Novel Irritable Bowel Syndrome Subgroups are Reproducible in the Global Adult Population.

BACKGROUND & AIMS: Current classification systems for irritable bowel syndrome (IBS) based on bowel habit do not consider psychological impact. We validated a classification model in a UK population with confirmed IBS, using latent class analysis, incorporating psychological factors. We applied this model in the Rome Foundation Global Epidemiological Survey (RFGES), assessing impact of IBS on the individual and the healthcare system, as well as examining reproducibility. METHODS: We applied our model to 2195 individuals in the RFGES with Rome IV-defined IBS. As described previously, we identified seven clusters, based on gastrointestinal symptom severity and psychological burden. We assessed demographics, healthcare-seeking, symptom severity, and quality of life in each. We also used the RFGES to derive a new model, examining whether the broader concepts of our original model were replicated, in terms of breakdown and characteristics of identified clusters. RESULTS: All seven clusters were identified. Those in clusters with highest psychological burden, and particularly cluster 6 with high overall gastrointestinal symptom severity, were more often female, exhibited higher levels of healthcare-seeking, were more likely to have undergone previous abdominal surgeries, and had higher symptom severity and lower quality of life (p<0.001 for trend for all). When deriving a new model, the best solution consisted of 10 clusters, although at least two appeared to be duplicates, and almost all mapped on to the previous clusters. CONCLUSIONS: Even in the community, our original clusters derived from patients with physician-confirmed IBS identified groups of individuals with significantly higher rates of healthcare-seeking and abdominal surgery, more severe symptoms, and impairments in quality of life.

Demographic and clinical characteristics associated with advanced stage colorectal cancer: a registry-based cohort study in Saudi Arabia.

BACKGROUND: In Saudi Arabia, approximately one-third of colorectal cancer (CRC) patients are diagnosed at an advanced stage. Late diagnosis is often associated with a worse prognosis. Understanding the risk factors for late-stage presentation of CRC is crucial for developing targeted interventions enabling earlier detection and improved patient outcomes. METHODS: We conducted a retrospective cohort study on 17,541 CRC patients from the Saudi Cancer Registry (1997-2017). We defined distant CRCs as late-stage and localized and regional CRCs as early-stage. To assess risk factors for late-stage CRC, we first used multivariable logistic regression, then developed a decision tree to segment regions by late-stage CRC risk, and finally used stratified logistic regression models to examine geographical and sex variations in risk factors. RESULTS: Of all cases, 29% had a late-stage diagnosis, and 71% had early-stage CRC. Young (< 50 years) and unmarried women had an increased risk of late-stage CRC, overall and in some regions. Regional risk variations by sex were observed. Sex-related differences in late-stage rectosigmoid cancer risk were observed in specific regions but not in the overall population. Patients diagnosed after 2001 had increased risks of late-stage presentation. CONCLUSION: Our study identified risk factors for late-stage CRC that can guide targeted early detection efforts. Further research is warranted to fully understand these relationships and develop and evaluate effective prevention strategies.

The effectiveness of anti-stigma interventions for reducing mental health stigma in young people: A systematic review and meta-analysis.

Experiencing mental health stigma during adolescence can exacerbate mental health conditions, reduce quality of life and inhibit young people's help-seeking for their mental health needs. For young people, education and contact have most often been viewed as suitable approaches for stigma reduction. However, evidence on the effectiveness of these anti-stigma interventions has not been consistent. This systematic review evaluated the effectiveness of interventions to reduce mental health stigma among youth aged 10-19 years. The review followed Cochrane and PRISMA guidelines. Eight databases were searched: PubMed, PsycINFO, MEDLINE, Web of Science, Scopus, EMBASE, British Education Index and CNKI. Hand searching from included studies was also conducted. Randomised controlled trials and experimental designs that included randomised allocation to interventions and control groups were included in the review. Narrative synthesis was employed to analyse the results. A meta-analysis was conducted to determine the effectiveness of included interventions. Twenty-two studies were included in the review. Eight studies reported positive effects, 11 studies found mixed effects and 3 studies reported no effect on indicators of mental health stigma among youth. Seven of the effective studies were education-based. Eleven studies were suitable for meta-analysis, and the multivariate meta-analytic model indicated a small, significant effect at post-intervention (d = .21, p < .001), but not at follow-up (d = .069, p = .347). Interventions to reduce stigma associated with mental health conditions showed small, short-term effects in young people. Education-based interventions showed relatively more significant effects than other types of interventions.

Supporting Pain Self-Management in Patients With Cancer: App Development Based on a Theoretical and Evidence-Driven Approach.

BACKGROUND: To inform the development of an intervention, it is essential to have a well-developed theoretical understanding of how an intervention causes change, as stated in the UK Medical Research Council guidelines for developing complex interventions. Theoretical foundations are often ignored in the development of mobile health apps intended to support pain self-management for patients with cancer. OBJECTIVE: This study aims to systematically set a theory- and evidence-driven design for a pain self-management app and specify the app's active features. METHODS: The Behavior Change Wheel (BCW) framework, a step-by-step theoretical approach to the development of interventions, was adopted to achieve the aim of this study. This started by understanding and identifying sources of behavior that could be targeted to support better pain management. Ultimately, the application of the BCW framework guided the identification of the active contents of the app, which were characterized using the Behavior Change Technique Taxonomy version 1. RESULTS: The theoretical analysis revealed that patients may have deficits in their capability, opportunity, and motivation that prevent them from performing pain self-management. The app needs to use education, persuasion, training, and enablement intervention functions because, based on the analysis, they were found the most likely to address the specified factors. Eighteen behavior change techniques were selected to describe precisely how the intervention functions can be presented to induce the desired change regarding the intervention context. In other words, they were selected to form the active contents of the app, potentially reducing barriers and serving to support patients in the self-management of pain while using the app. CONCLUSIONS: This study fully reports the design and development of a pain self-management app underpinned by theory and evidence and intended for patients with cancer. It provides a model example of the BCW framework application for health app development. The work presented in this study is the first systematic theory- and evidence-driven design for a pain app for patients with cancer. This systematic approach can support clarity in evaluating the intervention's underlying mechanisms and support future replication.

Penicillin allergy status and its effect on antibiotic prescribing, patient outcomes and antimicrobial resistance (ALABAMA): protocol for a multicentre, parallel-arm, open-label, randomised pragmatic trial.

INTRODUCTION: Incorrect penicillin allergy records are recognised as an important barrier to the safe treatment of infection and affect an estimated 2.7 million people in England. Penicillin allergy records are associated with worse health outcome and antimicrobial resistance. The ALlergy AntiBiotics And Microbial resistAnce (ALABAMA) trial aims to determine if an intervention package, centred around a penicillin allergy assessment pathway (PAAP) initiated in primary care, is safe and effective in improving patient health outcomes and antibiotic prescribing. METHODS AND ANALYSIS: The ALABAMA trial is a multicentre, parallel-arm, open-label, randomised pragmatic trial with a nested pilot study. Adults (≥18 years) with a penicillin allergy record and who have received antibiotics in the previous 24 months will be eligible for participation. Between 1592 and 2090 participants will be recruited from participating National Health Service general practices in England. Participants will be randomised to either usual care or intervention to undergo a pre-emptive PAAP using a 1:1 allocation ratio. The primary outcome measure is the percentage of treatment response failures within 28 days of an index prescription. 2090 and 1592 participants are estimated to provide 90% and 80% power, respectively, to detect a clinically important absolute difference of 7.9% in primary outcome at 1 year between groups. The trial includes a mixed-methods process evaluation and cost-effectiveness evaluation. ETHICS AND DISSEMINATION: This trial has been approved by London Bridge Research Ethics Committee (ref: 19/LO/0176). It will be conducted in compliance with Good Clinical Practice guidelines according to the Declaration of Helsinki. Informed consent will be obtained from all subjects involved in the study. The primary trial results will be submitted for publication to an international, peer-reviewed journal. TRIAL REGISTRATION: ISRCTN20579216.

Randomized control trial of a culturally adapted behavioral activation therapy for Muslim patients with depression in Pakistan.

BACKGROUND: Behavioral activation therapy (BA) is as effective as cognitive behavior therapy (CBT) in treating depression and can be delivered by practitioners with much less psychological training, making it particularly suitable for low resource settings. BA that is culturally adapted for Muslims (BA-M) is a culturally adapted form of BA that has been found acceptable and feasible for Muslims with depression in the United Kingdom and Turkey; however, this is the first time that its efficacy has been determined through a definitive randomized controlled trial. AIM: To compare the effectiveness of BA-M with CBT for Muslim patients with depression in Pakistan. METHODS: One hundred and eight patients were randomized 1:1 to treatment arms in a parallel-group randomized controlled trial in hospital or community sites in Lahore, Pakistan. Recruitment followed self-referral or referrals from clinicians, consultants or relevant professionals at each site. Four measures were recorded by blinded assessors: The patient health questionnaire-9 (PHQ-9); the BA for depression scale short form (BADS-SF); symptom checklist-revised and the World Health Organization Quality-of-Life Brief Scale. All measures were recorded at baseline and post treatment; PHQ-9 and BADS-SF were also recorded at each session and at three month follow up. The primary analysis was to regress the PHQ-9 score after therapy upon the PHQ-9 score before therapy (baseline) and the type of therapy given, that is, analysis of covariance. In addition, analysis using PHQ-9 scores collected at each therapy session was employed in a 2-level regression model. RESULTS: Patients in the BA-M arm experienced greater improvement in PHQ-9 score of 1.95 units compared to the CBT arm after adjusting for baseline values (P = 0.006) The key reason behind this improvement was that patients were retained in therapy longer under BA-M, in which patients were retained for an average 0.75 sessions more than CBT patients (P = 0.013). Patients also showed significant differences on physical (P < 0.001), psychological (P = 0.004) and social (P = 0.047) domains of Quality of Life (QoL) at post treatment level, indicating an increased QoL in the BA-M group as compared to the treatment as usual group. Some baseline differences were noted in both groups for BA scores and two domains of QoL scale: Physical and environment, which might have influenced the results, though the BA-M group showed more improvement at completion of therapy. CONCLUSION: Results proved the efficacy of BA-M in reducing symptoms for depressed patients in Pakistan, indicating BA-M is a promising treatment modality for depression in future, particularly in low resource settings.

Trends in incidence of recorded diagnosis of osteoporosis, osteopenia, and fragility fractures in people aged 50 years and above: retrospective cohort study using UK primary care data.

This study used primary care data to estimate the incidence of recorded diagnosis of osteoporosis, osteopenia, and fragility fracture in the UK during 2000-2018 accounting for age, sex, calendar year and social deprivation. More than 3 million people aged 50-99 years were included. We found that men living in the most deprived areas had a 45% higher risk of being diagnosed with osteoporosis and 50% higher risk of fragility fracture compared to men living in the least deprived areas. PURPOSE: a) To estimate the incidence trends of a recorded diagnosis of osteoporosis, osteopenia, and fragility fracture in the UK over time; b) to describe differences according to age, sex, and social deprivation. METHODS: This is a longitudinal population-based cohort study using routinely collected primary care data obtained via IQVIA Medical Research Database (IMRD). All patients aged 50-99 years registered with a practice participating in THIN (The Health Improvement Network) between 2000-2018 were included. The first recorded diagnosis of osteoporosis, osteopenia, or fragility fracture was used to estimate incidence rates (IR) per 10,000 person-years at risk. Poisson regression was used to provide Incidence Rate Ratios (IRR) adjusted by age, sex, social deprivation, calendar year, and practice effect. RESULTS: The year-specific adjusted IRR of recorded osteoporosis was highest in 2009 in women [IRR 1.44(95%CI 1.38-1.50)], whereas in men it was highest in 2013-2014 [IRR 1.94(95%CI 1.72-2.18)] compared to 2000. The year-specific adjusted IRR of fragility fracture was highest in 2012 in women [IRR 1.77(95%CI 1.69-1.85)], whereas in men it was highest in 2013 [IRR 1.64(95%CI 1.51-1.78)] compared to 2000. Men in the most deprived areas had a higher risk of being diagnosed with osteoporosis [IRR 1.45(95%CI 1.38-1.53)], osteopenia [IRR 1.17(95%CI 1.09-1.26)], and fragility fracture [IRR 1.50(95%CI 1.44-1.56)] compared to those living in the least deprived areas, but smaller differences were seen in women. CONCLUSION: Use of fracture risk assessment tools may enhance the detection of osteoporosis cases in primary care. Further research is needed on the effect of social deprivation on diagnosis of osteoporosis and fractures.

The national prevalence of disorders of gut brain interaction in the United Kingdom in comparison to their worldwide prevalence: Results from the Rome foundation global epidemiology study.

BACKGROUND: There are minimal epidemiological data comparing the burden of disorders of gut brain interaction (DGBI) in the UK with other countries. We compared the prevalence of DGBI in the UK with other countries that participated in the Rome Foundation Global Epidemiology Study (RFGES) online. METHODS: Participants from 26 countries completed the RFGES survey online including the Rome IV diagnostic questionnaire and an in-depth supplemental questionnaire with questions about dietary habits. UK sociodemographic and prevalence data were compared with the other 25 countries pooled together. KEY RESULTS: The proportion of participants with at least one DGBI was lower in UK participants compared with in the other 25 countries (37.6% 95% CI 35.5%-39.7% vs. 41.2%; 95% CI 40.8%-41.6%, p = 0.001). The UK prevalence of 14 of 22 Rome IV DGBI, including irritable bowel syndrome (4.3%) and functional dyspepsia (6.8%), was similar to the other countries. Fecal incontinence, opioid-induced constipation, chronic nausea and vomiting, and cannabinoid hyperemesis (p < 0.05) were more prevalent in the UK. Cyclic vomiting, functional constipation, unspecified functional bowel disorder, and proctalgia fugax (p < 0.05) were more prevalent in the other 25 countries. Diet in the UK population consisted of higher consumption of meat and milk (p < 0.001), and lower consumption of rice, fruit, eggs, tofu, pasta, vegetables/legumes, and fish (p < 0.001). CONCLUSIONS AND INFERENCES: The prevalence and burden of DGBI is consistently high in the UK and in the rest of the world. Opioid prescribing, cultural, dietary, and lifestyle factors may contribute to differences in the prevalence of some DGBI between the UK and other countries.

Associations with Non-Persistence with Intra-Vitreal Therapy for Neovascular Age-Related Macular Degeneration at 24 Months.

AIMS: The aim of the study was to investigate non-persistence with treatment for neovascular age-related macular degeneration (NvAMD) before day 720 (24 months) after initiation, explore associations with baseline characteristics and variation between sites. METHODS: Anonymised demographic and clinical data were extracted from electronic medical records at treating National Health Service (NHS) Trusts for NvAMD eyes starting intra-vitreal therapy from 2017 to 2018. Time to non-persistence with treatment, defined as no recorded attendance for either monitoring or treatment for a period ≥6 months, was visualised with a Kaplan-Meier survival plot. Associations with treatment non-persistence were investigated using a Cox proportional hazards model. RESULTS: Analysis included 7,970 eyes of 7,112 patients treated at 13 NHS trusts. Censoring deaths and those eyes in which treatment was stopped permanently, the Kaplan-Meier analyses demonstrated survival figures of 77.7% for persistence with treatment to day 360 and 71.8% to day 720. Hazard ratios for non-persistence with treatment were reduced at 10 sites, relative to the reference, with first-treated eye status and with baseline acuity worse than or equal to LogMAR 1.0. Hazard ratios increased with younger age, in the presence of other ocular co-morbidities and with baseline acuity better than or equal to LogMAR 0.5. After an episode of non-persistence, visual acuity decreased by at least 0.1 and 0.3 LogMAR in 39% and 18% of eyes, respectively. CONCLUSIONS: Non-persistence with treatment was common, especially in the first year of treatment, and was often associated with a decrease in visual acuity. Treatment site, baseline visual acuity, and age were the strongest predictors of treatment non-persistence before day 720. Understanding and addressing reasons for non-persistence are important to ensure that effective but expensive treatments are used cost-effectively and to maintain acuity. Variation in non-persistence between sites, even after adjustment for other variables, suggests that local factors in treatment provision may be particularly important.

Blood loss and transfusion risk in intramedullary nailing for subtrochanteric fractures.

BACKGROUND: The incidence of hip fractures and subtrochanteric fractures in particular is increasing, along with the globally expanding aging population. Intramedullary nailing remains the 'gold standard' of their treatment. Blood loss can be a result of the original trauma, but also secondary to the subsequent surgical insult, especially during the reaming of the intramedullary canal. OBJECTIVES: The aim of our study was to report on the blood loss and incidence of blood transfusion in patients presenting with a subtrochanteric fracture treated with intramedullary nailing. Most importantly, we aim to identify factors associated with the need for transfusion within the first 48 h post-operatively. METHODS: Following institutional board approval, 431 consecutive patients (131 males; age: 79.03 years old, SD 13.68 years) presenting in a Level 1 Trauma Centre with a subtrochanteric fracture treated with an intramedullary nail were retrospectively identified, over an 8-year period. Exclusion criteria included patients with high energy injuries, pathological fractures, primary operations at other institutions and patients lost to follow-up. To identify risk factors leading to increased risk of transfusion, we first compared patients requiring intra-operative transfusion or transfusion during the first 48 h post-operatively against those who did not require transfusion. This was then followed by multivariate regression analysis adjusted for confounding factors to identify the most important risk factors associated with need for transfusion within the first 48 h post-operatively. RESULTS: Incidence of blood transfusion was 6.0% pre-operatively, compared to 62.7% post-operatively. A total of 230 patients (52.3%) required either intra-operative transfusion or transfusion during the first 48 h following surgery. Patients having a transfusion within the first 48 h post-operatively had a higher incidence of escalation in their care (p = 0.050), LOS (p = 0.015), 30-day (p = 0.033) and one-year mortality (p = 0.004). Multivariate regression analysis adjusted for confounding factors identified that the most important association of a need for transfusion within the first 48 post-operative hours was a pre-operative Hb <100 g/L (OR 6.64); a nail/canal ratio <70% (OR 3.92), followed by need for open reduction (OR 2.66). Fracture involving the lesser trochanter was also implicated with an increased risk (OR 2.08). Additionally, pre-operative moderate/severe renal impairment (OR 4.56), as well as hypoalbuminaemia on admission (OR 2.10) were biochemical predictors of an increased risk of transfusion. Most importantly, the need for transfusion was associated with an increase in 30-day mortality (OR 12.07). CONCLUSION: Several patient, fracture and surgery related factors are implicated with an increased risk for transfusion within the first 48-h post-operatively. Early identification, and where possible correction of these factors can potentially reduce blood loss and risk of transfusion, along with all the associated sequelae and mortality risk. LEVEL OF EVIDENCE: III.

Statistical methods for measuring trends in colorectal cancer incidence in registries: A systematic review.

Background: Monitoring cancer trends in a population is essential for tracking the disease's burden, allocating resources, and informing public health policies. This review describes variations in commonly employed methods to estimate colorectal cancer (CRC) incidence trends. Methods: We performed a systematic literature search in four databases to identify population-based studies reporting CRC incidence trends, published between January 2010 and May 2020. We extracted and described data on methods to estimate trends and assess model validity, and the software used. Results: This review included 145 articles based on studies conducted in five continents. The majority (93%) presented visual summaries of trends combined with absolute, relative, or annual change estimates. Fourteen (10%) articles exclusively calculated the relative change in incidence over a given time interval, presented as the percentage of change in rates. Joinpoint regression analysis was the most commonly used method for assessing incidence trends (n= 65, 45%), providing estimates of the annual percentage change (APC) in rates. Nineteen (13%) studies performed Poisson regression and 18 (12%) linear regression analysis. Age-period-cohort modeling- a type of generalized linear models- was conducted in 18 (12%) studies. Thirty-nine (37%) of the studies modeling incidence trends (n=104, 72%) indicated the method used to evaluate model fitness. The joinpoint program (52%) was the statistical software most commonly used. Conclusion: This review identified variation in the calculation of CRC incidence trends and inadequate reporting of model fit statistics. Our findings highlight the need for increasing clarity and transparency in reporting methods to facilitate interpretation, reproduction, and comparison with findings from previous studies.

Procalcitonin Evaluation of Antibiotic Use in COVID-19 Hospitalised Patients (PEACH): Protocol for a Retrospective Observational Study.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel virus responsible for the coronavirus disease 2019 (COVID-19) pandemic. Although COVID-19 is a viral illness, many patients admitted to hospital are prescribed antibiotics, based on concerns that COVID-19 patients may experience secondary bacterial infections, and the assumption that they may respond well to antibiotic therapy. This has led to an increase in antibiotic use for some hospitalised patients at a time when accumulating antibiotic resistance is a major global threat to health. Procalcitonin (PCT) is an inflammatory marker measured in blood samples and widely recommended to help diagnose bacterial infections and guide antibiotic treatment. The PEACH study will compare patient outcomes from English and Welsh hospitals that used PCT testing during the first wave of the COVID-19 pandemic with those from hospitals not using PCT. It will help to determine whether, and how, PCT testing should be used in the NHS in future waves of COVID-19 to protect patients from antibiotic overuse. PEACH is a retrospective observational cohort study using patient-level clinical data from acute hospital Trusts and Health Boards in England and Wales. The primary objective is to measure the difference in antibiotic use between COVID-19 patients who did or did not have PCT testing at the time of diagnosis. Secondary objectives include measuring differences in length of stay, mortality, intensive care unit admission, and resistant bacterial infections between these groups.

Sex differences in health-related quality of life trajectories following myocardial infarction: national longitudinal cohort study.

OBJECTIVES: To investigate sex-based differences in baseline values and longitudinal trajectories of health-related quality of life (HRQoL) in a large cohort of myocardial infarction (MI) survivors after adjusting for other important factors. DESIGN: Longitudinal cohort study. SETTING: Population-based longitudinal study the Evaluation of the Methods and Management of Acute Coronary Events study linked with national cardiovascular registry. Data were collected from 77 hospitals in England between 1 November 2011 and 24 June 2015. PARTICIPANTS: 9551 patients with MI. Patients were eligible for the study if they were ≥18 years of age. PRIMARY AND SECONDARY OUTCOME MEASURES: HRQoL was measured by EuroQol five-dimension, visual analogue scale (EQ-5D, EQ VAS) survey at baseline, 1, 6 and 12 months after discharge. Multi-level linear and logistic regression models coupled with inverse probability weighted propensity scoring were used to evaluate sex differences in HRQoL following MI. RESULTS: Of the 9551 patients with MI and complete data on sex, 25.1% (2,397) were women. At baseline, women reported lower HRQoL (EQ VAS (mean (SD) 59.8 (20.4) vs 64.5 (20.9)) (median (IQR) 60.00 (50.00-75.00) vs 70.00 (50.00-80.00))) (EQ-5D (mean (SD) 0.66 (0.31) vs 0.74 (0.28)) (median (IQR) 0.73 (0.52-0.85) vs 0.81 (0.62-1.00))) and were more likely to report problems in each HRQoL domain compared with men. In the covariate balanced and adjusted multi-level model sex differences in HRQoL persisted during follow-up, with lower EQ VAS and EQ-5D scores in women compared with men (adjusted EQ VAS model sex coefficient: -4.41, 95% CI -5.16 to -3.66 and adjusted EQ-5D model sex coefficient: -0.07, 95% CI -0.08 to -0.06). CONCLUSIONS: Women have lower HRQoL compared with men at baseline and during 12 months follow-up after MI. Tailored interventions for women following an MI could improve their quality of life. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT04598048, NCT01808027, NCT01819103.

HABIT: Health visitors delivering Advice in Britain on Infant Toothbrushing - an early-phase feasibility study of a complex oral health intervention.

OBJECTIVES: To conduct an early-phase feasibility study of an oral health intervention, Health visitors delivering Advice on Britain on Infant Toothbrushing (HABIT), delivered by Health Visitors to parents of children aged 9-12 months old. DESIGN: A mixed-methods, early-phase, non-controlled, feasibility study. PARTICIPANTS: Recruitment consisted of Group A-HABIT-trained Health Visitors (n=11) and Group B-parents of children aged 9-12 months old about to receive their universal health check (n=35). SETTING: Bradford, West Yorkshire, UK. INTERVENTION: A multidisciplinary team co-developed digital and paper-based training resources with health visitors and parents of young children. The intervention comprised of two components: (A) training for health visitors to deliver the HABIT intervention and (B) HABIT resources for parents, including a website, videos, toothbrushing demonstration and a paper-based leaflet with an oral health action plan. PRIMARY AND SECONDARY OUTCOME MEASURES: Recruitment, retention and intervention delivery were analysed as key process outcomes for Groups A and B. Group B demographics, self-reported toothbrushing behaviours, dietary habits and three objective measures of toothbrushing including plaque scores were collected at baseline, 2 weeks and 3 months post intervention. RESULTS: HABIT intervention delivery was feasible. Although the intended sample size was recruited (Group A=11 and Group B=35) it was more challenging than anticipated. Retention of Group B participants to final data collection was satisfactory (n=26). Total compliance with toothbrushing guidelines at baseline was low (30%), but significantly improved and was maintained 3 months after the intervention (68%). Plaque scores improved post intervention and participants found video recording of toothbrushing acceptable. Dietary habits remained largely unchanged. CONCLUSION: This feasibility study has demonstrated that HABIT is an appropriate oral health intervention. Adaptions to the study design are recommended to maximise recruitment and data collection in a definitive study. These quantitative findings have demonstrated an early signal of impact for improved oral health behaviours for young children at high risk of decay. TRIAL REGISTRATION NUMBER: ISRCTN55332414.

Subtrochanteric femoral fractures and intramedullary nailing complications: a comparison of two implants.

INTRODUCTION: Intramedullary (IM) nails are considered the 'gold' standard treatment for subtrochanteric femoral fractures. The incidence and risk factors for re-operation in subtrochanteric fractures remain unclear. Furthermore, no studies have compared the outcomes of different nailing systems used to treat subtrochanteric fractures in the same study population. AIMS/OBJECTIVES: Our study aimed to (i) investigate the cumulative incidence and factors associated with an increased risk of re-operation in subtrochanteric fractures treated with a long intramedullary (IM) nail, (ii) compare the outcomes of subtrochanteric fractures treated with long Affixus and Gamma nails, and (iii) establish whether the addition of a proximal anti-rotation screw in the Affixus nail confers any clinical benefit. METHODS: A retrospective review of all adult patients admitted to a level 1 trauma centre with a subtrochanteric femur fracture treated with a long cephalomedullary IM nail over an 8-year period was conducted. Exclusion criteria were primary surgery performed at another institution, prophylactic nailing because of tumours, incomplete fractures, and patients who were lost to follow-up or died before fracture healing. Data variables were assessed for normality prior to determining the use of either parametric or non-parametric tests. Logistic regression analysis was performed to identify potential factors associated with re-operation. For the comparison between the two nail types, patients were matched into two groups of 119 each by age (10-year intervals), gender and mechanism of injury (low energy, high energy and pathological fractures). A p-value < 0.05 was considered significant. The Kaplan-Meier nail survival curve was used to demonstrate the survival of each nail. Data were analysed using the statistical package R (R version 3.6.0). RESULTS: A total of 309 subtrochanteric fractures were treated with a distally locked long IM nail (re-operation rate: 22.33%) over an 8-year period. Logistic regression identified six factors associated with an increased risk of re-operation, including age < 75 years old, use of a long Gamma nail, pre-injury coxa-vara femoral neck shaft angles, an immediate post-operative reduction angle of > 10° varus, deep wound infection and non-union. Following matching, we compared the two long cephalomedullary nailing systems used (Gamma versus Affixus nail). The only differences identified from the unadjusted analysis were a higher overall incidence of nail failure in Gamma nails due to any cause, re-operation, and impingement of the nail tip distally against the anterior femoral cortex. When we corrected for covariates, no significant differences remained evident between the two nails. From the Kaplan-Meier nail survival curves, however, the Affixus nail demonstrated better survivorship up to 5 years post-implantation in terms of nail failure and re-operation for all causes. Finally, the addition of a proximal anti-rotation screw in the Affixus nail did not seem to confer any benefit. CONCLUSION: We reported a 22.3% re-operation rate in our cohort of subtrochanteric fractures treated with a long IM nail. We have identified six risk factors associated with re-operation: age < 75 years old, pre-injury femoral neck shaft angle, choice of nail, varus reduction angle, fracture-related infection and non-union. The addition of a proximal anti-rotation screw in the Affixus nail did not confer any benefit.

A systematic review of methods to estimate colorectal cancer incidence using population-based cancer registries.

BACKGROUND: Epidemiological studies of incidence play an essential role in quantifying disease burden, resource planning, and informing public health policies. A variety of measures for estimating cancer incidence have been used. Appropriate reporting of incidence calculations is essential to enable clear interpretation. This review uses colorectal cancer (CRC) as an exemplar to summarize and describe variation in commonly employed incidence measures and evaluate the quality of reporting incidence methods. METHODS: We searched four databases for CRC incidence studies published between January 2010 and May 2020. Two independent reviewers screened all titles and abstracts. Eligible studies were population-based cancer registry studies evaluating CRC incidence. We extracted data on study characteristics and author-defined criteria for assessing the quality of reporting incidence. We used descriptive statistics to summarize the information. RESULTS: This review retrieved 165 relevant articles. The age-standardized incidence rate (ASR) (80%) was the most commonly reported incidence measure, and the 2000 U.S. standard population the most commonly used reference population (39%). Slightly more than half (54%) of the studies reported CRC incidence stratified by anatomical site. The quality of reporting incidence methods was suboptimal. Of all included studies: 45 (27%) failed to report the classification system used to define CRC; 63 (38%) did not report CRC codes; and only 20 (12%) documented excluding certain CRC cases from the numerator. Concerning the denominator estimation: 61% of studies failed to state the source of population data; 24 (15%) indicated census years; 10 (6%) reported the method used to estimate yearly population counts; and only 5 (3%) explicitly explained the population size estimation procedure to calculate the overall average incidence rate. Thirty-three (20%) studies reported the confidence interval for incidence, and only 7 (4%) documented methods for dealing with missing data. CONCLUSION: This review identified variations in incidence calculation and inadequate reporting of methods. We outlined recommendations to optimize incidence estimation and reporting practices. There is a need to establish clear guidelines for incidence reporting to facilitate assessment of the validity and interpretation of reported incidence.

Safeguarding adolescent mental health in India (SAMA): study protocol for codesign and feasibility study of a school systems intervention targeting adolescent anxiety and depression in India.

INTRODUCTION: Symptoms of anxiety and depression in Indian adolescents are common. Schools can be opportune sites for delivery of mental health interventions. India, however, is without a evidence-based and integrated whole-school mental health approach. This article describes the study design for the safeguarding adolescent mental health in India (SAMA) project. The aim of SAMA is to codesign and feasibility test a suite of multicomponent interventions for mental health across the intersecting systems of adolescents, schools, families and their local communities in India. METHODS AND ANALYSIS: Our project will codesign and feasibility test four interventions to run in parallel in eight schools (three assigned to waitlist) in Bengaluru and Kolar in Karnataka, India. The primary aim is to reduce the prevalence of adolescent anxiety and depression. Codesign of interventions will build on existing evidence and resources. Interventions for adolescents at school will be universal, incorporating curriculum and social components. Interventions for parents and teachers will target mental health literacy, and also for teachers, training in positive behaviour practices. Intervention in the school community will target school climate to improve student mental health literacy and care. Intervention for the wider community will be via adolescent-led films and social media. We will generate intervention cost estimates, test outcome measures and identify pathways to increase policy action on the evidence. ETHICS AND DISSEMINATION: Ethical approval has been granted by the National Institute of Mental Health Neurosciences Research Ethics Committee (NIMHANS/26th IEC (Behv Sc Div/2020/2021)) and the University of Leeds School of Psychology Research Ethics Committee (PSYC-221). Certain data will be available on a data sharing site. Findings will be disseminated via peer-reviewed journals and conferences.

Demographic, clinical and neuroimaging markers of post-stroke emotionalism: A preliminary investigation.

INTRODUCTION: Post stroke emotionalism (PSE) is a common but poorly understood condition. The value of altered brain structure as a putative risk factor for PSE alongside routinely available demographic and clinical variables has yet to be elucidated. METHODS: 85 patients were recruited from acute inpatient settings within 2 weeks of stroke. PSE was diagnosed using a validated semi-structured interview and standardised measures of stroke severity, functional ability, cognition, mood and quality of life were obtained. Neuroimaging variables (intracranial volume and volumes of cortical grey matter, subcortical grey matter, normal appearing white matter, cerebrum, cerebrospinal fluid and stroke; white matter hyperintensities; and mean cortical thickness) were derived using standardised methods from Magnetic Resonance Imaging (MRI) studies. The relationships between PSE diagnosis, brain structure, demographic and clinical variables were investigated using machine learning algorithms to determine how well different sets of predictors could classify PSE. RESULTS: The model with the best performance was derived from neuroradiological variables alone (sensitivity = 0.75; specificity = 0.8235), successfully classifying 9/12 individuals with PSE and 28/34 non-PSE cases. CONCLUSIONS: Neuroimaging measures appear to be important in PSE. Future work is needed to determine which specific variables are key. Imaging may complement standard behavioural measures and aid clinicians and researchers.

Burden of allergic disease among ethnic minority groups in high-income countries.

The COVID-19 pandemic raised acute awareness regarding inequities and inequalities and poor clinical outcomes amongst ethnic minority groups. Studies carried out in North America, the UK and Australia have shown a relatively high burden of asthma and allergies amongst ethnic minority groups. The precise reasons underpinning the high disease burden are not well understood, but it is likely that this involves complex gene-environment interaction, behavioural and cultural elements. Poor clinical outcomes have been related to multiple factors including access to health care, engagement with healthcare professionals and concordance with advice which are affected by deprivation, literacy, cultural norms and health beliefs. It is unclear at present if allergic conditions are intrinsically more severe amongst patients from ethnic minority groups. Most evidence shaping our understanding of disease pathogenesis and clinical management is biased towards data generated from white population resident in high-income countries. In conjunction with standards of care, it is prudent that a multi-pronged approach towards provision of composite, culturally tailored, supportive interventions targeting demographic variables at the individual level is needed, but this requires further research and validation. In this narrative review, we provide an overview of epidemiology, sensitization patterns, poor clinical outcomes and possible factors underpinning these observations and highlight priority areas for research.