Publications by authors named "Willie Hamilton"

91 Publications

The impact of changing risk thresholds on the number of people in England eligible for urgent investigation for possible cancer: an observational cross-sectional study.

Br J Cancer 2021 Sep 16. Epub 2021 Sep 16.

University of Exeter Medical School, College of Medicine & Health, St Luke's Campus, Magdalen Road, Exeter, UK.

Background: Expediting cancer diagnosis may be achieved by targeted decreases in referral thresholds to increase numbers of patients referred for urgent investigation.

Methods: Clinical Practice Research Datalink data from England for 150,921 adults aged ≥40 were used to identify participants with features of possible cancer equating to risk thresholds ≥1%, ≥2% or ≥3% for breast, lung, colorectal, oesophago-gastric, pancreatic, renal, bladder, prostatic, ovarian, endometrial and laryngeal cancers.

Results: The mean age of participants was 60 (SD 13) years, with 73,643 males (49%). In 2016, 8576 consultation records contained coded features having a positive predictive value (PPV) of ≥3% for any of the 11 cancers. This equates to a rate of 5682/100,000 patients compared with 4601/100,000 Suspected Cancer NHS referrals for these cancers from April 2016-March 2017. Nine thousands two hundred ninety-one patient-consultation records had coded features equating to a ≥2% PPV, 8% more than met PPV ≥ 3%. Similarly, 19,517 had features with a PPV ≥ 1%, 136% higher than for PPV ≥ 3%.

Conclusions: This study estimated the number of primary-care patients presenting at lower thresholds of cancer risk. The resource implications of liberalising this threshold to 2% are modest and manageable. The details across individual cancer sites should assist planning of English cancer services.
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http://dx.doi.org/10.1038/s41416-021-01541-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8445014PMC
September 2021

Combining simple blood tests to identify primary care patients with unexpected weight loss for cancer investigation: Clinical risk score development, internal validation, and net benefit analysis.

PLoS Med 2021 Aug 31;18(8):e1003728. Epub 2021 Aug 31.

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.

Background: Unexpected weight loss (UWL) is a presenting feature of cancer in primary care. Existing research proposes simple combinations of clinical features (risk factors, symptoms, signs, and blood test data) that, when present, warrant cancer investigation. More complex combinations may modify cancer risk to sufficiently rule-out the need for investigation. We aimed to identify which clinical features can be used together to stratify patients with UWL based on their risk of cancer.

Methods And Findings: We used data from 63,973 adults (age: mean 59 years, standard deviation 21 years; 42% male) to predict cancer in patients with UWL recorded in a large representative United Kingdom primary care electronic health record between January 1, 2000 and December 31, 2012. We derived 3 clinical prediction models using logistic regression and backwards stepwise covariate selection: Sm, symptoms-only model; STm, symptoms and tests model; Tm, tests-only model. Fifty imputations replaced missing data. Estimates of discrimination and calibration were derived using 10-fold internal cross-validation. Simple clinical risk scores are presented for models with the greatest clinical utility in decision curve analysis. The STm and Tm showed improved discrimination (area under the curve ≥ 0.91), calibration, and greater clinical utility than the Sm. The Tm was simplest including age-group, sex, albumin, alkaline phosphatase, liver enzymes, C-reactive protein, haemoglobin, platelets, and total white cell count. A Tm score of 5 balanced ruling-in (sensitivity 84.0%, positive likelihood ratio 5.36) and ruling-out (specificity 84.3%, negative likelihood ratio 0.19) further cancer investigation. A Tm score of 1 prioritised ruling-out (sensitivity 97.5%). At this threshold, 35 people presenting with UWL in primary care would be referred for investigation for each person with cancer referred, and 1,730 people would be spared referral for each person with cancer not referred. Study limitations include using a retrospective routinely collected dataset, a reliance on coding to identify UWL, and missing data for some predictors.

Conclusions: Our findings suggest that combinations of simple blood test abnormalities could be used to identify patients with UWL who warrant referral for investigation, while people with combinations of normal results could be exempted from referral.
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http://dx.doi.org/10.1371/journal.pmed.1003728DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8407560PMC
August 2021

Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT.

Health Technol Assess 2021 Aug;25(48):1-158

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Background: Rotator cuff-related shoulder pain is very common, but there is uncertainty regarding which modes of exercise delivery are optimal and the long-term benefits of corticosteroid injections.

Objectives: To assess the clinical effectiveness and cost-effectiveness of progressive exercise compared with best-practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.

Design: This was a pragmatic multicentre superiority randomised controlled trial (with a 2 × 2 factorial design).

Setting: Twenty NHS primary care-based musculoskeletal and related physiotherapy services.

Participants: Adults aged ≥ 18 years with a new episode of rotator cuff-related shoulder pain in the previous 6 months.

Interventions: A total of 708 participants were randomised (March 2017-May 2019) by a centralised computer-generated 1 : 1 : 1 : 1 allocation ratio to one of four interventions: (1) progressive exercise ( = 174) (six or fewer physiotherapy sessions), (2) best-practice advice ( = 174) (one physiotherapy session), (3) corticosteroid injection then progressive exercise ( = 182) (six or fewer physiotherapy sessions) or (4) corticosteroid injection then best-practice advice ( = 178) (one physiotherapy session).

Main Outcome Measures: The primary outcome was Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes included SPADI subdomains, the EuroQol 5 Dimensions, five-level version, sleep disturbance, fear avoidance, pain self-efficacy, return to activity, Global Impression of Treatment and health resource use. Outcomes were collected by postal questionnaires at 8 weeks and at 6 and 12 months. A within-trial economic evaluation was also conducted. The primary analysis was intention to treat.

Results: Participants had a mean age of 55.5 (standard deviation 13.1) years and 49.3% were female. The mean baseline SPADI score was 54.1 (standard deviation 18.5). Follow-up rates were 91% at 8 weeks and 87% at 6 and 12 months. There was an overall improvement in SPADI score from baseline in each group over time. Over 12 months, there was no evidence of a difference in the SPADI scores between the progressive exercise intervention and the best-practice advice intervention in shoulder pain and function (adjusted mean difference between groups over 12 months -0.66, 99% confidence interval -4.52 to 3.20). There was also no difference in SPADI scores between the progressive exercise intervention and best-practice advice intervention when analysed at the 8-week and 6- and 12-month time points. Injection resulted in improvement in shoulder pain and function at 8 weeks compared with no injection (adjusted mean difference -5.64, 99% confidence interval -9.93 to -1.35), but not when analysed over 12 months (adjusted mean difference -1.11, 99% confidence interval -4.47 to 2.26), or at 6 and 12 months. There were no serious adverse events. In the base-case analysis, adding injection to best-practice advice gained 0.021 quality-adjusted life-years ( = 0.184) and increased the cost by £10 per participant ( = 0.747). Progressive exercise alone was £52 ( = 0.247) more expensive per participant than best-practice advice, and gained 0.019 QALYs ( = 0.220). At a ceiling ratio of £20,000 per quality-adjusted life-year, injection plus best-practice advice had a 54.93% probability of being the most cost-effective treatment.

Limitations: Participants and physiotherapists were not blinded to group allocation. Twelve-month follow-up may be insufficient for identifying all safety concerns.

Conclusions: Progressive exercise was not superior to a best-practice advice session with a physiotherapist. Subacromial corticosteroid injection improved shoulder pain and function, but provided only modest short-term benefit. Best-practice advice in combination with corticosteroid injection was expected to be most cost-effective, although there was substantial uncertainty.

Future Work: Longer-term follow-up, including any serious adverse effects of corticosteroid injection.

Trial Registration: Current Controlled Trials ISRCTN16539266 and EudraCT 2016-002991-28.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 48. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25480DOI Listing
August 2021

Predictive values for different cancers and inflammatory bowel disease of 6 common abdominal symptoms among more than 1.9 million primary care patients in the UK: A cohort study.

PLoS Med 2021 Aug 2;18(8):e1003708. Epub 2021 Aug 2.

Epidemiology of Cancer Healthcare and Outcomes (ECHO) Research Group, Department of Behavioural Science and Health, University College London, London, United Kingdom.

Background: The diagnostic assessment of abdominal symptoms in primary care presents a challenge. Evidence is needed about the positive predictive values (PPVs) of abdominal symptoms for different cancers and inflammatory bowel disease (IBD).

Methods And Findings: Using data from The Health Improvement Network (THIN) in the United Kingdom (2000-2017), we estimated the PPVs for diagnosis of (i) cancer (overall and for different cancer sites); (ii) IBD; and (iii) either cancer or IBD in the year post-consultation with each of 6 abdominal symptoms: dysphagia (n = 86,193 patients), abdominal bloating/distension (n = 100,856), change in bowel habit (n = 106,715), rectal bleeding (n = 235,094), dyspepsia (n = 517,326), and abdominal pain (n = 890,490). The median age ranged from 54 (abdominal pain) to 63 years (dysphagia and change in bowel habit); the ratio of women/men ranged from 50%:50% (rectal bleeding) to 73%:27% (abdominal bloating/distension). Across all studied symptoms, the risk of diagnosis of cancer and the risk of diagnosis of IBD were of similar magnitude, particularly in women, and younger men. Estimated PPVs were greatest for change in bowel habit in men (4.64% cancer and 2.82% IBD) and for rectal bleeding in women (2.39% cancer and 2.57% IBD) and lowest for dyspepsia (for cancer: 1.41% men and 1.03% women; for IBD: 0.89% men and 1.00% women). Considering PPVs for specific cancers, change in bowel habit and rectal bleeding had the highest PPVs for colon and rectal cancer; dysphagia for esophageal cancer; and abdominal bloating/distension (in women) for ovarian cancer. The highest PPVs of abdominal pain (either sex) and abdominal bloating/distension (men only) were for non-abdominal cancer sites. For the composite outcome of diagnosis of either cancer or IBD, PPVs of rectal bleeding exceeded the National Institute of Health and Care Excellence (NICE)-recommended specialist referral threshold of 3% in all age-sex strata, as did PPVs of abdominal pain, change in bowel habit, and dyspepsia, in those aged 60 years and over. Study limitations include reliance on accuracy and completeness of coding of symptoms and disease outcomes.

Conclusions: Based on evidence from more than 1.9 million patients presenting in primary care, the findings provide estimated PPVs that could be used to guide specialist referral decisions, considering the PPVs of common abdominal symptoms for cancer alongside that for IBD and their composite outcome (cancer or IBD), taking into account the variable PPVs of different abdominal symptoms for different cancers sites. Jointly assessing the risk of cancer or IBD can better support decision-making and prompt diagnosis of both conditions, optimising specialist referrals or investigations, particularly in women.
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http://dx.doi.org/10.1371/journal.pmed.1003708DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8367005PMC
August 2021

Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 × 2 factorial, randomised controlled trial.

Lancet 2021 07 12;398(10298):416-428. Epub 2021 Jul 12.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; College of Medicine and Health, University of Exeter, Exeter, UK.

Background: Corticosteroid injections and physiotherapy exercise programmes are commonly used to treat rotator cuff disorders but the treatments' effectiveness is uncertain. We aimed to compare the clinical effectiveness and cost-effectiveness of a progressive exercise programme with a single session of best practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.

Methods: In this pragmatic, multicentre, superiority, randomised controlled trial (2 × 2 factorial), we recruited patients from 20 UK National Health Service trusts. We included patients aged 18 years or older with a rotator cuff disorder (new episode within the past 6 months). Patients were excluded if they had a history of significant shoulder trauma (eg, dislocation, fracture, or full-thickness tear requiring surgery), neurological disease affecting the shoulder, other shoulder conditions (eg, inflammatory arthritis, frozen shoulder, or glenohumeral joint instability), received corticosteroid injection or physiotherapy for shoulder pain in the past 6 months, or were being considered for surgery. Patients were randomly assigned (centralised computer-generated system, 1:1:1:1) to progressive exercise (≤6 sessions), best practice advice (one session), corticosteroid injection then progressive exercise, or corticosteroid injection then best practice advice. The primary outcome was the Shoulder Pain and Disability Index (SPADI) score over 12 months, analysed on an intention-to-treat basis (statistical significance set at 1%). The trial was registered with the International Standard Randomised Controlled Trial Register, ISRCTN16539266, and EuDRACT, 2016-002991-28.

Findings: Between March 10, 2017, and May 2, 2019, we screened 2287 patients. 708 patients were randomly assigned to progressive exercise (n=174), best practice advice (n=174), corticosteroid injection then progressive exercise (n=182), or corticosteroid injection then best practice advice (n=178). Over 12 months, SPADI data were available for 166 (95%) patients in the progressive exercise group, 164 (94%) in the best practice advice group, 177 (97%) in the corticosteroid injection then progressive exercise group, and 175 (98%) in the corticosteroid injection then best practice advice group. We found no evidence of a difference in SPADI score between progressive exercise and best practice advice when analysed over 12 months (adjusted mean difference -0·66 [99% CI -4·52 to 3·20]). We also found no evidence of a difference between corticosteroid injection compared with no injection when analysed over 12 months (-1·11 [-4·47 to 2·26]). No serious adverse events were reported.

Interpretation: Progressive exercise was not superior to a best practice advice session with a physiotherapist in improving shoulder pain and function. Subacromial corticosteroid injection provided no long-term benefit in patients with rotator cuff disorders.

Funding: UK National Institute for Health Research Technology Assessment Programme.
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http://dx.doi.org/10.1016/S0140-6736(21)00846-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8343092PMC
July 2021

Could Ovarian Cancer Prediction Models Improve the Triage of Symptomatic Women in Primary Care? A Modelling Study Using Routinely Collected Data.

Cancers (Basel) 2021 Jun 9;13(12). Epub 2021 Jun 9.

The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge CB1 8RN, UK.

CA125 is widely used as an initial investigation in women presenting with symptoms of possible ovarian cancer. We sought to develop CA125-based diagnostic prediction models and to explore potential implications of implementing model-based thresholds for further investigation in primary care. This retrospective cohort study used routinely collected primary care and cancer registry data from symptomatic, CA125-tested women in England (2011-2014). A total of 29,962 women were included, of whom 279 were diagnosed with ovarian cancer. Logistic regression was used to develop two models to estimate ovarian cancer probability: Model 1 consisted of age and CA125 level; Model 2 incorporated further risk factors. Model discrimination (AUC) was evaluated using 10-fold cross-validation. The sensitivity and specificity of various model risk thresholds (≥1% to ≥3%) were compared with that of the current CA125 cut-off (≥35 U/mL). Model 1 exhibited excellent discrimination (AUC: 0.94) on cross-validation. The inclusion of additional variables (Model 2) did not improve performance. At a risk threshold of ≥1%, Model 1 exhibited greater sensitivity (86.4% vs. 78.5%) but lower specificity (89.1% vs. 94.5%) than CA125 (≥35 U/mL). Applying the ≥1% model threshold to the cohort in place of the current CA125 cut-off, 1 in every 74 additional women identified had ovarian cancer. Following external validation, Model 1 could be used as part of a 'risk-based triage' system in which women at high risk of undiagnosed ovarian cancer are selected for urgent specialist investigation, while women at 'low risk but not no risk' are offered non-urgent investigation or interval CA125 re-testing. Such an approach has the potential to expedite ovarian cancer diagnosis, but further research is needed to evaluate the clinical impact and health-economic implications.
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http://dx.doi.org/10.3390/cancers13122886DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8228892PMC
June 2021

Guideline interval: A new time interval in the diagnostic pathway for symptomatic cancer.

Cancer Epidemiol 2021 08 19;73:101969. Epub 2021 Jun 19.

College House, University of Exeter Medical School, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK. Electronic address:

Background: A standard measure of the cancer diagnostic pathway, diagnostic interval, is the time from "first presentation of cancer" to diagnosis. Cancer presentation may be unclear in patients with multimorbidity or non-specific symptoms, signs or test results ("features"). We propose an alternative, guideline interval, with a more certain start date; namely, when the patient first meets suspected-cancer criteria for investigation or referral.

Methods: This retrospective cohort study used Clinical Practice Research Datalink (CPRD) and English cancer registry data. Participants, aged ≥55 years, had diagnostic codes for oesophagogastric cancers in 1/1/12-31/12/17. Features of oesophagogastric cancer in the year before diagnosis were identified from CPRD codes for dysphagia, haematemesis, upper-abdominal mass or pain, low haemoglobin, reflux, dyspepsia, nausea, vomiting, weight loss or thrombocytosis. Diagnostic interval was the time from first feature to diagnosis; guidance interval, the time from first meeting criteria in NICE suspected-cancer guidance to diagnosis. Multimorbidity burden was quantified using Adjusted Clinical Groups®. Accelerated failure-time models explored associations between multimorbidity burden and length of both diagnostic and guideline interval.

Results: There were 3,793 eligible participants (69.0 % male), mean age 74.1 years (SD 10.5). 3,097 (81.7 %) presented with ≥1 feature in the year before diagnosis, and 1,990 (52.5 %) met NICE suspected-cancer criteria. The median for both intervals was 11 days in healthy users, and rose with increasing morbidity burden. At very high multimorbidity burden, diagnostic interval was 5.47 (95%CI 3.25-9.20) times longer and guideline interval was 3.91 (2.63-5.80) times longer than for healthy users.

Conclusions: Guideline interval is proposed as a new measure of the cancer diagnostic pathway. It has a more certain start date than diagnostic interval, and is lengthened less than diagnostic interval in people with a very high multimorbidity burden. Guideline interval has potential for assessing the implementation of suspected-cancer policies.
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http://dx.doi.org/10.1016/j.canep.2021.101969DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8316604PMC
August 2021

Non-specific symptoms-based pathways for diagnosing less common cancers in primary care: a service evaluation.

Br J Gen Pract 2021 Jun 4. Epub 2021 Jun 4.

College of Medicine and Health, University of Exeter Medical School, Exeter.

Background: Although less common cancers account for almost half of all cancer diagnoses in England, their relative scarcity and complex presentation, often with non-specific symptoms, means that patients often experience multiple primary care consultations, long times to diagnosis, and poor clinical outcomes. An urgent referral pathway for non-specific symptoms, the Multidisciplinary Diagnostic Centre (MDC), may address this problem.

Aim: To examine the less common cancers identified during the MDC pilots and consider whether such an approach improves the diagnosis of these cancers.

Design And Setting: A service evaluation of five MDC pilot projects in England from December 2016 to March 2019.

Method: Data items were collected by pilot sites in near-real time, based mainly on the English cancer outcomes and services dataset, with additional project-specific items. Simple descriptive and comparative statistics were used, including χ tests for proportions and -tests for means where appropriate.

Results: From 5134 referrals, 378 cancers were diagnosed, of which 218 (58%) were less common. More than 30 different less common tumour types were diagnosed in this cohort. Of the MDC patients with less common cancers, 23% ( = 50) had ≥3 GP consultations before referral and, at programme level, a median time of 57 days was recorded from GP urgent referral to treatment for these tumour types.

Conclusion: A non-specific symptomatic referral route diagnoses a broad range of less common cancers, and can support primary care case management for patients with symptoms of possible cancer that do not qualify for a site-specific urgent referral.
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http://dx.doi.org/10.3399/BJGP.2020.1108DOI Listing
June 2021

CA125 test result, test-to-diagnosis interval, and stage in ovarian cancer at diagnosis: a retrospective cohort study using electronic health records.

Br J Gen Pract 2021 06 27;71(707):e465-e472. Epub 2021 May 27.

The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge.

Background: In the UK, the cancer antigen 125 (CA125) test is recommended as a first-line investigation in women with symptoms of possible ovarian cancer.

Aim: To compare time between initial primary care CA125 test and diagnosis, tumour morphology, and stage in women with normal (<35 U/ml) and abnormal (≥35 U/ml) CA125 levels prior to ovarian cancer diagnosis.

Design And Setting: Retrospective cohort study using English primary care and cancer registry data.

Method: Associations between CA125 test results and test-to-diagnosis interval, stage, and ovarian cancer morphology were examined.

Results: In total, 456 women were diagnosed with ovarian cancer in the 12 months after having a CA125 test. Of these, 351 (77%) had an abnormal, and 105 (23%) had a normal, CA125 test result. The median test-to-diagnosis interval was 35 days (interquartile range [IQR] 21-53) for those with abnormal CA125 levels, and 64 days (IQR 42-127) for normal CA125 levels. Tumour morphology differed by CA125 result: indolent borderline tumours were less common in those with abnormal CA125 levels ( = 47, 13%) than those with normal CA125 levels ( = 51, 49%) (<0.001). Staging data were available for 304 women with abnormal, and 77 with normal, CA125 levels. Of those with abnormal CA125 levels, 35% ( = 106) were diagnosed at an early stage, compared to 86% ( = 66) of women with normal levels. The odds of being diagnosed with early-stage disease were higher in women with normal as opposed to abnormal CA125 levels (odds ratio 12.2, 95% confidence interval = 5.8 to 25.1, <0.001).

Conclusion: Despite longer intervals between testing and diagnosis, women with normal, compared with abnormal, CA125 levels more frequently had indolent tumours and were more commonly diagnosed at an early stage in the course of the disease. Although testing approaches that have greater sensitivity might expedite diagnosis for some women, it is not known if this would translate to earlier-stage diagnosis.
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http://dx.doi.org/10.3399/BJGP.2020.0859DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8074643PMC
June 2021

Electronic clinical decision support tool for assessing stomach symptoms in primary care (ECASS): a feasibility study.

BMJ Open 2021 03 18;11(3):e041795. Epub 2021 Mar 18.

School of Medicine, University of Leeds, Leeds, UK.

Objective: To determine the feasibility of a definitive trial in primary care of electronic clinical decision support (eCDS) for possible oesophago-gastric (O-G) cancer.

Design And Setting: Feasibility study in 42 general practices in two regions of England, cluster randomised controlled trial design without blinding, nested qualitative and health economic evaluation.

Participants: Patients aged 55 years or older, presenting to their general practitioner (GP) with symptoms associated with O-G cancer. 530 patients (mean age 68 years, 58% female) participated.

Intervention: Practices randomised 1:1 to usual care (control) or to receive a previously piloted eCDS tool for suspected cancer (intervention), for use at the discretion of the GPs, supported by a theory-based implementation package and ongoing support. We conducted semistructured interviews with GPs in intervention practices. Recruitment lasted 22 months.

Outcomes: Patient participation rate, use of eCDS, referrals and route to diagnosis, O-G cancer diagnoses; acceptability to GPs; cost-effectiveness. Participants followed up 6 months after index encounter.

Results: From control and intervention practices, we screened 3841 and 1303 patients, respectively; 1189 and 434 were eligible, 392 and 138 consented to participate. Ten patients (1.9%) had O-G cancer. eCDS was used eight times in total by five unique users. GPs experienced interoperability problems between the eCDS tool and their clinical system and also found it did not fit with their workflow. Unexpected restrictions on software installation caused major problems with implementation.

Conclusions: The conduct of this study was hampered by technical limitations not evident during an earlier pilot of the eCDS tool, and by regulatory controls on software installation introduced by primary care trusts early in the study. This eCDS tool needed to integrate better with clinical workflow; even then, its use for suspected cancer may be infrequent. Any definitive trial of eCDS for cancer diagnosis should only proceed after addressing these constraints.

Trial Registration Number: ISRCTN125595588.
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http://dx.doi.org/10.1136/bmjopen-2020-041795DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7978254PMC
March 2021

Diagnosing groin lumps.

BMJ 2021 03 12;372:n578. Epub 2021 Mar 12.

Devon Sexual Health, Exeter, UK.

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http://dx.doi.org/10.1136/bmj.n578DOI Listing
March 2021

Artificial Intelligence Techniques That May Be Applied to Primary Care Data to Facilitate Earlier Diagnosis of Cancer: Systematic Review.

J Med Internet Res 2021 03 3;23(3):e23483. Epub 2021 Mar 3.

Primary Care Unit, Department of Public Health & Primary Care, University of Cambridge, Cambridge, United Kingdom.

Background: More than 17 million people worldwide, including 360,000 people in the United Kingdom, were diagnosed with cancer in 2018. Cancer prognosis and disease burden are highly dependent on the disease stage at diagnosis. Most people diagnosed with cancer first present in primary care settings, where improved assessment of the (often vague) presenting symptoms of cancer could lead to earlier detection and improved outcomes for patients. There is accumulating evidence that artificial intelligence (AI) can assist clinicians in making better clinical decisions in some areas of health care.

Objective: This study aimed to systematically review AI techniques that may facilitate earlier diagnosis of cancer and could be applied to primary care electronic health record (EHR) data. The quality of the evidence, the phase of development the AI techniques have reached, the gaps that exist in the evidence, and the potential for use in primary care were evaluated.

Methods: We searched MEDLINE, Embase, SCOPUS, and Web of Science databases from January 01, 2000, to June 11, 2019, and included all studies providing evidence for the accuracy or effectiveness of applying AI techniques for the early detection of cancer, which may be applicable to primary care EHRs. We included all study designs in all settings and languages. These searches were extended through a scoping review of AI-based commercial technologies. The main outcomes assessed were measures of diagnostic accuracy for cancer.

Results: We identified 10,456 studies; 16 studies met the inclusion criteria, representing the data of 3,862,910 patients. A total of 13 studies described the initial development and testing of AI algorithms, and 3 studies described the validation of an AI algorithm in independent data sets. One study was based on prospectively collected data; only 3 studies were based on primary care data. We found no data on implementation barriers or cost-effectiveness. Risk of bias assessment highlighted a wide range of study quality. The additional scoping review of commercial AI technologies identified 21 technologies, only 1 meeting our inclusion criteria. Meta-analysis was not undertaken because of the heterogeneity of AI modalities, data set characteristics, and outcome measures.

Conclusions: AI techniques have been applied to EHR-type data to facilitate early diagnosis of cancer, but their use in primary care settings is still at an early stage of maturity. Further evidence is needed on their performance using primary care data, implementation barriers, and cost-effectiveness before widespread adoption into routine primary care clinical practice can be recommended.
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http://dx.doi.org/10.2196/23483DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7970165PMC
March 2021

Impact of influenza vaccination on amoxicillin prescriptions in older adults: A retrospective cohort study using primary care data.

PLoS One 2021 29;16(1):e0246156. Epub 2021 Jan 29.

Institute of Health Research, University of Exeter Medical School, Exeter, United Kingdom.

Background: Bacterial infections of the upper and lower respiratory tract are a frequent complication of influenza and contribute to the widespread use of antibiotics. Influenza vaccination may help reduce both appropriate and inappropriate prescribing of antibiotics. Electronic health records provide a rich source of information for assessing secondary effects of influenza vaccination.

Methods: We conducted a retrospective study to estimate effects of influenza vaccine on antibiotic (amoxicillin) prescription in the elderly based on data from the Clinical Practice Research Datalink. The introduction of UK policy to recommend the influenza vaccine to older adults in 2000 led to a substantial increase in uptake, creating a natural experiment. Of 259,753 eligible patients that were unvaccinated in 1999 and aged≥65y by January 2000, 88,519 patients received influenza vaccination in 2000. These were propensity score matched 1:1 to unvaccinated patients. Time-to-amoxicillin was analysed using the Prior Event Rate Ratio (PERR) Pairwise method to address bias from time-invariant measured and unmeasured confounders. A simulation study and negative control outcome were used to help strengthen the validity of results.

Results: Compared to unvaccinated patients, those from the vaccinated group were more likely to be prescribed amoxicillin in the year prior to vaccination: hazard ratio (HR) 1.90 (95% confidence interval 1.83, 1.98). Following vaccination, the vaccinated group were again more likely to be prescribed amoxicillin, HR 1.64 (1.58,1.71). After adjusting for prior differences between the two groups using PERR Pairwise, overall vaccine effectiveness was 0.86 (0.81, 0.92). Additional analyses suggested that provided data meet the PERR assumptions, these estimates were robust.

Conclusions: Once differences between groups were taken into account, influenza vaccine had a beneficial effect, lowering the frequency of amoxicillin prescribing in the vaccinated group. Ensuring successful implementation of national programmes of vaccinating older adults against influenza may help contribute to reducing antibiotic resistance.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0246156PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7846013PMC
June 2021

Diagnostic performance of a faecal immunochemical test for patients with low-risk symptoms of colorectal cancer in primary care: an evaluation in the South West of England.

Br J Cancer 2021 03 19;124(7):1231-1236. Epub 2021 Jan 19.

University of Exeter Medical School, St Luke's Campus, Magdalen Road, Exeter, EX1 2LU, UK.

Background: The faecal immunochemical test (FIT) was introduced to triage patients with low-risk symptoms of possible colorectal cancer in English primary care in 2017, underpinned by little primary care evidence.

Methods: All healthcare providers in the South West of England (population 4 million) participated in this evaluation. 3890 patients aged ≥50 years presenting in primary care with low-risk symptoms of colorectal cancer had a FIT from 01/06/2018 to 31/12/2018. A threshold of 10 μg Hb/g faeces defined a positive test.

Results: Six hundred and eighteen (15.9%) patients tested positive; 458 (74.1%) had an urgent referral to specialist lower gastrointestinal (GI) services within three months. Forty-three were diagnosed with colorectal cancer within 12 months. 3272 tested negative; 324 (9.9%) had an urgent referral within three months. Eight were diagnosed with colorectal cancer within 12 months. Positive predictive value was 7.0% (95% CI 5.1-9.3%). Negative predictive value was 99.8% (CI 99.5-99.9%). Sensitivity was 84.3% (CI 71.4-93.0%), specificity 85.0% (CI 83.8-86.1%). The area under the ROC curve was 0.92 (CI 0.86-0.96). A threshold of 37 μg Hb/g faeces would identify patients with an individual 3% risk of cancer.

Conclusions: FIT performs exceptionally well to triage patients with low-risk symptoms of colorectal cancer in primary care; a higher threshold may be appropriate in the wake of the COVID-19 crisis.
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http://dx.doi.org/10.1038/s41416-020-01221-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8007716PMC
March 2021

Time from presentation to pre-diagnostic chest X-ray in patients with symptomatic lung cancer: a cohort study using electronic patient records from English primary care.

Br J Gen Pract 2021 04 26;71(705):e273-e279. Epub 2021 Mar 26.

Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge.

Background: National guidelines in England recommend prompt chest X-ray (within 14 days) in patients presenting in general practice with unexplained symptoms of possible lung cancer, including persistent cough, shortness of breath, or weight loss.

Aim: To examine time to chest X-ray in symptomatic patients in English general practice before lung cancer diagnosis, and explore demographical variation.

Design And Setting: Retrospective cohort study using routinely collected general practice, cancer registry, and imaging data from England.

Method: Patients with lung cancer who presented symptomatically in general practice in the year pre-diagnosis and who had a pre-diagnostic chest X-ray were included. Time from presentation to chest X-ray (presentation-test interval) was determined and intervals classified based on national guideline recommendations as concordant (≤14 days) or non-concordant (>14 days). Variation in intervals was examined by age, sex, smoking status, and deprivation.

Results: In a cohort of 2102 patients with lung cancer, the median presentation-test interval was 49 (interquartile range [IQR] 5-172) days. Of these, 727 (35%) patients had presentation-test intervals of ≤14 days (median 1 [IQR 0-6] day) and 1375 (65%) had presentation-test intervals of >14 days (median 128 [IQR 52-231] days). Intervals were longer among patients who smoke (equivalent to 63% longer than non-smokers; <0.001), older patients (equivalent to 7% longer for every 10 years from age 27; = 0.013), and females (equivalent to 12% longer than males; = 0.016).

Conclusion: In symptomatic primary care patients who underwent chest X-ray before lung cancer diagnosis, only 35% were tested within the timeframe recommended by national guidelines. Patients who smoke, older patients, and females experienced longer intervals. These findings could help guide initiatives aimed at improving timely lung cancer diagnosis.
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http://dx.doi.org/10.3399/bjgp20X714077DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7805412PMC
April 2021

Identifying Ovarian Cancer in Symptomatic Women: A Systematic Review of Clinical Tools.

Cancers (Basel) 2020 Dec 8;12(12). Epub 2020 Dec 8.

The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge CB1 8RN, UK.

In the absence of effective ovarian cancer screening programs, most women are diagnosed following the onset of symptoms. Symptom-based tools, including symptom checklists and risk prediction models, have been developed to aid detection. The aim of this systematic review was to identify and compare the diagnostic performance of these tools. We searched MEDLINE, EMBASE and Cochrane CENTRAL, without language restriction, for relevant studies published between 1 January 2000 and 3 March 2020. We identified 1625 unique records and included 16 studies, evaluating 21 distinct tools in a range of settings. Fourteen tools included only symptoms; seven also included risk factors or blood tests. Four tools were externally validated-the Goff Symptom Index (sensitivity: 56.9-83.3%; specificity: 48.3-98.9%), a modified Goff Symptom Index (sensitivity: 71.6%; specificity: 88.5%), the Society of Gynaecologic Oncologists consensus criteria (sensitivity: 65.3-71.5%; specificity: 82.9-93.9%) and the QCancer Ovarian model (10% risk threshold-sensitivity: 64.1%; specificity: 90.1%). Study heterogeneity precluded meta-analysis. Given the moderate accuracy of several tools on external validation, they could be of use in helping to select women for ovarian cancer investigations. However, further research is needed to assess the impact of these tools on the timely detection of ovarian cancer and on patient survival.
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http://dx.doi.org/10.3390/cancers12123686DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7764009PMC
December 2020

Delivering better value colonoscopy: bridging the gap with FIT.

Gut 2021 Jun 24;70(6):1006-1007. Epub 2020 Nov 24.

Department of Primary Care, University of Exeter, Exeter, UK.

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http://dx.doi.org/10.1136/gutjnl-2020-323118DOI Listing
June 2021

Association of non-malignant diseases with thrombocytosis: a prospective cohort study in general practice.

Br J Gen Pract 2020 12 26;70(701):e852-e857. Epub 2020 Nov 26.

DISCO Cancer Diagnostics Group, University of Exeter Medical School, College House, St Luke's Campus, University of Exeter, Exeter.

Background: Thrombocytosis is an excess of platelets, which is diagnosed as a platelet count >400 × 10/l. An association of thrombocytosis with undiagnosed cancer has recently been established, but the association with non-malignant disease has not been studied in primary care.

Aim: To examine, in English primary care, the 1-year incidence of non-malignant diseases in patients with new thrombocytosis and the incidence of pre-existing non-malignant diseases in patients who develop new thrombocytosis.

Design And Setting: Prospective cohort study using English Clinical Practice Research Datalink data from 2000 to 2013.

Method: Newly incident and pre-existing rates of non-malignant diseases associated with thrombocytosis were compared between patients with thrombocytosis and age- and sex-matched patients with a normal platelet count. Fifteen candidate non-malignant diseases were identified from literature searches.

Results: In the thrombocytosis cohort of 39 850 patients, 4579 (11.5%) were newly diagnosed with any one of the candidate diseases, compared with 443 out of 9684 patients (4.6%) in the normal platelet count cohort (relative risk [RR] 2.5, 95% confidence intervals [CI] = 2.3 to 2.8); iron-deficiency anaemia was the most common new diagnosis (4.5% of patients with thrombocytosis, RR 4.9, 95% CI = 4.0 to 6.1). A total of 22 612 (57.0%) patients with thrombocytosis had a pre-existing non-malignant diagnosis compared with 4846 patients (50%) in the normal platelet count cohort (odds ratio 1.3, 95% CI = 1.2 to 1.4). There was no statistically significant difference in cancer diagnoses between patients with and without pre-existing disease in the thrombocytosis cohort.

Conclusion: Thrombocytosis is associated with several non-malignant diseases. Clinicians can use these findings as part of their holistic diagnostic approach to help guide further investigations and management of patients with thrombocytosis.
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http://dx.doi.org/10.3399/bjgp20X713501DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7679146PMC
December 2020

The diagnostic performance of CA125 for the detection of ovarian and non-ovarian cancer in primary care: A population-based cohort study.

PLoS Med 2020 10 28;17(10):e1003295. Epub 2020 Oct 28.

The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.

Background: The serum biomarker cancer antigen 125 (CA125) is widely used as an investigation for possible ovarian cancer in symptomatic women presenting to primary care. However, its diagnostic performance in this setting is unknown. We evaluated the performance of CA125 in primary care for the detection of ovarian and non-ovarian cancers.

Methods And Findings: We studied women in the United Kingdom Clinical Practice Research Datalink with a CA125 test performed between 1 May 2011-31 December 2014. Ovarian and non-ovarian cancers diagnosed in the year following CA125 testing were identified from the cancer registry. Women were categorized by age: <50 years and ≥50 years. Conventional measures of test diagnostic accuracy, including sensitivity, specificity, and positive predictive value, were calculated for the standard CA125 cut-off (≥35 U/ml). The probability of a woman having cancer at each CA125 level between 1-1,000 U/ml was estimated using logistic regression. Cancer probability was also estimated on the basis of CA125 level and age in years using logistic regression. We identified CA125 levels equating to a 3% estimated cancer probability: the "risk threshold" at which the UK National Institute for Health and Care Excellence advocates urgent specialist cancer investigation. A total of 50,780 women underwent CA125 testing; 456 (0.9%) were diagnosed with ovarian cancer and 1,321 (2.6%) with non-ovarian cancer. Of women with a CA125 level ≥35 U/ml, 3.4% aged <50 years and 15.2% aged ≥50 years had ovarian cancer. Of women with a CA125 level ≥35 U/ml who were aged ≥50 years and who did not have ovarian cancer, 20.4% were diagnosed with a non-ovarian cancer. A CA125 value of 53 U/ml equated to a 3% probability of ovarian cancer overall. This varied by age, with a value of 104 U/ml in 40-year-old women and 32 U/ml in 70-year-old women equating to a 3% probability. The main limitations of our study were that we were unable to determine why CA125 tests were performed and that our findings are based solely on UK primary care data, so caution is need in extrapolating them to other healthcare settings.

Conclusions: CA125 is a useful test for ovarian cancer detection in primary care, particularly in women ≥50 years old. Clinicians should also consider non-ovarian cancers in women with high CA125 levels, especially if ovarian cancer has been excluded, in order to prevent diagnostic delay. Our results enable clinicians and patients to determine the estimated probability of ovarian cancer and all cancers at any CA125 level and age, which can be used to guide individual decisions on the need for further investigation or referral.
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http://dx.doi.org/10.1371/journal.pmed.1003295DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7592785PMC
October 2020

Raised inflammatory markers as a predictor of one-year mortality: a cohort study in primary care in the UK using electronic health record data.

BMJ Open 2020 10 15;10(10):e036027. Epub 2020 Oct 15.

University of Exeter Medical School, University of Exeter, Exeter, UK.

Objectives: Identification of patients at increased mortality risk is important in the context of increasing multimorbidity and an ageing population, to help facilitate the planning and delivery of services. The aim of this study was to examine 1-year all-cause mortality in a cohort of primary care patients in whom inflammatory markers including C reactive protein (CRP), erythrocyte sedimentation rate (ESR) and plasma viscosity (PV), had been tested.

Design: Observational cohort study using general practitioner Electronic Health Records from the Clinical Practice Research Datalink, with linkage to Office for National Statistics (ONS) Death Registry.

Setting: UK Primary Care.

Participants: 159 325 patients with inflammatory marker tests done in 2014 and 39 928 age, sex and practice-matched controls without inflammatory marker testing. ONS Death registry data were available for 109 966 participants.

Primary And Secondary Outcome Measures: One-year mortality in those with raised inflammatory markers compared with normal inflammatory markers and untested controls. Subanalyses stratified 1-year mortality by age group, gender and cause of death.

Results: Patients with a raised inflammatory marker (n=47 797) had an overall 1-year all-cause mortality of 6.89%, compared with 1.41% in those with normal inflammatory markers (p<0.001) and 1.62% in untested controls. A raised CRP is associated with the highest mortality rate at 8.76% compared with 4.99% for ESR and 4.66% for PV. One-year mortality is higher in men with a raised inflammatory marker compared with women (9.78% vs 5.29%). The C-statistic of a simple mortality prediction model containing age, sex and CRP test result is 0.89.

Conclusions: Inflammatory markers are a strong predictor of all-cause mortality in primary care, with a C-statistic comparable to several previously developed frailty indices. Future research should consider the added value of CRP testing, in combination with other risk factors, to improve prediction of mortality in primary care. Evidence- based interventions for frailty are needed alongside predictive tools.
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http://dx.doi.org/10.1136/bmjopen-2019-036027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7566728PMC
October 2020

Trends in time to cancer diagnosis around the period of changing national guidance on referral of symptomatic patients: A serial cross-sectional study using UK electronic healthcare records from 2006-17.

Cancer Epidemiol 2020 12 9;69:101805. Epub 2020 Sep 9.

University of Exeter Medical School, University of Exeter, Exeter, UK. Electronic address:

Background: UK primary-care referral guidance describes the signs, symptoms, and test results ("features") of undiagnosed cancer. Guidance revision in 2015 liberalised investigation by introducing more low-risk features. We studied adults with cancer whose features were in the 2005 guidance ("Old-NICE") or were introduced in the revision ("New-NICE"). We compared time to diagnosis between the groups, and its trend over 2006-2017.

Methods: Clinical Practice Research Datalink records were analysed for adults with incident myeloma, breast, bladder, colorectal, lung, oesophageal, ovarian, pancreatic, prostate, stomach or uterine cancers in 1/1/2006-31/12/2017. Cancer-specific features in the year before diagnosis were used to create New-NICE and Old-NICE groups. Diagnostic interval was time between the index feature and diagnosis. Semiparametric varying-coefficient analyses compared diagnostic intervals between New-NICE and Old-NICE groups over 1/1/2006-31/12/2017.

Results: Over all cancers (N = 83,935), median (interquartile range) Old-NICE diagnostic interval rose over 2006-2017, from 51 (20-132) to 64 (30-148) days, with increases in breast (15 vs 25 days), lung (103 vs 135 days), ovarian (65·5 vs 100 days), prostate (80 vs 93 days) and stomach (72·5 vs 102 days) cancers. Median New-NICE values were consistently longer (99, 40-212 in 2006 vs 103, 42-236 days in 2017) than Old-NICE values over all cancers. After guidance revision, New-NICE diagnostic intervals became shorter than Old-NICE values for colorectal cancer.

Conclusions: Despite improvements for colorectal cancer, scope remains to reduce diagnostic intervals for most cancers. Liberalised investigation requires protecting and enhancing cancer-diagnostic services to avoid their becoming a rate-limiting step in the diagnostic pathway.
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http://dx.doi.org/10.1016/j.canep.2020.101805DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7480981PMC
December 2020

Prioritising primary care patients with unexpected weight loss for cancer investigation: diagnostic accuracy study.

BMJ 2020 08 13;370:m2651. Epub 2020 Aug 13.

Medical School, University of Exeter, Exeter, UK.

Objective: To quantify the predictive value of unexpected weight loss (WL) for cancer according to patient's age, sex, smoking status, and concurrent clinical features (symptoms, signs, and abnormal blood test results).

Design: Diagnostic accuracy study.

Setting: Clinical Practice Research Datalink electronic health records data linked to the National Cancer Registration and Analysis Service in primary care, England.

Participants: 63 973 adults (≥18 years) with a code for unexpected WL from 1 January 2000 to 31 December 2012.

Main Outcome Measures: Cancer diagnosis in the six months after the earliest weight loss code (index date). Codes for additional clinical features were identified in the three months before to one month after the index date. Diagnostic accuracy measures included positive and negative likelihood ratios, positive predictive values, and diagnostic odds ratios.

Results: Of 63 973 adults with unexpected WL, 37 215 (58.2%) were women, 33 167 (51.8%) were aged 60 years or older, and 16 793 (26.3%) were ever smokers. 908 (1.4%) had a diagnosis of cancer within six months of the index date, of whom 882 (97.1%) were aged 50 years or older. The positive predictive value for cancer was above the 3% threshold recommended by the National Institute for Health and Care Excellence for urgent investigation in male ever smokers aged 50 years or older, but not in women at any age. 10 additional clinical features were associated with cancer in men with unexpected WL, and 11 in women. Positive likelihood ratios in men ranged from 1.86 (95% confidence interval 1.32 to 2.62) for non-cardiac chest pain to 6.10 (3.44 to 10.79) for abdominal mass, and in women from 1.62 (1.15 to 2.29) for back pain to 20.9 (10.7 to 40.9) for jaundice. Abnormal blood test results associated with cancer included low albumin levels (4.67, 4.14 to 5.27) and raised values for platelets (4.57, 3.88 to 5.38), calcium (4.28, 3.05 to 6.02), total white cell count (3.76, 3.30 to 4.28), and C reactive protein (3.59, 3.31 to 3.89). However, no normal blood test result in isolation ruled out cancer. Clinical features co-occurring with unexpected WL were associated with multiple cancer sites.

Conclusion: The risk of cancer in adults with unexpected WL presenting to primary care is 2% or less and does not merit investigation under current UK guidelines. However, in male ever smokers aged 50 years or older and in patients with concurrent clinical features, the risk of cancer warrants referral for invasive investigation. Clinical features typically associated with specific cancer sites are markers of several cancer types when they occur with unexpected WL.
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http://dx.doi.org/10.1136/bmj.m2651DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7424394PMC
August 2020

Online patient simulation training to improve clinical reasoning: a feasibility randomised controlled trial.

BMC Med Educ 2020 Jul 31;20(1):245. Epub 2020 Jul 31.

Department of Applied Health Research, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.

Background: Online patient simulations (OPS) are a novel method for teaching clinical reasoning skills to students and could contribute to reducing diagnostic errors. However, little is known about how best to implement and evaluate OPS in medical curricula. The aim of this study was to assess the feasibility, acceptability and potential effects of eCREST - the electronic Clinical Reasoning Educational Simulation Tool.

Methods: A feasibility randomised controlled trial was conducted with final year undergraduate students from three UK medical schools in academic year 2016/2017 (cohort one) and 2017/2018 (cohort two). Student volunteers were recruited in cohort one via email and on teaching days, and in cohort two eCREST was also integrated into a relevant module in the curriculum. The intervention group received three patient cases and the control group received teaching as usual; allocation ratio was 1:1. Researchers were blind to allocation. Clinical reasoning skills were measured using a survey after 1 week and a patient case after 1 month.

Results: Across schools, 264 students participated (18.2% of all eligible). Cohort two had greater uptake (183/833, 22%) than cohort one (81/621, 13%). After 1 week, 99/137 (72%) of the intervention and 86/127 (68%) of the control group remained in the study. eCREST improved students' ability to gather essential information from patients over controls (OR = 1.4; 95% CI 1.1-1.7, n = 148). Of the intervention group, most (80/98, 82%) agreed eCREST helped them to learn clinical reasoning skills.

Conclusions: eCREST was highly acceptable and improved data gathering skills that could reduce diagnostic errors. Uptake was low but improved when integrated into course delivery. A summative trial is needed to estimate effectiveness.
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http://dx.doi.org/10.1186/s12909-020-02168-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395338PMC
July 2020

Cancer incidence following a high-normal platelet count: cohort study using electronic healthcare records from English primary care.

Br J Gen Pract 2020 09 27;70(698):e622-e628. Epub 2020 Aug 27.

University of Exeter Medical School, Exeter.

Background: A raised platelet count (thrombocytosis) measuring >400 × 10/l is associated with high cancer incidence. It is uncertain whether platelet counts at the upper end of the normal range (high-normal: 326-400 × 10/l) are also associated with cancer.

Aim: To investigate cancer incidence following a normal platelet count in primary care.

Design And Setting: A prospective cohort study was undertaken using data from the Clinical Practice Research Datalink and National Cancer Registration and Analysis Service, dating from 1 May 2005 to 30 April 2014.

Method: One-year cancer incidence was estimated for 295 312 patients with normal platelet counts (150-400 × 10/l). Patients with platelet counts >325 × 10/l were oversampled to maximise precision of estimates of cancer incidence. All patients were aged ≥40 years with no prior cancer diagnoses. The effects of age, sex, and smoking were explored. Non-melanoma skin cancers were omitted from exclusions and incidence.

Results: One-year cancer incidence increased greatly with age, male sex, and higher platelet count. Males aged ≥60 years with a high-normal count had an incidence of 4.2% (95% confidence interval [CI] = 4.0 to 4.4). The highest incidence of 6.7% (95% CI = 5.3 to 8.4) was found in males aged ≥80 years, who had platelets in the range of 376-400 × 10/l; this was 3.1 percentage points higher than the incidence for patients in the same age group with lower-normal counts of 150-325 × 10/l. Risks for all female subgroups were <3%. Patients with high-normal platelet counts were most at risk of lung and colorectal cancers and, in general, had advanced-stage cancer at diagnosis.

Conclusion: Platelet counts at the high-normal range in males aged ≥60 years may be indicative of an underlying malignancy, and referral for further investigation should be considered.
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http://dx.doi.org/10.3399/bjgp20X710957DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7390285PMC
September 2020

Effect of pre-existing conditions on bladder cancer stage at diagnosis: a cohort study using electronic primary care records in the UK.

Br J Gen Pract 2020 09 27;70(698):e629-e635. Epub 2020 Aug 27.

College of Medicine and Health, University of Exeter, Exeter, UK.

Background: Pre-existing concurrent medical conditions (multimorbidity) complicate cancer diagnosis when they provide plausible diagnostic alternatives for cancer symptoms.

Aim: To investigate associations in bladder cancer between: first, pre-existing condition count and advanced-stage diagnosis; and, second, comorbidities that share symptoms with bladder cancer and advanced-stage diagnosis.

Design And Setting: This observational UK cohort study was set in the Clinical Practice Research Datalink with Public Health England National Cancer Registration and Analysis Service linkage.

Method: Included participants were aged ≥40 years with an incident diagnosis of bladder cancer between 1 January 2000 and 31 December 2015, and primary care records of attendance for haematuria, dysuria, or abdominal mass in the year before diagnosis. Stage at diagnosis (stage 1 or 2 versus stage 3 or 4) was the outcome variable. Putative explanatory variables using logistic regression were examined, including patient-level count of pre-existing conditions and 'alternative-explanations', indicating whether pre-existing condition(s) were plausible diagnostic alternatives for the index cancer symptom.

Results: In total, 1468 patients (76.4% male) were studied, of which 399 (35.6%) males and 217 (62.5%) females had alternative explanations for their index cancer symptom, the most common being urinary tract infection with haematuria. Females were more likely than males to be diagnosed with advanced-stage cancer (adjusted odds ratio [aOR] 1.62; 95% confidence interval [CI] = 1.20 to 2.18; = 0.001). Alternative explanations were strongly associated with advanced-stage diagnosis in both sexes (aOR 1.69; 95% CI = 1.20 to 2.39; = 0.003).

Conclusion: Alternative explanations were associated with advanced-stage diagnosis of bladder cancer. Females were more likely than males to be diagnosed with advanced-stage disease, but the effect was not driven entirely by alternative explanations.
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http://dx.doi.org/10.3399/bjgp20X710921DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7363276PMC
September 2020

Faecal immunochemical test to triage patients with abdominal symptoms for suspected colorectal cancer in primary care: review of international use and guidelines.

Fam Pract 2020 10;37(5):606-615

DISCOVERY Group, University of Exeter Medical School, University of Exeter, Exeter, UK.

Background: Recently, faecal immunochemical tests (FITs) have been introduced for investigation of primary care patients with low-risk symptoms of colorectal cancer (CRC), but recommendations vary across the world. This systematic review of clinical practice guidelines aimed to determine how FITs are used in symptomatic primary care patients and the underpinning evidence for these guidelines.

Methods: MEDLINE, Embase and TRIP databases were systematically searched, from 1 November 2008 to 1 November 2018 for guidelines on the assessment of patients with symptoms suggestive of CRC. Known guideline databases, websites and references of related literature were searched. The following questions were addressed: (i) which countries use FIT for symptomatic primary care patients; (ii) in which populations is FIT used; (iii) what is the cut-off level used for haemoglobin in the faeces (FIT) and (iv) on what evidence are FIT recommendations based.

Results: The search yielded 2433 publications; 25 covered initial diagnostic assessment of patients with symptoms of CRC in 15 countries (Asia, n = 1; Europe, n = 13; Oceania, n = 4; North America, n = 5; and South America, n = 2). In three countries (Australia, Spain and the UK), FIT was recommended for patients with abdominal symptoms, unexplained weight loss, change in bowel habit or anaemia despite a low level of evidence in the symptomatic primary care patient population.

Conclusions: Few countries recommend FITs in symptomatic patients in primary care either because of limited evidence or because symptomatic patients are directly referred to secondary care without triage. These results demonstrate a clear need for research on FIT in the symptomatic primary care population.
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http://dx.doi.org/10.1093/fampra/cmaa043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7571772PMC
October 2020

The association between unexpected weight loss and cancer diagnosis in primary care: a matched cohort analysis of 65,000 presentations.

Br J Cancer 2020 06 15;122(12):1848-1856. Epub 2020 Apr 15.

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.

Background: We aimed to understand the time period of cancer diagnosis and the cancer types detected in primary care patients with unexpected weight loss (UWL) to inform cancer guidelines.

Methods: This retrospective matched cohort study used cancer registry linked electronic health records from the UK's Clinical Practice Research Datalink from between 2000 and 2014. Univariable and multivariable time-to-event analyses examined the association between UWL, and all cancers combined, cancer site and stage.

Results: In all, 63,973 patients had UWL recorded, of whom 1375 (2.2%) were diagnosed with cancer within 2 years (days-to-diagnosis: mean 181; median 80). Men with UWL (HR 3.28 (2.88-3.73)) and women (1.87 (1.68-2.08)) were more likely than comparators to be diagnosed with cancer within 3 months. The association was greatest in men aged ≥50 years and women ≥70 years. The commonest cancers were pancreas, cancer of unknown primary, gastro-oesophageal, lymphoma, hepatobiliary, lung, bowel and renal-tract. The majority were late-stage, but there was some evidence of association with stage II and stage III cancers. In the 3-24 months after presenting with UWL, cancer diagnosis was less likely than in comparators.

Conclusion: UWL recorded in primary care is associated with a broad range of cancer sites of early and late-stage.
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http://dx.doi.org/10.1038/s41416-020-0829-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7283307PMC
June 2020

Development and implementation of the physiotherapy-led exercise interventions for the treatment of rotator cuff disorders for the 'Getting it Right: Addressing Shoulder Pain' (GRASP) trial.

Physiotherapy 2020 06 9;107:252-266. Epub 2019 Jul 9.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Objectives: The Getting it Right: Addressing Shoulder Pain (GRASP) trial is a large-scale, multicentre, 2×2 factorial randomised controlled trial investigating clinical and cost-effectiveness of a progressive exercise programme versus best-practice advice, with or without corticosteroid injection, for treating people with rotator cuff disorders. Here we describe the development, implementation and details of the physiotherapy-led interventions.

Methods: Medical Research Council guidance for developing complex interventions were used, taking into account clinical guidelines, expert and patient opinion, research evidence, current practice variation, and deliverability. A stakeholder meeting of 26 experts, clinicians, researchers, and patient representatives was used to design key components of the interventions. Stakeholders prioritised strengthening posterior rotator cuff muscles and using practical, easy-to-do exercises. The interventions were designed to be deliverable across the UK National Health Service.

Results: Progressive exercise consists of up to six sessions with a physiotherapist over 16 weeks. The best-practice advice consists of one face-to-face session with a physiotherapist with substantially greater reliance on self-management. Both interventions include self-management advice, home-exercise instruction, and behaviour-change strategies to target exercise adherence. All participants receive a Participant Information Booklet. The best-practice advice intervention is a self-guided system of progressively challenging exercises, with demonstration videos and written materials. The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback.

Conclusion: GRASP has recruited 708 participants and will provide high quality evidence to inform management of people with shoulder pain due to a rotator cuff disorder. Results are anticipated in 2020.

Trial Registration Number: ISRCTN16539266; EudraCT number:2016-002991-28.
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http://dx.doi.org/10.1016/j.physio.2019.07.002DOI Listing
June 2020

Changes in the presenting symptoms of lung cancer from 2000-2017: a serial cross-sectional study of observational records in UK primary care.

Br J Gen Pract 2020 03 27;70(692):e193-e199. Epub 2020 Feb 27.

College of Medicine and Health, University of Exeter, Exeter.

Background: Most patients diagnosed with lung cancer present with symptoms. It is not known if the proportions of patients presenting with each symptom has changed over time. Identifying trends in lung cancer's presenting symptoms is important for medical education and early-diagnosis initiatives.

Aim: To identify the first reported symptom of possible lung cancer (index symptom), and to test whether the percentages of patients with each index symptom changed during 2000-2017.

Design And Setting: This was a serial, cross-sectional, observational study using UK Clinical Practice Research Datalink (CPRD) data with cancer registry linkage.

Method: The index symptom was identified for patients with an incident diagnosis of lung cancer in annual cohorts between 1 January 2000 and 31 December 2017. Searches were constrained to symptoms in National Institute for Health and Care Excellence (NICE) suspected-cancer referral guidelines, and to the year before diagnosis. Generalised linear models (with a binomial function) were used to test if the percentages of patients with each index symptom varied during 2000-2017.

Results: The percentage of patients with an index symptom of cough (odds ratio [OR] 1.01; 95% confidence interval [CI] = 1.00 to 1.02 per year; <0.0001) or dyspnoea (OR 1.05; CI = 1.05 to 1.06 per year; <0.0001) increased. The percentages of patients with other index symptoms decreased, notably haemoptysis (OR 0.93; CI = 0.92 to 0.95; <0.0001) and appetite loss (OR 0.94; CI = 0.90 to 0.97; <0.0001).

Conclusion: During 2000-2017, the proportions of lung cancer patients with an index symptom of cough or dyspnoea increased, while the proportion of those with the index symptom haemoptysis decreased. This trend has implications for medical education and symptom awareness campaigns.
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http://dx.doi.org/10.3399/bjgp20X708137DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6988682PMC
March 2020

Cross-sectional study using primary care and cancer registration data to investigate patients with cancer presenting with non-specific symptoms.

BMJ Open 2020 01 10;10(1):e033008. Epub 2020 Jan 10.

Primary Care, Medical School, University of Exeter, Exeter, UK.

Introduction: Patients presenting to primary care with site-specific alarm symptoms can be referred onto urgent suspected cancer pathways, whereas those with non-specific symptoms currently have no dedicated referral routes leading to delays in cancer diagnosis and poorer outcomes. Pilot Multidisciplinary Diagnostic Centres (MDCs) provide a referral route for such patients in England.

Objectives: This work aimed to use linked primary care and cancer registration data to describe diagnostic pathways for patients similar to those being referred into MDCs and compare them to patients presenting with more specific symptoms.

Methods: This cross-sectional study linked primary care data from the National Cancer Diagnosis Audit (NCDA) to national cancer registration and Route to Diagnosis records. Patient symptoms recorded in the NCDA were used to allocate patients to one of two groups - those presenting with symptoms mirroring referral criteria of MDCs (non-specific but concerning symptoms (NSCS)) and those with at least one site-specific alarm symptom (non-NSCS). Descriptive analyses compared the two groups and regression analysis by group investigated associations with long primary care intervals (PCIs).

Results: Patients with NSCS were more likely to be diagnosed at later stage (32% stage 4, compared with 21% in non-NSCS) and via an emergency presentation (34% vs 16%). These patients also had more multiple pre-referral general practitioner consultations (59% vs 43%) and primary care-led diagnostics (blood tests: 57% vs 35%). Patients with NSCS had higher odds of having longer PCIs (adjusted OR: 1.24 (1.11 to 1.36)). Patients with lung and urological cancers also had higher odds of longer PCIs overall and in both groups.

Conclusions: Differences in the diagnostic pathway show that patients with symptoms mirroring the MDC referral criteria could benefit from a new referral pathway.
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http://dx.doi.org/10.1136/bmjopen-2019-033008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955554PMC
January 2020
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