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.

Hospitalisation in high-risk pregnancy patients: is prenatal attachment affected?

Objective: To compare prenatal attachment in women hospitalised due to high-risk pregnancy with prenatal attachment in non-hospitalised patients. To describe the impact of social support, socio-demographic factors and the nature of the pregnancy on prenatal attachment, anxiety and depression. Study Design: An exploratory, cross-sectional and descriptive study utilising the Maternal Antenatal Attachment Scale, the Edinburgh Postnatal Depression Scale and the State-Trait Anxiety Inventory. The sample comprised 80 hospitalised and 88 non-hospitalised patients. Result: No difference in prenatal attachment was found between the two groups. The hospitalised group presented higher levels of depressive symptomatology and anxiety. Social support had a significant effect on the hospitalised group, improving attachment quality. Conclusion: Incorporation of members of the patient's support network may help to improve quality of prenatal attachment during hospitalisation. Detection and treatment of anxiety and/or depression in hospitalised patients is recommended given their impact on the mental health of mother and baby.

Comparing the use of static versus dynamic images to evaluate a smile.

STATEMENT OF PROBLEM: Smile analysis, as part of the overall facial analysis, is an important component of diagnosis and treatment planning in the esthetic rehabilitation of a patient. Most studies that refer to smile analysis are based on static images. A more comprehensive evaluation can be made with dynamic video images that can be stopped at the most appropriate frame to ensure the best static images for analysis. PURPOSE: The purpose of this clinical study was to evaluate the posed and dynamic smiles of both sexes, considering the type of smile, prevalence of gingival display, dental display at rest, dentogingival display at posed and spontaneous smile, and lip mobility, through digital image acquisition (photographs and video clips) manipulated by using a software program. MATERIAL AND METHODS: Three photographs and 1 video clip were made for each of the 380 voluntary participants aged between 18 and 32 years by using an iPhone 6 iSight 8 MP camera, Moment lens, and artificial 5500 Kelvin light (IceLight). Digital files were evaluated by using a software program (Keynote), determining each point to be evaluated with posed and spontaneous smiles. RESULTS: With static images, 90% of women and 74% of men had gingival display, with only 35% of women and 21% of men having continuous gingival display. With dynamic analysis, these values increased to 100% of women and 95% of men having gingival display and 62% of men and 81% of women having a continuous gingival display (P<.05). The difference between dentogingival display during posed and spontaneous smiles was clear, with 68% of the participants having 2.25 mm more gingival display. Women tend to show slightly more dental display at rest, posed and spontaneous dentogingival display, as well as lip mobility, than men. CONCLUSIONS: The type of smile changes significantly when posed and spontaneous smiles are compared. Women generally show more gingiva and teeth in all the parameters evaluated than men. Dental treatments should be individually planned according to each patient's smile characteristics.

Results of a randomized controlled trial to increase cervical cancer screening among rural Latinas.

BACKGROUND: Latinas have the highest rates of cervical cancer in the United States and the second highest rate of cervical cancer mortality. One factor in the disparity is the relatively low rate of screening for cervical cancer in this population. METHODS: Eligible women who were out of adherence with cervical cancer screening (>3 years since their last Papanicolaou [Pap] test) were identified via medical record review by a federally qualified local health center. The effects of a low-intensity intervention (video delivered to participants' homes; n = 150) and a high-intensity intervention (video plus a home-based educational session; n = 146) on cervical cancer screening uptake in comparison with a control arm (usual care; n = 147) were investigated. A cost-effectiveness analysis of the interventions was conducted: all intervention costs were calculated, and the incremental cost-effectiveness ratio was computed. Finally, women with positive Pap tests were provided navigation by a community health educator to ensure that they received follow-up care. RESULTS: A total of 443 Latinas participated. Seven months after randomization, significantly more women in the high-intensity arm received a Pap test (53.4%) in comparison with the low-intensity arm (38.7%; P < .001) and the usual-care arm (34.0%; P < .01). The incremental cost-effectiveness ratio for high-intensity women versus the control group amounted to $4.24. Twelve women had positive Pap tests, which encompassed diagnoses ranging from atypical squamous cells of unknown significance to invasive cancer; these women received navigation for follow-up care. CONCLUSIONS: A culturally appropriate, in-home, promotora-led educational intervention was successful in increasing cervical cancer screening among Latinas. Cancer 2017;123:666-674. © 2016 American Cancer Society.

Development of mobile technologies for the prevention of cervical cancer in Santiago, Chile study protocol: a randomized controlled trial.

BACKGROUND: In Chile, more than 500 women die every year from cervical cancer, and a majority of Chilean women are not up-to-date with their Papanicolau (Pap) test. Mobile health has great potential in many health areas, particularly in health promotion and prevention. There are no randomized controlled trials in Latin America assessing its use in cervical cancer screening. The 'Development of Mobile Technologies for the Prevention of Cervical Cancer in Santiago, Chile' study aims to determine the efficacy of a text-message intervention on Pap test adherence among Chilean women in the metropolitan region of Santiago. METHODS/DESIGN: This study is a parallel randomized-controlled trial of 400 Chilean women aged 25-64 who are non-adherent with current recommendations for Pap test screening. Participants will be randomly assigned to (1) a control arm (usual care) or (2) an intervention arm, where text and voice messages containing information and encouragement to undergo screening will be sent to the women. The primary endpoint is completion of a Pap test within 6 months of baseline assessment, as determined by medical record review at community-based clinics. Medical record reviewers will be blinded to randomization arms. The secondary endpoint is an evaluation of the implementation and usability of the text message intervention as a strategy to improve screening adherence. DISCUSSION: This intervention using mobile technology intends to raise cervical cancer screening adherence and compliance among a Chilean population of low and middle-low socioeconomic status. If successful, this strategy may reduce the incidence of cervical cancer. TRIAL REGISTRATION: Clinicaltrials.gov NCT02376023 Registered 2/17/2015. First participant enrolled Feb 22nd 2016.

[Health and humanization Diploma: the value of reflection and face to face learning]. / Diplomado de salud y humanización: el valor de la reflexión y el aprendizaje presencial.

BACKGROUND: In a rapidly changing culture like ours, with emphasis on productivity, there is a strong need to find the meaning of health care work using learning instances that privilege reflection and face to face contact with others. The Diploma in Health and Humanization (DSH), was developed as an interdisciplinary space for training on issues related to humanization. AIM: To analyze the experience of DSH aiming to identify the elements that students considered key factors for the success of the program. MATERIAL AND METHODS: We conducted a focus group with DSH graduates, identifying factors associated with satisfaction. Transcripts were coded and analyzed by two independent reviewers. RESULTS: DSH graduates valued a safe space, personal interaction, dialogue and respect as learning tools of the DSH. They also appreciates the opportunity to have emotional interactions among students and between them and the teacher as well as the opportunity to share personal stories and their own search for meaning. DISCUSSION: DSH is a learning experience in which their graduates value the ability to think about their vocation and the affective interaction with peers and teachers. We hope to contribute to the development of face to face courses in the area of humanization. Face to face methodology is an excellent teaching technique for contents related to the meaning of work, and more specifically, to a group of learners that require affective communication and a personal connection of their work with their own values and beliefs.

Production of alginate by Azotobacter vinelandii grown at two bioreactor scales under oxygen-limited conditions.

The oxygen transfer rate (OTR) was evaluated as a scale-up criterion for alginate production in 3- and 14-L stirred fermentors. Batch cultures were performed at different agitation rates (200, 300, and 600 rpm) and airflow rates (0.25, 0.5, and 1 vvm), resulting in different maximum OTR levels (OTRmax). Although the two reactors had a similar OTRmax (19 mmol L(-1) h(-1)) and produced the same alginate concentration (3.8 g L(-1)), during the cell growth period the maximum molecular weight of the alginate was 1,250 kDa in the 3-L stirred fermentor and 590 kDa in 14-L stirred fermentor. The results showed for the first time the evolution of the molecular weight of alginate and OTR profiles for two different scales of stirred fermentors. There was a different maximum specific oxygen uptake rate between the two fermenters, reaching 8.3 mmol g(-1) h(-1) in 3-L bioreactor and 10.6 mmol g(-1) h(-1) in 14-L bioreactor, which could explain the different molecular weights observed. These findings open the possibility of using [Formula: see text] instead of OTRmax as a scaling criterion to produce polymers with similar molecular weights during fermentation.

Optimising a clinical decision support tool to improve chronic kidney disease management in general practice.

BACKGROUND: Early identification and treatment of chronic disease is associated with better clinical outcomes, lower costs, and reduced hospitalisation. Primary care is ideally placed to identify patients at risk of, or in the early stages of, chronic disease and to implement prevention and early intervention measures. This paper evaluates the implementation of a technological intervention called Future Health Today that integrates with general practice EMRs to (1) identify patients at-risk of, or with undiagnosed or untreated, chronic kidney disease (CKD), and (2) provide guideline concordant recommendations for patient care. The evaluation aimed to identify the barriers and facilitators to successful implementation. METHODS: Future Health Today was implemented in 12 general practices in Victoria, Australia. Fifty-two interviews with 30 practice staff were undertaken between July 2020 and April 2021. Practice characteristics were collected directly from practices via survey. Data were analysed using inductive and deductive qualitative analysis strategies, using Clinical Performance - Feedback Intervention Theory (CP-FIT) for theoretical guidance. RESULTS: Future Health Today was acceptable, user friendly and useful to general practice staff, and supported clinical performance improvement in the identification and management of chronic kidney disease. CP-FIT variables supporting use of FHT included the simplicity of design and delivery of actionable feedback via FHT, good fit within existing workflow, strong engagement with practices and positive attitudes toward FHT. Context variables provided the main barriers to use and were largely situated in the external context of practices (including pressures arising from the COVID-19 pandemic) and technical glitches impacting installation and early use. Participants primarily utilised the point of care prompt rather than the patient management dashboard due to its continued presence, and immediacy and relevance of the recommendations on the prompt, suggesting mechanisms of compatibility, complexity, actionability and credibility influenced use. Most practices continued using FHT after the evaluation phase was complete. CONCLUSIONS: This study demonstrates that FHT is a useful and acceptable software platform that provides direct support to general practice in identifying and managing patients with CKD. Further research is underway to explore the effectiveness of FHT, and to expand the conditions on the platform.

Should I Take Aspirin? (SITA): randomised controlled trial of a decision aid for cancer chemoprevention.

BACKGROUND: Australian guidelines recommend that people aged 50-70 years consider taking low-dose aspirin to reduce their risk of colorectal cancer (CRC). AIM: To determine the effect of a consultation with a researcher before an appointment in general practice using a decision aid presenting the benefits and harms of taking low-dose aspirin compared with a general CRC prevention brochure on patients' informed decision making and low-dose aspirin use. DESIGN AND SETTING: Individually randomised controlled trial in six general practices in Victoria, Australia, from October 2020 to March 2021. METHOD: Participants were recruited from a consecutive sample of patients aged 50-70 years attending a GP. The intervention was a consultation using a decision aid to discuss taking aspirin to reduce CRC risk while control consultations discussed reducing CRC risk generally. Self-reported co-primary outcomes were the proportion of individuals making informed choices about taking aspirin at 1 month and on low-dose aspirin uptake at 6 months, respectively. The intervention effect was estimated using a generalised linear model and reported with Bonferroni-adjusted 95% confidence intervals (CIs) and P-values. RESULTS: A total of 261 participants (86% of eligible patients) were randomised into trial arms (n = 129 intervention; n = 132 control). Of these participants, 17.7% (n = 20/113) in the intervention group and 7.6% (n = 9/118) in the control group reported making an informed choice about taking aspirin at 1 month, an estimated 9.1% (95% CI = 0.29 to 18.5) between-arm difference in proportions (odds ratio [OR] 2.47, 97.5% CI = 0.94 to 6.52, P = 0.074). The proportions of individuals who reported taking aspirin at 6 months were 10.2% (n = 12/118) of the intervention group versus 13.8% (n = 16/116) of the control group, an estimated between-arm difference of -4.0% (95% CI = -13.5 to 5.5; OR 0.68 [97.5% CI = 0.27 to 1.70, P = 0.692]). CONCLUSION: The decision aid improved informed decision making but this did not translate into long-term regular use of aspirin to reduce CRC risk. In future research, decision aids should be delivered alongside various implementation strategies.

Perceptions of primary care patients on the use of electronic clinical decision support tools to facilitate health care: A systematic review.

OBJECTIVE: Electronic clinical decision support tools (eCDSTs) are interventions designed to facilitate clinical decision-making using targeted medical knowledge and patient information. While eCDSTs have been demonstrated to improve quality of care, there is a paucity of research relating to the acceptability of eCDSTs in primary care from the patients' perspective. This study aims to summarize current evidence relating to primary care patients' perceptions and experiences on the use of eCDSTs by their clinician to provide care. METHODS: Four databases (Medline, Embase, CINAHL and Cochrane Library) were searched for qualitative and quantitative studies with outcomes relating to patients' perceptions of the use of clinician-facing or shared-eCDSTs. Data extraction and critical appraisal using the Johanna Briggs Institute Critical Appraisal checklists were carried out independently by reviewers. Qualitative and quantitative outcomes were synthesized independently. We used Richardson et al. 'Patient Evaluation of Artificial Intelligence (AI) in Healthcare' framework for qualitative analysis. FINDINGS: 20 papers were included for synthesis. eCDSTs were generally well-regarded by patients. The key facilitators for use were promoting informed decision-making, prompting discussions, aiding clinical decision-making, and enabling information sharing. Key barriers for use were lack of holistic care, 'medicalized' language, and confidentiality concerns. CONCLUSION: Our study identified important aspects to consider in the development of future eCDSTs. Patients were generally positive regarding the use of eCDSTs; however, patient's perspectives should be included from the conception of new eCDSTs to ensure recommendations align with the needs of patients and clinicians. PRACTICE IMPLICATIONS: The study results contribute to ensuring the acceptability of eCDSTs for patients and their unique needs. Encouragement is given for future development to adopt and build upon these findings. Additional research focusing on patients' perceptions of using eCDSTs for specific health conditions is deemed necessary.

Increasing bowel cancer screening using SMS in general practice: the SMARTscreen cluster randomised trial.

BACKGROUND: Australia has one of the highest incidences of colorectal cancer (CRC) worldwide. The Australian National Bowel Cancer Screening Program (NBCSP) is a best-practice, organised screening programme, but uptake is low (40.9%) and increasing participation could reduce morbidity and mortality associated with CRC. Endorsement by GPs is strongly associated with increasing screening uptake. AIM: This study (SMARTscreen) aimed to test whether a multi-intervention short message service (SMS) sent by general practices to 50-60-year-old patients who were due to receive the NBCSP kit would increase NBCSP uptake, by comparing it with usual care. DESIGN AND SETTING: A stratified cluster randomised controlled trial was undertaken, involving 21 Australian general practices in Western Victoria, Australia. METHOD: For intervention practices, people due to receive the NBCSP kit within a 6-month study period were sent an SMS just before receiving the kit. The SMS included a personalised message from the person's general practice endorsing the kit, a motivational narrative video, an instructional video, and a link to more information. Control practices continued with usual care, comprising at-home testing with a faecal immunochemical test (FIT) through the NBCSP. The primary outcome was the between-arm percentage difference in uptake of FIT screening within 12 months from randomisation, which was estimated using generalised linear model regression. RESULTS: In total, 39.2% (1143/2914) of people in 11 intervention practices and 23.0% (583/2537) of people in 10 control practices had a FIT result in their electronic health records - a difference of 16.5% (95% confidence interval = 2.02 to 30.9). CONCLUSION: The SMS intervention increased NBCSP kit return in 50-60-year-old patients in general practice. This finding informed a larger trial - SMARTERscreen - to test this intervention in a broader Australian population.

A scoping review of unexpected weight loss and cancer: risk, guidelines, and recommendations for follow-up in primary care.

BACKGROUND: Cancer diagnoses often begin with consultations with general practitioners (GPs), but the nonspecific nature of symptoms can lead to delayed diagnosis. Unexpected weight loss (UWL) is a common nonspecific symptom linked to undiagnosed cancer, yet guidelines for its diagnostic assessment in general practice lack consistency. AIM: To synthesise evidence on the association between UWL and cancer diagnosis, and to review clinical guidelines and recommendations for assessing patients with UWL. DESIGN AND SETTINGS: Systematic search and analysis of studies conducted in primary care. METHOD: Four databases searched for peer-reviewed literature from 2012 to 2023. Two reviewers conducted all the steps. A narrative review was conducted detailing the evidence for UWL as a risk factor for undiagnosed cancer, existing clinical guidance, and recommended diagnostic approach. RESULTS: We included 25 studies involving 916,092 patients; 92% provided strong evidence of an association between UWL and undiagnosed cancer. The National Institute for Health Care and Excellence Cancer Guideline in the UK was frequently cited. General suggestions encompassed regular weight monitoring, family history, risk factor evaluation, additional signs and symptoms, and a comprehensive physical examination. Commonly recommended pathology tests included C-reactive protein, complete blood count, alkaline phosphatase, and thyroid-stimulating hormone. Immunochemical faecal occult blood test, abdominal ultrasound, and chest X-ray were also prevalent. One large cohort study provided age, sex, and differential diagnosis-specific recommendations. CONCLUSION: This evidence review informs recommendations for investigating patients with UWL and will contribute to a computer decision support tool implementation in primary care, enhancing UWL assessment and potentially facilitating earlier cancer diagnosis.

Plans to obtain a mammogram among Chilean women: the roles of recommendations and self-efficacy.

Social factors may heavily influence cancer screening decisions and practices among Latinas, given the importance their culture places on close, interpersonal relationships. Recommendations by healthcare providers, family and friends have been associated with early detection strategies among US-based Latina populations, but little is known about other Latin American populations. Furthermore, less is known about mechanisms underlying this relationship. In this study, we sought to (i) understand if different types of recommendations were associated with subsequent plans to obtain a mammogram and (ii) assess the potential mediating roles of perceived importance of these recommendations and self-efficacy. Our sample included 250 women residing in a low-income, urban area of Santiago, Chile, and who had participated in a 6-month intervention to increase mammography screening, but remained non-compliant. Women who received family recommendations were more likely to indicate they planned to receive a mammogram in the next 6 months. Perceived self-efficacy mediated this relationship, such that women who received a family recommendation appeared to be more likely to plan to get a mammogram because of increased perceived capabilities to do so. Future research should consider the cultural context of family and self-efficacy in the development of screening interventions for Latinas.

"Appagalo" a Customized Mobile Health Intervention (mHealth) for Smoking Cessation in Women: A Randomized Controlled Trial.

BACKGROUND: Almost 30% of Chilean women report cigarette smoking with important repercussions on their health. OBJECTIVE: Design and test a mobile phone intervention for smoking cessation in young women. STUDY DESIGN: A mobile application (app) was created using the best available evidence and consumer input. Its effectiveness was assessed through a randomized clinical trial. STUDY PARTICIPANTS: Women 18 to 44 years old from middle-class neighborhoods in Santiago, Chile. Inclusion criteria were intention to quit cigarette smoking in the following month and having a smartphone cell phone. Women with positive screening for risky alcohol consumption were excluded. INTERVENTION: App with content to support cigarette smoking cessation over 6 months. The control arm included an app that delivered general messages to promote permanence in the study. Telephone follow-up was performed at 6 weeks, and at 3 and 6 months after randomization. MAIN OUTCOME MEASURE: No smoking in the past 7 days at 6 weeks from enrolment. Intention-to-treat analysis was carried out using SPSS 17.0 with a significance level set at .05. RESULTS: 309 women entered the study. Mean number of cigarettes smoked in a day was 8.8. 58.6% of the participants (n = 181) completed the follow-up for the primary outcome. With intention-to-treat analysis, 9.7% of participants in the intervention group reported not having smoked any cigarettes in the last 7 days vs 3.2% in the control group (RR 2.98 CI 95% 1.11-8.0, P = .022). Additionally, 12.3% vs 1.9% of the participants in the intervention group and control group reported continuous abstinence at 6 weeks, respectively (RR 6.29 95% CI 1.9-20.8, P < .001). Continuous abstinence was also significant at 6 months (P-value of .036). CONCLUSIONS: The "Appagalo" app is an effective tool to support smoking cessation in young women. It is a simple mHealth alternative for smoking cessation that can contribute to improving women's health in the Americas and worldwide.

Optimization of a Quality Improvement Tool for Cancer Diagnosis in Primary Care: Qualitative Study.

BACKGROUND: The most common route to a diagnosis of cancer is through primary care. Delays in diagnosing cancer occur when an opportunity to make a timely diagnosis is missed and is evidenced by patients visiting the general practitioner (GP) on multiple occasions before referral to a specialist. Tools that minimize prolonged diagnostic intervals and reduce missed opportunities to investigate patients for cancer are therefore a priority. OBJECTIVE: This study aims to explore the usefulness and feasibility of a novel quality improvement (QI) tool in which algorithms flag abnormal test results that may be indicative of undiagnosed cancer. This study allows for the optimization of the cancer recommendations before testing the efficacy in a randomized controlled trial. METHODS: GPs, practice nurses, practice managers, and consumers were recruited to participate in individual interviews or focus groups. Participants were purposively sampled as part of a pilot and feasibility study, in which primary care practices were receiving recommendations relating to the follow-up of abnormal test results for prostate-specific antigen, thrombocytosis, and iron-deficiency anemia. The Clinical Performance Feedback Intervention Theory (CP-FIT) was applied to the analysis using a thematic approach. RESULTS: A total of 17 interviews and 3 focus groups (n=18) were completed. Participant themes were mapped to CP-FIT across the constructs of context, recipient, and feedback variables. The key facilitators to use were alignment with workflow, recognized need, the perceived importance of the clinical topic, and the GPs' perception that the recommendations were within their control. Barriers to use included competing priorities, usability and complexity of the recommendations, and knowledge of the clinical topic. There was consistency between consumer and practitioner perspectives, reporting language concerns associated with the word cancer, the need for more patient-facing resources, and time constraints of the consultation to address patients' worries. CONCLUSIONS: There was a recognized need for the QI tool to support the diagnosis of cancer in primary care, but barriers were identified that hindered the usability and actionability of the recommendations in practice. In response, the tool has been refined and is currently being evaluated as part of a randomized controlled trial. Successful and effective implementation of this QI tool could support the detection of patients at risk of undiagnosed cancer in primary care and assist in preventing unnecessary delays.

The SMARTscreen Trial: a randomised controlled trial investigating the efficacy of a GP-endorsed narrative SMS to increase participation in the Australian National Bowel Cancer Screening Program.

BACKGROUND: Increasing participation in the Australian National Bowel Cancer Screening Program (NBCSP) is the most efficient and cost-effective way of reducing mortality associated with colorectal cancer by detecting and treating early-stage disease. Currently, only 44% of Australians aged 50-74 years complete the NBCSP. This efficacy trial aims to test whether this SMS intervention is an effective method for increasing participation in the NBCSP. Furthermore, a process evaluation will explore the barriers and facilitators to sending the SMS from general practice. METHODS: We will recruit 20 general practices in the western region of Victoria, Australia to participate in a cluster randomised controlled trial. General practices will be randomly allocated with a 1:1 ratio to either a control or intervention group. Established general practice software will be used to identify patients aged 50 to 60 years old who are due to receive a NBCSP kit in the next month. The SMS intervention includes GP endorsement and links to narrative messages about the benefits of and instructions on how to complete the NBCSP kit. It will be sent from intervention general practices to eligible patients prior to receiving the NBCSP kit. We require 1400 eligible patients to provide 80% power with a two-sided 5% significance level to detect a 10% increase in CRC screening participation in the intervention group compared to the control group. Our primary outcome is the difference in the proportion of eligible patients who completed a faecal occult blood test (FOBT) between the intervention and control group for up to 12 months after the SMS was sent, as recorded in their electronic medical record (EMR). A process evaluation using interview data collected from general practice staff (GP, practice managers, nurses) and patients will explore the feasibility and acceptability of sending and receiving a SMS to prompt completing a NBCSP kit. DISCUSSION: This efficacy trial will provide initial trial evidence of the utility of an SMS narrative intervention to increase participation in the NBCSP. The results will inform decisions about the need for and design of a larger, multi-state trial of this SMS intervention to determine its cost-effectiveness and future implementation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001020976 . Registered on 17 October 2020.

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.

Identifying Novel Biomarkers Ready for Evaluation in Low-Prevalence Populations for the Early Detection of Upper Gastrointestinal Cancers: A Systematic Review.

INTRODUCTION: Detecting upper gastrointestinal (GI) cancers in primary care is challenging, as cancer symptoms are common, often non-specific, and most patients presenting with these symptoms will not have cancer. Substantial investment has been made to develop biomarkers for cancer detection, but few have reached routine clinical practice. We aimed to identify novel biomarkers for upper GI cancers which have been sufficiently validated to be ready for evaluation in low-prevalence populations. METHODS: We systematically searched MEDLINE, Embase, Emcare, and Web of Science for studies published in English from January 2000 to October 2019 (PROSPERO registration CRD42020165005). Reference lists of included studies were assessed. Studies had to report on second measures of diagnostic performance (beyond discovery phase) for biomarkers (single or in panels) used to detect pancreatic, oesophageal, gastric, and biliary tract cancers. We included all designs and excluded studies with less than 50 cases/controls. Data were extracted on types of biomarkers, populations and outcomes. Heterogeneity prevented pooling of outcomes. RESULTS: We identified 149 eligible studies, involving 22,264 cancer cases and 49,474 controls. A total of 431 biomarkers were identified (183 microRNAs and other RNAs, 79 autoantibodies and other immunological markers, 119 other proteins, 36 metabolic markers, 6 circulating tumour DNA and 8 other). Over half (n = 231) were reported in pancreatic cancer studies. Only 35 biomarkers had been investigated in at least two studies, with reported outcomes for that individual marker for the same tumour type. Apolipoproteins (apoAII-AT and apoAII-ATQ), and pepsinogens (PGI and PGII) were the most promising biomarkers for pancreatic and gastric cancer, respectively. CONCLUSION: Most novel biomarkers for the early detection of upper GI cancers are still at an early stage of matureness. Further evidence is needed on biomarker performance in low-prevalence populations, in addition to implementation and health economic studies, before extensive adoption into clinical practice can be recommended.

Identifying Novel Biomarkers Ready for Evaluation in Low-Prevalence Populations for the Early Detection of Lower Gastrointestinal Cancers: A Systematic Review and Meta-Analysis.

INTRODUCTION: Lower gastrointestinal (GI) cancers are a major cause of cancer deaths worldwide. Prognosis improves with earlier diagnosis, and non-invasive biomarkers have the potential to aid with early detection. Substantial investment has been made into the development of biomarkers; however, studies are often carried out in specialist settings and few have been evaluated for low-prevalence populations. METHODS: We aimed to identify novel biomarkers for the detection of lower GI cancers that have the potential to be evaluated for use in primary care. MEDLINE, Embase, Emcare and Web of Science were systematically searched for studies published in English from January 2000 to October 2019. Reference lists of included studies were also assessed. Studies had to report on measures of diagnostic performance for biomarkers (single or in panels) used to detect colorectal or anal cancers. We included all designs and excluded studies with fewer than 50 cases/controls. Data were extracted from published studies on types of biomarkers, populations and outcomes. Narrative synthesis was used, and measures of specificity and sensitivity were meta-analysed where possible. RESULTS: We identified 142 studies reporting on biomarkers for lower GI cancers, for 24,844 cases and 45,374 controls. A total of 378 unique biomarkers were identified. Heterogeneity of study design, population type and sample source precluded meta-analysis for all markers except methylated septin 9 (mSEPT9) and pyruvate kinase type tumour M2 (TuM2-PK). The estimated sensitivity and specificity of mSEPT9 was 80.6% (95% CI 76.6-84.0%) and 88.0% (95% CI 79.1-93.4%) respectively; TuM2-PK had an estimated sensitivity of 81.6% (95% CI 75.2-86.6%) and specificity of 80.1% (95% CI 76.7-83.0%). CONCLUSION: Two novel biomarkers (mSEPT9 and TuM2-PK) were identified from the literature with potential for use in lower-prevalence populations. Further research is needed to validate these biomarkers in primary care for screening and assessment of symptomatic patients.