Should I take aspirin? A qualitative study on the implementation of a decision aid on taking aspirin for bowel cancer prevention.

OBJECTIVES: Australian guidelines recommend 50-70 years consider taking aspirin to reduce their bowel cancer risk. We trialled a decision aid in general practice to facilitate the implementation of these guidelines into clinical practice. This publication reports on the qualitative results from the process evaluation of the trial. We aimed to explore general practitioners' (GPs) and their patients' approach to shared decision-making (SDM) about taking aspirin to prevent bowel cancer and how the decision aids were used in practice. METHODS: Semistructured interviews were conducted with 17 participants who received the decision aid and 12 GPs who participated in the trial between June and November 2021. The interviews were coded inductively, and emerging themes were mapped onto the Revised Programme Theory for SDM. RESULTS: The study highlighted the dynamics of SDM for taking aspirin to prevent bowel cancer. Some participants discussed the decision aid with their GPs as advised prior to taking aspirin, others either took aspirin or dismissed it outright without discussing it with their GPs. Notably, participants' trust in their GPs, and participants' diverse worldviews played pivotal roles in their decisions. Although the decision aid supported SDM for some, it was not always prioritised in a consultation. This was likely impacted during the trial period as the COVID-19 pandemic was the focus for general practice. CONCLUSION: In summary, this study illustrated the complexities of SDM through using a decision aid in general practice to implement the guidelines for low-dose aspirin to prevent bowel cancer. While the decision aid prompted some participants to speak to their GPs, they were also heavily influenced by their unwavering trust in the GPs and their different worldviews. In the face of the COVID-19 pandemic, SDM was not highly prioritised. This study provides insights into the implementation of guidelines into clinical practice and highlights the need for ongoing support and prioritisation of cancer prevention in general practice consultations. TRIAL REGISTRATION NUMBER: ACTRN12620001003965.

Surveillance for liver cancer in primary care: A systematic review of the evidence.

BACKGROUND AND OBJECTIVES: In Australia, mortality rates for hepatocellular carcinoma (HCC) are rising. Targeted surveillance is recommended to increase early diagnosis. The aim of this study was to synthesise evidence regarding HCC surveillance in primary care and identify barriers and facilitators to surveillance. METHOD: A systematic review was performed, with searches conducted in five biomedical databases, the Centre for Reviews and Dissemination website and the grey literature. Study quality was assessed using the National Institute for Heath and Care Excellence (NICE) quality appraisal checklists. RESULTS: In all, 32 studies, focusing on viral hepatitis and cirrhosis patients, were included in the review. HCC surveillance rates were lower for patients managed by primary care providers (PCPs) than for those managed by gastroenterologists/hepatologists. HCC surveillance rates increased when additional support was provided to PCPs (eg reminder systems, nurse follow-up). Key barriers were a lack of awareness of HCC risks and surveillance recommendations, as well as competing priorities PCPs must address when working with patients with multimorbidity. DISCUSSION: HCC surveillance programs in primary care should be accompanied by additional support for PCPs and strategies to increase awareness of clinical recommendations.

Failure to follow up abnormal test results associated with cervical cancer in primary and ambulatory care: a systematic review.

BACKGROUND: Cervical cancer is a preventable and treatable form of cancer yet continues to be the fourth most common cancer among women globally. Primary care is the first point of contact most patients have with health services and is where most cancer prevention and early detection occur. Inadequate follow-up of abnormal test results for cervical abnormalities in primary care can lead to suboptimal patient outcomes including higher mortality and decreased quality of life. AIMS: To explore the magnitude of and factors associated with, inadequate follow-up of test results for cervical abnormalities in primary and ambulatory care. METHODS: MEDLINE, Embase, Cochrane Library and CINAHL were searched for peer-reviewed literature from 2000-2022, excluding case-studies, grey literature, and systematic reviews. Studies were included if they reported on patients aged ≥ 18 years with no previous cancer diagnosis, in a primary care/ambulatory setting. Risk of bias was assessed using the Joanna Briggs Institute Critical appraisal checklists, appropriate to the study design. A segregated methodology was used to perform a narrative synthesis, maintaining the distinction between quantitative and qualitative research. RESULTS: We included 27 publications reporting on 26 studies in our review; all were conducted in high-income countries. They included 265,041 participants from a variety of ambulatory settings such as family medicine, primary care, women's services, and colposcopy clinics. Rates of inadequate follow-up ranged from 4 to 75%. Studies reported 41 different factors associated with inadequate follow-up. Personal factors associated with inadequate follow-up included younger age, lower education, and socioeconomic status. Psychological factors were reported by only 3/26 studies and 2/3 found no significant association. System protective factors included the presence of a regular primary care provider and direct notification of abnormal test results. DISCUSSION: This review describes inadequate follow-up of abnormal cervical abnormalities in primary care. Prevalence varied and the evidence about causal factors is unclear. Most interventions evaluated were effective in decreasing inadequate follow-up. Examples of effective interventions were appointment reminders via telephone, direct notification of laboratory results, and HPV self-sampling. Even though rates of cervical cancer have decreased over the years, there is a lack of information on factors affecting follow-up in primary care and ambulatory settings, particularly in low and middle-income countries. This information is crucial if we are to achieve WHO's interim targets by 2030, and hope to avert 62 million cervical cancer deaths by 2120. TRIAL REGISTRATION: PROSPERO ID CRD42021250136.

Designing a decision aid for cancer prevention: a qualitative study.

OBJECTIVES: Australian guidelines recommend people aged 50-70 years old consider taking low-dose aspirin to reduce their risk of colorectal cancer. The aim was to design sex-specific decision aids (DAs) with clinician and consumer input, including expected frequency trees (EFTs) to communicate the risks and benefits of taking aspirin. METHODS: Semi-structured interviews were conducted with clinicians. Focus groups were conducted with consumers. The interview schedules covered ease of comprehension, design, potential effects on decision-making, and approaches to implementation of the DAs. Thematic analysis was employed; independent coding by 2 researchers was inductive. Themes were developed through consensus between authors. RESULTS: Sixty-four clinicians were interviewed over 6 months in 2019. Twelve consumers aged 50-70 years participated in two focus groups in February and March 2020. The clinicians agreed that the EFTs would be helpful to facilitate a discussion with patients but suggested including an additional estimate of the effects of aspirin on all-cause mortality. The consumers felt favourable about the DAs and suggested changes to the design and wording to ease comprehension. CONCLUSION: DAs were designed to communicate the risks and benefits of low-dose aspirin for disease prevention. The DAs are currently being trialled in general practice to determine their impact on informed decision-making and aspirin uptake.

Aspirin can help to prevent bowel cancer up by to 25% and the chances of dying from it by up to 33%. Australian guidelines recommend that people aged 50­70 years old to consider taking low-dose aspirin to reduce their risk of bowel cancer. To encourage GPs and their patients to discuss the guidelines, we designed a brochure called a decision aid with the help of clinicians and people in the community of Victoria, Australia. The decision aid covered the benefits and risks of taking aspirin. Clinicians participated in interviews and provided feedback on the statistics presented in a chart called an expected frequency tree. People in the community participated in group discussions and improved the design and comprehension of the decision aid. The clinicians and people who participated in this study do not fully represent the diversity of the Australian population, as they were mostly white and highly educated. We are now testing if the decision aid is effective for supporting a discussion between patients and general practitioners, helping their patients make an informed decision about taking aspirin, and whether it encourages them to take aspirin daily after being shown the decision aid in general practice.

The Colorectal cancer RISk Prediction (CRISP) trial: a randomised controlled trial of a decision support tool for risk-stratified colorectal cancer screening.

BACKGROUND: A risk-stratified approach to colorectal cancer (CRC) screening could result in a more acceptable balance of benefits and harms, and be more cost-effective. AIM: To determine the effect of a consultation in general practice using a computerised risk assessment and decision support tool (Colorectal cancer RISk Prediction, CRISP) on risk-appropriate CRC screening. DESIGN AND SETTING: Randomised controlled trial in 10 general practices in Melbourne, Australia, from May 2017 to May 2018. METHOD: Participants were recruited from a consecutive sample of patients aged 50-74 years attending their GP. Intervention consultations included CRC risk assessment using the CRISP tool and discussion of CRC screening recommendations. Control group consultations focused on lifestyle CRC risk factors. The primary outcome was risk-appropriate CRC screening at 12 months. RESULTS: A total of 734 participants (65.1% of eligible patients) were randomised (369 intervention, 365 control); the primary outcome was determined for 722 (362 intervention, 360 control). There was a 6.5% absolute increase (95% confidence interval [CI] = -0.28 to 13.2) in risk-appropriate screening in the intervention compared with the control group (71.5% versus 65.0%; odds ratio [OR] 1.36, 95% CI = 0.99 to 1.86, P = 0.057). In those due CRC screening during follow-up, there was a 20.3% (95% CI = 10.3 to 30.4) increase (intervention 59.8% versus control 38.9%; OR 2.31, 95% CI = 1.51 to 3.53, P<0.001) principally by increasing faecal occult blood testing in those at average risk. CONCLUSION: A risk assessment and decision support tool increases risk-appropriate CRC screening in those due screening. The CRISP intervention could commence in people in their fifth decade to ensure people start CRC screening at the optimal age with the most cost-effective test.

The nature and impact of patient and public involvement in cancer prevention, screening and early detection research: A systematic review.

Patient and public involvement can produce high-quality, relevant research that better addresses the needs of patients and their families. This systematic review investigated the nature and impact of patient and public involvement in cancer prevention, screening and early detection research. Two patient representatives were involved as members of the review team. Databases (Medline, EMBASE, Emcare, Involve Evidence Library) were searched for English-language studies published 1995-March 2022. Titles/abstracts were screened by two reviewers independently. For eligible studies, data were extracted on study characteristics, patient and public involvement (who, when, how, and impact on research outcomes), and reporting quality using the Guidance for Reporting Involvement of Patients and the Public 2-Short Form. Of 4095 articles screened, 58 were eligible. Most research was from the United States (81%) and examined cancer screening or prevention (82%). Community members/organisations/public were the most involved (71%); fewer studies involved patients and/or carers (14%). Over half reported a high-level of involvement (i.e. partner and/or expert involvement), although this declined in later stages of the research cycle, e.g. data analysis. Common positive impacts included improved study design, research methods and recruitment, although most papers (62%) did not describe methods to determine impact. Reporting quality was sub-optimal, largely due to failure to consider challenges. This review found that high-level involvement of patients and the public in cancer prevention, screening and early detection research is feasible and has several advantages. However, improvements are needed to encourage involvement across the research cycle, and in evaluating and reporting its impact.

General practice-based cancer research publications: a bibliometric analysis 2013-2019.

BACKGROUND: General practice plays a critical role in the prevention, diagnosis, management, and survivorship care of patients with cancer. Mapping research outputs over time provides valuable insights into the evolving role of general practice in cancer care. AIM: To describe and compare the distribution of cancer in general practice research publications by country, cancer type, area of the cancer continuum, author sex, and journal impact factor. DESIGN AND SETTING: A bibliometric analysis using a systematic approach to identify publications. METHOD: MEDLINE and Embase databases were searched for studies published between 2013 and 2019, which reported on cancer in general practice. Included studies were mapped to the cancer continuum framework. Descriptive statistics were used to present data from the included studies. RESULTS: A total of 2798 publications were included from 714 journals, spanning 79 countries. The publication rate remained stable over this period. Overall, the US produced the most publications (n = 886, 31.7%), although, per general population capita, Denmark produced nearly 10 times more publications than the US (20.0 publications per million compared with 2.7 publications per million). Research across the cancer continuum varied by country, but, overall, most studies focused on cancer screening, diagnosis, and survivorship. More than half of included studies used observational study designs (n = 1523, 54.4%). Females made up 66.5% (n = 1304) of first authors, but only 47.0% (n = 927) of last authors. CONCLUSION: Cancer in general practice is a stable field where research is predominantly observational. There is geographical variation in the focus of cancer in general practice research, which may reflect different priorities and levels of investment between countries. Overall, these results support future consideration of how to improve under-represented research areas and the design, conduct, and translation of interventional research.

The SYMPTOM-upper gastrointestinal study: A mixed methods study exploring symptom appraisal and help-seeking in Australian upper gastrointestinal cancer patients.

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.

Time to diagnosis and treatment of lung cancer: A systematic overview of risk factors, interventions and impact on patient outcomes.

Over half of patients with lung cancer are diagnosed at a stage when curative treatment is not possible, suggesting an earlier diagnosis could improve outcomes. This comprehensive overview summarises the evidence on 1) times to diagnosis and treatment, 2) their impact on patient outcomes, 3) risk factors and 4) interventions to reduce time intervals, and 5) key methodological issues in such studies. Eligible articles were relevant systematic or scoping reviews and meta-analyses, searched via PubMed, Embase, Web of Science, and Cochrane Library; published from database inception to 6 August 2020 (PROSPERO identifier: CRD42020203530). A total of 18 systematic and scoping reviews were included. Times to diagnosis and treatment significantly varied and were often longer than recommended in international guidelines. Results regarding the impact of time intervals on survival or tumour stage indicated mixed associations (positive, negative, or no); in each review, however, more studies reported either no or negative association. Risk factors were considerable, categorized at the disease, patient, healthcare provider and system levels. Interventions including fast-access diagnosis programs, patient navigation and multidisciplinary strategies were effective in reducing times to diagnosis and treatment. Methodological issues included large variations in interval definitions and summary measures, lack of addressing an important potential source of bias-the "waiting time paradox"-and few studies of trends over time of these intervals. The current evidence indicates that patients with lung cancer experience diagnosis and treatment delays given guidelines' recommendations, but there are inconsistent findings about the association between times to diagnosis and treatment and patient outcomes. This is partially due to variations in definitions of time intervals, and limitations in analytic approaches that fail to account for a potential waiting time paradox. The identified risk factors and effective interventions demonstrate the potential for improvements in addressing diagnostic and treatment delays, regionally and globally.

Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19.

BACKGROUND: Many non-COVID-19 trials were disrupted in 2020 and either struggled to recruit participants or stopped recruiting altogether. In December 2019, just before the pandemic, we were awarded a grant to conduct a randomised controlled trial, the Should I Take Aspirin? (SITA) trial, in Victoria, the Australian state most heavily affected by COVID-19 during 2020. MAIN BODY: We originally modelled the SITA trial recruitment method on previous trials where participants were approached and recruited in general practice waiting rooms. COVID-19 changed the way general practices worked, with a significant increase in telehealth consultations and restrictions on in person waiting room attendance. This prompted us to adapt our recruitment methods to this new environment to reduce potential risk to participants and staff, whilst minimising any recruitment bias. We designed a novel teletrial model, which involved calling participants prior to their general practitioner appointments to check their eligibility. We delivered the trial both virtually and face-to-face with similar overall recruitment rates to our previous studies. CONCLUSION: We developed an effective teletrial model which allowed us to complete recruitment at a high rate. The teletrial model is now being used in our other primary care trials as we continue to face the impacts of the COVID-19 pandemic.

An RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases: a study protocol for the SITA (Should I Take Aspirin?) trial.

BACKGROUND: Australian guidelines recommend that all people aged 50-70 years old actively consider taking daily low-dose aspirin (100-300 mg per day) for 2.5 to 5 years to reduce their risk of colorectal cancer (CRC). Despite the change of national CRC prevention guidelines, there has been no active implementation of the guidelines into clinical practice. We aim to test the efficacy of a health consultation and decision aid, using a novel expected frequency tree (EFT) to present the benefits and harms of low dose aspirin prior to a general practice consultation with patients aged 50-70 years, on informed decision-making and uptake of aspirin. METHODS: Approximately five to seven general practices in Victoria, Australia, will be recruited to participate. Patients 50-70 years old, attending an appointment with their general practitioner (GP) for any reason, will be invited to participate in the trial. Two hundred fifty-eight eligible participants will be randomly allocated 1:1 to intervention or active control arms using a computer-generated allocation sequence stratified by general practice, sex, and mode of trial delivery (face-to-face or teletrial). There are two co-primary outcomes: informed decision-making at 1-month post randomisation, measured by the Multi-dimensional Measure of Informed Choice (MMIC), and self-reported daily use of aspirin at 6 months. Secondary outcomes include decisional conflict at 1-month and other behavioural changes to reduce CRC risk at both time points. DISCUSSION: This trial will test the efficacy of novel methods for implementing national guidelines to support informed decision-making about taking aspirin in 50-70-year-olds to reduce the risk of CRC and other chronic diseases. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001003965 . Registered on 10 October 2020.

Clinicians' opinions on recommending aspirin to prevent colorectal cancer to Australians aged 50-70 years: a qualitative study.

OBJECTIVES: Australian guidelines recommend all adults aged 50-70 years old without existing contraindications consider taking low-dose aspirin (100-300 mg per day) for at least 2.5 years to reduce their risk of developing colorectal cancer. We aimed to explore clinicians' practices, knowledge, opinions, and barriers and facilitators to the implementation of these new guidelines. METHODS: Semistructured interviews were conducted with clinicians to whom the new guidelines may be applicable (Familial Cancer Clinic staff (geneticists, oncologists and genetic counsellors), gastroenterologists, pharmacists and general practitioners (GPs)). The Consolidated Framework for Implementation Research (CFIR) underpinned the development of the interview guide. Coding was inductive and themes were developed through consensus between the authors. Emerging themes were mapped onto the CFIR domains: characteristics of the intervention, outer setting, inner setting, individual characteristics and process. RESULTS: Sixty-four interviews were completed between March and October 2019. Aspirin was viewed as a safe and cheap option for cancer prevention. GPs were considered by all clinicians as the most important health professionals for implementation of the guidelines. Cancer Council Australia, as a trusted organisation, was an important facilitator to guideline adoption. Uncertainty about aspirin dosage and perceived strength of the evidence, precise wording of the recommendation, previous changes to guidelines about aspirin and conflicting findings from trials in older populations were barriers to implementation. CONCLUSION: Widespread adoption of these new guidelines could be an important strategy to reduce the incidence of bowel cancer, but this will require more active implementation strategies focused on primary care and the wider community. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12620001003965).