Identifying patient-valued outcomes for use in early phase trials of ocular surface disease interventions.

BACKGROUND: Patient-reported outcomes (PROs) can be used to evaluate the impact of dry eye symptoms (DES) on daily life. Early-phase clinical trials provide an opportunity to evaluate PRO strategies. Existing measures identified through systematic review omitted important concepts that mattered to patients. The aim of our work was to develop a conceptual map of DES and assess the relative importance of identified concepts. METHODS: Web-based group concept mapping software was used to develop a conceptual map. This semi-quantitative mixed-methods approach consists of three stages 1) statement generation, 2) thematic sorting, 3) rating of statements for importance [1 (not important), 2 (important), 3 (very important)] and relevance [1 (not my experience), 2 (sometimes my experience); 3 (definitely my experience)]. Thirty-nine participants were recruited from two UK-based patient support groups (British Sjögren's Syndrome Association, PemFriends). Three withdrew, two for health reasons and one struggled with the web-based format. RESULTS: 125 statements and six thematic clusters were generated. The Environmental Impacts cluster scored highest for importance (2.45), followed by Pain and Discomfort (2.35), Eye Treatments (2.32), Daily Impact (2.07), Psychosocial Issues (1.78) and Miscellaneous (1.78). Mapping statements against existing PRO measures confirmed a number of important missing issues including the impact of 'UV levels' (2.50), hot dry weather (2.33), the temporal aspects of pain (2.64), and issues with night-driving (2.59). CONCLUSIONS: Group concept mapping identified important issues for people living with DES not currently captured by existing PROs, highlighting the need for additional PRO items to be considered for use in clinical trials.

Patient experience of scar assessment and the use of scar assessment tools during burns rehabilitation: a qualitative study.

BACKGROUND: Scar assessment plays a key role during burns aftercare, to monitor scar remodelling and patients' psychosocial well-being. To aid assessment, subjective scar assessment scales are available that use health-care professionals' and patients' opinions to score scar characteristics. The subjective scales are more widely used in clinical practice over objective scar measures. To date, there is no research that considers patients' views on scar assessment and the role of subjective and objective assessment tools. Therefore, the aim of this qualitative study was to explore patients' perspectives on scar assessment and the utility of scar assessment tools during burns rehabilitation. METHODS: Semi-structured interviews were conducted with 10 adult burn patients who were being reviewed in clinic for scarring. Participants were recruited via their clinical care team and research nurses at the Queen Elizabeth Hospital, Birmingham, UK. Topics covered during interview included patient experience of scar assessment, the use of scar assessment tools and discussion surrounding important factors to be addressed when assessing scars. A thematic analysis using the Framework Method was conducted. RESULTS: Participants identified key subthemes that contribute towards the overarching theme of patient-centred scar assessment. These are: patient-led care; continuity in care; learning how to self-manage scarring; and psychological assessment. Links were demonstrated between these subthemes and the remaining themes that describe scar assessment strategies, indicating their potential patient-centred contributions. The subjective opinions of clinicians were found to be valued above the use of subjective or objective scar assessment tools. Scar assessment scales were perceived to be a beneficial method for self-reflection in relation to psychosocial functioning. However, minimal feedback and review of completed assessment scales led to uncertainty regarding their purpose. Patients perceived objective tools to be of primary use for health-care professionals, though the measures may aid patients' understanding of scar properties. CONCLUSIONS: Scar assessment tools should be used to support, rather than replace, health-care professionals' subjective judgements of scarring. Adapting the way in which clinicians introduce and use scar assessment tools, according to patient needs, can support a patient-centred approach to scar assessment.

Assessment of hospitalization rates for immune-related adverse events with immune checkpoint inhibitors.

INTRODUCTION: Immune checkpoint inhibitors (ICIs) have become the standard of care in many cancer types. As the number of patients receiving ICIs for various cancers continues to expand, patients and practitioners should be aware of potentially severe immune-related adverse events (irAEs). Despite reports of the incidence of grade 3/4 toxicities, the proportion of patients whose symptoms were clinically severe enough to warrant hospitalization for adverse event management is unknown. METHODS: This single center, retrospective, observational study was designed to determine the impact of irAEs on patients and the hospital. Patients who started ICIs from May 2016 through May 2019 for melanoma or lung cancer were included. The primary outcome was incidence of hospitalization for irAE. Secondary outcomes included median length of hospitalization, time to onset of irAE, rates of hospitalization for irAE per each checkpoint inhibitor regimen, organ system affected, progression free survival, and overall survival. RESULTS: Of 384 patients with melanoma or lung cancer, 27 (7%) were hospitalized at our institution for an irAE. The most common irAE leading to hospitalization was colitis for patients with melanoma and pneumonitis for patients with lung cancer. The median length of stay across all hospitalizations was 10 days. Twenty-five patients required the use of corticosteroids while hospitalized, while eight of these patients required second line irAE treatment. For the total patient population, 34.7% experienced a grade 1/2 irAE and 13.1% experienced a grade 3/4 irAE. CONCLUSION: Our cohort of patients experienced similar rates irAEs as reported in clinical trials and published reports.

Comparing physician associates and foundation year two doctors-in-training undertaking emergency medicine consultations in England: a mixed-methods study of processes and outcomes.

OBJECTIVES: To compare the contribution of physician associates to the processes and outcomes of emergency medicine consultations with that of foundation year two doctors-in-training. DESIGN: Mixed-methods study: retrospective chart review using 4 months' anonymised clinical record data of all patients seen by physician associates or foundation year two doctors-in-training in 2016; review of a subsample of 40 records for clinical adequacy; semi-structured interviews with staff and patients; observations of physician associates. SETTING: Three emergency departments in England. PARTICIPANTS: The records of 8816 patients attended by 6 physician associates and 40 foundation year two doctors-in-training; of these n=3197 had the primary outcome recorded (n=1129 physician associates, n=2068 doctor); 14 clinicians and managers and 6 patients or relatives for interview; 5 physician associates for observation. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was unplanned re-attendance at the same emergency department within 7 days. SECONDARY OUTCOMES: consultation processes, clinical adequacy of care, and staff and patient experience. RESULTS: Re-attendances within 7 days (n=194 (6.1%)) showed no difference between physician associates and foundation year two doctors-in-training (OR 0.87, 95% CI 0.61 to 1.24, p=0.437). If seen by a physician associate, patients were more likely receive an X-ray investigation (OR 2.10, 95% CI 1.72 to 4.24), p<0.001), after adjustment for patient characteristics, triage severity of condition and statistically significant clinician intraclass correlation. Clinical reviewers found almost all patients' charts clinically adequate. Physician associates were evaluated as assessing patients in a similar way to foundation year two doctors-in-training and providing continuity in the team. Patients were positive about the care they had received from a physician associate, but had poor understanding of the role. CONCLUSIONS: Physician associates in emergency departments in England treated patients with a range of conditions safely, and at a similar level to foundation year two doctors-in-training, providing clinical operational efficiencies.

What is the contribution of physician associates in hospital care in England? A mixed methods, multiple case study.

OBJECTIVES: To investigate the deployment of physician associates (PAs); the factors supporting and inhibiting their employment and their contribution and impact on patients' experience and outcomes and the organisation of services. DESIGN: Mixed methods within a case study design, using interviews, observations, work diaries and documentary analysis. SETTING: Six acute care hospitals in three regions of England in 2016-2017. PARTICIPANTS: 43 PAs, 77 other health professionals, 28 managers, 28 patients and relatives. RESULTS: A key influencing factor supporting the employment of PAs in all settings was a shortage of doctors. PAs were found to be acceptable, appropriate and safe members of the medical/surgical teams by the majority of doctors, managers and nurses. They were mainly deployed to undertake inpatient ward work in the medical/surgical team during core weekday hours. They were reported to positively contribute to: continuity within their medical/surgical team, patient experience and flow, inducting new junior doctors, supporting the medical/surgical teams' workload, which released doctors for more complex patients and their training. The lack of regulation and attendant lack of authority to prescribe was seen as a problem in many but not all specialties. The contribution of PAs to productivity and patient outcomes was not quantifiable separately from other members of the team and wider service organisation. Patients and relatives described PAs positively but most did not understand who and what a PA was, often mistaking them for doctors. CONCLUSIONS: This study offers new insights concerning the deployment and contribution of PAs in medical and surgical specialties in English hospitals. PAs provided a flexible addition to the secondary care workforce without drawing from existing professions. Their utility in the hospital setting is unlikely to be completely realised without the appropriate level of regulation and authority to prescribe medicines and order ionising radiation within their scope of practice.

Contribution of physician assistants/associates to secondary care: a systematic review.

OBJECTIVE: To appraise and synthesise research on the impact of physician assistants/associates (PA) in secondary care, specifically acute internal medicine, care of the elderly, emergency medicine, trauma and orthopaedics, and mental health. DESIGN: Systematic review. SETTING: Electronic databases (Medline, Embase, ASSIA, CINAHL, SCOPUS, PsycINFO, Social Policy and Practice, EconLit and Cochrane), reference lists and related articles. INCLUDED ARTICLES: Peer-reviewed articles of any study design, published in English, 1995-2017. INTERVENTIONS: Blinded parallel processes were used to screen abstracts and full text, data extractions and quality assessments against published guidelines. A narrative synthesis was undertaken. OUTCOME MEASURES: Impact on: patients' experiences and outcomes, service organisation, working practices, other professional groups and costs. RESULTS: 5472 references were identified and 161 read in full; 16 were included-emergency medicine (7), trauma and orthopaedics (6), acute internal medicine (2), mental health (1) and care of the elderly (0). All studies were observational, with variable methodological quality. In emergency medicine and in trauma and orthopaedics, when PAs are added to teams, reduced waiting and process times, lower charges, equivalent readmission rate and good acceptability to staff and patients are reported. Analgesia prescribing, operative complications and mortality outcomes were variable. In internal medicine outcomes of care provided by PAs and doctors were equivalent. CONCLUSIONS: PAs have been deployed to increase the capacity of a team, enabling gains in waiting time, throughput, continuity and medical cover. When PAs were compared with medical staff, reassuringly there was little or no negative effect on health outcomes or cost. The difficulty of attributing cause and effect in complex systems where work is organised in teams is highlighted. Further rigorous evaluation is required to address the complexity of the PA role, reporting on more than one setting, and including comparison between PAs and roles for which they are substituting. PROSPERO REGISTRATION NUMBER: CRD42016032895.