference Proceedings Citation Index; CINAHL; DARE; Embase; HMIC; MEDLINE; MEDLINE In-Process; PsycINFO; Science Citation Index; Social Care Online; Social Policy & Practice; ClinicalTrials.gov; WHO International Clinical Trials Registry Platform (ICTRP); and the UK Clinical Trials Gateway were searched up to February 2017. Eligibility criteria: Studies evaluating pharmacological or non-pharmacological interventions for children (≤ 18 years old) with a neurodisability and experiencing non-respiratory sleep disturbance. Data extraction and synthesis: Outcomes related to child and parent sleep-related outcomes; measures of perceived parenting confidence, efficacy or understanding of sleep management; child-related quality of life, daytime behaviour and cognition; parent/carer outcomes; and adverse events were listed from each study and categorised into domains. Results: Thirty-nine studies (13 melatonin and 26 non-pharmacological) assessed five core outcome areas: child sleep, other child outcomes, parent outcomes, adverse events and process measures. There were 54 different measures of child related sleep across five domains: global measures; sleep initiation; maintenance; scheduling; and other outcomes. The most commonly reported measure in melatonin studies was total sleep time (n=12; 92%); and for non-pharmacological studies was the parent-reported Child Sleep Habits Questionnaire (CSHQ; 58%), both classified as global measures. Fifteen non-pharmacological (58%) and four pharmacological studies (31%) reported child outcomes other than sleep. The domains assessed (using 29 different measures) were child behaviour, quality of life, ADHD symptoms, cognition, school-related, and other. One pharmacological and 14 non-pharmacological (54%) studies reported parent outcomes (17 different measures). Eleven melatonin studies (85%) recorded adverse events, with variation in how data were collected and reported. One non-pharmacological study reported an explicit method of collecting on adverse events. Several process measures were reported, related to adherence, feasibility of delivery, acceptability and experiences of receiving the intervention. Conclusions: There is a lack of consistency between studies in the outcome measures used to assess the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities. A minimum core outcome set, with international consensus, should be developed in consultation with parents, children and young people, and those involved in supporting families. Registration number systematic review PROSPERO (CRD42016034067

Oral Melatonin for Non-Respiratory Sleep Disturbance in Children with Neurodisabilities: Systematic Review and Meta-Analyses

Aim: To evaluate the effectiveness of pharmacological interventions for managing non-respiratory sleep disturbances in children with neurodisabilities. Method: We performed a systematic review and meta-analyses of randomized controlled trials (RCTs). We searched 16 databases, grey literature, and reference lists of included papers up to February 2017. Data were extracted and assessed for quality by two researchers (B.B., C.M., G.S., A.S., A.P.). Results: Thirteen trials were included, all evaluating oral melatonin. All except one were at high or unclear risk of bias. There was a statistically significant increase in diary-reported total sleep time for melatonin compared with placebo (pooled mean difference 29.6min, 95% confidence interval [CI] 6.9–52.4, p=0.01). Statistical heterogeneity was high (97%). For the single RCT with low risk of bias, the unadjusted mean difference in total sleep time was 13.2 minutes (95% CI −13.3 to 39.7) favouring melatonin, while the mean difference adjusted for baseline total sleep time was statistically significant (22.4min, 95% CI 0.5–44.3, p=0.04). Adverse event profile suggested that melatonin was well-tolerated. Interpretation: There is a paucity of evidence on managing sleep disturbances in children with neurodisabilities, and it is mostly of limited scope and poor quality. There is evidence of the benefit and safety of melatonin compared with placebo, although the extent of this benefit is unclear. What this paper adds: Melatonin for the management of non-respiratory sleep disturbances in children with neurodisabilities was well tolerated with minimal adverse effects. The extent of benefit and which children might benefit most from melatonin use is uncertain. Benefit may be greatest in those with autism spectrum disorder; however, this finding should be interpreted with caution