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.

Experiences of Patient-Led Surveillance, Including Patient-Performed Teledermoscopy, in the MEL-SELF Pilot Randomized Controlled Trial: Qualitative Interview Study.

BACKGROUND: Current clinician-led melanoma surveillance models require frequent routinely scheduled clinic visits, with associated travel, cost, and time burden for patients. Patient-led surveillance is a new model of follow-up care that could reduce health care use such as clinic visits and medical procedures and their associated costs, increase access to care, and promote early diagnosis of a subsequent new melanoma after treatment of a primary melanoma. Understanding patient experiences may allow improvements in implementation. OBJECTIVE: This study aims to explore patients' experiences and perceptions of patient-led surveillance during the 6 months of participation in the MEL-SELF pilot randomized controlled trial. Patient-led surveillance comprised regular skin self-examination, use of a mobile dermatoscope to image lesions of concern, and a smartphone app to track and send images to a teledermatologist for review, in addition to usual care. METHODS: Semistructured interviews were conducted with patients previously treated for melanoma localized to the skin in New South Wales, Australia, who were randomized to the patient-led surveillance (intervention group) in the trial. Thematic analysis was used to analyze the data with reference to the technology acceptance model. RESULTS: We interviewed 20 patients (n=8, 40% women and n=12, 60% men; median age 62 years). Patients who were more adherent experienced benefits such as increased awareness of their skin and improved skin self-examination practice, early detection of melanomas, and opportunities to be proactive in managing their clinical follow-up. Most participants experienced difficulty in obtaining clear images and technical problems with the app. These barriers were overcome or persevered by participants with previous experience with digital technology and with effective help from a skin check partner (such as a spouse, sibling, or friend). Having too many or too few moles decreased perceived usefulness. CONCLUSIONS: Patients with melanoma are receptive to and experience benefits from patient-led surveillance using teledermoscopy. Increased provision of training and technical support to patients and their skin check partners may help to realize the full potential benefits of this new model of melanoma surveillance.

Perspectives and Experiences of Patient-Led Melanoma Surveillance Using Digital Technologies From Clinicians Involved in the MEL-SELF Pilot Randomized Controlled Trial: Qualitative Interview Study.

BACKGROUND: The growing number of melanoma patients who need long-term surveillance increasingly exceeds the capacity of the dermatology workforce, particularly outside of metropolitan areas. Digital technologies that enable patients to perform skin self-examination and send dermoscopic images of lesions of concern to a dermatologist (mobile teledermoscopy) are a potential solution. If these technologies and the remote delivery of melanoma surveillance are to be incorporated into routine clinical practice, they need to be accepted by clinicians providing melanoma care, such as dermatologists and general practitioners (GPs). OBJECTIVE: This study aimed to explore perceptions of potential benefits and harms of mobile teledermoscopy, as well as experiences with this technology, among clinicians participating in a pilot randomized controlled trial (RCT) of patient-led melanoma surveillance. METHODS: This qualitative study was nested within a pilot RCT conducted at dermatologist and skin specialist GP-led melanoma clinics in New South Wales, Australia. We conducted semistructured interviews with 8 of the total 11 clinicians who were involved in the trial, including 4 dermatologists (3 provided teledermatology, 2 were treating clinicians), 1 surgical oncologist, and 3 GPs with qualifications in skin cancer screening (the remaining 3 GPs declined an interview). Thematic analysis was used to analyze the data with reference to the concepts of "medical overuse" and "high-value care." RESULTS: Clinicians identified several potential benefits, including increased access to dermatology services, earlier detection of melanomas, reassurance for patients between scheduled visits, and a reduction in unnecessary clinic visits. However, they also identified some potential concerns regarding the use of the technology and remote monitoring that could result in diagnostic uncertainty. These included poor image quality, difficulty making assessments from a 2D digital image (even if good quality), insufficient clinical history provided, and concern that suspicious lesions may have been missed by the patient. Clinicians thought that uncertainty arising from these concerns, together with perceived potential medicolegal consequences from missing a diagnosis, might lead to increases in unnecessary clinic visits and procedures. Strategies suggested for achieving high-value care included managing clinical uncertainty to decrease the potential for medical overuse and ensuring optimal placement of patient-led teledermoscopy within existing clinical care pathways to increase the potential for benefits. CONCLUSIONS: Clinicians were enthusiastic about the potential and experienced benefits of mobile teledermoscopy; however, managing clinical uncertainty will be necessary to achieve these benefits in clinical care outside of trial contexts and minimize potential harms from medical overuse. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12616001716459; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371865.

Patients' Experiences of Using Skin Self-monitoring Apps With People at Higher Risk of Melanoma: Qualitative Study.

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.

Using an electronic self-completion tool to identify patients at increased risk of melanoma in Australian primary care.

BACKGROUND/OBJECTIVES: Some international guidelines recommend a risk-based approach to screening for melanoma, but few suggest how to account for multiple risk factors or how to implement risk-based screening in practice. This study investigated the acceptability and feasibility of identifying patients at increased risk of melanoma in Australian general practice using a self-completed risk assessment tool. Stratification of risk was based on the validated Williams melanoma risk prediction model. METHODS: Patients and companions aged 18 or older in Australian general practices were approached in the waiting room and invited to enter information about their melanoma risk factors into the tool using an iPad. Acceptability was measured by the proportion of people willing to participate from those invited and feasibility by the number of people able to complete the tool unaided. Risk of developing melanoma was stratified into four risk categories using the Williams model. RESULTS: 1535 (90.4%) participants were recruited from two general practices. Only 200 participants (13%) needed assistance to complete the tool. The mean risk score for participants was 15.2 (±SD 9.8). The Williams model estimated between 5% and 19% of the sample were at increased risk accounting for an estimated 30% to 60% of future incident melanomas. CONCLUSIONS: A risk-stratified tool using the Williams model was acceptable and feasible for patients to self-complete in general practice clinics. This could be an effective way to identify people in primary care for implementing risk-based targeted melanoma screening and prevention.

The Chest Australia Trial: a randomised controlled trial of an intervention to increase consultation rates in smokers at risk of lung cancer.

BACKGROUND: International research has focused on screening and mass media campaigns to promote earlier patient presentation and detect lung cancer earlier. This trial tested the effect of a behavioural intervention in people at increased risk of lung cancer on help-seeking for respiratory symptoms. METHODS: Parallel, individually randomised controlled trial. Eligible participants were long-term smokers with at least 20 pack-years, aged 55 and above. The CHEST intervention entailed a consultation to discuss and implement a self-help manual, followed by self-monitoring reminders to encourage help-seeking for respiratory symptoms. The control group received a brief discussion about lung health. Both groups had baseline spirometry. Telephone randomisation was conducted, 1:1, stratified Medical Research Council (MRC) dyspnoea score and general practice. Participants could not be blinded; data extraction and statistical analyses were performed blinded to group assignment. The primary outcome was respiratory consultation rates. RESULTS: We randomised 551 participants (274 intervention, 277 control) from whom the primary outcome was determined for 542 (269 intervention, 273 control). There was a 40% relative increase in respiratory consultations in the intervention group: (adjusted rates (95% CI) intervention 0.57 (0.47 to 0.70), control 0.41 (0.32 to 0.52), relative rate 1.40 (1.08 to 1.82); p=0.0123). There were no significant differences in time to first respiratory consultation, total consultation rates or measures of psychological harm. The incremental cost-effectiveness ratio was $A1289 per additional respiratory consultation. CONCLUSIONS: A behavioural intervention can significantly increase consulting for respiratory symptoms in patients at increased risk of lung cancer. This intervention could have an important role in primary care as part of a broader approach to improve respiratory health in patients at higher risk. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trial Registry (1261300039 3752). This was registered pre-results.

Reducing barriers to consulting a General Practitioner in patients at increased risk of lung cancer: a qualitative evaluation of the CHEST Australia intervention.

Background: Lung cancer has one of the lowest survival outcomes of any cancer because over two-thirds of patients are diagnosed when curative treatment is no longer possible, partly due to later presentation with symptoms to a healthcare provider. Objective: To explore the theoretical underpinning of the Scottish CHEST intervention in participants randomized to the intervention group within the CHEST Australia trial. Methods: A purposive maximum variation sample of participants who received the intervention in the CHEST trial in Perth, Western Australia (N = 13) and Melbourne, Victoria, (N = 7) were interviewed. Patients were asked about their experience of the CHEST consultation, their recall of the main messages, their symptom appraisal and issues relating to help seeking when they develop symptoms. Thematic analysis was conducted to draw common themes between the participants. Results: We identified themes consistent with the theoretical basis of the CHEST intervention. Barriers to consultation identified in the CHEST Australia trial participants were smoker stigmatization, guilt, fatalism and symptom normalization. We identified a general perceived mistrust of GPs based on previous negative experiences of visiting their GP in relation to their smoking. The intervention tackled barriers around lecturing and feelings of guilt and stigma related to smoking. We identified expected effects on salience and personal relevance of symptoms. Participants reported a clearer understanding of what to look out for and when to take action after the CHEST intervention. Conclusions: These findings suggest that the CHEST Australia intervention is achieving the desired objectives at the qualitative level through the proposed theoretical mechanisms.

Health outcomes of school-aged children conceived using donor sperm.

The use of donor sperm is increasing, yet limited information is available about the health and development of children conceived from donor sperm. This retrospective descriptive study aimed to assess health and development in a cohort of school-aged children who were conceived using donor sperm. Participants included 224 children, aged 5-11 years, who were conceived using donor sperm. Participants' mothers completed a questionnaire comprising validated scales examining their child's current and past physical, psychosocial and mental health, healthcare needs and child development, as well as the mothers' health and wellbeing. At the conclusion of the study, the response rate was 296 out of 407 (72.7%), with a participation rate of 224 out o 407 (55.0%). Compared with the normative Australian population, sperm donor-conceived children had similar physical, psychosocial and mental health and development. A modest increase in healthcare needs was evident. The study concludes that in school-aged children conceived using donor sperm, most aspects of child health and wellbeing are similar to the general population.

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer.

OBJECTIVES: To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer. PATIENTS AND METHODS: Men who had completed treatment for low- to moderate-risk prostate cancer within the previous 8 weeks were eligible. Participants were randomized to usual care or shared care. Shared care entailed substituting two hospital visits with three visits in primary care, a survivorship care plan, recall and reminders, and screening for distress and unmet needs. Outcome measures included psychological distress, prostate cancer-specific quality of life, satisfaction and preferences for care and healthcare resource use. RESULTS: A total of 88 men were randomized (shared care n = 45; usual care n = 43). There were no clinically important or statistically significant differences between groups with regard to distress, prostate cancer-specific quality of life or satisfaction with care. At the end of the trial, men in the intervention group were significantly more likely to prefer a shared care model to hospital follow-up than those in the control group (intervention 63% vs control 24%; P<0.001). There was high compliance with prostate-specific antigen monitoring in both groups. The shared care model was cheaper than usual care (shared care AUS$1411; usual care AUS$1728; difference AUS$323 [plausible range AUS$91-554]). CONCLUSION: Well-structured shared care for men with low- to moderate-risk prostate cancer is feasible and appears to produce clinically similar outcomes to those of standard care, at a lower cost.

Protocol for the CHEST Australia Trial: a phase II randomised controlled trial of an intervention to reduce time-to-consult with symptoms of lung cancer.

INTRODUCTION: Lung cancer is the most common cancer worldwide, with 1.3 million new cases diagnosed every year. It has one of the lowest survival outcomes of any cancer because over two-thirds of patients are diagnosed when curative treatment is not possible. International research has focused on screening and community interventions to promote earlier presentation to a healthcare provider to improve early lung cancer detection. This paper describes the protocol for a phase II, multisite, randomised controlled trial, for patients at increased risk of lung cancer in the primary care setting, to facilitate early presentation with symptoms of lung cancer. METHODS/ANALYSIS: The intervention is based on a previous Scottish CHEST Trial that comprised of a primary-care nurse consultation to discuss and implement a self-help manual, followed by self-monitoring reminders to improve symptom appraisal and encourage help-seeking in patients at increased risk of lung cancer. We aim to recruit 550 patients from two Australian states: Western Australia and Victoria. Patients will be randomised to the Intervention (a health consultation involving a self-help manual, monthly prompts and spirometry) or Control (spirometry followed by usual care). Eligible participants are long-term smokers with at least 20 pack years, aged 55 and over, including ex-smokers if their cessation date was less than 15 years ago. The primary outcome is consultation rate for respiratory symptoms. ETHICS AND DISSEMINATION: Ethical approval has been obtained from The University of Western Australia's Human Research Ethics Committee (RA/4/1/6018) and The University of Melbourne Human Research Committee (1 441 433). A summary of the results will be disseminated to participants and we plan to publish the main trial outcomes in a single paper. Further publications are anticipated after further data analysis. Findings will be presented at national and international conferences from late 2016. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trial Registry ACTRN 1261300039 3752.