Qualitative study exploring the design of a patient-reported symptom-based risk stratification system for suspected head and neck cancer referrals: protocol for work packages 1 and 2 within the EVEREST-HN programme.

INTRODUCTION: Between 2009/2010 and 2019/2020, England witnessed an increase in suspected head and neck cancer (sHNC) referrals from 140 to 404 patients per 100 000 population. 1 in 10 patients are not seen within the 2-week target, contributing to patient anxiety. We will develop a pathway for sHNC referrals, based on the Head and Neck Cancer Risk Calculator. The evolution of a patient-reported symptom-based risk stratification system to redesign the sHNC referral pathway (EVEREST-HN) Programme comprises six work packages (WPs). This protocol describes WP1 and WP2. WP1 will obtain an understanding of language to optimise the SYmptom iNput Clinical (SYNC) system patient-reported symptom questionnaire for sHNC referrals and outline requirements for the SYNC system. WP2 will codesign key elements of the SYNC system, including the SYNC Questionnaire, and accompanying behaviour change materials. METHODS AND ANALYSIS: WP1 will be conducted at three acute National Health Service (NHS) trusts with variation in service delivery models and ensuring a broad mixture of social, economic and cultural backgrounds of participants. Up to 150 patients with sHNC (n=50 per site) and 15 clinicians (n=5 per site) will be recruited. WP1 will use qualitative methods including interviews, observation and recordings of consultations. Rapid qualitative analysis and inductive thematic analysis will be used to analyse the data. WP2 will recruit lay patient representatives to participate in online focus groups (n=8 per focus group), think-aloud technique and experience-based codesign and will be analysed using qualitative and quantitative approaches. ETHICS AND DISSEMINATION: The committee for clinical research at The Royal Marsden, a research ethics committee and the Health Research Authority approved this protocol. All participants will give informed consent. Ethical issues of working with patients on an urgent cancer diagnostic pathway have been considered. Findings will be disseminated via journal publications, conference presentations and public engagement activities.

Patient and public co-creation of healthcare safety and healthcare system resilience: The case of COVID-19.

INTRODUCTION: Healthcare system resilience is a conceptual approach that seeks to explore how health services adapt and respond to variability in demand and resources. As has been witnessed since the beginning of the COVID-19 pandemic, healthcare services have undergone many reconfigurations. One understudied aspect of how the 'system' is able to adapt and respond is the contribution of key stakeholders-patients and families, and in the context of the pandemic, the general public as a whole. This study aimed to understand what people were doing during the first wave of the pandemic to protect the safety of their health, and the health of others from COVID-19, and the resilience of the healthcare system. METHODS: Social media (Twitter) was used as a method of recruitment due to its ability for social reach. Twenty-one participants took part in 57 semistructured interviews over three time points from June to September 2020. The included an initial interview and invitation to two follow-up interviews after 3 and 6 weeks. Interviews were conducted virtually using Zoom-an encrypted secure video conferencing software. A reflexive thematic analysis approach to analysis was used. RESULTS: Three themes, each with its own subthemes were identified in the analysis: (1) A 'new safety normal'; (2) Existing vulnerabilities and heightened safety and (3) Are we all in this together? CONCLUSION: This study found that the public had a role in supporting the resilience of healthcare services and systems during the first wave of the pandemic by adapting their behaviour to protect themselves and others, and to avoid overwhelming the National Health Service. People who had existing vulnerabilities were more likely to experience safety gaps in their care, and be required to step in to support their safety, despite it being more difficult for them to do so. It may be that the most vulnerable were previously required to do this extra work to support the safety of their care and that the pandemic has just illuminated this issue. Future research should explore existing vulnerabilities and inequalities, and the heightened safety consequences created by the pandemic. PATIENT AND PUBLIC CONTRIBUTION: The National Institute for Health Research (NIHR) Yorkshire and Humber Patient Safety Translational Research Centre (NIHR Yorkshire and Humber PSTRC), Patient and Public Involvement and Engagement Research Fellow and NIHR Yorkshire and Humber PSTRC Patient Involvement in Patient Safety theme lay leader are involved in the preparation of a lay version of the findings within this manuscript.

Identifying Safety Practices Perceived as Low Value: An Exploratory Survey of Healthcare Staff in the United Kingdom and Australia.

OBJECTIVES: Up to 30% of healthcare spending is considered unnecessary and represents systematic waste. While much attention has been given to low-value clinical tests and treatments, much less has focused on identifying low-value safety practices in healthcare settings. With increasing recognition of the problem of "safety clutter" in organizations, it is important to consider deimplementing safety practices that do not benefit patients, to create the time needed to deliver effective, person-centered, and safe care. This study surveyed healthcare staff to identify safety practices perceived to be of low value. METHODS: Purposive and snowball sampling was used. Data collection was conducted from April 2018 to November 2019 (United Kingdom) and May 2020 to November 2020 (Australia). Participants completed the survey online or in hard copy to identify practices they perceived to not contribute to safe care. Responses were analyzed using content and thematic analysis. RESULTS: A total of 1394 responses from 1041 participants were analyzed. Six hundred sixty-three responses were collected from 526 UK participants and 515 Australian participants contributed 731 responses. Frequently identified categories of practices identified included "paperwork," "duplication," and "intentional rounding." Five cross-cutting themes (e.g., covering ourselves) offered an underpinning rationale for why staff perceived the practices to be of low value. CONCLUSIONS: Staff identified safety practices that they perceived to be low value. In healthcare systems under strain, removing existing low-value practices should be a priority. Careful evaluation of these identified safety practices is required to determine whether they are appropriate for deimplementation and, if not, to explore how to better support healthcare workers to perform them.

Capturing Parents' Perspectives of Child Wellness to Support Identification of Acutely Unwell Children in the Emergency Department.

OBJECTIVE: Early signs of serious illness can be difficult to recognize in children and a delayed response can result in poor outcomes. Drawing on the unique knowledge of parents and carers may improve identification of the deteriorating child. However, there is a lack of evidence exploring parental perspectives as part of track and trigger systems. This study examines the utility of capturing parent-reported child wellness, using the Patient Wellness Questionnaire for Pediatrics, to support identification of acutely unwell children presenting to the Emergency Department. METHODS: Parent-reported child wellness was recorded alongside the Pediatric Observation Priority Score (POPS), a multidimensional scoring system akin to a Pediatric Early Warning Score, used as part of routine care. Multiple linear regression assessed the independent effects of 3 variables (parent-reported child wellness, nurse concern, and child age) on POPS and hospital admission. RESULTS: Data were collected for 407 children. All 3 variables explained a statistically significant proportion of variance in POPS (F(3, 403) = 7.525, P < 0.001, R2 = 0.053), with parent-reported child wellness (B = 0.223, SE = 0.054, ß = 0.202, P < 0.001) having the strongest effect. Approximately 10% of the children with no physiological derangement were rated as "very poorly" by their parents. CONCLUSIONS: The findings suggest that parents have insight in to the wellness of their children that is reflected in the physiological assessment. Some parents' perceptions about their child's wellness were not consistent with the score captured in the same assessment. More work is needed to understand how to use and address parental perspectives and concerns to support clinical decision making and the management of acute illness.

What do primary care staff think about patients accessing electronic health records? A focus group study.

BACKGROUND: Patients have expressed a growing interest in having easy access to their personal health information, and internationally there has been increasing policy focus on patient and care records being more accessible. Limited research from the UK has qualitatively explored this topic from the primary care staff perspective. This study aimed to understand what primary care staff think about patients accessing electronic health records, highlighting errors in electronic health records, and providing feedback via online patient portals. METHODS: A focus group study involving 19 clinical and non-clinical primary care staff. Primary care practices were purposively sampled based on practice size and the percentage of patients using online services. Data were analysed inductively using reflexive thematic analysis. RESULTS: Three themes were generated: (1) Information - what, why and when? (2) Changing behaviours and protecting relationships, and (3) Secure access and safeguarding. The emotional considerations and consequences for staff and patients featured prominently in the data as an overarching theme. CONCLUSIONS: Primary care staff described being invested and supportive of patients accessing their electronic health records, and acknowledged the numerous potential benefits for safety. Uncertainty around the parameters of access, the information available and what this might look like in the future, processes for patients highlighting errors in records, relational issues, security and safeguarding and equitable access, were key areas warranting examination in future research.

Systemic safety inequities for people with learning disabilities: a qualitative integrative analysis of the experiences of English health and social care for people with learning disabilities, their families and carers.

BACKGROUND: Failures in care for people with learning disabilities have been repeatedly highlighted and remain an international issue, exemplified by a disparity in premature death due to poor quality and unsafe care. This needs urgent attention. Therefore, the aim of the study was to understand the care experiences of people with learning disabilities, and explore the potential patient safety issues they, their carers and families raised. METHODS: Two data sources exploring the lived experience of care for people with learning disabilities were synthesised using an integrative approach, and explored using reflexive thematic analysis. This comprised two focus groups with a total of 13 people with learning disabilities and supportive staff, and 377 narratives posted publicly via the feedback platform Care Opinion. RESULTS: The qualitative exploration highlighted three key themes. Firstly, health and social care systems operated with varying levels of rigidity. This contributed to an inability to effectively cater to; complex and individualised care needs, written and verbal communication needs and needs for adequate time and space. Secondly, there were various gaps and traps within systems for this population. This highlighted the importance of care continuity, interoperability and attending to the variation in support provision from professionals. Finally, essential 'dependency work' was reliant upon social capital and fulfilled by paid and unpaid caring roles to divergent extents, however, advocacy provided an additional supportive safety net. CONCLUSIONS: A series of safety inequities have been identified for people with learning disabilities, alongside potential protective buffers. These include; access to social support and advocacy, a malleable system able to accommodate for individualised care and communication needs, adequate staffing levels, sufficient learning disabilities expertise within and between care settings, and the interoperability of safety initiatives. In order to attend to the safety inequities for this population, these factors need to be considered at a policy and organisational level, spanning across health and social care systems. Findings have wide ranging implications for those with learning disabilities, their carers and families and health and social care providers, with the potential for international learning more widely.

Exploring patient safety outcomes for people with learning disabilities in acute hospital settings: a scoping review.

OBJECTIVES: To produce a narrative synthesis of published academic and grey literature focusing on patient safety outcomes for people with learning disabilities in an acute hospital setting. DESIGN: Scoping review with narrative synthesis. METHODS: The review followed the six stages of the Arksey and O'Malley framework. We searched four research databases from January 2000 to March 2021, in addition to handsearching and backwards searching using terms relating to our eligibility criteria-patient safety and adverse events, learning disability and hospital setting. Following stakeholder input, we searched grey literature databases and specific websites of known organisations until March 2020. Potentially relevant articles and grey literature materials were screened against the eligibility criteria. Findings were extracted and collated in data charting forms. RESULTS: 45 academic articles and 33 grey literature materials were included, and we organised the findings around six concepts: (1) adverse events, patient safety and quality of care; (2) maternal and infant outcomes; (3) postoperative outcomes; (4) role of family and carers; (5) understanding needs in hospital and (6) supporting initiatives, recommendations and good practice examples. The findings suggest inequalities and inequities for a range of specific patient safety outcomes including adverse events, quality of care, maternal and infant outcomes and postoperative outcomes, in addition to potential protective factors, such as the roles of family and carers and the extent to which health professionals are able to understand the needs of people with learning disabilities. CONCLUSION: People with learning disabilities appear to experience poorer patient safety outcomes in hospital. The involvement of family and carers, and understanding and effectively meeting the needs of people with learning disabilities may play a protective role. Promising interventions and examples of good practice exist, however many of these have not been implemented consistently and warrant further robust evaluation.

Health professionals' perspectives of safety issues in mental health services: A qualitative study.

The study aimed to explore mental health professionals' perceptions of patient safety issues across community and inpatient mental health services. Fourteen mental health professionals across community and inpatient settings participated in qualitative interviews. Framework analysis, guided by the Yorkshire Contributory Factors Framework - Mental Health, was used to analyse the data. Safety issues identified by mental health professionals mapped on to 19 of the 21 factors in the Yorkshire Contributory Factors Framework - Mental Health. The factors most frequently mentioned by participants were 'safety culture' which focused on raising concerns, learning from incidents and the influence of targets; 'communication systems' to support effective communication between staff; 'service user factors' including a perceived increase in illness acuity; 'service process' including how patients access and interact with services; and 'staff workload' perceived being as unmanageable. Mental health professionals consider there to be a broad range of safety issues associated with mental health services. Future research should aim to develop interventions to improve safety focused across the factors raised by professionals.

Can Routinely Collected, Patient-Reported Wellness Predict National Early Warning Scores? A Multilevel Modeling Approach.

OBJECTIVE: Measures exist to improve early recognition of and response to deteriorating patients in hospital. However, management of critical illness remains a problem globally; in the United Kingdom, 7% of the deaths reported to National Reporting and Learning System from acute hospitals in 2015 related to failure to recognize or respond to deterioration. The current study explored whether routinely recording patient-reported wellness is associated with objective measures of physiology to support early recognition of hospitalized deteriorating patients. METHODS: A prospective observation study design was used. Nurses on four inpatient wards were invited to participate and record patient-reported wellness during every routine observation (where possible) using an electronic observation system. Linear multilevel modeling was used to examine the relationship between patient-reported wellness, and national early warning scores (NEWS), and whether patient-reported wellness predicted subsequent NEWS. RESULTS: A significant positive relationship was found between patient-reported wellness and NEWS recorded at the next observation while controlling for baseline NEWS (ß = 0.180, P = 0.033). A significant positive relationship between patient-reported wellness and NEWS (ß = 0.229, P = 0.005) recorded during an observation 24 hours later while controlling for baseline NEWS was also found. Patient-reported wellness added to the predictive model for subsequent NEWS. CONCLUSIONS: The preliminary findings suggest that patient-reported wellness may predict subsequent improvement or decline in their condition as indicated by objective measurements of physiology (NEWS). Routinely recording patient-reported wellness during observation shows promise for supporting the early recognition of clinical deterioration in practice, although confirmation in larger-scale studies is required.

A qualitative exploration of mental health service user and carer perspectives on safety issues in UK mental health services.

BACKGROUND: Service user and carer perspectives on safety issues in mental health services are not well known and may be important in preventing and reducing harm. The development of the Yorkshire Contributory Factors Framework-Mental Health (YCFF-MH) provides a broad structure within which to explore these perspectives. OBJECTIVE: To explore what service users of mental health services and their carers consider to be safety issues. DESIGN, SETTING AND PARTICIPANTS: Qualitative interviews with 13 service users and 7 carers in the UK. Participants were asked about their experiences and perceptions of safety within mental health services. Perceived safety issues were identified using framework analysis, guided by the YCFF-MH. RESULTS: Service users and carers identified a broad range of safety issues. These were categorized under 'safety culture' and included psychological concepts of safety and raising concerns; 'social environment' involved threatened violence and sexual abuse; 'individual service user and staff factors' dominated by not being listened to; 'management of staff and staffing levels' resulting in poor continuity of care; and 'service process' typified by difficulty accessing services during a crisis. Several examples of 'active failures' were also described. DISCUSSION AND CONCLUSIONS: Safety issues appear broader than those recorded and reported by health services and inspectorates. Many safety issues have also been identified in other care settings supporting the notion that there are overlaps between service users and carers' perspectives of safety in mental health services and those of users in other settings. Areas for further research are suggested.

Involving patients in recognising clinical deterioration in hospital using the Patient Wellness Questionnaire: A mixed-methods study.

BACKGROUND: Measures exist to improve early recognition of, and response to deteriorating patients in hospital. Despite these, 7% of the deaths reported to the National Reporting and Learning System from acute hospitals in 2015 related to a failure to recognise or respond to deterioration. Interventions have been developed that allow patients and relatives to escalate patient deterioration to a critical care outreach team. However, there is not a strong evidence base for the clinical effectiveness of these interventions, or patients' ability to recognise deterioration. AIMS: The aims of this study were as follows. (a) To identify methods of involving patients in recognising deterioration in hospital, generated by health professionals. (b) To develop and evaluate an identified method of patient involvement in practice, and explore its feasibility and acceptability from the perspectives of patients. METHODS: The study used a mixed-methods design. A measure to capture patient-reported wellness during observation was developed (Patient Wellness Questionnaire) through focus group discussion with health professionals and patients, and piloted on inpatient wards. RESULTS: There was limited uptake where patients were asked to record ratings of their wellness using the Patient Wellness Questionnaire themselves. However, where the researcher asked patients about their wellness using the Patient Wellness Questionnaire and recorded their responses during observation, this was acceptable to most patients. CONCLUSIONS: This study has developed a measure that can be used to routinely collect patient-reported wellness during observation in hospital and may potentially improve early detection of deterioration.

Validation of revised patient measures of safety: PMOS-30 and PMOS-10.

OBJECTIVES: There is growing evidence that patients can provide feedback on the safety of their care. The 44-item Patient Measure of Safety (PMOS) was developed for this purpose. While valid and reliable, the length of this questionnaire makes it potentially challenging for routine use. Our study aimed to produce revised, shortened versions of PMOS (PMOS-30 and PMOS-10), which retained the psychometric properties of the longer version. PARTICIPANTS: To produce a shortened diagnostic measure, we analysed data from 2002 patients who completed PMOS-44, and examined the reliability of the revised measure (PMOS-30) in a sample of 751 patients. To produce a brief standalone measure, we again analysed data from 2002 patients who completed PMOS-44, and tested the reliability and validity of the brief standalone measure (PMOS-10) in a sample of 165 patients. METHODS: The process of shortening the questionnaire involved a combination of secondary data analysis (eg, Standard Deviation and inter-item correlations) and a consensus group exercise to produce PMOS-30 and examine face validity. Analysis of PMOS-30 data examined reliability (eg, Cronbach's alpha). Further secondary data analysis (ie, corrected item-total correlations) produced PMOS-10, and primary data collection assessed its reliability and validity (eg, Cronbach's alpha, analysis of variance). RESULTS: Fourteen items were removed to produce PMOS-30 and the percentage of negatively worded items was reduced from 57% to 33%. PMOS-30 demonstrated good internal reliability (α=0.89). The 10 items with the highest corrected item-total correlations across both PMOS-44 and PMOS-30 composed PMOS-10. PMOS-10 had good internal reliability (α=0.79), demonstrated convergent validity; however, discriminant validity was not established. CONCLUSIONS: Two revised, shortened versions of the original PMOS-44 (PMOS-30 and PMOS-10) were produced to capture patient feedback about safety in hospital. The measures demonstrated good reliability and validity, and preserved the psychometric properties of the original measure.

Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials.

PURPOSE: This review aimed to determine the clinician and patient reported outcome (PRO) instruments currently usedin randomized controlled trials (RCTs) of radical radiation therapy for nonmetastatic prostate cancer to report acute and late adverse events (AEs), review the quality of methodology and PRO reporting, and report the prevalence of acute and late AEs. METHODS AND MATERIALS: The MEDLINE, EMBASE, and Cochrane databases were searched between April and August 2014 according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. Identified reports were reviewed according to the PRO Consolidated Standards of Reporting Trials (CONSORT) guidelines and the Cochrane Risk of Bias tool. In all, 1149 records were screened, and 21 articles were included in the final review. RESULTS: We determined the acute and late AEs for 9040 patients enrolled in 15 different RCTs. Only clinician reported instruments were used to report acute AEs <3 months (eg, Radiation Therapy Oncology Group [RTOG] and Common Terminology Criteria for Adverse Events [CTCAE]). For late clinician reporting, the Late Effects on Normal Tissues-Subjective, Objective, Management and Analytic scale and RTOG were used and were often augmented with additional items to provide comprehensive coverage of sexual functioning and anorectal symptoms. Some late AEs were reported (48% articles) using PROs (eg, ULCA-PCI [University of California, Los Angeles Prostate Cancer Index], FACT-G and P [Functional Assessment of Cancer Therapy General & Prostate Module], EORTC QLQC-30 + PR25 [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire & Prostate Module]); however, a definitive "preferred" instrument was not evident. DISCUSSION: Our findings are at odds with recent movements toward including patient voices in reporting of AEs and patient engagement in clinical research. We recommend including PRO to evaluate radical radiation therapy before, during, and after the treatment to fully capture patient experiences, and we support the development of predictive models for late effects based on the severity of early toxicity. CONCLUSION: Patient reporting of acute and late AEs is underrepresented in radiation therapy trials. We recommend working toward a consistent approach to PRO assessment of radiation therapy-related AEs.

Is there a role for patients and their relatives in escalating clinical deterioration in hospital? A systematic review.

BACKGROUND: Measures exist to improve early recognition of, and response to, deteriorating patients in hospital. However, deteriorating patients continue to go unrecognized. To address this, interventions have been developed that invite patients and relatives to escalate patient deterioration to a rapid response team (RRT). OBJECTIVE: To systematically review articles that describe these interventions and investigate their effectiveness at reducing preventable deterioration. SEARCH STRATEGY: Following PRISMA guidelines, four electronic databases and two web search engines were searched to identify literature investigating patient and relative led escalation. INCLUSION CRITERIA: Articles investigating the implementation or use of systems involving patients and relatives in the detection of clinical patient deterioration and escalation of patient care to address any clinical or non-clinical outcomes were included. Articles' eligibility was validated by a second reviewer (20%). DATA EXTRACTION: Data were extracted according to pre-defined criteria. DATA SYNTHESIS: Narrative synthesis was applied to included studies. MAIN RESULTS: Nine empirical studies and 36 grey literature articles were included in the review. Limited studies were conducted to establish the clinical effectiveness of patient and relative led escalation. Instead, studies investigated the impact of this intervention on health-care staff and available resources. Although appropriate, this reflects the infancy of research in this area. Patients and relatives did not overwhelm resources by activating the RRT. However, they did activate it to address concerns unrelated to patient deterioration. CONCLUSIONS: Activating a RRT may not be the most appropriate or cost-effective method of resolving non-life-threatening concerns.