General Practice - Research Publications

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    The SYMPTOM-upper gastrointestinal study: A mixed methods study exploring symptom appraisal and help-seeking in Australian upper gastrointestinal cancer patients
    Karnchanachari, N ; Milton, S ; Muhlen-Schulte, T ; Scarborough, R ; Holland, JF ; Walter, FM ; Zalcberg, J ; Emery, J (WILEY, 2022-05-06)
    OBJECTIVE: There is limited evidence on the development of pancreatic and oesophagogastric cancer, how patients decide to seek help and the factors impacting help-seeking. Our study, the first in Australia, aimed to explore symptom appraisal and diagnostic pathways in these patients. A secondary aim was to examine the potential to recruit cancer patients through a cancer quality registry. METHODS: Patients diagnosed with pancreatic or oesophagogastric cancer were recruited through Monash University's Upper-Gastrointestinal Cancer Registry. Data collected through general practitioners (GP) and patient questionnaires included symptoms and their onset, whereas patient interviews focused on the patient's decision-making in seeking help from healthcare pracitioners. Data collection and analysis was informed by the Aarhus statement. Coding was inductive, and themes were mapped onto the Model of Pathways to Treatment. RESULTS: Between November 2018 and March 2020, 27 patient questionnaires and 13 phone interviews were completed. Prior to diagnosis, patients lacked awareness of pancreatic and oesophagogastric cancer symptoms, leading to the normalisation, dismissal and misattribution of the symptoms. Patients initially self-managed symptoms, but worsening of symptoms and jaundice triggered help-seeking. Competing priorities, beliefs about illnesses and difficulties accessing healthcare delayed help-seeking. CONCLUSION: Increased awareness of insidious pancreatic and oesophagogastric cancer symptoms in patients and general practitioners may prompt more urgent investigations and lead to earlier diagnosis.
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    Cytology for the diagnosis of endometrial cancer in symptomatic women
    O'Flynn, H ; Jones, E ; Njoku, K ; Rana, D ; Shelton, D ; Narine, N ; Ramchander, NC ; Patel, V ; Walter, FM ; Walsh, T ; Crosbie, EJ (Wiley, 2021-05-06)
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    Patient-centred outcomes of imaging tests: recommendations for patients, clinicians and researchers
    Thompson, MJ ; Suchsland, MZ ; Hardy, V ; Lavallee, DC ; Lord, S ; Devine, EB ; Jarvik, JG ; Findlay, S ; Trikalinos, TA ; Walter, FM ; Chou, R ; Green, BB ; Wernli, KJ ; Fitzpatrick, AL ; Bossuyt, PM (BMJ PUBLISHING GROUP, 2021-10-05)
    BACKGROUND: Imaging tests are one of the most frequently used diagnostic modalities in healthcare, but the benefits of their direct impacts on clinical decision-making have been countered by concerns that they can be overused. Assessing the relative value of imaging tests has largely focused on measures of test accuracy, which overlooks more comprehensive benefits and risks of imaging tests, particularly their impact on patient-centred outcomes (PCOs). We present the findings of the Patient Reported Outcomes of Diagnostics (PROD) research study in response to a methodological gap in the area of diagnostic test comparative effectiveness research. METHODS: Over a 3-year period, the PROD Study engaged with multiple stakeholders to identify existing conceptual models related to PCOs for imaging testing, conducted primary research and evidence synthesis, and developed consensus recommendations to describe and categorise PCOs related to imaging testing. RESULTS: The PROD framework categorises PCOs from imaging studies within four main domains: information or knowledge yielded, physical impact, emotional outcomes and test burden. PCOs interact with each other and influence effects across domains, and can be modified by factors related to the patient, clinical situation, healthcare team and the testing environment. CONCLUSIONS: Using PCOs to inform healthcare decision-making will require ways of collating and presenting information on PCOs in ways that can inform patient-provider decision-making, and developing methods to determine the relative importance of outcomes (including test accuracy) to one another.
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    Primary care use by men with symptoms of possible prostate cancer: A multi-method study with an ethnically diverse sample in London
    Martins, T ; Walter, FM ; Penfold, C ; Abel, G ; Hamilton, W (WILEY, 2021-06-21)
    OBJECTIVE: The objective of this study is to investigate primary care use by men with recent onset of lower urinary tract symptoms (LUTS) to identify differences in presentation and investigation that may explain ethnic inequality in prostate cancer outcomes. METHODS: This is a multi-method study of men presenting LUTS to primary care. Two hundred seventy-four men completed a self-administered questionnaire, and 23 participated in face-to-face interviews. Regression analyses investigated ethnic differences in (a) the period between symptom onset and first primary care presentation (patient interval) and (b) the interval between first primary care presentation and investigation with prostate-specific antigen (PSA) and digital rectal examination (DRE). Interview data were analysed using thematic analysis. RESULTS: Half (144, 53%) reported a solitary first symptom, although multiple first symptoms were also common, particularly in Asian and Black men. There was no difference between ethnicities in patient interval or time from presentation to investigation. However, Asian men were offered less PSA testing (odds ratio 0.39; 95% confidence interval 0.17-0.92; p = 0.03). Qualitative data revealed ethnic differences in general practitioners' offer of DRE and PSA testing and highlighted limitations in doctor-patient communication and safety netting. CONCLUSION: Our study showed only small differences in primary care experiences, insufficient to explain ethnic inequalities in prostate cancer outcomes.
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    Comprehensive epithelial tubo-ovarian cancer risk prediction model incorporating genetic and epidemiological risk factors
    Lee, A ; Yang, X ; Tyrer, J ; Gentry-Maharaj, A ; Ryan, A ; Mavaddat, N ; Cunningham, AP ; Carver, T ; Archer, S ; Leslie, G ; Kalsi, J ; Gaba, F ; Manchanda, R ; Gayther, S ; Ramus, SJ ; Walter, FM ; Tischkowitz, M ; Jacobs, I ; Menon, U ; Easton, DF ; Pharoah, P ; Antoniou, AC (BMJ PUBLISHING GROUP, 2021-11-21)
    BACKGROUND: Epithelial tubo-ovarian cancer (EOC) has high mortality partly due to late diagnosis. Prevention is available but may be associated with adverse effects. A multifactorial risk model based on known genetic and epidemiological risk factors (RFs) for EOC can help identify women at higher risk who could benefit from targeted screening and prevention. METHODS: We developed a multifactorial EOC risk model for women of European ancestry incorporating the effects of pathogenic variants (PVs) in BRCA1, BRCA2, RAD51C, RAD51D and BRIP1, a Polygenic Risk Score (PRS) of arbitrary size, the effects of RFs and explicit family history (FH) using a synthetic model approach. The PRS, PV and RFs were assumed to act multiplicatively. RESULTS: Based on a currently available PRS for EOC that explains 5% of the EOC polygenic variance, the estimated lifetime risks under the multifactorial model in the general population vary from 0.5% to 4.6% for the first to 99th percentiles of the EOC risk distribution. The corresponding range for women with an affected first-degree relative is 1.9%-10.3%. Based on the combined risk distribution, 33% of RAD51D PV carriers are expected to have a lifetime EOC risk of less than 10%. RFs provided the widest distribution, followed by the PRS. In an independent partial model validation, absolute and relative 5-year risks were well calibrated in quintiles of predicted risk. CONCLUSION: This multifactorial risk model can facilitate stratification, in particular among women with FH of cancer and/or moderate-risk and high-risk PVs. The model is available via the CanRisk Tool (www.canrisk.org).
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    Patients’ Experiences of Using Skin Self-monitoring Apps with People at Higher Risk of Melanoma: Qualitative Study
    Habgood, E ; McCormack, C ; Walter, FM ; Emery, JD (JMIR Publications Inc., 2021-07-01)
    Background Melanoma is the fourth most commonly diagnosed cancer in Australia. Up to 75% of melanomas are first detected by patients or their family or friends. Many mobile apps for melanoma exist, including apps to encourage skin self-monitoring to improve the likelihood of early detection. Previous research in this area has focused on their development, diagnostic accuracy, or validation. Little is known about patients’ views and experiences of using these apps. Objective This study aims to understand patients’ views and experiences of using commercially available melanoma skin self-monitoring mobile apps for a period of 3 months. Methods This qualitative study was conducted in two populations: primary care (where the MelatoolsQ tool was used to identify patients who were at increased risk of melanoma) and secondary care (where patients had a previous diagnosis of melanoma, stages T0-T3a). Participants downloaded 2 of the 4 mobile apps for skin self-monitoring (SkinVision, UMSkinCheck, Mole Monitor, or MySkinPal) and were encouraged to use them for 3 months. After 3 months, a semistructured interview was conducted with participants to discuss their experiences of using the skin self-monitoring mobile apps. Results A total of 54 participants were recruited in the study, with 37% (20) of participants from primary care and 62% (34) from secondary care. Interviews were conducted with 34 participants when data saturation was reached. Most participants did not use the apps at all (n=12) or tried them once but did not continue (n=14). Only 8 participants used the apps to assist with skin self-monitoring for the entire duration of the study. Patients discussed the apps in the context of the importance of early detection and their current skin self-monitoring behaviors. A range of features of perceived quality of each app affected engagement to support skin self-monitoring. Participants described their skin self-monitoring routines and potential mismatches with the app reminders. They also described the technical and practical difficulties experienced when using the apps for skin self-monitoring. The app’s positioning within existing relationships with health care providers was crucial to understand the use of the apps. Conclusions This study of patients at increased risk of melanoma highlights several barriers to engagement with apps to support skin self-monitoring. The results highlight the wide-ranging and dynamic influences on engagement with mobile apps, which extend beyond app design and relate to broader contextual factors about skin self-monitoring routines and relationships with health care providers.
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    Effectiveness of interventions for improving timely diagnosis of breast and cervical cancers in low-income and middle-income countries: a systematic review
    Nnaji, CA ; Kuodi, P ; Walter, FM ; Moodley, J (BMJ PUBLISHING GROUP, 2022-04-01)
    OBJECTIVES: To systematically synthesise available evidence on the nature and effectiveness of interventions for improving timely diagnosis of breast and cervical cancers in low and middle-income countries (LMICs). DESIGN: A systematic review of published evidence. The review was conducted and reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analyses. DATA SOURCES: A comprehensive search of published literature was conducted. In addition, relevant grey literature sources and bibliographical references of included studies were searched for potentially eligible evidence. STUDY SELECTION: Studies published between January 2010 and November 2020 were eligible for inclusion. To be eligible, studies had to report on interventions/strategies targeted at women, the general public or healthcare workers, aimed at improving the timely diagnosis of breast and/or cervical cancers in LMIC settings. DATA EXTRACTION AND SYNTHESIS: Literature search, screening, study selection, data extraction and quality appraisal were conducted by two independent reviewers. Evidence was synthesised and reported using a global taxonomy framework for early cancer diagnosis. RESULTS: From the total of 10 593 records identified, 21 studies conducted across 20 LMICs were included in this review. Most of the included studies (16/21) focused primarily on interventions addressing breast cancers; two focused on cervical cancer while the rest examined multiple cancer types. Reported interventions targeted healthcare workers (12); women and adolescent girls (7) and both women and healthcare workers (3). Eight studies reported on interventions addressing access delays; seven focused on interventions addressing diagnostic delays; two reported on interventions targeted at addressing both access and diagnostic delays, and four studies assessed interventions addressing access, diagnostic and treatment delays. While most interventions were demonstrated to be feasible and effective, many of the reported outcome measures are of limited clinical relevance to diagnostic timeliness. CONCLUSIONS: Though limited, evidence suggests that interventions aimed at addressing barriers to timely diagnosis of breast and cervical cancer are feasible in resource-limited contexts. Future interventions need to address clinically relevant measures to better assess efficacy of interventions. PROSPERO REGISTRATION NUMBER: CRD42020177232.
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    Pre-diagnostic clinical features and blood tests in patients with colorectal cancer: br a retrospective linked-data study
    Moullet, M ; Zhou, Y ; Mounce, LTA ; Abel, GA ; Funston, G ; de Wit, N ; Walter, FM (ROYAL COLL GENERAL PRACTITIONERS, 2022-06-07)
    BACKGROUND: The majority of colorectal cancer is diagnosed in patients following symptomatic presentation in the UK. AIM: To identify windows of opportunity for timely investigations or referrals in patients presenting with colon and rectal cancer-relevant symptoms or abnormal blood tests. DESIGN AND SETTING: A retrospective cohort study was undertaken using linked primary care and cancer registry data for patients with colorectal cancer diagnosed in England between 2012 and 2015. METHOD: Monthly consultation rates for relevant clinical features (change in bowel habit, rectal bleeding, abdominal pain, abdominal mass, constitutional symptoms, and other bowel symptoms) and abnormal blood test results (low haemoglobin, high platelets, and high inflammatory markers) up to 24 months pre-diagnosis were calculated. Poisson regression adjusted for age, sex, and relevant comorbidities was used to estimate the most likely month when consultation rates increased above baseline. RESULTS: In total, 5033 patients with colon cancer and 2516 with rectal cancer were included. Consultations for all examined clinical features and abnormal blood tests increased in the year pre-diagnosis. Rectal bleeding was the earliest clinical feature to increase from the baseline rate: at 10 months (95% confidence interval [CI] = 8.3 to 11.7) pre-diagnosis for colon cancer and at 8 months (95% CI = 6.1 to 9.9) pre-diagnosis for rectal cancer. Low haemoglobin, high platelets, and high inflammatory markers increased from as early as 9 months pre-diagnosis. CONCLUSION: This study found evidence for an early increase in rates of consultation for relevant clinical features and abnormal blood tests in patients with colorectal cancer, suggesting that earlier instigation of cancer-specific investigations or referrals may be warranted in some patients who were symptomatic.
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    Patient-reported experiences and views on the Cytosponge test: a mixed-methods analysis from the BEST3 trial
    Maroni, R ; Barnes, J ; Offman, J ; Scheibl, F ; Smith, SG ; Debiram-Beecham, I ; Waller, J ; Sasieni, P ; Fitzgerald, RC ; Rubin, G ; Walter, FM (BMJ PUBLISHING GROUP, 2022-04-01)
    OBJECTIVES: The BEST3 trial demonstrated the efficacy and safety of the Cytosponge-trefoil factor 3, a cell collection device coupled with the biomarker trefoil factor 3, as a tool for detecting Barrett's oesophagus, a precursor of oesophageal adenocarcinoma (OAC), in primary care. In this nested study, our aim was to understand patient experiences. DESIGN: Mixed-methods using questionnaires (including Inventory to Assess Patient Satisfaction, Spielberger State-Trait Anxiety Inventory-6 and two-item perceived risk) and interviews. OUTCOME MEASURES: Participant satisfaction, anxiety and perceived risk of developing OAC. SETTING: General practices in England. PARTICIPANTS: Patients with acid reflux enrolled in the intervention arm of the BEST3 trial and attending the Cytosponge appointment (N=1750). RESULTS: 1488 patients successfully swallowing the Cytosponge completed the follow-up questionnaires, while 30 were interviewed, including some with an unsuccessful swallow.Overall, participants were satisfied with the Cytosponge test. Several items showed positive ratings, in particular convenience and accessibility, staff's interpersonal skills and perceived technical competence. The most discomfort was reported during the Cytosponge removal, with more than 60% of participants experiencing gagging. Nevertheless, about 80% were willing to have the procedure again or to recommend it to friends; this was true even for participants experiencing discomfort, as confirmed in the interviews.Median anxiety scores were below the predefined level of clinically significant anxiety and slightly decreased between baseline and follow-up (p < 0.001). Interviews revealed concerns around the ability to swallow, participating in a clinical trial, and waiting for test results.The perceived risk of OAC increased following the Cytosponge appointment (p<0.001). Moreover, interviews suggested that some participants had trouble conceptualising risk and did not understand the relationships between test results, gastro-oesophageal reflux and risk of Barrett's oesophagus and OAC. CONCLUSIONS: When delivered during a trial in primary care, the Cytosponge is well accepted and causes little anxiety. TRIAL REGISTRATION NUMBER: ISRCTN68382401.
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    Systematic review and meta-analysis of the diagnostic accuracy of prostate-specific antigen (PSA) for the detection of prostate cancer in symptomatic patients.
    Merriel, SWD ; Pocock, L ; Gilbert, E ; Creavin, S ; Walter, FM ; Spencer, A ; Hamilton, W (Springer Science and Business Media LLC, 2022-02-07)
    BACKGROUND: Prostate-specific antigen (PSA) is a commonly used test to detect prostate cancer. Attention has mostly focused on the use of PSA in screening asymptomatic patients, but the diagnostic accuracy of PSA for prostate cancer in patients with symptoms is less well understood. METHODS: A systematic database search was conducted of Medline, EMBASE, Web of Science, and the Cochrane library. Studies reporting the diagnostic accuracy of PSA for prostate cancer in patients with symptoms were included. Two investigators independently assessed the titles and abstracts of all database search hits and full texts of potentially relevant studies against the inclusion criteria, and data extracted into a proforma. Study quality was assessed using the QUADAS-2 tool by two investigators independently. Summary estimates of diagnostic accuracy were calculated with meta-analysis using bivariate mixed effects regression. RESULTS: Five hundred sixty-three search hits were assessed by title and abstract after de-duplication, with 75 full text papers reviewed. Nineteen studies met the inclusion criteria, 18 of which were conducted in secondary care settings with one from a screening study cohort. All studies used histology obtained by transrectal ultrasound-guided biopsy (TRUS) as a reference test; usually only for patients with elevated PSA or abnormal prostate examination. Pooled data from 14,489 patients found estimated sensitivity of PSA for prostate cancer was 0.93 (95% CI 0.88, 0.96) and specificity was 0.20 (95% CI 0.12, 0.33). The area under the hierarchical summary receiver operator characteristic curve was 0.72 (95% CI 0.68, 0.76). All studies were assessed as having a high risk of bias in at least one QUADAS-2 domain. CONCLUSIONS: Currently available evidence suggests PSA is highly sensitive but poorly specific for prostate cancer detection in symptomatic patients. However, significant limitations in study design and reference test reduces the certainty of this estimate. There is very limited evidence for the performance of PSA in primary care, the healthcare setting where most PSA testing is performed.