Hip dysplasia is a significant public health issue, representing the single largest cause for total hip arthroplasty in young adults. To gain insight into patient concerns and the impact of hip dysplasia on young adults, we developed a patient-centred outcome measure, the 'Quality of Life Impact and Concerns' (QoLI&C) measure. This short report provides additional evidence on test-retest reliability and suggests refinements to the measure to enhance its research and clinical utility.

AIMS:To identify a suite of the key physical, emotional, and social outcomes to be employed in clinical practice and research concerning Perthes' disease in children. METHODS:The study follows the guidelines of the COMET-Initiative (Core Outcome Measures in Effectiveness Trials). A systematic review of the literature was performed to identify a list of outcomes reported in previous studies, which was supplemented by a qualitative study exploring the experiences of families affected by Perthes' disease. Collectively, these outcomes formed the basis of a Delphi survey (two rounds), where 18 patients with Perthes' disease, 46 parents, and 36 orthopaedic surgeons rated each outcome for importance. The International Perthes Study Group (IPSG) (Dallas, Texas, USA (October 2018)) discussed outcomes that failed to reach any consensus (either 'in' or 'out') before a final consensus meeting with representatives of surgeons, patients, and parents. RESULTS:In total, 23 different outcome domains were identified from the systematic review, and a further ten from qualitative interviews. After round one of the Delphi survey, participants suggested five further outcome domains. A total of 38 outcomes were scored in round two of the Delphi. Among these, 16 outcomes were scored over the prespecified 70% threshold for importance (divided into six main categories: adverse events; life impact; resource use; pathophysiological manifestations; death; and technical considerations). Following the final consensus meeting, 14 outcomes were included in the final Core Outcome Set (COS). CONCLUSION:Core Outcome Sets (COSs) are important to improve standardization of outcomes in clinical research and to aid communication between patients, clinicians, and funding bodies. The results of this study should be a catalyst to develop high-quality clinical research in order to determine the optimal treatments for children with Perthes' disease. Cite this article: Bone Joint J 2020;102-B(5):611-617.

Andrew F Long Tina Gambling 1School of Healthcare, Faculty of Health and Social Care, University of Leeds, Leeds, UK; 2School of Health Sciences, College of Biomedical and Life Sciences, Cardiff University, Cardiff, Wales, UK Purpose: To explore the question of ‘how to evaluate a qualitative patient-centred outcome measure’, comprising predominantly open-ended items, including perhaps emojis, story writing and/or pictures, in a way that does not compromise the strictures of the qualitative paradigm, doing so in a credible and authoritative manner. The paper aims to promote debate and discussion in the measurement validation community. Methods: Comprehensive literature review of three electronic databases (PubMed; SCOPUS; Web of Science/Knowledge) and searches of three outcome-focused journals. Results: The vast majority (>90%) of the papers only used qualitative methods in the initial, in particular, content validation of a measure and then used (quantitative) psychometric validation procedures. The remaining papers comprised articles that were either methodologically or methods focused and the role of qualitative research. A number of key issues are raised, inter alia: giving primacy to the patient’s perspective; exploring the meaning and interpretation respondents place on the concept and possible items in a measure; prioritising maximising meaningful discrimination from the respondent’s perspective; ensuring face and content validity and relevance of items in the item content pool; and using appropriate qualitative methods, for example, concept elicitation, “think-aloud” and cognitive interviews and expert respondent panels/judges. This approach is applied to validate a child-friendly outcome measure for children with Perthes disease, a paediatric hip condition presenting primarily amongst male children aged 5-8 years. Conclusions: The core messages are to: (i) not force validation of a qualitative outcome measure into psychometric validation; but (ii) retain full adherence to the principles of the qualitative paradigm and employ procedures drawn from that paradigm. In this manner, primary emphasis would lie on issues of meaningfulness, face and content validity, the meaning of item and measure scores to respondents and, for a child-friendly measure, the child-friendliness of the measure.

Purpose: To develop and validate a patient-centered, evaluative outcome measure to assess patient-significant and identified impacts of the three pediatric hip conditions (the "Quality of Life, Concerns and Impact Measure" (QoLC&I)), for use by patients and clinicians in discussions over treatment options and the evaluation of treatment and post-operative rehabilitation. Patients and methods: The measure was developed through a qualitative study, via two web-based forums (patient narratives, n=84) and one specialist orthopedic adult hip clinic (conducting interviews, n=38). The draft (1) measure was piloted in an asynchronous web-based discussion group forum; following revision, it was piloted with a group of clinicians and patients to assess its patient and clinical utility, face and content validity. The final, refined prototype measure (QoLC&I, draft 3) was subjected to psychometric evaluation. Results: A total of 230 patients provided useable data for the psychometric analysis: 70% (160) had a confirmed diagnosis of Developmental Dysplasia of the Hip, 15% (35) Perthes, 11% (26) Slipped Upper Femoral Epiphyses; 4% (9) PHC not stated. The scale showed good acceptability (few missing items, good spread, low floor/ceiling effects), relevance (76% stating they would find the measure useful in their discussions with clinicians), and good internal consistency (Cronbach's alpha=0.98; average ICC=0.98). Hypotheses on convergent validity (with the General Health Questionnaire, to measure depression, and the International Hip Outcome Tool Short Form, to measure quality of life) and divergent validity (with the General Self-Efficacy Scale, to measure coping) were confirmed. Conclusion: The 64-item QoL&CI measure is a practical and valid measure addressing areas of clinical and patient significance and has potential value to assist patients and clinicians in discussions about treatment choices and treatment progress. Future research will address further psychometric testing (test-retest validity and responsiveness to change), in additional sites, and embedding the measure into clinical practice.

Aim. To determine the social, physical, and emotional impact of living with Perthes’ disease on affected children and their family (caregivers). Patients and Methods. Through a mixed methods approach, we interviewed 18 parents and explored the perspectives of 12 children affected by Perthes’ disease (mean = 7.1 years, SD = ±4.1 years) using a survey tool. Thematic analysis of parents’ interviews provided an insight into disease-specific factors influencing patients and family’s daily life activities. Using the childhood survey tool, good and bad day scores were analyzed using MANOVA (multivariate analysis of variance). Results. Thematic analysis of the parent interviews (main themes n = 4) identified a marked effect of the disease on many facets of the child’s life, particularly pain and the impact on sleep, play, and school attendance. In addition, the interviews identified a negative effect on the family life of the parents and siblings. Children indicated that activities of daily living were affected even during “good days” ( P < .05), but pain was the key limiting factor. Conclusion. Perthes’ disease negatively affects the social, physical, and emotional well-being of children and their family. These findings provide outcome domains that are important to measure in day-to-day care and add in-depth insight into the challenges caused by this disease for health care professionals involved in clinical management.

Objectives: Symptomatic developmental dysplasia of the hip can present in the young, active adult patient and can lead to severe pain and disability at a young age. The overall aim of the study was to deepen the understanding of the impact of developmental dysplasia of the hip on young adults’ quality of life and psycho-social well-being, focusing on how differential access to early diagnosis impacted the trajectory of the disease and treatment options. Methods: We conducted semi-structured interviews and gathered online stories from 97 participants. A narrative and thematic analysis was used to integrate the dataset producing a multi-dimensional view. Results: A narrative plot showing how events unfolded over time was identified for each participant. Two common plots were identified: Plot 1 focused around those participants who received a prompt diagnosis and were treated within 12 months of diagnosis (n = 22) and Plot 2 focused around those who experienced a late/delayed diagnosis (mean = 8 years; range = 12–364 months) (n = 75) and thus delayed treatment. Participants in Plot 2 became more debilitated over time and experienced chronic hip pain for a prolonged period before an accurate diagnosis and/or intervention was made. It was clear from the narratives when pain persists over time, participants’ quality of life and psycho-social well-being were affected. Conclusions: Developmental dysplasia of the hip is an under-recognised condition; more research is needed to develop a clear clinical picture that can be used to alert frontline health professionals to the potential for developmental dysplasia of the hip so that they can promptly diagnose patients and refer them to specialist centres. Patients can also experience a profound impact on their quality of life and psycho-social well-being. Patients actively seek information from support groups about all aspects of their condition. Further research is required to determine the long-term impact of developmental dysplasia of the hip to develop evidence-based information for clinicians and patients.

Purpose To explore the question of ‘how to evaluate a qualitative patient-centred outcome measure’, comprising predominantly open-ended items, including perhaps emojis, story writing and/or pictures, in a way that does not compromise the strictures of the qualitative paradigm, doing so in a credible and authoritative manner. The paper aims to promote debate and discussion in the measurement validation community. Methods Comprehensive literature review of three electronic databases (PubMed; SCOPUS; Web of Science/Knowledge) and searches of three outcome-focused journals. Results The vast majority (>90%) of the papers only used qualitative methods in the initial, in particular, content validation of a measure and then used (quantitative) psychometric validation procedures. The remaining papers comprised articles that were either methodologically or methods focused and the role of qualitative research. A number of key issues are raised, inter alia: giving primacy to the patient’s perspective; exploring the meaning and interpretation respondents place on the concept and possible items in a measure; prioritising maximising meaningful discrimination from the respondent’s perspective; ensuring face and content validity and relevance of items in the item content pool; and using appropriate qualitative methods, for example, concept elicitation, “think-aloud” and cognitive interviews and expert respondent panels/judges. This approach is applied to validate a child-friendly outcome measure for children with Perthes disease, a paediatric hip condition presenting primarily amongst male children aged 5-8 years. Conclusions The core messages are to: (i) not force validation of a qualitative outcome measure into psychometric validation; but (ii) retain full adherence to the principles of the qualitative paradigm and employ procedures drawn from that paradigm. In this manner, primary emphasis would lie on issues of meaningfulness, face and content validity, the meaning of item and measure scores to respondents and, for a child-friendly measure, the child-friendliness of the measure.

Background: There have been concerns about the quality and safety of NHS hospital services since the turn of the millennium. This study investigated the progress that acute NHS hospital trusts have made in developing and using technology infrastructures to enable them to monitor quality and safety following the publication in 2013 of the second Francis report on the scandal at Mid Staffordshire NHS Foundation Trust (The Mid Staffordshire NHS Foundation Trust Public Inquiry. Chaired by Sir Robert Francis QC. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. HC 898. London: The Stationery Office; 2013). Methods: A telephone survey of 15 acute NHS trusts in the Yorkshire and the Humber region, and a review of board papers of all acute NHS trusts in England for January 2015, were undertaken. The telephone survey was used to identify trusts for a larger field study, which was undertaken in four acute NHS trusts between April 2015 and September 2016. The methods included the direct observation of the use of whiteboards and other technologies on two wards in each trust, an observation of board quality committees, semistructured interviews and an analysis of the quality and safety data in board papers. Published sources about national and local agencies were reviewed to identify the trust quality and safety data that these agencies accessed and used. An interview programme was also undertaken with those organisations. The Biography of Artefacts approach was used to analyse the data. Findings: The data and technology infrastructures within trusts had developed over many years. The overall design had been substantially determined by national agencies, and was geared to data processing: capturing and validating data for submission to national agencies. Trust boards had taken advantage of these data and used them to provide assurance about quality and safety. Less positively, the infrastructures were fragmented, with different technologies used to handle different quality and safety data. Real-time management systems on wards, including electronic whiteboards and mobile devices, were used and valued by nurses and other staff. The systems support the proactive management of clinical risks. These developments have occurred within a broad context, with trusts focusing on improving the quality and safety of services and publishing far more data on their performance than they did just 3 years earlier. Trust-level data suggest that quality and safety improved at all four trusts between 2013 and 2016. Our findings indicate that the technology infrastructures contributed to these improvements. There remains considerable scope to rationalise those infrastructures. Limitations: The four trusts in the main study were, in part, purposively selected, and deliberately biased towards sites that had made progress with designing and deploying real-time ward management systems. This limits the generalisability of the study. The study focused more on the work of nurses and nurse managers, and has relatively little to say about the experiences of doctors or allied health professionals. Future work: Future research might focus on the effects of mobile technologies and electronic whiteboards on acute wards, the value of current national data returns, and the uses and value of trust data warehouses. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Background Perthes’ disease is an idiopathic osteonecrosis of a developmental hip that is most frequent in Northern Europe. Currently, the absence of a common set of standardised outcomes makes comparisons between studies of different interventions challenging. This study aims to summarise the outcomes used in clinical research of interventions for Perthes’ disease and define a set of core outcomes (COS) to ensure that the variables of primary importance are measured and reported in future research studies investigating Perthes’ disease. Methods A systematic review of the current literature will be used to identify a list of outcomes reported in previous studies. Additional important outcomes will be sought by interviewing a group of children with Perthes’ disease, adults who were treated with the disease in infancy and parents of children with the disease. This list will then be evaluated by experts in Perthes’ disease using a Delphi survey divided into two rounds to ascertain the importance of each outcome. The final outcomes list obtained from the Delphi survey will be then discussed during a consensus meeting of representative key stakeholders in order to define the COS to be reported in future clinical trials related to Perthes’ disease. Discussion The absence of high-quality research and clear guidelines concerning the management of Perthes’ disease is, at least in part, due to the difficulties in the comparing the results from previous studies. The development of a COS seeks to standardise outcomes collected in future research studies to enable comparisons between studies to be made and to facilitate meta-analyses of results. Trial registration Core Outcome Measures in Effectiveness Trials Initiative (COMET), 1003 . Registered on 20 July 2017. Prospero International Prospective Register of Systematic Reviews, CRD 42017069742 . Registered on 10 July 2017.

Objective To assess developments over time in the capture, curation and use of quality and safety information in managing hospital services. Setting Four acute National Health Service hospitals in England. Participants 111.5 hours of observation of hospital board and directorate meetings, and 72 hours of ward observations. 86 interviews with board level and middle managers and with ward managers and staff. Results There were substantial improvements in the quantity and quality of data produced for boards and middle managers between 2013 and 2016, starting from a low base. All four hospitals deployed data warehouses, repositories where datasets from otherwise disparate departmental systems could be managed. Three of them deployed real-time ward management systems, which were used extensively by nurses and other staff. Conclusions The findings, particularly relating to the deployment of real-time ward management systems, are a corrective to the many negative accounts of information technology implementations. The hospital information infrastructures were elements in a wider move, away from a reliance on individual professionals exercising judgements and towards team-based and data-driven approaches to the active management of risks. They were not, though, using their fine-grained data to develop ultrasafe working practices.

This article recounts our experience of eliciting, cataloguing and prioritizing conjectured Context-Mechanism-Outcome configurations at the outset of a realist evaluation, to provide new insight into how Context-Mechanism-Outcome configurations can be generated and theorized. Our construction of Context-Mechanism-Outcome configurations centred on how, why and in what circumstances teamwork was impacted by robotic surgery, rather than how and why this technology improved surgical outcomes as intended. We found that, as well as offering resources, robotic surgery took away resources from the theatre team, by physically reconfiguring the operating theatre and redistributing the surgical task load, essentially changing the context in which teamwork was performed. We constructed Context-Mechanism-Outcome configurations that explain how teamwork mechanisms were both constrained by the contextual changes, and triggered in the new context through the use of informal strategies. We conclude by reflecting on our application of realist evaluation to understand the potential impacts of robotic surgery on teamwork.

Length and complexity of illness and treatment in early breast cancer mean that the acute phase may extend over months. Employing concepts of “trajectory” and “work” from chronic illness, we explored the temporality of the illness experience for women as it unfolded from diagnosis through acute treatment. We performed multiple, qualitative interviews with 14 women at critical points in their first year postdiagnosis. We differentiated between subphases of the acute breast cancer trajectory: becoming a person with breast cancer: a turning point; first steps in treatment: struggling to protect self-concept; being and feeling ill: “cure” as suffering; and conditional “recovering”: an uncertain future. Each subphase represented the distinctive context in which illness management took place with consequences for the work women and those close to them engaged in, to manage the practical, emotional, relational, and existential demands of an illness that intruded every aspect of their lives.

Health systems around the world are investing increasing effort in monitoring care quality and safety. Dashboards can support this process, providing summary data on processes and outcomes of care, making use of data visualization techniques such as graphs. As part of a study exploring development and use of dashboards in English hospitals, we interviewed senior managers across 15 healthcare providers. Findings revealed substantial variation in sophistication of the dashboards in place, largely presenting retrospective data items determined by national bodies and dependent on manual collation from a number of systems. Where real time systems were in place, they supported staff in proactively managing quality and safety.

While an increasing number of healthcare providers are purchasing surgical robots because of anticipated improvements in patient outcomes, their implementation into practice is highly variable. In robotic surgery, the surgeon is physically separated from the patient and the rest of the team with the potential to impact communication and decision making in the operating theatre and subsequently patient safety. Drawing on the approach of realist evaluation, in this article we review reports of the experience of surgical teams that have introduced robotic surgery to identify how and in what contexts robotic surgery is successfully integrated into practice and how and in what contexts it affects communication and decision making. Our analysis indicates that, while robotic surgery might bring about a number of benefits, it also creates new challenges. Robotic surgery is associated with increased operation duration, which has implications for patient safety, but strategies to reduce it can be effective with appropriate support from hospital administration and nursing management. The separation of the surgeon from the team can compromise communication but may be overcome through use of standardised communication. While surgeon situation awareness may be affected by the separation, the ergonomic benefits of robotic surgery may reduce stress and tiredness and enhance surgeon decision making. Our review adds to the existing literature by revealing strategies to support the introduction of robotic surgery and contextual factors that need to be in place for these to be effective.