Optimising recruitment to a lung cancer screening trial: A comparison of general practitioner and community-based recruitment.

OBJECTIVES: Pre-trial focus groups of the Early detection of Cancer of the Lung Scotland (ECLS) trial indicated that those at high risk of lung cancer are more likely to engage with community-based recruitment methods. The current study aimed to understand if general practitioner (GP) and community-based recruitment might attract different groups of people, and to quantitatively explore the demographic and psychosocial differences between people responding to GP or community-based recruitment. DESIGN: Secondary data analysis of ECLS trial baseline data. METHODS: Adults (n = 11,164) aged 50 to 75 years completed a baseline questionnaire as part of their participation in the ECLS trial. The questionnaire assessed smoking behaviour, health state, health anxiety and illness perception. Alongside demographic characteristics, how participants were made aware of the study/participant recruitment method (GP recruitment/community recruitment) was also obtained via trial records. RESULTS: The likelihood of being recruited via community-based methods increased as deprivation level decreased. Those recruited via the community had higher levels of perceived personal control of developing lung cancer and were more likely to understand their own risk of developing lung cancer, compared to those who were recruited to the trial via their GP. Health state and health anxiety did not predict recruitment methods in multivariable analysis. CONCLUSIONS: Community and opportunistic screening invitations were associated with uptake in people from less-deprived backgrounds, and therefore might not be the optimal method to reach those at high risk of lung cancer and living in more deprived areas.

Breast Cancer Screening Among Females With and Without Schizophrenia.

Importance: Breast cancer screening with mammography is recommended in Ontario, Canada, for females 50 years or older. Females with schizophrenia are at higher risk of breast cancer, but in Ontario it is currently unknown whether breast cancer screening completion differs between those with vs without schizophrenia and whether primary care payment models are a factor. Objective: To compare breast cancer screening completion within 2 years after the 50th birthday among females with and without schizophrenia, and to identify the association between breast cancer screening completion and different primary care payment models. Design, Setting, and Participants: This case-control study analyzed Ontario-wide administrative data on females with and without schizophrenia who turned 50 years of age between January 1, 2010, and December 31, 2019. Those with schizophrenia (cases) were matched 1:10 to those without schizophrenia (controls) on local health integration network, income quintile, rural residence, birth dates, and weighted Aggregated Diagnosis Group score. Data analysis was performed from November 2021 to February 2023. Exposures: Exposures were schizophrenia and primary care payment models. Main Outcomes and Measures: Outcomes included breast cancer screening completion among cases and controls within 2 years after their 50th birthday and the association with receipt of care from primary care physicians enrolled in different primary care payment models, which were analyzed using logistic regression and reported as odds ratios (ORs) and 95% CIs. Results: The study included 11 631 females with schizophrenia who turned 50 years of age during the study period and a matched cohort of 115 959 females without schizophrenia, for a total of 127 590 patients. Overall, 69.3% of cases and 77.1% of controls had a mammogram within 2 years after their 50th birthday. Cases had lower odds of breast cancer screening completion within 2 years after their 50th birthday (OR, 0.67; 95% CI, 0.64-0.70). Cases who received care from a primary care physician in a fee-for-service (OR, 0.57; 95% CI, 0.53-0.60) or enhanced fee-for-service (OR, 0.79; 95% CI, 0.75-0.82) payment model had lower odds of having a mammogram than cases whose physicians were paid under a Family Health Team model. Conclusions and Relevance: This case-control study found that, in Ontario, Canada, breast cancer screening completion was lower among females with schizophrenia, and differences from those without schizophrenia may partially be explained by differences in primary care payment models. Widening the availability of team-based primary care for females with schizophrenia may play a role in increased breast cancer screening rates.

Personalised lung cancer risk stratification and lung cancer screening: do general practice electronic medical records have a role?

BACKGROUND: In the United Kingdom (UK), cancer screening invitations are based on general practice (GP) registrations. We hypothesize that GP electronic medical records (EMR) can be utilised to calculate a lung cancer risk score with good accuracy/clinical utility. METHODS: The development cohort was Secure Anonymised Information Linkage-SAIL (2.3 million GP EMR) and the validation cohort was UK Biobank-UKB (N = 211,597 with GP-EMR availability). Fast backward method was applied for variable selection and area under the curve (AUC) evaluated discrimination. RESULTS: Age 55-75 were included (SAIL: N = 574,196; UKB: N = 137,918). Six-year lung cancer incidence was 1.1% (6430) in SAIL and 0.48% (656) in UKB. The final model included 17/56 variables in SAIL for the EMR-derived score: age, sex, socioeconomic status, smoking status, family history, body mass index (BMI), BMI:smoking interaction, alcohol misuse, chronic obstructive pulmonary disease, coronary heart disease, dementia, hypertension, painful condition, stroke, peripheral vascular disease and history of previous cancer and previous pneumonia. The GP-EMR-derived score had AUC of 80.4% in SAIL and 74.4% in UKB and outperformed ever-smoked criteria (currently the first step in UK lung cancer screening pilots). DISCUSSION: A GP-EMR-derived score may have a role in UK lung cancer screening by accurately targeting high-risk individuals without requiring patient contact.

Long-term exposure to air pollution and mortality in Scotland: A register-based individual-level longitudinal study.

BACKGROUND: Air pollution is associated with several adverse health outcomes. However, heterogeneity in the size of effect estimates between cohort studies for long-term exposures exist and pollutants like SO2 and mental/behavioural health outcomes are little studied. This study examines the association between long-term exposure to multiple ambient air pollutants and all-cause and cause-specific mortality from both physical and mental illnesses. METHODS: We used individual-level administrative data from the Scottish-Longitudinal-Study (SLS) on 202,237 individuals aged 17 and older, followed between 2002 and 2017. The SLS dataset was linked to annual concentrations of NO2, SO2, and particulate-matter (PM10, PM2.5) pollution at 1 km2 spatial resolution using the individuals' residential postcode. We applied survival analysis to assess the association between air pollution and all-cause, cardiovascular, respiratory, cancer, mental/behavioural disorders/suicides, and other-causes mortality. RESULTS: Higher all-cause mortality was associated with increasing concentrations of PM2.5, PM10, NO2, and SO2 pollutants. NO2, PM10, and PM2.5 were also associated with cardiovascular, respiratory, cancer and other-causes mortality. For example, the mortality hazard from respiratory diseases was 1.062 (95%CI = 1.028-1.096), 1.025 (95%CI = 1.005-1.045), and 1.013 (95%CI = 1.007-1.020) per 1 µg/m3 increase in PM2.5, PM10 and NO2 pollutants, respectively. In contrast, mortality from mental and behavioural disorders was associated with 1 µg/m3 higher exposure to SO2 pollutant (HR = 1.042; 95%CI = 1.015-1.069). CONCLUSION: This study revealed an association between long-term (16-years) exposure to ambient air pollution and all-cause and cause-specific mortality. The results suggest that policies and interventions to enhance air quality would reduce the mortality hazard from cardio-respiratory, cancer, and mental/behavioural disorders in the long-term.

Intranasal steroid use and COVID-19 mortality among patients with asthma and COPD: A retrospective cohort study.

BACKGROUND: Systemic corticosteroids have been widely used for treating patients with severe acute respiratory distress syndrome. Inhaled corticosteroids may have a protective effect for treating acute coronavirus disease 2019 (COVID-19); however, little is known about the potential effect of intranasal corticosteroids (INCS) on COVID-19 outcomes and severity. OBJECTIVE: To assess the impact of prior long-term INCS exposure on COVID-19 mortality among patients with chronic respiratory disease and in the general population. METHODS: A retrospective cohort study was conducted. Cox regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for the association between INCS exposure and all-cause and COVID-19 mortality, adjusted by age, sex, deprivation, exacerbations in the last year, and comorbidities. RESULTS: Exposure to INCS did not have a significant association with COVID-19 mortality among the general population or cohorts with chronic obstructive pulmonary disease or asthma, with HRs of 0.8 (95% CI, 0.6-1.0, P = .06), 0.6 (95% CI, 0.3-1.1, P = .1), and 0.9 (95% CI, 0.2-3.9, P = .9), respectively. Exposure to INCS was, however, significantly associated with reduction in all-cause mortality in all groups, which was 40% lower (HR, 0.6 [95% CI, 0.5-0.6, P < .001]) among the general population, 30% lower (HR, 0.7; 95% CI, 0.6-0.8, P < .001) among patients with chronic obstructive pulmonary disease, and 50% lower (HR, 0.5; 95% CI, 0.3-0.7, P = .003) among patients with asthma. CONCLUSION: The role of INCS in COVID-19 is still unclear, but exposure to INCS does not adversely affect COVID-19 mortality. Further studies are needed to explore the association between their use and inflammatory activation, viral load, angiotensin-converting enzyme 2 gene expression, and outcomes, exploring different types and doses of INCS.

'You feel like you've been duped': is the current system for health professionals declaring potential conflicts of interest in the UK fit for purpose? A mixed methods study.

OBJECTIVE: To understand: if professionals, citizens and patients can locate UK healthcare professionals' statements of declarations of interests, and what citizens understand by these. DESIGN: The study sample included two groups of participants in three phases. First, healthcare professionals working in the public domain (health professional participants, HPP) were invited to participate. Their conflicts and declarations of interest were searched for in publicly available data, which the HPP checked and confirmed as the 'gold standard'. In the second phase, laypeople, other healthcare professionals and healthcare students were invited to complete three online tasks. The first task was a questionnaire about their own demographics. The second task was questions about doctors' conflicts of interest in clinical vignette scenarios. The third task was a request for each participant to locate and describe the declarations of interest of one of the named healthcare professionals identified in the first phase, randomly assigned. At the end of this task, all lay participants were asked to indicate willingness to be interviewed at a later date. In the third phase, each lay respondent who was willing to be contacted was invited to a qualitative interview to obtain their views on the conflicts and declaration of interest they found and their meaning. SETTING: Online, based in the UK. PARTICIPANTS: 13 public-facing health professionals, 379 participants (healthcare professionals, students and laypeople), 21 lay interviewees. OUTCOME MEASURES: (1) Participants' level of trust in professionals with variable conflicts of interest, as expressed in vignettes, (2) participants' ability to locate the declarations of interest of a given well-known healthcare professional and (3) laypeoples' understanding of healthcare professionals declarations and conflicts of interest. RESULTS: In the first phase, 13 health professionals (HPP) participated and agreed on a 'gold standard' of their declarations. In the second phase, 379 citizens, patients, other healthcare professionals and students participated. Not all completed all aspects of the research. 85% of participants thought that knowing about professional declarations was definitely or probably important, but 76.8% were not confident they had found all relevant information after searching. As conflicts of interest increased in the vignettes, participants trusted doctors less. Least trust was associated with doctors who had not disclosed their conflicts of interest. 297 participants agreed to search for the HPP 'gold standard' declaration of interest, and 169 reported some data. Of those reporting any findings, 61 (36%) located a relevant link to some information deemed fit for purpose, and 5 (3%) participants found all the information contained in the 'gold standard'. In the third phase, qualitative interviews with 21 participants highlighted the importance of transparency but raised serious concerns about how useful declarations were in their current format, and whether they could improve patient care. Unintended consequences, such as the burden for patients and professionals to use declarations were identified, with participants additionally expressing concerns about professional bias and a lack of insight over conflicts. Suggestions for improvements included better regulation and organisation, but also second opinions and independent advice where conflicts of interest were suspected. CONCLUSION: Declarations of interest are important and conflicts of interest concern patients and professionals, particularly in regard to trust in decision-making. If declarations, as currently made, are intended to improve transparency, they do not achieve this, due to difficulties in locating and interpreting them. Unintended consequences may arise if transparency alone is assumed to provide management of conflicts. Increased trust resulting from transparency may be misplaced, given the evidence on the hazards associated with conflicts of interest. Clarity about the purposes of transparency is required. Future policies may be more successful if focused on reducing the potential for negative impacts of conflicts of interest, rather than relying on individuals to locate declarations and interpret them. TRIAL REGISTRATION NUMBER: The protocol was pre-registered at https://osf.io/e7gtq.

Effect of Free Medicine Distribution on Health Care Costs in Canada Over 3 Years: A Secondary Analysis of the CLEAN Meds Randomized Clinical Trial.

Importance: Few interventions are proven to reduce total health care costs, and addressing cost-related nonadherence has the potential to do so. Objective: To determine the effect of eliminating out-of-pocket medication fees on total health care costs. Design, Setting, and Participants: This secondary analysis of a multicenter randomized clinical trial using a prespecified outcome took place across 9 primary care sites in Ontario, Canada (6 in Toronto and 3 in rural areas), where health care services are generally publicly funded. Adult patients (≥18 years old) reporting cost-related nonadherence to medicines in the past 12 months were recruited between June 1, 2016, and April 28, 2017, and followed up until April 28, 2020. Data analysis was completed in 2021. Interventions: Access to a comprehensive list of 128 medicines commonly prescribed in ambulatory care with no out-of-pocket costs for 3 years vs usual medicine access. Main Outcome and Measures: Total publicly funded health care costs over 3 years, including costs of hospitalizations. Health care costs were determined using administrative data from Ontario's single-payer health care system, and all costs are reported in Canadian dollars with adjustments for inflation. Results: A total of 747 participants from 9 primary care sites were included in the analysis (mean [SD] age, 51 [14] years; 421 [56.4%] female). Free medicine distribution was associated with a lower median total health care spending over 3 years of $1641 (95% CI, $454-$2792; P = .006). Mean total spending was $4465 (95% CI, -$944 to $9874) lower over the 3-year period. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, eliminating out-of-pocket medication expenses for patients with cost-related nonadherence in primary care was associated with lower health care spending over 3 years. These findings suggest that eliminating out-of-pocket medication costs for patients could reduce overall costs of health care. Trial Registration: ClinicalTrials.gov Identifier: NCT02744963.

The spatial-temporal effect of air pollution on individuals' reported health and its variation by ethnic groups in the United Kingdom: a multilevel longitudinal analysis.

BACKGROUND: Air pollution is associated with poor health; though it is unclear whether this association is stronger for ethnic minorities compared to the rest of the population. This study uses longitudinal data to investigate the spatial-temporal effect of air pollution on individuals' reported health and its variation by ethnicity in the United-Kingdom (UK). METHODS: Longitudinal individual-level data from Understanding Society: the UK Household Longitudinal Study including 67,982 adult individuals with 404,264 repeated responses over 11 years (2009-2019) were utilized and were linked to yearly concentrations of NO2, SO2, and particulate-matter (PM10, PM2.5) pollution once at the local authority and once at the census Lower Super Output Area (LSOA) of residence for each individual. This allows for analysis at two geographical scales over time. The association between air pollution and individuals' health (Likert scale: 1-5, Excellent to poor) and its variation by ethnicity was assessed using three-level mixed-effects ordered logistic models. Analysis distinguished between spatial (between areas) and temporal (across time within each area) effects of air pollution on health. RESULTS: Higher concentrations of NO2, SO2, PM10, and PM2.5 pollution were associated with poorer health. Decomposing air pollution into between (spatial: across local authorities or LSOAs) and within (temporal: across years within each local authority or LSOA) effects showed a significant between effect for NO2 and SO2 pollutants at both geographical scales, while a significant between effect for PM10 and PM2.5 was shown only at the LSOAs level. No significant within effects were detected at an either geographical level. Indian, Pakistani/Bangladeshi, Black/African/Caribbean and other ethnic groups and non-UK-born individuals reported poorer health with increasing concentrations of NO2, SO2, PM10, and PM2.5 pollutants in comparison to the British-white and UK-born individuals. CONCLUSION: Using longitudinal data on individuals' health linked with air pollution data at two geographical scales (local authorities and LSOAs), this study supports the presence of a spatial-temporal association between air pollution and poor self-reported health, which is stronger for ethnic minorities and foreign-born individuals in the UK, partly explained by location-specific differences. Air pollution mitigation is necessary to improve individuals' health, especially for ethnic minorities who are affected the most.

Conservative management versus tonsillectomy in adults with recurrent acute tonsillitis in the UK (NATTINA): a multicentre, open-label, randomised controlled trial.

BACKGROUND: Tonsillectomy is regularly performed in adults with acute tonsillitis, but with scarce evidence. A reduction in tonsillectomies has coincided with an increase in acute adult hospitalisation for tonsillitis complications. We aimed to assess the clinical effectiveness and cost-effectiveness of conservative management versus tonsillectomy in patients with recurrent acute tonsillitis. METHODS: This pragmatic multicentre, open-label, randomised controlled trial was conducted in 27 hospitals in the UK. Participants were adults aged 16 years or older who were newly referred to secondary care otolaryngology clinics with recurrent acute tonsillitis. Patients were randomly assigned (1:1) to receive tonsillectomy or conservative management using random permuted blocks of variable length. Stratification by recruiting centre and baseline symptom severity was assessed using the Tonsil Outcome Inventory-14 score (categories defined as mild 0-35, moderate 36-48, or severe 49-70). Participants in the tonsillectomy group received elective surgery to dissect the palatine tonsils within 8 weeks after random assignment and those in the conservative management group received standard non-surgical care during 24 months. The primary outcome was the number of sore throat days collected during 24 months after random assignment, reported once per week with a text message. The primary analysis was done in the intention-to-treat (ITT) population. This study is registered with the ISRCTN registry, 55284102. FINDINGS: Between May 11, 2015, and April 30, 2018, 4165 participants with recurrent acute tonsillitis were assessed for eligibility and 3712 were excluded. 453 eligible participants were randomly assigned (233 in the immediate tonsillectomy group vs 220 in the conservative management group). 429 (95%) patients were included in the primary ITT analysis (224 vs 205). The median age of participants was 23 years (IQR 19-30), with 355 (78%) females and 97 (21%) males. Most participants were White (407 [90%]). Participants in the immediate tonsillectomy group had fewer days of sore throat during 24 months than those in the conservative management group (median 23 days [IQR 11-46] vs 30 days [14-65]). After adjustment for site and baseline severity, the incident rate ratio of total sore throat days in the immediate tonsillectomy group (n=224) compared with the conservative management group (n=205) was 0·53 (95% CI 0·43 to 0·65; <0·0001). 191 adverse events in 90 (39%) of 231 participants were deemed related to tonsillectomy. The most common adverse event was bleeding (54 events in 44 [19%] participants). No deaths occurred during the study. INTERPRETATION: Compared with conservative management, immediate tonsillectomy is clinically effective and cost-effective in adults with recurrent acute tonsillitis. FUNDING: National Institute for Health Research.

Diabetes care among individuals with and without schizophrenia in three Canadian provinces: A retrospective cohort study.

OBJECTIVE: Diabetes is present in approximately 10% of people living with schizophrenia and substantially contributes to early mortality, but some aspects of diabetes care among those with schizophrenia have been inadequately investigated to date. We assessed diabetes care and comorbidity management among people with and without schizophrenia. METHODS: We conducted a cohort study with data obtained from primary care electronic medical records stored in the Diabetes Action Canada (DAC) National Repository from Alberta, Ontario, and Quebec, Canada. The population studied included patients with diabetes, with and without schizophrenia, who had at least 3 primary care visits in a 2 year period between July 2017 and June 2019. Outcomes included glycemia; diabetes complication screening and monitoring; antihyperglycemic and cardioprotective medication prescription; health service use. RESULTS: We identified 69,512 patients with diabetes; 911 (1.3%) of whom also had schizophrenia. Prevalence of high HbA1C (>8.5%) (9083/68601; 13.2% vs. 137/911; 15.0%) and high blood pressure (>130/80 mmHg) (4248/68601; 6.2% vs. 73/911; 8.0%) was similar between the two groups. Half (50.0%) of patients with schizophrenia (n = 455) had 11 or more primary care visits in the past year, compared with 27.8% of people without schizophrenia. (p < 0.0001). Patients with schizophrenia had lower odds of ever having blood pressure recorded (OR = 0.81, 95% CI 0.71-0.94) and fewer of those with chronic kidney disease (CKD) were prescribed renin-angiotensin aldosterone system inhibitors, compared to patients without schizophrenia (10.3% vs 15.8%, p = 0.0005). CONCLUSIONS: Patients with diabetes and schizophrenia achieved similar blood glucose and blood pressure levels to those without schizophrenia, and had more primary care visits. However, they had fewer blood pressure readings and lower prescription of recommended medications among those who also had CKD. These results are both encouraging and represent opportunities for improvement in care.

Factors associated with recruitment to randomised controlled trials in general practice: a systematic mixed studies review.

BACKGROUND: A common challenge for randomised controlled trials (RCTs) is recruiting enough participants to be adequately powered to answer the research question. Recruitment has been set as a priority research area in trials to improve recruitment and thereby reduce wasted resources in conducted trials that fail to recruit sufficiently. METHODS: We conducted a systematic mixed studies review to identify the factors associated with recruitment to RCTs in general practice. On September 8, 2020, English language studies were identified from MEDLINE, EMBASE, Cochrane Database of Systematic Reviews and CENTRAL databases for published studies. NTIS and OpenGrey were searched for grey literature, and BMC Trials was hand searched. A narrative synthesis was conducted for qualitative studies and a thematic synthesis for qualitative studies. RESULTS: Thirty-seven studies met the inclusion criteria. These were of different study types (10 cross-sectional, 5 non-randomised studies of interventions, 2 RCTs, 10 qualitative and 10 mixed methods). The highest proportion was conducted in the UK (48%). The study quality was generally poor with 24 (65%) studies having major concerns. A complex combination of patient, practitioner or practice factors, and patient, practitioner or practice recruitment were assessed to determine the possible associations. There were more studies of patients than of practices or practitioners. CONCLUSIONS: For practitioners and patients alike, a trial that is clinically relevant is critical in influencing participation. Competing demands are given as an important reason for declining participation. There are concerns about randomisation relating to its impact on shared decision-making and not knowing which treatment will be assigned. Patients make decisions about whether they are a candidate for the trial even when they objectively fulfil the eligibility criteria. General practice processes, such as difficulties arranging appointments, can hinder recruitment, and a strong pre-existing doctor-patient relationship can improve recruitment. For clinicians, the wish to contribute to the research enterprise itself is seldom an important reason for participating, though clinicians reported being motivated to participate when the research could improve their clinical practice. One of the few experimental findings was that opportunistic recruitment resulted in significantly faster recruitment compared to systematic recruitment. These factors have clear implications for trial design. Methodologically, recruitment research of practices and practitioners should have increased priority. Higher quality studies of recruitment are required to find out what actually works rather than what might work. TRIAL REGISTRATION: PROSPERO CRD42018100695. Registered on 03 July 2018.

Emulating a Target Trial Using Primary-Care Electronic Health Records: Sodium-Glucose Cotransporter 2 Inhibitor Medications and Hemoglobin A1c.

Substantial effort has been dedicated to conducting randomized controlled experiments to generate clinical evidence for diabetes treatment. Randomized controlled experiments are the gold standard for establishing cause and effect. However, due to their high cost and time commitment, large observational databases such as those comprised of electronic health record (EHR) data collected in routine primary care may provide an alternative source with which to address such causal objectives. We used a Canadian primary-care data repository housed at the University of Toronto (Toronto, Ontario, Canada) to emulate a randomized experiment. We estimated the effectiveness of sodium-glucose cotransporter 2 inhibitor (SGLT-2i) medications for patients with diabetes using hemoglobin A1c (HbA1c) as a primary outcome and marker for glycemic control from 2018 to 2021. We assumed an intention-to-treat analysis for prescribed treatment, with analyses based on the treatment assigned rather than the treatment eventually received. We defined the causal contrast of interest as the net change in HbA1c (percent) between the group receiving the standard of care versus the group receiving SGLT-2i medication. Using a counterfactual framework, marginal structural models demonstrated a reduction in mean HbA1c level with the initiation of SGLT-2i medications. These findings provided effect sizes similar to those from earlier clinical trials on assessing the effectiveness of SGLT-2i medications.

Tonsillectomy compared with conservative management in patients over 16 years with recurrent sore throat: the NATTINA RCT and economic evaluation.

Background: The place of tonsillectomy in the management of sore throat in adults remains uncertain. Objectives: To establish the clinical effectiveness and cost-effectiveness of tonsillectomy, compared with conservative management, for tonsillitis in adults, and to evaluate the impact of alternative sore throat patient pathways. Design: This was a multicentre, randomised controlled trial comparing tonsillectomy with conservative management. The trial included a qualitative process evaluation and an economic evaluation. Setting: The study took place at 27 NHS secondary care hospitals in Great Britain. Participants: A total of 453 eligible participants with recurrent sore throats were recruited to the main trial. Interventions: Patients were randomised on a 1 : 1 basis between tonsil dissection and conservative management (i.e. deferred surgery) using a variable block-stratified design, stratified by (1) centre and (2) severity. Main outcome measures: The primary outcome measure was the total number of sore throat days over 24 months following randomisation. The secondary outcome measures were the number of sore throat episodes and five characteristics from Sore Throat Alert Return, describing severity of the sore throat, use of medications, time away from usual activities and the Short Form questionnaire-12 items. Additional secondary outcomes were the Tonsil Outcome Inventory-14 total and subscales and Short Form questionnaire-12 items 6 monthly. Evaluation of the impact of alternative sore throat patient pathways by observation and statistical modelling of outcomes against baseline severity, as assessed by Tonsil Outcome Inventory-14 score at recruitment. The incremental cost per sore throat day avoided, the incremental cost per quality-adjusted life-year gained based on responses to the Short Form questionnaire-12 items and the incremental net benefit based on costs and responses to a contingent valuation exercise. A qualitative process evaluation examined acceptability of trial processes and ramdomised arms. Results: There was a median of 27 (interquartile range 12-52) sore throats over the 24-month follow-up. A smaller number of sore throats was reported in the tonsillectomy arm [median 23 (interquartile range 11-46)] than in the conservative management arm [median 30 (interquartile range 14-65)]. On an intention-to-treat basis, there were fewer sore throats in the tonsillectomy arm (incident rate ratio 0.53, 95% confidence interval 0.43 to 0.65). Sensitivity analyses confirmed this, as did the secondary outcomes. There were 52 episodes of post-operative haemorrhage reported in 231 participants undergoing tonsillectomy (22.5%). There were 47 re-admissions following tonsillectomy (20.3%), 35 relating to haemorrhage. On average, tonsillectomy was more costly and more effective in terms of both sore throat days avoided and quality-adjusted life-years gained. Tonsillectomy had a 100% probability of being considered cost-effective if the threshold for an additional quality-adjusted life year was £20,000. Tonsillectomy had a 69% probability of having a higher net benefit than conservative management. Trial processes were deemed to be acceptable. Patients who received surgery were unanimous in reporting to be happy to have received it. Limitations: The decliners who provided data tended to have higher Tonsillectomy Outcome Inventory-14 scores than those willing to be randomised implying that patients with a higher burden of tonsillitis symptoms may have declined entry into the trial. Conclusions: The tonsillectomy arm had fewer sore throat days over 24 months than the conservative management arm, and had a high probability of being considered cost-effective over the ranges considered. Further work should focus on when tonsillectomy should be offered. National Trial of Tonsillectomy IN Adults has assessed the effectiveness of tonsillectomy when offered for the current UK threshold of disease burden. Further research is required to define the minimum disease burden at which tonsillectomy becomes clinically effective and cost-effective. Trial registration: This trial is registered as ISRCTN55284102. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/146/06) and is published in full in Health Technology Assessment; Vol. 27, No. 31. See the NIHR Funding and Awards website for further award information.

Tonsillectomy is an operation to take out the pair of tonsil glands at the back of the throat. It is an option for adults who suffer from repeated, severe sore throats. Adults who have a tonsillectomy say that they get fewer sore throats afterwards, but it is not clear whether or not they would have got better over time without the operation. There is pressure on doctors to limit the number of tonsillectomies carried out. At the same time, emergency hospital admissions for adults with severe throat infections have been increasing. NAtional Trial of Tonsillectomy IN Adults aimed to find out whether tonsillectomy is an effective and worthwhile treatment for repeated severe sore throats or whether patients would be better off treated without an operation. A total of 453 patients from 27 hospitals in Great Britain took part in the study. Patients were assigned at random to receive either tonsillectomy or conservative management (treatment as needed from their general practitioner). We measured how many sore throats patients had in the next 2 years by sending them text messages every week. We asked about the impact of their sore throats on their quality of life and time off work, and looked at the costs of treatment. We also interviewed 47 patients, general practitioners and hospital staff about their experiences of tonsillectomy and NAtional Trial of Tonsillectomy IN Adults. The typical patient in the tonsillectomy arm had 23 days of sore throat compared with 30 days of sore throat in the conservative management arm. Tonsillectomy resulted in higher quality of life. We looked to see whether or not it was only those with the most severe sore throats who benefited from tonsillectomy, but we found that patients with more or less severe sore throats at the start all did better with tonsillectomy. Patients who had a tonsillectomy were happy to have undertaken this. Our findings suggest a clear benefit of tonsillectomy using modest additional NHS resources for adults with repeated severe sore throats.

Understanding patient barriers and facilitators to uptake of lung screening using low dose computed tomography: a mixed methods scoping review of the current literature.

BACKGROUND: Targeted lung cancer screening is effective in reducing mortality by upwards of twenty percent. However, screening is not universally available and uptake is variable and socially patterned. Understanding screening behaviour is integral to designing a service that serves its population and promotes equitable uptake. We sought to review the literature to identify barriers and facilitators to screening to inform the development of a pilot lung screening study in Scotland. METHODS: We used Arksey and O'Malley's scoping review methodology and PRISMA-ScR framework to identify relevant literature to meet the study aims. Qualitative, quantitative and mixed methods primary studies published between January 2000 and May 2021 were identified and reviewed by two reviewers for inclusion, using a list of search terms developed by the study team and adapted for chosen databases. RESULTS: Twenty-one articles met the final inclusion criteria. Articles were published between 2003 and 2021 and came from high income countries. Following data extraction and synthesis, findings were organised into four categories: Awareness of lung screening, Enthusiasm for lung screening, Barriers to lung screening, and Facilitators or ways of promoting uptake of lung screening. Awareness of lung screening was low while enthusiasm was high. Barriers to screening included fear of a cancer diagnosis, low perceived risk of lung cancer as well as practical barriers of cost, travel and time off work. Being health conscious, provider endorsement and seeking reassurance were all identified as facilitators of screening participation. CONCLUSIONS: Understanding patient reported barriers and facilitators to lung screening can help inform the implementation of future lung screening pilots and national lung screening programmes.

How are declarations of interest working? A cross-sectional study in declarations of interest in healthcare practice in Scotland and England in 2020/2021.

OBJECTIVE: To understand arrangements for healthcare organisations' declarations of staff interest in Scotland and England in the context of current recommendations. DESIGN: Cross-sectional study of a random selection of National Health Service (NHS) hospital registers of interest by two independent observers in England, all NHS Boards in Scotland and a random selection of Clinical Commissioning Groups (CCGs) in England. SETTING: NHS Trusts in England (NHSE), NHS Boards in Scotland, CCGs in England, and private healthcare organisations. PARTICIPANTS: Registers of declarations of interest published in a random sample of 67 of 217 NHS Trusts, a random sample of 15 CCGs of in England, registers held by all 14 NHS Scotland Boards and a purposeful selection of private hospitals/clinics in the UK. MAIN OUTCOME MEASURES: Adherence to NHSE guidelines on declarations of interests, and comparison in Scotland. RESULTS: 76% of registers published by Trusts did not routinely include all declaration of interest categories recommended by NHS England. In NHS Scotland only 14% of Boards published staff registers of interest. Of these employee registers (most obtained under Freedom of Information), 27% contained substantial retractions. In England, 96% of CCGs published a Gifts and Hospitality register, with 67% of CCG staff declaration templates and 53% of governor registers containing full standard NHS England declaration categories. Single organisations often held multiple registers lacking enough information to interpret them. Only 35% of NHS Trust registers were organised to enable searching. None of the private sector organisations studied published a comparable declarations of interest register. CONCLUSION: Despite efforts, the current system of declarations frequently lacks ability to meaningfully obtain complete healthcare professionals' declaration of interests.

Optimizing the implementation of lung cancer screening in Scotland: Focus group participant perspectives in the LUNGSCOT study.

INTRODUCTION: Targeted lung cancer screening is effective in reducing lung cancer and all-cause mortality according to major trials in the United Kingdom and Europe. However, the best ways of implementing screening in local communities requires an understanding of the population the programme will serve. We undertook a study to explore the views of those potentially eligible for, and to identify potential barriers and facilitators to taking part in, lung screening, to inform the development of a feasibility study. METHODS: Men and women aged 45-70, living in urban and rural Scotland, and either self-reported people who smoke or who recently quit, were invited to take part in the study via research agency Taylor McKenzie. Eleven men and 14 women took part in three virtual focus groups exploring their views on lung screening. Focus group transcripts were transcribed and analysed using thematic analysis, assisted by QSR NVivo. FINDINGS: Three overarching themes were identified: (1) Knowledge, awareness and acceptability of lung screening, (2) Barriers and facilitators to screening and (3) Promoting screening and implementation ideas. Participants were largely supportive of lung screening in principle and described the importance of the early detection of cancer. Emotional and psychological concerns as well as system-level and practical issues were discussed as posing barriers and facilitators to lung screening. CONCLUSIONS: Understanding the views of people potentially eligible for a lung health check can usefully inform the development of a further study to test the feasibility and acceptability of lung screening in Scotland. PATIENT OR PUBLIC CONTRIBUTION: The LUNGSCOT study has convened a patient advisory group to advise on all aspects of study development and implementation. Patient representatives commented on the focus group study design, study materials and ethics application, and two representatives read the focus group transcripts.

Tayside Screening For Cardiac Events (TASCFORCE) study: a prospective cardiovascular risk screening study.

PURPOSE: Risk factor-based models struggle to accurately predict the development of cardiovascular disease (CVD) at the level of the individual. Ways of identifying people with low predicted risk who will develop CVD would allow stratified advice and support informed treatment decisions about the initiation or adjustment of preventive medication, and this is the aim of this prospective cohort study. PARTICIPANTS: The Tayside Screening for Cardiac Events (TASCFORCE) study recruited men and women aged≥40 years, free from known CVD, with a predicted 10-year risk of coronary heart disease<20%. If B-type natriuretic peptide (BNP) was greater than their gender median, participants were offered a whole-body contrast-enhanced MRI (WBCE-MRI) scan (cardiac imaging, whole-body angiography to determine left ventricular parameters, delayed gadolinium enhancement, atheroma burden). Blood, including DNA, was stored for future biomarker assays. Participants are being followed up using electronic record-linkage cardiovascular outcomes. FINDINGS TO DATE: 4423 (1740, 39.3% men) were recruited. Mean age was 52.3 years with a median BNP of 7.50 ng/L and 15.30 ng/L for men and women, respectively. 602 had a predicted 10-year risk of 10%-19.9%, with the remainder<10%. Age, female sex, ex-smoking status, lower heart rate, higher high-density lipoprotein and lower total cholesterol were independently associated with higher log10 BNP levels. Mean left ventricular mass was 129.2 g and 87.0 g in men and women, respectively. FUTURE PLANS: The TASCFORCE study is investigating the ability of a screening programme, using BNP and WBCE-MRI, at the time of enrolment, to evaluate prediction of CVD in a population at low/intermediate risk. Blood stored for future biomarker analyses will allow testing/development of novel biomarkers. We believe this could be a new UK Framingham study allowing study for many years to come. CLINICAL TRIAL REGISTRATION: ISRCTN38976321.

Outcomes and Complications of Corticosteroid Injection of Rheumatoid Nodules.

Objective: Rheumatoid nodules (RN), a classic cutaneous extra-articular manifestation of rheumatoid arthritis, can often cause discomfort or cosmetic embarrassment. This research determined the effectiveness and complications of corticosteroid injection of the RN. Methods: Using a repeated measure design, 66 consecutive symptomatic RN were measured, underwent corticosteroid injection with 1 to 2mL of a 50:50 mixture of 1% lidocaine and triamcinolone acetonide (20-40mg), and then reassessed at four months for softening, reduction in size, and complications, including infection. Results: The mean age of our patient group was 53.3±10.6 years; 45 percent were Hispanic, 55 percent were non-Hispanic White, 100 percent were seropositive (rheumatoid factor and/or anti-CCP antibody), and 87.5 percent were female. Baseline mean RN diameter was 0.50±0.51cm and four months after injection was reduced to 0.29±0.33cm (decreased 42% or 0.21±0.57cm reduction, 95% CI: 0.46 <0.21< 0.37, p=0.013), 100 percent (66/66) were less painful, and 77 percent (51/66) were palpably softened. However, 70 percent (46/66) demonstrated cutaneous atrophy and/or hypopigmentation at four months, 53 percent (35/66) nodules recurred within 12 months, and 47 percent (31/66) nodules were eventually surgically removed. Limitations: Two (3%) of the larger RN (2.5cm on the olecranon and 2cm on the 2nd toe) became infected and failed antibiotic therapy, necessitating surgical excision for complete resolution. Conclusion: For short-term symptomatic relief, smaller RN can be safely injected with triamcinolone. Large symptomatic RN (≥2cm) are at greater risk of infection; thus, in these cases, lower corticosteroid doses or surgical excision may be preferred. In the long-term, effective systemic antirheumatic therapy with treat-to-target is the best approach.