The effect of two speech and language approaches on speech problems in people with Parkinson's disease: the PD COMM RCT.

Background: Speech impairments are common with Parkinson's disease (reported prevalence 68%), increasing conversational demands, reliance on family and social withdrawal. Objective(s): The PD COMM trial compared the clinical and cost-effectiveness of two speech and language therapy approaches: Lee Silverman Voice Treatment LOUD and National Health Service speech and language therapy for the treatment of speech or voice problems in people with Parkinson's disease to no speech and language therapy (control) and against each other. Design: PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Participants were randomised in a 1 : 1 : 1 ratio to control, National Health Service speech and language therapy or Lee Silverman Voice Treatment LOUD via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Mixed-methods process and health economic evaluations were conducted. Setting: United Kingdom outpatient and home settings. Participants: People with idiopathic Parkinson's disease, with self-reported or carer-reported speech or voice problems. We excluded people with dementia, laryngeal pathology and those within 24 months of previous speech and language therapy. Interventions: The Lee Silverman Voice Treatment LOUD intervention included maximum effort drills and high-effort speech production tasks delivered over four 50-minute therapist-led personalised sessions per week, for 4 weeks with prescribed daily home practice. National Health Service speech and language therapy content and dosage reflected local non-Lee Silverman Voice Treatment speech and language therapy practices, usually 1 hour, once weekly, for 6 weeks. Trained, experienced speech and language therapists or assistants provided interventions. The control was no speech and language therapy until the trial was completed. Main outcome measures: Primary outcome: Voice Handicap Index total score at 3 months. Secondary outcomes: Voice Handicap Index subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5L; ICEpop Capabilities Measure for Older Adults; Parkinson's Disease Questionnaire - Carers; resource utilisation; and adverse events. Assessments were completed pre-randomisation and at 3, 6 and 12 months post randomisation. Results: Three hundred and eighty-eight participants were randomised to Lee Silverman Voice Treatment LOUD (n = 130), National Health Service speech and language therapy (n = 129) and control (n = 129). The impact of voice problems at 3 months after randomisation was lower for Lee Silverman Voice Treatment LOUD participants than control [-8.0 (99% confidence interval: -13.3, -2.6); p = 0.001]. There was no evidence of improvement for those with access to National Health Service speech and language therapy when compared to control [1.7 (99% confidence interval: -3.8, 7.1); p = 0.4]. Participants randomised to Lee Silverman Voice Treatment LOUD reported a lower impact of their voice problems than participants randomised to National Health Service speech and language therapy [99% confidence interval: -9.6 (-14.9, -4.4); p < 0.0001]. There were no reports of serious adverse events. Staff were confident with the trial interventions; a range of patient and therapist enablers of implementing Lee Silverman Voice Treatment LOUD were identified. The economic evaluation results suggested Lee Silverman Voice Treatment LOUD was more expensive and more effective than control or National Health Service speech and language therapy but was not cost-effective with incremental cost-effectiveness ratios of £197,772 per quality-adjusted life-year gained and £77,017 per quality-adjusted life-year gained, respectively. Limitations: The number of participants recruited to the trial did not meet the pre-specified power. Conclusions: People that had access to Lee Silverman Voice Treatment LOUD described a significantly greater reduction in the impact of their Parkinson's disease-related speech problems 3 months after randomisation compared to people that had no speech and language therapy. There was no evidence of a difference between National Health Service speech and language therapy and those that received no speech and language therapy. Lee Silverman Voice Treatment LOUD resulted in a significantly lower impact of voice problems compared to National Health Service speech and language therapy 3 months after randomisation which was still present after 12 months; however, Lee Silverman Voice Treatment LOUD was not found to be cost-effective. Future work: Implementing Lee Silverman Voice Treatment LOUD in the National Health Service and identifying alternatives to Lee Silverman Voice Treatment LOUD for those who cannot tolerate it. Investigation of less costly alternative options for Lee Silverman Voice Treatment delivery require investigation, with economic evaluation using a preference-based outcome measure that captures improvement in communication. Study registration: This study is registered as ISRCTN12421382. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 10/135/02) and is published in full in Health Technology Assessment; Vol. 28, No. 58. See the NIHR Funding and Awards website for further award information.

Most people with Parkinson's disease develop difficulties with their speech and voice. Communicating becomes difficult. This affects their relationships, work, social life and how they feel about themselves. Our PD COMM trial compared two types of speech and language therapy to find out if they helped the speech and voice problems people with Parkinson's have. We measured changes in the way their voice and speech problems affected their lives and how much therapy cost the National Health Service and families. Everyone taking part had speech or voice problems because of their Parkinson's disease. People could not take part if they had dementia, evidence of laryngeal pathology or previous laryngeal surgery or received speech and therapy for Parkinson's disease in the last 2 years. People who agreed to take part joined one of three groups, which were alike except for the therapy they received. A computer decided which group they joined by chance. National Health Service speech and language therapy Lee Silverman Voice Treatment LOUD No speech and language therapy for 12 months The 388 people who took part came from 41 outpatient clinics in Scotland, England and Wales. Most were older men. The people that received Lee Silverman Voice Treatment LOUD felt better about their speech and voice after 3 months compared to people in the other groups. A year later, they still felt better about it. People that received National Health Service therapy had no benefit compared to people with no access to therapy. Analysis of cost-effectiveness indicated that Lee Silverman Voice Treatment LOUD did not offer value for money and the intervention cost more because more speech and language therapy time was needed to deliver it. Our next question is to ask how we can provide Lee Silverman Voice Treatment LOUD in a way that costs less, for example, using therapy assistants and computer packages or at home. Clear speech and language therapy approaches for people with Parkinson's disease and speech or voice problems should be tested in trials that measure changes in people's lives.

Cost-effectiveness of an extended-role general practitioner clinic for persistent physical symptoms: results from the Multiple Symptoms Study 3 (MSS3) pragmatic randomised controlled trial.

OBJECTIVES: To evaluate the cost-effectiveness of an extended-role general practitioner (GP) symptoms clinic (SC), added to usual care (UC) for patients with multiple persistent physical symptoms (sometimes known as "medically unexplained symptoms"). METHODS: A 52-week within-trial cost-utility analysis of a pragmatic multicentre randomised controlled trial comparing SC+UC (n=178) against UC alone (n=176), conducted from the primary perspective of the UK National Health Service (NHS) and personal and social services (PSS). Base-case quality-adjusted life-years (QALYs) were measured using EQ-5D-5L. Missing data were imputed using multiple imputation (MI). Cost-effectiveness results were presented as incremental cost-effectiveness ratios (ICERs) and incremental net monetary benefits (INMBs). Uncertainty was explored using cost-effectiveness acceptability curves (using 1000 non-parametric bootstrapped samples) and sensitivity analysis (including societal costs, using SF-6D and capability ICECAP-A outcomes to estimate QALYs and years of full capability (YFC) respectively, varying intervention costs, missing data mechanism assumptions). RESULTS: Multiple imputation analysis showed that, compared to UC alone, SC+UC was more expensive [(adjusted mean cost difference: 704; 95% CI:£605, £807)] and more effective [(adjusted mean QALY difference: 0.0447 (95% CI:0.0067, 0.0826)] yielding an ICER of £15,765/QALY, INMB of £189.22 (95% CI:-£573.62, £948.28) and a 69% probability of the SC+UC intervention arm being cost-effective at a threshold of £20000 per QALY. Results were robust to most sensitivity analyses, but sensitive to missing data assumptions (2 of the 8 scenarios investigated), SF-6D and ICECAP-A quality of life outcomes. CONCLUSIONS: A Symptoms Clinic is likely to be a potentially cost-effective treatment for patients with persistent physical symptoms.

Use of emergency departments by children and young people following telephone triage: a large database study.

BACKGROUND: Although one objective of NHS 111 is to ease the strain on urgent and emergency care services, studies suggest the telephone triage service may be contributing to increased demand. Moreover, while parents and caregivers generally find NHS 111 satisfactory, concerns exist about its integration with the healthcare system and the appropriateness of advice. This study aimed to analyse the advice provided in NHS 111 calls, the duration between the call and ED attendance, and the outcomes of such attendances made by children and young people (C&YP). METHODS: A retrospective cohort study was carried out of C&YP (≤17) attending an ED in the Yorkshire and Humber region of the UK following contact with NHS 111 between 1 April 2016 and 31 March 2017. This linked-data study examined NHS 111 calls and ED outcomes. Lognormal mixture distributions were fit to compare the time taken to attend ED following calls. Logistic mixed effects regression models were used to identify predictors of low-acuity NHS 111-related ED attendances. RESULTS: Our study of 348 401 NHS 111 calls found they were primarily concerning children aged 0-4 years. Overall, 13.1% of calls were followed by an ED attendance, with a median arrival time of 51 minutes. Of the 34 664 calls advising ED attendance 41% complied, arriving with a median of 38 minutes-27% of which defined as low-acuity. Although most calls advising primary care were not followed by an ED attendance (93%), those seen in an ED generally attended later (median 102 minutes) with 23% defined as low-acuity. Younger age (<1) was a statistically significant predictor of low-acuity ED attendance following all call dispositions apart from home care. CONCLUSION: More tailored options for unscheduled healthcare may be needed for younger children. Both early low-acuity attendance and late high-acuity attendance following contact with NHS 111 could act as useful entry points for clinical audits of the telephone triage service.

Diagnosis of occult scaphoid fractures: an exploratory study to assess whether clusters of clinical features are diagnostic in comparison to reduced sequence magnetic resonance imaging.

BACKGROUND: Occult scaphoid fractures are difficult to diagnose radiographically. Evidence regarding prevalence and diagnostic accuracy of clinical tests is growing; however, gaps in knowledge remain and further research is needed. PURPOSE: This study aimed to determine the prevalence of occult scaphoid fractures and other hand/wrist fractures, plus any clinical/demographic findings diagnostic of scaphoid fractures. METHODS: Prognostic prospective cohort study. Patients referred with diagnosis of occult scaphoid fractures, non-diagnostic radiographs, and one or more positive provocative test for scaphoid fractures were included. Clinical data were compared to reduce sequence magnetic resonance imaging. Univariate logistic regression was used to determine significance. Multivariable logistic regression was used to determine the effect size of these variables. RESULTS: Of 197 included participants, 43(22%) had a scaphoid fracture and 59(30%) had an occult fracture other than scaphoid. Average age of patients with confirmed occult scaphoid fractures was 22 years old. Distal pole fractures were the most common scaphoid fracture (n = 28/65.1%, average age 16.9 years). Three clinical tests (pain with ulnar-deviation, anatomical snuffbox swelling and pain-free grip) plus two demographics (age <23 and male) resulted in accuracy of 81.7%, positive predictive value of 73.3%, and negative predictive value of 82.4% in diagnosing scaphoid fractures. CONCLUSION: This study confirms a high prevalence of occult fractures in our population. Patients demonstrating the relevant demographics and positive clinical tests may be appropriate to treat as scaphoid fractures without advanced imaging. Most patients will present with differing clinical findings and/or demographics, and routine use of magnetic resonance imaging is recommended.

Emergency admission predictive risk stratification models: assessment of implementation consequences (PRISMATIC 2): protocol for a mixed methods study.

BACKGROUND: Emergency admissions are costly, increasingly numerous, and associated with adverse patient outcomes. Policy responses have included the widespread introduction of emergency admission risk stratification (EARS) tools in primary care. These tools generate scores that predict patients' risk of emergency hospital admission and can be used to support targeted approaches to improve care and reduce admissions. However, the impact of EARS is poorly understood and there may be unintended consequences. AIM: To assess effects, mechanisms, costs, and patient and healthcare professionals' views related to the introduction of EARS tools in England. DESIGN & SETTING: Quasi-experimental mixed methods design using anonymised routine data and qualitative methods. METHOD: We will apply multiple interrupted time series analysis to data, aggregated at former Clinical Commissioning Group level, to look at changes in emergency admission and other healthcare use following EARS introduction across England. We will investigate GP decision-making at practice level using linked general practice and secondary care data to compare case-mix, demographics, indicators of condition severity and frailty associated with emergency admissions before and after EARS introduction. We will undertake interviews (n~48) with GPs and healthcare staff to understand how patient care may have changed. We will conduct focus groups (n=2) and interviews (n~16) with patients to explore how they perceive that communication of individual risk scores might affect their experiences and health seeking behaviours. CONCLUSION: Findings will provide policymakers, healthcare professionals, and patients, with a better understanding of the effects, costs and stakeholder perspectives related to the introduction of EARS tools.

Lee Silverman voice treatment versus NHS speech and language therapy versus control for dysarthria in people with Parkinson's disease (PD COMM): pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial.

OBJECTIVES: To assess the clinical effectiveness of two speech and language therapy approaches versus no speech and language therapy for dysarthria in people with Parkinson's disease. DESIGN: Pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial. SETTING: The speech and language therapy interventions were delivered in outpatient or home settings between 26 September 2016 and 16 March 2020. PARTICIPANTS: 388 people with Parkinson's disease and dysarthria. INTERVENTIONS: Participants were randomly assigned to one of three groups (1:1:1): 130 to Lee Silverman voice treatment (LSVT LOUD), 129 to NHS speech and language therapy, and 129 to no speech and language therapy. LSVT LOUD consisted of four, face-to-face or remote, 50 min sessions each week delivered over four weeks. Home based practice activities were set for up to 5-10 mins daily on treatment days and 15 mins twice daily on non-treatment days. Dosage for the NHS speech and language therapy was determined by the local therapist in response to the participants' needs (estimated from prior research that NHS speech and language therapy participants would receive an average of one session per week over six to eight weeks). Local practices for NHS speech and language therapy were accepted, except for those within the LSVT LOUD protocol. Analyses were based on the intention to treat principle. MAIN OUTCOME MEASURES: The primary outcome was total score at three months of self-reported voice handicap index. RESULTS: People who received LSVT LOUD reported lower voice handicap index scores at three months after randomisation than those who did not receive speech and language therapy (-8.0 points (99% confidence interval -13.3 to -2.6); P<0.001). No evidence suggests a difference in voice handicap index scores between NHS speech and language therapy and no speech and language therapy (1.7 points (-3.8 to 7.1); P=0.43). Patients in the LSVT LOUD group also reported lower voice handicap index scores than did those randomised to NHS speech and language therapy (-9.6 points (-14.9 to -4.4); P<0.001). 93 adverse events (predominately vocal strain) were reported in the LSVT LOUD group, 46 in the NHS speech and language therapy group, and none in the no speech and language therapy group. No serious adverse events were recorded. CONCLUSIONS: LSVT LOUD was more effective at reducing the participant reported impact of voice problems than was no speech and language therapy and NHS speech and language therapy. NHS speech and language therapy showed no evidence of benefit compared with no speech and language therapy. TRIAL REGISTRATION: ISRCTN registry ISRCTN12421382.

Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England: the Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial.

BACKGROUND: People with multiple and persistent physical symptoms have impaired quality of life and poor experiences of health care. We aimed to evaluate the effectiveness of a community-based symptom-clinic intervention in people with multiple and persistent physical symptoms, hypothesising that this symptoms clinic plus usual care would be superior to usual care only. METHODS: The Multiple Symptoms Study 3 was a pragmatic, multicentre, parallel-group, individually randomised controlled trial conducted in 108 general practices in the UK National Health Service in four regions of England between Dec 6, 2018, and June 30, 2023. Participants were individually randomised (1:1) to the symptom-clinic intervention plus usual care or to usual care only via a computer-generated, pseudo-random list stratified by trial centre. Allocation was done by the trial statistician and concealed with a centralised, web-based randomisation system; masking participants was not possible due to the nature of the intervention. The symptom-clinic intervention was a sequence of up to four medical consultations that aimed to elicit a detailed clinical history, fully hear and validate the participant, offer rational explanations for symptoms, and assist the participant to develop ways of managing their symptoms; it was delivered by general practitioners with an extended role. The primary outcome was Patient Health Questionnaire-15 (PHQ-15) score 52 weeks after randomisation, analysed by intention to treat. The trial is registered on the ISRCTN registry (ISRCTN57050216). FINDINGS: 354 participants were randomly assigned; 178 (50%) were assigned to receive the community-based symptoms clinic plus usual care and 176 (50%) were assigned to receive usual care only. At the primary-outcome point of 52 weeks, PHQ-15 scores were 14·1 (SD 3·7) in the group receiving usual care and 12·2 (4·5) in the group receiving the intervention. The adjusted between-group difference of -1·82 (95% CI -2·67 to -0·97) was statistically significantly in favour of the intervention group (p<0·0001). There were 39 adverse events in the group receiving usual care and 36 adverse events in the group receiving the intervention. There were no statistically significant between-group differences in the proportion of participants who had non-serious adverse events (-0·03, 95% CI -0·11 to 0·05) or serious adverse events (0·02, -0·02 to 0·07). No serious adverse event was deemed to be related to the trial intervention. INTERPRETATION: Our symptom-clinic intervention, which focused on explaining persistent symptoms to participants in order to support self-management, led to sustained improvement in multiple and persistent physical symptoms. FUNDING: UK National Institute for Health and Care Research.

Explanation for symptoms and biographical repair in a clinic for persistent physical symptoms.

Introduction: Biographical disruption describes the process by which illness impacts not just on a person's body and their participation in activities, but also on their sense of self. Biographical disruption is often followed by a process of biographical repair in which identity is reconstructed and a new normality is restored. People with persistent physical symptoms (sometimes referred to as medically unexplained symptoms) experience biographical disruption. This can be complicated by lack of explanation and the implication that if the problem is not medical, then it might be the person/psychological. We aimed to examine this tension in people attending a novel "Symptoms Clinic" for people with persistent physical symptoms. Methods: This study reports an embedded qualitative study in a UK based randomised controlled trial. Data were collected by audio recordings of consultations and semi-structured interviews with patients. We used theoretically informed thematic analysis with regular coding and discussion meetings of the analysis team. This analysis explores the role of intervention components in facilitating biographical repair. Results: The lack of acceptable explanation for persistent symptoms acted as a block to biographical repair. In the clinic, multi-layered explanations were offered and negotiated that viewed persistent symptoms as understandable entities rather than as indicators of something still hidden. These explanations allowed study participants to make sense of their symptoms and in turn opened new opportunities for self-management. The result was that participants were able to reframe their symptoms in a way that enabled them to see themselves differently. Even if symptoms had not yet improved, there was a sense of being better. This can be understood as a process of biographical repair. Conclusion: Explaining persistent physical symptoms enables biographical repair.

Persistent physical symptoms: definition, genesis, and management.

Persistent physical symptoms (synonymous with persistent somatic symptoms) is an umbrella term for distressing somatic complaints that last several months or more, regardless of their cause. These symptoms are associated with substantial disability and represent a major burden for patients, health-care professionals, and society. Persistent physical symptoms can follow infections, injuries, medical diseases, stressful life events, or arise de novo. As symptoms persist, their link to clearly identifiable pathophysiology often weakens, making diagnosis and treatment challenging. Multiple biological and psychosocial risk factors and mechanisms contribute to the persistence of somatic symptoms, including persistent inflammation; epigenetic profiles; immune, metabolic and microbiome dysregulation; early adverse life experiences; depression; illness-related anxiety; dysfunctional symptom expectations; symptom focusing; symptom learning; and avoidance behaviours, with many factors being common across symptoms and diagnoses. Basic care consists of addressing underlying pathophysiology and using person-centred communication techniques with validation, appropriate reassurance, and biopsychosocial explanation. If basic care is insufficient, targeted psychological and pharmacological interventions can be beneficial. A better understanding of the multifactorial persistence of somatic symptoms should lead to more specific, personalised, and mechanism-based treatment, and a reduction in the stigma patients commonly face.

Stigmatisation in medical encounters for persistent physical symptoms/functional disorders: Scoping review and thematic synthesis.

OBJECTIVE: To conduct a scoping review of stigma in medical encounters for persistent physical symptoms and functional disorders (PPS/FD). Stigma is a social attribute that links a person to an undesirable characteristic. It has been extensively studied in relation to mental illness but less so in relation to PPS/FD. METHODS: We followed PRISMA-ScR reporting guidelines for scoping reviews. Searches for were designed using the SPIDER tool. We used descriptive and thematic analysis. RESULTS: The searches identified 68 articles, of which 32 were eligible for inclusion. 31 out of the 32 studies used a qualitative methodology. 8 studies used an explicit definition of stigma, of which 6 used the Goffman (1963) definition. Only 2 studies directly examined clinical consultations, the remainder relied on recalled accounts by patients or professionals. Descriptive analysis identified the focus of the studies included: patient-physician interaction (n = 13); health care professionals' perceptions (n = 7); experiences of illness/stigma (n = 6); broader meaning of illness (n = 3); and patients' experiences of stigma in health care consultations (n = 3). CONCLUSION: Patients experience stigmatisation in consultations for a wide range of PPS/FD. This suggests the presence of structural stigmatisation. PRACTICE IMPLICATIONS: There is a need for effective stigma reduction strategies in consultations about persistent physical symptoms.

Identifying models of care to improve outcomes for older people with urgent care needs: a mixed methods approach to develop a system dynamics model.

Background: We aimed to understand urgent and emergency care pathways for older people and develop a decision support tool using a mixed methods study design. Objective(s), study design, settings and participants: Work package 1 identified best practice through a review of reviews, patient, carer and professional interviews. Work package 2 involved qualitative case studies of selected urgent and emergency care pathways in the Yorkshire and Humber region. Work package 3 analysed linked databases describing urgent and emergency care pathways identifying patient, provider and pathway factors that explain differences in outcomes and costs. Work package 4 developed a system dynamics tool to compare emergency interventions. Results: A total of 18 reviews summarising 128 primary studies found that integrated social and medical care, screening and assessment, follow-up and monitoring of service outcomes were important. Forty patient/carer participants described emergency department attendances; most reported a reluctance to attend. Participants emphasised the importance of being treated with dignity, timely and accurate information provision and involvement in decision-making. Receiving care in a calm environment with attention to personal comfort and basic physical needs were key. Patient goals included diagnosis and resolution, well-planned discharge home and retaining physical function. Participants perceived many of these goals of care were not attained. A total of 21 professional participants were interviewed and 23 participated in focus groups, largely confirming the review evidence. Implementation challenges identified included the urgent and emergency care environment, organisational approaches to service development, staff skills and resources. Work package 2 involved 45 interviews and 30 hours of observation in four contrasting emergency departments. Key themes relating to implementation included: intervention-related staff: frailty mindset and behaviours resources: workforce, space, and physical environment operational influences: referral criteria, frailty assessment, operating hours, transport. context-related links with community, social and primary care organisation and management support COVID-19 pandemic. approaches to implementation service/quality improvement networks engaging staff and building relationships education about frailty evidence. The linked databases in work package 3 comprised 359,945 older people and 1,035,045 observations. The most powerful predictors of four-hour wait and transfer to hospital were age, previous attendance, out-of-hours attendance and call handler designation of urgency. Drawing upon the previous work packages and working closely with a wide range of patient and professional stakeholders, we developed an system dynamics tool that modelled five evidence-based urgent and emergency care interventions and their impact on the whole system in terms of reducing admissions, readmissions, and hospital related mortality. Limitations: Across the reviews there was incomplete reporting of interventions. People living with severe frailty and from ethnic minorities were under-represented in the patient/carer interviews. The linked databases did not include patient reported outcomes. The system dynamics model was limited to evidence-based interventions, which could not be modelled conjointly. Conclusions: We have reaffirmed the poor outcomes frequently experienced by many older people living with urgent care needs. We have identified interventions that could improve patient and service outcomes, as well as implementation tools and strategies to help including clinicians, service managers and commissioners improve emergency care for older people. Future work: Future work will focus on refining the system dynamics model, specifically including patient-reported outcome measures and pre-hospital services for older people living with frailty who have urgent care needs. Study registrations: This study is registered as PROSPERO CRD42018111461. WP 1.2: University of Leicester ethics: 17525-spc3-ls:healthsciences, WP 2: IRAS 262143, CAG 19/CAG/0194, WP 3: IRAS 215818, REC 17/YH/0024, CAG 17/CAG/0024. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme [project number 17/05/96 (Emergency Care for Older People)] and will be published in full in Health and Social Care Delivery Research; Vol. 11, No. 14. See the NIHR Journals Library website for further project information.

Many older people attending emergency care have poor outcomes; this project aimed to: describe best practice in emergency care understand how best practice might be delivered describe outcomes from emergency care, and synthesise this information in a computer simulation tool that can help teams decide which interventions might work best in their setting. The existing literature showed that holistic interventions (caring for the whole person), spanning emergency and community care, designed with the needs of older people in mind, work best. We checked these findings with front line clinicians, who agreed, but identified that implementing best practice in the emergency department was challenging. Limitations included the emergency department environment itself and the lack of staff with the right skillset. We also asked older people and their carers who had recently received emergency care what mattered. They prioritised basic needs such as comfort, communication, and timely care. They also stated that getting better, maintaining their usual level of function, and getting home safely were important outcomes. We then analysed data that linked together ambulance, emergency department, and hospital care in Yorkshire and Humber from 2011­17 for over 1 million emergency department attendances and hospital admissions. We found a novel and accurate predictor of long emergency department waits and hospital admission: the level of urgency according to the ambulance call handler. Drawing upon all the above and guided by a wide range of patient and professionals, we developed a computer model which allows emergency care teams to simulate different best practice emergency department interventions and estimate the impact on reducing admissions, readmissions, and hospital mortality. In summary, we have reaffirmed the poor outcomes experienced by many older people with urgent care needs. We have identified interventions that could improve patient and service outcomes, as well as implementation tools to help including clinicians, hospital managers and funders transform emergency care for older people.

Did the evidence-based intervention (EBI) programme reduce inappropriate procedures, lessen unwarranted variation or lead to spill-over effects in the National Health Service?

BACKGROUND: Health systems are under pressure to maintain services within limited resources. The Evidence-Based Interventions (EBI) programme published a first list of guidelines in 2019, which aimed to reduce inappropriate use of interventions within the NHS in England, reducing potential harm and optimising the use of limited resources. Seventeen procedures were selected in the first round, published in April 2019. METHODS: We evaluated changes in the trends for each procedure after its inclusion in the EBI's first list of guidelines using interrupted time series analysis. We explored whether there was any evidence of spill-over effects onto related or substitute procedures, as well as exploring changes in geographical variation following the publication of national guidance. RESULTS: Most procedures were experiencing downward trends in the years prior to the launch of EBI. We found no evidence of a trend change in any of the 17 procedures following the introduction of the guidance. No evidence of spill-over increases in substitute or related procedures was found. Geographic variation in the number of procedures performed across English CCGs remained at similar levels before and after EBI. CONCLUSIONS: The EBI programme had little success in its aim to further reduce the use of the 17 procedures it deemed inappropriate in all or certain circumstances. Most procedure rates were already decreasing before EBI and all continued with a similar trend afterwards. Geographical variation in the number of procedures remained at a similar level post EBI. De-adoption of inappropriate care is essential in maintaining health systems across the world. However, further research is needed to explore context specific enablers and barriers to effective identification and de-adoption of such inappropriate health care to support future de-adoption endeavours.

Recognition, explanation, action, learning: Teaching and delivery of a consultation model for persistent physical symptoms.

OBJECTIVE: To describe the teaching and delivery of an extended consultation model designed for clinicians to use with patients with persistent physical symptoms and functional disorders. The model is underpinned by current scientific knowledge about persistent physical symptoms and the communication problems that arise in dealing with them. METHODS: Process evaluation of training and delivery of the Recognition, Explanation, Action, Learning (REAL) model within the Multiple Symptoms Study 3: a randomised controlled trial of an extended-role GP "Symptoms Clinic". Evaluation used clinician and patient interviews and consultation transcripts. RESULTS: 7 GPs were trained in the intervention and 6 of them went on to deliver the REAL model in Symptoms Clinics either face-to-face or online. The Symptoms Clinic provided a set of 4 extended consultations to approximately 170 patients. Evaluation of training indicated that there was a considerable load in terms of new knowledge and skills. Evaluation of delivery found clinicians could adapt the model to individual patients while maintaining a high level of fidelity to its core components. CONCLUSION: REAL is a teachable consultation model addressing specific clinical communication issues for people with persistent physical symptoms. PRACTICE IMPLICATIONS: REAL enables clinicians to explain persistent physical symptoms in a beneficial way.

Syrian hamster convalescence from prototype SARS-CoV-2 confers measurable protection against the attenuated disease caused by the Omicron variant.

The mutation profile of the SARS-CoV-2 Omicron (lineage BA.1) variant posed a concern for naturally acquired and vaccine-induced immunity. We investigated the ability of prior infection with an early SARS-CoV-2 ancestral isolate (Australia/VIC01/2020, VIC01) to protect against disease caused by BA.1. We established that BA.1 infection in naïve Syrian hamsters resulted in a less severe disease than a comparable dose of the ancestral virus, with fewer clinical signs including less weight loss. We present data to show that these clinical observations were almost absent in convalescent hamsters challenged with the same dose of BA.1 50 days after an initial infection with ancestral virus. These data provide evidence that convalescent immunity against ancestral SARS-CoV-2 is protective against BA.1 in the Syrian hamster model of infection. Comparison with published pre-clinical and clinical data supports consistency of the model and its predictive value for the outcome in humans. Further, the ability to detect protection against the less severe disease caused by BA.1 demonstrates continued value of the Syrian hamster model for evaluation of BA.1-specific countermeasures.

What influences GPs' use of pelvic examination? A qualitative investigation in primary care.

BACKGROUND: Omission of pelvic examination (PE) has been associated with diagnostic delay in women diagnosed with gynaecological cancer. However, PEs are often not carried out by GPs. AIM: To determine the perceptions of GPs about the role of PEs, the barriers to and facilitators of PEs, and GPs' experience of PEs in practice. DESIGN AND SETTING: Qualitative semi-structured interview study conducted in one health board in Scotland (mixed urban and rural) with an approximate population of 500 000. METHOD: Interviews were conducted face-to-face or by telephone between March and June 2019. Framework analysis used the COM-B behaviour change model concepts of capability, opportunity, and motivation. RESULTS: Data was compatible with all three domains of the COM-B framework. Capability related to training in and maintenance of skills. These went beyond carrying out the examination to interpreting it reliably. Opportunity related to the clinical environment and the provision of chaperones for intimate examination. Interviewees described a range of motivations towards or against PEs that were unrelated to either capability or opportunity. These all related to providing high-quality care, but this was defined in different ways: 'doing what is best for the individual', 'doctors examine', and 'GPs as pragmatists'. CONCLUSION: GPs' reasons for carrying out, or not carrying out, PEs in women with symptoms potentially indicating cancer are complex. The COM-B framework provides a way of understanding this complexity. Interventions to increase the use of PEs, and critics of its non-use, need to consider these multiple factors.

Within and between-day variation and associations of symptoms in Long Covid: Intensive longitudinal study.

BACKGROUND: People with Long Covid (Post Covid-19 Condition) describe multiple symptoms which vary between and within individuals over relatively short time intervals. We aimed to describe the real-time associations between different symptoms and between symptoms and physical activity at the individual patient level. METHODS AND FINDINGS: Intensive longitudinal study of 82 adults with self-reported Long Covid (median duration 12-18 months). Data collection involved a smartphone app with 5 daily entries over 14 days and continuous wearing of a wrist accelerometer. Data items included 7 symptoms (Visual Analog Scales) and perceived demands in the preceding period (Likert scales). Activity was measured using mean acceleration in the 3-hour periods preceding and following app data entry. Analysis used within-person correlations of symptoms pairs and both pooled and individual symptom networks derived from graphical vector autoregression. App data was suitable for analysis from 74 participants (90%) comprising 4022 entries representing 77.6% of possible entries. Symptoms varied substantially within individuals and were only weakly autocorrelated. The strongest between-subject symptom correlations were of fatigue with pain (partial coefficient 0.5) and cognitive difficulty with light-headedness (0.41). Pooled within-subject correlations showed fatigue correlated with cognitive difficulty (partial coefficient 0.2) pain (0.19) breathlessness (0.15) and light-headedness (0.12) but not anxiety. Cognitive difficulty was correlated with anxiety and light-headedness (partial coefficients 0.16 and 0.17). Individual participant correlation heatmaps and symptom networks showed no clear patterns indicative of distinct phenotypes. Symptoms, including fatigue, were inconsistently correlated with prior or subsequent physical activity: this may reflect adjustment of activity in response to symptoms. Delayed worsening of symptoms after the highest activity peak was observed in 7 participants. CONCLUSION: Symptoms of Long Covid vary within individuals over short time scales, with heterogenous patterns of symptom correlation. The findings are compatible with altered central symptom processing as an additional factor in Long Covid.

Examining the effect of interventions in emergency care for older people using a system dynamics decision support tool.

BACKGROUND: Rising demand for Emergency and Urgent Care is a major international issue and outcomes for older people remain sub-optimal. Embarking upon large-scale service development is costly in terms of time, energy and resources with no guarantee of improved outcomes; computer simulation modelling offers an alternative, low risk and lower cost approach to explore possible interventions. METHOD: A system dynamics computer simulation model was developed as a decision support tool for service planners. The model represents patient flow through the emergency care process from the point of calling for help through ED attendance, possible admission, and discharge or death. The model was validated against five different evidence-based interventions (geriatric emergency medicine, front door frailty, hospital at home, proactive care and acute frailty units) on patient outcomes such as hospital-related mortality, readmission and length of stay. RESULTS: The model output estimations are consistent with empirical evidence. Each intervention has different levels of effect on patient outcomes. Most of the interventions show potential reductions in hospital admissions, readmissions and hospital-related deaths. CONCLUSIONS: System dynamics modelling can be used to support decisions on which emergency care interventions to implement to improve outcomes for older people.

Factors associated with longer wait times, admission and reattendances in older patients attending emergency departments: an analysis of linked healthcare data.

BACKGROUND AND OBJECTIVE: Care for older patients in the ED is an increasingly important issue with the ageing society. To better assess the quality of care in this patient group, we assessed predictors for three outcomes related to ED care: being seen and discharged within 4 hours of ED arrival; being admitted from ED to hospital and reattending the ED within 30 days. We also used these outcomes to identify better-performing EDs. METHODS: The CUREd Research Database was used for a retrospective observational study of all 1 039 251 attendances by 368 754 patients aged 75+ years in 18 type 1 EDs in the Yorkshire and the Humber region of England between April 2012 and March 2017. We estimated multilevel logit models, accounting for patients' characteristics and contact with emergency services prior to ED arrival, time variables and the ED itself. RESULTS: Patients in the oldest category (95+ years vs 75-80 years) were more likely to have a long ED wait (OR=1.13 (95% CI=1.10 to 1.15)), hospital admission (OR=1.26 (95% CI=1.23 to 1.29)) and ED reattendance (OR=1.09 (95% CI=1.06 to 1.12)). Those who had previously attended (3+ vs 0 previous attendances) were more likely to have long wait (OR=1.07 (95% CI=1.06 to 1.08)), hospital admission (OR=1.10 (95% CI=1.09 to 1.12)) and ED attendance (OR=3.13 (95% CI=3.09 to 3.17)). Those who attended out of hours (vs not out of hours) were more likely to have a long ED wait (OR=1.33 (95% CI=1.32 to 1.34)), be admitted to hospital (OR=1.19 (95% CI=1.18 to 1.21)) and have ED reattendance (OR=1.07 (95% CI=1.05 to 1.08)). Those living in less deprived decile (vs most deprived decile) were less likely to have any of these three outcomes: OR=0.93 (95% CI=0.92 to 0.95), 0.92 (95% CI=0.90 to 0.94), 0.86 (95% CI=0.84 to 0.88). These characteristics were not strongly associated with long waits for those who arrived by ambulance. Emergency call handler designation was the strongest predictor of long ED waits and hospital admission: compared with those who did not arrive by ambulance; ORs for these outcomes were 1.18 (95% CI=1.16 to 1.20) and 1.85 (95% CI=1.81 to 1.89) for those designated less urgent; 1.37 (95% CI=1.33 to 1.40) and 2.13 (95% CI=2.07 to 2.18) for urgent attendees; 1.26 (95% CI=1.23 to 1.28) and 2.40 (95% CI=2.36 to 2.45) for emergency attendees; and 1.37 (95% CI=1.28 to 1.45) and 2.42 (95% CI=2.26 to 2.59) for those with life-threatening conditions. We identified two EDs whose patients were less likely to have a long ED, hospital admission or ED reattendance than other EDs in the region. CONCLUSIONS: Age, previous attendance and attending out of hours were all associated with an increased likelihood of exceeding 4 hours in the ED, hospital admission and reattendance among patients over 75 years. These differences were less pronounced among those arriving by ambulance. Emergency call handler designation could be used to identify those at the highest risk of long ED waits, hospital admission and ED reattendance.