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.

Analysis of therapy monitoring in the International Congenital Adrenal Hyperplasia Registry.

OBJECTIVE: Congenital adrenal hyperplasia (CAH) requires exogenous steroid replacement. Treatment is commonly monitored by measuring 17-OH progesterone (17OHP) and androstenedione (D4). DESIGN: Retrospective cohort study using real-world data to evaluate 17OHP and D4 in relation to hydrocortisone (HC) dose in CAH patients treated in 14 countries. PATIENTS: Pseudonymized data from children with 21-hydroxylase deficiency (21OHD) recorded in the International CAH Registry. MEASUREMENTS: Assessments between January 2000 and October 2020 in patients prescribed HC were reviewed to summarise biomarkers 17OHP and D4 and HC dose. Longitudinal assessment of measures was carried out using linear mixed-effects models (LMEM). RESULTS: Cohort of 345 patients, 52.2% female, median age 4.3 years (interquartile range: 3.1-9.2) were taking a median 11.3 mg/m2 /day (8.6-14.4) of HC. Median 17OHP was 35.7 nmol/l (3.0-104.0). Median D4 under 12 years was 0 nmol/L (0-2.0) and above 12 years was 10.5 nmol/L (3.9-21.0). There were significant differences in biomarker values between centres (p < 0.05). Correlation between D4 and 17OHP was good in multiple regression with age (p < 0.001, R2 = 0.29). In longitudinal assessment, 17OHP levels did not change with age, whereas D4 levels increased with age (p < 0.001, R2 = 0.08). Neither biomarker varied directly with dose or weight (p > 0.05). Multivariate LMEM showed HC dose decreasing by 1.0 mg/m2 /day for every 1 point increase in weight standard deviation score. DISCUSSION: Registry data show large variability in 17OHP and D4 between centres. 17OHP correlates with D4 well when accounting for age. Prescribed HC dose per body surface area decreased with weight gain.

Vocational Outcomes After Traumatic Brain Injury; Prevalence and Risk Factors After 1 Year in a Multivariable Model.

OBJECTIVE: To determine the prevalence of employment status (ES) or full-time study after traumatic brain injury (TBI) in a representative population and its predictive factors. DESIGN: Prospective cohort study. SETTING: Regional Major Trauma Centre. Participants: In total, 1734 consecutive individuals of working age, admitted with TBI to a Regional Trauma Centre, were recruited and followed up at 8 weeks and 1 year with face-to-face interview. Median age was 37.2 years (17.5-58.2); 51% had mild TBI, and 36.8% had a normal computed tomographic (CT) scan. MAIN OUTCOME MEASURE: Complete or partial/modified return to employment or study as an ordinal variable. RESULTS: At 1 year, only 44.9% returned to full-time work/study status, 28.7% had a partial or modified return, and 26.4% had no return at all. In comparison with status at 6 weeks, 9.9% had lower or reduced work status. Lower ES was associated with greater injury severity, more CT scan abnormality, older age, mechanism of assault, and presence of depression, alcohol intoxication, or a psychiatric history. The multivariable model was highly significant (P < .001) and had a Nagelkerke R2 of 0.353 (35.3%). CONCLUSIONS: Employment at 1 year is poor and changes in work status are frequent, occurring in both directions. While associations with certain features may allow targeting of vulnerable individuals in future, the majority of model variance remains unexplained and requires further investigation.

"Can differences in hospitalised mild traumatic brain injury (mTBI) outcomes at 12 months be predicted?"

OBJECTIVES: To identify risk factors for poor outcome one year post-mild traumatic brain injury (mTBI). DESIGN: This study was a prospective observational study using consecutive adult hospital admissions with mTBI. SUBJECTS: A total of 869 consecutive mTBI patients were enrolled in this study. METHODS: All patients were reviewed by the specialist TBI rehabilitation team at six weeks and one year following mTBI. Demographic and injury data collected included: age, gender, TBI severity and Glasgow Coma Scale (GCS). At twelve months, global outcome was assessed by the Extended Glasgow Outcome Score (GOSE) and participation restriction by the Rivermead Head Injury Follow-up Questionnaire (RHFUQ) via semi-structured interview. An ordinal regression (OR) was used to identify associated factors for poor GOSE outcome and a linear regression for a poor RHFUQ outcome. RESULTS: In the GOSE analysis, lower GCS (p < 0.001), medical comorbidity (p = 0.027), depression (p < 0.001) and male gender (p = 0.008) were identified as risk factors for poor outcome. The RHFUQ analysis identified: lower GCS (p = 0.002), female gender (p = 0.001) and injuries from assault (p = 0.003) were variables associated with worse social functioning at one year. CONCLUSION: mTBI is associated with a significant impact upon the physical health and psychosocial function of affected individuals. The results of this study demonstrate that differences in mTBI outcome can be identified at twelve months post-mTBI and that certain features, particularly GCS, are associated with poorer outcomes.

Post-concussion symptoms 1-year after traumatic brain injury: using the Rivermead Post-concussion Questionnaire to identify predictors of severity.

BACKGROUND: Patients who suffer traumatic brain injury (TBI) often experience a constellation of physical, cognitive, and emotional/behavioral symptoms called "post-concussion symptoms" and subsequent long-term disability. This study aimed to investigate the incidence of persistent post-concussion symptoms and possible predictors of long-term disability focusing on demographic, injury, and psychological factors. It was hoped to identify groups at high risk. METHODS: A prospective cohort of 1322 individuals admitted with TBI were assessed in a specialist neurorehabilitation clinic at 10 weeks and 1-year post injury between August 2011 and July 2015. The outcome (post-concussion symptoms) was measured using the Rivermead Post-concussion Questionnaire (RPQ) at 1-year post injury. RESULTS: At 1 yr, 1131 individuals were identified (>90% follow-up). Over 20% exhibited moderate or severe symptom levels on RPQ. A linear regression model showed that previous psychiatric history, lower Glasgow Coma Scale (GCS), severe CT abnormalities, injury caused by assault, pre-injury unemployment, and inability to return to work at 6 weeks post-injury were associated with worse symptoms at 1 yr. The adjusted R2 of the model was 25.1%. CONCLUSION: These findings confirm the high incidence of post-concussion symptoms at 1 yr and identify certain associated features that increase risk. This may allow targeting of certain groups, e.g., return to work or victims of assault.

Scaling up the "24/7 BHU" strategy to provide round-the-clock maternity care in Punjab, Pakistan: a theory-driven, coproduced implementation study.

BACKGROUND: Pakistan's maternal mortality rate remains persistently high at 186/100,000 live births. The country's government-run first-level healthcare facilities, the basic health units (BHUs), are an important source of maternity care for rural women. However,BHUsonly operate on working days from 8:00 am to 2:00 pm. Recognizing that this severely constrains access to maternity services, the government is implementing the "24/7 BHU" initiative to upgrade BHUs to provide round-the-clock care. Although based on a successful pilot project, initial reports reveal challenges in scaling up the initiative. This implementation research project aims to address a key concern of the Government of Punjab: How can the 24/7 BHU initiative be successfully implemented at scale to provide high-quality, round-the-clock skilled maternity care in rural Punjab? METHODS: The project consists of two overlapping work packages (WP). WP1 includes three modules generating data at the directorate, district and BHU levels. Module 1 uses document analysis and policy-maker interviews to explicateprogrammetheory and begin to build a system model. Module 2 compares government-collected data with data generated from a survey of 1500 births to assess BHU performance. Module 3 uses institutional ethnographies in 4-5 BHUs in three districts to provide a detailed system for understanding and identifying processes that influence scale-up. WP2 includes two modules. First, two workshops and regular meetings with stakeholders integrate WP1 findings, identify feasible changes and establish priorities. Next, "change ideas" are selected for testing in one district and 2-3 BHUs through carefully documented pilots using the PDSA (plan-do-study-act) improvement approach. An integrated knowledge translation approach will engage key policy and practice stakeholders throughout the project. DISCUSSION: This theory-driven implementation research project willcoproducesignificant new understandings of the wider system in which the 24/7 BHU initiative is being implemented, and actionable knowledge that will highlight ways the implementation processes might be modified to enable BHUs to meet service provision goals. This study will also produce insights that will be relevant for other South Asian and low- and middle-income countries (LMICs) that experience similar challenges of programme scale-up and delivery of maternal health services to remote and marginalized communities.

Organizational citizenship behaviour as a protective factor against the occurrence of adverse nursing-sensitive outcomes: A multilevel investigation.

AIMS: This study aimed to investigate the association between organizational citizenship behaviour enacted by nurses and the occurrence of adverse nursing-sensitive patient outcomes. BACKGROUND: Managing psychosocial factors (i.e., aspects concerning the work environment) is key to ensure patient safety, to prevent exacerbation of case complexity and to cope with critical shortages in human and financial resources. METHODS: Self-report measures of nurses' organizational citizenship behaviour were combined with objective data on the incidence of adverse nursing-sensitive outcomes (i.e., pressure ulcers and restraint use) collected through patients' medical records. Participants were 11,345 patients and 1346 nurses across 52 teams working in 14 Italian hospitals. Data were analysed using multilevel binary logistic regression models. RESULTS: A negative relationship between nurses' organizational citizenship behaviour and restraint use was identified, with an odds ratio of 0.11. Thus, for a one-unit higher organizational citizenship behaviour score, the odds of using restraints shrink to about one eighth of the previous level. CONCLUSIONS: Intervention strategies to foster the implementation of organizational citizenship behaviour among nurses may inhibit the occurrence of critical outcomes affecting patients' health and well-being (i.e., using restraint devices). IMPLICATIONS FOR NURSING MANAGEMENT: In health care organizations, shaping a psychosocial environment encouraging organizational citizenship behaviour can mitigate the occurrence of adverse nursing-sensitive outcomes such as restraint use on patients.

Effectiveness of a group intervention to reduce the psychological distress of healthcare staff: a pre-post quasi-experimental evaluation.

BACKGROUND: Work stress and compassion fatigue are prevalent among healthcare staff and their negative effects on staff well-being and patient care are well-known. This paper reports on the implementation and evaluation of Schwartz Rounds® (Rounds) in UK healthcare organizations, predominantly part of the National Health Service (NHS). Rounds are one-hour, typically monthly, multidisciplinary forums during which clinical and nonclinical healthcare staff discuss the emotional and social demands of delivering patient care. The purpose of this research was to evaluate the effectiveness of Rounds attendance on the psychological distress, work engagement, compassion and self-reflection of healthcare staff. METHODS: We used a pre-post control design to assess the effect of Rounds attendance across 10 UK healthcare organizations. This design was most appropriate given the voluntary nature of Rounds and ensured the study had ecological validity. Self-reported data were collected from attenders and non-attenders at baseline and at eight-months follow-up. The outcomes were psychological distress, work engagement, compassion and self-reflection. RESULTS: During the 8 months' study duration, regular attenders (N = 51) attended Rounds on average 4 times (2-8). Attenders showed a significantly greater decrease in psychological distress (as measured with the General Health Questionnaire (GHQ)) than non-attenders (N = 233; odds ratio of 0.197; 95% confidence interval (0.047-0.823)). However, Rounds attendance had no significant effect on work engagement, compassion and self-reflection. CONCLUSIONS: Rounds attendance was linked to a 19% reduction in psychological distress adjusting for covariates. As an organization-wide intervention, Rounds thus constitute an effective, relatively low-cost intervention to assist staff in dealing with the demands of their work and to improve their well-being.

What are the functional consequences after TBI? The SHEFBIT cohort experience.

OBJECTIVES: To investigate functional outcome after TBI and identify variables that predict outcome in a multiordinal regression model. BACKGROUND: The results of global outcome studies after Traumatic Brain Injury(TBI) differ widely due to differences in outcome measure, attrition to follow-up and selection bias. Outcome information would inform patients/families, guide service development and target high-risk individuals. SUBJECTS/SETTING: prospective cohort of 1322 admissions with TBI, assessed by face to face interviews at 1 yr. MEASURES: Extended Glasgow Outcome Scale (GOSE) by structured questionnaire. RESULTS: At 1 year, outcome was determined in 1207(91.3%). Mean age was 46.9(SD17.3); Almost half(49.2%) had mild injury. At one year, 42.9% achieved Good Recovery but GOSE declined in 11.4% of the cohort compared to 10 weeks including 60(4.9%) deaths. In an ordinal logistic regression, increasing TBI severity, etiology (assault), more prominent CT abnormality, past psychiatric history and alcohol intoxication were independent predictors of worse GOSE. A pseudo-R2 of 0.38 suggested that many unmeasured factors also contribute to TBI outcome. Future work needs to identify other variables that may influence outcome. CONCLUSIONS: In a large TBI cohort, there is still considerable functional disability at 1 year. It may be possible to target high-risk groups for rehabilitation.

Parametric optimization of visible wavelength gold lattice geometries for improved plasmon-enhanced fluorescence spectroscopy.

We report the exploitation of spectroplasmonics for innovations in optical transducer development, specifically in the well-established application of labeled fluorescent analytes known as fluorescence spectroscopy. Presented herein are comprehensive analyses of nanoscale plasmonic lattice feature geometries using finite-difference time-domain software to determine the largest surface electric ($E$E) field enhancement resulting from localized surface plasmon resonance for reducing the limit of detection of plasmon-enhanced fluorescence. This parametric optimization of the critical dimensions of the plasmon resonance of noble metal nanostructures will enable improved excitation and emission enhancement of fluorophores used in visible wavelength fluorescence spectroscopy.

Openness in the NHS: a secondary longitudinal analysis of national staff and patient surveys.

BACKGROUND: Improving openness-including candour when things go wrong, and willingness to learn from mistakes-is increasingly seen as a priority in many healthcare systems. This study explores perceptions of openness in England before and after the publication of the Francis report (2013), which examined failings of openness at one English hospital. We examine whether staff and patients' views on openness, and experiences of giving voice to concerns, have changed since the report's publication for better or worse. METHODS: Organisational-level data was collated for all trusts from the NHS National Staff Survey (2007-2017), NHS Acute Inpatient Survey (2004-2016) and NHS Community Mental Health Service User Survey (2007-2017). Survey items related to openness were identified and longitudinal statistical analysis conducted (piecewise growth curve and interrupted latent growth curve analysis) to determine whether there was evidence of a shift in the rate or direction of change following publication of the Francis report. RESULTS: For some variables there was a discernible change in trajectory after the publication of the Francis report. Staff survey variables continued to rise after 2013, with a statistically significant increase in rate for "fairness and effectiveness of incident reporting procedures" (from + 0.02 to + 0.06 per year; p < .001). For the patient surveys, the picture was more mixed: patient views about information provided by accident and emergency staff rose from a 0.3% increase per year before 2013 to 0.8% per year afterwards (p < .01), and inpatients being involved in decision making increased from a 0.4% rise per year before 2013 to 0.8% per year afterwards (p < .01); however, there were not rises in the other questions. Mental health patients reported a decrease after 2013 in being listened to (decreasing at a rate of 1.9% per year, p < .001). CONCLUSIONS: Data suggest that the Francis inquiry may have had a positive impact on staff and acute inpatients' perceptions and experiences of openness in the NHS. However such improvements have not transpired in mental health. How best to create an environment in which patients can discuss their care and raise concerns openly in mental health settings may require further consideration.

Correction to: Openness in the NHS: a secondary longitudinal analysis of national staff and patient surveys.

An amendment to this paper has been published and can be accessed via the original article.

The effect of socioeconomic deprivation on 12 month Traumatic Brain Injury (TBI) outcome.

Objectives: To assess the impact of social deprivation on Traumatic Brain Injury (TBI) global outcome.Design: The study was a prospective observational study conducted using consecutive admissions with TBI.Subjects: 1322 consecutive adult patients with TBI were recruited into the study between 2010 and 2015.Methods: All patients were assessed by the TBI rehabilitation team at both six weeks and 12 months following TBI. Details of the injury and demographic data was collated at six weeks. This included age, gender and ZIP Code. Social deprivation was measured by the Indices of Multiple Deprivation (IMD) Score. The outcome measure used was the Extended Glasgow Outcome Score (GOSE) at 12 months. Univariate analysis was followed by a Multi-Ordinal Regression to evaluate predictor variables.Results: With regard to the representation of IMD deciles, the study population approximated to the general Sheffield population (p = .139). Within the univariate analysis, statistically significant relationships were noted between IMD and GOSE (p = <.001). The Ordinal Regression revealed a significant relationship between worse GOSE and IMD (p = .002), age (p = .001), GCS (p < .001), alcohol intoxication (p < .001) and Medical Comorbidity (p = .041).Conclusion: Increasing social deprivation is associated with poorer global TBI outcomes at 12 months.

Comparison of early and late depression after TBI; (the SHEFBIT study).

OBJECTIVE: Evaluate the prevalence and risk factors for depression at 1 year after traumatic brain injury (TBI) and contrast against those at 10 weeks. METHODS: Prospective TBI admissions over 2 years to an emergency department were recruited to form a representative TBI population. Depression was recorded at 10 weeks and 1 year by HADS (Hospital Anxiety and Depression Scale) with score>8. Demographic and injury features were analyzed for association with depression. RESULTS: A total of 774 individuals were recruited of whom 690 attended  1-year follow-up; 38 had died. Only 6% of the cohort was lost to follow-up. The prevalence of depression at 10 weeks was 56.3% [95% CI 52.8-59.8] and at 1 year 41.2% [95% CI 37.6-44.9] A multivariable analysis identified the independent predictors of 1 year depression as an abnormal CT scan, past psychiatric history, alcohol intoxication, and female gender. TBI severity, age, etiology, and medical comorbidity were not significant. By contrast at 10weeks, increasing severity and CT findings were highly significant. CONCLUSIONS: Depression at 1 year post-TBI remains high but injury features are less predictive than early after injury. It is likely that pre-injury personality and coping mechanisms are more important in determining long term outcome. The predictors identified may allow targeting of vulnerable sub-populations.

Predicting functional recovery after mild traumatic brain injury: the SHEFBIT cohort.

Background: Current prognostic models for mild Traumatic Brain Injury (mTBI) are unsatisfactory in identifying patients at risk of an unfavorable outcome following injury. Objective: To identify prognostic indicators of recovery one-year following mTBI. Methods: A large population (n = 596) of patients with mTBI were prospectively recruited following admission to the Emergency Department. Data were collected at brain injury clinics at 8-10 weeks and one-year after injury. Functional recovery at one year was assessed using the Glasgow Outcome Scale-Extended (GOSE). Results: A follow-up rate of 92% was achieved. The most common aetiologies of mTBI were falls (n = 222) and road traffic collisions (n = 154). Distribution of GCS was 15 (n = 363), 14 (n = 156) and 13 (n = 77). Ordinal regression analysis found that psychiatric history (p < .001), alcohol intoxication (p = .011), assault (p = .022) and GCS < 15 (p =< 0.001), were associated with worse outcome. An abnormal CT scan was not a predictor of disability. Conclusion: Patients with a previous psychiatric history, GCS < 15, etiology of assault, and alcohol intoxication result in worse long-term outcomes after mTBI. The predictors identified should be implemented when developing a future-validated a prognostic model for mTBI recovery.

Description of the predictors of persistent post-concussion symptoms and disability after mild traumatic brain injury: the SHEFBIT cohort.

Introduction: Several patients who suffer Mild Traumatic Brain Injury (mTBI) develop Persistent Post-Concussion Symptoms (PPCS) and long-term disability. Current prognostic models for mTBI have a large unexplained variance, which limits their use in a clinical setting. Aim: This study aimed to identify background demographics and mTBI details that are associated with PPCS and long-term disability. Methods: Patients from the SHEFfield Brain Injury after Trauma (SHEFBIT) cohort with mTBI in the Emergency Department (ED) were analysed as part of the study. PPCS and long-term disability were measured using the Rivermead Post-Concussion Questionnaire and the Rivermead Post-Injury Follow-up Questionnaire respectively, during follow up brain injury clinics. Results: A representative mTBI sample of 647 patients was recruited with a follow-up rate of 89%. Non-attenders were older (p < 0.001), a greater proportion were retired (p < 0.001) and had a greater burden of comorbidity (p = 0.009). Multivariate analysis identified that female gender, previous psychiatric history, GCS <15, aetiology of assault and alcohol intoxication, were associated with worse recovery. Conclusion: These findings will support and add to current understanding of MBTI recovery in pursuit of developing a validated prognostic model. This will allow for more accurate prognostication and eventual improved treatment for sufferers of this complex disorder.

Prevalence of depression after TBI in a prospective cohort: The SHEFBIT study.

OBJECTIVE: The objective is to measure the prevalence of depression after traumatic brain injury (TBI) and the features associated with increased risk in a cohort that reflects clinical practice. METHODS: Prospective TBI admissions to a large Teaching Hospital Emergency Department were recruited over a 2-year period. Assessments for depression and other psychosocial and global outcomes were completed at 3 months post-injury. Comparisons were made with demographic and injury features of interest to establish any associations of depression risk. RESULTS: Out of 827 individuals, 774 (94%) successfully attended follow-up. A percentage of 56.3 had depression using a HADS-D >8. Depressed individuals had higher levels of post-concussion symptoms and worse psychosocial and global outcome ratings. In multivariable analysis, features associated with depression were TBI severity, previous psychiatric history, alcohol intoxication at time of injury, female gender and nonwhite ethnicity. Those with a normal CT scan showed higher risk than those with only mild abnormality and were comparable to those with much more marked CT changes. CONCLUSION: The 3-month prevalence of depression after TBI is very high and associated with several injury and demographic features. Future long-term follow-up of this cohort aims to confirm the features that increase risk; this may allow the earlier targeting of susceptible individuals for depression interventions.

The incidence of anosmia after traumatic brain injury: the SHEFBIT cohort.

BACKGROUND: While anosmia is common after Traumatic Brain Injury(TBI) (prevalence 4%-68%),studies differ in the associations found with other variables. AIMS: To assess the incidence of anosmia within a large, mixed TBI cohort and examine relationships with other injury or demographic features, including depression and global outcome(GOSE). DESIGN, SUBJECTS AND SETTING: 774 consecutive TBI admissions over 2 years, assessed within a specialist neurorehabilitation clinic. METHODS: All patients assessed at 6-8 weeks and 1 year. Tools included the Extended Glasgow Outcome Scale(GOSE), Rivermead Head Injury Follow-up Questionnaire, Rivermead Post-Concussion Symptoms and the Hospital Anxiety and Depression Score. Olfactory function assessed with sensitivity to coffee granules. RESULTS: The overall incidence of anosmia was 19.7%; mild TBI (9.55%), moderate (20.01%), and severe (43.5%). On a logistic regression, features of TBI severity (p < 0.001 (95% CI 0.098-0.438)), medical comorbidities (p = 0.026 (95% CI 0.301-0.927)) and depression (p = 0.006 (95% CI 1.202-2.981)) were significant. Sixty percent of patients with anosmia at 1 year were found to be clinically depressed, compared to 36% of patients without anosmia. CONCLUSION: In the largest prospective study of post-TBI anosmia, the incidence increased with TBI severity and other medical illness. The presence of anosmia should also raise the clinical suspicion of depression.

Capturing the carer's experience: a researcher's reflections.

AIM: To reflect on the methodological challenges of conducting a study exploring the effects on quality of life of being an informal carer for a person with palliative heart failure, as well as the factors that influence a carer's perception of caring. BACKGROUND: There are multi-faceted influences on the positive and negative effects of being a carer for a patient with palliative heart failure. By conducting a mixed methods study the aim was to examine and explore similarities and differences of the phenomenon of being a carer. DATA SOURCES: Quantitative data obtained from the Family Quality of Life Questionnaire (FAMQOL), and qualitative data obtained from 14 interviews with informal carers of patients living with palliative heart failure. REVIEW METHODS: The study was conducted as part of a PhD, University of Sheffield, and the supervisory team reviewed the research process throughout the study. DISCUSSION: The study had a two-phase sequential mixed methods design. A sample of carers was recruited from heart failure nurse service caseloads in a UK urban setting. Carers were invited to complete the Family Quality of Life Questionnaire, a tool developed for carers of patients with heart failure. Participants were also asked to provide contact details if they were willing to be interviewed for the second phase of the study. CONCLUSION: The study highlights important methodological considerations for recruiting carers. As the intention was to begin the analysis of the questionnaires before beginning the second phase of the study, the researcher was compelled to consider how integration was maintained and how to improve access to carers for research. IMPLICATIONS FOR PRACTICE: The complexities associated with the population in this study led the researcher to use a pragmatic design to address research questions. When reflecting on the research and the challenges associated with recruiting to the quantitative phase of the study, the researcher used an iterative approach to meet the unfolding complexities. Such an approach could prove beneficial for mixed methods studies that aim to engage with hard to reach populations.

Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo intervention.

BACKGROUND: Long-term sickness costs businesses in the United Kingdom (UK) approximately £7 billion per annum. Most long-term sickness absences are attributed to common mental health conditions, which are also highly prevalent in people with acute or musculoskeletal health conditions. This study will pilot the IGLOo (Individual, Group, Leaders, Organisation, overarching context) intervention which aims to support workers in returning to and remaining in work following long-term sickness absence. The potential impact of the intervention is a timely return to work (main trial primary outcome) and prevention of a further episode of long-term sick leave. The intervention will be piloted in a randomised controlled trial (RCT) to examine the feasibility of the intervention (pilot trial primary outcome) and to inform a fully powered definitive trial to evaluate sustainable return to work (RTW) in people with primary or secondary mental ill-health who go on long-term sick leave. METHODS AND DESIGN: A two-arm feasibility randomised controlled trial (with a 30-month study period including 12-month follow-up) of the IGLOo intervention will be conducted in large organisations (≥ 600 workers) from the Yorkshire and Humberside regions, in the UK. Eight consenting organisations will be recruited and randomised to the intervention or control arms of the study (1:1 ratio), with a minimum recruitment target of 13 workers eligible to participate from each. Organisations assigned to the control group will continue with their usual practice. Feasibility data will include data collected on recruitment, retention and attrition of participants; completion of research outcome measures; and intervention compliance. Measurements of mental health, RTW, work outcomes, quality-of-life, workplace support and communication and other demographic data will be taken at baseline, 3, 6, 9 and 12 months in all participants. Qualitative interviews and survey data with all participants will explore the experiences of participants, acceptability of the intervention components and evaluation measures. Exploratory economic evaluation will be conducted to further inform a definitive trial. DISCUSSION: The findings from this pilot study will help to inform the development of a definitive cluster RCT designed to examine the efficacy of this intervention on health and work-related outcomes in UK workers on long-term sick leave. TRIAL REGISTRATION: ISRCTN11788559 (prospectively registered, date registered 6 October 2022).