Objectives Physical exertion is a high-risk activity for aerosol emission of respiratory pathogens. We aimed to determine the safety and tolerability of healthy young adults wearing different types of face mask during moderate-to-high intensity exercise. Design Cross-over randomised controlled study, completed between June 2021 and January 2022. Participants Volunteers aged 18-35 years, who exercised regularly and had no significant pre-existing health conditions. Interventions Comparison of wearing a surgical, cloth and filtering face piece (FFP3) mask to no mask during 4\u00d715 min bouts of exercise. Exercise was running outdoors or indoor rowing at moderate-to-high intensity, with consistency of distance travelled between bouts confirmed using a smartphone application (Strava). Each participant completed each bout in random order. Outcomes The primary outcome was change in oxygen saturations. Secondary outcomes were change in heart rate, perceived impact of face mask wearing during exercise and willingness to wear a face mask for future exercise. Results All 72 volunteers (mean age 23.9) completed the study. Changes in oxygen saturations did not exceed the prespecified non-inferiority margin (2% difference) with any mask type compared with no mask. At the end of exercise, the estimated average difference in oxygen saturations for cloth mask was -0.07% (95% CI -0.39% to 0.25%), for surgical 0.28% (-0.04% to 0.60%) and for FFP3 -0.21% (-0.53% to 0.11%). The corresponding estimated average difference in heart rate for cloth mask was -1.20 bpm (95% CI -4.56 to 2.15), for surgical 0.36 bpm (95% CI -3.01 to 3.73) and for FFP3 0.52 bpm (95% CI -2.85 to 3.89). Wearing a face mask caused additional symptoms such as breathlessness (n=13, 18%) and dizziness (n=7, 10%). 33 participants broadly supported face mask wearing during exercise, particularly indoors, but 22 were opposed. Conclusion This study adds to previous findings (mostly from non-randomised studies) that exercising at moderate-to-high intensity wearing a face mask appears to be safe in healthy, young adults. Trial registration number NCT04932226
\n \n\n \n \nBackground: Wearable devices could be used to continuously monitor vital signs in patients who are hospitalized, but they require validation. Objective: This study aimed to evaluate the clinical validity of the prototype of a semiautomated wearable wrist device (ChroniSense Polso) to measure vital signs and provide National Early Warning Scores (NEWSs). Methods: Vital signs and NEWSs measured using the wearable device were compared with standard, nurse-lead manual measurements. We enrolled adult patients (aged \u226518 years) who required vital sign measurements at least every 6 hours in a UK teaching district general hospital. Wearable device measurements were not used for clinical decision-making. The primary outcome was the agreement on the individual National Early Warning parameter scores and vital sign measurements: respiratory rate, oxygen saturation, body temperature, systolic blood pressure, and heart rate. Secondary outcomes were the agreement on the total NEWS, incidence of adverse events, and user acceptance. To compare the wearable device measurements with the standard measurements, we analyzed vital sign measurements by limits of agreement (Bland-Altman analysis) and conducted \u03ba agreement analyses for NEWSs. A user experience survey was conducted with questions about comfort of the wrist device, safety, preference, and use. Results: We included 132 participants in the study, with a mean age of 62 (SD 15.81) years; most of them were men (102/132, 77.3%). The highest weighted \u03ba values were found for heart rate (0.69, 95% CI 0.57-0.81 for all 385 measurements) and systolic blood pressure (0.39, 95% CI 0.30-0.47 for all 339 measurements). Weighted \u03ba values were low for respiration rate (0.03, 95% CI -0.001 to 0.05 for all 445 measurements), temperature (0, 95% CI 0-0 for all 231 measurements), and oxygen saturation (-0.11, 95% CI -0.20 to -0.02 for all 187 measurements). Weighted \u03ba using Cicchetti-Allison weights showed \u03ba of 0.20 (95% CI 0.03-0.38) when using all 56 total NEWSs. The user acceptance survey found that approximately half (45/91, 49%) of the participants found it comfortable to wear the device and liked its appearance. Most (85/92, 92%) of them said that they would wear the device during their next hospital visit, and many (74/92, 80%) said that they would recommend it to others. Conclusions: This study shows the promising use of a prototype wearable device to measure vital signs in a hospital setting. Agreement between the standard measurements and wearable device measurements was acceptable for systolic blood pressure and heart rate, but needed to be improved for respiration rate, temperature, and oxygen saturation. Future studies need to improve the clinical validity of this wearable device. Large studies are required to assess clinical outcomes and cost-effectiveness of wearable devices for vital sign measurement.
\n \n\n \n \nBackground: Faecal immunochemical tests (FITs) are used to triage primary care patients with symptoms that could be caused by colorectal cancer for referral to colonoscopy. The aim of this study was to determine whether combining FIT with routine blood test results could improve the performance of FIT in the primary care setting. Methods: Results of all consecutive FITs requested by primary care providers between March 2017 and December 2020 were retrieved from the Oxford University Hospitals NHS Foundation Trust. Demographic factors (age, sex), reason for referral, and results of blood tests within 90 days were also retrieved. Patients were followed up for incident colorectal cancer in linked hospital records. The sensitivity, specificity, positive and negative predictive values of FIT alone, FIT paired with blood test results, and several multivariable FIT models, were compared. Results: One hundred thirty-nine colorectal cancers were diagnosed (0.8%). Sensitivity and specificity of FIT alone at a threshold of 10 \u03bcg Hb/g were 92.1 and 91.5% respectively. Compared to FIT alone, blood test results did not improve the performance of FIT. Pairing blood test results with FIT increased specificity but decreased sensitivity. Multivariable models including blood tests performed similarly to FIT alone. Conclusions: FIT is a highly sensitive tool for identifying higher risk individuals presenting to primary care with lower risk symptoms. Combining blood test results with FIT does not appear to lead to better discrimination for colorectal cancer than using FIT alone.
\n \n\n \n \nBackground: Current UK vaccination policy is to offer future COVID-19 booster doses to individuals at high risk of serious illness from COVID-19, but it is still uncertain which groups of the population could benefit most. In response to an urgent request from the UK Joint Committee on Vaccination and Immunisation, we aimed to identify risk factors for severe COVID-19 outcomes (ie, COVID-19-related hospitalisation or death) in individuals who had completed their primary COVID-19 vaccination schedule and had received the first booster vaccine. Methods: We constructed prospective cohorts across all four UK nations through linkages of primary care, RT-PCR testing, vaccination, hospitalisation, and mortality data on 30 million people. We included individuals who received primary vaccine doses of BNT162b2 (tozinameran; Pfizer\u2013BioNTech) or ChAdOx1 nCoV-19 (Oxford\u2013AstraZeneca) vaccines in our initial analyses. We then restricted analyses to those given a BNT162b2 or mRNA-1273 (elasomeran; Moderna) booster and had a severe COVID-19 outcome between Dec 20, 2021, and Feb 28, 2022 (when the omicron (B.1.1.529) variant was dominant). We fitted time-dependent Poisson regression models and calculated adjusted rate ratios (aRRs) and 95% CIs for the associations between risk factors and COVID-19-related hospitalisation or death. We adjusted for a range of potential covariates, including age, sex, comorbidities, and previous SARS-CoV-2 infection. Stratified analyses were conducted by vaccine type. We then did pooled analyses across UK nations using fixed-effect meta-analyses. Findings: Between Dec 8, 2020, and Feb 28, 2022, 16 208 600 individuals completed their primary vaccine schedule and 13 836 390 individuals received a booster dose. Between Dec 20, 2021, and Feb 28, 2022, 59 510 (0\u00b74%) of the primary vaccine group and 26 100 (0\u00b72%) of those who received their booster had severe COVID-19 outcomes. The risk of severe COVID-19 outcomes reduced after receiving the booster (rate change: 8\u00b78 events per 1000 person-years to 7\u00b76 events per 1000 person-years). Older adults (\u226580 years vs 18\u201349 years; aRR 3\u00b760 [95% CI 3\u00b745\u20133\u00b775]), those with comorbidities (\u22655 comorbidities vs none; 9\u00b751 [9\u00b707\u20139\u00b797]), being male (male vs female; 1\u00b723 [1\u00b720\u20131\u00b726]), and those with certain underlying health conditions\u2014in particular, individuals receiving immunosuppressants (yes vs no; 5\u00b780 [5\u00b753\u20136\u00b709])\u2014and those with chronic kidney disease (stage 5 vs no; 3\u00b771 [2\u00b790\u20134\u00b774]) remained at high risk despite the initial booster. Individuals with a history of COVID-19 infection were at reduced risk (infected \u22659 months before booster dose vs no previous infection; aRR 0\u00b741 [95% CI 0\u00b729\u20130\u00b758]). Interpretation: Older people, those with multimorbidity, and those with specific underlying health conditions remain at increased risk of COVID-19 hospitalisation and death after the initial vaccine booster and should, therefore, be prioritised for additional boosters, including novel optimised versions, and the increasing array of COVID-19 therapeutics. Funding: National Core Studies\u2013Immunity, UK Research and Innovation (Medical Research Council), Health Data Research UK, the Scottish Government, and the University of Edinburgh.
\n \n\n \n \nObjective: High-fat high-protein (HFHP) meals are associated with post-prandial hyperglycemia in type 1 diabetes (T1D), administration of additional insulin for such meals is recommended in order to optimize glucose levels. Optimal timing of additional insulin for HFHP meals in children and young people receiving multiple daily injections (MDI) remains unclear. Aim: To investigate the glycemic impact of additional insulin doses given before or after eating a HFHP meal in children with T1D using MDI. Research Design and Methods: A randomized, controlled three period crossover trial of 27 participants aged 13 years (6.1\u201317.7) at two Pediatric Diabetes centers was conducted. Additional rapid-acting insulin for the fat\u2013protein content of a standardized HFHP meal was given at three time points (Formula presented.) calculated using an algorithm extrapolated from current evidence base and clinical recommendations. Post-prandial glucose (PPG) parameters were calculated for 420 minutes using continuous glucose monitoring. The primary outcome was mean PPG excursion. Secondary outcomes included peak glucose, time to peak and hypoglycemia incidence. Results: There was no difference in post-prandial glucose parameters when additional HFHP insulin was administered at (Formula presented.) mean glucose excursion (mmol/L) (SE): 1.9(0.7), 1.2(0.7), 2.5(0.7); p = 0.5); mean peak glucose (mmol/L)(SE): 10.9(0.9), 11.5(0.8), 11.5(0.9); p = 0.9; time to peak glucose (mins)(SE): 82.3(35.4), 113.6(30.9), 95.1(32.1); p = 0.8. Mild hypoglycemia was common (55%) in all groups (p = 0.97). Conclusion: We found no benefit in giving additional insulin as a split dose for HFHP meals in children using MDI, mild hypoglycemia was common. Future studies would benefit from refinement of the insulin dose algorithm.
\n \n\n \n \nBackground: Limited data are available regarding whether computer-aided diagnosis (CAD) improves assessment of malignancy risk in indeterminate pulmonary nodules (IPNs). Purpose: To evaluate the effect of an artificial intelligence\u2013based CAD tool on clinician IPN diagnostic performance and agreement for both malignancy risk categories and management recommendations. Materials and Methods: This was a retrospective multireader multicase study performed in June and July 2020 on chest CT studies of IPNs. Readers used only CT imaging data and provided an estimate of malignancy risk and a management recommendation for each case without and with CAD. The effect of CAD on average reader diagnostic performance was assessed using the Obuchowski-Rockette and Dorfman-Berbaum-Metz method to calculate estimates of area under the receiver operating characteristic curve (AUC), sensitivity, and specificity. Multirater Fleiss k statistics were used to measure interobserver agreement for malignancy risk and management recommendations. Results: A total of 300 chest CT scans of IPNs with maximal diameters of 5\u201330 mm (50.0% malignant) were reviewed by 12 readers (six radiologists, six pulmonologists) (patient median age, 65 years; IQR, 59\u201371 years; 164 [55%] men). Readers\u2019 average AUC improved from 0.82 to 0.89 with CAD (P , .001). At malignancy risk thresholds of 5% and 65%, use of CAD improved average sensitivity from 94.1% to 97.9% (P = .01) and from 52.6% to 63.1% (P , .001), respectively. Average reader specificity improved from 37.4% to 42.3% (P = .03) and from 87.3% to 89.9% (P = .05), respectively. Reader interobserver agreement improved with CAD for both the less than 5% (Fleiss k, 0.50 vs 0.71; P , .001) and more than 65% (Fleiss k, 0.54 vs 0.71; P , .001) malignancy risk categories. Overall reader interobserver agreement for management recommendation categories (no action, CT surveillance, diagnostic procedure) also improved with CAD (Fleiss k, 0.44 vs 0.52; P = .001). Conclusion: Use of computer-aided diagnosis improved estimation of indeterminate pulmonary nodule malignancy risk on chest CT scans and improved interobserver agreement for both risk stratification and management recommendations.
\n \n\n \n \nObjective To investigate childhood, teenage and young adult cancer diagnostic pathways during the first wave of the COVID-19 pandemic in England. Design Population-based cohort study. Setting and participants QResearch, a nationally representative primary care database, linked to hospital admission, mortality and cancer registry data, was used to identify childhood, teenage and young adult cancers (0-24 years) diagnosed between 1 January 2017 and 15 August 2020. Main outcomes Main outcomes of interest were: (1) number of incident cancer diagnoses per month, (2) diagnostic, treatment time intervals and (3) cancer-related intensive care admissions. Results 2607 childhood, teenage and young adult cancers were diagnosed from 1 January 2017 to 15 August 2020; 380 were diagnosed during the pandemic period. Overall, 17% (95% CI-28.0% to-4.0%) reduction in the incidence rate ratio of cancers was observed during the pandemic. Specific decreases were seen for central nervous system tumour (-38% (95% CI-52% to-21%)) and lymphoma (-28% (95% CI-45% to-5%)) diagnoses. Additionally, childhood cancers diagnosed during the pandemic were significantly more likely to have intensive care admissions (adjusted OR 2.2 (95% CI 1.33 to 3.47)). Median time-To-diagnosis did not significantly differ across periods (+4.5 days (95% CI-20.5 to +29.5)), while median time-To-Treatment was shorter during the pandemic (-0.7 days (95% CI-1.1 to-0.3)). Conclusions Collectively, our findings of a significant reduction in cancer diagnoses and increase in intensive care admissions provide initial insight into the changes that occurred to childhood, teenage and young adult cancer diagnostic pathways during the first wave of the pandemic.
\n \n\n \n \nRationale and objectives: Medical humanities are becoming increasingly recognized as positively impacting medical education and medical practice. However, the extent of medical humanities teaching in medical schools is largely unknown. We reviewed medical school curricula in Canada, the UK and the US. We also explored the relationship between medical school ranking and the inclusion of medical humanities in the curricula. Methods: We searched the curriculum websites of all accredited medical schools in Canada, the UK and the US to check which medical humanities topics were taught, and whether they were mandatory or optional. We then noted rankings both by Times Higher Education and U.S. News and World Report and calculated the average rank. We formally explored whether there was an association between average medical school ranking and medical humanities offerings using Spearman's correlation and inverse variance weighting meta-analysis. Results: We identified 18 accredited medical school programmes in Canada, 41 in the UK, and 154 in the US. Of these, nine (56%) in Canada, 34 (73%) in the UK and 124 (80%) in the US offered at least one medical humanity that was not ethics. The most common medical humanities were medical humanities (unspecified), history, and literature (Canada); sociology and social medicine, medical humanities (unspecified), and art (UK); and medical humanities (unspecified), literature and history (US). Higher ranked medical schools appeared less likely to offer medical humanities. Conclusions: The extent and content of medical humanities offerings at accredited medical schools in Canada, the UK and the US varies, and there appears to be an inverse relationship between medical school quality and medical humanities offerings. Our analysis was limited by the data provided on the Universities' websites. Given the potential for medical humanities to improve medical education and medical practice, opportunities to reduce this variation should be exploited.
\n \n\n \n \nBackground Cam morphology, a distinct bony morphology of the hip, is prevalent in many athletes, and a risk factor for hip-related pain and osteoarthritis. Secondary cam morphology, due to existing or previous hip disease (eg, Legg-Calve-Perthes disease), is well-described. Cam morphology not clearly associated with a disease is a challenging concept for clinicians, scientists and patients. We propose this morphology, which likely develops during skeletal maturation as a physiological response to load, should be referred to as primary cam morphology. The aim of this study was to introduce and clarify the concept of primary cam morphology. Design We conducted a concept analysis of primary cam morphology using articles that reported risk factors associated with primary cam morphology; we excluded articles on secondary cam morphology. The concept analysis method is a rigorous eight-step process designed to clarify complex ' concepts'; the end product is a precise definition that supports the theoretical basis of the chosen concept. Results We propose five defining attributes of primary cam morphology-tissue type, size, site, shape and ownership-in a new conceptual and operational definition. Primary cam morphology is a cartilage or bony prominence (bump) of varying size at the femoral head-neck junction, which changes the shape of the femoral head from spherical to aspherical. It often occurs in asymptomatic male athletes in both hips. The cartilage or bone alpha angle (calculated from radiographs, CT or MRI) is the most common method to measure cam morphology. We found inconsistent reporting of primary cam morphology taxonomy, terminology, and how the morphology is operationalised. Conclusion We introduce and clarify primary cam morphology, and propose a new conceptual and operational definition. Several elements of the concept of primary cam morphology remain unclear and contested. Experts need to agree on the new taxonomy, terminology and definition that better reflect the primary cam morphology landscape- A bog-standard bump in most athletic hips, and a possible hip disease burden in a selected few.
\n \n\n \n \nBackground: Combinations of inflammatory markers are used as prognostic scores in cancer patients with cachexia. We investigated whether they could also be used to prioritise patients attending primary care with unexpected weight loss for cancer investigation. Methods: We used English primary care electronic health records data linked to cancer registry data from 12,024 patients with coded unexpected weight loss. For each individual inflammatory marker and score we estimated the sensitivity, specificity, likelihood ratios, positive predictive value (PPV) and the area under the curve along with 95% confidence intervals for a cancer diagnosis within six months. Results: The risk of cancer associated with two abnormal inflammatory markers combined in a score was higher than the risk associated with individual inflammatory marker abnormalities. However, the risk of cancer in weight loss associated with individual abnormalities, notably a raised C-reactive protein, was sufficient to trigger further investigation for cancer under current NICE guidelines. Conclusions: If scores including pairs of inflammatory marker abnormalities were to be used, in preference to individual abnormalities, fewer people would be investigated to diagnose one cancer with fewer false positives, but fewer people with cancer would be diagnosed overall.
\n \n\n \n \nBackground Guidelines recommend that clinicians identify individuals at high cardiometabolic risk and support weight loss in those with overweight or obesity. However, we lack individual level data quantifying the benefits of weight change for individuals to guide consultations in primary care. Aim To examine how weight change affects cardiometabolic risk factors, and to facilitate shared decision making between patients and clinicians regarding weight loss. Design and setting Observational analysis using data from two trials of referral of individuals with overweight or obesity in primary care to community weight-loss groups. Method Linear mixed effects regression modelling examining the association between weight change and change in systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting glucose, glycated haemoglobin (HbA1c), and lipid profile across multiple timepoints (baseline to 24 months). Subgroup analyses examined changes in individuals with hypertension, diabetes, and hyperlipidaemia. Results In total, 2041 participants had a mean (standard deviation) age of 50 (SD 13.5) years, mean baseline weight of 90.6 (14.8) kg and mean body mass index (BMI) of 32.7 (SD 4.1) kg/m2. Mean (SD) weight change was \u20134.3 (SD 6.0) kg. All outcome measures showed statistically significant improvements. Each 1 kg weight loss was associated with 0.4 mmHg reduction in SBP and 0.3 mmHg reduction in DBP, or 0.5 mmHg and 0.4 mmHg/kg respectively in people with hypertension. Each 1 kg weight loss was associated with 0.2 mmol/mol reduction in HbA1c, or 0.6 mmol/mol in people with diabetes. Effects on plasma lipids were negligible. Conclusion Weight loss achieved through referral to community weight-loss programmes, which are commonly accessible in primary care, can lead to clinically relevant reductions in BP and glucose regulation, especially in those at highest risk.
\n \n\n \n \nIntroduction: We aimed to determine the analytical capabilities of a commonly used faecal immunochemical test (FIT) to detect faecal haemoglobin (Hb) in symptomatic people attending primary care in the context of the English NICE DG30 guidance. Materials and Methods: Data obtained from independent verification studies and clinical testing of the HM-JACKarc FIT method in routine primary care practice were analysed to derive performance characteristics. Results: Detection capabilities for the FIT method were 0.5 \u00b5g/g (limit of blank), 1.3 \u00b5g/g (limit of detection) and 3.0 \u00b5g/g (limit of quantitation). Of 33 non-homogenized specimens, 31 (93.9%) analysed in triplicate were consistently categorized relative to 10 \u00b5g/g, compared to all 33 (100%) homogenized specimens. Imprecision was higher (median 27.8%, (range 20.5% to 48.6%)) in non-homogenized specimens than in homogenized specimens (10.2%, (7.0 to 13.5%)). Considerable variation was observed in sequential clinical specimens from individual patients but no positive or negative trend in specimen degradation was observed over time (p = 0.26). Discussion: The FIT immunoassay evaluated is capable of detecting faecal Hb at concentrations well below the DG30 threshold of 10 \u00b5g/g and is suitable for application in this context. The greatest practical challenge to FIT performance is reproducible sampling, the pre-analytical step associated with most variability. Further research should focus on reducing sampling variability, particularly as post-COVID-19 guidance recommends greater FIT utilization.
\n \n\n \n \nObjective To ascertain the diagnostic performance of faecal immunochemical test (FIT) in symptomatic primary care patients, to provide objective data on which to base referral guidelines. Design Stool samples from routine primary care practice in Oxfordshire, UK were analysed using the HM-JACKarc FIT method between March 2017 to March 2020. Clinical details described on the test request were recorded. Patients were followed up for up-to 36 months in linked hospital records for evidence of benign and serious (colorectal cancer, high-risk adenomas and bowel inflammation) colorectal disease. The diagnostic accuracy of FIT is reported by gender, age, and FIT threshold. Results In 9,896 adult patients with at least 6 months of follow-up, a FIT result \u226510 \u03bcg/g had an overall sensitivity for colorectal cancer of 90.5% (95% CI 84.9%-96.1%), women 90.0 (80.7-99.3), men 90.8 (83.7-97.8); overall specificity 91.3 (90.8-91.9), women 92.4 (91.8-93.1), men 89.8 (88.8-90.7); overall Positive Predictive Value (PPV) 10.1 (8.15-12.0), women 7.64 (5.24-10.0), men 12.5 (9.52-15.5)); and an overall Negative Predictive Value (NPV) 99.9 (99.8-100.0), women 99.8 (99.7-100.), men 99.9 (99.9-100.0). The PPV and specificity of FIT were higher for serious colorectal disease combined and the sensitivity and NPV were lower than for colorectal cancer alone. The Area Under the Curve (AUC) for all patients did not change substantially by increasing the minimum age of testing. In this population, 10% would be further investigated to detect 91% of the cancers at 10ug/g and 3% further investigated to detect 54% of the cancers at 150ug/g. The number needed to scope to detect one cancer was ten using FIT at 10ug/g. Conclusion A FIT threshold of 10 \u00b5g/g is appropriate to triage adult patients presenting to primary care with symptoms of serious colorectal disease. FIT may provide an appropriate approach to reprioritising patients colorectal cancer symptoms whose tests have been delayed by the COVID-19 pandemic. What is already known on this subject? Faecal Immunochemical Testing (FIT) is recommended by NICE to triage symptomatic primary care patients into further investigation for serious colorectal disease, including colorectal cancer. Almost no real-world data exists documenting the diagnostic accuracy of low FIT thresholds associated with colorectal cancer or serious colorectal disease in primary care with symptoms of colorectal cancer. What are the new findings? In 9,896 consecutive FITs submitted by English General Practitioners to a large English laboratory, using a threshold of 10ug/g, FIT had a sensitivity and specificity of 91% for colorectal cancer, a sensitivity of 53% and a specificity of 92% for serious colorectal disease. Of the population tested with FIT, 10% would be further investigated to detect 91% of the cancers at 10ug/g, 4% would be further investigated to detect 74% of the cancers at 50ug/g, and 3% further investigated to detect 54% of the cancers at 150ug/g. How might it impact on clinical practice in the foreseeable future? Low threshold FIT could be used as a triage test without overburdening endoscopy resources, supporting widespread implementation of the NICE recommendations for its use in low-risk patients in primary care. FIT may be an effective test for re-prioritizing patients whose endoscopy test have been deferred due to the COVID-19 pandemic to match available endoscopy resources to those at highest risk of colorectal cancer.
\n \n\n \n \nBackground Guidelines recommend reducing saturated fat (SFA) intake to decrease cardiovascular disease (CVD) risk, but there is limited evidence on scalable and effective approaches to change dietary intake, given the large proportion of the population exceeding SFA recommendations. We aimed to develop a system to provide monthly personalized feedback and healthier swaps based on nutritional analysis of loyalty card data from the largest United Kingdom grocery store together with brief advice and support from a healthcare professional (HCP) in the primary care practice. Following a hybrid effectiveness-feasibility design, we tested the effects of the intervention on SFA intake and low-density lipoprotein (LDL) cholesterol as well as the feasibility and acceptability of providing nutritional advice using loyalty card data. Methods and findings The Primary Care Shopping Intervention for Cardiovascular Disease Prevention (PC-SHOP) study is a parallel randomized controlled trial with a 3 month follow-up conducted between 21 March 2018 to 16 January2019. Adults \u226518 years with LDL cholesterol >3 mmol/L (n = 113) were recruited from general practitioner (GP) practices in Oxfordshire and randomly allocated to \u201cBrief Support\u201d (BS, n = 48), \u201cBrief Support + Shopping Feedback\u201d (SF, n = 48) or \u201cControl\u201d (n = 17). BS consisted of a 10-minute consultation with an HCP to motivate participants to reduce their SFA intake. Shopping feedback comprised a personalized report on the SFA content of grocery purchases and suggestions for lower SFA swaps. The primary outcome was the between-group difference in change in SFA intake (% total energy intake) at 3 months adjusted for baseline SFA and GP practice using intention-to-treat analysis. Secondary outcomes included %SFA in purchases, LDL cholesterol, and feasibility outcomes. The trial was powered to detect an absolute reduction in SFA of 3% (SD3). Neither participants nor the study team were blinded to group allocation. A total of 106 (94%) participants completed the study: 68% women, 95% white ethnicity, average age 62.4 years (SD 10.8), body mass index (BMI) 27.1 kg/m2 (SD 4.7). There were small decreases in SFA intake at 3 months: control = \u22120.1% (95% CI \u22121.8 to 1.7), BS = \u22120.7% (95% CI \u22121.8 to 0.3), SF = \u22120.9% (95% CI \u22122.0 to 0.2); but no evidence of a significant effect of either intervention compared with control (difference adjusted for GP practice and baseline: BS versus control = \u22120.33% [95% CI \u22122.11 to 1.44], p = 0.709; SF versus control = \u22120.11% [95% CI \u22121.92 to 1.69], p = 0.901). There were similar trends in %SFA based on supermarket purchases: control = \u22120.5% (95% CI \u22122.3 to 1.2), BS = \u22121.3% (95% CI \u22122.3 to \u22120.3), SF = \u22121.5% (95% CI \u22122.5 to \u22120.5) from baseline to follow-up, but these were not significantly different: BS versus control p = 0.379; SF versus control p = 0.411. There were small reductions in LDL from baseline to follow-up (control = \u22120.14 mmol/L [95% CI \u22120.48, 0.19), BS: \u22120.39 mmol/L [95% CI \u22120.59, \u22120.19], SF: \u22120.14 mmol/L [95% CI \u22120.34, 0.07]), but these were not significantly different: BS versus control p = 0.338; SF versus control p = 0.790. Limitations of this study include the small sample of participants recruited, which limits the power to detect smaller differences, and the low response rate (3%), which may limit the generalisability of these findings. Conclusions In this study, we have shown it is feasible to deliver brief advice in primary care to encourage reductions in SFA intake and to provide personalized advice to encourage healthier choices using supermarket loyalty card data. There was no evidence of large reductions in SFA, but we are unable to exclude more modest benefits. The feasibility, acceptability, and scalability of these interventions suggest they have potential to encourage small changes in diet, which could be beneficial at the population level.
\n \n\n \n \nBackground: Faecal immunochemical testing (FIT) is recommended by the National Institute for Health and Care Excellence (NICE) to triage symptomatic primary care patients for further investigation of colorectal cancer. Aim: To ascertain the diagnostic performance of FIT in symptomatic adult primary care patients. Methods: Faecal samples from routine primary care practice in Oxfordshire, UK were analysed using the HM-JACKarc FIT method between March 2017 and March 2020. Clinical details were recorded. Patients were followed for up to 36 months in linked hospital records for evidence of benign and serious (colorectal cancer, high-risk adenomas and bowel inflammation) colorectal disease. The diagnostic accuracy of FIT is reported by gender, age group and FIT threshold. Results: In 9896 adult patients with at least 6-month follow-up, a FIT result \u226510 \u00b5g Hb/g faeces had a sensitivity for colorectal cancer of 90.5% (95% CI 84.9%-96.1%), specificity 91.3% (90.8%-91.9%), positive predictive value (PPV) 10.1% (8.15%-12.0%) and negative predictive value (NPV) 99.9% (99.8%-100.0%). The PPV and specificity for serious colorectal disease were higher and the sensitivity and NPV lower than for colorectal cancer alone. The area under the curve for all adults did not change substantially by gender or by increasing the minimum age of testing. Using \u226510 \u00b5g Hb/g faeces, 10% of adults would be investigated to detect 91% of cancers, a number needed to scope of ten to detect one cancer. Using \u22657, \u226550 and \u2265150 \u00b5g Hb/g faeces, 11%, 4% and 3% of adults would be investigated, and 91%, 74% and 54% cancers detected, respectively. Conclusion: A FIT threshold of \u226510 \u00b5g Hb/g faeces would be appropriate to triage adult patients presenting to primary care with symptoms of serious colorectal disease. FIT may be used to reprioritise patients referred with colorectal cancer symptoms whose investigations have been delayed by the COVID-19 pandemic.
\n \n\n \n \n